SOLIGENIX, INC.
For the period ended Jun 30, 2025. Filed Aug 14, 2025.
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Jun 30, 2025 · Filed Aug 14, 2025
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Notes to Condensed Consolidated Financial Statements
(Unaudited)
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 into psoriasis (SGX302), and the Company’s first-in-class Innate Defense Regulator technology, dusquetide, for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer (SGX942) and aphthous ulcers in Behçet’s Disease (“BD”) (SGX945).
The Company’s Public Health Solutions business segment includes development programs for (i) RiVax®, a ricin toxin vaccine candidate, (ii) SGX943, a therapeutic candidate for antibiotic resistant and emerging infectious disease, and (iii) various vaccine programs, including a program targeting filoviruses (such as Marburg and Ebola) and CiVax™, a 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.
Results for the three and six months ended June 30, 2025 are not necessarily indicative of results that may be expected for the full year.
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 condensed consolidated financial statements are issued. As of June 30, 2025, the Company had an accumulated deficit of $239,623,996 and working capital of $1,691,345. For the six months ended June 30, 2025, the Company incurred a net loss of $5,653,244 and used $4,588,835 of cash in operating activities. The Company expects to continue generating losses in 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 first quarter of 2026. However, as of the date of filing this Quarterly Report on Form 10-Q, 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, as of June 30, 2025, 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. |
| ● | 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”). The Company sold the remaining capacity of its At-The-Market (“ATM”) facility as of July 1, 2025 under the prospectus supplement dated August 16, 2024. From July 1, 2025 through August 7, 2025, the Company issued 780,620 shares of common stock pursuant to its ATM facility at a weighted average price of $1.84 per share for total gross proceeds of approximately $1,439,300. |
There is no assurance that the Company will be successful in securing sufficient financing on acceptable terms, if at all, to continue operations, enter into strategic transactions that provide the necessary capital, or implement other strategies to mitigate the substantial doubt about its ability to continue as a going concern. If these alternatives are unavailable or not secured on satisfactory terms, the Company will not have sufficient cash resources or liquidity to fund its operations for at least 12 months after the financial statements are issued. Failure to obtain adequate capital when needed may force the Company to delay, reduce, or eliminate business development efforts, negatively impacting its ability to achieve its objectives, remain competitive, and maintain its financial condition and operating results. On July 1, 2025, the Company sold 772,900 shares of common stock pursuant to its ATM facility for total gross proceeds of approximately $1,429,100 and in doing so, as of July 1, 2025 the Company has no further capacity on its ATM facility.
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.
The Company’s plans with respect to its liquidity management include, but are not limited to, the following:
| ● | 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 remains 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 is currently evaluating additional equity/royalty/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. |
Business Strategy Overview
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 BD 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. |
Note 2. Summary of Significant Accounting Policies
Principles of Consolidation
The condensed consolidated financial statements include Soligenix, Inc., and its wholly and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated as a result of consolidation.
Operating Segments
Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision maker (“CODM”), which is the Company’s Chief Executive Officer, 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.
Impairment of Long-Lived Assets
Office furniture and equipment and right of use assets with finite lives are evaluated and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.
The Company didnot record any impairment of long-lived assets for the three and six months ended June 30, 2025 and 2024.
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 about the fair value of financial instruments are based on pertinent information available to the Company on June 30, 2025. Accordingly, the estimates presented in these financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments.
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 condensed consolidated balance sheet for cash and cash equivalents, contracts and grants 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.
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.
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 2025 Equity Incentive Plan (the “2025 Plan”) and 2015 Equity Incentive Plan (the “2015 Plan”). The 2025 Plan and 2015 Plan provide 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 2025 Plan and the 2015 Plan are registered on Form S-8. 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 six months ended June 30, 2025 and 2024 was estimated using the Black-Scholes option-pricing model and the following assumptions:
| ● | a dividend yield of 0%; |
| ● | an expected life of 6 years; |
| ● | volatility of 116% for 2025 and 108% for 2024; and |
| ● | risk free interest rates of 4.06% for 2025 and 4.76% for 2024. |
The fair value of each option grant made during the six months ended June 30, 2025 and 2024 was estimated on the date of each grant and recognized as share-based compensation expense ratably over the option vesting periods, which approximates the requisite service period.
Foreign Currency Transactions and Translation
The Company’s UK Subsidiary’s functional currency, the British Pound, is translated into the U.S. Dollar for reporting purposes during consolidation, with related translation adjustments reported as a cumulative translation adjustment, which is a component of accumulated other comprehensive income. The Company recognizes foreign currency related transaction gains or losses as a component of net loss when incurred. Such transaction related foreign currency gains or losses were de minimus for the three and six months ended June 30, 2025 and 2024, respectively.
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.
The following table summarizes outstanding instruments which were not included in the computation of diluted EPS as to do so would have been antidilutive:
| | | | | | |
|---|---|---|---|---|---|
| · · As of June 30, · | |||||
| · 2025 · 2024 | |||||
| Common stock purchase warrants | | 1,467,581 | | 1,150,834 | |
| Stock options | 300,467 | 56,699 | |||
| Convertible debt | — | 100,947 | |||
| Total | 1,768,048 | 1,308,480 | |||
Use of Estimates and Assumptions
The preparation of financial statements 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.
Correction of an Estimate
During the three months ended June 30, 2025, the Company identified an error in amounts previously reported in its Quarterly Report on Form 10-Q for the three-month period ended March 31, 2025, regarding an estimate for the accrual of certain research and development costs and the related expense. During the three months ended June 30, 2025, upon further discussion with the Company's third-party manufacturer in connection with its accounting policies and procedures in place, the Company determined that during the three months ended March 31, 2025, the Company’s estimate and related accrual with respect to certain costs of product development had been recognized in advance of the point in time at which the Company received the benefit from and incurred the related obligation. Such costs totaled approximately $285,000 as of March 31, 2025.
The following table summarizes the impact of the correction on the Company's condensed consolidated balance sheet as of March 31, 2025 and the condensed consolidated statement of operations for the three months ended March 31, 2025. The accompanying results of operations for the three and six-month periods ended June 30, 2025, appropriately reflect the accrual, timing and recognition of costs related to product development.
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · · Impact of correction of error | |||||||||
| | | | As previously reported | | | Adjustments | | | As restated |
| As of March 31, 2025: (unaudited) | | | | | | | | | |
| Accrued expenses | | $3,404,332 | | $(285,495) | | $3,118,837 | |||
| Total liabilities | | $4,133,682 | | $(285,495) | | $3,848,187 | |||
| Total liabilities and shareholder's equity | | $7,746,120 | | $ | - | | $7,746,120 | ||
| For the three months ended March 31, 2025: (unaudited) | | | | | | | | | |
| Research and development expenses | | $2,227,175 | | $(285,495) | | $1,941,680 | |||
| Total operating expenses | | $3,312,003 | | $(285,495) | | $3,026,508 | |||
| Loss from operations | | $(3,312,003) | | $285,495 | | $(3,026,508) | |||
| Net loss applicable to common stockholders | | $(3,236,763) | | $285,495 | | $(2,951,268) | |||
| Basic and diluted net loss per share | | $(1.06) | | $0.09 | | $(0.97) | |||
Note 3. Accrued Expenses
The following is a summary of the Company’s accrued expenses:
| · · · · · · · | |||||
|---|---|---|---|---|---|
| | | June 30, | | December 31, | |
| · 2025 · 2024 | |||||
| Clinical trial expenses | | $1,730,818 | | $1,135,542 | |
| Other | | 1,052,331 | | 1,223,797 | |
| Total | | $2,783,149 | | $2,359,339 | |
Note 4. Debt
In December 2020, the Company entered into a $20 million convertible debt financing agreement with Pontifax (the “Loan Agreement”). Under the terms of the Loan Agreement, the Company had access to up to $20 million in convertible debt financing which accrued interest at a 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. Payments of interest only were due for the firsttwo years and thereafter, the outstanding principal was to be repaid in quarterly installments, as defined.
Upon the closing of this transaction, the Company borrowed an initial amount of $10 million and made no further borrowings through the term of the agreement.
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 adjusted certain payment provisions, and provided for an adjustment to the conversion price provisions 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 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. As a result, the Company recognized $260,933 of other income from the change in the fair value of the convertible debt in the accompanying condensed consolidated statements of operations during the six months ended June 30, 2024. The fair value of the convertible debt was estimated using the Monte Carlo valuation method.
During the six months ended June 30, 2024, Pontifax delivered notices of conversion to the Company electing to convert a portion of the then outstanding principal balance into shares of the Company’s common stock. Accordingly, the Company issued 36,790 shares of the Company’s common stock resulting in a reduction of the outstanding principal balance totaling $254,256.
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 continued in effect with minimal, non-material modifications to those terms. Pursuant to applicable accounting standards, after the 2024 amendment, the Company elected not to account for the amended convertible debt under the fair value option. Accordingly, there was no further recognition for the impact of changes in fair value in the Company’s financial statements.
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.
Note 5. Shareholders’ Equity
Common Stock
Common stock transactions for the six months ended June 30, 2025 are as follows:
| ● | The Company issued a vendor 12,346 shares of common stock with a fair value of $2.43 per share. |
| ● | The Company sold 978,105 shares of common stock pursuant to the AGP Sales Agreement at a weighted average price of $3.35 per share. |
The issuance of the Company’s common stock to the vendor described above was exempt from registration under Section 4(a)(2) of the Securities Act of 1933, as amended. The recipient is knowledgeable, sophisticated and experienced in making investment decisions of this kind and received adequate information about the Company or had adequate access to information about the Company. The vendor represented to the Company that the vendor is not a “consultant” for purposes of Nasdaq Listing Rule 5635(c). 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.
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 the ATM program. In connection with the sale of shares via the 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 ATM. The Company has no obligation to sell any shares under the ATM, and may suspend solicitation and offers at any time. The 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 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 ATM, (c) the termination of the AGP Sales Agreement as permitted therein, or (d) the mutual agreement of the parties.
The AGP Sales Agreement provided for the offer and sale of shares of common stock having an aggregate offering price of up to $5.8 million. As of July 1, 2025, the Company sold the remaining capacity of the ATM facility subject to the AGP Sales Agreement.
Note 6. Commitments and Contingencies
Contractual Obligations
The Company has commitments of approximately $230,000 as of June 30, 2025 over the next five years for several licensing agreements with partners and universities. Additionally, the Company is party to other agreements which include cash milestone payments, royalties and other fees payable, which are all contingent upon clinical or commercialization success. There can be no assurance that clinical or commercialization success will occur.
In May 2025, the Company entered into an amendment of its lease for office space, resulting in the recognition of right-of-use assets and lease liabilities during the six months ended June 30, 2025 totaling $360,604. Pursuant to the amendment, the lease has been extended through October 2028. The current rent is $11,625 per month through October 2026. It increases to $11,883 in November 2026 and to $12,142 in November 2027 where it remains until expiration.
In September 2014, the Company entered into an asset purchase agreement with Hy Biopharma Inc. (“Hy Biopharma”) pursuant to which the Company acquired certain intangible assets, properties and rights of Hy Biopharma related to the development of Hy BioPharma’s synthetic hypericin product. As consideration for the assets acquired, the Company paid $275,000 in cash and issued 771 shares of common stock with a fair value based on the Company’s stock price on the date of grant of $3.75 million. These amounts were charged to research and development expense during the third quarter of 2014 as the assets will be used in the Company’s research and development activities and do not have alternative future use.
In March 2020, the Company filed a prospectus supplement covering the offer and sale of up to 8,151 shares of its common stock which were issued to Hy Biopharma as payment for achieving a milestone: the Company determining the Phase 3 clinical trial of HyBryte™ to be successful in the treatment of CTCL. The number of shares of common stock issued to Hy Biopharma was calculated using an effective price of $614.40 per share, based upon a formula set forth in the purchase agreement.
Provided the sole remaining future success-oriented milestone of FDA approval is attained, the Company will be required to make an additional payment of $5 million, if and when achieved. Such payment will be payable in restricted securities of the Company provided such number of shares does not exceed 19.9% ownership of the Company’s outstanding stock. As of June 30, 2025, no other milestone or royalty payments have been paid or accrued.
In May 2025, the Company entered into an amendment to Dr. Schaber’s employment agreement to increase the number of shares of common stock, from 2,084 to 200,000, issuable to Dr. Schaber immediately prior to the completion of a transaction, or series or a combination of related transactions, negotiated by its Board of Directors whereby, directly or indirectly, a majority of its capital stock or a majority of its assets are transferred from the Company and/or its stockholders to a third party.
As a result of the above agreements, the Company has the following contractual obligations:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · Research and · · | |||||||||
| Year · Development · Leases · Total | |||||||||
| 2025 | | $46,000 | | $69,750 | | $115,750 | |||
| 2026 | | 46,000 | | 140,017 | | 186,017 | |||
| 2027 | | 46,000 | | 143,117 | | 189,117 | |||
| 2028 | | | 46,000 | | | 121,416 | | | 167,416 |
| 2029 | | | 46,000 | | | — | | | 46,000 |
| Total | | $230,000 | | $474,300 | | $704,300 | |||
Note 7. Operating Segments
The Company 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 CODM 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 three months ended June 30, 2025:
| | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · SpecializedBioTherapeutics · · Public HealthSolutions · · TotalSegments · · Adjustments · · Corporate · · Adjustments · · Consolidated | |||||||||||||||||||||
| Revenues | | $ | - | | $ | - | | $ | - | | $ | - | | $ | - | | $ | - | | $ | - |
| Cost of revenues | | | - | | | - | | | - | | | - | | | - | | | - | | | - |
| Gross profit | | | - | | | - | | | - | | | - | | | - | | | - | | | - |
| Significant expenses: | | | | | | | | | | | | | | | | | | | | | |
| Research and development | | | 1,523,099 | | | 3,332 | | | 1,526,431 | | | 27,819 | | | 122,764 | | | - | | | 1,677,014 |
| General and administrative | | | - | | | - | | | - | | | - | | | 1,014,468 | | | 72,397 | | | 1,086,865 |
| Adjusted loss from operations | | | (1,523,099) | | | (3,332) | | | (1,526,431) | | | (27,819) | | | (1,137,232) | | | (72,397) | | | (2,763,879) |
| Share-based compensation | | | 26,487 | | | 839 | | | 27,326 | | | (27,326) | | | 72,187 | | | (72,187) | | | - |
| Depreciation and amortization | | | 423 | | | 70 | | | 493 | | | (493) | | | 210 | | | (210) | | | - |
| Loss from operations | | | (1,550,009) | | | (4,241) | | | (1,554,250) | | | - | | | (1,209,629) | | | - | | | (2,763,879) |
| Other (expenses) income, net | | | - | | | - | | | - | | | - | | | 61,903 | | | - | | | 61,903 |
| Net loss before income taxes | | $(1,550,009) | | $(4,241) | | $(1,554,250) | | $ | - | | $(1,147,726) | | $ | - | | $(2,701,976) | |||||
The following table presents the revenues, significant expenses, and operating results of the Company's reportable segments for the three months ended June 30, 2024:
| | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · SpecializedBioTherapeutics · · Public HealthSolutions · · TotalSegments · · Adjustments · · Corporate · · Adjustments · · Consolidated | |||||||||||||||||||||
| Revenues | | $2,342 | | $ | - | | $2,342 | | $ | - | | $ | - | | $ | - | | $2,342 | |||
| Cost of revenues | | | (2,342) | | | - | | | (2,342) | | | - | | | - | | | - | | | (2,342) |
| Gross profit | | | - | | | - | | | - | | | - | | | - | | | - | | | - |
| Significant expenses: | | | | | | | | | | | | | | | | | | | | | |
| Research and development | | | 261,313 | | | 61,276 | | | 322,589 | | | 22,669 | | | 155,900 | | | - | | | 501,158 |
| General and administrative | | | - | | | - | | | - | | | - | | | 1,206,923 | | | 36,594 | | | 1,243,517 |
| Adjusted loss from operations | | | (261,313) | | | (61,276) | | | (322,589) | | | (22,669) | | | (1,362,823) | | | (36,594) | | | (1,744,675) |
| Share-based compensation | | | 20,940 | | | 617 | | | 21,557 | | | (21,557) | | | 36,118 | | | (36,118) | | | - |
| Depreciation and amortization | | | 953 | | | 159 | | | 1,112 | | | (1,112) | | | 476 | | | (476) | | | - |
| Loss from operations | | | (283,206) | | | (62,052) | | | (345,258) | | | - | | | (1,399,417) | | | - | | | (1,744,675) |
| Other (expenses) income, net | | | (31,346) | | | - | | | (31,346) | | | - | | | 131,519 | | | - | | | 100,173 |
| Net loss before income taxes | | $(314,552) | | $(62,052) | | $(376,604) | | $ | - | | $(1,267,898) | | $ | - | | $(1,644,502) | |||||
The following table presents the revenues, significant expenses, and operating results of the Company's reportable segments for the six months ended June 30, 2025:
| | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · SpecializedBioTherapeutics · · Public HealthSolutions · · TotalSegments · · Adjustments · · Corporate · · Adjustments · · Consolidated | |||||||||||||||||||||
| Revenues | | $ | - | | $ | - | | $ | - | | $ | - | | $ | - | | $ | - | | $ | - |
| Cost of revenues | | | - | | | - | | | - | | | - | | | - | | | - | | | - |
| Gross profit | | | - | | | - | | | - | | | - | | | - | | | - | | | - |
| Significant expenses: | | | | | | | | | | | | | | | | | | | | | |
| Research and development | | | 3,273,701 | | | 61,667 | | | 3,335,368 | | | 55,572 | | | 227,754 | | | - | | | 3,618,694 |
| General and administrative | | | - | | | - | | | - | | | - | | | 2,062,842 | | | 108,851 | | | 2,171,693 |
| Adjusted loss from operations | | | (3,273,701) | | | (61,667) | | | (3,335,368) | | | (55,572) | | | (2,290,596) | | | (108,851) | | | (5,790,387) |
| Share-based compensation | | | 52,975 | | | 1,679 | | | 54,654 | | | (54,654) | | | 108,458 | | | (108,458) | | | - |
| Depreciation and amortization | | | 787 | | | 131 | | | 918 | | | (918) | | | 393 | | | (393) | | | - |
| Loss from operations | | | (3,327,463) | | | (63,477) | | | (3,390,940) | | | - | | | (2,399,447) | | | - | | | (5,790,387) |
| Other (expenses) income, net | | | - | | | - | | | - | | | - | | | 137,143 | | | - | | | 137,143 |
| Net loss before income taxes | | $(3,327,463) | | $(63,477) | | $(3,390,940) | | $ | - | | $(2,262,304) | | $ | - | | $(5,653,244) | |||||
The following table presents the revenues, significant expenses, and operating results of the Company's reportable segments for the six months ended June 30, 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 | | | 1,100,292 | | | 106,526 | | | 1,206,818 | | | 45,041 | | | 344,339 | | | - | | | 1,596,198 |
| General and administrative | | | - | | | - | | | - | | | - | | | 2,189,797 | | | 75,771 | | | 2,265,568 |
| Adjusted loss from operations | | | (1,100,292) | | | (106,526) | | | (1,206,818) | | | (45,041) | | | (2,534,136) | | | (75,771) | | | (3,861,766) |
| Share-based compensation | | | 41,612 | | | 1,205 | | | 42,817 | | | (42,817) | | | 74,819 | | | (74,819) | | | - |
| Depreciation and amortization | | | 1,906 | | | 318 | | | 2,224 | | | (2,224) | | | 952 | | | (952) | | | - |
| Loss from operations | | | (1,143,810) | | | (108,049) | | | (1,251,859) | | | - | | | (2,609,907) | | | - | | | (3,861,766) |
| Other (expenses) income, net | | | (23,806) | | | - | | | (23,806) | | | - | | | 325,743 | | | - | | | 301,937 |
| Net loss before income taxes | | $(1,167,616) | | $(108,049) | | $(1,275,665) | | $ | - | | $(2,284,164) | | $ | - | | $(3,559,829) | |||||
The following table provides a reconciliation of total segment loss to consolidated loss before income taxes for the three months ended June 30:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · 2025 · · 2024 | ||||||
| Loss from operations - reportable segments | | $(1,554,250) | | $(345,258) | ||
| Loss from operations - corporate | | | (1,209,629) | | | (1,399,417) |
| Interest income (expense), net | | | 69,823 | | | 35,925 |
| Other income (expense), net | | | (7,920) | | | 64,248 |
| Net loss before income taxes | | $(2,701,976) | | $(1,644,502) | ||
The following table provides a reconciliation of total segment loss to consolidated loss before income taxes for the six months ended June 30:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · 2025 · · 2024 | ||||||
| Loss from operations - reportable segments | | $(3,390,940) | | $(1,251,859) | ||
| Loss from operations - corporate | | | (2,399,447) | | | (2,609,907) |
| Interest income (expense), net | | | 145,851 | | | 64,767 |
| Other income (expense), net | | | (8,708) | | | 237,170 |
| Net loss before income taxes | | $(5,653,244) | | $(3,559,829) | ||
Segment Assets
The Company’s total assets by segment as of June 30, 2025, are presented below:
| · · · · · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| | | Specialized BioTherapeutics | | Public HealthSolutions | | TotalSegments | | Corporate | | Consolidated |
| Total assets | | $112,342 | | $2,705 | | $115,047 | | $5,645,600 | | $5,760,647 |
The Company’s total assets by segment as of June 30, 2024, are presented below:
| · · · · · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| | | Specialized BioTherapeutics | | Public Health Solutions | | TotalSegments | | Corporate | | Consolidated |
| Total assets | | $183,858 | | $2,917 | | $186,775 | | $9,678,304 | | $9,865,079 |
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. |
CODM 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.