SOLIGENIX, INC.
For the period ended Dec 31, 2024. Filed Mar 21, 2025.
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FY2024 · Filed Mar 21, 2025
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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 maintainstwo active business segments: Specialized BioTherapeutics and Public Health Solutions.
The Company’s Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With successful completion of the first Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study and agreement from the European Medicines Agency (“EMA”) on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ in the treatment of CTCL patients with early stage disease, the Company began patient enrollment during December 2024 for the second Phase 3 study, called “FLASH2” (Fluorescent Light Activated Synthetic Hypericin 2). The Company anticipates top-line results in the second half of 2026. Upon successful completion of the Phase 3 FLASH2 study, regulatory approval will be sought to support potential commercialization worldwide.
Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, and the Company’s first-in-class Innate Defense Regulator (“IDR”) technology, and dusquetide (SGX942 and SGX945) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer and aphthous ulcers in Behçet’s Disease.
The Company’s Public Health Solutions business segment includes development programs for RiVax®, 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 CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of the vaccine programs incorporates the use of the Company’s proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.
The Company primarily generates revenues under government grants and contracts. The Company was awarded a subcontract that originally provided for approximately $1.1 million from a U.S. Food and Drug Administration (“FDA”) Orphan Products Development grant over four years 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.
Liquidity
The Company has evaluated whether conditions and events, considered in the aggregate, raise substantial doubt about its ability to continue as a going concern within one year after the date the consolidated financial statements are issued. As of December 31, 2024, the Company had an accumulated deficit of $233,970,752 and working capital of $3,980,218. For the year ended December 31, 2024, the Company incurred a net loss of $8,266,576 and used $8,403,618 of cash in operating activities. The Company expects to continue generating losses for the foreseeable future, and its liquidity needs will depend largely on budgeted operational expenditures related to the advancement of its product candidates.
Management believes that the Company has sufficient resources to support development activities, business operations, and meet its obligations through the fourth quarter of 2025. However, as of the date of this filing, the Company does not
have sufficient cash and cash equivalents to fund operations for at least 12 months following the issuance of these financial statements. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
To alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, the Company’s plans include securing:
| ● | additional capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations; |
| ● | additional proceeds from government contract and grant programs; and |
| ● | additional proceeds from the sale of shares of the Company’s common stock via the At Market Issuance Sales Agreement (“AGP Sales Agreement”) with A.G.P/Alliance Global Partners (“AGP”). |
While the AGP Sales Agreement is in place, none of the other funding alternatives are currently committed. There is no assurance that the Company will be successful in securing sufficient financing on acceptable terms, if at all. Failure to obtain adequate funding may require the Company to delay, reduce, or eliminate certain business activities and development programs, materially impacting its financial condition and results of operations.
Additionally, macroeconomic and geopolitical uncertainties may further restrict access to capital, exacerbating liquidity challenges. Furthermore, concerns regarding the Company’s ability to continue as a going concern could negatively impact relationships with business partners, vendors, and other stakeholders.
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.
Management’s business strategy can be outlined as follows:
| ● | Following agreement from the EMA on the key design components for the second confirmatory Phase 3 placebo-controlled FLASH2 clinical trial of HyBryte™ in CTCL and positive primary endpoint results from the first Phase 3 FLASH study, continue enrollment and execution of the FLASH2 study, while at the same time, continuing discussions with the FDA on potential modifications to the development path to adequately address their feedback. |
| ● | Expand development of synthetic hypericin under the research name SGX302 into psoriasis with the conduct of a Phase 2a clinical trial, following the positive Phase 3 FLASH study and positive proof-of-concept demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients. |
| ● | Following feedback from the United Kingdom (“UK”) Medicines and Healthcare products Regulatory Agency (“MHRA”) that a second Phase 3 clinical trial of SGX942 (dusquetide) in the treatment in oral mucositis would be required to support a marketing authorization, design a second study and attempt to identify a potential partner(s) to continue this development program. |
| ● | Expand development of dusquetide under the research name SGX945 into Behçet’s Disease by conducting a Phase 2a clinical trial, where previous studies with dusquetide in oral mucositis have validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation. |
| ● | Continue development of the Company’s heat stabilization platform technology, ThermoVax®, in combination with its programs for RiVax® (ricin toxin vaccine), and filovirus vaccines (targeting Ebola, Sudan, and Marburg viruses and multivalent combinations), with United States (“U.S.”) government or non-governmental organization funding support. |
| ● | Continue to apply for and secure additional government funding for the Specialized BioTherapeutics and Public Health Solutions programs through grants, contracts and/or procurements. |
| ● | Pursue business development opportunities for pipeline programs, as well as explore all strategic alternatives, including but not limited to merger/acquisition strategies. |
| ● | Acquire or in-license new clinical-stage compounds for development, as well as evaluate new indications with existing pipeline compounds for development. |
The Company’s plans with respect to its liquidity management include, but are not limited to, the following:
| ● | The Company has up to approximately $554,000 in active government grant funding still available as of December 31, 2024 to support its associated research programs through May 2026, provided the federal agencies do not elect to terminate the grants for convenience. The Company plans to submit additional contract and grant applications for further support of its programs with various funding agencies. However, there can be no assurance that the Company will obtain additional governmental grant funding. |
| ● | The Company will continue to use equity instruments to provide a portion of the compensation due to vendors and collaboration partners and expects to continue to do so for the foreseeable future. |
| ● | The Company will continue to pursue Net Operating Loss (“NOL”) sales in the state of New Jersey pursuant to its Technology Business Tax Certificate Transfer Program if the program is available. |
| ● | The Company plans to pursue potential partnerships for pipeline programs as well as continue to explore merger and acquisition strategies. However, there can be no assurances that the Company can consummate such transactions. |
| ● | The Company plans to use the proceeds from a completed public offering on April 22, 2024 of 204,694 shares of its common stock, pre-funded warrants to purchase 537,500 shares of its common stock and common warrants to purchase up to 742,194 shares of its common stock at a combined public offering price of $6.40 for further support of its programs, as well as for working capital. The pre-funded warrants have an exercise price of $0.02. The common warrants have an exercise price of $6.40 per share, are exercisable immediately and expire five years from the issuance date. The total gross proceeds to the Company from this offering were approximately $4.75 million before deducting commissions and other estimated offering expenses of approximately $0.45 million. |
| ● | The Company plans to use the proceeds from a warrant inducement agreement (the “Inducement Agreement”) on July 9, 2024 with certain holders (the “Holders”) of the Company’s existing Warrant to Purchase Shares of Common Stock (“Existing Warrants”) to purchase shares of common stock of the Company for further support of its programs, as well as for working capital. In consideration of the Holders’ agreement to exercise their Existing Warrants, the Company (i) decreased the exercise price of the Existing Warrants from $6.40 per share to $6.00 per share and (ii) issued new warrants (“New Warrants”) to the Holders to purchase a number of shares of common stock equal to 150% of the number of shares of common stock issued upon exercise of the Holders’ Existing Warrants. Pursuant to the Inducement Agreement, the Holders agreed to exercise for cash their Existing Warrants to purchase up to 703,125 shares of the Company’s common stock at a reduced exercise price of $6.00 per share on July 9, 2024, the date of the Inducement Agreement, until 1:30 p.m., Eastern Time. The total gross proceeds to the Company was approximately $4.2 million from the exercise of the Existing Warrants before deducting financial advisory fees and other expenses. |
| ● | The Company has up to approximately $2.1 million remaining from the AGP Sales Agreement as of March 14, 2025 under the prospectus supplement dated August 16, 2024. From January 1, 2025 through March 14, 2025, the Company sold 628,758 shares of common stock pursuant to the AGP Sales Agreement at a weighted average price of $4.23 per share for total gross proceeds of approximately $2.7 million. |
| ● | The Company is currently evaluating additional equity/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that it can consummate such a transaction, or consummate a transaction at favorable pricing. |
Reverse Stock Split
On June 5, 2024, the Company completed a reverse stock split of its issued and outstanding shares of common stock at a ratio ofone-for-sixteen, whereby every sixteen shares of the Company’s issued and outstanding common stock were automatically combined intoone 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 June 6, 2024. All share and per share data have been restated to reflect this reverse stock split.
Note 2. Summary of Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements include Soligenix, Inc., and its wholly and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated as a result of consolidation.
Operating Segments
Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision maker, or decision-making group, in deciding how to allocate resources to an individual segment and in assessing the performance of the segment. The Company divides its operations intotwo operating segments: Specialized BioTherapeutics and Public Health Solutions.
Cash and Cash Equivalents
The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents.
Contracts and Grants Receivable
Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from NIAID, an institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no allowance for credit losses has been established. If amounts become uncollectible, they are charged to operations.
Impairment of Long-Lived Assets
Office furniture and equipment, 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 didnot record any impairment of long-lived assets for the years ended December 31, 2024 and 2023.
Fair Value of Financial Instruments
Fair value is defined 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. Disclosures regarding the fair value of all financial instruments are required for financial statement purposes, regardless of whether they are recognized in the financial statements. Fair value disclosures are based on information available to the Company as of December 31, 2024 and 2023. Accordingly, the estimates presented in these financial statements may not necessarily reflect the amounts that could be realized upon the disposition of these financial instruments.
Fair Value valuation techniques include a three-level hierarchy based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).
The three levels of the fair value hierarchy are as follows:
| ● | Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. |
| ● | Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. |
| ● | Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. |
In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability.
The carrying amounts reported in the consolidated balance sheets for cash and cash equivalents, contracts and grants receivable, research and development incentives receivable, accounts payable, accrued expenses, and accrued compensation approximate their fair value based on the short-term maturity of these instruments.
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.
Change in Accounting Estimates
The Company accrues clinical trial expenses per contracts with clinical sites over the course of the clinical trial period. Accrued trial expenses are assessed for accuracy on an ongoing basis during the trial period and beyond. For the year ended December 31, 2024, the Company made adjustments to estimated accrued clinical trial expenses for completed trials of approximately $1.4 million. These adjustments resulted in decreases to research and development expenses in the accompanying consolidated statements of operations during the year ended December 31, 2024.
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 applicable accounting guidance which requires an entity to recognize 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 this guidance, 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 this guidance, 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 applicable accounting guidance. 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 ofone 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 ofthree years. These options have aten 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.
The fair value of options issued during the years ended December 31, 2024 and 2023 was estimated using the Black-Scholes option-pricing model and the following assumptions:
| ● | a dividend yield of 0%; |
| ● | an expected life of four years; |
| ● | volatility of 108% - 130% for 2024 and 94% - 110% for 2023; and |
| ● | risk-free interest rates ranging from 4.16% to 4.76% in 2024 and ranging from 3.48% to 4.35% in 2023. |
The fair value of each option grant made during 2024 and 2023 was estimated on the date of each grant and recognized as share-based compensation expense ratably over the option vesting periods, which approximates the service period. The expected term of options granted is derived using company history of options exercised. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term. The Company accounts for forfeitures as they are incurred.
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.
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 830Foreign 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 2024 and 2023, the Company recognized foreign currency transaction gains of $1,591 and $1,483, 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 sold 2023, 2022 and 2021 New Jersey NOL carryforwards resulting in the recognition of income tax benefits, net of transaction costs of $409,114 and $1,767,803 during the years ended December 31, 2024 and 2023, respectively. The Company sold its 2023 New Jersey NOLs and has recorded a receivable of $409,114 which is included in prepaid expenses and other current assets on the accompanying consolidated balance sheet for the year ended December 31, 2024. The Company recognizes accrued interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There wereno tax related interest and penalties recorded for 2024 and 2023. Additionally, the Company has not recorded an asset for unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2024 or 2023.
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 $0 and $49,000 as of December 31, 2024 and 2023, respectively in the consolidated balance sheets. As a result of certain rule changes to the SME research and development tax relief program, the Company is no longer participating in the program as of December 31, 2024. Accordingly, during 2024, the Company adjusted previously recorded research and development
incentive receivables tozero resulting in a loss of $25,468 recognized in the accompanying 2024 consolidated statement of operations.
The following table shows the change in the UK research and development incentives receivable from December 31, 2023 to December 31, 2024:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · Current · Long-Term · Total | |||||||||
| Balance at December 31, 2023 | $23,894 | | $25,468 | | $49,362 | ||||
| UK research and development incentives, transfer | | 25,468 | | | (25,468) | | — | ||
| UK research and development incentives, adjustments | | | (25,468) | | | (20) | | | (25,488) |
| UK research and development incentives cash receipt | | (23,848) | | — | | (23,848) | |||
| Foreign currency translation | | (46) | | 20 | | (26) | |||
| Balance at December 31, 2024 | | $— | | $— | | $— | |||
Loss Per Share
Basic earnings per share (“EPS”) 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 (basic and diluted) for the year ended December 31, 2024, are common shares issuable upon the exercise of the pre-funded warrants as these pre-funded warrants are exercisable at any time for nominal consideration.
The following table summarizes outstanding instruments which were not included in the computation of diluted EPS as to do so would have been antidilutive:
| | | | | |
|---|---|---|---|---|
| | | December 31, | | December 31, |
| · 2024 · 2023 | ||||
| Common stock purchase warrants | | 1,467,581 | | 408,640 |
| Stock options | 229,919 | 56,609 | ||
| Convertible debt | 360,335 | 273,973 | ||
| Total | 2,057,835 | 739,222 | ||
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.
Recent Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07,Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This update enhances the segment reporting requirements by increasing transparency and providing investors with additional insights into how an entity’s Chief Operating Decision Maker (“CODM”) evaluates segment performance and allocates resources.
The standard requires public entities to disclose significant segment expenses that are regularly reviewed by the CODM and included in the reported measure of segment profit or loss. Additionally, entities must provide a reconciliation of total segment amounts to consolidated financial statements, as well as enhanced qualitative disclosures regarding the methodology used to identify reportable segments and assess performance. The update applies to all public entities, including those with a single reportable segment, and expands segment disclosures in interim financial statements.
ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company has adopted ASU 2023-07 for the year ended December 31, 2024, and has updated its segment disclosures accordingly. The adoption of this standard did not impact the recognition or measurement of the Company’s financial statements but resulted in enhanced segment-related disclosures in the notes to the consolidated financial statements.
Note 3. Leases
The Company classifies a lease for its office space as an operating lease, and records a related right-of-use lease asset and lease liability accordingly. Pursuant to the lease which expires October 2025, the current rent is $11,625 per month.
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, 2024 | | | | |
| 2025 | $116,250 | | ||
| Less implied interest | | | 4,388 | |
| Total | | $111,862 | | |
| Discount rate applied | | 8.47% | ||
| Remaining lease term (months) as of December 31, 2024 | | 10 | | |
| | | | | |
| Lease expense for the year ended December 31, 2023: | | | ||
| Lease expense | | $136,022 | | |
| Total | | $136,022 | | |
| | | | | |
| Lease expense for the year ended December 31, 2024: | | | | |
| Lease expense | | $136,022 | | |
| Total | | $136,022 | | |
| | | | | |
**Note 4.**Accrued Expenses
The following is a summary of the Company’s accrued expenses:
| · · · · · · | ||||
|---|---|---|---|---|
| · · December 31, | ||||
| · 2024 · 2023 | ||||
| Clinical trial expenses | | $1,135,542 | | $1,993,784 |
| Other | | 1,223,797 | | 424,218 |
| Total | | $2,359,339 | | $2,418,002 |
**Note 5.**Debt
In December 2020, the Company entered into a $20 million convertible debt financing agreement (the “Loan 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 Loan Agreement, the Company had access to up to $20 million in convertible debt financing inthree tranches, which will mature on June 15, 2025 and had an interest-only period for the firsttwo 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 was secured by a lien covering substantially all of the Company’s assets, other than intellectual property.
Upon the closing of this transaction, the Company accessed the first tranche of $10 million, had the option to draw the second tranche of $5 million at any time during the initial 12 months of the loan and the third tranche of $5 million upon filing of the HyBryte™ NDA, subject to certain conditions. The Company elected to let the options to borrow both the second and third tranches expire as of December 15, 2021 and March 15, 2022, respectively.
In April 2023, the Company entered into an amendment to the Loan Agreement (the “2023 Amendment”). The 2023 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 2023 Amendment also provided for interest only through June 30, 2024, reduced quarterly principal repayments to $750,000 and eliminated the minimum cash covenant. Further, the 2023 Amendment reduced the
conversion price with respect to the remaining principal amount to (i)90% of the closing price of the Company’s common stock on the day before the delivery of a conversion notice with respect to the first 36,790 shares of the Company’s common stock issuable upon conversion and to (ii) $27.20 with respect to all shares of the Company’s common stock issuable upon conversion thereafter. The remaining terms of the agreement remained unmodified.
On January 3, 2024, Pontifax delivered a conversion notice to the Company electing to convert a portion of the remaining principal balance into shares of the Company’s common stock. Upon conversion, the Company issued 9,139 shares of the Company’s common stock at $10.88 per share, reducing the remaining principal balance by $99,416.
On April 15, 2024, Pontifax delivered a conversion notice to the Company electing to convert a portion of the remaining principal balance into shares of the Company’s common stock. Upon conversion, the Company issued 27,651 shares of the Company’s common stock at $5.60 per share, reducing the remaining principal balance by $154,840.
The 2023 Amendment resulted in the extinguishment of the original convertible debt for accounting purposes. The Company elected to account for the amended convertible debt using the fair value option. The fair value of the convertible debt on the date of the amendment was approximately $3,304,000, which resulted in the recognition of a loss on extinguishment of approximately $394,000 on the Company’s accompanying consolidated statements of operations for the year ended December 31, 2023. The fair value of the convertible debt as of December 31, 2023 was approximately $3,260,934, which resulted in the recognition of $43,066 of other income from the change in the fair value of the convertible debt on the Company’s accompanying consolidated statements of operations for the year ended December 31, 2023. For 2023 and through the 2024 Amendment (described below), the fair value of the convertible debt was estimated using the Monte Carlo valuation method.
In October 2024, the Company entered into an amendment (the “2024 Amendment”) to the Loan Agreement, as amended. The 2024 Amendment reduced the conversion price with respect to the remaining principal amount outstanding to (i) $3.81 for the first 501,648 shares of the Company’s common stock issuable upon conversion and (ii) $4.23 with respect to all shares of the Company’s common stock issuable upon conversion thereafter. The remaining terms of the agreement remained in effect with minimal, non-material modifications to those terms. The 2024 Amendment resulted in a substantial modification of the debt for accounting purposes, as defined, which is accounted for as an extinguishment. The difference between the fair value, or net carrying amount, of the debt before the 2024 Amendment and upon reacquisition was diminimus. Accordingly, no gain or loss was recognized related to the extinguishment related to the 2024 Amendment. Furthermore, as the 2024 Amendment resulted in a substantial modification, as defined, the Company elected not to account for the convertible debt using the fair value option in accordance with the applicable guidance. The Company determined the embedded conversion feature, after the 2024 Amendment, does not require bifurcation and is therefore the convertible debt, as amended, has been recorded as a single liability classified instrument in accordance with ASU 2020-06. As a result of this election, the Company recognized a gain of $260,933 of other income from the change in the fair value of the convertible debt on the Company’s accompanying 2024 consolidated statement of operations.
In February 2025, the Company fully repaid all outstanding obligations and terminated the Loan Agreement. As a result, all related liens and security interests securing the Company’s obligations were released. The Company did not incur any prepayment penalties for the early repayment.
Interest expense incurred during the years ended December 31, 2024 and 2023 was $192,998 and $402,615, respectively. Interest expense paid during the years ended December 31, 2024 and 2023 was $227,735 and $552,058, respectively.
Annual principal and interest payments due, according to the agreement’s contractual terms, assuming no conversion is as follows as of December 31, 2024:
| · · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| Year · Principal · Interest · Total | ||||||
| 2025 | | 1,372,873 | | 43,646 | | 1,416,519 |
| Total | | $1,372,873 | | $43,646 | | $1,416,519 |
Note 6. Income Taxes
The income tax benefit consisted of the following for the years ended December 31, 2024 and 2023:
| · · · · · · | ||||
|---|---|---|---|---|
| · 2024 · 2023 | ||||
| State & Local | | (409,114) | | (1,767,803) |
| Income tax benefit | | $(409,114) | | $(1,767,803) |
The significant components of the Company’s deferred tax assets and liabilities at December 31, 2024 and 2023 are as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · 2024 · 2023 | ||||||
| Net operating loss carry forwards | | $28,438,000 | | $27,522,000 | ||
| Orphan drug and research and development credit carry forwards | | 9,617,000 | | 8,921,000 | ||
| Equity based compensation | | 227,000 | | 246,000 | ||
| Intangibles | | 1,401,000 | | 1,409,000 | ||
| Capitalized research and development | | 2,482,000 | | 2,311,000 | ||
| Lease liability | | 69,000 | | 66,000 | ||
| Other | | | (85,000) | | | (12,000) |
| Total | | 42,149,000 | | 40,463,000 | ||
| Valuation allowance | | | (42,087,000) | | | (40,398,000) |
| Net deferred tax assets | | | 62,000 | | | 65,000 |
| Right of use asset | | | (62,000) | | | (65,000) |
| Total gross deferred tax liabilities | | (62,000) | | (65,000) | ||
| Net deferred tax assets | | $— | | $— | ||
The Company had gross NOLs at December 31, 2024 of approximately $124.6 million for federal tax purposes, approximately $21.9 million for state tax purposes and approximately $3.7 million for foreign tax purposes. Federal losses generated in 2018 or later will carry forward indefinitely. In addition, the Company has approximately $9.6 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, 2024 and 2023 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 $409,114 and $1,767,803, respectively, of income tax benefit, net of transaction costs. The Company sold its 2023 New Jersey NOLs and has recorded a receivable of $409,114 which is included in prepaid expenses and other current assets on the accompanying consolidated balance sheet for the year ended December 31, 2024. 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, 2024 and 2023 were as follows:
| · · · · · | |||
|---|---|---|---|
| · 2024 · 2023 | |||
| Federal tax at statutory rate | (21.0)% | (21.0)% | |
| State tax benefits, plus sale of NJ NOL, net of federal benefit | (12.2) | (21.6) | |
| Foreign tax rate difference | — | 0.1 | |
| Orphan drug and research and development credits | (8.1) | (2.0) | |
| Permanent differences | 1.3 | 0.9 | |
| Foreign NOL adjustments | 0.6 | 0.7 | |
| Expiration of tax attributes | 15.2 | 14.2 | |
| Change in valuation allowance | 19.5 | 6.3 | |
| Income tax benefit | (4.7)% | (22.4)% | |
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, 2024, 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 2005, 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 didnot have any unrecognized tax benefits and hasnot accrued any interest or penalties for the years ended December 31, 2024 and 2023.
Note 7. Shareholders’ Equity
Preferred Stock
The Company has 350,000 shares of preferred stock authorized as of December 31, 2024.
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 oneone-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
The following items represent transactions in the Company’s common stock for the year ended December 31, 2024:
| ● | The Company issued Pontifax 9,139 shares of fully vested common stock pursuant to conversion of a portion of the convertible debt principal balance at a conversion price of $10.88 per share on January 3, 2024. The conversion price was based on 90% of the closing price of the Company’s common stock on the day before the delivery of the conversion notice. |
| ● | The Company issued Pontifax 27,651 shares of fully vested common stock pursuant to conversion of a portion of the convertible debt principal balance at a conversion price of $5.60 per share on April 15, 2024. The conversion price was based on 90% of the closing price of the Company’s common stock on the day before the delivery of the conversion notice. |
| ● | The Company sold 204,694 shares of common stock and 537,500 pre-funded warrants pursuant to the April 2024 public offering for $6.40 per share on April 22, 2024. |
| ● | The Company issued 97,375 shares of common stock pursuant to the exercise of pre-funded warrants associated with the April 2024 public offering with an exercise price of $0.02 on April 22, 2024. |
| ● | The Company issued 69,125 shares of common stock pursuant to the exercise of pre-funded warrants associated with the April 2024 public offering with an exercise price of $0.02 on June 11, 2024. |
| ● | The Company issued 117,000 shares of common stock pursuant to the exercise of pre-funded warrants associated with the April 2024 public offering with an exercise price of $0.02 on June 14, 2024. |
| ● | The Company issued 130,000 shares of common stock pursuant to the exercise of pre-funded warrants associated with the April 2024 public offering with an exercise price of $0.02 on June 20, 2024. |
| ● | The Company issued 124,000 shares of common stock pursuant to the exercise of pre-funded warrants associated with the April 2024 public offering with an exercise price of $0.02 on June 25, 2024. |
| ● | The Company issued 703,125 shares of common stock pursuant to the exercise of warrants associated with the April 2024 public offering with an exercise price of $6.00 on July 10, 2024. |
| ● | The Company issued 31,250 shares of common stock pursuant to the exercise of warrants associated with the April 2024 public offering with an exercise price of $6.40 on July 10, 2024. |
| ● | The Company issued 2,190 shares of common stock pursuant to the exercise of warrants associated with the April 2024 public offering with an exercise price of $6.40 on July 11, 2024. |
| ● | The Company issued 1,376 shares of common stock pursuant to the exercise of warrants associated with the April 2024 public offering with an exercise price of $6.40 on July 23, 2024. |
| ● | The Company sold 229,078 shares of common stock pursuant to the AGP Sales Agreement at a weighted average price of $4.72 per share. |
The issuance of the Company’s common stock in connection with the convertible debt financing agreement as described above was exempt under Section 3(a)(9) of the Securities Act of 1933, as amended.
The issuances of the Company’s common stock in connection with the April 2024 public offering and upon the exercise of warrants described above were registered on a Registration Statement on Form S-1.
The issuance of the Company’s common stock pursuant to the AGP Sales Agreement described above was registered on a Registration Statement on Form S-3.
The following items represent transactions in the Company’s common stock for the year ended December 31, 2023:
| ● | The Company issued a vendor 3,125 shares of fully vested common stock with a fair value based on a closing price of $23.36 per share on April 27, 2023, the date of issuance. |
| ● | The Company sold 53,202 shares of common stock pursuant to an At Market Issuance Sales Agreement with B. Riley Securities, Inc. (“B. Riley”) at a weighted average price of $58.11 per share. |
| ● | The Company issued 1,978 shares of fully vested common stock pursuant to an exclusive option agreement at $25.28 per share on May 2, 2023. The share price was calculated using the average closing price of the common stock for the ten days immediately preceding April 27, 2023, the effective date of the option agreement. |
| ● | The Company sold 143,844 shares of common stock and 264,815 pre-funded warrants pursuant to the May 2023 public offering for $20.80 per share on May 9, 2023. |
| ● | The Company issued 126,438 shares of common stock pursuant to the exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.02 on May 9, 2023. |
| ● | The Company issued 58,625 shares of common stock pursuant to the exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.02 on May 10, 2023. |
| ● | The Company issued 21,125 shares of common stock pursuant to the exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.02 on May 22, 2023. |
| ● | The Company issued 25,001 shares of common stock pursuant to the cashless exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.02 on June 8, 2023. |
| ● | The Company issued 33,525 shares of common stock pursuant to the cashless exercise of pre-funded warrants associated with the May 2023 public offering with an exercise price of $0.02 on September 6, 2023. |
All issuances of the Company’s common stock for the years ended December 31, 2024 and 2023 described above, other than shares issued to vendors or issued pursuant to the exclusive option agreement, were registered on a Registration Statement on Form S-8 (SEC File No. 333-208515), a Registration Statement on Form S-1 (333-271049) and a Registration Statement on Form S-3 (SEC File No. 333-239928). The certificates evidencing unregistered shares reflect a Securities Act of 1933, as amended, restrictive legend.
The issuances of the Company’s common stock to vendors and pursuant to the exclusive option agreement as described above were exempt under Section 4(a)(2) of the Securities Act of 1933, as amended. The recipients are knowledgeable, sophisticated and experienced in making investment decisions of this kind and received adequate information about the Company or had adequate access to information about the Company. The vendors represented to the Company that the vendors are not “consultants” for purposes of Nasdaq Listing Rule 5635(c).
At Market Issuance Sales Agreement with B. Riley
On August 11, 2017, the Company entered into an At Market Issuance Sales Agreement with B. Riley (“B. Riley Sales Agreement”) to sell shares of the Company’s common stock from time to time, through an “at-the-market” equity offering program under which B. Riley acts as sales agent. Under the B. Riley Sales Agreement, the Company set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales may be requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. The B. Riley Sales Agreement provided that B. Riley was entitled to compensation for its services in an amount equal to 3% of the gross proceeds from the sale of shares sold under the B. Riley Sale Agreement. The B. Riley Sales Agreement has expired.
AGP At Market Issuance Sales Agreement
In August 2024, the Company entered into the AGP Sales Agreement to sell shares of the Company’s common stock from time to time, through an “at-the-market” equity offering program (the “AGP ATM”). In connection with the sale of shares via the AGP ATM, the Company determines, among other things, 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. Pursuant to the terms, AGP is entitled to compensation for its services in an amount up to 3% of the gross proceeds from the sale of shares under the AGP ATM. The Company has no obligation to sell any shares under the AGP ATM, and may suspend solicitation and offers at any time. The AGP ATM may be terminated by the Company or AGP upon notice, or at any time under certain circumstances, including but not limited to the occurrence of a material adverse change in the Company. The AGP ATM will terminate upon the earliest of (a) December 15, 2026, (b) the sale of all of the shares of common stock subject to the AGP ATM, (c) the termination of the AGP Sales Agreement as permitted therein, or (d) the mutual agreement of the parties.
The AGP Sales Agreement provides for the offer and sale of shares of common stock having an aggregate offering price of up to $5.8 million. As of March 14, 2025, there was approximately $2.1 million available for future sale of common stock pursuant to the AGP ATM.
July 2024 Warrant Inducement
On July 9, 2024, the Company entered into the Inducement Agreement with the Holders of the Company’s Existing Warrants to purchase shares of common stock of the Company. Pursuant to the Inducement Agreement, the Holders agreed to exercise for cash their Existing Warrants to purchase up to 703,125 shares of common stock at a reduced exercise price of $6.00 per share on July 9, 2024, the date of the Inducement Agreement, until 1:30 p.m. Eastern Time. The aggregate gross proceeds received by the Company was approximately $4.2 million from the exercise of the Existing Warrants offset by total issuance costs of approximately $7.5 million. Issuance costs include financial advisory, banker, and legal fees of approximately $0.4 million and the fair value of the warrant modification and the fair value of the New Warrants issued totaling approximately $7.2 million. Because the modification represented a short-term inducement, the Company applied modification accounting guidance related to the fair value of the modification associated with the warrants that were exercised under the Inducement Agreement. Accordingly, the Company recognized the incremental fair value of the modification of the Existing Warrants exercised along with the fair value of the New Warrants issued as compared to the original warrants, together totaling approximately $7.2 million, as an issuance cost of the warrant exercise. Per the terms of the Inducement Agreement, the Company issued an aggregate of 1,054,688 New Warrants.
The fair value of the New Warrants issued under the Inducement Agreement was estimated using the Black-Scholes warrant-pricing model and the following assumptions:
| ● | a dividend yield of 0%; |
| ● | an expected life of 5 years; |
| ● | volatility of 127.25%; and |
| ● | risk free interest rate of 4.24%. |
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. As of December 31, 2024, there are 5,770,122 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, 2024 | 5,943,590 | |
| Options granted | (173,740) | |
| Options forfeited | 272 | |
| Options exercised | | — |
| Shares available for grant at December 31, 2024 | 5,770,122 |
Activity under the 2005 Plan and the 2015 Plan for the years ended December 31, 2024 and 2023:
| | | | | | |
|---|---|---|---|---|---|
| | Weighted | ||||
| · · · · Average | |||||
| · · · · Exercise | |||||
| · Options · Price | |||||
| Balance outstanding at December 31, 2022 | 11,946 | | $435.32 | ||
| Granted | 45,715 | | 10.45 | ||
| Forfeited | (1,052) | | 533.80 | ||
| Cancelled | | — | | | — |
| Exercised | | — | | | — |
| Balance outstanding at December 31, 2023 | 56,609 | | $90.58 | ||
| Granted | 173,740 | | 3.35 | ||
| Forfeited | (430) | | 1,549.28 | ||
| Cancelled | | — | | | — |
| Exercised | — | | — | ||
| Balance outstanding at December 31, 2024 | 229,919 | | $21.94 | ||
As of December 31, 2024, there were 72,985 options exercisable with a weighted average exercise price of $59.19 and a weighted average remaining contractual term of 8.92 years. As of December 31, 2024, there were 229,919 options outstanding with a weighted average remaining term of 9.54 years. Options outstanding as of December 31, 2024 hadno intrinsic value.
The Company awarded 173,740 and 45,715 stock options during the years ended December 31, 2024 and 2023, respectively, which had a weighted average grant date fair value per share of $2.90 and $8.05, respectively. The weighted-average exercise price, by price range, for outstanding options to purchase common stock at December 31, 2024 was:
| | | | | | | |
|---|---|---|---|---|---|---|
| · Weighted | ||||||
| | | Average | | | | |
| | | Remaining | | | | |
| | | Contractual | | Outstanding | | Exercisable |
| Price Range · Life in Years · Options · Options | ||||||
| $3.31 - $10.78 | 9.74 | 218,268 | 61,868 | |||
| $129.60 - $640.80 | 5.83 | 11,382 | 10,848 | |||
| $1,776.00- $3,624.00 | | 1.05 | | 269 | | 269 |
| Total | 9.54 | 229,919 | 72,985 | |||
The Company’s share-based compensation expense for the years ended December 31, 2024 and 2023 was recognized as follows:
| · · · · · · | ||||
|---|---|---|---|---|
| Share-based compensation · 2024 · 2023 | ||||
| Research and development | | $131,917 | | $150,466 |
| General and administrative | | 197,898 | | 219,716 |
| Total | | $329,815 | | $370,182 |
At December 31, 2024, the total compensation cost for stock options not yet recognized was approximately $596,000 and will be expensed over the next three years.
Warrants to Purchase Common Stock
Warrant activity for the years ended December 31, 2024 and 2023 was as follows:
| · · · · · · | |||||
|---|---|---|---|---|---|
| · · Weighted | |||||
| | | | | | Average |
| | | | | | Exercise |
| · Warrants · Price | |||||
| Balance at December 31, 2022 | | 42 | | $468.00 | |
| Granted | | 673,455 | | 14.56 | |
| Exercised | | (264,815) | | 0.002 | |
| Expired | | (42) | | 468.00 | |
| Balance at December 31, 2023 | | 408,640 | | $24.00 | |
| Granted (1) | | 2,334,382 | | 2.73 | |
| Exercised | | (1,275,441) | | 3.71 | |
| Expired | | — | | — | |
| Balance at December 31, 2024 | | | 1,467,581 | | $11.01 |
| (1) | Excludes pre-funded warrants issued in connection with public offerings. |
The remaining life, by grant date, for outstanding warrants at December 31, 2024 was:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · Remaining | |||||||||
| · · Exercise · · Contractual · · Outstanding · · Exercisable | |||||||||
| Grant Date · Price · Life in Years · Warrants · Warrants | |||||||||
| May 09, 2023 | | $24.00 | 3.36 | 408,640 | 408,640 | ||||
| April 22, 2024 | | | 6.40 | | 4.31 | | 4,253 | | 4,253 |
| July 10, 2024 | | | 6.00 | | 4.53 | | 1,054,688 | | 1,054,688 |
| Total | | | | | | 1,467,581 | 1,467,581 | ||
Note 9. Concentrations
At December 31, 2024 and 2023, the Company had deposits in major financial institutions that exceeded the amount under protection by the Securities Investor Protection Corporation (“SIPC”) and the Federal Deposit Insurance Corporation (“FDIC”). Currently, the Company is covered up to $250,000 by the SIPC and FDIC and at times maintains cash balances in excess of the SIPC and FDIC coverages.
Note 10. Commitments and Contingencies
The Company has commitments of approximately $230,000 as of December 31, 2024 over the next five years for several licensing agreements with partners and universities. Additionally, the Company has collaboration and license agreements, which upon clinical or commercialization success, may require the payment of milestones of up to approximately $13.2 million, royalties on net sales of covered products ranging from 2% to 3%, sub-license 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. 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 the lease which expires October 2025, the current rent is $11,625 per month.
As a result of the above agreements, the Company has future contractual obligations over the next five years as follows:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · Research and · · | |||||||||
| Year · Development · Leases · Total | |||||||||
| 2025 | | $46,000 | | $116,250 | | $162,250 | |||
| 2026 | | 46,000 | | — | | 46,000 | |||
| 2027 | | 46,000 | | — | | 46,000 | |||
| 2028 | | | 46,000 | | | — | | | 46,000 |
| 2029 | | | 46,000 | | | — | | | 46,000 |
| Total | | $230,000 | | $116,250 | | $346,250 | |||
Note 11. Operating Segments
Soligenix, Inc. operates intwo reportable segments:
| ● | Specialized BioTherapeutics – Focuses on developing and commercializing products for orphan diseases and areas of unmet medical need in oncology and inflammation. |
| ● | Public Health Solutions – Concentrates on vaccines and therapeutics for biodefense and infectious diseases. |
The Company’s Chief Operating Decision Maker, identified as the Chief Executive Officer, evaluates segment performance and allocates resources primarily based on the ability of the Specialized BioTherapeutics segment to advance its product development pipeline through a combination of government grants and contracts as well as shareholder investment. This segment represents the Company’s primary focus and strategic priority.
In contrast, the Public Health Solutions segment is fully funded by government sources, with no investor capital used. The ability of this segment to secure government grants and contracts is a key determinant of its sustainability and its contribution to the Company’s overall financial position. Funding from Public Health Solutions enables the Company to cover employee salaries, allocate funds to certain overhead costs such as rent and utilities, and supplement working capital.
Secondary to this, the CODM considers Adjusted Loss from Operations, which excludes non-cash share-based compensation and depreciation/amortization from operating expenses (R&D and G&A), and Net Loss Before Income Taxes, which incorporates these costs along with other income and expenses.
Segment Revenues and Profit (Loss)
The following table presents the revenues, significant expenses, and operating results of the Company's reportable segments for the year ended December 31, 2024:
| | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · SpecializedBioTherapeutics · · Public HealthSolutions · · TotalSegments · · Adjustments · · Corporate · · Adjustments · · Consolidated | |||||||||||||||||||||
| Revenues | | $119,371 | | $ | - | | $119,371 | | $ | - | | $ | - | | $ | - | | $119,371 | |||
| Cost of revenues | | | (119,371) | | | - | | | (119,371) | | | - | | | - | | | - | | | (119,371) |
| Gross profit | | | - | | | - | | | - | | | - | | | - | | | - | | | - |
| Significant expenses: | | | | | | | | | | | | | | | | | | | | | |
| Research and development | | | 4,233,771 | | | 249,852 | | | 4,483,623 | | | 135,987 | | | 603,979 | | | - | | | 5,223,589 |
| General and administrative | | | - | | | - | | | - | | | | | | 4,016,266 | | | 199,642 | | | 4,215,908 |
| Adjusted loss from operations | | | (4,233,771) | | | (249,852) | | | (4,483,623) | | | (135,987) | | | (4,620,245) | | | (199,642) | | | (9,439,497) |
| Share-based compensation | | | 127,774 | | | 4,143 | | | 131,917 | | | (131,917) | | | 197,898 | | | (197,898) | | | - |
| Depreciation and amortization | | | 3,489 | | | 581 | | | 4,070 | | | (4,070) | | | 1,744 | | | (1,744) | | | - |
| Loss from operations | | | (4,365,034) | | | (254,576) | | | (4,619,610) | | | - | | | (4,819,887) | | | - | | | (9,439,497) |
| Other (expenses) income, net | | | (22,342) | | | - | | | (22,342) | | | - | | | 786,149 | | | - | | | 763,807 |
| Net loss before income taxes | | $(4,387,376) | | $(254,576) | | $(4,641,952) | | $ | - | | $(4,033,738) | | $ | - | | $(8,675,690) | |||||
The following table presents the revenues, significant expenses, and operating results of the Company's reportable segments for the year ended December 31, 2023:
| | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · SpecializedBioTherapeutics · · Public HealthSolutions · · TotalSegments · · Adjustments · · Corporate · · Adjustments · · Consolidated | |||||||||||||||||||||
| Revenues | | $395,124 | | $444,235 | | $839,359 | | $ | - | | $ | - | | $ | - | | $839,359 | ||||
| Cost of revenues | | | (395,124) | | | (346,924) | | | (742,048) | | | - | | | - | | | - | | | (742,048) |
| Gross profit | | | - | | | 97,311 | | | 97,311 | | | - | | | - | | | - | | | 97,311 |
| Significant expenses: | | | | | | | | | | | | | | | | | | | | | |
| Research and development | | | 2,524,356 | | | 128,405 | | | 2,652,761 | | | 155,052 | | | 504,886 | | | - | | | 3,312,699 |
| General and administrative | | | 138,332 | | | - | | | 138,332 | | | | | | 4,122,536 | | | 221,684 | | | 4,482,552 |
| Adjusted loss from operations | | | (2,662,688) | | | (31,094) | | | (2,693,782) | | | (155,052) | | | (4,627,422) | | | (221,684) | | | (7,697,940) |
| Share-based compensation | | | 145,683 | | | 4,782 | | | 150,465 | | | (150,465) | | | 219,717 | | | (219,717) | | | - |
| Depreciation and amortization | | | 3,932 | | | 655 | | | 4,587 | | | (4,587) | | | 1,967 | | | (1,967) | | | - |
| Loss from operations | | | (2,812,303) | | | (36,531) | | | (2,848,834) | | | - | | | (4,849,106) | | | - | | | (7,697,940) |
| Other (expenses) income, net | | | 25,267 | | | - | | | 25,267 | | | - | | | (235,860) | | | - | | | (210,593) |
| Net loss before income taxes | | $(2,787,036) | | $(36,531) | | $(2,823,567) | | $ | - | | $(5,084,966) | | $ | - | | $(7,908,533) | |||||
Reconciliation to Consolidated Loss Before Income Taxes
The following table provides a reconciliation of total segment loss to consolidated loss before income taxes:
| | | | | | | |
|---|---|---|---|---|---|---|
| Year ended December 31, · · 2024 · · 2023 | ||||||
| Loss from operations - reportable segments | | $(4,619,610) | | $(2,848,834) | ||
| Loss from operations - corporate | | | (4,819,887) | | | (4,849,106) |
| Interest income (expense), net | | | 213,975 | | | (49,129) |
| Other income (expense), net | | | 549,832 | | | (161,464) |
| Net loss before income taxes | | $(8,675,690) | | $(7,908,533) | ||
Segment Assets
The Company’s total assets by segment as of December 31, 2024, are presented below:
| · · · · · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| | | Specialized BioTherapeutics | | Public HealthSolutions | | TotalSegments | | Corporate | | Consolidated |
| Total assets | | $48,604 | | $2,038 | | $50,642 | | $8,915,841 | | $8,966,483 |
The Company’s total assets by segment as of December 31, 2023, are presented below:
| · · · · · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| | | Specialized BioTherapeutics | | Public Health Solutions | | TotalSegments | | Corporate | | Consolidated |
| Total assets | | $272,099 | | $3,976 | | $276,075 | | $9,521,251 | | $9,797,326 |
Significant Expense Categories Considered by CODM
The CODM regularly reviews the following significant expense categories when assessing segment performance and resource allocation:
| ● | Government Grant and Contract Funding – Both the Specialized BioTherapeutics and Public Health Solutions segments apply for and receive government grants and contracts. However, Public Health Solutions is exclusively funded by government sources, whereas Specialized BioTherapeutics utilizes a mix of government funding and shareholder investment. |
| ● | Research & Development – Includes expenses for clinical trials, regulatory compliance, and R&D-related payroll. |
| ● | General & Administrative – Comprises salaries, professional fees, and facility costs. |
| ● | Share-Based Compensation – Represents non-cash stock option and restricted stock unit expenses. |
| ● | Depreciation & Amortization – Costs related to the use of tangible and intangible assets. |
| ● | Other Income/Expenses – Includes interest income and one-time gains/losses. |
Chief Operating Decision Maker and Use of Multiple Measures of Segment Profit/Loss
The Company's CODM primarily evaluates segment performance based on two key financial measures:
| ● | Advancement of Specialized BioTherapeutics Through a Combination of Funding Sources – Assesses the effectiveness of shareholder investment and government grants in progressing product development. |
| ● | Ability to Secure Government Grants and Contracts (Public Health Solutions Only) – Determines segment sustainability and funding for shared resources. |
| ● | Adjusted Loss from Operations – Excludes non-cash share-based compensation and depreciation/amortization expenses for a clearer picture of operating performance. |
| ● | Net Loss Before Income Taxes – Incorporates all expenses, including non-cash charges and other income/expenses, for a comprehensive profitability analysis. |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.