Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 03, 2022 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2022 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-14778 | |
Entity Registrant Name | SOLIGENIX, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 41-1505029 | |
Entity Address, Address Line One | 29 EMMONS DRIVE, SUITE B-10 | |
Entity Address, City or Town | PRINCETON, | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 08540 | |
City Area Code | 609 | |
Local Phone Number | 538-8200 | |
Title of 12(b) Security | Common Stock, par value $.001 per share | |
Trading Symbol | SNGX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0000812796 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Entity Common Stock, Shares Outstanding | 43,227,288 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 16,865,642 | $ 26,043,897 |
Licensing, contracts and grants receivable | 130,742 | 138,889 |
Research and development incentives receivable | 100,372 | 103,832 |
Prepaid expenses and other current assets | 396,355 | 282,903 |
Total current assets | 17,493,111 | 26,569,521 |
Security deposit | 22,777 | 22,777 |
Office furniture and equipment, net of accumulated depreciation of $111,742 and $167,848 | 21,505 | 22,220 |
Deferred issuance cost | 20,266 | 20,266 |
Right-of-use lease assets | 367,375 | 106,155 |
Research and development incentives receivable | 22,339 | 121,238 |
Other assets | 7,750 | |
Total assets | 17,947,373 | 26,869,927 |
Current liabilities: | ||
Accounts payable | 4,164,627 | 2,925,544 |
Accrued expenses | 2,235,451 | 2,956,545 |
Accrued compensation | 59,790 | 302,936 |
Lease liabilities - current | 106,165 | 106,151 |
Convertible debt, current | 3,000,000 | |
Deferred revenue, current | 100,000 | |
Total current liabilities | 9,666,033 | 6,291,176 |
Non-current liabilities: | ||
Convertible debt, net of current portion and debt discount of $112,779 and $143,847 | 6,887,221 | 9,856,153 |
Lease liabilities, net of current portion | 262,117 | |
Deferred revenue, net of current portion | 100,000 | |
Total liabilities | 16,915,371 | 16,147,329 |
Commitments and contingencies | ||
Shareholders' equity: | ||
Preferred stock, 350,000 shares authorized; none issued or outstanding | ||
Common stock, $.001 par value; 75,000,000 shares authorized; 43,105,191 shares and 42,873,445 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 43,105 | 42,873 |
Additional paid-in capital | 216,773,316 | 216,402,890 |
Accumulated other comprehensive income | 25,472 | 41,942 |
Accumulated deficit | (215,809,891) | (205,765,107) |
Total shareholders' equity | 1,032,002 | 10,722,598 |
Total liabilities and shareholders' equity | $ 17,947,373 | $ 26,869,927 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Consolidated Balance Sheets | ||
Accumulated depreciation | $ 111,742 | $ 167,848 |
Debt discount, noncurrent | $ 112,779 | $ 143,847 |
Preferred stock, shares authorized | 350,000 | 350,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 75,000,000 | 75,000,000 |
Common stock, shares issued | 43,105,191 | 42,873,445 |
Common stock, shares outstanding | 43,105,191 | 42,873,445 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues: | ||||
Total revenues | $ 166,140 | $ 186,198 | $ 582,843 | $ 548,615 |
Cost of revenues | (129,440) | (166,265) | (414,957) | (492,942) |
Gross profit | 36,700 | 19,933 | 167,886 | 55,673 |
Operating expenses: | ||||
Research and development | 1,791,695 | 2,237,565 | 5,586,302 | 5,483,695 |
General and administrative | 1,326,249 | 1,147,279 | 5,250,510 | 3,159,155 |
Total operating expenses | 3,117,944 | 3,384,844 | 10,836,812 | 8,642,850 |
Loss from operations | (3,081,244) | (3,364,911) | (10,668,926) | (8,587,177) |
Other income (expense): | ||||
Gain on forgiveness of PPP loan | 421,584 | |||
Foreign currency transaction (loss)/gain | (12,613) | (66,967) | (26,006) | (22,384) |
Interest expense, net | (215,146) | (227,271) | (641,768) | (676,512) |
Research and development incentives | 40,844 | 136,981 | 121,896 | |
Other income (expense) | 30,754 | 30,754 | ||
Total other income (expense) | (227,759) | (222,640) | (530,793) | (124,662) |
Net loss before income taxes | (3,309,003) | (3,587,551) | (11,199,719) | (8,711,839) |
Income tax benefit | 1,154,935 | 864,742 | 1,154,935 | 864,742 |
Net loss applicable to common stockholders | $ (3,309,003) | $ (3,587,551) | $ (10,044,784) | $ (7,847,097) |
Basic net loss per share (in Dollars per share) | $ (0.08) | $ (0.09) | $ (0.23) | $ (0.20) |
Diluted net loss per share (in Dollars per share) | $ (0.08) | $ (0.09) | $ (0.23) | $ (0.20) |
Basic weighted average common shares outstanding (in Shares) | 43,083,690 | 40,697,888 | 43,005,912 | 39,210,984 |
Diluted weighted average common shares outstanding (in Shares) | 43,083,690 | 40,697,888 | 43,005,912 | 39,210,984 |
Licensing revenue | ||||
Revenues: | ||||
Revenues | $ 50,000 | |||
Contract revenue | ||||
Revenues: | ||||
Other revenue | $ 33,351 | |||
Grant revenue | ||||
Revenues: | ||||
Other revenue | $ 166,140 | $ 186,198 | $ 532,843 | $ 515,264 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Consolidated Statements of Comprehensive Loss | ||||
Net loss | $ (3,309,003) | $ (3,587,551) | $ (10,044,784) | $ (7,847,097) |
Other comprehensive loss: | ||||
Foreign currency translation adjustments | 14,403 | 81,616 | (16,470) | 73,895 |
Comprehensive loss | $ (3,294,600) | $ (3,505,935) | $ (10,061,254) | $ (7,773,202) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Shareholders' Equity (Unaudited) - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income/Loss | Accumulated Deficit | Total |
Balance at Dec. 31, 2020 | $ 30,644 | $ 196,949,655 | $ (24,337) | $ (193,214,134) | $ 3,741,828 |
Balance (in shares) at Dec. 31, 2020 | 30,643,656 | ||||
Issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement | $ 11,931 | 19,405,359 | 19,417,290 | ||
Issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 11,931,513 | ||||
Issuance costs associated with B. Riley At Market Issuance Sales Agreement | (639,906) | (639,906) | |||
Issuance of common stock to vendors | $ 25 | 27,475 | 27,500 | ||
Issuance of common stock to vendors (in shares) | 25,000 | ||||
Exercise of common stock options | $ 30 | 25,805 | 25,835 | ||
Exercise of common stock options (in shares) | 30,254 | ||||
Exercise of warrants | 51 | 51 | |||
Exercise of warrants (in shares) | 13 | ||||
Share-based compensation expense | 255,147 | 255,147 | |||
Foreign currency translation adjustment | 73,895 | 73,895 | |||
Net loss | (7,847,097) | (7,847,097) | |||
Balance at Sep. 30, 2021 | $ 42,630 | 216,023,586 | 49,558 | (201,061,231) | 15,054,543 |
Balance (in Shares) at Sep. 30, 2021 | 42,630,436 | ||||
Balance at Jun. 30, 2021 | $ 40,079 | 213,061,849 | (32,058) | (197,473,680) | 15,596,190 |
Balance (in shares) at Jun. 30, 2021 | 40,078,760 | ||||
Issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement | $ 2,496 | 2,924,465 | 2,926,961 | ||
Issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement (in shares) | 2,496,422 | ||||
Issuance costs associated with B. Riley At Market Issuance Sales Agreement | (95,729) | (95,729) | |||
Issuance of common stock to vendors | $ 25 | 27,475 | 27,500 | ||
Issuance of common stock to vendors (in shares) | 25,000 | ||||
Exercise of common stock options | $ 30 | 25,805 | 25,835 | ||
Exercise of common stock options (in shares) | 30,254 | ||||
Share-based compensation expense | 79,721 | 79,721 | |||
Foreign currency translation adjustment | 81,616 | 81,616 | |||
Net loss | (3,587,551) | (3,587,551) | |||
Balance at Sep. 30, 2021 | $ 42,630 | 216,023,586 | 49,558 | (201,061,231) | 15,054,543 |
Balance (in Shares) at Sep. 30, 2021 | 42,630,436 | ||||
Balance at Dec. 31, 2021 | $ 42,873 | 216,402,890 | 41,942 | (205,765,107) | 10,722,598 |
Balance (in shares) at Dec. 31, 2021 | 42,873,445 | ||||
Issuance of common stock to vendors | $ 232 | 149,770 | 150,002 | ||
Issuance of common stock to vendors (in shares) | 231,746 | ||||
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 | $ 43,105 | 216,773,316 | 25,472 | (215,809,891) | 1,032,002 |
Balance (in Shares) at Sep. 30, 2022 | 43,105,191 | ||||
Balance at Jun. 30, 2022 | $ 43,050 | 216,652,655 | 11,069 | (212,500,888) | 4,205,886 |
Balance (in shares) at Jun. 30, 2022 | 43,050,245 | ||||
Issuance of common stock to vendors | $ 55 | 49,946 | 50,001 | ||
Issuance of common stock to vendors (in shares) | 54,946 | ||||
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 | $ 43,105 | $ 216,773,316 | $ 25,472 | $ (215,809,891) | $ 1,032,002 |
Balance (in Shares) at Sep. 30, 2022 | 43,105,191 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating activities: | ||
Net loss | $ (10,044,784) | $ (7,847,097) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Amortization and depreciation | 21,538 | 26,614 |
Non-cash lease expense | 86,326 | 86,124 |
Share-based compensation | 220,656 | 255,147 |
Issuance of common stock to vendors for services | 150,002 | 27,500 |
Amortization of deferred issuance costs associated with convertible debt | 31,068 | 31,456 |
Gain on forgiveness of PPP loan | (421,584) | |
Change in operating assets and liabilities: | ||
Licensing, contracts and grants receivable | 8,147 | 159,590 |
Prepaid expenses and other current assets | (113,452) | (203,619) |
Research and development incentives receivable | 67,912 | 258,509 |
Operating lease liability | (85,415) | (86,124) |
Deferred revenue | 200,000 | |
Accounts payable and accrued expenses | 679,268 | (154,415) |
Accrued compensation | (243,146) | (816,367) |
Net cash used in operating activities | (9,021,880) | (8,684,266) |
Investing activities: | ||
Purchases of office furniture and equipment | (13,073) | |
Net cash used in investing activities | (13,073) | |
Financing activities: | ||
Proceeds from issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement | 19,417,290 | |
Costs associated with B. Riley At Market Issuance Sales Agreement | (584,334) | |
Proceeds from the exercise of warrants | 51 | |
Proceeds from the exercises of stock options | 25,835 | |
Costs associated with issuance of convertible debt | (45,512) | |
Principal repayment - financing lease | (6,149) | |
Net cash provided by financing activities | 18,807,181 | |
Effect of exchange rate on cash and cash equivalents | (143,302) | 67,909 |
Net (decrease)/increase in cash and cash equivalents | (9,178,255) | 10,190,824 |
Cash and cash equivalents at beginning of period | 26,043,897 | 18,676,663 |
Cash and cash equivalents at end of period | 16,865,642 | 28,867,487 |
Supplemental information: | ||
Cash paid for state income taxes | 13,243 | 7,382 |
Cash paid for interest | 643,921 | 444,814 |
Cash paid for lease liabilities: | ||
Operating lease | 99,975 | 99,975 |
Financing lease | 6,408 | |
Non-cash activities: | ||
Right-of-use assets and lease liabilities recorded | $ 347,546 | |
Deferred issuance cost in accounts payable | 22,700 | |
Deferred issuance cost reclassified to additional paid-in capital | $ 55,572 |
Nature of Business
Nature of Business | 9 Months Ended |
Sep. 30, 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), 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.”). 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 ® ® The Company primarily generates revenues under government grants and contracts principally from the National Institutes of Health (“NIH”). The Company has a subcontract of approximately $700,000 from a NIAID grant over five years for its thermostabilization technology, a DTRA subcontract of approximately $600,000 over three years for SGX943 and a subcontract of approximately $1.5 million from a NIAID grant over two years for development of CiVax™. 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 three and nine months ended September 30, 2022 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 consolidated financial statements are issued. As of September 30, 2022, the Company had an accumulated deficit of $215,809,891. During the nine months ended September 30, 2022, the Company incurred a net loss of $10,044,784 and used $9,021,880 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 partnerships and/or financings. Based on the Company’s approved operating budget, current rate of cash outflows, cash on hand, proceeds from government contract and grant programs, and proceeds available from the sale of shares of the Company’s common stock via the At Market Issuance Sales Agreement (“B. Riley Sales Agreement”) with B. Riley Securities, Inc. (“B. Riley”), 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. As of September 30, 2022, the Company had cash and cash equivalents of $16,865,642 as compared to $26,043,897 as of December 31, 2021, representing a decrease of $9,178,255 or 35%. As of September 30, 2022, the Company had working capital of $7,827,078 as compared to working capital of $20,278,345 as of December 31, 2021, representing a decrease of $12,451,267 or 61%. The decrease in cash and cash equivalents and working capital was primarily related to cash used in operating activities. 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), pursue a New Drug Application (“NDA”) filing and commercialization in the U.S. 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 $0.8 million in active government grant funding still available as of September 30, 2022 to support its associated research programs through March 2023, 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 $26.7 million remaining from the B. Riley Sales Agreement as of November 3, 2022 under the prospectus supplement updated August 13, 2021. ● 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 . |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 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 three and nine months ended September 30, 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. 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 three and nine months ended September 30, 2022 and 2021. Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. 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 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 license revenues. 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 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 three years three months From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed under the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, restricted stock, deferred stock and unrestricted stock to the Company’s employees and non-employees (including consultants). The shares issued under the 2015 Plan are registered on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates reflecting such shares reflect a Securities Act of 1933, as amended restrictive legend. Stock compensation expense for equity-classified awards to non-employees is measured on the date of grant and is recognized when the services are performed. The fair value of options issued during the nine months ended September 30, 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 87% for 2022 and 85% - 87% for 2021; and ● risk free interest rates ranging from 1.12% - 3.23% for 2022 and 0.27% - 0.67% for 2021. The fair value of each option grant made during the nine months ended September 30, 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 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 New Jersey NOL carryforwards during the nine months ended September 30, 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 the nine months ended September 30, 2022 and 2021. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at September 30, 2022 or December 31, 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 $123,000 and $225,000 as of September 30, 2022 and December 31, 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 September 30, 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 — 29,075 29,075 Additional 2020 incentive earned 107,906 — 107,906 UK research and development incentives cash receipt (209,166) — (209,166) Foreign currency translation (23,438) (6,736) (30,174) Balance at September 30, 2022 $ 100,372 $ 22,339 $ 122,711 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: As of September 30, 2022 2021 Common stock purchase warrants 59,872 5,731,464 Stock options 2,183,406 1,996,890 Convertible debt 2,439,024 4,878,048 Total 4,682,302 12,606,402 The weighted average exercise price of the Company’s warrants and stock options outstanding at September 30, 2022 were $2.41 and $2.30 per share, respectively, and at September 30, 2021 were $2.96 and $2.70 per share, respectively. 2,403,385 of the Company’s common stock warrants associated with the December 2016 public offering expired on December 15, 2021 and 3,268,200 of the Company’s common stock warrants associated with the July 2018 public offering expired on January 2, 2022. 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 |
Sep. 30, 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, 2022 and December 31, 2021, the Company’s consolidated balance sheets included a right-of-use lease asset of $367,375 and $106,155 for the office space, respectively. The Company’s consolidated balance sheets as of September 30, 2022 and December 31, 2021 included corresponding lease liabilities of $368,282 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 Right-of-use lease asset: Right-of-use lease asset, January 1, 2022 $ 106,155 New lease extension June 21, 2022 347,546 Reduction/amortization (86,326) Right of use lease asset, September 30, 2022 $ 367,375 Lease liability: Lease liability, January 1, 2022 $ 106,151 New lease extension June 21, 2022 347,546 Repayments (85,415) Lease liability, September 30, 2022 $ 368,282 Lease expense for the nine months ended September 30, 2022: Lease expense $ 100,887 Total $ 100,887 Lease expense for the nine months ended September 30, 2021: Lease expense $ 99,975 Total $ 99,975 Contractual cash payments for the remaining lease term as of September 30, 2022: 2022 $ 33,325 2023 133,817 2024 136,917 2025 116,250 Total $ 420,309 Remaining lease term (months) as of September 30, 2022 37 |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2022 | |
Accrued Expenses | |
Accrued Expenses | Note 4. Accrued Expenses The following is a summary of the Company’s accrued expenses: September 30, December 31, 2022 2021 Clinical trial expenses $ 1,913,221 $ 2,625,779 Other 322,230 330,766 Total $ 2,235,451 $ 2,956,545 |
Debt
Debt | 9 Months Ended |
Sep. 30, 2022 | |
Debt | |
Debt | 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 have an interest-only period for the first two 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. 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 three months ended September 30, 2022 and 2021 was $213,490 and $226,093, respectively. Interest expense incurred during the nine months ended September 30, 2022 and 2021 was $633,510 and $670,907, 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 $4.10 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, assuming no conversion is as follows: Year Principal Interest Total 2022 $ — $ 213,490 $ 213,490 2023 4,000,000 719,138 4,719,138 2024 4,000,000 380,338 4,380,338 2025 2,000,000 60,566 2,060,566 Total $ 10,000,000 $ 1,373,532 $ 11,373,532 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Taxes | |
Income Taxes | Note 6. Income Taxes The Company had gross NOLs at December 31, 2021 of approximately $123.8 million for federal tax purposes, approximately $25.2 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 $8.6 million of various tax credits, which the Company may be able to utilize 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 2021 and 2020, 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 carryforwards, resulting in the recognition of $1,154,935 and $864,742 of income tax benefit, net of transaction costs, during the nine months ended September 30, 2022 and 2021, respectively. The Company has not yet sold its 2021 New Jersey NOLs but may be able to do so in the future. There can be no assurance as to the continuation or magnitude of this program in the future. |
Shareholders' Equity
Shareholders' Equity | 9 Months Ended |
Sep. 30, 2022 | |
Shareholders' Equity | |
Shareholders' Equity | Note 7. Shareholders’ Equity Preferred Stock The Company has 350,000 shares of preferred stock authorized, none of which are issued or outstanding Common Stock The following items represent transactions in the Company’s common stock for the nine months ended September 30, 2022: ● The Company issued a vendor 80,646 shares of fully vested common stock with a fair value of $0.62 per share on February 7, 2022. ● The Company issued a vendor 96,154 shares of fully vested common stock with a fair value of $0.52 per share on May 6, 2022. ● The Company issued a vendor 54,946 shares of fully vested common stock with a fair value of $0.91 per share on August 5, 2022. The issuance of the Company’s common stock to the vendor as described above was exempt under Section 4(a)(2) of the Securities Act of 1933, as amended. The vendor 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 vendor represented to the Company that the vendor is not a “consultant” for purposes of Nasdaq Listing Rule 5635(c). B. Riley At Market Issuance Sales Agreement In August 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 3, 2022, there was $26.7 million available for future sale of common stock under the B. Riley Sales Agreement. |
Concentrations
Concentrations | 9 Months Ended |
Sep. 30, 2022 | |
Concentrations | |
Concentrations | Note 8. Concentrations At September 30, 2022 and 2021, 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. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies. | |
Commitments and Contingencies | Note 9. Commitments and Contingencies Contractual Obligations The Company has commitments of approximately $255,000 as of September 30, 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 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 from November 2022 to October 2025. 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 184,912 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 1,956,182 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 $2.56 per share, based upon a formula set forth in the purchase agreement. Provided the sole remaining future success-oriented milestone 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 September 30, 2022, 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, 2022 $ 21,000 $ 33,325 $ 54,325 2023 96,000 133,817 229,817 2024 46,000 136,917 182,917 2025 46,000 116,250 162,250 2026 46,000 — 46,000 Total $ 255,000 $ 420,309 $ 675,309 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. The continued global spread of COVID-19 has 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 three and nine months ended September 30, 2022 and 2021. 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 Proceeding). 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. The Company cannot offer any assurances as to any result of the challenge of the arbitration decision or that the Company will recover any damages from Emergent. |
Operating Segments
Operating Segments | 9 Months Ended |
Sep. 30, 2022 | |
Operating Segments | |
Operating Segments | Note 10. 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, 2022 2021 Revenues Specialized BioTherapeutics $ — $ — Public Health Solutions 166,140 186,198 Total $ 166,140 $ 186,198 Loss from Operations Specialized BioTherapeutics $ (1,856,553) $ (2,034,507) Public Health Solutions (9,578) (160,970) Corporate (1,215,113) (1,169,434) Total $ (3,081,244) $ (3,364,911) Amortization and Depreciation Expense Specialized BioTherapeutics $ 2,876 $ 1,883 Public Health Solutions 479 314 Corporate 1,438 6,678 Total $ 4,793 $ 8,875 Other (Expense) Income, Net Specialized BioTherapeutics $ (12,613) $ (26,123) Corporate (215,146) (196,517) Total $ (227,759) $ (222,640) Share-Based Compensation Specialized BioTherapeutics $ 28,343 $ 28,506 Public Health Solutions 1,054 6,518 Corporate 41,318 44,697 Total $ 70,715 $ 79,721 Nine Months Ended September 30, 2022 2021 Revenues Specialized BioTherapeutics $ — $ — Public Health Solutions 582,843 548,615 Total $ 582,843 $ 548,615 Loss from Operations Specialized BioTherapeutics $ (5,396,630) $ (4,867,481) Public Health Solutions (131,201) (399,512) Corporate (5,141,095) (3,320,184) Total $ (10,668,926) $ (8,587,177) Amortization and Depreciation Expense Specialized BioTherapeutics $ 8,273 $ 5,644 Public Health Solutions 1,379 941 Corporate 11,886 20,029 Total $ 21,538 $ 26,614 Other (Expense) Income, Net Specialized BioTherapeutics $ 110,975 $ 99,512 Corporate (641,768) (224,174) Total $ (530,793) $ (124,662) Share-Based Compensation Specialized BioTherapeutics $ 85,190 $ 86,816 Public Health Solutions 3,162 20,002 Corporate 132,304 148,329 Total $ 220,656 $ 255,147 As of As of September 30, December 31, 2022 2021 Identifiable Assets Specialized BioTherapeutics $ 121,567 $ 128,645 Public Health Solutions 137,910 146,296 Corporate 17,687,896 26,594,986 Total $ 17,947,373 $ 26,869,927 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Significant Accounting Policies | |
Principles 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 three and nine months ended September 30, 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. |
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. |
Licensing, Contracts and Grants Receivable | 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. |
Impairment of Long-Lived Assets | 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 three and nine months ended September 30, 2022 and 2021. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments FASB ASC 820 — Fair Value Measurements and Disclosures, FASB ASC 820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. 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 | Revenue Recognition The Company’s revenues include revenues generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs reimbursable internal expenses that are related to the government contracts and grants. The Company also records revenue from contracts with customers in accordance with Accounting Standards Codification Topic 606 (“ASC 606”), Revenue From Contracts with Customers Certain amounts received from or billed to customers in accordance with contract terms are deferred and recognized as future performance obligations are satisfied. All amounts earned under contracts with customers other than sales-based royalties are classified as license revenues. 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 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 three years three months From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed under the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, restricted stock, deferred stock and unrestricted stock to the Company’s employees and non-employees (including consultants). The shares issued under the 2015 Plan are registered on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates reflecting such shares reflect a Securities Act of 1933, as amended restrictive legend. Stock compensation expense for equity-classified awards to non-employees is measured on the date of grant and is recognized when the services are performed. The fair value of options issued during the nine months ended September 30, 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 87% for 2022 and 85% - 87% for 2021; and ● risk free interest rates ranging from 1.12% - 3.23% for 2022 and 0.27% - 0.67% for 2021. The fair value of each option grant made during the nine months ended September 30, 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 2018, the Company changed the status of a wholly-owned subsidiary in the UK from inactive to active and incurred expenditures in multiple currencies including the U.S. dollar, the British Pound and the Euro to fund its clinical trial operations in the UK and select countries in Europe. In accordance with FASB ASC 830 Foreign Currency Matters |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all available positive and negative evidence is considered, including the Company’s current and past performance, the market environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The Company recognized an income tax benefit of $1,154,935 and $864,742 from the sale of New Jersey NOL carryforwards during the nine months ended September 30, 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 the nine months ended September 30, 2022 and 2021. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at September 30, 2022 or December 31, 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 $123,000 and $225,000 as of September 30, 2022 and December 31, 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 September 30, 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 — 29,075 29,075 Additional 2020 incentive earned 107,906 — 107,906 UK research and development incentives cash receipt (209,166) — (209,166) Foreign currency translation (23,438) (6,736) (30,174) Balance at September 30, 2022 $ 100,372 $ 22,339 $ 122,711 |
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. 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, 2022 2021 Common stock purchase warrants 59,872 5,731,464 Stock options 2,183,406 1,996,890 Convertible debt 2,439,024 4,878,048 Total 4,682,302 12,606,402 The weighted average exercise price of the Company’s warrants and stock options outstanding at September 30, 2022 were $2.41 and $2.30 per share, respectively, and at September 30, 2021 were $2.96 and $2.70 per share, respectively. 2,403,385 of the Company’s common stock warrants associated with the December 2016 public offering expired on December 15, 2021 and 3,268,200 of the Company’s common stock warrants associated with the July 2018 public offering expired on January 2, 2022. |
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. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Significant Accounting Policies | |
Schedule of United Kingdom research and development incentives receivable | 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 — 29,075 29,075 Additional 2020 incentive earned 107,906 — 107,906 UK research and development incentives cash receipt (209,166) — (209,166) Foreign currency translation (23,438) (6,736) (30,174) Balance at September 30, 2022 $ 100,372 $ 22,339 $ 122,711 |
Schedule of potentially dilutive adjustments to the weighted average number of common shares excluded from the calculation | As of September 30, 2022 2021 Common stock purchase warrants 59,872 5,731,464 Stock options 2,183,406 1,996,890 Convertible debt 2,439,024 4,878,048 Total 4,682,302 12,606,402 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases | |
Schedule of lease expense | 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, 2022 $ 106,155 New lease extension June 21, 2022 347,546 Reduction/amortization (86,326) Right of use lease asset, September 30, 2022 $ 367,375 Lease liability: Lease liability, January 1, 2022 $ 106,151 New lease extension June 21, 2022 347,546 Repayments (85,415) Lease liability, September 30, 2022 $ 368,282 Lease expense for the nine months ended September 30, 2022: Lease expense $ 100,887 Total $ 100,887 Lease expense for the nine months ended September 30, 2021: Lease expense $ 99,975 Total $ 99,975 Contractual cash payments for the remaining lease term as of September 30, 2022: 2022 $ 33,325 2023 133,817 2024 136,917 2025 116,250 Total $ 420,309 Remaining lease term (months) as of September 30, 2022 37 |
Schedule of operating lease liability maturity | Operating Lease Right-of-use lease asset: Right-of-use lease asset, January 1, 2022 $ 106,155 New lease extension June 21, 2022 347,546 Reduction/amortization (86,326) Right of use lease asset, September 30, 2022 $ 367,375 Lease liability: Lease liability, January 1, 2022 $ 106,151 New lease extension June 21, 2022 347,546 Repayments (85,415) Lease liability, September 30, 2022 $ 368,282 Lease expense for the nine months ended September 30, 2022: Lease expense $ 100,887 Total $ 100,887 Lease expense for the nine months ended September 30, 2021: Lease expense $ 99,975 Total $ 99,975 Contractual cash payments for the remaining lease term as of September 30, 2022: 2022 $ 33,325 2023 133,817 2024 136,917 2025 116,250 Total $ 420,309 Remaining lease term (months) as of September 30, 2022 37 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accrued Expenses | |
Schedule of accrued expenses | September 30, December 31, 2022 2021 Clinical trial expenses $ 1,913,221 $ 2,625,779 Other 322,230 330,766 Total $ 2,235,451 $ 2,956,545 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Debt | |
Schedule of annual principle and interest payments due | Year Principal Interest Total 2022 $ — $ 213,490 $ 213,490 2023 4,000,000 719,138 4,719,138 2024 4,000,000 380,338 4,380,338 2025 2,000,000 60,566 2,060,566 Total $ 10,000,000 $ 1,373,532 $ 11,373,532 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies. | |
Schedule of contractual obligation | Research and Property and Year Development Other Leases Total October 1 through December 31, 2022 $ 21,000 $ 33,325 $ 54,325 2023 96,000 133,817 229,817 2024 46,000 136,917 182,917 2025 46,000 116,250 162,250 2026 46,000 — 46,000 Total $ 255,000 $ 420,309 $ 675,309 |
Operating Segments (Tables)
Operating Segments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Operating Segments | |
Schedule of operating segments | Three Months Ended September 30, 2022 2021 Revenues Specialized BioTherapeutics $ — $ — Public Health Solutions 166,140 186,198 Total $ 166,140 $ 186,198 Loss from Operations Specialized BioTherapeutics $ (1,856,553) $ (2,034,507) Public Health Solutions (9,578) (160,970) Corporate (1,215,113) (1,169,434) Total $ (3,081,244) $ (3,364,911) Amortization and Depreciation Expense Specialized BioTherapeutics $ 2,876 $ 1,883 Public Health Solutions 479 314 Corporate 1,438 6,678 Total $ 4,793 $ 8,875 Other (Expense) Income, Net Specialized BioTherapeutics $ (12,613) $ (26,123) Corporate (215,146) (196,517) Total $ (227,759) $ (222,640) Share-Based Compensation Specialized BioTherapeutics $ 28,343 $ 28,506 Public Health Solutions 1,054 6,518 Corporate 41,318 44,697 Total $ 70,715 $ 79,721 Nine Months Ended September 30, 2022 2021 Revenues Specialized BioTherapeutics $ — $ — Public Health Solutions 582,843 548,615 Total $ 582,843 $ 548,615 Loss from Operations Specialized BioTherapeutics $ (5,396,630) $ (4,867,481) Public Health Solutions (131,201) (399,512) Corporate (5,141,095) (3,320,184) Total $ (10,668,926) $ (8,587,177) Amortization and Depreciation Expense Specialized BioTherapeutics $ 8,273 $ 5,644 Public Health Solutions 1,379 941 Corporate 11,886 20,029 Total $ 21,538 $ 26,614 Other (Expense) Income, Net Specialized BioTherapeutics $ 110,975 $ 99,512 Corporate (641,768) (224,174) Total $ (530,793) $ (124,662) Share-Based Compensation Specialized BioTherapeutics $ 85,190 $ 86,816 Public Health Solutions 3,162 20,002 Corporate 132,304 148,329 Total $ 220,656 $ 255,147 As of As of September 30, December 31, 2022 2021 Identifiable Assets Specialized BioTherapeutics $ 121,567 $ 128,645 Public Health Solutions 137,910 146,296 Corporate 17,687,896 26,594,986 Total $ 17,947,373 $ 26,869,927 |
Nature of Business (Details)
Nature of Business (Details) | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) segment | Sep. 30, 2021 USD ($) | Nov. 03, 2022 USD ($) | Aug. 05, 2022 USD ($) | Dec. 31, 2021 USD ($) | Aug. 13, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Nature of business: | |||||||||
Number of operating segments | segment | 2 | ||||||||
Accumulated deficit | $ (215,809,891) | $ (215,809,891) | $ (205,765,107) | ||||||
Net loss | (3,309,003) | $ (3,587,551) | (10,044,784) | $ (7,847,097) | |||||
Net cash used in operating activities | (9,021,880) | (8,684,266) | |||||||
Cash and cash equivalents | 16,865,642 | $ 28,867,487 | 16,865,642 | 28,867,487 | 26,043,897 | $ 18,676,663 | |||
Net decrease in cash | 9,178,255 | (10,190,824) | |||||||
DO NOT USE Cash and cash equivalents, increase (decrease) | $ (9,178,255) | $ 10,190,824 | |||||||
Percentage change in cash and cash equivalent | (35.00%) | ||||||||
Working capital | 7,827,078 | $ 7,827,078 | 20,278,345 | ||||||
Working capital increase, decrease | $ (12,451,267) | ||||||||
Working capital increase (decrease) as a percent | (61.00%) | ||||||||
Government grant funding | 130,742 | $ 130,742 | $ 138,889 | ||||||
Common Stock, Value, Subscriptions | $ 26,700,000 | $ 30,000,000 | |||||||
Subsequent Event [Member] | |||||||||
Nature of business: | |||||||||
Common Stock, Value, Subscriptions | $ 26,700,000 | ||||||||
CiVax | |||||||||
Nature of business: | |||||||||
Revenue from collaborative arrangement | $ 1,500,000 | ||||||||
Term (in years) | two years | ||||||||
NIH | |||||||||
Nature of business: | |||||||||
Government grant funding | $ 800,000 | $ 800,000 | |||||||
NIAID | Contract revenue | |||||||||
Nature of business: | |||||||||
Revenue from collaborative arrangement | $ 700,000 | ||||||||
Term (in years) | five years | ||||||||
DTRA | Contract revenue | |||||||||
Nature of business: | |||||||||
Revenue from collaborative arrangement | $ 600,000 | ||||||||
Term (in years) | three years |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) segment | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
Finite-Lived Intangible Assets [Line Items] | |||||
Number of operating segments | segment | 2 | ||||
Impairment of long-lived assets | $ 0 | $ 0 | $ 0 | $ 0 | |
Expiration period | 10 years | ||||
Expiration period in event of termination of employment | 3 months | ||||
Dividend yield | 0% | 0% | |||
Expected life | 4 years | 4 years | |||
Volatility rate | 87% | ||||
Volatility rate minimum | 85% | ||||
Volatility rate maximum | 87% | ||||
Risk free interest rate, minimum | 1.12% | 0.27% | |||
Risk free interest rate, maximum | 3.23% | 0.67% | |||
Foreign currency transaction gain (loss) | (12,613) | (66,967) | $ (26,006) | $ (22,384) | |
Income tax benefit | (1,154,935) | (864,742) | (1,154,935) | (864,742) | |
Interest and penalties | 0 | $ 0 | 0 | $ 0 | |
Unrecognized Tax Benefits | 0 | 0 | $ 0 | ||
Liability for Uncertainty in Income Taxes, Current | $ 0 | $ 0 | $ 0 | ||
Directors | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Vesting period | 1 year | ||||
Employee | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Vesting percentage | 25% | ||||
Vesting period | 3 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Research and Development Incentives (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2021 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Research and development incentive receivable, total | $ 123,000 | $ 225,000 |
Incentives receivable, Beginning balance | 225,070 | |
Receivable for incentives earned, current year | 29,075 | |
Receivable for incentives earned, prior years | 107,906 | |
UK research and development incentives cash receipt | (209,166) | |
Foreign currency translation | (30,174) | |
Incentives receivable, Ending balance | 122,711 | |
Current Receivables | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Incentives receivable, Beginning balance | 103,832 | |
UK research and development incentives, transfer | 121,238 | |
Receivable for incentives earned, prior years | 107,906 | |
UK research and development incentives cash receipt | (209,166) | |
Foreign currency translation | (23,438) | |
Incentives receivable, Ending balance | 100,372 | |
Long Term Receivable | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Incentives receivable, Beginning balance | 121,238 | |
UK research and development incentives, transfer | (121,238) | |
Receivable for incentives earned, current year | 29,075 | |
Foreign currency translation | (6,736) | |
Incentives receivable, Ending balance | $ 22,339 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Loss per share, Warrants and Options expirations (Details) - $ / shares | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Jan. 02, 2022 | Dec. 15, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities excluded | 4,682,302 | 12,606,402 | ||
Weighted average exercise price, outstanding warrants | $ 2.41 | $ 2.96 | ||
Weighted average exercise price, outstanding options | $ 2.30 | $ 2.70 | ||
Common Stock Warrants, Number Of Expirations | 3,268,200 | 2,403,385 | ||
Warrants | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities excluded | 59,872 | 5,731,464 | ||
Stock options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities excluded | 2,183,406 | 1,996,890 | ||
Convertible debt securities | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities excluded | 2,439,024 | 4,878,048 |
Leases (Details)
Leases (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Lessee, Lease, Description [Line Items] | ||
Right-of-use asset, operating lease | $ 367,375 | $ 106,155 |
Lease liability, operating | 368,282 | $ 106,151 |
For Period Till November 2023 | ||
Lessee, Lease, Description [Line Items] | ||
Lease rent per month | 11,108 | |
From Period Till November 2024 | ||
Lessee, Lease, Description [Line Items] | ||
Lease rent per month | 11,367 | |
From Period Till Lease Expiration 2024 | ||
Lessee, Lease, Description [Line Items] | ||
Lease rent per month | $ 11,625 |
Leases - Reconciliation (Detail
Leases - Reconciliation (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Assets and Liabilities, Lessee [Abstract] | ||
Right-of-use lease asset, Beginning balance | $ 106,155 | |
New lease extension | 347,546 | |
Reduction/amortization | (86,326) | |
Right-of-use lease asset, Ending balance | 367,375 | |
Operating lease liability, beginning | 106,151 | |
Repayments | (85,415) | |
Operating lease liability, end | 368,282 | |
Lease expense | ||
Lease expense | 100,887 | $ 99,975 |
Contractual cash payments, operating lease | ||
2022 | 33,325 | |
2023 | 133,817 | |
2024 | 136,917 | |
2025 | 116,250 | |
Total | $ 420,309 | |
Remaining lease term (months) | 37 years |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Accrued Expenses | ||
Clinical trail expenses | $ 1,913,221 | $ 2,625,779 |
Other | 322,230 | 330,766 |
Accrued expenses | $ 2,235,451 | $ 2,956,545 |
Debt (Details)
Debt (Details) - Convertible Debt - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Dec. 31, 2020 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Debt instruments | |||||
Financing available | $ 20,000,000 | ||||
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% | ||||
Interest expense | $ 213,490 | $ 226,093 | $ 633,510 | $ 670,907 | |
Conversion price (in Dollars per share) | $ 4.10 | $ 4.10 | |||
First Tranche [Member] | |||||
Debt instruments | |||||
Convertible note | $ 10,000,000 | ||||
Second Tranche [Member] | |||||
Debt instruments | |||||
Financing available | 5,000,000 | ||||
Third Tranche [Member] | |||||
Debt instruments | |||||
Financing available | $ 5,000,000 |
Debt- Payments due (Details)
Debt- Payments due (Details) | Sep. 30, 2022 USD ($) |
Debt instruments | |
2022 | $ 213,490 |
2023 | 4,719,138 |
2024 | 4,380,338 |
2025 | 2,060,566 |
Total | 11,373,532 |
Principal [Member] | |
Debt instruments | |
2022 | |
2023 | 4,000,000 |
2024 | 4,000,000 |
2025 | 2,000,000 |
Total | 10,000,000 |
Interest [Member] | |
Debt instruments | |
2022 | 213,490 |
2023 | 719,138 |
2024 | 380,338 |
2025 | 60,566 |
Total | $ 1,373,532 |
Income Tax (Details)
Income Tax (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | |||||
Various tax credits, amount | $ 8,600,000 | $ 8,600,000 | |||
Income tax benefit | $ 1,154,935 | $ 864,742 | $ 1,154,935 | $ 864,742 | |
Domestic Tax Authority [Member] | |||||
Operating Loss Carryforwards [Line Items] | |||||
Operating Loss Carryforwards | $ 123,800,000 | ||||
State and Local Jurisdiction [Member] | |||||
Operating Loss Carryforwards [Line Items] | |||||
Operating Loss Carryforwards | 25,200,000 | ||||
Foreign Tax Authority [Member] | |||||
Operating Loss Carryforwards [Line Items] | |||||
Operating Loss Carryforwards | $ 1,400,000 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
Aug. 05, 2022 | May 06, 2022 | Feb. 07, 2022 | Aug. 31, 2017 | Sep. 30, 2021 | Sep. 30, 2021 | Nov. 03, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | Aug. 13, 2021 | |
Class of Stock [Line Items] | ||||||||||
Preferred stock, shares authorized | 350,000 | 350,000 | ||||||||
Preferred stock, shares issued | 0 | 0 | ||||||||
Preferred stock, shares outstanding | 0 | 0 | ||||||||
Shares issued to vendor | 54,946 | 96,154 | 80,646 | |||||||
Fair value per share | $ 0.91 | $ 0.52 | $ 0.62 | |||||||
Threshold percentage of compensation from gross proceeds | 3% | |||||||||
Common Stock, Value, Subscriptions | $ 26.7 | $ 30 | ||||||||
Subsequent Event [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Common Stock, Value, Subscriptions | $ 26.7 | |||||||||
Common Stock | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued on option exercises | 30,254 | 30,254 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) | 1 Months Ended | 9 Months Ended | |||||
Aug. 05, 2022 shares | May 06, 2022 shares | Feb. 07, 2022 shares | Jul. 31, 2020 USD ($) | Mar. 31, 2020 $ / shares shares | Sep. 30, 2014 USD ($) shares | Sep. 30, 2022 USD ($) ft² | |
Other Commitments [Line Items] | |||||||
Contractual obligation | $ 675,309 | ||||||
Maximum payment for commitment milestones | 13,200,000 | ||||||
Sub license milestones payments on covered products | $ 200,000 | ||||||
Percentage of sub license income on royalties | 15% | ||||||
Office space in square feet | ft² | 6,200 | ||||||
Issuance of common stock | shares | 54,946 | 96,154 | 80,646 | ||||
Amount of damages sought | $ 19,000,000 | ||||||
Research and Development Arrangement [Member] | |||||||
Other Commitments [Line Items] | |||||||
Contractual obligation | $ 255,000 | ||||||
Lease Agreements [Member] | |||||||
Other Commitments [Line Items] | |||||||
Contractual obligation | $ 420,309 | ||||||
Asset Purchase Agreement [Member] | |||||||
Other Commitments [Line Items] | |||||||
Cash paid to acquire intangible asset | $ 275,000 | ||||||
Issuance of shares for assets (in shares) | shares | 184,912 | ||||||
Fair value of shares issued in connection with asset purchase | $ 3,750,000 | ||||||
Issuance of common stock | shares | 1,956,182 | ||||||
Effective price per share (in Dollars per share) | $ / shares | $ 2.56 | ||||||
Ownership of company outstanding | 19.90% | ||||||
Minimum | |||||||
Other Commitments [Line Items] | |||||||
Percentage for royalties | 2% | ||||||
Percentage of global net sales royalties on covered products | 1.50% | ||||||
Maximum | |||||||
Other Commitments [Line Items] | |||||||
Percentage for royalties | 3% | ||||||
Percentage of global net sales royalties on covered products | 2.50% | ||||||
Maximum | Asset Purchase Agreement [Member] | Scenario, Plan [Member] | |||||||
Other Commitments [Line Items] | |||||||
Contingent consideration | $ 5,000,000 |
Commitments and Contingencies -
Commitments and Contingencies - Maturity (Details) | Sep. 30, 2022 USD ($) |
Contractual Obligation, Fiscal Year Maturity Schedule [Abstract] | |
October 1 through December 31, 2022 | $ 54,325 |
2023 | 229,817 |
2024 | 182,917 |
2025 | 162,250 |
2026 | 46,000 |
Total | 675,309 |
Research and Development Arrangement [Member] | |
Contractual Obligation, Fiscal Year Maturity Schedule [Abstract] | |
October 1 through December 31, 2022 | 21,000 |
2023 | 96,000 |
2024 | 46,000 |
2025 | 46,000 |
2026 | 46,000 |
Total | 255,000 |
Lease Agreements [Member] | |
Contractual Obligation, Fiscal Year Maturity Schedule [Abstract] | |
October 1 through December 31, 2022 | 33,325 |
2023 | 133,817 |
2024 | 136,917 |
2025 | 116,250 |
2026 | |
Total | $ 420,309 |
Operating Segments (Details)
Operating Segments (Details) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) segment | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
Segment reporting | |||||
Total revenues | $ 166,140 | $ 186,198 | $ 582,843 | $ 548,615 | |
Loss from operations | (3,081,244) | (3,364,911) | (10,668,926) | (8,587,177) | |
Amortization and depreciation | 4,793 | 8,875 | 21,538 | 26,614 | |
Other (Expense) Income, Net | (227,759) | (222,640) | (530,793) | (124,662) | |
Share-based compensation | 70,715 | 79,721 | 220,656 | 255,147 | |
Identifiable Assets | 17,947,373 | $ 17,947,373 | $ 26,869,927 | ||
Number of operating segments | segment | 2 | ||||
Operating Segments [Member] | Specialized BioTherapeutics [Member] | |||||
Segment reporting | |||||
Loss from operations | (1,856,553) | (2,034,507) | $ (5,396,630) | (4,867,481) | |
Amortization and depreciation | 2,876 | 1,883 | 8,273 | 5,644 | |
Other (Expense) Income, Net | (12,613) | (26,123) | 110,975 | 99,512 | |
Share-based compensation | 28,343 | 28,506 | 85,190 | 86,816 | |
Identifiable Assets | 121,567 | 121,567 | 128,645 | ||
Operating Segments [Member] | Public Health Solutions [Member] | |||||
Segment reporting | |||||
Total revenues | 166,140 | 186,198 | 582,843 | 548,615 | |
Loss from operations | (9,578) | (160,970) | (131,201) | (399,512) | |
Amortization and depreciation | 479 | 314 | 1,379 | 941 | |
Share-based compensation | 1,054 | 6,518 | 3,162 | 20,002 | |
Identifiable Assets | 137,910 | 137,910 | 146,296 | ||
Corporate, Non-Segment [Member] | |||||
Segment reporting | |||||
Loss from operations | (1,215,113) | (1,169,434) | (5,141,095) | (3,320,184) | |
Amortization and depreciation | 1,438 | 6,678 | 11,886 | 20,029 | |
Other (Expense) Income, Net | (215,146) | (196,517) | (641,768) | (224,174) | |
Share-based compensation | 41,318 | $ 44,697 | 132,304 | $ 148,329 | |
Identifiable Assets | $ 17,687,896 | $ 17,687,896 | $ 26,594,986 |