Document And Entity Information
Document And Entity Information | 9 Months Ended |
Sep. 30, 2023 | |
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 - USD ($) | Sep. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | |||||||
Cash and cash equivalents | $ 10,298,534 | $ 13,359,615 | $ 16,865,642 | $ 26,043,897 | $ 18,676,663 | ||
Contracts and grants receivable | 66,051 | 115,130 | 138,889 | ||||
Research and development incentives receivable, current | 22,852 | 104,198 | 103,832 | ||||
Prepaid expenses and other current assets | 584,438 | 274,209 | 282,903 | ||||
Total current assets | 10,971,875 | 13,853,152 | 26,569,521 | ||||
Security deposit | 22,777 | 22,777 | 22,777 | ||||
Office furniture and equipment, net of accumulated depreciation of $119,730 and $114,766 | 13,517 | 18,481 | 22,220 | ||||
Deferred issuance cost | 17,867 | 20,206 | 20,266 | ||||
Right-of-use lease assets | 258,487 | 340,987 | 106,155 | 222,445 | |||
Research and development incentives receivable, net of current portion | 18,306 | 24,114 | 121,238 | ||||
Other assets | 7,750 | ||||||
Total assets | 11,302,829 | 14,279,717 | 26,869,927 | ||||
Current liabilities: | |||||||
Accounts payable | 1,460,715 | 3,865,796 | 2,925,544 | ||||
Accrued expenses | 2,386,836 | 2,307,746 | 2,956,545 | ||||
Accrued compensation | 55,543 | 336,692 | 302,936 | ||||
Lease liabilities, current | 118,459 | 108,948 | 106,151 | ||||
Convertible debt, net of debt discount of $0 and $102,309 | 1,500,000 | 9,897,691 | |||||
Total current liabilities | 5,521,553 | 16,516,873 | 6,291,176 | ||||
Non-current liabilities: | |||||||
Convertible debt | 1,416,463 | 0 | 9,856,153 | ||||
Lease liabilities, net of current portion | 143,658 | 233,627 | |||||
Total liabilities | 7,081,674 | 16,750,500 | 16,147,329 | ||||
Commitments and contingencies | |||||||
Series D preferred stock, $.001 par value; 0 and 50,000 shares authorized, none issued or outstanding as of September 30, 2023 and December 31, 2022, respectively | 43 | ||||||
Shareholders' equity/(deficit): | |||||||
Preferred stock, 350,000 and 300,000 shares authorized as of September 30, 2023 and December 31, 2022, respectively; none issued or outstanding | 0 | 0 | |||||
Common stock, $.001 par value; 75,000,000 shares authorized; 10,378,238 and 2,908,578 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 10,378 | 2,909 | 2,859 | ||||
Additional paid-in capital | 228,070,740 | 217,064,964 | 216,442,904 | ||||
Accumulated other comprehensive income | 24,318 | 24,747 | 41,942 | ||||
Accumulated deficit | (223,884,281) | (219,563,446) | (205,765,107) | ||||
Total shareholders' equity/(deficit) | 4,221,155 | $ 5,800,200 | (2,470,826) | $ 1,032,002 | $ 4,205,886 | 10,722,598 | $ 3,741,828 |
Total liabilities, mezzanine equity and shareholders' equity/(deficit) | $ 11,302,829 | $ 14,279,717 | $ 26,869,927 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) | Feb. 10, 2023 | Feb. 09, 2023 | Sep. 30, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) shares |
Accumulated depreciation | $ | $ 119,730 | $ 114,766 | $ 167,848 | ||
Debt discount, current | $ | $ 0 | 102,309 | |||
Debt discount, noncurrent | $ | $ 143,847 | ||||
Preferred stock, shares authorized | 350,000 | 300,000 | 350,000 | ||
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 | |||
Common stock, shares authorized | 75,000,000 | 75,000,000 | 75,000,000 | ||
Common stock, shares issued | 10,378,238 | 2,908,578 | 2,858,244 | ||
Common stock, shares outstanding | 10,378,238 | 2,908,578 | 2,858,244 | ||
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 | |||
Subsequent Event | |||||
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 | |||
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 | |||
Temporary equity, Liquidation Preference | $ | $ 43 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Total revenues | $ 130,440 | $ 166,140 | $ 594,547 | $ 582,843 | $ 948,911 | $ 824,268 |
Cost of revenues | (110,441) | (129,440) | (520,502) | (414,957) | (550,822) | (728,640) |
Gross profit | 19,999 | 36,700 | 74,045 | 167,886 | 398,089 | 95,628 |
Operating expenses: | ||||||
Research and development | 826,015 | 1,791,695 | 2,535,165 | 5,586,302 | 7,944,089 | 8,185,850 |
General and administrative | 973,040 | 1,326,249 | 3,098,949 | 5,250,510 | 6,692,904 | 5,008,738 |
Total operating expenses | 1,799,055 | 3,117,944 | 5,634,114 | 10,836,812 | 14,636,993 | 13,194,588 |
Loss from operations | (1,779,056) | (3,081,244) | (5,560,069) | (10,668,926) | (14,238,904) | (13,098,960) |
Other income (expense): | ||||||
Foreign currency transaction gain (loss) | (3,046) | (12,613) | 310 | (26,006) | (30,549) | (39,361) |
Interest income (expense), net | 66,363 | (215,146) | (97,399) | (641,768) | (822,611) | (904,502) |
Research and development incentives | 4,729 | 17,386 | 136,981 | 132,869 | 174,770 | |
CARES Act Employee Retention Credit | 120,771 | 120,771 | ||||
Other income | 43,223 | 5,921 | 30,754 | |||
Loss on extinguishment of debt | (393,791) | 421,584 | ||||
Change in fair value of convertible debt | (72,463) | 387,537 | ||||
Total other income (expense) | 116,354 | (227,759) | 78,037 | (530,793) | (714,370) | (316,755) |
Net loss before income taxes | (1,662,702) | (3,309,003) | (5,482,032) | (11,199,719) | (14,953,274) | (13,415,715) |
Income tax benefit | 1,161,197 | 1,154,935 | 1,154,935 | 864,742 | ||
Net loss applicable to common stockholders | $ (1,662,702) | $ (3,309,003) | $ (4,320,835) | $ (10,044,784) | $ (13,798,339) | $ (12,550,973) |
Basic net loss per share (in Dollars per share) | $ (0.16) | $ (1.15) | $ (0.63) | $ (3.50) | $ (4.81) | $ (4.69) |
Diluted net loss per share (in Dollars per share) | $ (0.16) | $ (1.15) | $ (0.63) | $ (3.50) | $ (4.81) | $ (4.69) |
Basic weighted average common shares outstanding (in Shares) | 10,379,854 | 2,872,262 | 6,874,493 | 2,867,076 | 2,871,345 | 2,675,488 |
Diluted weighted average common shares outstanding (in Shares) | 10,379,854 | 2,872,262 | 6,874,493 | 2,867,076 | 2,871,345 | 2,675,488 |
Licensing revenue | ||||||
Total revenues | $ 50,000 | $ 250,000 | ||||
Contract revenue | ||||||
Total revenues | $ 33,351 | |||||
Grant revenue | ||||||
Total revenues | $ 130,440 | $ 166,140 | $ 594,547 | $ 532,843 | $ 698,911 | $ 790,917 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Parenthetical) | Feb. 10, 2023 | Feb. 09, 2023 |
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 |
Subsequent Event | ||
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Condensed Consolidated Statements of Comprehensive Loss | ||||||
Net loss | $ (1,662,702) | $ (3,309,003) | $ (4,320,835) | $ (10,044,784) | $ (13,798,339) | $ (12,550,973) |
Other comprehensive income (loss): | ||||||
Foreign currency translation adjustments | 18,257 | 14,403 | (429) | (16,470) | (17,195) | 66,279 |
Comprehensive loss | $ (1,644,445) | $ (3,294,600) | $ (4,321,264) | $ (10,061,254) | $ (13,815,534) | $ (12,484,694) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Changes in Mezzanine Equity and Shareholders' Equity (Deficit) - USD ($) | Common Stock Pre-funded warrants | Common Stock | Additional Paid-In Capital B Riley Sales Agreement [Member] | Additional Paid-In Capital Public Offering | Additional Paid-In Capital Pre-funded warrants | Additional Paid-In Capital | Accumulated Other Comprehensive Income/Loss | Accumulated Deficit | B Riley Sales Agreement [Member] | Public Offering | Pre-funded warrants | Total |
Balance at Dec. 31, 2020 | $ 2,043 | $ 196,978,256 | $ (24,337) | $ (193,214,134) | $ 3,741,828 | |||||||
Balance (in shares) at Dec. 31, 2020 | 2,042,911 | |||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement | $ 812 | 19,704,835 | 19,705,647 | |||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 811,646 | |||||||||||
Issuance costs | (655,156) | (655,156) | ||||||||||
Issuance of common stock to vendors | $ 2 | 27,498 | 27,500 | |||||||||
Issuance of common stock to vendors (in shares) | 1,667 | |||||||||||
Exercise of common stock options | $ 2 | 25,833 | $ 25,835 | |||||||||
Exercise of common stock options (in shares) | 2,018 | 2,018 | ||||||||||
Exercise of warrants | 79 | $ 79 | ||||||||||
Exercise of warrants (in shares) | 2 | |||||||||||
Share-based compensation expense | 361,559 | 361,559 | ||||||||||
Foreign currency translation adjustment | 66,279 | 66,279 | ||||||||||
Net loss | (12,550,973) | (12,550,973) | ||||||||||
Balance at Dec. 31, 2021 | $ 2,859 | 216,442,904 | 41,942 | (205,765,107) | 10,722,598 | |||||||
Balance (in Shares) at Dec. 31, 2021 | 2,858,244 | |||||||||||
Issuance of common stock to vendors | $ 15 | 149,987 | 150,002 | |||||||||
Issuance of common stock to vendors (in shares) | 15,452 | |||||||||||
Share-based compensation expense | 220,656 | 220,656 | ||||||||||
Foreign currency translation adjustment | (16,470) | (16,470) | ||||||||||
Net loss | (10,044,784) | (10,044,784) | ||||||||||
Balance at Sep. 30, 2022 | $ 2,874 | 216,813,547 | 25,472 | (215,809,891) | 1,032,002 | |||||||
Balance (in Shares) at Sep. 30, 2022 | 2,873,696 | |||||||||||
Balance at Dec. 31, 2021 | $ 2,859 | 216,442,904 | 41,942 | (205,765,107) | 10,722,598 | |||||||
Balance (in shares) at Dec. 31, 2021 | 2,858,244 | |||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement | $ 8 | 79,346 | 79,354 | |||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 8,542 | |||||||||||
Issuance costs | (2,593) | (2,593) | ||||||||||
Declaration of Series D preferred stock | (43) | (43) | ||||||||||
Issuance of common stock in reverse stock split (Shares) | 19,544 | |||||||||||
Issuance of common stock in reverse stock split | $ 20 | (20) | ||||||||||
Issuance of common stock to vendors | $ 22 | 211,981 | 212,003 | |||||||||
Issuance of common stock to vendors (in shares) | 22,248 | |||||||||||
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 | $ 2,909 | 217,064,964 | 24,747 | (219,563,446) | (2,470,826) | |||||||
Balance (in Shares) at Dec. 31, 2022 | 2,908,578 | |||||||||||
Balance at Jun. 30, 2022 | $ 2,870 | 216,692,835 | 11,069 | (212,500,888) | 4,205,886 | |||||||
Balance (in shares) at Jun. 30, 2022 | 2,870,032 | |||||||||||
Issuance of common stock to vendors | $ 4 | 49,997 | 50,001 | |||||||||
Issuance of common stock to vendors (in shares) | 3,664 | |||||||||||
Share-based compensation expense | 70,715 | 70,715 | ||||||||||
Foreign currency translation adjustment | 14,403 | 14,403 | ||||||||||
Net loss | (3,309,003) | (3,309,003) | ||||||||||
Balance at Sep. 30, 2022 | $ 2,874 | 216,813,547 | 25,472 | (215,809,891) | 1,032,002 | |||||||
Balance (in Shares) at Sep. 30, 2022 | 2,873,696 | |||||||||||
Balance at Dec. 31, 2022 | $ 2,909 | 217,064,964 | 24,747 | (219,563,446) | (2,470,826) | |||||||
Balance (in shares) at Dec. 31, 2022 | 2,908,578 | |||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement | $ 851 | 3,090,611 | 3,091,462 | |||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 851,130 | |||||||||||
Issuance costs | $ (95,348) | $ (834,061) | $ (95,348) | $ (834,061) | ||||||||
Issuance of common stock and pre-funded warrants in connection with May 2023 public offering | $ 2,301 | 8,493,516 | 8,495,817 | |||||||||
Issuance of common stock and pre-funded warrants in connection with May 2023 public offering (in shares) | 2,301,500 | |||||||||||
Issuance of common stock to vendors | $ 50 | 72,950 | 73,000 | |||||||||
Issuance of common stock to vendors (in shares) | 50,000 | |||||||||||
Issuance of common stock upon exercise of pre-funded warrants | $ 4,235 | $ (936) | $ 3,299 | |||||||||
Issuance of common stock upon exercise of pre-funded warrants (in shares) | 4,235,384 | |||||||||||
Issuance of common stock in connection with Silk Roads purchase option | $ 32 | 49,968 | 50,000 | |||||||||
Issuance of common stock in connection with Silk Roads purchase option (in shares) | 31,646 | |||||||||||
Share-based compensation expense | 229,076 | 229,076 | ||||||||||
Foreign currency translation adjustment | (429) | (429) | ||||||||||
Net loss | (4,320,835) | (4,320,835) | ||||||||||
Balance at Sep. 30, 2023 | $ 10,378 | 228,070,740 | 24,318 | (223,884,281) | 4,221,155 | |||||||
Balance (in Shares) at Sep. 30, 2023 | 10,378,238 | |||||||||||
Balance at Jun. 30, 2023 | $ 9,842 | 228,005,876 | 6,061 | (222,221,579) | 5,800,200 | |||||||
Balance (in shares) at Jun. 30, 2023 | 9,841,854 | |||||||||||
Issuance of common stock upon exercise of pre-funded warrants | $ 536 | $ (536) | ||||||||||
Issuance of common stock upon exercise of pre-funded warrants (in shares) | 536,384 | |||||||||||
Share-based compensation expense | 65,400 | 65,400 | ||||||||||
Foreign currency translation adjustment | 18,257 | 18,257 | ||||||||||
Net loss | (1,662,702) | (1,662,702) | ||||||||||
Balance at Sep. 30, 2023 | $ 10,378 | $ 228,070,740 | $ 24,318 | $ (223,884,281) | $ 4,221,155 | |||||||
Balance (in Shares) at Sep. 30, 2023 | 10,378,238 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Changes in Mezzanine Equity and Shareholders' Equity (Deficit) (Parenthetical) | 9 Months Ended | 12 Months Ended | |||
Feb. 10, 2023 | Feb. 09, 2023 | Sep. 30, 2023 USD ($) shares | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) | |
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Balance | $ 43 | ||||
Balance | $ 43 | ||||
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 | |||
Series D Preferred Stock | |||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Balance (Shares) | shares | 0 | ||||
Balance (Shares) | shares | 0 | 0 | |||
Series D Preferred Stock | Preferred Stock | |||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Balance | $ 43 | $ 0 | $ 0 | ||
Declaration of Series D preferred stock | 43 | ||||
Redemption of Series D preferred stock (in shares) | shares | (43) | ||||
Net Loss | 0 | 0 | |||
Balance | $ 43 | $ 0 | |||
Subsequent Event | |||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 |
Condensed Consolidated Statem_6
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities: | ||||
Net loss | $ (4,320,835) | $ (10,044,784) | $ (13,798,339) | $ (12,550,973) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Amortization and depreciation | 4,964 | 21,538 | 24,562 | 34,161 |
Non-cash lease expense | 82,500 | 86,326 | 112,714 | 116,290 |
Share-based compensation | 229,076 | 220,656 | 333,389 | 361,559 |
Issuance of common stock to vendors for services | 73,000 | 150,002 | 212,003 | 27,500 |
Issuance of common stock to Silk Roads for purchase option | 50,000 | |||
Loss on extinguishment of debt | 393,791 | (421,584) | ||
Change in fair value of convertible debt | (387,537) | |||
Amortization of deferred issuance costs associated with convertible debt | 12,518 | 31,068 | 41,538 | 41,926 |
Change in operating assets and liabilities: | ||||
Licensing, contracts and grants receivable | 49,079 | 8,147 | 23,759 | 64,885 |
Prepaid expenses and other current assets | (310,229) | (113,452) | 8,694 | (57,430) |
Research and development incentives receivable | 92,092 | 67,912 | 73,374 | 205,237 |
Operating lease liability | (80,458) | (85,415) | (111,122) | (116,290) |
Deferred revenue | 200,000 | |||
Accounts payable and accrued expenses | (2,382,708) | 679,268 | 396,651 | 1,127,259 |
Accrued compensation | (281,149) | (243,146) | 33,756 | (572,160) |
Net cash used in operating activities | (6,775,896) | (9,021,880) | (12,649,021) | (11,739,620) |
Investing activities: | ||||
Purchases of office furniture and equipment | (13,073) | (13,073) | (11,789) | |
Net cash used in investing activities | (13,073) | (13,073) | (11,789) | |
Financing activities: | ||||
Proceeds from issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement | 3,091,462 | 79,354 | 19,705,647 | |
Stock issuance costs associated | (2,533) | (621,899) | ||
Proceeds from issuance of common stock and pre-funded warrants pursuant to public offering | 8,495,817 | |||
Convertible debt repayments | (7,000,000) | |||
Net cash provided by financing activities | 3,709,688 | 76,821 | 19,058,001 | |
Proceeds from the exercise of warrants | 79 | |||
Proceeds from the exercises of stock options | 25,835 | |||
Costs associated with issuance of convertible debt | (45,512) | |||
Principal repayment - financing lease | (6,149) | |||
Effect of exchange rate on cash and cash equivalents | 5,127 | (143,302) | (99,009) | 60,642 |
Net decrease in cash and cash equivalents | (3,061,081) | (9,178,255) | (12,684,282) | 7,367,234 |
Cash and cash equivalents at beginning of period | 13,359,615 | 26,043,897 | 26,043,897 | 18,676,663 |
Cash and cash equivalents at end of period | 10,298,534 | 16,865,642 | 13,359,615 | 26,043,897 |
Supplemental information: | ||||
Cash paid for state income taxes | 13,006 | 13,243 | 16,043 | 7,727 |
Cash paid for interest | 488,011 | 643,921 | 857,411 | 668,715 |
Cash paid for lease liabilities: | ||||
Operating lease | 99,975 | 99,975 | 133,300 | 133,300 |
Financing lease | 6,408 | |||
Non-cash investing and financing activities: | ||||
Right-of-use assets and lease liabilities recorded | $ 347,546 | 347,546 | ||
Deferred issuance cost reclassified to additional paid-in capital | 2,339 | 60 | $ 33,257 | |
Redemption liability for Series D preferred stock | 43 | |||
Stock issuance costs included in accounts payable | 46,180 | |||
Declaration of Series D preferred stock | $ 43 | |||
At Market Issuance Sales Agreement | ||||
Financing activities: | ||||
Stock issuance costs associated | (93,009) | |||
Public Offering | ||||
Financing activities: | ||||
Stock issuance costs associated | (787,881) | |||
Pre-funded warrants | ||||
Financing activities: | ||||
Proceeds from the exercise of pre-funded warrants | $ 3,299 |
Nature of Business
Nature of Business | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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 commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy (“PDT”) utilizing 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, the Company received a refusal to file (“RTF”) letter from the U.S. Food and Drug Administration (“FDA”). 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. The FDA indicated that it is open to engaging in protocol discussions regarding the second, Phase 3 pivotal study. Based on this feedback, the Company is collaboratively engaging in active discussions with the FDA 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 FDA marketing approval. Development programs in this business segment also include expansion of synthetic hypericin sodium (SGX302) into psoriasis, the Company’s first-in-class innate defense regulator (“IDR”) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (“BDP”) for the prevention/treatment of gastrointestinal (“GI”) disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203). The Company’s Public Health Solutions business segment includes active development programs for RiVax ® , its ricin toxin vaccine candidate and SGX943, its therapeutic candidate for antibiotic resistant and emerging infectious disease, and vaccine programs, including a program targeting filoviruses (such as Marburg and Ebola) and a program developing CiVax™, its vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of the vaccine programs is currently supported by the heat stabilization platform technology, known as ThermoVax ® . To date, this business segment has been supported with grant and contract funding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Biomedical Advanced Research and Development Authority (“BARDA”) and the Defense Threat Reduction Agency (“DTRA”). 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 for approximately $1.5 million from a NIAID grant over two years for development of CiVax™ and a subcontract that originally provided for approximately $1.1 million from a FDA Orphan Products Development grant over four years for an expanded study of HyBryte™ in the treatment of CTCL. The Company will continue to apply for additional government funding. 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 nine months ended September 30, 2023 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 September 30, 2023, the Company had an accumulated deficit of $223,884,281 . During the nine months ended September 30, 2023, the Company incurred a net loss of $4,320,835 and used $6,775,896 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. The Company’s plans to meet its liquidity needs primarily include its ability to control the timing and spending on its research and development programs and raising additional funds through potential partnership and/or financings. Based on the Company’s operating budget, current rate of cash outflows, cash on hand, and proceeds from government contract and grant programs, management believes that its current cash will be sufficient to meet the anticipated cash needs for working capital and capital expenditures for at least the next twelve months from issuance of these financial statements on this Quarterly Report on Form 10-Q. As of September 30, 2023, the Company had cash and cash equivalents of $10,298,534 as compared to $13,359,615 as of December 31, 2022, representing a decrease of $3,061,081 or 23% . As of September 30, 2023, the Company had working capital of $5,450,322 as compared to a working capital deficit of ($2,663,721) as of December 31, 2022, representing an increase in working capital of $8,114,043 or 305% . The decrease in cash and cash equivalents was primarily related to the repayment of $7 million of debt principal and cash used in operating activities of approximately $6.8 million offset by the net proceeds of approximately $7.7 million from the public offering in May 2023 and approximately $3.0 million of proceeds from shares sold via the At Market Issuance Sales Agreement (“B.Riley Sales Agreement”) with B. Riley Securities, Inc. (“B. Riley”) during the nine months ended September 30, 2023. The increase in working capital is primarily the result of the net proceeds received from the financing activities during the nine months ended September 30, 2023 and the reclassification of $1,416,463 of the Company’s convertible debt balance from a current liability as of December 31, 2022 to a non-current liability as of September 30, 2023 (resulting from the amendment to the loan and security agreement with Pontifax Medison Finance (“Pontifax”) – see Note 5) , partially offset by cash used in operating activities during the nine months ended September 30, 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 the FDA in order to define the protocol and evaluate the feasibility of conducting a second Phase 3 pivotal 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 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. ● Continue development of the Company’s heat stabilization platform technology, ThermoVax ® , in combination with its programs for RiVax ® (ricin toxin vaccine), CiVax™ (COVID-19 vaccine) and filovirus vaccines for Ebola, Sudan, and Marburg Viruses, with U.S. government funding support. ● Continue to apply for and secure additional government funding for each of the Company’s Specialized BioTherapeutics and Public Health Solutions programs through grants, contracts and/or procurements. ● Pursue business development opportunities for the Company’s pipeline programs, as well as explore 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 $1.0 million in active government grant funding still available as of September 30, 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 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 has up to $23.6 million remaining from the B. Riley Sales Agreement as of November 6, 2023 under the prospectus supplement updated August 13, 2021. The Company is currently subject to the limitations contained in General Instruction I.B.6 of Form S-3. As a result, the Company is limited to selling no more than one-third of the aggregate market value of the equity held by non-affiliates, or the public float, during any 12-month period. From January 1, 2023 through November 6, 2023, the Company sold 851,130 shares of common stock pursuant to the B. Riley Sales Agreement at a weighted average price of $3.63 per share for total gross proceeds of $3,091,462 . As of November 6, 2023, the Company does not currently have any remaining capacity for sales under the Form S-3 pursuant to General Instruction I.B.6. If the Company’s public float increases, the Company will have additional availability under such limitations, and if the Company’s public float increases to $75 million or more, the Company will no longer be subject to such limitations. There can be no assurance that the Company’s public float will increase or that the Company will no longer be subject to such limitations. ● The Company completed a public offering of 2,301,500 shares of its common stock, pre-funded warrants to purchase 4,237,000 shares of its common stock and common warrants to purchase up to 6,538,500 shares of its common stock at a combined public offering price of $1.30 . The pre-funded warrants have an exercise price of $0.001 . The common warrants have an exercise price of $1.50 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 $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. ● The Company may seek additional capital in the private and/or public equity markets, to continue its operations, respond to competitive pressures, develop new products and services, and to support new strategic partnerships. The Company is 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. Reverse Stock Split On February 9, 2023, the Company completed a reverse stock split of its issued and outstanding shares of common stock at a ratio of one-for-fifteen , whereby every fifteen shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock without any change in the par value per share. No fractional shares were issued as a result of the reverse stock split. Any fractional shares that would otherwise have resulted from the reverse stock split were rounded up to the next whole number. The Company’s common stock began trading on The NASDAQ Capital Market on a reverse split basis at the market opening on February 10, 2023. All share and per share data have been restated to reflect this reverse stock split. Exclusive Option Agreement with Silk Road Therapeutics On April 27, 2023, the Company entered into an exclusive option agreement with Silk Road Therapeutics, Inc. (“Silk Road”) to complete its due diligence assessment. The option agreement granted the Company an exclusive option to purchase all assets and rights, including intellectual property and regulatory documents, related to Silk Road’s Pentoxifylline (“PTX”) product candidate, a non-biological anti-TNF-alpha inhibitor, for the treatment of mucocutaneous ulcers in patient’s suffering from Behcet’s Disease (“BD”) and expired on August 25, 2023. In consideration for the option, the Company paid $50,000 of cash and issued 31,646 shares of common stock with a value of $50,000 . The consideration paid for the option was recorded as general and administrative expense during the nine months ended September 30, 2023 on the accompanying condensed consolidated statements of operations. As of August 25, 2023, the Company concluded its due diligence activities and decided to allow the option to expire. A director of the Company has an ownership interest in Silk Road. Nasdaq Capital Market Listing Requirements As previously reported, on December 20, 2022, the Company received a written notice from Nasdaq providing that the staff (the “Staff”) of Nasdaq determined to delist the Company’s common stock from The Nasdaq Capital Market because the closing bid price of the Company’s common stock had not been at least $1.00 per share as required by Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Requirement”) and because the Company’s shareholders’ equity had not been at least $2,500,000 nor had the alternatives of market value of listed securities or net income from continuing operations been met, as required by Listing Rule 5550(b) (the “Shareholders’ Equity Requirement”). On February 2, 2023, the Company had an oral hearing with a Nasdaq Hearings Panel to appeal the Staff’s delisting determination. On February 21, 2023, the Company received a letter from Nasdaq, stating that the Nasdaq Hearings Panel granted the Company’s request to continue its listing on Nasdaq, on the condition that (1) on February 24, 2023, the Company had demonstrated compliance with the Bid Price Requirement, by evidencing a closing bid price of $1.00 or more per share for a minimum of ten consecutive trading sessions; and (2) on or before March 31, 2023, the Company had demonstrated compliance with the Shareholders’ Equity Requirement. As of the close of the market on February 24, 2023, the Company satisfied the first condition – compliance with the Bid Price Requirement for a minimum of ten consecutive trading sessions. On April 6, 2023, Nasdaq granted the Company’s request for an extension of the deadline by which it must regain compliance with the Shareholders’ Equity Requirement from March 31, 2023 to May 15, 2023. As of the close of the market on May 9, 2023, the Company came into compliance with the Shareholders’ Equity Requirement based on capital raising activities - see Note 1 - Liquidity. On May 23, 2023, the Company received a letter from Nasdaq confirming that the Company had regained compliance with the Shareholders’ Equity Requirement and was in compliance with all other applicable requirements for listing on Nasdaq. Accordingly, the Panel determined to continue the listing of the Company’s securities on Nasdaq and closed the matter. The Panel has also determined to impose a Panel Monitor on the Company for a period of one year. During the Panel Monitor period, the Company will be under an obligation to notify the Panel in the event its closing bid price falls below $1.00 on any trading day and if the Company falls out of compliance with any applicable listing requirement. If, during the Panel Monitor period, the Nasdaq Listing Qualifications Department determines that the Company has failed to meet any requirement for continued listing on Nasdaq, the Nasdaq Listing Qualifications Department may issue a delisting determination. In such event, the Company may seek a review of the delisting determination and the Nasdaq Hearings Department will schedule a hearing with regard to the deficiency. On June 23, 2023, the Company received a letter from Nasdaq indicating that the Company was not in compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market. The notification of noncompliance had no immediate effect on the listing or trading of the Company’s common stock on The Nasdaq Capital Market under the symbol “SNGX,” and the Company continues to monitor the closing bid price of its common stock and to evaluate its alternatives, if appropriate, to resolve the deficiency and regain compliance with this rule. The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price for the last 30 consecutive business days, the Company no longer meets this requirement. The June 23, 2023 letter indicated that the Company was provided 180 calendar days, or until December 20, 2023, in which to regain compliance. If at any time during this period the bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of ten consecutive business days, the Nasdaq Staff will provide the Company with a written confirmation of compliance and the matter will be closed. In the event the Company does not regain compliance with Rule 5550(a)(2) prior to the expiration of the 180 calendar day period, the Nasdaq Staff will provide the Company with written notification that its securities are subject to delisting from The Nasdaq Capital Market. At that time, the Company may appeal the delisting determination to a Nasdaq Listing Qualifications Panel. Alternatively, if the Company fails to regain compliance with Rule 5550(a)(2) prior to the expiration of the 180 calendar day period, but meets the continued listing requirement for market value of publicly held shares and all of the other applicable standards for initial listing on The Nasdaq Capital Market, with the exception of the minimum bid price, and provides written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary, then the Company may be granted an additional 180 calendar days to regain compliance with Rule 5550(a)(2). | 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 commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic (hypericin), a novel photodynamic therapy (“PDT”) utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”)). With a successful Phase 3 study complete, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the United States (“U.S.”). In response to the HyBryte™ new drug application (“NDA”) for the treatment of CTCL, the Company recently received a refusal to file (“RTF”) letter from the U.S. Food and Drug Administration (“FDA”). The Company is preparing for a meeting, categorized as Type A, 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 marketing approval and U.S. commercialization. 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, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (“BDP”) for the prevention/treatment of gastrointestinal (“GI”) disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203). The Company’s Public Health Solutions business segment includes active development programs for RiVax ® , its ricin toxin vaccine candidate and SGX943, its therapeutic candidate for antibiotic resistant and emerging infectious disease, and vaccine programs, including a program targeting filoviruses (such as Marburg and Ebola) and a program developing CiVax™, its vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of the vaccine programs is currently supported by the heat stabilization platform technology, known as ThermoVax ® . To date, this business segment has been supported with grant and contract funding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Biomedical Advanced Research and Development Authority (“BARDA”) and the Defense Threat Reduction Agency (“DTRA”). The Company primarily generates revenues under government grants and contracts principally from the National Institutes of Health (“NIH”). The Company has a DTRA subcontract of approximately $600,000 over three years for SGX943, a subcontract of approximately $1.5 million from a NIAID grant over two years for development of CiVax™ and a subcontract of approximately $1.1 million from a U.S. FDA grant over four years for the expanded study of HyBryte™ in the treatment of CTCL. The Company will continue to apply for additional government funding. 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, 2022, the Company had an accumulated deficit of $ 219,563,446 and a working capital deficit of $ 2,663,721 . During the year ended December 31, 2022, the Company incurred a net loss of $13,798,339 and used $12,649,021 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 third quarter of 2023. 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 the At Market Issuance Sales Agreement (“B. Riley Sales Agreement”) with B. Riley Securities, Inc. (“B. Riley”) 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, 2022, the Company had cash and cash equivalents of $13,359,615 as compared to $26,043,897 as of December 31, 2021, representing a decrease of $12,684,282 or 49% . As of December 31, 2022, the Company had a working capital deficit of $ 2,663,721 as compared to working capital of $20,278,345 as of December 31, 2021, representing a decrease of $22,942,066 or 113% . The decrease in cash and cash equivalents and working capital was primarily related to cash used in operating activities. The decrease in working capital is also due to the impact of the entire convertible debt balance being classified as a current liability as of December 31, 2022 due to a subjective acceleration clause included in the debt agreement and a potential breach of a cash debt covenant during the twelve month look-forward period from the filing of these financial statements. Management’s business strategy can be outlined as follows: ● Following positive primary endpoint results for the Phase 3 FLASH ( F lorescent L ight A ctivated S ynthetic H ypericin) 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), meet with the U.S. FDA to discuss the contents of a RTF letter recently issued by the FDA in response to the HyBryte™ NDA for the treatment of CTCL. The Company is preparing for a meeting, categorized as Type A, 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 marketing approval and U.S. commercialization while continuing to explore ex-U.S. partnership. ● 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 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. ● Continue development of the Company’s heat stabilization platform technology, ThermoVax ® , in combination with its programs for RiVax ® (ricin toxin vaccine), CiVax™ (COVID-19 vaccine) and filovirus vaccines for Ebola, Sudan, and Marburg Viruses, with U.S. government funding support. ● Continue to apply for and secure additional government funding for each of the Company’s Specialized BioTherapeutics and Public Health Solutions programs through grants, contracts and/or procurements. ● Pursue business development opportunities for the Company’s pipeline programs, as well as explore 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 $1.7 million in active government grant funding still available as of December 31, 2022 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 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 has up to $26.6 million remaining from the B. Riley Sales Agreement as of March 24, 2023 under the prospectus supplement updated August 13, 2021. The Company is currently subject to the limitations contained in General Instruction I.B.6 of Form S-3. As a result, the Company is limited to selling no more than one-third of the aggregate market value of the equity held by non-affiliates, or the public float, during any 12-month period, and as of March 24, 2023, the Company has approximately $6.6 million remaining that is permitted to be sold under the Form S-3 pursuant to General Instruction I.B.6. If the Company’s public float increases, the Company will have additional availability under such limitations, and if the Company’s public float increases to $75 million or more, the Company will no longer be subject to such limitations. There can be no assurance that the Company’s public float will increase or that the Company will no longer be subject to such limitations. ● The Company may seek additional capital in the private and/or public equity markets, to continue its operations, respond to competitive pressures, develop new products and services, and to support new strategic partnerships. The Company is 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. Reverse Stock Split On February 9, 2023, the Company completed a reverse stock split of its issued and outstanding shares of common stock at a ratio of one-for-fifteen , whereby, every fifteen shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock without any change in the par value per share. No fractional shares were issued as a result of the reverse stock split. Any fractional shares that would otherwise have resulted from the reverse stock split were rounded up to the next whole number. The Company’s common stock began trading on The NASDAQ Capital Market on a reverse split basis at the market opening on February 10, 2023. All share and per share data have been restated to reflect this reverse stock split. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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 doubtful accounts 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 no t record any impairment of long-lived assets for the three and nine months ended September 30, 2023 and 2022. Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. Disclosures about the fair value of financial instruments are based on pertinent information available to the Company on September 30, 2023. 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 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 September 30, 2023 for the convertible debt is its fair value - see Note 5. The principal amount of the convertible debt was $3,000,000 at September 30, 2023 and the fair value was approximately $2,916,463 . 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 September 30, 2023 is as follows: Balance, December 31, 2022 Issued Adjustment to fair value Balance, September 30, 2023 Convertible debt at fair value $ - $ 3,304,000 $ (387,537) $ 2,916,463 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 . Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. 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 . Research and development includes costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, equipment depreciation and allocation of various corporate costs. 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 nine months ended September 30, 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 4 years ; ● volatility of 94% for 2023 and 87% for 2022; and ● risk free interest rates of 3.48% for 2023 and ranging from 1.12% - 3.23% for 2022. The fair value of each option grant made during the nine months ended September 30, 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. Foreign Currency Transactions and Translation In accordance with FASB ASC 830 Foreign Currency Matters , the UK subsidiary expresses its U.S. dollar and Euro denominated transactions in its functional currency, the British Pound, with related transaction gains or losses included in net loss. On a quarterly basis, the financial statements of the UK subsidiary are translated into U.S. dollars and consolidated into the Company’s financials, with related translation adjustments reported as a cumulative translation adjustment (“CTA”), which is a component of accumulated other comprehensive income. During the three months ended September 30, 2023 and 2022, the Company recognized foreign currency transaction losses of ($3,046) and ($12,613) , respectively, in the accompanying condensed consolidated statements of operations. During the nine months ended September 30, 2023 and 2022, the Company recognized a foreign currency transaction gain of $310 and a foreign currency transaction loss of ($26,006) , respectively, in the accompanying condensed consolidated statements of operations. 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 recognized an income tax benefit of $1,161,197 and $1,154,935 from the sale of 2021 and 2020 New Jersey NOL carryforwards during the nine months ended September 30, 2023 and 2022, respectively. 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 nine months ended September 30, 2023 and 2022. Additionally, the Company has no t recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at September 30, 2023 or December 31, 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 $41,000 and $128,000 as of September 30, 2023 and December 31, 2022, respectively, in the condensed consolidated balance sheets. The following table shows the change in the UK research and development incentives receivable from December 31, 2022 to September 30, 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 — 18,536 18,536 Adjustments to 2021 and 2022 incentives earned (1,150) — (1,150) UK research and development incentives cash receipt (104,422) — (104,422) Foreign currency translation 112 (230) (118) Balance at September 30, 2023 $ 22,852 $ 18,306 $ 41,158 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 and nine months ended September 30, 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: As of September 30, 2023 2022 Common stock purchase warrants 6,538,500 3,992 Stock options 206,589 145,505 Convertible debt 2,159,414 162,602 Total 8,904,503 312,099 The weighted average exercise prices of the Company’s warrants and stock options outstanding at September 30, 2023 were $1.50 and $24.83 per share, respectively. The weighted average exercise prices of the Company’s warrants and stock options outstanding at September 30, 2022 were $36.12 and $34.49 per share, respectively. The weighted average conversion price of the Company’s convertible debt at September 30, 2023 and 2022 was $1.39 and $61.50 per share, respectively. 217,880 of the Company’s common stock warrants associated with the July 2018 public offering expired on January 2, 2022 and 667 of the Company’s common stock warrants associated with the opening of the first clinical site in the United Kingdom expired on March 28, 2023. 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. | 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. Reclassifications Certain amounts in the statement of operations for the year ended December 31, 2021 have been reclassified to conform to the current year presentation. 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. Licensing, 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 doubtful accounts has been established. If amounts become uncollectible, they are charged to operations. Licensing receivables consist of amounts billed to customers pursuant to contracts with those customers. No allowance for doubtful accounts has been established for licensing receivables as all amounts billed were collected shortly thereafter. Website Development Costs In June 2019, the Company capitalized website development costs of $46,500 in accordance with FASB Codification ASC 350-50 “Accounting for Web Site Development Costs.” The Company began amortizing the website development costs on a straight-line basis over three years , the estimated useful life of the website. The Company reviews its capitalized website development costs periodically for impairment. Website amortization expense for 2022 and 2021 was $7,750 and $15,500 , respectively, and accumulated amortization was $46,500 and $38,750 , respectively, as of December 31, 2022 and 2021. Website development costs were included in other assets in the accompanying consolidated balance sheets. 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, 2022 and 2021. Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. Disclosures about the fair value of financial instruments are based on pertinent information available to the Company on December 31, 2022 and 2021. 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. The carrying amounts reported in the consolidated balance sheets for cash and cash equivalents, licensing, contracts and/or 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 sheets for convertible debt approximates its fair value based on its interest rate and maturity date. 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 . Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. 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 . Research and development includes costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, equipment depreciation and allocation of various corporate costs. 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, 2022 and 2021 was estimated using the Black-Scholes option-pricing model and the following assumptions: ● a dividend yield of 0% ; ● an expected life of 4 years ; ● volatility of 84% - 87% for 2022 and 2021; and ● risk-free interest rates ranging from 1.12% to 4.51% in 2022 and 0.27% to 1.13% in 2021. The fair value of each option grant made during 2022 and 2021 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. 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 , the UK subsidiary expresses its U.S. dollar and Euro denominated transactions in its functional currency, the British Pound, with related transaction gains or losses included in net loss. On a quarterly basis, the financial statements of the UK subsidiary are translated into U.S. dollars and consolidated into the Company’s financials, with related translation adjustments reported as a cumulative translation adjustment (“CTA”), which is a component of accumulated other comprehensive loss. In 2022 and 2021, the Company recognized foreign currency transaction losses of $30,549 and $39,361 , respectively, in the accompanying consolidated statements of operations. 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 recognized an income tax benefit of $1,154,935 and $864,742 from the sale of 2020 and 2019 New Jersey NOL carryforwards during the years ended December 31, 2022 and 2021, respectively. 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 2022 and 2021. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2022 or 2021. 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 $128,000 and $225,000 as of December 31, 2022 and 2021, respectively in the consolidated balance sheets. The following table shows the change in the UK research and development incentives receivable from December 31, 2021 to December 31, 2022: Current Long-Term Total Balance at December 31, 2021 $ 103,832 $ 121,238 $ 225,070 UK research and development incentives, transfer 121,238 (121,238) — UK research and development incentives — 24,963 24,963 Additional 2020 incentive earned 107,906 — 107,906 UK research and development incentives cash receipt (209,166) — (209,166) Foreign currency translation (19,612) (849) (20,461) Balance at December 31, 2022 $ 104,198 $ 24,114 $ 128,312 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. 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, 2022 2021 Common stock purchase warrants 667 221,872 Stock options 192,273 140,996 Convertible debt 162,602 162,602 Total 355,542 525,470 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 | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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 $11,108 per month will be maintained until November 2023 when it will be increased to $11,367 and then will increase to $11,625 in November 2024 where it will remain until expiration. As of September 30, 2023 and December 31, 2022, the Company’s condensed consolidated balance sheets included a right-of-use lease asset of $258,487 and $340,987 for the office space, respectively. The Company’s condensed consolidated balance sheets as of September 30, 2023 and December 31, 2022 included corresponding lease liabilities of $262,117 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 Right-of-use lease asset: Right-of-use lease asset, January 1, 2023 $ 340,987 Less: reduction/amortization 82,500 Right-of-use lease asset, September 30, 2023 $ 258,487 Lease liability: Lease liability, January 1, 2023 $ 342,575 Less: repayments 80,458 Lease liability, September 30, 2023 $ 262,117 Lease expense for the nine months ended September 30, 2023: Lease expense $ 102,016 Total $ 102,016 Lease expense for the nine months ended September 30, 2022: Lease expense $ 100,887 Total $ 100,887 Contractual cash payments for the remaining lease term as of September 30, 2023: 2023 $ 33,841 2024 136,917 2025 116,250 Total $ 287,008 Remaining lease term (months) as of September 30, 2023 25 | 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 $11,108 per month will be maintained until November 2023 when it will be increased to $11,367 and then will increase to $11,625 in November 2024 where it will remain until expiration. As of December 31, 2022 and 2021, the Company’s consolidated balance sheets included a right-of-use lease asset of $340,987 and $106,155 for the office space, respectively. The Company’s consolidated balance sheets as of December 31, 2022 and 2021 included corresponding lease liabilities of $342,575 and $106,151 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, 2022 2023 $ 133,817 2024 136,917 2025 116,250 Total $ 386,984 Discount rate applied 8.47 % Remaining lease term (months) as of December 31, 2022 34 Right-of-use lease asset: Right-of-use lease asset, January 1, 2021 $ 222,445 Less: reduction/amortization 116,290 Right-of-use lease asset, December 31, 2021 106,155 New lease extension June 21, 2022 347,546 Reduction/amortization 112,714 Right of use lease asset, December 31, 2022 $ 340,987 Lease liability: Lease liability, January 1, 2021 $ 222,441 Less: repayments 116,290 Lease liability, December 31, 2021 106,151 New lease extension June 21, 2022 347,546 Less: repayments 111,122 Lease liability, December 31, 2022 $ 342,575 Lease expense for the year ended December 31, 2021: Lease expense $ 133,300 Total $ 133,300 Lease expense for the year ended December 31, 2022: Lease expense $ 134,892 Total $ 134,892 |
Accrued Expenses
Accrued Expenses | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Accrued Expenses | ||
Accrued Expenses | Note 4. Accrued Expenses The following is a summary of the Company’s accrued expenses: September 30, December 31, 2023 2022 Clinical trial expenses $ 2,082,200 $ 1,884,117 Other 304,636 423,629 Total $ 2,386,836 $ 2,307,746 | Note 4. Accrued Expenses The following is a summary of the Company’s accrued expenses: December 31, 2022 2021 Clinical trial expenses $ 1,884,117 $ 2,625,779 Other 423,629 330,766 Total $ 2,307,746 $ 2,956,545 |
Debt
Debt | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Debt | ||
Debt | Note 5. 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 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 was 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 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 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 588,599 shares of the Company’s common stock issuable upon conversion and to (ii) $1.70 with respect to all shares of the Company’s common stock issuable upon conversion in excess of the first 588,599 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 condensed consolidated statements of operations during the nine months ended September 30, 2023. The fair value of the convertible debt as of September 30, 2023 was approximately $2,916,463 , which resulted in the recognition of ($72,463) of other loss and $387,537 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 and nine months ended September 30, 2023, respectively. 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 follow: Assumptions 4/19/2023 9/30/2023 Stock price $ 1.72 $ 0.56 Volatility 75.20% 110.50% Discount rate 16.28% 14.84% Risk-free rate 4.27% 5.24% Interest expense incurred during the three months ended September 30, 2023 and 2022 was $64,047 and $213,490 , respectively. Interest expense incurred during the nine months ended September 30, 2023 and 2022 was $338,568 and $633,510 . Interest expense paid during the three months ended September 30, 2023 and 2022 was $63,351 and $211,170 . Interest expense paid during the nine months ended September 30, 2023 and 2022 was $488,011 and $643,921 , respectively. Annual principal and interest payments due as of September 30, 2023 in accordance with the amended terms of the Pontifax loan agreement, assuming no conversion is as follows: Year Principal Interest Total 2023 $ — $ 128,094 $ 128,094 2024 2,250,000 206,761 2,456,761 2025 750,000 16,012 766,012 Total $ 3,000,000 $ 350,867 $ 3,350,867 | 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. The agreement contains customary representations, warranties and covenants, including covenants by the Company limiting additional indebtedness, liens, including on intellectual property, guaranties, mergers and consolidations, substantial asset sales, investments and loans, certain corporate changes, transactions with affiliates and fundamental changes. Affirmative covenants include, among others, covenants requiring the Company to protect and maintain its intellectual property and comply with all applicable laws, deliver certain financial reports, maintain a minimum cash balance and maintain its insurance coverage. As of December 31, 2022, the Company projected a violation of the minimum cash balance requirement during 2023 and the debt agreement contains a subjective acceleration clause, therefore has classified the entire debt balance as a current liability. 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. Interest expense incurred during the years ended December 31, 2022 and 2021 was $847,000 and $894,808 , respectively. Interest expense paid during the years ended December 31, 2022 and 2021 was $857,411 and $668,715 , respectively. Pontifax may elect to convert the outstanding loan drawn into shares of the Company’s common stock at any time prior to repayment at a conversion price of $61.50 per share. 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 2023 $ 4,000,000 $ 634,438 $ 4,634,438 2024 4,000,000 295,638 4,295,638 2025 2,000,000 21,349 2,021,349 Total $ 10,000,000 $ 951,425 $ 10,951,425 |
Income Taxes
Income Taxes | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Income Taxes | ||
Income Taxes | Note 6. Income Taxes The Company had gross NOLs at December 31, 2022 of approximately $124 million for federal tax purposes, approximately $13.2 million for state tax purposes and approximately $1.4 million for foreign tax purposes. Federal losses generated in 2018 or later will carry forward indefinitely. In addition, the Company has approximately $8.8 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 2022 and 2021, the Company sold New Jersey NOL carryforwards 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. During the nine months ended September 30, 2023 and 2022, the Company recognized $1,161,197 and $1,154,935 of income tax benefit, net of transaction costs from the sale of its 2021 and 2020 NOL carryforwards, respectively. The Company has not yet sold its 2022 New Jersey NOL carryforwards but may do so in the future. There can be no assurance as to the continuation or magnitude of this program in future years. | Note 6. Income Taxes The income tax benefit consisted of the following for the years ended December 31, 2022 and 2021: 2022 2021 Federal $ — $ — Foreign — — State (1,154,935) (864,742) Income tax benefit $ (1,154,935) $ (864,742) The significant components of the Company’s deferred tax assets and liabilities at December 31, 2022 and 2021 are as follows: 2022 2021 Net operating loss carry forwards $ 27,252,000 $ 28,065,000 Orphan drug and research and development credit carry forwards 8,837,000 8,605,000 Equity based compensation 285,000 264,000 Intangibles 1,696,000 1,953,000 Capitalized research and development (Section 174) 1,832,000 — Lease liability 96,000 30,000 Total 39,998,000 38,917,000 Valuation allowance (39,902,000) (38,887,000) Net deferred tax assets 96,000 30,000 Right of use asset (96,000) (30,000) Total gross deferred tax liabilities (96,000) (30,000) Net deferred tax assets $ — $ — The Company had gross NOLs at December 31, 2022 of approximately $124.0 million for federal tax purposes, approximately $13.2 million for state tax purposes and approximately $1.4 million for foreign tax purposes. Federal losses generated in 2018 or later will carry forward indefinitely. In addition, the Company has approximately $8.8 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, 2022 and 2021 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 $1,154,935 and $ 864,742 , respectively, of income tax benefit, net of transaction costs. The Company has not yet sold its 2022 New Jersey NOLs but may do so in the future. There can be no assurance as to the continuation or magnitude of this program in the future. 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, 2022 and 2021 were as follows: 2022 2021 Federal tax at statutory rate (21.0) % (21.0) % State tax benefits, plus sale of NJ NOL, net of federal benefit (2.4) (7.6) Foreign tax rate difference 0.2 0.1 Orphan drug and research and development credits (3.9) (4.3) Permanent differences 3.1 1.3 Foreign NOL adjustments 0.4 0.6 Expiration of tax attributes 9.1 4.9 Change in valuation allowance 6.8 19.6 Income tax benefit (7.7) % (6.4) % 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, 2022, 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 no t have any unrecognized tax benefits and has no t accrued any interest or penalties for the years ended December 31, 2022 and 2021. |
Shareholders' Equity
Shareholders' Equity | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Shareholders' Equity | ||
Shareholders' Equity | Note 7. Shareholders’ Equity Preferred Stock The Company has 350,000 shares of preferred stock authorized, of which 50,000 were designated as Series D preferred stock as of December 31, 2022. 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 consisted of one one-thousandth of a share of Series D preferred stock, par value $0.001 per share, for each outstanding share of the Company's common stock. The Series D preferred stock had the following rights and restrictions: 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 of a Series D preferred stock share transferred for each common stock share transferred. 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 On May 9, 2023, the Company completed a public offering of 2,301,500 shares of its common stock, pre-funded warrants to purchase 4,237,000 shares of its common stock and common warrants to purchase up to 6,538,500 shares of its common stock at a combined public offering price of $1.30 . The pre-funded warrants have an exercise price of $0.001 . As of September 30, 2023, there were no pre-funded warrants outstanding. The common warrants have an exercise price of $1.50 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 $8.5 million before deducting commissions and other estimated offering expenses payable by the Company. The following items represent transactions in the Company’s common stock for the nine months ended September 30, 2023: ● The Company issued a vendor 50,000 shares of fully vested common stock with a fair value based on a closing price of $1.46 per share on April 27, 2023, the date of issuance. ● The Company sold 851,130 shares of common stock pursuant to the B. Riley Sales Agreement at a weighted average price of $3.63 per share. ● The Company issued 31,646 shares of fully vested common stock pursuant to an exclusive option agreement at $1.58 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 2,301,500 shares of common stock and 4,237,000 pre-funded warrants pursuant to the May 2023 public offering for $1.30 per share on May 9, 2023. ● The Company issued 2,023,000 shares of common stock pursuant to the exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.001 on May 9, 2023. ● The Company issued 938,000 shares of common stock pursuant to the exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.001 on May 10, 2023. ● The Company issued 338,000 shares of common stock pursuant to the exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.001 on May 22, 2023. ● The Company issued 400,000 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 $ 0.001 on June 8, 2023. ● The Company issued 536,384 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 $0.001 on September 6, 2023. The issuance of the Company’s common stock to vendor described above was made under the 2015 Plan and, are registered on a Registration Statement on Form S-8. However, as shares of common stock are not covered by a reoffer prospectus, the certificates evidencing such shares reflect a Securities Act restrictive legend. The issuance of the Company’s common stock pursuant to the B. Riley Sales Agreement described above was registered on a Registration Statement on Form S-3. The issuance of the Company’s common stock in connection with the exclusive option agreement as described above was exempt under Section 4(a)(2) of the Securities Act of 1933, as amended. The recipient is 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 issuances of the Company’s common stock in connection with the May 2023 public offering and upon the exercise of the pre-funded warrants described above were registered on a Registration Statement on Form S-1. 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 sets 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 provides that B. Riley is 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 Company has no obligation to sell any shares under the B. Riley Sales Agreement, and may suspend solicitation and offers under the B. Riley Sales Agreement at any time. The B. Riley Sales Agreement expires on December 31, 2023. On August 13, 2021, the Company filed a prospectus supplement relating to the B. Riley Sales Agreement to offer and sell shares of Company common stock having an aggregate offering price of up to $30 million under the July 2020 Registration Statement. As of November 6, 2023, there was $23.6 million available for future sale of common stock under the B. Riley Sales Agreement. The Company is currently subject to the limitations contained in General Instruction I.B.6 of Form S-3. As a result, the Company is limited to selling no more than one-third of the aggregate market value of the equity held by non-affiliates, or the public float, during any 12-month period. As of November 6, 2023, the Company does not currently have any remaining capacity for sales under the Form S-3 pursuant to General Instruction I.B.6. If the Company’s public float increases, the Company will have additional availability under such limitations, and if the Company’s public float increases to $75 million or more, the Company will no longer be subject to such limitations. There can be no assurance that the Company’s public float will increase or that the Company will no longer be subject to such limitations. | 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, 2022. 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 of a share of Series D preferred stock, par value $0.001 per share, for each outstanding share of the Company's common stock. The Series D preferred stock has the following rights and restrictions: 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 of a Series D preferred stock share transferred for each common stock share transferred. 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: 3. Any plan to change the Company's Certificate of Incorporation for a reverse stock split. 4. 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: 3. The Board decides to redeem the shares at a time and date of their choosing. 4. 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 are classified as mezzanine equity as of December 31, 2022 since they are not mandatorily redeemable but are redeemable based on an event not entirely controlled by the Company. Common Stock The following items represent transactions in the Company’s common stock for the year ended December 31, 2022: ● The Company issued a vendor 5,377 shares of fully vested common stock with a fair value of $9.30 per share on February 7, 2022. ● The Company issued a vendor 6,411 shares of fully vested common stock with a fair value of $7.80 per share on May 6, 2022. ● The Company issued a vendor 3,664 shares of fully vested common stock with a fair value of $13.65 per share on August 5, 2022. ● The Company issued a vendor 1,667 shares of fully vested common stock with a fair value of $7.20 per share on October 4, 2022. ● The Company issued a vendor 5,129 shares of fully vested common stock with a fair value of $9.75 per share on November 7, 2022. ● The Company issued 8,542 shares of common stock pursuant to the B. Riley Sales Agreement at a weighted average price of $9.29 per share. The following items represent transactions in the Company’s common stock for the year ended December 31, 2021: ● The Company issued 2 shares of common stock as a result of a warrant exercise. The weighted average exercise price per share was $59.25 . ● The Company issued 811,646 shares of common stock pursuant to the B. Riley Sales Agreement at a weighted average price of $24.28 per share. ● The Company issued 2,018 shares of common stock as a result of option exercises. The weighted average exercise price per share was $12.81 . ● The Company issued a vendor 1,667 shares of fully vested common stock with a fair value of $16.50 per share on September 29, 2021. All issuances of the Company’s common stock for the years ended December 31, 2022 and 2021 described above, other than shares issued under the B. Riley Sales Agreement and the issuance to vendors, were issued under the 2015 Plan and are registered on a Registration Statement on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates evidencing such shares reflect a Securities Act of 1933, as amended, restrictive legend. The shares issued under the B. Riley Sales Agreement were registered on a Registration Statement on Form S-3 (SEC File No. 333-239928). The issuance of the Company’s common stock to vendors as described above was exempt under Section 4(a)(2) of the Securities Act of 1933, as amended. The vendors 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 sets 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 provides that B. Riley is 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 Company has no obligation to sell any shares under the B. Riley Sales Agreement, and may suspend solicitation and offers under the B. Riley Sales Agreement at any time. The B. Riley Sales Agreement expires on December 31, 2023. The Company’s shelf registration statement on Form S-3 (File No. 333- 217738) filed on May 5, 2017 (the “May 2017 Registration Statement”) with the U.S. Securities and Exchange Commission (the “SEC”) expired on August 10, 2020, but was available to be utilized for a period up to six months or until a new shelf registration statement was declared effective, whichever occurred first. All sales under the B. Riley Sales Agreement from August 11, 2017 through August 10, 2020 were made pursuant to the May 2017 Registration Statement. All sales of common stock made pursuant to the B. Riley Sales Agreement since the expiration of the May 2017 Registration Statement have been, and future sales will be, made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333- 239928) filed on July 17, 2020 (the "July 2020 Registration Statement") with the SEC, and any amendments thereto, the base prospectus filed as part of such registration statement, and any prospectus supplements. The July 2020 Registration Statement was declared effective on August 28, 2020. On August 13, 2021, the Company filed a prospectus supplement relating to the B. Riley Sales Agreement to offer and sell shares of Company common stock having an aggregate offering price of up to $30 million under the July 2020 Registration Statement. As of March 24, 2023, there was $26.6 million available for the sale of common stock under the B. Riley Sales Agreement. The Company is currently subject to the limitations contained in General Instruction I.B.6 of Form S-3. As a result, the Company is limited to selling no more than one-third of the aggregate market value of the equity held by non-affiliates, or the public float, during any 12-month period, and as of March 24, 2023, the Company has approximately $6.6 million remaining that is permitted to be sold under the Form S-3 pursuant to General Instruction I.B.6. If the Company’s public float increases, the Company will have additional availability under such limitations, and if the Company’s public float increases to $75 million or more, the Company will no longer be subject to such limitations. There can be no assurance that the Company’s public float will increase or that the Company will no longer be subject to such limitations. |
Concentrations
Concentrations | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Concentrations | ||
Concentrations | Note 8. Concentrations At September 30, 2023 and 2022, the Company had deposits in major financial institutions that exceeded the amount under protection by the Federal Deposit Insurance Corporation (“FDIC”). Currently, the Company is covered up to $250,000 by the FDIC and at times maintains cash balances in excess of the FDIC coverage. Although the Company currently believes that the financial institutions with whom it does business will be able to fulfill their commitments to the Company, there is no assurance that those institutions will be able to continue to do so. The Company has not experienced any credit losses associated with its balances in such accounts. | Note 9. Concentrations At December 31, 2022 and 2021, the Company had deposits in major financial institutions that exceeded the amount under protection by the Securities Investor Protection Corporation (“SIPC”). Currently, the Company is covered up to $250,000 by the SIPC and at times maintains cash balances in excess of the SIPC coverage. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies. | ||
Commitments and Contingencies | Note 9. Commitments and Contingencies Contractual Obligations The Company has commitments of approximately $205,000 as of September 30, 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 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 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 to October 2025. The current rent of $11,108 per month will be maintained until November 2023 when it will be increased to $11,367 and then will increase to $11,625 in November 2024 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 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 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 September 30, 2023, 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 October 1 through December 31, 2023 $ 21,000 $ 33,841 $ 54,841 2024 46,000 136,917 182,917 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 Total $ 205,000 $ 287,008 $ 492,008 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. CARES Act Employee Retention Credit The Coronavirus Aid, Relief, and Economic Security Act provides for an employee retention credit (“CARES ERC”), which is a refundable tax credit equal to 70% of qualified wages paid to employees during a quarter, capped at $10,000 of qualified wages per employee. The Company qualified for the CARES ERC for qualified wages through September 30, 2021. The Company has submitted filings for refunds of the CARES ERC but cannot reasonably estimate when or if it will receive any or all of the requested refunds. The Company has elected to follow subtopic 450-30 of the FASB Accounting Standards Codification and to account for the CARES ERC only when all uncertainties regarding realization have been resolved. Subsequent to September 30, 2023 and as of the date of this Quarterly Report on Form 10-Q, the Company has received a refund of $120,771 . The refund was recorded as other income during the three and nine months ended September 30, 2023 on the accompanying condensed consolidated statements of operations. 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 its business, operating results, financial condition or cash flows as of and for the nine months ended September 30, 2023 and 2022. 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. Emergent BioSolutions Legal Proceedings In July 2020, the Company filed a demand for arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries (collectively, “Emergent”) with the American Arbitration Association in Mercer County, New Jersey. The Company alleges in the arbitration various breaches of contracts and warranties as well as acts of fraud. Emergent has answered that demand for arbitration denying the allegations and asserting affirmative defenses. The Company presented its case at an arbitration hearing over 12 days in January 2022. Following submission of post-hearing briefs, the arbitration panel heard closing oral arguments in April 2022 (see Part II, Item 1 – Legal Proceedings). The Company was seeking to recover damages in excess of $19 million from Emergent. On July 6, 2022, the American Arbitration Association entered a final decision in connection with this arbitration. Despite the arbitration panel ruling that Emergent had committed a number of breaches of the parties’ contracts, the panel did not award monetary damages to the Company. On September 30, 2022, the Company filed a petition to vacate the arbitration decision with the Delaware Court of Chancery, requesting that the Court vacate the arbitration decision and remand the matter to the arbitration panel for rehearing. After hearing oral arguments, the Court of Chancery granted summary judgment in favor of Emergent on July 17, 2023, thereby confirming the decision of the arbitration panel. | Note 10. Commitments and Contingencies The Company has commitments of approximately $230,000 as of December 31, 2022 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 $11,108 per month and will remain so through October 2023. The rent for lease periods starting November 2023 and November 2024 is approximately $11,367 per month and $11,625 per month, respectively. 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 $38.34 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 $5.0 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, 2022, 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 2023 $ 46,000 $ 133,817 $ 179,817 2024 46,000 136,917 182,917 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 Total $ 230,000 $ 386,984 $ 616,984 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, 2022. 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. Emergent BioSolutions Legal Proceedings On July 1, 2020, the Company filed a demand for arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries (collectively, “Emergent”) with the American Arbitration Association in Mercer County, New Jersey. The Company alleges in the arbitration various breaches of contracts and warranties as well as acts of fraud. Emergent has answered that demand for arbitration denying the allegations and asserting affirmative defenses. The Company presented its case at an arbitration hearing over 12 days in January 2022. Following submission of post-hearing briefs, the arbitration panel heard closing oral arguments in April 2022. The Company sought to recover damages in excess of $19 million from Emergent. On July 6, 2022, the American Arbitration Association entered a final decision in connection with this arbitration. Despite the arbitration panel ruling that Emergent had committed a number of breaches of the parties’ contracts, the panel did not award monetary damages to the Company. On September 30, 2022, the Company filed a petition to vacate the arbitration decision with the Delaware Court of Chancery, requesting that the Court vacate the arbitration decision and remand the matter to the arbitration panel for rehearing. The Company cannot offer any assurances as to any result of its challenge of the arbitration decision or that the Company will recover any damages from Emergent (see Part I, Item 3 – Legal Proceedings). The Company has received invoices from Emergent related to the above matter. No accrual has been made for these invoices as management deems them invalid and not probable of being required to pay them based on the numerous breaches sited in the arbitration. These invoices total approximately $331,000 . |
Related Party Transaction
Related Party Transaction | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transaction | |
Related Party Transaction | Note 10. Related Party Transaction On April 27, 2023, the Company entered into an exclusive option agreement with Silk Road to complete its due diligence assessment. The option agreement granted the Company an exclusive option to purchase all assets and rights, including intellectual property and regulatory documents, related to Silk Road’s PTX product candidate, a non-biological anti-TNF-alpha inhibitor, for the treatment of mucocutaneous ulcers in patient’s suffering from BD and expired on August 25, 2023. In consideration for the option, the Company paid $50,000 of cash and issued 31,646 shares of common stock with a value of $50,000 . The consideration paid for the option was recorded as general and administrative expense during the nine months ended September 30, 2023 on the accompanying condensed consolidated statements of operations. As of August 25, 2023, the Company concluded its due diligence activities and decided to allow the option to expire. A director of the Company has an ownership interest in Silk Road. |
Operating Segments
Operating Segments | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Operating Segments | ||
Operating Segments | 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. Three Months Ended September 30, 2023 2022 Revenues Specialized BioTherapeutics $ — $ — Public Health Solutions 130,440 166,140 Total $ 130,440 $ 166,140 Income (loss) from Operations Specialized BioTherapeutics $ (705,753) $ (1,856,553) Public Health Solutions (24,819) (9,578) Corporate (1,048,484) (1,215,113) Total $ (1,779,056) $ (3,081,244) Amortization and Depreciation Expense Specialized BioTherapeutics $ 954 $ 2,876 Public Health Solutions 159 479 Corporate 476 1,438 Total $ 1,589 $ 4,793 Other (Expense) Income, Net Specialized BioTherapeutics $ 1,683 $ (12,613) Corporate 114,671 (215,146) Total $ 116,354 $ (227,759) Share-Based Compensation Specialized BioTherapeutics $ 27,427 $ 28,343 Public Health Solutions 994 1,054 Corporate 36,979 41,318 Total $ 65,400 $ 70,715 Nine Months Ended September 30, 2023 2022 Revenues Specialized BioTherapeutics $ 223,870 $ — Public Health Solutions 370,677 582,843 Total $ 594,547 $ 582,843 Income (loss) from Operations Specialized BioTherapeutics $ (2,227,430) $ (5,396,630) Public Health Solutions (26,639) (131,201) Corporate (3,306,000) (5,141,095) Total $ (5,560,069) $ (10,668,926) Amortization and Depreciation Expense Specialized BioTherapeutics $ 2,979 $ 8,273 Public Health Solutions 496 1,379 Corporate 1,489 11,886 Total $ 4,964 $ 21,538 Other (Expense) Income, Net Specialized BioTherapeutics $ 17,696 $ 110,975 Corporate 60,341 (641,768) Total $ 78,037 $ (530,793) Share-Based Compensation Specialized BioTherapeutics $ 82,281 $ 85,190 Public Health Solutions 2,982 3,162 Corporate 143,813 132,304 Total $ 229,076 $ 220,656 As of As of September 30, December 31, 2023 2022 Identifiable Assets Specialized BioTherapeutics $ 58,704 $ 103,742 Public Health Solutions 70,557 121,290 Corporate 11,173,568 14,054,685 Total $ 11,302,829 $ 14,279,717 | 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, 2022 2021 Revenues Specialized BioTherapeutics $ 31,929 $ — Public Health Solutions 916,982 824,268 Total $ 948,911 $ 824,268 (Loss) Income from Operations Specialized BioTherapeutics $ (7,614,988) $ (7,216,450) Public Health Solutions 26,612 (542,270) Corporate (6,650,528) (5,340,240) Total $ (14,238,904) $ (13,098,960) Amortization and Depreciation Expense Specialized BioTherapeutics $ 10,087 $ 7,804 Public Health Solutions 1,681 1,301 Corporate 12,794 25,056 Total $ 24,562 $ 34,161 Other (Expense) Income, Net Specialized BioTherapeutics $ 102,320 $ 135,409 Corporate (816,690) (452,164) Total $ (714,370) $ (316,755) Share-Based Compensation Specialized BioTherapeutics $ 138,075 $ 136,594 Public Health Solutions 4,804 21,884 Corporate 190,510 203,081 Total $ 333,389 $ 361,559 As of December 31, 2022 2021 Identifiable Assets Specialized BioTherapeutics $ 103,742 $ 128,645 Public Health Solutions 121,290 146,296 Corporate 14,054,685 26,594,986 Total $ 14,279,717 $ 26,869,927 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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. |
Reclassifications | Reclassifications Certain amounts in the statement of operations for the year ended December 31, 2021 have been reclassified to conform to the current year presentation. | |
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 doubtful accounts has been established. If amounts become uncollectible, they are charged to operations. | Licensing, 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 doubtful accounts has been established. If amounts become uncollectible, they are charged to operations. |
Website Development Costs | Website Development Costs In June 2019, the Company capitalized website development costs of $46,500 in accordance with FASB Codification ASC 350-50 “Accounting for Web Site Development Costs.” The Company began amortizing the website development costs on a straight-line basis over three years , the estimated useful life of the website. The Company reviews its capitalized website development costs periodically for impairment. Website amortization expense for 2022 and 2021 was $7,750 and $15,500 , respectively, and accumulated amortization was $46,500 and $38,750 , respectively, as of December 31, 2022 and 2021. Website development costs were included in other assets in the accompanying consolidated balance sheets. | |
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 no t record any impairment of long-lived assets for the three and nine months ended September 30, 2023 and 2022. | 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, 2022 and 2021. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. Disclosures about the fair value of financial instruments are based on pertinent information available to the Company on September 30, 2023. 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 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 September 30, 2023 for the convertible debt is its fair value - see Note 5. The principal amount of the convertible debt was $3,000,000 at September 30, 2023 and the fair value was approximately $2,916,463 . 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 September 30, 2023 is as follows: Balance, December 31, 2022 Issued Adjustment to fair value Balance, September 30, 2023 Convertible debt at fair value $ - $ 3,304,000 $ (387,537) $ 2,916,463 | Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. Disclosures about the fair value of financial instruments are based on pertinent information available to the Company on December 31, 2022 and 2021. 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. The carrying amounts reported in the consolidated balance sheets for cash and cash equivalents, licensing, contracts and/or 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 sheets for convertible debt approximates its fair value based on its interest rate and maturity date. |
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. | |
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 . Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. 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 . Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. 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 includes costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, equipment depreciation and allocation of various corporate 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 includes costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, equipment depreciation and allocation of various corporate costs. |
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 (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 nine months ended September 30, 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 4 years ; ● volatility of 94% for 2023 and 87% for 2022; and ● risk free interest rates of 3.48% for 2023 and ranging from 1.12% - 3.23% for 2022. The fair value of each option grant made during the nine months ended September 30, 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. | 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, 2022 and 2021 was estimated using the Black-Scholes option-pricing model and the following assumptions: ● a dividend yield of 0% ; ● an expected life of 4 years ; ● volatility of 84% - 87% for 2022 and 2021; and ● risk-free interest rates ranging from 1.12% to 4.51% in 2022 and 0.27% to 1.13% in 2021. The fair value of each option grant made during 2022 and 2021 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. |
Foreign Currency Transactions and Translation | Foreign Currency Transactions and Translation In accordance with FASB ASC 830 Foreign Currency Matters , the UK subsidiary expresses its U.S. dollar and Euro denominated transactions in its functional currency, the British Pound, with related transaction gains or losses included in net loss. On a quarterly basis, the financial statements of the UK subsidiary are translated into U.S. dollars and consolidated into the Company’s financials, with related translation adjustments reported as a cumulative translation adjustment (“CTA”), which is a component of accumulated other comprehensive income. During the three months ended September 30, 2023 and 2022, the Company recognized foreign currency transaction losses of ($3,046) and ($12,613) , respectively, in the accompanying condensed consolidated statements of operations. During the nine months ended September 30, 2023 and 2022, the Company recognized a foreign currency transaction gain of $310 and a foreign currency transaction loss of ($26,006) , respectively, in the accompanying condensed consolidated statements of operations. | 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 , the UK subsidiary expresses its U.S. dollar and Euro denominated transactions in its functional currency, the British Pound, with related transaction gains or losses included in net loss. On a quarterly basis, the financial statements of the UK subsidiary are translated into U.S. dollars and consolidated into the Company’s financials, with related translation adjustments reported as a cumulative translation adjustment (“CTA”), which is a component of accumulated other comprehensive loss. In 2022 and 2021, the Company recognized foreign currency transaction losses of $30,549 and $39,361 , respectively, in the accompanying consolidated statements of operations. |
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 recognized an income tax benefit of $1,161,197 and $1,154,935 from the sale of 2021 and 2020 New Jersey NOL carryforwards during the nine months ended September 30, 2023 and 2022, respectively. 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 nine months ended September 30, 2023 and 2022. Additionally, the Company has no t recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at September 30, 2023 or December 31, 2022. | 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 recognized an income tax benefit of $1,154,935 and $864,742 from the sale of 2020 and 2019 New Jersey NOL carryforwards during the years ended December 31, 2022 and 2021, respectively. 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 2022 and 2021. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2022 or 2021. |
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 $41,000 and $128,000 as of September 30, 2023 and December 31, 2022, respectively, in the condensed consolidated balance sheets. The following table shows the change in the UK research and development incentives receivable from December 31, 2022 to September 30, 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 — 18,536 18,536 Adjustments to 2021 and 2022 incentives earned (1,150) — (1,150) UK research and development incentives cash receipt (104,422) — (104,422) Foreign currency translation 112 (230) (118) Balance at September 30, 2023 $ 22,852 $ 18,306 $ 41,158 | 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 $128,000 and $225,000 as of December 31, 2022 and 2021, respectively in the consolidated balance sheets. The following table shows the change in the UK research and development incentives receivable from December 31, 2021 to December 31, 2022: Current Long-Term Total Balance at December 31, 2021 $ 103,832 $ 121,238 $ 225,070 UK research and development incentives, transfer 121,238 (121,238) — UK research and development incentives — 24,963 24,963 Additional 2020 incentive earned 107,906 — 107,906 UK research and development incentives cash receipt (209,166) — (209,166) Foreign currency translation (19,612) (849) (20,461) Balance at December 31, 2022 $ 104,198 $ 24,114 $ 128,312 |
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 and nine months ended September 30, 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: As of September 30, 2023 2022 Common stock purchase warrants 6,538,500 3,992 Stock options 206,589 145,505 Convertible debt 2,159,414 162,602 Total 8,904,503 312,099 The weighted average exercise prices of the Company’s warrants and stock options outstanding at September 30, 2023 were $1.50 and $24.83 per share, respectively. The weighted average exercise prices of the Company’s warrants and stock options outstanding at September 30, 2022 were $36.12 and $34.49 per share, respectively. The weighted average conversion price of the Company’s convertible debt at September 30, 2023 and 2022 was $1.39 and $61.50 per share, respectively. 217,880 of the Company’s common stock warrants associated with the July 2018 public offering expired on January 2, 2022 and 667 of the Company’s common stock warrants associated with the opening of the first clinical site in the United Kingdom expired on March 28, 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. 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, 2022 2021 Common stock purchase warrants 667 221,872 Stock options 192,273 140,996 Convertible debt 162,602 162,602 Total 355,542 525,470 |
Use of Estimates and Assumptions | 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. | 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) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Summary of Significant Accounting Policies | ||
Schedule of carrying value of convertible debt | A roll forward of the carrying value of the convertible debt to September 30, 2023 is as follows: Balance, December 31, 2022 Issued Adjustment to fair value Balance, September 30, 2023 Convertible debt at fair value $ - $ 3,304,000 $ (387,537) $ 2,916,463 | |
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 — 18,536 18,536 Adjustments to 2021 and 2022 incentives earned (1,150) — (1,150) UK research and development incentives cash receipt (104,422) — (104,422) Foreign currency translation 112 (230) (118) Balance at September 30, 2023 $ 22,852 $ 18,306 $ 41,158 | Current Long-Term Total Balance at December 31, 2021 $ 103,832 $ 121,238 $ 225,070 UK research and development incentives, transfer 121,238 (121,238) — UK research and development incentives — 24,963 24,963 Additional 2020 incentive earned 107,906 — 107,906 UK research and development incentives cash receipt (209,166) — (209,166) Foreign currency translation (19,612) (849) (20,461) Balance at December 31, 2022 $ 104,198 $ 24,114 $ 128,312 |
Schedule of potentially dilutive adjustments to the weighted average number of common shares excluded from the calculation | As of September 30, 2023 2022 Common stock purchase warrants 6,538,500 3,992 Stock options 206,589 145,505 Convertible debt 2,159,414 162,602 Total 8,904,503 312,099 | December 31, December 31, 2022 2021 Common stock purchase warrants 667 221,872 Stock options 192,273 140,996 Convertible debt 162,602 162,602 Total 355,542 525,470 |
Leases (Tables)
Leases (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Leases | ||
Schedule of lease expense | Operating Lease Right-of-use lease asset: Right-of-use lease asset, January 1, 2023 $ 340,987 Less: reduction/amortization 82,500 Right-of-use lease asset, September 30, 2023 $ 258,487 Lease liability: Lease liability, January 1, 2023 $ 342,575 Less: repayments 80,458 Lease liability, September 30, 2023 $ 262,117 Lease expense for the nine months ended September 30, 2023: Lease expense $ 102,016 Total $ 102,016 Lease expense for the nine months ended September 30, 2022: Lease expense $ 100,887 Total $ 100,887 Contractual cash payments for the remaining lease term as of September 30, 2023: 2023 $ 33,841 2024 136,917 2025 116,250 Total $ 287,008 Remaining lease term (months) as of September 30, 2023 25 | Operating Lease Contractual cash payments for the remaining lease term as of December 31, 2022 2023 $ 133,817 2024 136,917 2025 116,250 Total $ 386,984 Discount rate applied 8.47 % Remaining lease term (months) as of December 31, 2022 34 Right-of-use lease asset: Right-of-use lease asset, January 1, 2021 $ 222,445 Less: reduction/amortization 116,290 Right-of-use lease asset, December 31, 2021 106,155 New lease extension June 21, 2022 347,546 Reduction/amortization 112,714 Right of use lease asset, December 31, 2022 $ 340,987 Lease liability: Lease liability, January 1, 2021 $ 222,441 Less: repayments 116,290 Lease liability, December 31, 2021 106,151 New lease extension June 21, 2022 347,546 Less: repayments 111,122 Lease liability, December 31, 2022 $ 342,575 Lease expense for the year ended December 31, 2021: Lease expense $ 133,300 Total $ 133,300 Lease expense for the year ended December 31, 2022: Lease expense $ 134,892 Total $ 134,892 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Accrued Expenses | ||
Schedule of accrued expenses | September 30, December 31, 2023 2022 Clinical trial expenses $ 2,082,200 $ 1,884,117 Other 304,636 423,629 Total $ 2,386,836 $ 2,307,746 | December 31, 2022 2021 Clinical trial expenses $ 1,884,117 $ 2,625,779 Other 423,629 330,766 Total $ 2,307,746 $ 2,956,545 |
Debt (Tables)
Debt (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Debt | ||
Debt Assumptions | Assumptions 4/19/2023 9/30/2023 Stock price $ 1.72 $ 0.56 Volatility 75.20% 110.50% Discount rate 16.28% 14.84% Risk-free rate 4.27% 5.24% | |
Schedule of annual principle and interest payments due | Year Principal Interest Total 2023 $ — $ 128,094 $ 128,094 2024 2,250,000 206,761 2,456,761 2025 750,000 16,012 766,012 Total $ 3,000,000 $ 350,867 $ 3,350,867 | Year Principal Interest Total 2023 $ 4,000,000 $ 634,438 $ 4,634,438 2024 4,000,000 295,638 4,295,638 2025 2,000,000 21,349 2,021,349 Total $ 10,000,000 $ 951,425 $ 10,951,425 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies. | ||
Schedule of contractual obligation | Research and Property and Year Development Other Leases Total October 1 through December 31, 2023 $ 21,000 $ 33,841 $ 54,841 2024 46,000 136,917 182,917 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 Total $ 205,000 $ 287,008 $ 492,008 | Research and Property and Year Development Other Leases Total 2023 $ 46,000 $ 133,817 $ 179,817 2024 46,000 136,917 182,917 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 Total $ 230,000 $ 386,984 $ 616,984 |
Operating Segments (Tables)
Operating Segments (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Operating Segments | ||
Schedule of operating segments | Three Months Ended September 30, 2023 2022 Revenues Specialized BioTherapeutics $ — $ — Public Health Solutions 130,440 166,140 Total $ 130,440 $ 166,140 Income (loss) from Operations Specialized BioTherapeutics $ (705,753) $ (1,856,553) Public Health Solutions (24,819) (9,578) Corporate (1,048,484) (1,215,113) Total $ (1,779,056) $ (3,081,244) Amortization and Depreciation Expense Specialized BioTherapeutics $ 954 $ 2,876 Public Health Solutions 159 479 Corporate 476 1,438 Total $ 1,589 $ 4,793 Other (Expense) Income, Net Specialized BioTherapeutics $ 1,683 $ (12,613) Corporate 114,671 (215,146) Total $ 116,354 $ (227,759) Share-Based Compensation Specialized BioTherapeutics $ 27,427 $ 28,343 Public Health Solutions 994 1,054 Corporate 36,979 41,318 Total $ 65,400 $ 70,715 Nine Months Ended September 30, 2023 2022 Revenues Specialized BioTherapeutics $ 223,870 $ — Public Health Solutions 370,677 582,843 Total $ 594,547 $ 582,843 Income (loss) from Operations Specialized BioTherapeutics $ (2,227,430) $ (5,396,630) Public Health Solutions (26,639) (131,201) Corporate (3,306,000) (5,141,095) Total $ (5,560,069) $ (10,668,926) Amortization and Depreciation Expense Specialized BioTherapeutics $ 2,979 $ 8,273 Public Health Solutions 496 1,379 Corporate 1,489 11,886 Total $ 4,964 $ 21,538 Other (Expense) Income, Net Specialized BioTherapeutics $ 17,696 $ 110,975 Corporate 60,341 (641,768) Total $ 78,037 $ (530,793) Share-Based Compensation Specialized BioTherapeutics $ 82,281 $ 85,190 Public Health Solutions 2,982 3,162 Corporate 143,813 132,304 Total $ 229,076 $ 220,656 As of As of September 30, December 31, 2023 2022 Identifiable Assets Specialized BioTherapeutics $ 58,704 $ 103,742 Public Health Solutions 70,557 121,290 Corporate 11,173,568 14,054,685 Total $ 11,302,829 $ 14,279,717 | For the Years Ended December 31, 2022 2021 Revenues Specialized BioTherapeutics $ 31,929 $ — Public Health Solutions 916,982 824,268 Total $ 948,911 $ 824,268 (Loss) Income from Operations Specialized BioTherapeutics $ (7,614,988) $ (7,216,450) Public Health Solutions 26,612 (542,270) Corporate (6,650,528) (5,340,240) Total $ (14,238,904) $ (13,098,960) Amortization and Depreciation Expense Specialized BioTherapeutics $ 10,087 $ 7,804 Public Health Solutions 1,681 1,301 Corporate 12,794 25,056 Total $ 24,562 $ 34,161 Other (Expense) Income, Net Specialized BioTherapeutics $ 102,320 $ 135,409 Corporate (816,690) (452,164) Total $ (714,370) $ (316,755) Share-Based Compensation Specialized BioTherapeutics $ 138,075 $ 136,594 Public Health Solutions 4,804 21,884 Corporate 190,510 203,081 Total $ 333,389 $ 361,559 As of December 31, 2022 2021 Identifiable Assets Specialized BioTherapeutics $ 103,742 $ 128,645 Public Health Solutions 121,290 146,296 Corporate 14,054,685 26,594,986 Total $ 14,279,717 $ 26,869,927 |
Nature of Business (Details)
Nature of Business (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||||||||
Nov. 06, 2023 USD ($) $ / shares shares | May 09, 2023 USD ($) $ / shares shares | May 02, 2023 $ / shares shares | Apr. 27, 2023 shares | Feb. 10, 2023 | Feb. 09, 2023 shares | Nov. 07, 2022 shares | Oct. 04, 2022 shares | Aug. 05, 2022 shares | Feb. 07, 2022 shares | Sep. 29, 2021 shares | Sep. 30, 2023 USD ($) shares | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) segment shares | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) segment shares | Dec. 31, 2021 USD ($) shares | Mar. 22, 2023 USD ($) | Dec. 31, 2020 USD ($) | |
Nature of business: | |||||||||||||||||||
Number of operating segments | segment | 2 | 2 | |||||||||||||||||
Accumulated deficit | $ (223,884,281) | $ (223,884,281) | $ (219,563,446) | $ (205,765,107) | |||||||||||||||
Net loss | (1,662,702) | $ (3,309,003) | (4,320,835) | $ (10,044,784) | (13,798,339) | (12,550,973) | |||||||||||||
Net cash used in operating activities | (6,775,896) | (9,021,880) | (12,649,021) | (11,739,620) | |||||||||||||||
Reclassification of convertible debt from current to non-current liability | 1,416,463 | ||||||||||||||||||
Number of shares sold | 3,091,462 | 79,354 | 19,705,647 | ||||||||||||||||
Cash and cash equivalents | 10,298,534 | 16,865,642 | 10,298,534 | 16,865,642 | 13,359,615 | 26,043,897 | $ 18,676,663 | ||||||||||||
Net decrease in cash | $ 3,061,081 | 9,178,255 | $ 12,684,282 | (7,367,234) | |||||||||||||||
Percentage change in cash and cash equivalent | 23% | 49% | |||||||||||||||||
Accumulated deficit | 223,884,281 | $ 223,884,281 | $ 219,563,446 | 205,765,107 | |||||||||||||||
Working capital | 5,450,322 | 5,450,322 | (2,663,721) | 20,278,345 | |||||||||||||||
Working capital increase, decrease | $ (8,114,043) | 2,663,721 | $ (22,942,066) | ||||||||||||||||
Working capital increase (decrease) as a percent | 305% | 113% | |||||||||||||||||
Government grant funding | $ 66,051 | $ 66,051 | $ 115,130 | $ 138,889 | |||||||||||||||
Common Stock, Shares, Issued | shares | 10,378,238 | 10,378,238 | 2,908,578 | 2,858,244 | |||||||||||||||
Number of shares issued | shares | 50,000 | 5,129 | 1,667 | 3,664 | 5,377 | 1,667 | |||||||||||||
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 | |||||||||||||||||
Fractional shares issue under reverse stock split | shares | 0 | ||||||||||||||||||
Repayment of debt principal | $ 7,000,000 | ||||||||||||||||||
Consideration paid recorded in general and administrative expense | $ 973,040 | $ 1,326,249 | 3,098,949 | $ 5,250,510 | $ 6,692,904 | $ 5,008,738 | |||||||||||||
Issuance of common stock in connection with Silk Roads purchase option | 50,000 | ||||||||||||||||||
Public Offering | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Proceeds from Issuance of Common Stock | $ 8,500,000 | ||||||||||||||||||
Shares issued price per share | $ / shares | $ 1.30 | ||||||||||||||||||
Exercise price of warrants | $ / shares | $ 0.001 | ||||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||||
At Market Issuance Sales Agreement | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Proceeds from Issuance of Common Stock | 7,700,000 | ||||||||||||||||||
Number of shares sold | 3,000,000 | ||||||||||||||||||
Common Stock | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Number of shares sold | $ 851 | 8 | $ 812 | ||||||||||||||||
Issuance of common stock in connection with Silk Roads purchase option (in shares) | shares | 31,646 | ||||||||||||||||||
Issuance of common stock in connection with Silk Roads purchase option | $ 32 | ||||||||||||||||||
Common Stock | Public Offering | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Shares issued price per share | $ / shares | $ 1.30 | ||||||||||||||||||
Number of shares issued | shares | 2,301,500 | ||||||||||||||||||
Exercise price of warrants | $ / shares | $ 1.50 | ||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 | |||||||||||||||||
Pre-funded warrants | Public Offering | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Number of common warrants to purchase shares issued | shares | 4,237,000 | ||||||||||||||||||
Common warrants | Public Offering | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Number of common warrants to purchase shares issued | shares | 6,538,500 | ||||||||||||||||||
Exercise price of warrants | $ / shares | $ 1.50 | ||||||||||||||||||
CiVax | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Revenue from collaborative arrangement | $ 1,500,000 | $ 1,500,000 | |||||||||||||||||
Term (in years) | P2Y | two years | |||||||||||||||||
HyBryte | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Revenue from collaborative arrangement | $ 1,100,000 | $ 1,100,000 | |||||||||||||||||
Term (in years) | P4Y | four years | |||||||||||||||||
NIH | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Government grant funding | $ 1,000,000 | $ 1,000,000 | $ 1,700,000 | ||||||||||||||||
DTRA | Contract revenue | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Revenue from collaborative arrangement | $ 600,000 | ||||||||||||||||||
Term (in years) | three years | ||||||||||||||||||
Exclusive option agreement | Silk Road | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Consideration paid recorded in general and administrative expense | $ 50,000 | ||||||||||||||||||
Exclusive option agreement | Common Stock | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Shares issued price per share | $ / shares | $ 1.58 | ||||||||||||||||||
Number of shares issued | shares | 31,646 | ||||||||||||||||||
Exclusive option agreement | Common Stock | Silk Road | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Issuance of common stock in connection with Silk Roads purchase option (in shares) | shares | 31,646 | ||||||||||||||||||
Issuance of common stock in connection with Silk Roads purchase option | $ 50,000 | ||||||||||||||||||
B Riley Sales Agreement [Member] | Underwritten public offering | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Maximum Percentage Of Shares Available For Sale Of Market Value | 33.33% | ||||||||||||||||||
B Riley Sales Agreement [Member] | Subsequent Event | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Proceeds from Issuance of Common Stock | $ 3,091,462 | ||||||||||||||||||
Common stock available for sale (in Dollars) | $ 23,600,000 | $ 26,600,000 | |||||||||||||||||
Maximum Percentage Of Shares Available For Sale Of Market Value | 33.33% | ||||||||||||||||||
Shares issued price per share | $ / shares | $ 3.63 | ||||||||||||||||||
Common Stock, Shares, Issued | shares | 851,130 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Jun. 30, 2019 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2019 | Sep. 30, 2023 USD ($) segment | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) segment shares | Dec. 31, 2021 USD ($) shares | Apr. 19, 2023 USD ($) | Dec. 31, 2020 USD ($) | |
Finite-Lived Intangible Assets [Line Items] | ||||||||||
Number of operating segments | segment | 2 | 2 | ||||||||
Website development cost | $ 46,500 | |||||||||
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% | 0% | 0% | ||||||
Expected life | 4 years | 4 years | 4 years | |||||||
Volatility rate | 94% | 87% | ||||||||
Volatility rate minimum | 84% | 84% | ||||||||
Volatility rate maximum | 87% | 87% | ||||||||
Risk-free interest rate | 3.48% | |||||||||
Risk free interest rate, minimum | 1.12% | 1.12% | 0.27% | |||||||
Risk free interest rate, maximum | 3.23% | 4.51% | 1.13% | |||||||
Foreign currency transaction gain (loss) | (3,046) | (12,613) | $ 310 | $ (26,006) | $ (30,549) | $ (39,361) | ||||
Income tax benefit | (1,161,197) | (1,154,935) | (1,154,935) | (864,742) | ||||||
Interest and penalties | 0 | $ 0 | 0 | $ 0 | 0 | 0 | ||||
Unrecognized Tax Benefits | 0 | 0 | $ 0 | $ 0 | ||||||
Number of options issued | shares | 55,730 | 32,925 | ||||||||
Convertible debt fair value | 2,916,463 | 2,916,463 | ||||||||
Convertible Debt | ||||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||||
Debt instrument, face amount | 3,000,000 | 3,000,000 | $ 20,000,000 | |||||||
Convertible debt fair value | $ 2,916,463 | $ 2,916,463 | $ 3,304,000 | |||||||
Warrants | ||||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||||
DO NOT USE FOR WARRANTS Expired (in shares) | shares | (221,205) | (160,225) | ||||||||
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 | ||||||||
Website development | ||||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||||
Intangible assets, estimated useful life | 3 years | |||||||||
Intangible, amortization expense | $ 7,750 | $ 15,500 | ||||||||
Intangible, accumulated amortization | $ 46,500 | $ 38,750 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Carrying Value of Convertible Debt (Details) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | |
Debt instruments | ||
Adjustment to fair value | $ 72,463 | $ (387,537) |
Convertible Debt | ||
Debt instruments | ||
Issued | 3,304,000 | |
Adjustment to fair value | (72,463) | (387,537) |
Convertible debt at fair value as of September 30, 2023 | $ 2,916,463 | $ 2,916,463 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Research and Development Incentives (Details) - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Research and development incentive receivable, total | $ 41,000 | $ 128,000 | $ 225,000 |
Incentives receivable, Beginning balance | 128,312 | 225,070 | |
UK research and development incentives | 18,536 | 24,963 | |
Adjustments to 2021 and 2022 incentives earned | (1,150) | ||
Additional 2019 incentive earned | 107,906 | ||
UK research and development incentives cash receipt | (104,422) | (209,166) | |
Foreign currency translation | (118) | (20,461) | |
Incentives receivable, Ending balance | 41,158 | 128,312 | |
Current Receivables | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Incentives receivable, Beginning balance | 104,198 | 103,832 | |
UK research and development incentives, transfer | 24,114 | 121,238 | |
Adjustments to 2021 and 2022 incentives earned | (1,150) | ||
Additional 2019 incentive earned | 107,906 | ||
UK research and development incentives cash receipt | (104,422) | (209,166) | |
Foreign currency translation | 112 | (19,612) | |
Incentives receivable, Ending balance | 22,852 | 104,198 | |
Long Term Receivable | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Incentives receivable, Beginning balance | 24,114 | 121,238 | |
UK research and development incentives, transfer | (24,114) | (121,238) | |
UK research and development incentives | 18,536 | 24,963 | |
Foreign currency translation | (230) | (849) | |
Incentives receivable, Ending balance | $ 18,306 | $ 24,114 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Loss per share, Warrants and Options expirations (Details) - $ / shares | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 28, 2023 | Jan. 02, 2022 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||
Securities excluded | 8,904,503 | 312,099 | 355,542 | 525,470 | |||
Weighted average exercise price, outstanding warrants | $ 1.50 | $ 36.12 | |||||
Weighted average exercise price, outstanding options | 24.83 | 34.49 | $ 27.56 | $ 37.12 | $ 44.41 | ||
Common Stock Warrants, Number Of Expirations | 667 | 217,880 | |||||
Weighted Average | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||
Conversion price | $ 1.39 | $ 61.50 | |||||
Warrants | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||
Securities excluded | 6,538,500 | 3,992 | 667 | 221,872 | |||
Stock options | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||
Securities excluded | 206,589 | 145,505 | 192,273 | 140,996 | |||
Convertible debt securities | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||
Securities excluded | 2,159,414 | 162,602 | 162,602 | 162,602 |
Leases (Details)
Leases (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Jun. 21, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Lessee, Lease, Description [Line Items] | |||||
Lease rent per month | $ 11,108 | ||||
Right-of-use asset, operating lease | $ 258,487 | $ 340,987 | $ 106,155 | $ 222,445 | |
Lease liability, operating | 262,117 | 342,575 | $ 106,151 | $ 222,441 | |
For Period Till November 2023 | |||||
Lessee, Lease, Description [Line Items] | |||||
Lease rent per month | 11,108 | 11,108 | 11,367 | ||
From Period Till November 2024 | |||||
Lessee, Lease, Description [Line Items] | |||||
Lease rent per month | 11,367 | 11,367 | $ 11,625 | ||
From Period Till Lease Expiration 2024 | |||||
Lessee, Lease, Description [Line Items] | |||||
Lease rent per month | $ 11,625 | $ 11,625 |
Leases - Reconciliation (Detail
Leases - Reconciliation (Details) - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Right-of-use lease asset: | ||||
Right-of-use lease asset, Beginning balance | $ 340,987 | $ 106,155 | $ 106,155 | $ 222,445 |
Less: reduction/amortization | 82,500 | 112,714 | 116,290 | |
Right-of-use lease asset, Ending balance | 258,487 | 340,987 | 106,155 | |
Lease liability: | ||||
Lease liability, Beginning | 342,575 | 106,151 | 106,151 | 222,441 |
Less: repayments | 80,458 | 111,122 | 116,290 | |
Lease liability, Ending | 262,117 | 342,575 | 106,151 | |
Lease expense | ||||
Lease expense | 102,016 | $ 100,887 | 134,892 | $ 133,300 |
Contractual cash payments for the remaining lease term | ||||
2023 | 33,841 | |||
2024 | 136,917 | 133,817 | ||
2025 | 116,250 | 136,917 | ||
2025 | 116,250 | |||
Total | $ 287,008 | $ 386,984 | ||
Operating Lease, Discount rate applied | 8.47% | |||
Remaining lease term (months) | 25 years | 34 months |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Expenses | |||
Clinical trail expenses | $ 2,082,200 | $ 1,884,117 | $ 2,625,779 |
Other | 304,636 | 423,629 | 330,766 |
Total | $ 2,386,836 | $ 2,307,746 | $ 2,956,545 |
Debt (Details)
Debt (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Apr. 19, 2023 | Apr. 18, 2023 | Dec. 16, 2020 | Dec. 31, 2020 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Debt instruments | ||||||||||
Outstanding principal | $ 1,416,463 | $ 1,416,463 | $ 0 | $ 9,856,153 | ||||||
Loss on extinguishment of debt | (393,791) | 421,584 | ||||||||
Convertible debt fair value | 2,916,463 | 2,916,463 | ||||||||
Change in fair value of convertible debt | 72,463 | (387,537) | ||||||||
Convertible Debt | ||||||||||
Debt instruments | ||||||||||
Debt instrument, face amount | $ 20,000,000 | 3,000,000 | 3,000,000 | |||||||
Number of tranches | three | |||||||||
Interest rate percentage | 8.47% | |||||||||
Interest-only period | 2 years | |||||||||
Outstanding principal periodic payment | $ 1,000,000 | |||||||||
Unused line of credit fee, as a percent | 1% | 1% | ||||||||
Interest expense | 64,047 | $ 213,490 | 338,568 | $ 633,510 | 847,000 | 894,808 | ||||
Interest paid | 63,351 | $ 211,170 | 488,011 | $ 643,921 | $ 857,411 | $ 668,715 | ||||
Conversion price (in Dollars per share) | $ 61.50 | |||||||||
Loss on extinguishment of debt | (394,000) | |||||||||
Convertible debt fair value | $ 3,304,000 | 2,916,463 | 2,916,463 | |||||||
Change in fair value of convertible debt | $ (72,463) | $ (387,537) | ||||||||
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 | 588,599 | |||||||||
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% | |||||||||
Reduction in conversion price | $ 1.70 |
Debt - (Assumptions) (Details)
Debt - (Assumptions) (Details) | 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 | 0.56 | 1.72 |
Measurement Input, Price Volatility [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt Instrument, Measurement Input | 1.1050 | 0.7520 |
Measurement Input, Discount Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt Instrument, Measurement Input | 0.1484 | 0.1628 |
Measurement Input, Risk Free Interest Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt Instrument, Measurement Input | 0.0524 | 0.0427 |
Debt- Payments due (Details)
Debt- Payments due (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Debt instruments | ||
2023 | $ 128,094 | |
2024 | 2,456,761 | $ 4,634,438 |
2025 | 766,012 | 4,295,638 |
2025 | 2,021,349 | |
Total | 3,350,867 | 10,951,425 |
Principal [Member] | ||
Debt instruments | ||
2024 | 2,250,000 | 4,000,000 |
2025 | 750,000 | 4,000,000 |
2025 | 2,000,000 | |
Total | 3,000,000 | 10,000,000 |
Interest [Member] | ||
Debt instruments | ||
2023 | 128,094 | |
2024 | 206,761 | 634,438 |
2025 | 16,012 | 295,638 |
2025 | 21,349 | |
Total | $ 350,867 | $ 951,425 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Income Taxes | |||
NOL for Federal tax | $ 124,000,000 | ||
NOL for State tax | 13,200,000 | ||
NOL for Foreign tax | 1,400,000 | ||
Various tax credits, amount | $ 8,800,000 | 8,800,000 | |
NOL carryforwards | $ 1,161,197 | 1,154,935 | $ 864,742 |
Interest or penalties accrued | $ 0 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) | 9 Months Ended | 12 Months Ended | |||||||||||||||||||||
Nov. 06, 2023 USD ($) $ / shares | Sep. 06, 2023 $ / shares shares | Jun. 08, 2023 $ / shares shares | May 22, 2023 $ / shares shares | May 10, 2023 $ / shares shares | May 09, 2023 USD ($) $ / 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 shares | May 06, 2022 $ / shares shares | Feb. 07, 2022 $ / shares shares | Sep. 29, 2021 $ / shares shares | Aug. 11, 2017 | Sep. 30, 2023 Vote $ / shares shares | Dec. 31, 2022 Vote $ / shares shares | Dec. 31, 2021 $ / shares shares | Mar. 24, 2023 USD ($) | Mar. 22, 2023 USD ($) | Aug. 13, 2021 USD ($) | Dec. 31, 2020 shares | |
Class of Stock [Line Items] | |||||||||||||||||||||||
Preferred stock, shares authorized | 350,000 | 300,000 | 350,000 | ||||||||||||||||||||
Preferred stock, shares issued | 0 | 0 | 0 | ||||||||||||||||||||
Number of shares issued | 50,000 | 5,129 | 1,667 | 3,664 | 5,377 | 1,667 | |||||||||||||||||
Fair value per share | $ / shares | $ 1.46 | $ 9.75 | $ 7.20 | $ 13.65 | $ 7.80 | $ 9.30 | $ 16.50 | ||||||||||||||||
Common Stock, Value, Subscriptions | $ | $ 30,000,000 | ||||||||||||||||||||||
Shares issues (in shares) | 851,130 | 192,273 | 140,996 | 128,858 | |||||||||||||||||||
Weighted average price per share (in Dollars per share) | $ / shares | $ 3.63 | $ 8.85 | $ 13.68 | ||||||||||||||||||||
Shares issued on option exercises | 6,411 | 2,018 | |||||||||||||||||||||
Weighted average exercise price | $ / shares | $ 12.81 | ||||||||||||||||||||||
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% | ||||||||||||||||||||||
Common Stock, Value, Subscriptions | $ | 26,600,000 | ||||||||||||||||||||||
B Riley Sales Agreement [Member] | Subsequent Event | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Shares issued price per share | $ / shares | $ 3.63 | ||||||||||||||||||||||
Total gross proceeds | $ | $ 3,091,462 | ||||||||||||||||||||||
Common Stock, Value, Subscriptions | $ | $ 6,600,000 | ||||||||||||||||||||||
Common stock available for sale (in Dollars) | $ | $ 23,600,000 | $ 26,600,000 | |||||||||||||||||||||
B Riley Sales Agreement [Member] | Maximum | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Aggregate offering price (in Dollars) | $ | $ 30,000,000 | ||||||||||||||||||||||
Pre-funded warrants | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Warrants Issued | 4,237,000 | ||||||||||||||||||||||
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 | 0.001 | |||||||||||||||||||||
Number of votes per Series D preferred stock | Vote | 1,000,000 | 1,000,000 | |||||||||||||||||||||
Liquidation, cash payment per share | $ / shares | $ 0.001 | $ 0.001 | |||||||||||||||||||||
Threshold number of shares redeemed | 100 | 100 | |||||||||||||||||||||
Redemption price per share | $ / shares | $ 0.10 | $ 0.10 | |||||||||||||||||||||
Public Offering | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Shares issued price per share | $ / shares | $ 1.30 | ||||||||||||||||||||||
Exercise price of warrants | $ / shares | $ 0.001 | ||||||||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||||||||
Total gross proceeds | $ | $ 8,500,000 | ||||||||||||||||||||||
Public Offering | Pre-funded warrants | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Number of common warrants to purchase shares issued | 4,237,000 | ||||||||||||||||||||||
Exercise price of warrants | $ / shares | $ 0.001 | ||||||||||||||||||||||
Warrants outstanding | 0 | ||||||||||||||||||||||
Public Offering | Common warrants | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Number of common warrants to purchase shares issued | 6,538,500 | ||||||||||||||||||||||
Exercise price of warrants | $ / shares | $ 1.50 | ||||||||||||||||||||||
FBR Capital Markets & Co. [Member] | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Shares issues (in shares) | 8,542 | ||||||||||||||||||||||
Weighted average price per share (in Dollars per share) | $ / shares | $ 9.29 | ||||||||||||||||||||||
Common Stock | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Warrants issued to purchase shares | 2 | ||||||||||||||||||||||
Warrants exercise price (in Dollars per share) | $ / shares | $ 59.25 | ||||||||||||||||||||||
Shares issued on option exercises | 2,018 | ||||||||||||||||||||||
Common Stock | Exclusive option agreement | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Number of shares issued | 31,646 | ||||||||||||||||||||||
Shares issued price per share | $ / shares | $ 1.58 | ||||||||||||||||||||||
Period considered for average closing price | 10 days | ||||||||||||||||||||||
Common Stock | Pre-funded warrants | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Exercise price of warrants | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||||||||||
Number of shares issued on exercise of warrants | 536,384 | 400,000 | 338,000 | 938,000 | 2,023,000 | ||||||||||||||||||
Common Stock | B. Riley Sales Agreement | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Weighted average price per share (in Dollars per share) | $ / shares | $ 24.28 | ||||||||||||||||||||||
Common Stock | Public Offering | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Number of shares issued | 2,301,500 | ||||||||||||||||||||||
Shares issued price per share | $ / shares | $ 1.30 | ||||||||||||||||||||||
Exercise price of warrants | $ / shares | $ 1.50 | ||||||||||||||||||||||
Common Stock | FBR Capital Markets & Co. [Member] | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Shares issues (in shares) | 811,646 | ||||||||||||||||||||||
Preferred Stock | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Preferred stock, shares authorized | 350,000 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||||
Apr. 27, 2023 shares | Nov. 07, 2022 shares | Oct. 04, 2022 shares | Aug. 05, 2022 shares | Feb. 07, 2022 shares | Sep. 29, 2021 shares | Jul. 01, 2020 USD ($) | Nov. 03, 2014 USD ($) shares | Jul. 31, 2020 USD ($) | Mar. 31, 2020 $ / shares shares | Jan. 31, 2020 USD ($) | Sep. 30, 2014 USD ($) shares | Sep. 30, 2023 USD ($) ft² | Sep. 30, 2023 USD ($) ft² | Dec. 31, 2022 USD ($) m² | Jun. 21, 2022 USD ($) | Mar. 30, 2020 $ / shares | |
Other Commitments [Line Items] | |||||||||||||||||
Contractual obligation | $ 492,008 | $ 492,008 | $ 616,984 | ||||||||||||||
Maximum payment for commitment milestones | 13,200,000 | $ 13,200,000 | |||||||||||||||
Sub license milestones payments on covered products | 200,000 | 200,000 | |||||||||||||||
Employee Retention Credit, CARES ACT | $ 120,771 | $ 120,771 | |||||||||||||||
Percentage of sub license income on royalties | 15% | 15% | |||||||||||||||
Office space in square feet | 6,200 | 6,200 | 6,200 | ||||||||||||||
Lease rent per month | $ 11,108 | ||||||||||||||||
Fair value of shares issued in connection with asset purchase | $ 50,000 | ||||||||||||||||
Issuance of common stock | shares | 50,000 | 5,129 | 1,667 | 3,664 | 5,377 | 1,667 | |||||||||||
Amount of damages sought | $ 19,000,000 | $ 19,000,000 | |||||||||||||||
For Period Till November 2023 [Member] | |||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||
Lease rent per month | $ 11,108 | 11,108 | $ 11,108 | 11,367 | |||||||||||||
From Period Till November 2024 [Member] | |||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||
Lease rent per month | 11,367 | 11,367 | 11,367 | $ 11,625 | |||||||||||||
Research and Development Arrangement [Member] | |||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||
Contractual obligation | $ 205,000 | $ 205,000 | $ 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 | 12,328 | |||||||||||||||
Fair value of shares issued in connection with asset purchase | $ 3,750,000 | $ 3,750,000 | |||||||||||||||
Issuance of common stock | shares | 130,413 | ||||||||||||||||
Effective price per share (in Dollars per share) | $ / shares | $ 38.34 | $ 38.40 | |||||||||||||||
Ownership of company outstanding | 19.90% | 19.90% | |||||||||||||||
Emergent BioSolutions | |||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||
Invoices | $ 331,000 | ||||||||||||||||
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 ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Contractual Obligation, Fiscal Year Maturity Schedule [Abstract] | ||
October 1 through December 31, 2023 | $ 54,841 | |
2024 | 182,917 | $ 179,817 |
2025 | 162,250 | 182,917 |
2026 | 46,000 | 162,250 |
2027 | 46,000 | 46,000 |
Total | 492,008 | 616,984 |
Research and Development Arrangement [Member] | ||
Contractual Obligation, Fiscal Year Maturity Schedule [Abstract] | ||
October 1 through December 31, 2023 | 21,000 | |
2024 | 46,000 | 46,000 |
2025 | 46,000 | 46,000 |
2026 | 46,000 | 46,000 |
2027 | 46,000 | 46,000 |
Total | 205,000 | 230,000 |
Lease Agreements [Member] | ||
Contractual Obligation, Fiscal Year Maturity Schedule [Abstract] | ||
October 1 through December 31, 2023 | 33,841 | |
2024 | 136,917 | 133,817 |
2025 | 116,250 | 136,917 |
2026 | 116,250 | |
Total | $ 287,008 | $ 386,984 |
Related Party Transaction (Deta
Related Party Transaction (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Jun. 30, 2019 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | |||||||
Consideration paid recorded in general and administrative expense | $ 973,040 | $ 1,326,249 | $ 3,098,949 | $ 5,250,510 | $ 6,692,904 | $ 5,008,738 | |
Issuance of common stock in connection with Silk Roads purchase option | $ 50,000 | ||||||
Website development cost | $ 46,500 | ||||||
Common Stock | |||||||
Related Party Transaction [Line Items] | |||||||
Issuance of common stock in connection with Silk Roads purchase option (in shares) | 31,646 | ||||||
Issuance of common stock in connection with Silk Roads purchase option | $ 32 | ||||||
Website development | |||||||
Related Party Transaction [Line Items] | |||||||
Intangible, amortization expense | $ 7,750 | $ 15,500 | |||||
Silk Road | Exclusive option agreement | |||||||
Related Party Transaction [Line Items] | |||||||
Consideration paid recorded in general and administrative expense | $ 50,000 | ||||||
Silk Road | Exclusive option agreement | Common Stock | |||||||
Related Party Transaction [Line Items] | |||||||
Issuance of common stock in connection with Silk Roads purchase option (in shares) | 31,646 | ||||||
Issuance of common stock in connection with Silk Roads purchase option | $ 50,000 |
Operating Segments (Details)
Operating Segments (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) segment | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) segment | Dec. 31, 2021 USD ($) | |
Segment reporting | ||||||
Revenues | $ 130,440 | $ 166,140 | $ 594,547 | $ 582,843 | $ 948,911 | $ 824,268 |
Income (loss) from Operations | (1,779,056) | (3,081,244) | (5,560,069) | (10,668,926) | (14,238,904) | (13,098,960) |
Amortization and Depreciation Expense | 1,589 | 4,793 | 4,964 | 21,538 | 24,562 | 34,161 |
Other (Expense) Income, Net | 116,354 | (227,759) | 78,037 | (530,793) | (714,370) | (316,755) |
Share-Based Compensation | 65,400 | 70,715 | 229,076 | 220,656 | 333,389 | 361,559 |
Identifiable Assets | 11,302,829 | $ 11,302,829 | $ 14,279,717 | 26,869,927 | ||
Number of operating segments | segment | 2 | 2 | ||||
Operating Segments [Member] | Specialized BioTherapeutics [Member] | ||||||
Segment reporting | ||||||
Revenues | $ 223,870 | $ 31,929 | ||||
Income (loss) from Operations | (705,753) | (1,856,553) | (2,227,430) | (5,396,630) | (7,614,988) | (7,216,450) |
Amortization and Depreciation Expense | 954 | 2,876 | 2,979 | 8,273 | 10,087 | 7,804 |
Other (Expense) Income, Net | 1,683 | (12,613) | 17,696 | 110,975 | 102,320 | 135,409 |
Share-Based Compensation | 27,427 | 28,343 | 82,281 | 85,190 | 138,075 | 136,594 |
Identifiable Assets | 58,704 | 58,704 | 103,742 | 128,645 | ||
Operating Segments [Member] | Public Health Solutions [Member] | ||||||
Segment reporting | ||||||
Revenues | 130,440 | 166,140 | 370,677 | 582,843 | 916,982 | 824,268 |
Income (loss) from Operations | (24,819) | (9,578) | (26,639) | (131,201) | 26,612 | (542,270) |
Amortization and Depreciation Expense | 159 | 479 | 496 | 1,379 | 1,681 | 1,301 |
Share-Based Compensation | 994 | 1,054 | 2,982 | 3,162 | 4,804 | 21,884 |
Identifiable Assets | 70,557 | 70,557 | 121,290 | 146,296 | ||
Corporate [Member] | ||||||
Segment reporting | ||||||
Income (loss) from Operations | (1,048,484) | (1,215,113) | (3,306,000) | (5,141,095) | (6,650,528) | (5,340,240) |
Amortization and Depreciation Expense | 476 | 1,438 | 1,489 | 11,886 | 12,794 | 25,056 |
Other (Expense) Income, Net | 114,671 | (215,146) | 60,341 | (641,768) | (816,690) | (452,164) |
Share-Based Compensation | 36,979 | $ 41,318 | 143,813 | $ 132,304 | 190,510 | 203,081 |
Identifiable Assets | $ 11,173,568 | $ 11,173,568 | $ 14,054,685 | $ 26,594,986 |
Condensed Consolidated Balanc_3
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | |||||||
Cash and cash equivalents | $ 10,298,534 | $ 13,359,615 | $ 16,865,642 | $ 26,043,897 | $ 18,676,663 | ||
Contracts and grants receivable | 66,051 | 115,130 | 138,889 | ||||
Research and development incentives receivable, current | 22,852 | 104,198 | 103,832 | ||||
Prepaid expenses and other current assets | 584,438 | 274,209 | 282,903 | ||||
Total current assets | 10,971,875 | 13,853,152 | 26,569,521 | ||||
Security deposit | 22,777 | 22,777 | 22,777 | ||||
Office furniture and equipment, net of accumulated depreciation of $119,730 and $114,766 | 13,517 | 18,481 | 22,220 | ||||
Deferred issuance cost | 17,867 | 20,206 | 20,266 | ||||
Right-of-use lease assets | 258,487 | 340,987 | 106,155 | 222,445 | |||
Research and development incentives receivable, net of current portion | 18,306 | 24,114 | 121,238 | ||||
Other assets | 7,750 | ||||||
Total assets | 11,302,829 | 14,279,717 | 26,869,927 | ||||
Current liabilities: | |||||||
Accounts payable | 1,460,715 | 3,865,796 | 2,925,544 | ||||
Accrued expenses | 2,386,836 | 2,307,746 | 2,956,545 | ||||
Accrued compensation | 55,543 | 336,692 | 302,936 | ||||
Lease liabilities, current | 118,459 | 108,948 | 106,151 | ||||
Convertible debt, net of debt discount of $0 and $102,309 | 1,500,000 | 9,897,691 | |||||
Total current liabilities | 5,521,553 | 16,516,873 | 6,291,176 | ||||
Non-current liabilities: | |||||||
Convertible debt | 1,416,463 | 0 | 9,856,153 | ||||
Lease liabilities, net of current portion | 143,658 | 233,627 | |||||
Total liabilities | 7,081,674 | 16,750,500 | 16,147,329 | ||||
Commitments and contingencies | |||||||
Series D preferred stock, $.001 par value; 0 and 50,000 shares authorized, none issued or outstanding as of September 30, 2023 and December 31, 2022, respectively | 43 | ||||||
Shareholders' equity/(deficit): | |||||||
Preferred stock, 350,000 and 300,000 shares authorized as of September 30, 2023 and December 31, 2022, respectively; none issued or outstanding | 0 | 0 | |||||
Common stock, $.001 par value; 75,000,000 shares authorized; 10,378,238 and 2,908,578 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 10,378 | 2,909 | 2,859 | ||||
Additional paid-in capital | 228,070,740 | 217,064,964 | 216,442,904 | ||||
Accumulated other comprehensive income | 24,318 | 24,747 | 41,942 | ||||
Accumulated deficit | (223,884,281) | (219,563,446) | (205,765,107) | ||||
Total shareholders' equity/(deficit) | 4,221,155 | $ 5,800,200 | (2,470,826) | $ 1,032,002 | $ 4,205,886 | 10,722,598 | $ 3,741,828 |
Total liabilities, mezzanine equity and shareholders' equity/(deficit) | $ 11,302,829 | $ 14,279,717 | $ 26,869,927 |
Condensed Consolidated Balanc_4
Condensed Consolidated Balance Sheets (Parenthetical) | Feb. 10, 2023 | Feb. 09, 2023 | Sep. 30, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) shares |
Accumulated depreciation | $ | $ 119,730 | $ 114,766 | $ 167,848 | ||
Debt discount, current | $ | $ 0 | 102,309 | |||
Debt discount, noncurrent | $ | $ 143,847 | ||||
Preferred stock, shares authorized | 350,000 | 300,000 | 350,000 | ||
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 | |||
Common stock, shares authorized | 75,000,000 | 75,000,000 | 75,000,000 | ||
Common stock, shares issued | 10,378,238 | 2,908,578 | 2,858,244 | ||
Common stock, shares outstanding | 10,378,238 | 2,908,578 | 2,858,244 | ||
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 | |||
Subsequent Event | |||||
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 | |||
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 | |||
Temporary equity, Liquidation Preference | $ | $ 43 |
Condensed Consolidated Statem_7
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Total revenues | $ 130,440 | $ 166,140 | $ 594,547 | $ 582,843 | $ 948,911 | $ 824,268 |
Cost of revenues | (110,441) | (129,440) | (520,502) | (414,957) | (550,822) | (728,640) |
Gross profit | 19,999 | 36,700 | 74,045 | 167,886 | 398,089 | 95,628 |
Operating expenses: | ||||||
Research and development | 826,015 | 1,791,695 | 2,535,165 | 5,586,302 | 7,944,089 | 8,185,850 |
General and administrative | 973,040 | 1,326,249 | 3,098,949 | 5,250,510 | 6,692,904 | 5,008,738 |
Total operating expenses | 1,799,055 | 3,117,944 | 5,634,114 | 10,836,812 | 14,636,993 | 13,194,588 |
Loss from operations | (1,779,056) | (3,081,244) | (5,560,069) | (10,668,926) | (14,238,904) | (13,098,960) |
Other income (expense): | ||||||
Foreign currency transaction gain (loss) | (3,046) | (12,613) | 310 | (26,006) | (30,549) | (39,361) |
Interest income (expense), net | 66,363 | (215,146) | (97,399) | (641,768) | (822,611) | (904,502) |
Research and development incentives | 4,729 | 17,386 | 136,981 | 132,869 | 174,770 | |
CARES Act Employee Retention Credit | 120,771 | 120,771 | ||||
Other income | 43,223 | 5,921 | 30,754 | |||
Loss on extinguishment of debt | (393,791) | 421,584 | ||||
Change in fair value of convertible debt | (72,463) | 387,537 | ||||
Total other income (expense) | 116,354 | (227,759) | 78,037 | (530,793) | (714,370) | (316,755) |
Net loss before income taxes | (1,662,702) | (3,309,003) | (5,482,032) | (11,199,719) | (14,953,274) | (13,415,715) |
Income tax benefit | 1,161,197 | 1,154,935 | 1,154,935 | 864,742 | ||
Net loss applicable to common stockholders | $ (1,662,702) | $ (3,309,003) | $ (4,320,835) | $ (10,044,784) | $ (13,798,339) | $ (12,550,973) |
Basic net loss per share (in Dollars per share) | $ (0.16) | $ (1.15) | $ (0.63) | $ (3.50) | $ (4.81) | $ (4.69) |
Diluted net loss per share (in Dollars per share) | $ (0.16) | $ (1.15) | $ (0.63) | $ (3.50) | $ (4.81) | $ (4.69) |
Basic weighted average common shares outstanding (in Shares) | 10,379,854 | 2,872,262 | 6,874,493 | 2,867,076 | 2,871,345 | 2,675,488 |
Diluted weighted average common shares outstanding (in Shares) | 10,379,854 | 2,872,262 | 6,874,493 | 2,867,076 | 2,871,345 | 2,675,488 |
Licensing revenue | ||||||
Total revenues | $ 50,000 | $ 250,000 | ||||
Contract revenue | ||||||
Total revenues | $ 33,351 | |||||
Grant revenue | ||||||
Total revenues | $ 130,440 | $ 166,140 | $ 594,547 | $ 532,843 | $ 698,911 | $ 790,917 |
Condensed Consolidated Statem_8
Condensed Consolidated Statements of Operations (Parenthetical) | Feb. 10, 2023 | Feb. 09, 2023 |
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 |
Subsequent Event | ||
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 |
Condensed Consolidated Statem_9
Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Condensed Consolidated Statements of Comprehensive Loss | ||||||
Net loss | $ (1,662,702) | $ (3,309,003) | $ (4,320,835) | $ (10,044,784) | $ (13,798,339) | $ (12,550,973) |
Other comprehensive income (loss): | ||||||
Foreign currency translation adjustments | 18,257 | 14,403 | (429) | (16,470) | (17,195) | 66,279 |
Comprehensive loss | $ (1,644,445) | $ (3,294,600) | $ (4,321,264) | $ (10,061,254) | $ (13,815,534) | $ (12,484,694) |
Condensed Consolidated State_10
Condensed Consolidated Statements of Changes in Mezzanine Equity and Shareholders' Equity (Deficit) - USD ($) | Common Stock Pre-funded warrants | Common Stock | Additional Paid-In Capital B Riley Sales Agreement [Member] | Additional Paid-In Capital Public Offering | Additional Paid-In Capital Pre-funded warrants | Additional Paid-In Capital | Accumulated Other Comprehensive Income/Loss | Accumulated Deficit | B Riley Sales Agreement [Member] | Public Offering | Pre-funded warrants | Total |
Balance at Dec. 31, 2020 | $ 2,043 | $ 196,978,256 | $ (24,337) | $ (193,214,134) | $ 3,741,828 | |||||||
Balance (in shares) at Dec. 31, 2020 | 2,042,911 | |||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement | $ 812 | 19,704,835 | 19,705,647 | |||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 811,646 | |||||||||||
Issuance costs | (655,156) | (655,156) | ||||||||||
Issuance of common stock to vendors | $ 2 | 27,498 | 27,500 | |||||||||
Issuance of common stock to vendors (in shares) | 1,667 | |||||||||||
Exercise of common stock options | $ 2 | 25,833 | $ 25,835 | |||||||||
Exercise of common stock options (in shares) | 2,018 | 2,018 | ||||||||||
Exercise of warrants | 79 | $ 79 | ||||||||||
Exercise of warrants (in shares) | 2 | |||||||||||
Share-based compensation expense | 361,559 | 361,559 | ||||||||||
Foreign currency translation adjustment | 66,279 | 66,279 | ||||||||||
Net loss | (12,550,973) | (12,550,973) | ||||||||||
Balance at Dec. 31, 2021 | $ 2,859 | 216,442,904 | 41,942 | (205,765,107) | 10,722,598 | |||||||
Balance (in Shares) at Dec. 31, 2021 | 2,858,244 | |||||||||||
Issuance of common stock to vendors | $ 15 | 149,987 | 150,002 | |||||||||
Issuance of common stock to vendors (in shares) | 15,452 | |||||||||||
Share-based compensation expense | 220,656 | 220,656 | ||||||||||
Foreign currency translation adjustment | (16,470) | (16,470) | ||||||||||
Net loss | (10,044,784) | (10,044,784) | ||||||||||
Balance at Sep. 30, 2022 | $ 2,874 | 216,813,547 | 25,472 | (215,809,891) | 1,032,002 | |||||||
Balance (in Shares) at Sep. 30, 2022 | 2,873,696 | |||||||||||
Balance at Dec. 31, 2021 | $ 2,859 | 216,442,904 | 41,942 | (205,765,107) | 10,722,598 | |||||||
Balance (in shares) at Dec. 31, 2021 | 2,858,244 | |||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement | $ 8 | 79,346 | 79,354 | |||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 8,542 | |||||||||||
Issuance costs | (2,593) | (2,593) | ||||||||||
Declaration of Series D preferred stock | (43) | (43) | ||||||||||
Issuance of common stock in reverse stock split (Shares) | 19,544 | |||||||||||
Issuance of common stock in reverse stock split | $ 20 | (20) | ||||||||||
Issuance of common stock to vendors | $ 22 | 211,981 | 212,003 | |||||||||
Issuance of common stock to vendors (in shares) | 22,248 | |||||||||||
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 | $ 2,909 | 217,064,964 | 24,747 | (219,563,446) | (2,470,826) | |||||||
Balance (in Shares) at Dec. 31, 2022 | 2,908,578 | |||||||||||
Balance at Jun. 30, 2022 | $ 2,870 | 216,692,835 | 11,069 | (212,500,888) | 4,205,886 | |||||||
Balance (in shares) at Jun. 30, 2022 | 2,870,032 | |||||||||||
Issuance of common stock to vendors | $ 4 | 49,997 | 50,001 | |||||||||
Issuance of common stock to vendors (in shares) | 3,664 | |||||||||||
Share-based compensation expense | 70,715 | 70,715 | ||||||||||
Foreign currency translation adjustment | 14,403 | 14,403 | ||||||||||
Net loss | (3,309,003) | (3,309,003) | ||||||||||
Balance at Sep. 30, 2022 | $ 2,874 | 216,813,547 | 25,472 | (215,809,891) | 1,032,002 | |||||||
Balance (in Shares) at Sep. 30, 2022 | 2,873,696 | |||||||||||
Balance at Dec. 31, 2022 | $ 2,909 | 217,064,964 | 24,747 | (219,563,446) | (2,470,826) | |||||||
Balance (in shares) at Dec. 31, 2022 | 2,908,578 | |||||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement | $ 851 | 3,090,611 | 3,091,462 | |||||||||
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 851,130 | |||||||||||
Issuance costs | $ (95,348) | $ (834,061) | $ (95,348) | $ (834,061) | ||||||||
Issuance of common stock and pre-funded warrants in connection with May 2023 public offering | $ 2,301 | 8,493,516 | 8,495,817 | |||||||||
Issuance of common stock and pre-funded warrants in connection with May 2023 public offering (in shares) | 2,301,500 | |||||||||||
Issuance of common stock to vendors | $ 50 | 72,950 | 73,000 | |||||||||
Issuance of common stock to vendors (in shares) | 50,000 | |||||||||||
Issuance of common stock upon exercise of pre-funded warrants | $ 4,235 | $ (936) | $ 3,299 | |||||||||
Issuance of common stock upon exercise of pre-funded warrants (in shares) | 4,235,384 | |||||||||||
Issuance of common stock in connection with Silk Roads purchase option | $ 32 | 49,968 | 50,000 | |||||||||
Issuance of common stock in connection with Silk Roads purchase option (in shares) | 31,646 | |||||||||||
Share-based compensation expense | 229,076 | 229,076 | ||||||||||
Foreign currency translation adjustment | (429) | (429) | ||||||||||
Net loss | (4,320,835) | (4,320,835) | ||||||||||
Balance at Sep. 30, 2023 | $ 10,378 | 228,070,740 | 24,318 | (223,884,281) | 4,221,155 | |||||||
Balance (in Shares) at Sep. 30, 2023 | 10,378,238 | |||||||||||
Balance at Jun. 30, 2023 | $ 9,842 | 228,005,876 | 6,061 | (222,221,579) | 5,800,200 | |||||||
Balance (in shares) at Jun. 30, 2023 | 9,841,854 | |||||||||||
Issuance of common stock upon exercise of pre-funded warrants | $ 536 | $ (536) | ||||||||||
Issuance of common stock upon exercise of pre-funded warrants (in shares) | 536,384 | |||||||||||
Share-based compensation expense | 65,400 | 65,400 | ||||||||||
Foreign currency translation adjustment | 18,257 | 18,257 | ||||||||||
Net loss | (1,662,702) | (1,662,702) | ||||||||||
Balance at Sep. 30, 2023 | $ 10,378 | $ 228,070,740 | $ 24,318 | $ (223,884,281) | $ 4,221,155 | |||||||
Balance (in Shares) at Sep. 30, 2023 | 10,378,238 |
Condensed Consolidated State_11
Condensed Consolidated Statements of Changes in Mezzanine Equity and Shareholders' Equity (Deficit) (Parenthetical) | 9 Months Ended | 12 Months Ended | |||
Feb. 10, 2023 | Feb. 09, 2023 | Sep. 30, 2023 USD ($) shares | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) | |
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Balance | $ 43 | ||||
Balance | $ 43 | ||||
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 | |||
Series D Preferred Stock | |||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Balance (Shares) | shares | 0 | ||||
Balance (Shares) | shares | 0 | 0 | |||
Series D Preferred Stock | Preferred Stock | |||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Balance | $ 43 | $ 0 | $ 0 | ||
Declaration of Series D preferred stock | 43 | ||||
Redemption of Series D preferred stock (in shares) | shares | (43) | ||||
Net Loss | 0 | 0 | |||
Balance | $ 43 | $ 0 | |||
Subsequent Event | |||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 |
Condensed Consolidated State_12
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities: | ||||
Net loss | $ (4,320,835) | $ (10,044,784) | $ (13,798,339) | $ (12,550,973) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Amortization and depreciation | 4,964 | 21,538 | 24,562 | 34,161 |
Non-cash lease expense | 82,500 | 86,326 | 112,714 | 116,290 |
Share-based compensation | 229,076 | 220,656 | 333,389 | 361,559 |
Issuance of common stock to vendors for services | 73,000 | 150,002 | 212,003 | 27,500 |
Issuance of common stock to Silk Roads for purchase option | 50,000 | |||
Loss on extinguishment of debt | 393,791 | (421,584) | ||
Change in fair value of convertible debt | (387,537) | |||
Amortization of deferred issuance costs associated with convertible debt | 12,518 | 31,068 | 41,538 | 41,926 |
Change in operating assets and liabilities: | ||||
Licensing, contracts and grants receivable | 49,079 | 8,147 | 23,759 | 64,885 |
Prepaid expenses and other current assets | (310,229) | (113,452) | 8,694 | (57,430) |
Research and development incentives receivable | 92,092 | 67,912 | 73,374 | 205,237 |
Operating lease liability | (80,458) | (85,415) | (111,122) | (116,290) |
Deferred revenue | 200,000 | |||
Accounts payable and accrued expenses | (2,382,708) | 679,268 | 396,651 | 1,127,259 |
Accrued compensation | (281,149) | (243,146) | 33,756 | (572,160) |
Net cash used in operating activities | (6,775,896) | (9,021,880) | (12,649,021) | (11,739,620) |
Investing activities: | ||||
Purchases of office furniture and equipment | (13,073) | (13,073) | (11,789) | |
Net cash used in investing activities | (13,073) | (13,073) | (11,789) | |
Financing activities: | ||||
Proceeds from issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement | 3,091,462 | 79,354 | 19,705,647 | |
Stock issuance costs associated | (2,533) | (621,899) | ||
Proceeds from issuance of common stock and pre-funded warrants pursuant to public offering | 8,495,817 | |||
Convertible debt repayments | (7,000,000) | |||
Net cash provided by financing activities | 3,709,688 | 76,821 | 19,058,001 | |
Proceeds from the exercise of warrants | 79 | |||
Proceeds from the exercises of stock options | 25,835 | |||
Costs associated with issuance of convertible debt | (45,512) | |||
Principal repayment - financing lease | (6,149) | |||
Effect of exchange rate on cash and cash equivalents | 5,127 | (143,302) | (99,009) | 60,642 |
Net decrease in cash and cash equivalents | (3,061,081) | (9,178,255) | (12,684,282) | 7,367,234 |
Cash and cash equivalents at beginning of period | 13,359,615 | 26,043,897 | 26,043,897 | 18,676,663 |
Cash and cash equivalents at end of period | 10,298,534 | 16,865,642 | 13,359,615 | 26,043,897 |
Supplemental information: | ||||
Cash paid for state income taxes | 13,006 | 13,243 | 16,043 | 7,727 |
Cash paid for interest | 488,011 | 643,921 | 857,411 | 668,715 |
Cash paid for lease liabilities: | ||||
Operating lease | 99,975 | 99,975 | 133,300 | 133,300 |
Financing lease | 6,408 | |||
Non-cash investing and financing activities: | ||||
Right-of-use assets and lease liabilities recorded | $ 347,546 | 347,546 | ||
Deferred issuance cost reclassified to additional paid-in capital | 2,339 | 60 | $ 33,257 | |
Redemption liability for Series D preferred stock | 43 | |||
Stock issuance costs included in accounts payable | 46,180 | |||
Declaration of Series D preferred stock | $ 43 | |||
At Market Issuance Sales Agreement | ||||
Financing activities: | ||||
Stock issuance costs associated | (93,009) | |||
Public Offering | ||||
Financing activities: | ||||
Stock issuance costs associated | (787,881) | |||
Pre-funded warrants | ||||
Financing activities: | ||||
Proceeds from the exercise of pre-funded warrants | $ 3,299 |
Nature of Business_2
Nature of Business | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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 commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy (“PDT”) utilizing 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, the Company received a refusal to file (“RTF”) letter from the U.S. Food and Drug Administration (“FDA”). 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. The FDA indicated that it is open to engaging in protocol discussions regarding the second, Phase 3 pivotal study. Based on this feedback, the Company is collaboratively engaging in active discussions with the FDA 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 FDA marketing approval. Development programs in this business segment also include expansion of synthetic hypericin sodium (SGX302) into psoriasis, the Company’s first-in-class innate defense regulator (“IDR”) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (“BDP”) for the prevention/treatment of gastrointestinal (“GI”) disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203). The Company’s Public Health Solutions business segment includes active development programs for RiVax ® , its ricin toxin vaccine candidate and SGX943, its therapeutic candidate for antibiotic resistant and emerging infectious disease, and vaccine programs, including a program targeting filoviruses (such as Marburg and Ebola) and a program developing CiVax™, its vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of the vaccine programs is currently supported by the heat stabilization platform technology, known as ThermoVax ® . To date, this business segment has been supported with grant and contract funding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Biomedical Advanced Research and Development Authority (“BARDA”) and the Defense Threat Reduction Agency (“DTRA”). 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 for approximately $1.5 million from a NIAID grant over two years for development of CiVax™ and a subcontract that originally provided for approximately $1.1 million from a FDA Orphan Products Development grant over four years for an expanded study of HyBryte™ in the treatment of CTCL. The Company will continue to apply for additional government funding. 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 nine months ended September 30, 2023 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 September 30, 2023, the Company had an accumulated deficit of $223,884,281 . During the nine months ended September 30, 2023, the Company incurred a net loss of $4,320,835 and used $6,775,896 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. The Company’s plans to meet its liquidity needs primarily include its ability to control the timing and spending on its research and development programs and raising additional funds through potential partnership and/or financings. Based on the Company’s operating budget, current rate of cash outflows, cash on hand, and proceeds from government contract and grant programs, management believes that its current cash will be sufficient to meet the anticipated cash needs for working capital and capital expenditures for at least the next twelve months from issuance of these financial statements on this Quarterly Report on Form 10-Q. As of September 30, 2023, the Company had cash and cash equivalents of $10,298,534 as compared to $13,359,615 as of December 31, 2022, representing a decrease of $3,061,081 or 23% . As of September 30, 2023, the Company had working capital of $5,450,322 as compared to a working capital deficit of ($2,663,721) as of December 31, 2022, representing an increase in working capital of $8,114,043 or 305% . The decrease in cash and cash equivalents was primarily related to the repayment of $7 million of debt principal and cash used in operating activities of approximately $6.8 million offset by the net proceeds of approximately $7.7 million from the public offering in May 2023 and approximately $3.0 million of proceeds from shares sold via the At Market Issuance Sales Agreement (“B.Riley Sales Agreement”) with B. Riley Securities, Inc. (“B. Riley”) during the nine months ended September 30, 2023. The increase in working capital is primarily the result of the net proceeds received from the financing activities during the nine months ended September 30, 2023 and the reclassification of $1,416,463 of the Company’s convertible debt balance from a current liability as of December 31, 2022 to a non-current liability as of September 30, 2023 (resulting from the amendment to the loan and security agreement with Pontifax Medison Finance (“Pontifax”) – see Note 5) , partially offset by cash used in operating activities during the nine months ended September 30, 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 the FDA in order to define the protocol and evaluate the feasibility of conducting a second Phase 3 pivotal 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 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. ● Continue development of the Company’s heat stabilization platform technology, ThermoVax ® , in combination with its programs for RiVax ® (ricin toxin vaccine), CiVax™ (COVID-19 vaccine) and filovirus vaccines for Ebola, Sudan, and Marburg Viruses, with U.S. government funding support. ● Continue to apply for and secure additional government funding for each of the Company’s Specialized BioTherapeutics and Public Health Solutions programs through grants, contracts and/or procurements. ● Pursue business development opportunities for the Company’s pipeline programs, as well as explore 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 $1.0 million in active government grant funding still available as of September 30, 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 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 has up to $23.6 million remaining from the B. Riley Sales Agreement as of November 6, 2023 under the prospectus supplement updated August 13, 2021. The Company is currently subject to the limitations contained in General Instruction I.B.6 of Form S-3. As a result, the Company is limited to selling no more than one-third of the aggregate market value of the equity held by non-affiliates, or the public float, during any 12-month period. From January 1, 2023 through November 6, 2023, the Company sold 851,130 shares of common stock pursuant to the B. Riley Sales Agreement at a weighted average price of $3.63 per share for total gross proceeds of $3,091,462 . As of November 6, 2023, the Company does not currently have any remaining capacity for sales under the Form S-3 pursuant to General Instruction I.B.6. If the Company’s public float increases, the Company will have additional availability under such limitations, and if the Company’s public float increases to $75 million or more, the Company will no longer be subject to such limitations. There can be no assurance that the Company’s public float will increase or that the Company will no longer be subject to such limitations. ● The Company completed a public offering of 2,301,500 shares of its common stock, pre-funded warrants to purchase 4,237,000 shares of its common stock and common warrants to purchase up to 6,538,500 shares of its common stock at a combined public offering price of $1.30 . The pre-funded warrants have an exercise price of $0.001 . The common warrants have an exercise price of $1.50 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 $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. ● The Company may seek additional capital in the private and/or public equity markets, to continue its operations, respond to competitive pressures, develop new products and services, and to support new strategic partnerships. The Company is 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. Reverse Stock Split On February 9, 2023, the Company completed a reverse stock split of its issued and outstanding shares of common stock at a ratio of one-for-fifteen , whereby every fifteen shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock without any change in the par value per share. No fractional shares were issued as a result of the reverse stock split. Any fractional shares that would otherwise have resulted from the reverse stock split were rounded up to the next whole number. The Company’s common stock began trading on The NASDAQ Capital Market on a reverse split basis at the market opening on February 10, 2023. All share and per share data have been restated to reflect this reverse stock split. Exclusive Option Agreement with Silk Road Therapeutics On April 27, 2023, the Company entered into an exclusive option agreement with Silk Road Therapeutics, Inc. (“Silk Road”) to complete its due diligence assessment. The option agreement granted the Company an exclusive option to purchase all assets and rights, including intellectual property and regulatory documents, related to Silk Road’s Pentoxifylline (“PTX”) product candidate, a non-biological anti-TNF-alpha inhibitor, for the treatment of mucocutaneous ulcers in patient’s suffering from Behcet’s Disease (“BD”) and expired on August 25, 2023. In consideration for the option, the Company paid $50,000 of cash and issued 31,646 shares of common stock with a value of $50,000 . The consideration paid for the option was recorded as general and administrative expense during the nine months ended September 30, 2023 on the accompanying condensed consolidated statements of operations. As of August 25, 2023, the Company concluded its due diligence activities and decided to allow the option to expire. A director of the Company has an ownership interest in Silk Road. Nasdaq Capital Market Listing Requirements As previously reported, on December 20, 2022, the Company received a written notice from Nasdaq providing that the staff (the “Staff”) of Nasdaq determined to delist the Company’s common stock from The Nasdaq Capital Market because the closing bid price of the Company’s common stock had not been at least $1.00 per share as required by Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Requirement”) and because the Company’s shareholders’ equity had not been at least $2,500,000 nor had the alternatives of market value of listed securities or net income from continuing operations been met, as required by Listing Rule 5550(b) (the “Shareholders’ Equity Requirement”). On February 2, 2023, the Company had an oral hearing with a Nasdaq Hearings Panel to appeal the Staff’s delisting determination. On February 21, 2023, the Company received a letter from Nasdaq, stating that the Nasdaq Hearings Panel granted the Company’s request to continue its listing on Nasdaq, on the condition that (1) on February 24, 2023, the Company had demonstrated compliance with the Bid Price Requirement, by evidencing a closing bid price of $1.00 or more per share for a minimum of ten consecutive trading sessions; and (2) on or before March 31, 2023, the Company had demonstrated compliance with the Shareholders’ Equity Requirement. As of the close of the market on February 24, 2023, the Company satisfied the first condition – compliance with the Bid Price Requirement for a minimum of ten consecutive trading sessions. On April 6, 2023, Nasdaq granted the Company’s request for an extension of the deadline by which it must regain compliance with the Shareholders’ Equity Requirement from March 31, 2023 to May 15, 2023. As of the close of the market on May 9, 2023, the Company came into compliance with the Shareholders’ Equity Requirement based on capital raising activities - see Note 1 - Liquidity. On May 23, 2023, the Company received a letter from Nasdaq confirming that the Company had regained compliance with the Shareholders’ Equity Requirement and was in compliance with all other applicable requirements for listing on Nasdaq. Accordingly, the Panel determined to continue the listing of the Company’s securities on Nasdaq and closed the matter. The Panel has also determined to impose a Panel Monitor on the Company for a period of one year. During the Panel Monitor period, the Company will be under an obligation to notify the Panel in the event its closing bid price falls below $1.00 on any trading day and if the Company falls out of compliance with any applicable listing requirement. If, during the Panel Monitor period, the Nasdaq Listing Qualifications Department determines that the Company has failed to meet any requirement for continued listing on Nasdaq, the Nasdaq Listing Qualifications Department may issue a delisting determination. In such event, the Company may seek a review of the delisting determination and the Nasdaq Hearings Department will schedule a hearing with regard to the deficiency. On June 23, 2023, the Company received a letter from Nasdaq indicating that the Company was not in compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market. The notification of noncompliance had no immediate effect on the listing or trading of the Company’s common stock on The Nasdaq Capital Market under the symbol “SNGX,” and the Company continues to monitor the closing bid price of its common stock and to evaluate its alternatives, if appropriate, to resolve the deficiency and regain compliance with this rule. The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price for the last 30 consecutive business days, the Company no longer meets this requirement. The June 23, 2023 letter indicated that the Company was provided 180 calendar days, or until December 20, 2023, in which to regain compliance. If at any time during this period the bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of ten consecutive business days, the Nasdaq Staff will provide the Company with a written confirmation of compliance and the matter will be closed. In the event the Company does not regain compliance with Rule 5550(a)(2) prior to the expiration of the 180 calendar day period, the Nasdaq Staff will provide the Company with written notification that its securities are subject to delisting from The Nasdaq Capital Market. At that time, the Company may appeal the delisting determination to a Nasdaq Listing Qualifications Panel. Alternatively, if the Company fails to regain compliance with Rule 5550(a)(2) prior to the expiration of the 180 calendar day period, but meets the continued listing requirement for market value of publicly held shares and all of the other applicable standards for initial listing on The Nasdaq Capital Market, with the exception of the minimum bid price, and provides written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary, then the Company may be granted an additional 180 calendar days to regain compliance with Rule 5550(a)(2). | 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 commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic (hypericin), a novel photodynamic therapy (“PDT”) utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”)). With a successful Phase 3 study complete, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the United States (“U.S.”). In response to the HyBryte™ new drug application (“NDA”) for the treatment of CTCL, the Company recently received a refusal to file (“RTF”) letter from the U.S. Food and Drug Administration (“FDA”). The Company is preparing for a meeting, categorized as Type A, 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 marketing approval and U.S. commercialization. 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, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (“BDP”) for the prevention/treatment of gastrointestinal (“GI”) disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203). The Company’s Public Health Solutions business segment includes active development programs for RiVax ® , its ricin toxin vaccine candidate and SGX943, its therapeutic candidate for antibiotic resistant and emerging infectious disease, and vaccine programs, including a program targeting filoviruses (such as Marburg and Ebola) and a program developing CiVax™, its vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of the vaccine programs is currently supported by the heat stabilization platform technology, known as ThermoVax ® . To date, this business segment has been supported with grant and contract funding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Biomedical Advanced Research and Development Authority (“BARDA”) and the Defense Threat Reduction Agency (“DTRA”). The Company primarily generates revenues under government grants and contracts principally from the National Institutes of Health (“NIH”). The Company has a DTRA subcontract of approximately $600,000 over three years for SGX943, a subcontract of approximately $1.5 million from a NIAID grant over two years for development of CiVax™ and a subcontract of approximately $1.1 million from a U.S. FDA grant over four years for the expanded study of HyBryte™ in the treatment of CTCL. The Company will continue to apply for additional government funding. 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, 2022, the Company had an accumulated deficit of $ 219,563,446 and a working capital deficit of $ 2,663,721 . During the year ended December 31, 2022, the Company incurred a net loss of $13,798,339 and used $12,649,021 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 third quarter of 2023. 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 the At Market Issuance Sales Agreement (“B. Riley Sales Agreement”) with B. Riley Securities, Inc. (“B. Riley”) 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, 2022, the Company had cash and cash equivalents of $13,359,615 as compared to $26,043,897 as of December 31, 2021, representing a decrease of $12,684,282 or 49% . As of December 31, 2022, the Company had a working capital deficit of $ 2,663,721 as compared to working capital of $20,278,345 as of December 31, 2021, representing a decrease of $22,942,066 or 113% . The decrease in cash and cash equivalents and working capital was primarily related to cash used in operating activities. The decrease in working capital is also due to the impact of the entire convertible debt balance being classified as a current liability as of December 31, 2022 due to a subjective acceleration clause included in the debt agreement and a potential breach of a cash debt covenant during the twelve month look-forward period from the filing of these financial statements. Management’s business strategy can be outlined as follows: ● Following positive primary endpoint results for the Phase 3 FLASH ( F lorescent L ight A ctivated S ynthetic H ypericin) 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), meet with the U.S. FDA to discuss the contents of a RTF letter recently issued by the FDA in response to the HyBryte™ NDA for the treatment of CTCL. The Company is preparing for a meeting, categorized as Type A, 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 marketing approval and U.S. commercialization while continuing to explore ex-U.S. partnership. ● 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 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. ● Continue development of the Company’s heat stabilization platform technology, ThermoVax ® , in combination with its programs for RiVax ® (ricin toxin vaccine), CiVax™ (COVID-19 vaccine) and filovirus vaccines for Ebola, Sudan, and Marburg Viruses, with U.S. government funding support. ● Continue to apply for and secure additional government funding for each of the Company’s Specialized BioTherapeutics and Public Health Solutions programs through grants, contracts and/or procurements. ● Pursue business development opportunities for the Company’s pipeline programs, as well as explore 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 $1.7 million in active government grant funding still available as of December 31, 2022 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 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 has up to $26.6 million remaining from the B. Riley Sales Agreement as of March 24, 2023 under the prospectus supplement updated August 13, 2021. The Company is currently subject to the limitations contained in General Instruction I.B.6 of Form S-3. As a result, the Company is limited to selling no more than one-third of the aggregate market value of the equity held by non-affiliates, or the public float, during any 12-month period, and as of March 24, 2023, the Company has approximately $6.6 million remaining that is permitted to be sold under the Form S-3 pursuant to General Instruction I.B.6. If the Company’s public float increases, the Company will have additional availability under such limitations, and if the Company’s public float increases to $75 million or more, the Company will no longer be subject to such limitations. There can be no assurance that the Company’s public float will increase or that the Company will no longer be subject to such limitations. ● The Company may seek additional capital in the private and/or public equity markets, to continue its operations, respond to competitive pressures, develop new products and services, and to support new strategic partnerships. The Company is 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. Reverse Stock Split On February 9, 2023, the Company completed a reverse stock split of its issued and outstanding shares of common stock at a ratio of one-for-fifteen , whereby, every fifteen shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock without any change in the par value per share. No fractional shares were issued as a result of the reverse stock split. Any fractional shares that would otherwise have resulted from the reverse stock split were rounded up to the next whole number. The Company’s common stock began trading on The NASDAQ Capital Market on a reverse split basis at the market opening on February 10, 2023. All share and per share data have been restated to reflect this reverse stock split. |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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 doubtful accounts 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 no t record any impairment of long-lived assets for the three and nine months ended September 30, 2023 and 2022. Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. Disclosures about the fair value of financial instruments are based on pertinent information available to the Company on September 30, 2023. 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 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 September 30, 2023 for the convertible debt is its fair value - see Note 5. The principal amount of the convertible debt was $3,000,000 at September 30, 2023 and the fair value was approximately $2,916,463 . 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 September 30, 2023 is as follows: Balance, December 31, 2022 Issued Adjustment to fair value Balance, September 30, 2023 Convertible debt at fair value $ - $ 3,304,000 $ (387,537) $ 2,916,463 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 . Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. 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 . Research and development includes costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, equipment depreciation and allocation of various corporate costs. 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 nine months ended September 30, 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 4 years ; ● volatility of 94% for 2023 and 87% for 2022; and ● risk free interest rates of 3.48% for 2023 and ranging from 1.12% - 3.23% for 2022. The fair value of each option grant made during the nine months ended September 30, 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. Foreign Currency Transactions and Translation In accordance with FASB ASC 830 Foreign Currency Matters , the UK subsidiary expresses its U.S. dollar and Euro denominated transactions in its functional currency, the British Pound, with related transaction gains or losses included in net loss. On a quarterly basis, the financial statements of the UK subsidiary are translated into U.S. dollars and consolidated into the Company’s financials, with related translation adjustments reported as a cumulative translation adjustment (“CTA”), which is a component of accumulated other comprehensive income. During the three months ended September 30, 2023 and 2022, the Company recognized foreign currency transaction losses of ($3,046) and ($12,613) , respectively, in the accompanying condensed consolidated statements of operations. During the nine months ended September 30, 2023 and 2022, the Company recognized a foreign currency transaction gain of $310 and a foreign currency transaction loss of ($26,006) , respectively, in the accompanying condensed consolidated statements of operations. 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 recognized an income tax benefit of $1,161,197 and $1,154,935 from the sale of 2021 and 2020 New Jersey NOL carryforwards during the nine months ended September 30, 2023 and 2022, respectively. 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 nine months ended September 30, 2023 and 2022. Additionally, the Company has no t recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at September 30, 2023 or December 31, 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 $41,000 and $128,000 as of September 30, 2023 and December 31, 2022, respectively, in the condensed consolidated balance sheets. The following table shows the change in the UK research and development incentives receivable from December 31, 2022 to September 30, 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 — 18,536 18,536 Adjustments to 2021 and 2022 incentives earned (1,150) — (1,150) UK research and development incentives cash receipt (104,422) — (104,422) Foreign currency translation 112 (230) (118) Balance at September 30, 2023 $ 22,852 $ 18,306 $ 41,158 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 and nine months ended September 30, 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: As of September 30, 2023 2022 Common stock purchase warrants 6,538,500 3,992 Stock options 206,589 145,505 Convertible debt 2,159,414 162,602 Total 8,904,503 312,099 The weighted average exercise prices of the Company’s warrants and stock options outstanding at September 30, 2023 were $1.50 and $24.83 per share, respectively. The weighted average exercise prices of the Company’s warrants and stock options outstanding at September 30, 2022 were $36.12 and $34.49 per share, respectively. The weighted average conversion price of the Company’s convertible debt at September 30, 2023 and 2022 was $1.39 and $61.50 per share, respectively. 217,880 of the Company’s common stock warrants associated with the July 2018 public offering expired on January 2, 2022 and 667 of the Company’s common stock warrants associated with the opening of the first clinical site in the United Kingdom expired on March 28, 2023. 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. | 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. Reclassifications Certain amounts in the statement of operations for the year ended December 31, 2021 have been reclassified to conform to the current year presentation. 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. Licensing, 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 doubtful accounts has been established. If amounts become uncollectible, they are charged to operations. Licensing receivables consist of amounts billed to customers pursuant to contracts with those customers. No allowance for doubtful accounts has been established for licensing receivables as all amounts billed were collected shortly thereafter. Website Development Costs In June 2019, the Company capitalized website development costs of $46,500 in accordance with FASB Codification ASC 350-50 “Accounting for Web Site Development Costs.” The Company began amortizing the website development costs on a straight-line basis over three years , the estimated useful life of the website. The Company reviews its capitalized website development costs periodically for impairment. Website amortization expense for 2022 and 2021 was $7,750 and $15,500 , respectively, and accumulated amortization was $46,500 and $38,750 , respectively, as of December 31, 2022 and 2021. Website development costs were included in other assets in the accompanying consolidated balance sheets. 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, 2022 and 2021. Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. Disclosures about the fair value of financial instruments are based on pertinent information available to the Company on December 31, 2022 and 2021. 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. The carrying amounts reported in the consolidated balance sheets for cash and cash equivalents, licensing, contracts and/or 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 sheets for convertible debt approximates its fair value based on its interest rate and maturity date. 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 . Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. 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 . Research and development includes costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, equipment depreciation and allocation of various corporate costs. 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, 2022 and 2021 was estimated using the Black-Scholes option-pricing model and the following assumptions: ● a dividend yield of 0% ; ● an expected life of 4 years ; ● volatility of 84% - 87% for 2022 and 2021; and ● risk-free interest rates ranging from 1.12% to 4.51% in 2022 and 0.27% to 1.13% in 2021. The fair value of each option grant made during 2022 and 2021 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. 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 , the UK subsidiary expresses its U.S. dollar and Euro denominated transactions in its functional currency, the British Pound, with related transaction gains or losses included in net loss. On a quarterly basis, the financial statements of the UK subsidiary are translated into U.S. dollars and consolidated into the Company’s financials, with related translation adjustments reported as a cumulative translation adjustment (“CTA”), which is a component of accumulated other comprehensive loss. In 2022 and 2021, the Company recognized foreign currency transaction losses of $30,549 and $39,361 , respectively, in the accompanying consolidated statements of operations. 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 recognized an income tax benefit of $1,154,935 and $864,742 from the sale of 2020 and 2019 New Jersey NOL carryforwards during the years ended December 31, 2022 and 2021, respectively. 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 2022 and 2021. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2022 or 2021. 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 $128,000 and $225,000 as of December 31, 2022 and 2021, respectively in the consolidated balance sheets. The following table shows the change in the UK research and development incentives receivable from December 31, 2021 to December 31, 2022: Current Long-Term Total Balance at December 31, 2021 $ 103,832 $ 121,238 $ 225,070 UK research and development incentives, transfer 121,238 (121,238) — UK research and development incentives — 24,963 24,963 Additional 2020 incentive earned 107,906 — 107,906 UK research and development incentives cash receipt (209,166) — (209,166) Foreign currency translation (19,612) (849) (20,461) Balance at December 31, 2022 $ 104,198 $ 24,114 $ 128,312 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. 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, 2022 2021 Common stock purchase warrants 667 221,872 Stock options 192,273 140,996 Convertible debt 162,602 162,602 Total 355,542 525,470 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_2
Leases | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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 $11,108 per month will be maintained until November 2023 when it will be increased to $11,367 and then will increase to $11,625 in November 2024 where it will remain until expiration. As of September 30, 2023 and December 31, 2022, the Company’s condensed consolidated balance sheets included a right-of-use lease asset of $258,487 and $340,987 for the office space, respectively. The Company’s condensed consolidated balance sheets as of September 30, 2023 and December 31, 2022 included corresponding lease liabilities of $262,117 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 Right-of-use lease asset: Right-of-use lease asset, January 1, 2023 $ 340,987 Less: reduction/amortization 82,500 Right-of-use lease asset, September 30, 2023 $ 258,487 Lease liability: Lease liability, January 1, 2023 $ 342,575 Less: repayments 80,458 Lease liability, September 30, 2023 $ 262,117 Lease expense for the nine months ended September 30, 2023: Lease expense $ 102,016 Total $ 102,016 Lease expense for the nine months ended September 30, 2022: Lease expense $ 100,887 Total $ 100,887 Contractual cash payments for the remaining lease term as of September 30, 2023: 2023 $ 33,841 2024 136,917 2025 116,250 Total $ 287,008 Remaining lease term (months) as of September 30, 2023 25 | 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 $11,108 per month will be maintained until November 2023 when it will be increased to $11,367 and then will increase to $11,625 in November 2024 where it will remain until expiration. As of December 31, 2022 and 2021, the Company’s consolidated balance sheets included a right-of-use lease asset of $340,987 and $106,155 for the office space, respectively. The Company’s consolidated balance sheets as of December 31, 2022 and 2021 included corresponding lease liabilities of $342,575 and $106,151 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, 2022 2023 $ 133,817 2024 136,917 2025 116,250 Total $ 386,984 Discount rate applied 8.47 % Remaining lease term (months) as of December 31, 2022 34 Right-of-use lease asset: Right-of-use lease asset, January 1, 2021 $ 222,445 Less: reduction/amortization 116,290 Right-of-use lease asset, December 31, 2021 106,155 New lease extension June 21, 2022 347,546 Reduction/amortization 112,714 Right of use lease asset, December 31, 2022 $ 340,987 Lease liability: Lease liability, January 1, 2021 $ 222,441 Less: repayments 116,290 Lease liability, December 31, 2021 106,151 New lease extension June 21, 2022 347,546 Less: repayments 111,122 Lease liability, December 31, 2022 $ 342,575 Lease expense for the year ended December 31, 2021: Lease expense $ 133,300 Total $ 133,300 Lease expense for the year ended December 31, 2022: Lease expense $ 134,892 Total $ 134,892 |
Accrued Expenses_2
Accrued Expenses | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Accrued Expenses | ||
Accrued Expenses | Note 4. Accrued Expenses The following is a summary of the Company’s accrued expenses: September 30, December 31, 2023 2022 Clinical trial expenses $ 2,082,200 $ 1,884,117 Other 304,636 423,629 Total $ 2,386,836 $ 2,307,746 | Note 4. Accrued Expenses The following is a summary of the Company’s accrued expenses: December 31, 2022 2021 Clinical trial expenses $ 1,884,117 $ 2,625,779 Other 423,629 330,766 Total $ 2,307,746 $ 2,956,545 |
Debt_2
Debt | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Debt | ||
Debt | Note 5. 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 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 was 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 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 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 588,599 shares of the Company’s common stock issuable upon conversion and to (ii) $1.70 with respect to all shares of the Company’s common stock issuable upon conversion in excess of the first 588,599 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 condensed consolidated statements of operations during the nine months ended September 30, 2023. The fair value of the convertible debt as of September 30, 2023 was approximately $2,916,463 , which resulted in the recognition of ($72,463) of other loss and $387,537 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 and nine months ended September 30, 2023, respectively. 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 follow: Assumptions 4/19/2023 9/30/2023 Stock price $ 1.72 $ 0.56 Volatility 75.20% 110.50% Discount rate 16.28% 14.84% Risk-free rate 4.27% 5.24% Interest expense incurred during the three months ended September 30, 2023 and 2022 was $64,047 and $213,490 , respectively. Interest expense incurred during the nine months ended September 30, 2023 and 2022 was $338,568 and $633,510 . Interest expense paid during the three months ended September 30, 2023 and 2022 was $63,351 and $211,170 . Interest expense paid during the nine months ended September 30, 2023 and 2022 was $488,011 and $643,921 , respectively. Annual principal and interest payments due as of September 30, 2023 in accordance with the amended terms of the Pontifax loan agreement, assuming no conversion is as follows: Year Principal Interest Total 2023 $ — $ 128,094 $ 128,094 2024 2,250,000 206,761 2,456,761 2025 750,000 16,012 766,012 Total $ 3,000,000 $ 350,867 $ 3,350,867 | 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. The agreement contains customary representations, warranties and covenants, including covenants by the Company limiting additional indebtedness, liens, including on intellectual property, guaranties, mergers and consolidations, substantial asset sales, investments and loans, certain corporate changes, transactions with affiliates and fundamental changes. Affirmative covenants include, among others, covenants requiring the Company to protect and maintain its intellectual property and comply with all applicable laws, deliver certain financial reports, maintain a minimum cash balance and maintain its insurance coverage. As of December 31, 2022, the Company projected a violation of the minimum cash balance requirement during 2023 and the debt agreement contains a subjective acceleration clause, therefore has classified the entire debt balance as a current liability. 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. Interest expense incurred during the years ended December 31, 2022 and 2021 was $847,000 and $894,808 , respectively. Interest expense paid during the years ended December 31, 2022 and 2021 was $857,411 and $668,715 , respectively. Pontifax may elect to convert the outstanding loan drawn into shares of the Company’s common stock at any time prior to repayment at a conversion price of $61.50 per share. 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 2023 $ 4,000,000 $ 634,438 $ 4,634,438 2024 4,000,000 295,638 4,295,638 2025 2,000,000 21,349 2,021,349 Total $ 10,000,000 $ 951,425 $ 10,951,425 |
Income Taxes_2
Income Taxes | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Income Taxes | ||
Income Taxes | Note 6. Income Taxes The Company had gross NOLs at December 31, 2022 of approximately $124 million for federal tax purposes, approximately $13.2 million for state tax purposes and approximately $1.4 million for foreign tax purposes. Federal losses generated in 2018 or later will carry forward indefinitely. In addition, the Company has approximately $8.8 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 2022 and 2021, the Company sold New Jersey NOL carryforwards 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. During the nine months ended September 30, 2023 and 2022, the Company recognized $1,161,197 and $1,154,935 of income tax benefit, net of transaction costs from the sale of its 2021 and 2020 NOL carryforwards, respectively. The Company has not yet sold its 2022 New Jersey NOL carryforwards but may do so in the future. There can be no assurance as to the continuation or magnitude of this program in future years. | Note 6. Income Taxes The income tax benefit consisted of the following for the years ended December 31, 2022 and 2021: 2022 2021 Federal $ — $ — Foreign — — State (1,154,935) (864,742) Income tax benefit $ (1,154,935) $ (864,742) The significant components of the Company’s deferred tax assets and liabilities at December 31, 2022 and 2021 are as follows: 2022 2021 Net operating loss carry forwards $ 27,252,000 $ 28,065,000 Orphan drug and research and development credit carry forwards 8,837,000 8,605,000 Equity based compensation 285,000 264,000 Intangibles 1,696,000 1,953,000 Capitalized research and development (Section 174) 1,832,000 — Lease liability 96,000 30,000 Total 39,998,000 38,917,000 Valuation allowance (39,902,000) (38,887,000) Net deferred tax assets 96,000 30,000 Right of use asset (96,000) (30,000) Total gross deferred tax liabilities (96,000) (30,000) Net deferred tax assets $ — $ — The Company had gross NOLs at December 31, 2022 of approximately $124.0 million for federal tax purposes, approximately $13.2 million for state tax purposes and approximately $1.4 million for foreign tax purposes. Federal losses generated in 2018 or later will carry forward indefinitely. In addition, the Company has approximately $8.8 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, 2022 and 2021 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 $1,154,935 and $ 864,742 , respectively, of income tax benefit, net of transaction costs. The Company has not yet sold its 2022 New Jersey NOLs but may do so in the future. There can be no assurance as to the continuation or magnitude of this program in the future. 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, 2022 and 2021 were as follows: 2022 2021 Federal tax at statutory rate (21.0) % (21.0) % State tax benefits, plus sale of NJ NOL, net of federal benefit (2.4) (7.6) Foreign tax rate difference 0.2 0.1 Orphan drug and research and development credits (3.9) (4.3) Permanent differences 3.1 1.3 Foreign NOL adjustments 0.4 0.6 Expiration of tax attributes 9.1 4.9 Change in valuation allowance 6.8 19.6 Income tax benefit (7.7) % (6.4) % 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, 2022, 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 no t have any unrecognized tax benefits and has no t accrued any interest or penalties for the years ended December 31, 2022 and 2021. |
Shareholders' Equity_2
Shareholders' Equity | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Shareholders' Equity | ||
Shareholders' Equity | Note 7. Shareholders’ Equity Preferred Stock The Company has 350,000 shares of preferred stock authorized, of which 50,000 were designated as Series D preferred stock as of December 31, 2022. 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 consisted of one one-thousandth of a share of Series D preferred stock, par value $0.001 per share, for each outstanding share of the Company's common stock. The Series D preferred stock had the following rights and restrictions: 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 of a Series D preferred stock share transferred for each common stock share transferred. 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 On May 9, 2023, the Company completed a public offering of 2,301,500 shares of its common stock, pre-funded warrants to purchase 4,237,000 shares of its common stock and common warrants to purchase up to 6,538,500 shares of its common stock at a combined public offering price of $1.30 . The pre-funded warrants have an exercise price of $0.001 . As of September 30, 2023, there were no pre-funded warrants outstanding. The common warrants have an exercise price of $1.50 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 $8.5 million before deducting commissions and other estimated offering expenses payable by the Company. The following items represent transactions in the Company’s common stock for the nine months ended September 30, 2023: ● The Company issued a vendor 50,000 shares of fully vested common stock with a fair value based on a closing price of $1.46 per share on April 27, 2023, the date of issuance. ● The Company sold 851,130 shares of common stock pursuant to the B. Riley Sales Agreement at a weighted average price of $3.63 per share. ● The Company issued 31,646 shares of fully vested common stock pursuant to an exclusive option agreement at $1.58 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 2,301,500 shares of common stock and 4,237,000 pre-funded warrants pursuant to the May 2023 public offering for $1.30 per share on May 9, 2023. ● The Company issued 2,023,000 shares of common stock pursuant to the exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.001 on May 9, 2023. ● The Company issued 938,000 shares of common stock pursuant to the exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.001 on May 10, 2023. ● The Company issued 338,000 shares of common stock pursuant to the exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.001 on May 22, 2023. ● The Company issued 400,000 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 $ 0.001 on June 8, 2023. ● The Company issued 536,384 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 $0.001 on September 6, 2023. The issuance of the Company’s common stock to vendor described above was made under the 2015 Plan and, are registered on a Registration Statement on Form S-8. However, as shares of common stock are not covered by a reoffer prospectus, the certificates evidencing such shares reflect a Securities Act restrictive legend. The issuance of the Company’s common stock pursuant to the B. Riley Sales Agreement described above was registered on a Registration Statement on Form S-3. The issuance of the Company’s common stock in connection with the exclusive option agreement as described above was exempt under Section 4(a)(2) of the Securities Act of 1933, as amended. The recipient is 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 issuances of the Company’s common stock in connection with the May 2023 public offering and upon the exercise of the pre-funded warrants described above were registered on a Registration Statement on Form S-1. 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 sets 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 provides that B. Riley is 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 Company has no obligation to sell any shares under the B. Riley Sales Agreement, and may suspend solicitation and offers under the B. Riley Sales Agreement at any time. The B. Riley Sales Agreement expires on December 31, 2023. On August 13, 2021, the Company filed a prospectus supplement relating to the B. Riley Sales Agreement to offer and sell shares of Company common stock having an aggregate offering price of up to $30 million under the July 2020 Registration Statement. As of November 6, 2023, there was $23.6 million available for future sale of common stock under the B. Riley Sales Agreement. The Company is currently subject to the limitations contained in General Instruction I.B.6 of Form S-3. As a result, the Company is limited to selling no more than one-third of the aggregate market value of the equity held by non-affiliates, or the public float, during any 12-month period. As of November 6, 2023, the Company does not currently have any remaining capacity for sales under the Form S-3 pursuant to General Instruction I.B.6. If the Company’s public float increases, the Company will have additional availability under such limitations, and if the Company’s public float increases to $75 million or more, the Company will no longer be subject to such limitations. There can be no assurance that the Company’s public float will increase or that the Company will no longer be subject to such limitations. | 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, 2022. 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 of a share of Series D preferred stock, par value $0.001 per share, for each outstanding share of the Company's common stock. The Series D preferred stock has the following rights and restrictions: 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 of a Series D preferred stock share transferred for each common stock share transferred. 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: 3. Any plan to change the Company's Certificate of Incorporation for a reverse stock split. 4. 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: 3. The Board decides to redeem the shares at a time and date of their choosing. 4. 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 are classified as mezzanine equity as of December 31, 2022 since they are not mandatorily redeemable but are redeemable based on an event not entirely controlled by the Company. Common Stock The following items represent transactions in the Company’s common stock for the year ended December 31, 2022: ● The Company issued a vendor 5,377 shares of fully vested common stock with a fair value of $9.30 per share on February 7, 2022. ● The Company issued a vendor 6,411 shares of fully vested common stock with a fair value of $7.80 per share on May 6, 2022. ● The Company issued a vendor 3,664 shares of fully vested common stock with a fair value of $13.65 per share on August 5, 2022. ● The Company issued a vendor 1,667 shares of fully vested common stock with a fair value of $7.20 per share on October 4, 2022. ● The Company issued a vendor 5,129 shares of fully vested common stock with a fair value of $9.75 per share on November 7, 2022. ● The Company issued 8,542 shares of common stock pursuant to the B. Riley Sales Agreement at a weighted average price of $9.29 per share. The following items represent transactions in the Company’s common stock for the year ended December 31, 2021: ● The Company issued 2 shares of common stock as a result of a warrant exercise. The weighted average exercise price per share was $59.25 . ● The Company issued 811,646 shares of common stock pursuant to the B. Riley Sales Agreement at a weighted average price of $24.28 per share. ● The Company issued 2,018 shares of common stock as a result of option exercises. The weighted average exercise price per share was $12.81 . ● The Company issued a vendor 1,667 shares of fully vested common stock with a fair value of $16.50 per share on September 29, 2021. All issuances of the Company’s common stock for the years ended December 31, 2022 and 2021 described above, other than shares issued under the B. Riley Sales Agreement and the issuance to vendors, were issued under the 2015 Plan and are registered on a Registration Statement on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates evidencing such shares reflect a Securities Act of 1933, as amended, restrictive legend. The shares issued under the B. Riley Sales Agreement were registered on a Registration Statement on Form S-3 (SEC File No. 333-239928). The issuance of the Company’s common stock to vendors as described above was exempt under Section 4(a)(2) of the Securities Act of 1933, as amended. The vendors 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 sets 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 provides that B. Riley is 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 Company has no obligation to sell any shares under the B. Riley Sales Agreement, and may suspend solicitation and offers under the B. Riley Sales Agreement at any time. The B. Riley Sales Agreement expires on December 31, 2023. The Company’s shelf registration statement on Form S-3 (File No. 333- 217738) filed on May 5, 2017 (the “May 2017 Registration Statement”) with the U.S. Securities and Exchange Commission (the “SEC”) expired on August 10, 2020, but was available to be utilized for a period up to six months or until a new shelf registration statement was declared effective, whichever occurred first. All sales under the B. Riley Sales Agreement from August 11, 2017 through August 10, 2020 were made pursuant to the May 2017 Registration Statement. All sales of common stock made pursuant to the B. Riley Sales Agreement since the expiration of the May 2017 Registration Statement have been, and future sales will be, made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333- 239928) filed on July 17, 2020 (the "July 2020 Registration Statement") with the SEC, and any amendments thereto, the base prospectus filed as part of such registration statement, and any prospectus supplements. The July 2020 Registration Statement was declared effective on August 28, 2020. On August 13, 2021, the Company filed a prospectus supplement relating to the B. Riley Sales Agreement to offer and sell shares of Company common stock having an aggregate offering price of up to $30 million under the July 2020 Registration Statement. As of March 24, 2023, there was $26.6 million available for the sale of common stock under the B. Riley Sales Agreement. The Company is currently subject to the limitations contained in General Instruction I.B.6 of Form S-3. As a result, the Company is limited to selling no more than one-third of the aggregate market value of the equity held by non-affiliates, or the public float, during any 12-month period, and as of March 24, 2023, the Company has approximately $6.6 million remaining that is permitted to be sold under the Form S-3 pursuant to General Instruction I.B.6. If the Company’s public float increases, the Company will have additional availability under such limitations, and if the Company’s public float increases to $75 million or more, the Company will no longer be subject to such limitations. There can be no assurance that the Company’s public float will increase or that the Company will no longer be subject to such limitations. |
Stock Option Plans and Warrants
Stock Option Plans and Warrants to Purchase Common Stock | 12 Months Ended |
Dec. 31, 2022 | |
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 numbers of shares of common stock available for issuance under the plan by 4,000,000 shares. As of December 31, 2022, there are 5,812,991 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, 2022 1,866,719 Modification to Plan 4,000,000 Options granted (55,730) Options forfeited 2,002 Options exercised — Shares available for grant at December 31, 2022 5,812,991 Activity under the 2005 Plan and the 2015 Plan for the years ended December 31, 2022 and 2021 Weighted Average Exercise Options Price Balance outstanding at December 31, 2020 128,858 $ 44.41 Granted 32,925 13.68 Forfeited (15,982) 54.61 Cancelled (2,787) 11.70 Exercised (2,018) 12.81 Balance outstanding at December 31, 2021 140,996 $ 37.12 Granted 55,730 8.85 Forfeited (3,908) 107.83 Cancelled (545) 11.70 Exercised — — Balance outstanding at December 31, 2022 192,273 $ 27.56 As of December 31, 2022, there were 133,794 options exercisable with a weighted average exercise price of $34.47 and a weighted average remaining contractual term of 7.05 years. As of December 31, 2022, there were 192,273 options outstanding with a weighted average remaining term of 7.90 years. Options outstanding as of December 31, 2022 had no intrinsic value. The Company awarded 55,730 and 32,925 stock options during the years ended December 31, 2022 and 2021, respectively, which had a weighted average grant date fair value per share of $5.57 and $8.40 , respectively. The weighted-average exercise price, by price range, for outstanding options to purchase common stock at December 31, 2022 was: Weighted Average Remaining Contractual Outstanding Exercisable Price Range Life in Years Options Options $8.10 - $40.05 8.16 183,250 124,771 $111.00 - $234.00 2.99 6,309 6,309 $301.50 - $339.00 1.34 2,714 2,714 Total 7.90 192,273 133,794 The Company’s share-based compensation expense for the years ended December 31, 2022 and 2021 was recognized as follows: Share-based compensation 2022 2021 Research and development $ 142,879 $ 158,478 General and administrative 190,510 203,081 Total $ 333,389 $ 361,559 At December 31, 2022, the total compensation cost for stock options not yet recognized was approximately $427,000 and will be expensed over the next three years. Warrants to Purchase Common Stock Warrant activity for the years ended December 31, 2022 and 2021 was as follows: Weighted Average Exercise Warrants Price Balance at December 31, 2020 382,099 $ 44.47 Granted — — Exercised (2) 59.25 Expired (160,225) 59.25 Balance at December 31, 2021 221,872 $ 33.79 Granted — — Exercised — — Expired (221,205) 33.81 Balance at December 31, 2022 667 $ 29.25 The remaining life, by grant date, for outstanding warrants at December 31, 2022 was: Remaining Exercise Contractual Outstanding Exercisable Grant Date Price Life in Years Warrants Warrants March 29, 2018 $ 29.25 0.24 667 667 |
Concentrations_2
Concentrations | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Concentrations | ||
Concentrations | Note 8. Concentrations At September 30, 2023 and 2022, the Company had deposits in major financial institutions that exceeded the amount under protection by the Federal Deposit Insurance Corporation (“FDIC”). Currently, the Company is covered up to $250,000 by the FDIC and at times maintains cash balances in excess of the FDIC coverage. Although the Company currently believes that the financial institutions with whom it does business will be able to fulfill their commitments to the Company, there is no assurance that those institutions will be able to continue to do so. The Company has not experienced any credit losses associated with its balances in such accounts. | Note 9. Concentrations At December 31, 2022 and 2021, the Company had deposits in major financial institutions that exceeded the amount under protection by the Securities Investor Protection Corporation (“SIPC”). Currently, the Company is covered up to $250,000 by the SIPC and at times maintains cash balances in excess of the SIPC coverage. |
Commitments and Contingencies_3
Commitments and Contingencies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies. | ||
Commitments and Contingencies | Note 9. Commitments and Contingencies Contractual Obligations The Company has commitments of approximately $205,000 as of September 30, 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 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 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 to October 2025. The current rent of $11,108 per month will be maintained until November 2023 when it will be increased to $11,367 and then will increase to $11,625 in November 2024 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 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 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 September 30, 2023, 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 October 1 through December 31, 2023 $ 21,000 $ 33,841 $ 54,841 2024 46,000 136,917 182,917 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 Total $ 205,000 $ 287,008 $ 492,008 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. CARES Act Employee Retention Credit The Coronavirus Aid, Relief, and Economic Security Act provides for an employee retention credit (“CARES ERC”), which is a refundable tax credit equal to 70% of qualified wages paid to employees during a quarter, capped at $10,000 of qualified wages per employee. The Company qualified for the CARES ERC for qualified wages through September 30, 2021. The Company has submitted filings for refunds of the CARES ERC but cannot reasonably estimate when or if it will receive any or all of the requested refunds. The Company has elected to follow subtopic 450-30 of the FASB Accounting Standards Codification and to account for the CARES ERC only when all uncertainties regarding realization have been resolved. Subsequent to September 30, 2023 and as of the date of this Quarterly Report on Form 10-Q, the Company has received a refund of $120,771 . The refund was recorded as other income during the three and nine months ended September 30, 2023 on the accompanying condensed consolidated statements of operations. 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 its business, operating results, financial condition or cash flows as of and for the nine months ended September 30, 2023 and 2022. 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. Emergent BioSolutions Legal Proceedings In July 2020, the Company filed a demand for arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries (collectively, “Emergent”) with the American Arbitration Association in Mercer County, New Jersey. The Company alleges in the arbitration various breaches of contracts and warranties as well as acts of fraud. Emergent has answered that demand for arbitration denying the allegations and asserting affirmative defenses. The Company presented its case at an arbitration hearing over 12 days in January 2022. Following submission of post-hearing briefs, the arbitration panel heard closing oral arguments in April 2022 (see Part II, Item 1 – Legal Proceedings). The Company was seeking to recover damages in excess of $19 million from Emergent. On July 6, 2022, the American Arbitration Association entered a final decision in connection with this arbitration. Despite the arbitration panel ruling that Emergent had committed a number of breaches of the parties’ contracts, the panel did not award monetary damages to the Company. On September 30, 2022, the Company filed a petition to vacate the arbitration decision with the Delaware Court of Chancery, requesting that the Court vacate the arbitration decision and remand the matter to the arbitration panel for rehearing. After hearing oral arguments, the Court of Chancery granted summary judgment in favor of Emergent on July 17, 2023, thereby confirming the decision of the arbitration panel. | Note 10. Commitments and Contingencies The Company has commitments of approximately $230,000 as of December 31, 2022 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 $11,108 per month and will remain so through October 2023. The rent for lease periods starting November 2023 and November 2024 is approximately $11,367 per month and $11,625 per month, respectively. 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 $38.34 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 $5.0 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, 2022, 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 2023 $ 46,000 $ 133,817 $ 179,817 2024 46,000 136,917 182,917 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 Total $ 230,000 $ 386,984 $ 616,984 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, 2022. 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. Emergent BioSolutions Legal Proceedings On July 1, 2020, the Company filed a demand for arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries (collectively, “Emergent”) with the American Arbitration Association in Mercer County, New Jersey. The Company alleges in the arbitration various breaches of contracts and warranties as well as acts of fraud. Emergent has answered that demand for arbitration denying the allegations and asserting affirmative defenses. The Company presented its case at an arbitration hearing over 12 days in January 2022. Following submission of post-hearing briefs, the arbitration panel heard closing oral arguments in April 2022. The Company sought to recover damages in excess of $19 million from Emergent. On July 6, 2022, the American Arbitration Association entered a final decision in connection with this arbitration. Despite the arbitration panel ruling that Emergent had committed a number of breaches of the parties’ contracts, the panel did not award monetary damages to the Company. On September 30, 2022, the Company filed a petition to vacate the arbitration decision with the Delaware Court of Chancery, requesting that the Court vacate the arbitration decision and remand the matter to the arbitration panel for rehearing. The Company cannot offer any assurances as to any result of its challenge of the arbitration decision or that the Company will recover any damages from Emergent (see Part I, Item 3 – Legal Proceedings). The Company has received invoices from Emergent related to the above matter. No accrual has been made for these invoices as management deems them invalid and not probable of being required to pay them based on the numerous breaches sited in the arbitration. These invoices total approximately $331,000 . |
Operating Segments_2
Operating Segments | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Operating Segments | ||
Operating Segments | 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. Three Months Ended September 30, 2023 2022 Revenues Specialized BioTherapeutics $ — $ — Public Health Solutions 130,440 166,140 Total $ 130,440 $ 166,140 Income (loss) from Operations Specialized BioTherapeutics $ (705,753) $ (1,856,553) Public Health Solutions (24,819) (9,578) Corporate (1,048,484) (1,215,113) Total $ (1,779,056) $ (3,081,244) Amortization and Depreciation Expense Specialized BioTherapeutics $ 954 $ 2,876 Public Health Solutions 159 479 Corporate 476 1,438 Total $ 1,589 $ 4,793 Other (Expense) Income, Net Specialized BioTherapeutics $ 1,683 $ (12,613) Corporate 114,671 (215,146) Total $ 116,354 $ (227,759) Share-Based Compensation Specialized BioTherapeutics $ 27,427 $ 28,343 Public Health Solutions 994 1,054 Corporate 36,979 41,318 Total $ 65,400 $ 70,715 Nine Months Ended September 30, 2023 2022 Revenues Specialized BioTherapeutics $ 223,870 $ — Public Health Solutions 370,677 582,843 Total $ 594,547 $ 582,843 Income (loss) from Operations Specialized BioTherapeutics $ (2,227,430) $ (5,396,630) Public Health Solutions (26,639) (131,201) Corporate (3,306,000) (5,141,095) Total $ (5,560,069) $ (10,668,926) Amortization and Depreciation Expense Specialized BioTherapeutics $ 2,979 $ 8,273 Public Health Solutions 496 1,379 Corporate 1,489 11,886 Total $ 4,964 $ 21,538 Other (Expense) Income, Net Specialized BioTherapeutics $ 17,696 $ 110,975 Corporate 60,341 (641,768) Total $ 78,037 $ (530,793) Share-Based Compensation Specialized BioTherapeutics $ 82,281 $ 85,190 Public Health Solutions 2,982 3,162 Corporate 143,813 132,304 Total $ 229,076 $ 220,656 As of As of September 30, December 31, 2023 2022 Identifiable Assets Specialized BioTherapeutics $ 58,704 $ 103,742 Public Health Solutions 70,557 121,290 Corporate 11,173,568 14,054,685 Total $ 11,302,829 $ 14,279,717 | 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, 2022 2021 Revenues Specialized BioTherapeutics $ 31,929 $ — Public Health Solutions 916,982 824,268 Total $ 948,911 $ 824,268 (Loss) Income from Operations Specialized BioTherapeutics $ (7,614,988) $ (7,216,450) Public Health Solutions 26,612 (542,270) Corporate (6,650,528) (5,340,240) Total $ (14,238,904) $ (13,098,960) Amortization and Depreciation Expense Specialized BioTherapeutics $ 10,087 $ 7,804 Public Health Solutions 1,681 1,301 Corporate 12,794 25,056 Total $ 24,562 $ 34,161 Other (Expense) Income, Net Specialized BioTherapeutics $ 102,320 $ 135,409 Corporate (816,690) (452,164) Total $ (714,370) $ (316,755) Share-Based Compensation Specialized BioTherapeutics $ 138,075 $ 136,594 Public Health Solutions 4,804 21,884 Corporate 190,510 203,081 Total $ 333,389 $ 361,559 As of December 31, 2022 2021 Identifiable Assets Specialized BioTherapeutics $ 103,742 $ 128,645 Public Health Solutions 121,290 146,296 Corporate 14,054,685 26,594,986 Total $ 14,279,717 $ 26,869,927 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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. |
Reclassifications | Reclassifications Certain amounts in the statement of operations for the year ended December 31, 2021 have been reclassified to conform to the current year presentation. | |
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 doubtful accounts has been established. If amounts become uncollectible, they are charged to operations. | Licensing, 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 doubtful accounts has been established. If amounts become uncollectible, they are charged to operations. |
Website Development Costs | Website Development Costs In June 2019, the Company capitalized website development costs of $46,500 in accordance with FASB Codification ASC 350-50 “Accounting for Web Site Development Costs.” The Company began amortizing the website development costs on a straight-line basis over three years , the estimated useful life of the website. The Company reviews its capitalized website development costs periodically for impairment. Website amortization expense for 2022 and 2021 was $7,750 and $15,500 , respectively, and accumulated amortization was $46,500 and $38,750 , respectively, as of December 31, 2022 and 2021. Website development costs were included in other assets in the accompanying consolidated balance sheets. | |
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 no t record any impairment of long-lived assets for the three and nine months ended September 30, 2023 and 2022. | 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, 2022 and 2021. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. Disclosures about the fair value of financial instruments are based on pertinent information available to the Company on September 30, 2023. 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 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 September 30, 2023 for the convertible debt is its fair value - see Note 5. The principal amount of the convertible debt was $3,000,000 at September 30, 2023 and the fair value was approximately $2,916,463 . 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 September 30, 2023 is as follows: Balance, December 31, 2022 Issued Adjustment to fair value Balance, September 30, 2023 Convertible debt at fair value $ - $ 3,304,000 $ (387,537) $ 2,916,463 | Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC 820 requires disclosures about the fair value of all financial instruments, whether or not recognized, for financial statement purposes. Disclosures about the fair value of financial instruments are based on pertinent information available to the Company on December 31, 2022 and 2021. 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. The carrying amounts reported in the consolidated balance sheets for cash and cash equivalents, licensing, contracts and/or 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 sheets for convertible debt approximates its fair value based on its interest rate and maturity date. |
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. | |
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 . Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. 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 . Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. 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 includes costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, equipment depreciation and allocation of various corporate 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 includes costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, equipment depreciation and allocation of various corporate costs. |
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 (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 nine months ended September 30, 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 4 years ; ● volatility of 94% for 2023 and 87% for 2022; and ● risk free interest rates of 3.48% for 2023 and ranging from 1.12% - 3.23% for 2022. The fair value of each option grant made during the nine months ended September 30, 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. | 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, 2022 and 2021 was estimated using the Black-Scholes option-pricing model and the following assumptions: ● a dividend yield of 0% ; ● an expected life of 4 years ; ● volatility of 84% - 87% for 2022 and 2021; and ● risk-free interest rates ranging from 1.12% to 4.51% in 2022 and 0.27% to 1.13% in 2021. The fair value of each option grant made during 2022 and 2021 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. |
Foreign Currency Transactions and Translation | Foreign Currency Transactions and Translation In accordance with FASB ASC 830 Foreign Currency Matters , the UK subsidiary expresses its U.S. dollar and Euro denominated transactions in its functional currency, the British Pound, with related transaction gains or losses included in net loss. On a quarterly basis, the financial statements of the UK subsidiary are translated into U.S. dollars and consolidated into the Company’s financials, with related translation adjustments reported as a cumulative translation adjustment (“CTA”), which is a component of accumulated other comprehensive income. During the three months ended September 30, 2023 and 2022, the Company recognized foreign currency transaction losses of ($3,046) and ($12,613) , respectively, in the accompanying condensed consolidated statements of operations. During the nine months ended September 30, 2023 and 2022, the Company recognized a foreign currency transaction gain of $310 and a foreign currency transaction loss of ($26,006) , respectively, in the accompanying condensed consolidated statements of operations. | 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 , the UK subsidiary expresses its U.S. dollar and Euro denominated transactions in its functional currency, the British Pound, with related transaction gains or losses included in net loss. On a quarterly basis, the financial statements of the UK subsidiary are translated into U.S. dollars and consolidated into the Company’s financials, with related translation adjustments reported as a cumulative translation adjustment (“CTA”), which is a component of accumulated other comprehensive loss. In 2022 and 2021, the Company recognized foreign currency transaction losses of $30,549 and $39,361 , respectively, in the accompanying consolidated statements of operations. |
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 recognized an income tax benefit of $1,161,197 and $1,154,935 from the sale of 2021 and 2020 New Jersey NOL carryforwards during the nine months ended September 30, 2023 and 2022, respectively. 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 nine months ended September 30, 2023 and 2022. Additionally, the Company has no t recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at September 30, 2023 or December 31, 2022. | 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 recognized an income tax benefit of $1,154,935 and $864,742 from the sale of 2020 and 2019 New Jersey NOL carryforwards during the years ended December 31, 2022 and 2021, respectively. 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 2022 and 2021. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2022 or 2021. |
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 $41,000 and $128,000 as of September 30, 2023 and December 31, 2022, respectively, in the condensed consolidated balance sheets. The following table shows the change in the UK research and development incentives receivable from December 31, 2022 to September 30, 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 — 18,536 18,536 Adjustments to 2021 and 2022 incentives earned (1,150) — (1,150) UK research and development incentives cash receipt (104,422) — (104,422) Foreign currency translation 112 (230) (118) Balance at September 30, 2023 $ 22,852 $ 18,306 $ 41,158 | 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 $128,000 and $225,000 as of December 31, 2022 and 2021, respectively in the consolidated balance sheets. The following table shows the change in the UK research and development incentives receivable from December 31, 2021 to December 31, 2022: Current Long-Term Total Balance at December 31, 2021 $ 103,832 $ 121,238 $ 225,070 UK research and development incentives, transfer 121,238 (121,238) — UK research and development incentives — 24,963 24,963 Additional 2020 incentive earned 107,906 — 107,906 UK research and development incentives cash receipt (209,166) — (209,166) Foreign currency translation (19,612) (849) (20,461) Balance at December 31, 2022 $ 104,198 $ 24,114 $ 128,312 |
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 and nine months ended September 30, 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: As of September 30, 2023 2022 Common stock purchase warrants 6,538,500 3,992 Stock options 206,589 145,505 Convertible debt 2,159,414 162,602 Total 8,904,503 312,099 The weighted average exercise prices of the Company’s warrants and stock options outstanding at September 30, 2023 were $1.50 and $24.83 per share, respectively. The weighted average exercise prices of the Company’s warrants and stock options outstanding at September 30, 2022 were $36.12 and $34.49 per share, respectively. The weighted average conversion price of the Company’s convertible debt at September 30, 2023 and 2022 was $1.39 and $61.50 per share, respectively. 217,880 of the Company’s common stock warrants associated with the July 2018 public offering expired on January 2, 2022 and 667 of the Company’s common stock warrants associated with the opening of the first clinical site in the United Kingdom expired on March 28, 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. 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, 2022 2021 Common stock purchase warrants 667 221,872 Stock options 192,273 140,996 Convertible debt 162,602 162,602 Total 355,542 525,470 |
Use of Estimates and Assumptions | 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. | 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 Accou_10
Summary of Significant Accounting Policies (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Summary of Significant Accounting Policies | ||
Schedule of carrying value of convertible debt | A roll forward of the carrying value of the convertible debt to September 30, 2023 is as follows: Balance, December 31, 2022 Issued Adjustment to fair value Balance, September 30, 2023 Convertible debt at fair value $ - $ 3,304,000 $ (387,537) $ 2,916,463 | |
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 — 18,536 18,536 Adjustments to 2021 and 2022 incentives earned (1,150) — (1,150) UK research and development incentives cash receipt (104,422) — (104,422) Foreign currency translation 112 (230) (118) Balance at September 30, 2023 $ 22,852 $ 18,306 $ 41,158 | Current Long-Term Total Balance at December 31, 2021 $ 103,832 $ 121,238 $ 225,070 UK research and development incentives, transfer 121,238 (121,238) — UK research and development incentives — 24,963 24,963 Additional 2020 incentive earned 107,906 — 107,906 UK research and development incentives cash receipt (209,166) — (209,166) Foreign currency translation (19,612) (849) (20,461) Balance at December 31, 2022 $ 104,198 $ 24,114 $ 128,312 |
Schedule of potentially dilutive adjustments to the weighted average number of common shares excluded from the calculation | As of September 30, 2023 2022 Common stock purchase warrants 6,538,500 3,992 Stock options 206,589 145,505 Convertible debt 2,159,414 162,602 Total 8,904,503 312,099 | December 31, December 31, 2022 2021 Common stock purchase warrants 667 221,872 Stock options 192,273 140,996 Convertible debt 162,602 162,602 Total 355,542 525,470 |
Leases (Tables)_2
Leases (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Leases | ||
Schedule of lease expense | Operating Lease Right-of-use lease asset: Right-of-use lease asset, January 1, 2023 $ 340,987 Less: reduction/amortization 82,500 Right-of-use lease asset, September 30, 2023 $ 258,487 Lease liability: Lease liability, January 1, 2023 $ 342,575 Less: repayments 80,458 Lease liability, September 30, 2023 $ 262,117 Lease expense for the nine months ended September 30, 2023: Lease expense $ 102,016 Total $ 102,016 Lease expense for the nine months ended September 30, 2022: Lease expense $ 100,887 Total $ 100,887 Contractual cash payments for the remaining lease term as of September 30, 2023: 2023 $ 33,841 2024 136,917 2025 116,250 Total $ 287,008 Remaining lease term (months) as of September 30, 2023 25 | Operating Lease Contractual cash payments for the remaining lease term as of December 31, 2022 2023 $ 133,817 2024 136,917 2025 116,250 Total $ 386,984 Discount rate applied 8.47 % Remaining lease term (months) as of December 31, 2022 34 Right-of-use lease asset: Right-of-use lease asset, January 1, 2021 $ 222,445 Less: reduction/amortization 116,290 Right-of-use lease asset, December 31, 2021 106,155 New lease extension June 21, 2022 347,546 Reduction/amortization 112,714 Right of use lease asset, December 31, 2022 $ 340,987 Lease liability: Lease liability, January 1, 2021 $ 222,441 Less: repayments 116,290 Lease liability, December 31, 2021 106,151 New lease extension June 21, 2022 347,546 Less: repayments 111,122 Lease liability, December 31, 2022 $ 342,575 Lease expense for the year ended December 31, 2021: Lease expense $ 133,300 Total $ 133,300 Lease expense for the year ended December 31, 2022: Lease expense $ 134,892 Total $ 134,892 |
Accrued Expenses (Tables)_2
Accrued Expenses (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Accrued Expenses | ||
Schedule of accrued expenses | September 30, December 31, 2023 2022 Clinical trial expenses $ 2,082,200 $ 1,884,117 Other 304,636 423,629 Total $ 2,386,836 $ 2,307,746 | December 31, 2022 2021 Clinical trial expenses $ 1,884,117 $ 2,625,779 Other 423,629 330,766 Total $ 2,307,746 $ 2,956,545 |
Debt (Tables)_2
Debt (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Debt | ||
Debt Assumptions | Assumptions 4/19/2023 9/30/2023 Stock price $ 1.72 $ 0.56 Volatility 75.20% 110.50% Discount rate 16.28% 14.84% Risk-free rate 4.27% 5.24% | |
Schedule of annual principle and interest payments due | Year Principal Interest Total 2023 $ — $ 128,094 $ 128,094 2024 2,250,000 206,761 2,456,761 2025 750,000 16,012 766,012 Total $ 3,000,000 $ 350,867 $ 3,350,867 | Year Principal Interest Total 2023 $ 4,000,000 $ 634,438 $ 4,634,438 2024 4,000,000 295,638 4,295,638 2025 2,000,000 21,349 2,021,349 Total $ 10,000,000 $ 951,425 $ 10,951,425 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes | |
Schedule of federal and state statutory tax rates and the provision for income tax benefit | 2022 2021 Federal $ — $ — Foreign — — State (1,154,935) (864,742) Income tax benefit $ (1,154,935) $ (864,742) |
Schedule of deferred tax assets and liabilities | 2022 2021 Net operating loss carry forwards $ 27,252,000 $ 28,065,000 Orphan drug and research and development credit carry forwards 8,837,000 8,605,000 Equity based compensation 285,000 264,000 Intangibles 1,696,000 1,953,000 Capitalized research and development (Section 174) 1,832,000 — Lease liability 96,000 30,000 Total 39,998,000 38,917,000 Valuation allowance (39,902,000) (38,887,000) Net deferred tax assets 96,000 30,000 Right of use asset (96,000) (30,000) Total gross deferred tax liabilities (96,000) (30,000) Net deferred tax assets $ — $ — |
Schedule of federal and state statutory tax rates and the provision for income tax benefit | 2022 2021 Federal tax at statutory rate (21.0) % (21.0) % State tax benefits, plus sale of NJ NOL, net of federal benefit (2.4) (7.6) Foreign tax rate difference 0.2 0.1 Orphan drug and research and development credits (3.9) (4.3) Permanent differences 3.1 1.3 Foreign NOL adjustments 0.4 0.6 Expiration of tax attributes 9.1 4.9 Change in valuation allowance 6.8 19.6 Income tax benefit (7.7) % (6.4) % |
Stock Option Plans and Warran_2
Stock Option Plans and Warrants to Purchase Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 1,866,719 Modification to Plan 4,000,000 Options granted (55,730) Options forfeited 2,002 Options exercised — Shares available for grant at December 31, 2022 5,812,991 |
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, 2020 128,858 $ 44.41 Granted 32,925 13.68 Forfeited (15,982) 54.61 Cancelled (2,787) 11.70 Exercised (2,018) 12.81 Balance outstanding at December 31, 2021 140,996 $ 37.12 Granted 55,730 8.85 Forfeited (3,908) 107.83 Cancelled (545) 11.70 Exercised — — Balance outstanding at December 31, 2022 192,273 $ 27.56 |
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 $8.10 - $40.05 8.16 183,250 124,771 $111.00 - $234.00 2.99 6,309 6,309 $301.50 - $339.00 1.34 2,714 2,714 Total 7.90 192,273 133,794 |
Share-based Payment Arrangement | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of share-based compensation expense | Share-based compensation 2022 2021 Research and development $ 142,879 $ 158,478 General and administrative 190,510 203,081 Total $ 333,389 $ 361,559 |
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, 2020 382,099 $ 44.47 Granted — — Exercised (2) 59.25 Expired (160,225) 59.25 Balance at December 31, 2021 221,872 $ 33.79 Granted — — Exercised — — Expired (221,205) 33.81 Balance at December 31, 2022 667 $ 29.25 |
Schedule of remaining life, by grant date, for outstanding warrants | Remaining Exercise Contractual Outstanding Exercisable Grant Date Price Life in Years Warrants Warrants March 29, 2018 $ 29.25 0.24 667 667 |
Commitments and Contingencies_4
Commitments and Contingencies (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies. | ||
Schedule of contractual obligation | Research and Property and Year Development Other Leases Total October 1 through December 31, 2023 $ 21,000 $ 33,841 $ 54,841 2024 46,000 136,917 182,917 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 Total $ 205,000 $ 287,008 $ 492,008 | Research and Property and Year Development Other Leases Total 2023 $ 46,000 $ 133,817 $ 179,817 2024 46,000 136,917 182,917 2025 46,000 116,250 162,250 2026 46,000 — 46,000 2027 46,000 — 46,000 Total $ 230,000 $ 386,984 $ 616,984 |
Operating Segments (Tables)_2
Operating Segments (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Operating Segments | ||
Schedule of operating segments | Three Months Ended September 30, 2023 2022 Revenues Specialized BioTherapeutics $ — $ — Public Health Solutions 130,440 166,140 Total $ 130,440 $ 166,140 Income (loss) from Operations Specialized BioTherapeutics $ (705,753) $ (1,856,553) Public Health Solutions (24,819) (9,578) Corporate (1,048,484) (1,215,113) Total $ (1,779,056) $ (3,081,244) Amortization and Depreciation Expense Specialized BioTherapeutics $ 954 $ 2,876 Public Health Solutions 159 479 Corporate 476 1,438 Total $ 1,589 $ 4,793 Other (Expense) Income, Net Specialized BioTherapeutics $ 1,683 $ (12,613) Corporate 114,671 (215,146) Total $ 116,354 $ (227,759) Share-Based Compensation Specialized BioTherapeutics $ 27,427 $ 28,343 Public Health Solutions 994 1,054 Corporate 36,979 41,318 Total $ 65,400 $ 70,715 Nine Months Ended September 30, 2023 2022 Revenues Specialized BioTherapeutics $ 223,870 $ — Public Health Solutions 370,677 582,843 Total $ 594,547 $ 582,843 Income (loss) from Operations Specialized BioTherapeutics $ (2,227,430) $ (5,396,630) Public Health Solutions (26,639) (131,201) Corporate (3,306,000) (5,141,095) Total $ (5,560,069) $ (10,668,926) Amortization and Depreciation Expense Specialized BioTherapeutics $ 2,979 $ 8,273 Public Health Solutions 496 1,379 Corporate 1,489 11,886 Total $ 4,964 $ 21,538 Other (Expense) Income, Net Specialized BioTherapeutics $ 17,696 $ 110,975 Corporate 60,341 (641,768) Total $ 78,037 $ (530,793) Share-Based Compensation Specialized BioTherapeutics $ 82,281 $ 85,190 Public Health Solutions 2,982 3,162 Corporate 143,813 132,304 Total $ 229,076 $ 220,656 As of As of September 30, December 31, 2023 2022 Identifiable Assets Specialized BioTherapeutics $ 58,704 $ 103,742 Public Health Solutions 70,557 121,290 Corporate 11,173,568 14,054,685 Total $ 11,302,829 $ 14,279,717 | For the Years Ended December 31, 2022 2021 Revenues Specialized BioTherapeutics $ 31,929 $ — Public Health Solutions 916,982 824,268 Total $ 948,911 $ 824,268 (Loss) Income from Operations Specialized BioTherapeutics $ (7,614,988) $ (7,216,450) Public Health Solutions 26,612 (542,270) Corporate (6,650,528) (5,340,240) Total $ (14,238,904) $ (13,098,960) Amortization and Depreciation Expense Specialized BioTherapeutics $ 10,087 $ 7,804 Public Health Solutions 1,681 1,301 Corporate 12,794 25,056 Total $ 24,562 $ 34,161 Other (Expense) Income, Net Specialized BioTherapeutics $ 102,320 $ 135,409 Corporate (816,690) (452,164) Total $ (714,370) $ (316,755) Share-Based Compensation Specialized BioTherapeutics $ 138,075 $ 136,594 Public Health Solutions 4,804 21,884 Corporate 190,510 203,081 Total $ 333,389 $ 361,559 As of December 31, 2022 2021 Identifiable Assets Specialized BioTherapeutics $ 103,742 $ 128,645 Public Health Solutions 121,290 146,296 Corporate 14,054,685 26,594,986 Total $ 14,279,717 $ 26,869,927 |
Nature of Business (Details)_2
Nature of Business (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||||||||
Nov. 06, 2023 USD ($) $ / shares shares | May 09, 2023 USD ($) $ / shares shares | May 02, 2023 $ / shares shares | Apr. 27, 2023 shares | Feb. 10, 2023 | Feb. 09, 2023 shares | Nov. 07, 2022 shares | Oct. 04, 2022 shares | Aug. 05, 2022 shares | Feb. 07, 2022 shares | Sep. 29, 2021 shares | Sep. 30, 2023 USD ($) shares | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) segment shares | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) segment shares | Dec. 31, 2021 USD ($) shares | Mar. 22, 2023 USD ($) | Dec. 31, 2020 USD ($) | |
Nature of business: | |||||||||||||||||||
Number of operating segments | segment | 2 | 2 | |||||||||||||||||
Accumulated deficit | $ (223,884,281) | $ (223,884,281) | $ (219,563,446) | $ (205,765,107) | |||||||||||||||
Net loss | (1,662,702) | $ (3,309,003) | (4,320,835) | $ (10,044,784) | (13,798,339) | (12,550,973) | |||||||||||||
Net cash used in operating activities | (6,775,896) | (9,021,880) | (12,649,021) | (11,739,620) | |||||||||||||||
Reclassification of convertible debt from current to non-current liability | 1,416,463 | ||||||||||||||||||
Number of shares sold | 3,091,462 | 79,354 | 19,705,647 | ||||||||||||||||
Cash and cash equivalents | 10,298,534 | 16,865,642 | 10,298,534 | 16,865,642 | 13,359,615 | 26,043,897 | $ 18,676,663 | ||||||||||||
Net decrease in cash | $ 3,061,081 | 9,178,255 | $ 12,684,282 | (7,367,234) | |||||||||||||||
Percentage change in cash and cash equivalent | 23% | 49% | |||||||||||||||||
Accumulated deficit | 223,884,281 | $ 223,884,281 | $ 219,563,446 | 205,765,107 | |||||||||||||||
Working capital | 5,450,322 | 5,450,322 | (2,663,721) | 20,278,345 | |||||||||||||||
Working capital increase, decrease | $ (8,114,043) | 2,663,721 | $ (22,942,066) | ||||||||||||||||
Working capital increase (decrease) as a percent | 305% | 113% | |||||||||||||||||
Government grant funding | $ 66,051 | $ 66,051 | $ 115,130 | $ 138,889 | |||||||||||||||
Common Stock, Shares, Issued | shares | 10,378,238 | 10,378,238 | 2,908,578 | 2,858,244 | |||||||||||||||
Number of shares issued | shares | 50,000 | 5,129 | 1,667 | 3,664 | 5,377 | 1,667 | |||||||||||||
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 | |||||||||||||||||
Fractional shares issue under reverse stock split | shares | 0 | ||||||||||||||||||
Repayment of debt principal | $ 7,000,000 | ||||||||||||||||||
Consideration paid recorded in general and administrative expense | $ 973,040 | $ 1,326,249 | 3,098,949 | $ 5,250,510 | $ 6,692,904 | $ 5,008,738 | |||||||||||||
Issuance of common stock in connection with Silk Roads purchase option | 50,000 | ||||||||||||||||||
Public Offering | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Proceeds from Issuance of Common Stock | $ 8,500,000 | ||||||||||||||||||
Shares issued price per share | $ / shares | $ 1.30 | ||||||||||||||||||
Exercise price of warrants | $ / shares | $ 0.001 | ||||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||||
At Market Issuance Sales Agreement | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Proceeds from Issuance of Common Stock | 7,700,000 | ||||||||||||||||||
Number of shares sold | 3,000,000 | ||||||||||||||||||
Common Stock | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Number of shares sold | $ 851 | 8 | $ 812 | ||||||||||||||||
Issuance of common stock in connection with Silk Roads purchase option (in shares) | shares | 31,646 | ||||||||||||||||||
Issuance of common stock in connection with Silk Roads purchase option | $ 32 | ||||||||||||||||||
Common Stock | Public Offering | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Shares issued price per share | $ / shares | $ 1.30 | ||||||||||||||||||
Number of shares issued | shares | 2,301,500 | ||||||||||||||||||
Exercise price of warrants | $ / shares | $ 1.50 | ||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Reverse stock spilt effective from February 10, 2023 | 0.067 | 0.067 | |||||||||||||||||
Pre-funded warrants | Public Offering | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Number of common warrants to purchase shares issued | shares | 4,237,000 | ||||||||||||||||||
Common warrants | Public Offering | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Number of common warrants to purchase shares issued | shares | 6,538,500 | ||||||||||||||||||
Exercise price of warrants | $ / shares | $ 1.50 | ||||||||||||||||||
CiVax | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Revenue from collaborative arrangement | $ 1,500,000 | $ 1,500,000 | |||||||||||||||||
Term (in years) | P2Y | two years | |||||||||||||||||
HyBryte | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Revenue from collaborative arrangement | $ 1,100,000 | $ 1,100,000 | |||||||||||||||||
Term (in years) | P4Y | four years | |||||||||||||||||
NIH | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Government grant funding | $ 1,000,000 | $ 1,000,000 | $ 1,700,000 | ||||||||||||||||
DTRA | Contract revenue | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Revenue from collaborative arrangement | $ 600,000 | ||||||||||||||||||
Term (in years) | three years | ||||||||||||||||||
Exclusive option agreement | Silk Road | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Consideration paid recorded in general and administrative expense | $ 50,000 | ||||||||||||||||||
Exclusive option agreement | Common Stock | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Shares issued price per share | $ / shares | $ 1.58 | ||||||||||||||||||
Number of shares issued | shares | 31,646 | ||||||||||||||||||
Exclusive option agreement | Common Stock | Silk Road | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Issuance of common stock in connection with Silk Roads purchase option (in shares) | shares | 31,646 | ||||||||||||||||||
Issuance of common stock in connection with Silk Roads purchase option | $ 50,000 | ||||||||||||||||||
B Riley Sales Agreement [Member] | Underwritten public offering | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Maximum Percentage Of Shares Available For Sale Of Market Value | 33.33% | ||||||||||||||||||
B Riley Sales Agreement [Member] | Subsequent Event | |||||||||||||||||||
Nature of business: | |||||||||||||||||||
Proceeds from Issuance of Common Stock | $ 3,091,462 | ||||||||||||||||||
Common stock available for sale (in Dollars) | $ 23,600,000 | $ 26,600,000 | |||||||||||||||||
Maximum Percentage Of Shares Available For Sale Of Market Value | 33.33% | ||||||||||||||||||
Shares issued price per share | $ / shares | $ 3.63 | ||||||||||||||||||
Common Stock, Shares, Issued | shares | 851,130 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Jun. 30, 2019 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2019 | Sep. 30, 2023 USD ($) segment | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) segment shares | Dec. 31, 2021 USD ($) shares | Apr. 19, 2023 USD ($) | Dec. 31, 2020 USD ($) | |
Finite-Lived Intangible Assets [Line Items] | ||||||||||
Number of operating segments | segment | 2 | 2 | ||||||||
Website development cost | $ 46,500 | |||||||||
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% | 0% | 0% | ||||||
Expected life | 4 years | 4 years | 4 years | |||||||
Volatility rate | 94% | 87% | ||||||||
Volatility rate minimum | 84% | 84% | ||||||||
Volatility rate maximum | 87% | 87% | ||||||||
Risk-free interest rate | 3.48% | |||||||||
Risk free interest rate, minimum | 1.12% | 1.12% | 0.27% | |||||||
Risk free interest rate, maximum | 3.23% | 4.51% | 1.13% | |||||||
Foreign currency transaction gain (loss) | (3,046) | (12,613) | $ 310 | $ (26,006) | $ (30,549) | $ (39,361) | ||||
Income tax benefit | (1,161,197) | (1,154,935) | (1,154,935) | (864,742) | ||||||
Interest and penalties | 0 | $ 0 | 0 | $ 0 | 0 | 0 | ||||
Unrecognized Tax Benefits | 0 | 0 | $ 0 | $ 0 | ||||||
Number of options issued | shares | 55,730 | 32,925 | ||||||||
Convertible debt fair value | 2,916,463 | 2,916,463 | ||||||||
Convertible Debt | ||||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||||
Debt instrument, face amount | 3,000,000 | 3,000,000 | $ 20,000,000 | |||||||
Convertible debt fair value | $ 2,916,463 | $ 2,916,463 | $ 3,304,000 | |||||||
Warrants | ||||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||||
DO NOT USE FOR WARRANTS Expired (in shares) | shares | (221,205) | (160,225) | ||||||||
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 | ||||||||
Website development | ||||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||||
Intangible assets, estimated useful life | 3 years | |||||||||
Intangible, amortization expense | $ 7,750 | $ 15,500 | ||||||||
Intangible, accumulated amortization | $ 46,500 | $ 38,750 |
Summary of Significant Accou_12
Summary of Significant Accounting Policies - Carrying Value of Convertible Debt (Details) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | |
Debt instruments | ||
Adjustment to fair value | $ 72,463 | $ (387,537) |
Convertible Debt | ||
Debt instruments | ||
Issued | 3,304,000 | |
Adjustment to fair value | (72,463) | (387,537) |
Convertible debt at fair value as of September 30, 2023 | $ 2,916,463 | $ 2,916,463 |
Summary of Significant Accou_13
Summary of Significant Accounting Policies - Research and Development Incentives (Details) - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Research and development incentive receivable, total | $ 41,000 | $ 128,000 | $ 225,000 |
Incentives receivable, Beginning balance | 128,312 | 225,070 | |
UK research and development incentives | 18,536 | 24,963 | |
Adjustments to 2021 and 2022 incentives earned | (1,150) | ||
Additional 2019 incentive earned | 107,906 | ||
UK research and development incentives cash receipt | (104,422) | (209,166) | |
Foreign currency translation | (118) | (20,461) | |
Incentives receivable, Ending balance | 41,158 | 128,312 | |
Current Receivables | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Incentives receivable, Beginning balance | 104,198 | 103,832 | |
UK research and development incentives, transfer | 24,114 | 121,238 | |
Adjustments to 2021 and 2022 incentives earned | (1,150) | ||
Additional 2019 incentive earned | 107,906 | ||
UK research and development incentives cash receipt | (104,422) | (209,166) | |
Foreign currency translation | 112 | (19,612) | |
Incentives receivable, Ending balance | 22,852 | 104,198 | |
Long Term Receivable | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Incentives receivable, Beginning balance | 24,114 | 121,238 | |
UK research and development incentives, transfer | (24,114) | (121,238) | |
UK research and development incentives | 18,536 | 24,963 | |
Foreign currency translation | (230) | (849) | |
Incentives receivable, Ending balance | $ 18,306 | $ 24,114 |
Summary of Significant Accou_14
Summary of Significant Accounting Policies - Loss per share, Warrants and Options expirations (Details) - $ / shares | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 28, 2023 | Jan. 02, 2022 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||
Securities excluded | 8,904,503 | 312,099 | 355,542 | 525,470 | |||
Weighted average exercise price, outstanding warrants | $ 1.50 | $ 36.12 | |||||
Weighted average exercise price, outstanding options | 24.83 | 34.49 | $ 27.56 | $ 37.12 | $ 44.41 | ||
Common Stock Warrants, Number Of Expirations | 667 | 217,880 | |||||
Weighted Average | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||
Conversion price | $ 1.39 | $ 61.50 | |||||
Warrants | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||
Securities excluded | 6,538,500 | 3,992 | 667 | 221,872 | |||
Stock options | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||
Securities excluded | 206,589 | 145,505 | 192,273 | 140,996 | |||
Convertible debt securities | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||
Securities excluded | 2,159,414 | 162,602 | 162,602 | 162,602 |
Leases (Details)_2
Leases (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Jun. 21, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Lessee, Lease, Description [Line Items] | |||||
Lease rent per month | $ 11,108 | ||||
Right-of-use asset, operating lease | $ 258,487 | $ 340,987 | $ 106,155 | $ 222,445 | |
Lease liability, operating | 262,117 | 342,575 | $ 106,151 | $ 222,441 | |
For Period Till November 2023 | |||||
Lessee, Lease, Description [Line Items] | |||||
Lease rent per month | 11,108 | 11,108 | 11,367 | ||
From Period Till November 2024 | |||||
Lessee, Lease, Description [Line Items] | |||||
Lease rent per month | 11,367 | 11,367 | $ 11,625 | ||
From Period Till Lease Expiration 2024 | |||||
Lessee, Lease, Description [Line Items] | |||||
Lease rent per month | $ 11,625 | $ 11,625 |
Leases - Reconciliation (Deta_2
Leases - Reconciliation (Details) - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Right-of-use lease asset: | ||||
Right-of-use lease asset, Beginning balance | $ 340,987 | $ 106,155 | $ 106,155 | $ 222,445 |
Less: reduction/amortization | 82,500 | 112,714 | 116,290 | |
Right-of-use lease asset, Ending balance | 258,487 | 340,987 | 106,155 | |
Lease liability: | ||||
Lease liability, Beginning | 342,575 | 106,151 | 106,151 | 222,441 |
Less: repayments | 80,458 | 111,122 | 116,290 | |
Lease liability, Ending | 262,117 | 342,575 | 106,151 | |
Lease expense | ||||
Lease expense | 102,016 | $ 100,887 | 134,892 | $ 133,300 |
Contractual cash payments for the remaining lease term | ||||
2023 | 33,841 | |||
2024 | 136,917 | 133,817 | ||
2025 | 116,250 | 136,917 | ||
2025 | 116,250 | |||
Total | $ 287,008 | $ 386,984 | ||
Operating Lease, Discount rate applied | 8.47% | |||
Remaining lease term (months) | 25 years | 34 months |
Accrued Expenses (Details)_2
Accrued Expenses (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Expenses | |||
Clinical trail expenses | $ 2,082,200 | $ 1,884,117 | $ 2,625,779 |
Other | 304,636 | 423,629 | 330,766 |
Total | $ 2,386,836 | $ 2,307,746 | $ 2,956,545 |
Debt (Details)_2
Debt (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Apr. 19, 2023 | Apr. 18, 2023 | Dec. 16, 2020 | Dec. 31, 2020 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Debt instruments | ||||||||||
Outstanding principal | $ 1,416,463 | $ 1,416,463 | $ 0 | $ 9,856,153 | ||||||
Loss on extinguishment of debt | (393,791) | 421,584 | ||||||||
Convertible debt fair value | 2,916,463 | 2,916,463 | ||||||||
Change in fair value of convertible debt | 72,463 | (387,537) | ||||||||
Convertible Debt | ||||||||||
Debt instruments | ||||||||||
Debt instrument, face amount | $ 20,000,000 | 3,000,000 | 3,000,000 | |||||||
Number of tranches | three | |||||||||
Interest rate percentage | 8.47% | |||||||||
Interest-only period | 2 years | |||||||||
Outstanding principal periodic payment | $ 1,000,000 | |||||||||
Unused line of credit fee, as a percent | 1% | 1% | ||||||||
Interest expense | 64,047 | $ 213,490 | 338,568 | $ 633,510 | 847,000 | 894,808 | ||||
Interest paid | 63,351 | $ 211,170 | 488,011 | $ 643,921 | $ 857,411 | $ 668,715 | ||||
Conversion price (in Dollars per share) | $ 61.50 | |||||||||
Loss on extinguishment of debt | (394,000) | |||||||||
Convertible debt fair value | $ 3,304,000 | 2,916,463 | 2,916,463 | |||||||
Change in fair value of convertible debt | $ (72,463) | $ (387,537) | ||||||||
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 | 588,599 | |||||||||
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% | |||||||||
Reduction in conversion price | $ 1.70 |
Debt - (Assumptions) (Details_2
Debt - (Assumptions) (Details) | 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 | 0.56 | 1.72 |
Measurement Input, Price Volatility [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt Instrument, Measurement Input | 1.1050 | 0.7520 |
Measurement Input, Discount Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt Instrument, Measurement Input | 0.1484 | 0.1628 |
Measurement Input, Risk Free Interest Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt Instrument, Measurement Input | 0.0524 | 0.0427 |
Debt- Payments due (Details)_2
Debt- Payments due (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Debt instruments | ||
2023 | $ 128,094 | |
2024 | 2,456,761 | $ 4,634,438 |
2025 | 766,012 | 4,295,638 |
2025 | 2,021,349 | |
Total | 3,350,867 | 10,951,425 |
Principal [Member] | ||
Debt instruments | ||
2024 | 2,250,000 | 4,000,000 |
2025 | 750,000 | 4,000,000 |
2025 | 2,000,000 | |
Total | 3,000,000 | 10,000,000 |
Interest [Member] | ||
Debt instruments | ||
2023 | 128,094 | |
2024 | 206,761 | 634,438 |
2025 | 16,012 | 295,638 |
2025 | 21,349 | |
Total | $ 350,867 | $ 951,425 |
Income Taxes (Details)_2
Income Taxes (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Income Taxes | |||
NOL for Federal tax | $ 124,000,000 | ||
NOL for State tax | 13,200,000 | ||
NOL for Foreign tax | 1,400,000 | ||
Various tax credits, amount | $ 8,800,000 | 8,800,000 | |
NOL carryforwards | $ 1,161,197 | 1,154,935 | $ 864,742 |
Interest or penalties accrued | $ 0 |
Income Taxes - Schedule of inco
Income Taxes - Schedule of income tax benefit (Details) - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes | ||||
Federal | $ 0 | $ 0 | ||
Foreign | 0 | 0 | ||
State | (1,154,935) | (864,742) | ||
Income Tax Expense (Benefit), Total | $ (1,161,197) | $ (1,154,935) | $ (1,154,935) | $ (864,742) |
Income Taxes - Schedule of defe
Income Taxes - Schedule of deferred tax assets and liabilities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Income Taxes | ||
Net operating loss carry forwards | $ 27,252,000 | $ 28,065,000 |
Orphan drug and research and development credit carry forwards | 8,837,000 | 8,605,000 |
Equity based compensation | 285,000 | 264,000 |
Intangibles | 1,696,000 | 1,953,000 |
Capitalized R&D | 1,832,000 | |
Lease Liability | 96,000 | 30,000 |
Deferred tax assets, gross | 39,998,000 | 38,917,000 |
Valuation allowance | (39,902,000) | (38,887,000) |
Net deferred tax assets | 96,000 | 30,000 |
ROU Assets | (96,000) | (30,000) |
Total gross deferred tax liabilities | (96,000) | (30,000) |
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, 2022 | Dec. 31, 2021 | |
Income Taxes | ||
Federal tax at statutory rate | (21.00%) | (21.00%) |
State tax benefits, plus sale of NJ NOL, net of federal benefit | (2.40%) | (7.60%) |
Foreign tax rate difference | 0.20% | 0.10% |
Orphan drug and research and development credits | (3.90%) | (4.30%) |
Permanent differences | 3.10% | 1.30% |
Foreign NOL adjustments | 0.40% | 0.60% |
Expiration of tax attributes | 9.10% | 4.90% |
Change in valuation allowance | 6.80% | 19.60% |
Income tax benefit | (7.70%) | (6.40%) |
Shareholders' Equity (Details_2
Shareholders' Equity (Details) | 9 Months Ended | 12 Months Ended | |||||||||||||||||||||
Nov. 06, 2023 USD ($) $ / shares | Sep. 06, 2023 $ / shares shares | Jun. 08, 2023 $ / shares shares | May 22, 2023 $ / shares shares | May 10, 2023 $ / shares shares | May 09, 2023 USD ($) $ / 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 shares | May 06, 2022 $ / shares shares | Feb. 07, 2022 $ / shares shares | Sep. 29, 2021 $ / shares shares | Aug. 11, 2017 | Sep. 30, 2023 Vote $ / shares shares | Dec. 31, 2022 Vote $ / shares shares | Dec. 31, 2021 $ / shares shares | Mar. 24, 2023 USD ($) | Mar. 22, 2023 USD ($) | Aug. 13, 2021 USD ($) | Dec. 31, 2020 shares | |
Class of Stock [Line Items] | |||||||||||||||||||||||
Preferred stock, shares authorized | 350,000 | 300,000 | 350,000 | ||||||||||||||||||||
Preferred stock, shares issued | 0 | 0 | 0 | ||||||||||||||||||||
Number of shares issued | 50,000 | 5,129 | 1,667 | 3,664 | 5,377 | 1,667 | |||||||||||||||||
Fair value per share | $ / shares | $ 1.46 | $ 9.75 | $ 7.20 | $ 13.65 | $ 7.80 | $ 9.30 | $ 16.50 | ||||||||||||||||
Common Stock, Value, Subscriptions | $ | $ 30,000,000 | ||||||||||||||||||||||
Shares issues (in shares) | 851,130 | 192,273 | 140,996 | 128,858 | |||||||||||||||||||
Weighted average price per share (in Dollars per share) | $ / shares | $ 3.63 | $ 8.85 | $ 13.68 | ||||||||||||||||||||
Shares issued on option exercises | 6,411 | 2,018 | |||||||||||||||||||||
Weighted average exercise price | $ / shares | $ 12.81 | ||||||||||||||||||||||
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% | ||||||||||||||||||||||
Common Stock, Value, Subscriptions | $ | 26,600,000 | ||||||||||||||||||||||
B Riley Sales Agreement [Member] | Subsequent Event | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Shares issued price per share | $ / shares | $ 3.63 | ||||||||||||||||||||||
Total gross proceeds | $ | $ 3,091,462 | ||||||||||||||||||||||
Common Stock, Value, Subscriptions | $ | $ 6,600,000 | ||||||||||||||||||||||
Common stock available for sale (in Dollars) | $ | $ 23,600,000 | $ 26,600,000 | |||||||||||||||||||||
B Riley Sales Agreement [Member] | Maximum | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Aggregate offering price (in Dollars) | $ | $ 30,000,000 | ||||||||||||||||||||||
Pre-funded warrants | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Warrants Issued | 4,237,000 | ||||||||||||||||||||||
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 | 0.001 | |||||||||||||||||||||
Number of votes per Series D preferred stock | Vote | 1,000,000 | 1,000,000 | |||||||||||||||||||||
Liquidation, cash payment per share | $ / shares | $ 0.001 | $ 0.001 | |||||||||||||||||||||
Threshold number of shares redeemed | 100 | 100 | |||||||||||||||||||||
Redemption price per share | $ / shares | $ 0.10 | $ 0.10 | |||||||||||||||||||||
Public Offering | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Shares issued price per share | $ / shares | $ 1.30 | ||||||||||||||||||||||
Exercise price of warrants | $ / shares | $ 0.001 | ||||||||||||||||||||||
Expiration term of warrants | 5 years | ||||||||||||||||||||||
Total gross proceeds | $ | $ 8,500,000 | ||||||||||||||||||||||
Public Offering | Pre-funded warrants | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Number of common warrants to purchase shares issued | 4,237,000 | ||||||||||||||||||||||
Exercise price of warrants | $ / shares | $ 0.001 | ||||||||||||||||||||||
Warrants outstanding | 0 | ||||||||||||||||||||||
Public Offering | Common warrants | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Number of common warrants to purchase shares issued | 6,538,500 | ||||||||||||||||||||||
Exercise price of warrants | $ / shares | $ 1.50 | ||||||||||||||||||||||
FBR Capital Markets & Co. [Member] | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Shares issues (in shares) | 8,542 | ||||||||||||||||||||||
Weighted average price per share (in Dollars per share) | $ / shares | $ 9.29 | ||||||||||||||||||||||
Common Stock | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Warrants issued to purchase shares | 2 | ||||||||||||||||||||||
Warrants exercise price (in Dollars per share) | $ / shares | $ 59.25 | ||||||||||||||||||||||
Shares issued on option exercises | 2,018 | ||||||||||||||||||||||
Common Stock | Exclusive option agreement | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Number of shares issued | 31,646 | ||||||||||||||||||||||
Shares issued price per share | $ / shares | $ 1.58 | ||||||||||||||||||||||
Period considered for average closing price | 10 days | ||||||||||||||||||||||
Common Stock | Pre-funded warrants | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Exercise price of warrants | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||||||||||
Number of shares issued on exercise of warrants | 536,384 | 400,000 | 338,000 | 938,000 | 2,023,000 | ||||||||||||||||||
Common Stock | B. Riley Sales Agreement | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Weighted average price per share (in Dollars per share) | $ / shares | $ 24.28 | ||||||||||||||||||||||
Common Stock | Public Offering | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Number of shares issued | 2,301,500 | ||||||||||||||||||||||
Shares issued price per share | $ / shares | $ 1.30 | ||||||||||||||||||||||
Exercise price of warrants | $ / shares | $ 1.50 | ||||||||||||||||||||||
Common Stock | FBR Capital Markets & Co. [Member] | |||||||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||||||
Shares issues (in shares) | 811,646 |
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, 2022 USD ($) item $ / shares shares | Dec. 31, 2021 $ / shares shares | Sep. 30, 2023 shares | Dec. 31, 2020 shares | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) [Line Items] | |||||
Number of equity programs | item | 4 | ||||
Weighted average exercise price (in Dollars per share) | $ / shares | $ 12.81 | ||||
Shares issues (in shares) | 192,273 | 140,996 | 851,130 | 128,858 | |
Total compensation cost (in Dollars) | $ | $ 427,000 | ||||
Stock Option Plans [Member] | |||||
Stock Option Plans and Warrants to Purchase Common Stock (Details) [Line Items] | |||||
Exercisable options | 133,794 | ||||
Weighted average exercise price (in Dollars per share) | $ / shares | $ 34.47 | ||||
Exercisable, weighted average remaining contractual term | 7 years 18 days | ||||
Shares issues (in shares) | 192,273 | ||||
Weighted Average Remaining Term | 7 years 10 months 24 days | ||||
Stock options awarded | 55,730 | 32,925 | |||
Fair value per share (in Dollars per share) | $ / shares | $ 5.57 | $ 8.40 | |||
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 | 5,812,991 | ||||
Intrinsic value | $ | $ 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, 2022 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 | 1,866,719 |
Modification to Plan | 4,000,000 |
Options granted | (55,730) |
Options forfeited | 2,002 |
Shares available for grant | 5,812,991 |
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 | 9 Months Ended | 12 Months Ended | ||
May 06, 2022 | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
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 | 192,273 | 140,996 | 128,858 | |
Weighted Average Options Exercise Price outstanding beginning balance | $ 27.56 | $ 37.12 | $ 44.41 | |
Number of options issued | 55,730 | 32,925 | ||
Weighted average price per share (in Dollars per share) | $ 3.63 | $ 8.85 | $ 13.68 | |
Options Forfeited | (3,908) | (15,982) | ||
Options Cancelled | (545) | (2,787) | ||
Weighted Average Options Exercise Price Cancelled | $ 11.70 | $ 11.70 | ||
Weighted Average Options Exercise Price Forfeited | $ 107.83 | $ 54.61 | ||
Options Exercised | (6,411) | (2,018) | ||
Weighted average exercise price | $ 12.81 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance | 851,130 | 192,273 | 140,996 | |
Weighted Average Options Exercise Price outstanding ending balance | $ 24.83 | $ 27.56 | $ 37.12 |
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, 2022 $ / 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 | 7 years 10 months 24 days |
Outstanding Options | 192,273 |
Exercisable Options | 133,794 |
$8.10 - $40.05 [Member] | |
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 | $ 8.10 |
Exercise price, upper limit | $ / shares | $ 40.05 |
Weighted Average Remaining Contractual Life in Years | 8 years 1 month 28 days |
Outstanding Options | 183,250 |
Exercisable Options | 124,771 |
$111.00 - $234.00 [Member] | |
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 | $ 111 |
Exercise price, upper limit | $ / shares | $ 234 |
Weighted Average Remaining Contractual Life in Years | 2 years 11 months 26 days |
Outstanding Options | 6,309 |
Exercisable Options | 6,309 |
$301.50 - $339.00 [Member] | |
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 | $ 301.50 |
Exercise price, upper limit | $ / shares | $ 339 |
Weighted Average Remaining Contractual Life in Years | 1 year 4 months 2 days |
Outstanding Options | 2,714 |
Exercisable Options | 2,714 |
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 | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of share-based compensation expense [Line Items] | ||||||
Share-Based Compensation | $ 65,400 | $ 70,715 | $ 229,076 | $ 220,656 | $ 333,389 | $ 361,559 |
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 | 142,879 | 158,478 | ||||
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 | $ 190,510 | $ 203,081 |
Stock Option Plans and Warran_8
Stock Option Plans and Warrants to Purchase Common Stock - Schedule of warrant activity (Details) - $ / shares | 9 Months Ended | 12 Months Ended | ||
May 06, 2022 | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of warrant activity [Line Items] | ||||
Warrants, Granted | 55,730 | 32,925 | ||
Weighted Average Exercise Price, Granted | $ 3.63 | $ 8.85 | $ 13.68 | |
Exercise of common stock options (in shares) | 6,411 | 2,018 | ||
Weighted Average Exercise Price, Exercised | $ 12.81 | |||
Warrants | ||||
Stock Option Plans and Warrants to Purchase Common Stock (Details) - Schedule of warrant activity [Line Items] | ||||
Warrants opening, Balance | 667 | 221,872 | 382,099 | |
Weighted Average Exercise Price opening, Balance | $ 29.25 | $ 33.79 | $ 44.47 | |
Warrants closing, Balance | 667 | 221,872 | ||
Weighted Average Exercise Price closing, Balance | $ 29.25 | $ 33.79 | ||
Exercise of common stock options (in shares) | (2) | |||
Weighted Average Exercise Price, Exercised | $ 59.25 | |||
DO NOT USE FOR WARRANTS Expired (in shares) | (221,205) | (160,225) | ||
Weighted Average Exercise Price, Expired | $ 33.81 | $ 59.25 |
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, 2022 $ / shares shares | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise Price (in Dollars per share) | $ / shares | $ 29.25 |
Remaining Contractual Life in Years | 2 months 26 days |
Outstanding Warrants | 667 |
Exercisable Warrants | 667 |
Commitments and Contingencies_5
Commitments and Contingencies (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||||
Apr. 27, 2023 shares | Nov. 07, 2022 shares | Oct. 04, 2022 shares | Aug. 05, 2022 shares | Feb. 07, 2022 shares | Sep. 29, 2021 shares | Jul. 01, 2020 USD ($) | Nov. 03, 2014 USD ($) shares | Jul. 31, 2020 USD ($) | Mar. 31, 2020 $ / shares shares | Jan. 31, 2020 USD ($) | Sep. 30, 2014 USD ($) shares | Sep. 30, 2023 USD ($) ft² | Sep. 30, 2023 USD ($) ft² | Dec. 31, 2022 USD ($) m² | Jun. 21, 2022 USD ($) | Mar. 30, 2020 $ / shares | |
Other Commitments [Line Items] | |||||||||||||||||
Contractual obligation | $ 492,008 | $ 492,008 | $ 616,984 | ||||||||||||||
Maximum payment for commitment milestones | 13,200,000 | $ 13,200,000 | |||||||||||||||
Sub license milestones payments on covered products | 200,000 | 200,000 | |||||||||||||||
Employee Retention Credit, CARES ACT | $ 120,771 | $ 120,771 | |||||||||||||||
Percentage of sub license income on royalties | 15% | 15% | |||||||||||||||
Office space in square feet | 6,200 | 6,200 | 6,200 | ||||||||||||||
Lease rent per month | $ 11,108 | ||||||||||||||||
Fair value of shares issued in connection with asset purchase | $ 50,000 | ||||||||||||||||
Issuance of common stock | shares | 50,000 | 5,129 | 1,667 | 3,664 | 5,377 | 1,667 | |||||||||||
Amount of damages sought | $ 19,000,000 | $ 19,000,000 | |||||||||||||||
For Period Till November 2023 [Member] | |||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||
Lease rent per month | $ 11,108 | 11,108 | $ 11,108 | 11,367 | |||||||||||||
From Period Till November 2024 [Member] | |||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||
Lease rent per month | 11,367 | 11,367 | 11,367 | $ 11,625 | |||||||||||||
Research and Development Arrangement [Member] | |||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||
Contractual obligation | $ 205,000 | $ 205,000 | $ 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 | 12,328 | |||||||||||||||
Fair value of shares issued in connection with asset purchase | $ 3,750,000 | $ 3,750,000 | |||||||||||||||
Issuance of common stock | shares | 130,413 | ||||||||||||||||
Effective price per share (in Dollars per share) | $ / shares | $ 38.34 | $ 38.40 | |||||||||||||||
Ownership of company outstanding | 19.90% | 19.90% | |||||||||||||||
Emergent BioSolutions | |||||||||||||||||
Other Commitments [Line Items] | |||||||||||||||||
Invoices | $ 331,000 | ||||||||||||||||
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 ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Long-term Purchase Commitment [Line Items] | ||
2024 | $ 182,917 | $ 179,817 |
2025 | 162,250 | 182,917 |
2026 | 46,000 | 162,250 |
2027 | 46,000 | 46,000 |
2027 | 46,000 | |
Total | 492,008 | 616,984 |
Research and Development Arrangement [Member] | ||
Long-term Purchase Commitment [Line Items] | ||
2024 | 46,000 | 46,000 |
2025 | 46,000 | 46,000 |
2026 | 46,000 | 46,000 |
2027 | 46,000 | 46,000 |
2027 | 46,000 | |
Total | 205,000 | 230,000 |
Lease Agreements [Member] | ||
Long-term Purchase Commitment [Line Items] | ||
2024 | 136,917 | 133,817 |
2025 | 116,250 | 136,917 |
2026 | 116,250 | |
Total | $ 287,008 | $ 386,984 |
Operating Segments (Details)_2
Operating Segments (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) segment | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) segment | Dec. 31, 2021 USD ($) | |
Segment reporting | ||||||
Revenues | $ 130,440 | $ 166,140 | $ 594,547 | $ 582,843 | $ 948,911 | $ 824,268 |
Income (loss) from Operations | (1,779,056) | (3,081,244) | (5,560,069) | (10,668,926) | (14,238,904) | (13,098,960) |
Amortization and Depreciation Expense | 1,589 | 4,793 | 4,964 | 21,538 | 24,562 | 34,161 |
Other (Expense) Income, Net | 116,354 | (227,759) | 78,037 | (530,793) | (714,370) | (316,755) |
Share-Based Compensation | 65,400 | 70,715 | 229,076 | 220,656 | 333,389 | 361,559 |
Identifiable Assets | 11,302,829 | $ 11,302,829 | $ 14,279,717 | 26,869,927 | ||
Number of operating segments | segment | 2 | 2 | ||||
Operating Segments [Member] | Specialized BioTherapeutics [Member] | ||||||
Segment reporting | ||||||
Revenues | $ 223,870 | $ 31,929 | ||||
Income (loss) from Operations | (705,753) | (1,856,553) | (2,227,430) | (5,396,630) | (7,614,988) | (7,216,450) |
Amortization and Depreciation Expense | 954 | 2,876 | 2,979 | 8,273 | 10,087 | 7,804 |
Other (Expense) Income, Net | 1,683 | (12,613) | 17,696 | 110,975 | 102,320 | 135,409 |
Share-Based Compensation | 27,427 | 28,343 | 82,281 | 85,190 | 138,075 | 136,594 |
Identifiable Assets | 58,704 | 58,704 | 103,742 | 128,645 | ||
Operating Segments [Member] | Public Health Solutions [Member] | ||||||
Segment reporting | ||||||
Revenues | 130,440 | 166,140 | 370,677 | 582,843 | 916,982 | 824,268 |
Income (loss) from Operations | (24,819) | (9,578) | (26,639) | (131,201) | 26,612 | (542,270) |
Amortization and Depreciation Expense | 159 | 479 | 496 | 1,379 | 1,681 | 1,301 |
Share-Based Compensation | 994 | 1,054 | 2,982 | 3,162 | 4,804 | 21,884 |
Identifiable Assets | 70,557 | 70,557 | 121,290 | 146,296 | ||
Corporate [Member] | ||||||
Segment reporting | ||||||
Income (loss) from Operations | (1,048,484) | (1,215,113) | (3,306,000) | (5,141,095) | (6,650,528) | (5,340,240) |
Amortization and Depreciation Expense | 476 | 1,438 | 1,489 | 11,886 | 12,794 | 25,056 |
Other (Expense) Income, Net | 114,671 | (215,146) | 60,341 | (641,768) | (816,690) | (452,164) |
Share-Based Compensation | 36,979 | $ 41,318 | 143,813 | $ 132,304 | 190,510 | 203,081 |
Identifiable Assets | $ 11,173,568 | $ 11,173,568 | $ 14,054,685 | $ 26,594,986 |