Part I [Part I - Financial Information](index=4&type=section&id=Part%20I%20FINANCIAL%20INFORMATION) This section presents the company's unaudited financial statements, management's discussion and analysis, and disclosures on market risks and internal controls [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=4&type=section&id=Item%201%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) The unaudited condensed consolidated financial statements for Q1 2025 report an increased net loss and reduced cash, prompting a 'going concern' warning despite convertible debt repayment [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of March 31, 2025, shows decreased total assets and liabilities, primarily due to reduced cash and convertible debt repayment Condensed Consolidated Balance Sheet Highlights (unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $7,297,171 | $7,819,514 | | Total current assets | $7,640,742 | $8,828,630 | | Total assets | $7,746,120 | $8,966,483 | | Total liabilities | $4,133,682 | $4,848,412 | | Total shareholders' equity | $3,612,438 | $4,118,071 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statement of operations for Q1 2025 reports zero revenue and an increased net loss, primarily driven by higher research and development expenses Statement of Operations Summary (unaudited) | Metric | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Total revenues | $0 | $117,029 | | Research and development | $2,227,175 | $1,095,040 | | General and administrative | $1,084,828 | $1,022,051 | | Loss from operations | $(3,312,003) | $(2,117,091) | | Net loss | $(3,236,763) | $(1,915,327) | | Basic and diluted net loss per share | $(1.06) | $(2.91) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow for Q1 2025 shows net cash used in operations, partially offset by financing activities, resulting in a net decrease in cash Cash Flow Summary (unaudited) | Activity | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,847,012) | $(1,342,482) | | Net cash from financing activities | $1,324,669 | $(8,992) | | Net decrease in cash and cash equivalents | $(522,343) | $(1,354,610) | | Cash and cash equivalents at end of period | $7,297,171 | $7,091,548 | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes to the financial statements disclose a going concern warning due to recurring losses and limited cash, alongside details on segment operations and convertible debt repayment - The company's financial statements have been prepared on a going concern basis, but management has identified conditions that raise substantial doubt about its ability to continue as a going concern, lacking sufficient cash to fund operations for at least 12 months from the filing date[24](index=24&type=chunk)[27](index=27&type=chunk) - Management's plans to alleviate going concern issues include raising additional capital through equity offerings (including an existing At-the-Market agreement), securing government grants, and pursuing strategic partnerships or M&A[28](index=28&type=chunk)[30](index=30&type=chunk) - In February 2025, the company fully repaid all outstanding obligations under its convertible debt agreement with Pontifax and terminated the agreement, releasing all related liens[57](index=57&type=chunk) - The company has a contingent milestone payment of **$5 million** payable to Hy Biopharma if and when HyBryte™ receives FDA approval[66](index=66&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion covers increased Q1 2025 net loss due to higher R&D, reiterates going concern risk, and outlines strategies for clinical trials and funding [Business Overview and Strategy](index=24&type=section&id=Our%20Business%20Overview%20and%20Strategy) Soligenix, a biopharmaceutical company, focuses on advancing rare disease and public health programs, including the HyBryte™ FLASH2 trial and seeking strategic partnerships - The company's primary focus is on developing and commercializing products for rare diseases with unmet medical needs through its Specialized BioTherapeutics and Public Health Solutions segments[81](index=81&type=chunk) - Key strategic priorities include executing the FLASH2 trial for HyBryte™, expanding development of synthetic hypericin into psoriasis, and identifying a partner to continue the SGX942 oral mucositis program[88](index=88&type=chunk) [Product Candidates in Development](index=27&type=section&id=Our%20Product%20Candidates%20in%20Development) The development pipeline features HyBryte™ in a confirmatory Phase 3 trial for CTCL, alongside other candidates and public health programs like RiVax® with PRV potential - HyBryte™ (CTCL): Following an FDA Refusal to File letter, a second confirmatory Phase 3 trial (FLASH2) began enrollment in December 2024, with top-line results expected in the second half of 2026[82](index=82&type=chunk)[112](index=112&type=chunk)[115](index=115&type=chunk) - SGX942 (Oral Mucositis): After a Phase 3 trial did not meet its primary endpoint, the company is designing a second study and seeking a partner to continue development[88](index=88&type=chunk)[143](index=143&type=chunk) - Public Health Solutions programs, including RiVax® (ricin vaccine) and filovirus vaccines, are developed with the ThermoVax® heat stabilization technology and are contingent on government or non-governmental funding[84](index=84&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk) - The RiVax® vaccine program, if approved, has the potential to qualify for a biodefense Priority Review Voucher (PRV), which is transferable and has been sold for approximately **$100 million** in recent years[182](index=182&type=chunk) [Material Changes in Results of Operations](index=51&type=section&id=Material%20Changes%20in%20Results%20of%20Operations) Q1 2025 saw a **$1.3 million** increase in net loss, driven by higher R&D expenses and a lack of revenue compared to the prior year Key Expense Changes (Q1 2025 vs Q1 2024) | Expense/Income Item | Change (Increase/Decrease) | Reason | | :--- | :--- | :--- | | Revenue | -$117,029 | No government subaward revenue in Q1 2025 | | R&D Expenses | +$1,132,135 | Increased costs for Phase 2 BD and Phase 3 CTCL trials | | G&A Expenses | +$62,777 | Increases in professional fees and taxes | | Other Income | -$126,324 | Primarily due to a $165,382 gain on fair value of debt in 2024 with no corresponding gain in 2025 | [Financial Condition and Liquidity](index=51&type=section&id=Financial%20Condition%20and%20Liquidity) The company's cash decreased to **$7.3 million**, raising going concern doubts, with plans to secure funding through equity sales, grants, and partnerships - The company does not have sufficient cash to fund operations for at least 12 months, raising substantial doubt about its ability to continue as a going concern[195](index=195&type=chunk) - As of May 2, 2025, approximately **$1.8 million** remained available for sale under the AGP At Market Issuance Sales Agreement[199](index=199&type=chunk) - Management's plans to manage liquidity include selling stock via the AGP ATM, securing additional government grants, pursuing partnerships, and potentially other equity/debt financings[198](index=198&type=chunk)[199](index=199&type=chunk)[200](index=200&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=56&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risks primarily involve interest rate sensitivity and foreign exchange fluctuations, which are deemed immaterial - The company's main market risks are interest rate changes affecting income from short-term investments and foreign exchange fluctuations, which are not considered material[217](index=217&type=chunk) [Item 4. Controls and Procedures](index=56&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective[219](index=219&type=chunk) - There were no changes in internal controls over financial reporting during the last fiscal quarter that have materially affected, or are reasonably likely to materially affect, these controls[220](index=220&type=chunk) Part II [Part II - Other Information](index=57&type=section&id=Part%20II%20OTHER%20INFORMATION) This section provides information on legal proceedings, risk factors, equity sales, and other corporate disclosures [Item 1. Legal Proceedings](index=57&type=section&id=Item%201%20Legal%20Proceedings) The company is subject to ordinary course legal proceedings, for which it accrues potential losses when probable and estimable - The company is subject to ordinary course legal proceedings and claims, for which it provisions if a loss is probable and estimable[222](index=222&type=chunk) [Item 1A. Risk Factors](index=57&type=section&id=Item%201A%20Risk%20Factors) This section outlines significant risks including shareholder dilution, the uncertain drug approval process, regulatory compliance, and potential impacts from healthcare reform [Risks Related to Our Securities](index=57&type=section&id=Risks%20Related%20to%20Our%20Securities) Shareholders face significant potential dilution from outstanding warrants, options, and future equity issuances under the incentive plan Potential Dilutive Securities as of May 2, 2025 | Security Type | Number of Underlying Shares | | :--- | :--- | | Common stock warrants | 1,467,581 | | Stock options | 92,691 | | Available under 2015 Equity Plan | 5,770,122 | [Risks Related to Marketing Approval and Other Legal Compliance Matters](index=58&type=section&id=Risks%20Related%20to%20Marketing%20Approval%20and%20Other%20Legal%20Compliance%20Matters) Extensive regulatory risks include uncertain marketing approval processes, foreign jurisdiction challenges, post-approval compliance, and potential impacts from healthcare pricing reforms - The drug approval process is lengthy and uncertain, and regulatory authorities like the FDA may require additional clinical trials, as seen with the request for a second Phase 3 study for HyBryte™[228](index=228&type=chunk)[233](index=233&type=chunk) - Obtaining marketing approval in foreign jurisdictions is a separate process with unique risks, including Brexit-related changes for the UK market and potential pricing controls in the EU[240](index=240&type=chunk)[242](index=242&type=chunk) - The company is subject to numerous healthcare laws, including the Anti-Kickback Statute and False Claims Act, and data privacy laws like HIPAA, with non-compliance leading to severe penalties[298](index=298&type=chunk)[299](index=299&type=chunk)[300](index=300&type=chunk)[301](index=301&type=chunk) - Future revenue is at risk from legislative and regulatory actions aimed at controlling pharmaceutical prices and reimbursement, which could limit profitability even if products are approved[283](index=283&type=chunk)[285](index=285&type=chunk)[289](index=289&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=88&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On March 14, 2025, the company issued 12,346 common shares to a vendor, exempt from registration under Section 4(a)(2) - On March 14, 2025, the company issued **12,346 shares** of common stock to a vendor at a fair value of **$2.43 per share**, exempt from registration[326](index=326&type=chunk) [Item 5. Other Information](index=88&type=section&id=Item%205%20Other%20Information) On May 5, 2025, the company amended its CEO's employment agreement, significantly increasing shares issuable upon a change of control - The company amended its CEO's employment agreement to increase the number of shares he would receive upon a change of control transaction from **2,084 to 200,000**[327](index=327&type=chunk) [Item 6. Exhibits](index=89&type=section&id=Item%206%20Exhibits) This section lists exhibits filed with the Form 10-Q, including the CEO's employment agreement amendment and officer certifications - Exhibits filed with the report include the CEO's employment agreement amendment and required officer certifications[330](index=330&type=chunk)

Core Insights - Soligenix, Inc. is focused on developing and commercializing products for rare diseases with unmet medical needs, reporting recent accomplishments and financial results for Q1 2025 [1][9] Recent Accomplishments - The company anticipates significant milestones, including top-line results in 2026 from a Phase 3 study of HyBryte™ for early-stage cutaneous T-cell lymphoma and results from Phase 2 studies of SGX945 in Behçet's disease and SGX302 in psoriasis in the second half of 2025 [2] Financial Results - For the quarter ended March 31, 2025, Soligenix reported no revenue, a decrease from $0.1 million in the same quarter of 2024, primarily due to a reduction in revenue from a zero-margin grant for HyBryte™ [5] - The net loss for Q1 2025 was $3.2 million, or ($1.06) per share, compared to a net loss of $1.9 million, or ($2.91) per share, in Q1 2024, attributed to increased operating expenses and a decrease in other income [6] - Research and development expenses rose to $2.2 million in Q1 2025 from $1.1 million in Q1 2024, driven by costs related to ongoing clinical trials [7] - General and administrative expenses increased to $1.1 million in Q1 2025 from $1.0 million in Q1 2024, mainly due to higher professional expenses and taxes [8] Cash Position - As of March 31, 2025, the company's cash position was approximately $7.3 million, which is expected to provide sufficient operating runway through December 2025 [3][8]

Core Insights - The interim results from an FDA-funded study indicate that HyBryte™ shows a rapid response and strong safety profile in treating early-stage cutaneous T-cell lymphoma (CTCL), with 75% of patients achieving "Treatment Success" after 18 weeks of treatment [1][2][3] Company Overview - Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs, particularly in the area of CTCL [16][17] - The company is advancing HyBryte™ (SGX301), a novel photodynamic therapy utilizing synthetic hypericin, which has received orphan drug and fast track designations from the FDA [5][11] Study Details - The ongoing open-label, investigator-initiated study (IIS) has enrolled nine patients, with six out of eight evaluable patients achieving a predefined "Treatment Success" [2][3] - The study is designed to evaluate the efficacy of HyBryte™ over a treatment period of up to 54 weeks, with a focus on the cumulative mCAILS score [4][12] Treatment Efficacy - In the first Phase 3 FLASH study, HyBryte™ demonstrated a 16% response rate for at least a 50% reduction in lesions compared to 4% in the placebo group, indicating significant efficacy [6][7] - The second open-label treatment cycle showed a 40% response rate among patients treated for 12 weeks, further supporting the efficacy of extended treatment [7][8] Safety Profile - HyBryte™ has been reported to have a benign safety profile, with no significant systemic absorption and a mechanism of action that avoids DNA damage, making it a safer alternative to current therapies [9][10] - The treatment has been well tolerated across multiple cycles, with 66% of patients opting to continue treatment in the optional safety cycle [8][9] Future Developments - A confirmatory Phase 3 study, FLASH2, is expected to begin before the end of 2024, aiming to replicate the successful design of the first FLASH study and enroll approximately 80 subjects [11][12] - The study will assess the efficacy of HyBryte™ over an extended 18-week treatment period, with ongoing discussions with the FDA regarding study design [11][12] Financial Support - The FDA has awarded a grant of up to $2.6 million to support the investigator-initiated study evaluating HyBryte™ for expanded treatment options, including home use [13]

Core Insights - Soligenix Inc. is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs [1][5] - The company has selected IBN to lead its corporate communications efforts, leveraging IBN's extensive distribution network to enhance visibility [1][4] Company Overview - Soligenix operates through two main segments: Specialized BioTherapeutics, which targets oncology and inflammation therapies, and Public Health Solutions, which focuses on vaccines and therapeutics for biothreats and infectious diseases [2] - The company is advancing multiple late-stage clinical programs, including HyBryte™ (SGX301) for cutaneous T-cell lymphoma, and other candidates for psoriasis (SGX302), oral mucositis (SGX942), and Behçet's disease (SGX945) [2][5] Public Health Initiatives - The Public Health Solutions segment includes development programs for vaccines against ricin poisoning (RiVax®), Ebola (SuVax™), and Marburg (MarVax™), supported by approximately $60 million in non-dilutive government grants and contracts [3][6] - The vaccine development utilizes proprietary heat stabilization technology known as ThermoVax® [6] Strategic Partnerships - IBN will utilize its investor-focused distribution network, which includes over 5,000 syndication outlets and a large social media following, to increase awareness for Soligenix [4][5] - IBN has over 19 years of experience and has assisted more than 500 client partners, positioning it to effectively reach a broad audience [5]

Core Viewpoint - The combination of the COVID adenovirus vaccine and CiVax™ shows broader protection against COVID-19 variants compared to a two-shot mRNA vaccination series, indicating potential advantages in vaccine efficacy and distribution logistics [1][2]. Group 1: CiVax™ Vaccine Development - CiVax™ is a heat-stable subunit vaccine candidate for COVID-19, demonstrating broad immune responses in preclinical studies with mice and non-human primates [2][4]. - The vaccine can be stored at ambient temperatures and requires only reconstitution with sterile water before use, simplifying global vaccination efforts [2][3]. - Development of CiVax™ was partially funded by a $1.5 million Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) [5]. Group 2: Technological Advancements - The ThermoVax® platform has successfully stabilized vaccines for various pathogens, enhancing the standard protein subunit vaccination technology [2][9]. - CiVax™ has shown efficacy as a booster after other primary vaccinations against COVID-19, providing broad immune coverage [4][2]. Group 3: Collaboration and Research - The development of CiVax™ is a result of collaboration with Axel Lehrer, PhD, from the University of Hawaiʻi at Mānoa, focusing on heat-stable vaccines for both COVID-19 and filoviruses [2][3]. - The research emphasizes the need for robust technology platforms to rapidly develop vaccines for emerging infectious diseases, as demonstrated by the COVID-19 pandemic [6].

Part I [Business](index=6&type=section&id=Item%201.%20Business) Soligenix is a late-stage biopharmaceutical company with two segments: Specialized BioTherapeutics and Public Health Solutions, focusing on rare diseases and biodefense solutions - The company operates through two main segments: Specialized BioTherapeutics for rare diseases and Public Health Solutions for biodefense, supported by government funding[14](index=14&type=chunk)[15](index=15&type=chunk)[17](index=17&type=chunk) - A key strategy is to advance the confirmatory Phase 3 FLASH2 trial for HyBryte™ in CTCL, expand SGX302 into psoriasis, and seek partners for the SGX942 program for oral mucositis[18](index=18&type=chunk) - On June 5, 2024, the company executed a **one-for-sixteen reverse stock split**, with all share and per-share data restated to reflect this change[11](index=11&type=chunk) [Specialized BioTherapeutics](index=8&type=section&id=Specialized%20BioTherapeutics) This segment focuses on HyBryte™ for CTCL in its second Phase 3 trial, alongside SGX302 for psoriasis and dusquetide for inflammatory diseases - The lead product, HyBryte™ (SGX301), a photodynamic therapy for CTCL, began its second confirmatory Phase 3 study (FLASH2) in December 2024, with top-line results anticipated in **H2 2026**[15](index=15&type=chunk)[58](index=58&type=chunk) - The FDA issued a Refusal to File (RTF) letter in February 2023 for the HyBryte™ NDA, necessitating a second pivotal study, while the company proceeds with the EMA-accepted FLASH2 protocol[52](index=52&type=chunk)[53](index=53&type=chunk)[54](index=54&type=chunk) - The dusquetide program includes SGX942 for oral mucositis, requiring a second Phase 3 trial, and SGX945 for Behçet's Disease, which initiated a Phase 2a study in **Q4 2024**[18](index=18&type=chunk)[25](index=25&type=chunk)[100](index=100&type=chunk) Specialized BioTherapeutics Pipeline Status | Product Candidate | Therapeutic Indication | Stage of Development | | :--- | :--- | :--- | | **HyBryte™** | Cutaneous T-Cell Lymphoma | Second Phase 3 trial (FLASH2) initiated Dec 2024 | | **SGX302** | Mild-to-Moderate Psoriasis | Phase 2a study ongoing | | **SGX942** | Oral Mucositis in Head and Neck Cancer | Awaiting partnership for a second Phase 3 trial | | **SGX945** | Aphthous Ulcers in Behçet's Disease | Phase 2a study initiated Q4 2024 | [Public Health Solutions](index=32&type=section&id=Public%20Health%20Solutions) This government-funded segment develops biodefense vaccines and therapeutics, including RiVax® for ricin toxin and filovirus vaccines using the ThermoVax® platform - The ThermoVax® platform creates heat-stable vaccines, potentially eliminating cold chain storage, applied to RiVax® and filovirus candidates[17](index=17&type=chunk)[117](index=117&type=chunk)[118](index=118&type=chunk) - RiVax®, a ricin toxin vaccine candidate, completed Phase 1 trials, received FDA Orphan Drug and Fast Track designations, and secured approximately **$25 million** in NIH grant funding[143](index=143&type=chunk)[146](index=146&type=chunk)[151](index=151&type=chunk) - The filovirus vaccine program, in collaboration with the University of Hawai'i, develops thermostabilized Ebola and Marburg vaccines, with a bivalent candidate showing **100% protection** in non-human primates[135](index=135&type=chunk)[137](index=137&type=chunk)[140](index=140&type=chunk) Public Health Solutions Pipeline Status | Product Candidate | Indication | Stage of Development | | :--- | :--- | :--- | | **ThermoVax®** | Vaccine Thermostability Platform | Pre-clinical | | **RiVax®** | Vaccine against Ricin Toxin | Phase 1 trials completed | | **SGX943** | Therapeutic against Emerging Infectious Diseases | Pre-clinical | [Patents and Proprietary Rights](index=56&type=section&id=Patents%20and%20Proprietary%20Rights) The company's IP strategy combines patents, trade secrets, and regulatory exclusivities, covering synthetic hypericin, innate defense regulators, and the ThermoVax® platform - HyBryte™ (synthetic hypericin) is protected by production method patents, with key patents expiring in **2036**[211](index=211&type=chunk) - The SGX94 (dusquetide) technology is covered by composition of matter patents in the U.S. and abroad, expiring between **2028 and 2034**[213](index=213&type=chunk) - The ThermoVax® technology is protected by licensed patents, expiring between **2028 and 2040**, covering thermostable vaccine methods[214](index=214&type=chunk) - The company holds Orphan Drug designations for HyBryte™ (CTCL) and RiVax®, granting **seven years** of U.S. and **ten years** of E.U. market exclusivity post-approval[212](index=212&type=chunk) [Risk Factors](index=64&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including historical losses, funding needs, clinical and regulatory hurdles, reliance on government funding and third parties, and IP challenges - The company has an accumulated deficit of **$234.0 million** as of December 31, 2024, with substantial doubt about its going concern ability without additional financing[232](index=232&type=chunk)[238](index=238&type=chunk)[244](index=244&type=chunk) - The independent auditor's report includes an explanatory paragraph regarding the company's going concern ability, potentially hindering future financing[232](index=232&type=chunk)[246](index=246&type=chunk) - The Public Health Solutions segment is highly dependent on uncertain government funding, subject to budgetary changes and potential termination[232](index=232&type=chunk)[263](index=263&type=chunk) - Biodefense product development, like RiVax®, relies on the FDA's Animal Rule, posing challenges for efficacy and safety correlation and potential non-acceptance by foreign regulators[232](index=232&type=chunk)[261](index=261&type=chunk) - The company relies on single suppliers for drug substances and third-party manufacturers, creating risks of delays and supply disruptions[232](index=232&type=chunk)[264](index=264&type=chunk) [Cybersecurity](index=101&type=section&id=Item%201C.%20Cybersecurity) The CFO manages the company's cybersecurity program, overseen by the Board, integrated into enterprise risk management, with no material incidents reported - The Chief Financial Officer (CFO) is responsible for the company's cybersecurity program and strategy[354](index=354&type=chunk) - The Board of Directors oversees cybersecurity risk, receiving annual updates and prompt notification of potentially material incidents[358](index=358&type=chunk) - The company has experienced minor cybersecurity incidents, none of which have had a material adverse effect on the business[359](index=359&type=chunk) [Properties](index=103&type=section&id=Item%202.%20Properties) Soligenix leases 6,200 square feet of office space in Princeton, NJ, serving as its corporate headquarters, with the lease expiring in October 2025 - The company's principal executive offices are located in a leased **6,200 square foot** space in Princeton, NJ[360](index=360&type=chunk) - The current lease expires in **October 2025**, with a monthly rent of approximately **$11,625**[360](index=360&type=chunk) [Legal Proceedings](index=103&type=section&id=Item%203.%20Legal%20Proceedings) The company reports no legal proceedings as of the current report date - As of the report date, there are no legal proceedings involving the company[361](index=361&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=104&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under "SNGX," with 3,155,603 shares outstanding as of March 14, 2025, and no history or plans for cash dividends - As of March 14, 2025, **3,155,603 shares** of common stock were outstanding[4](index=4&type=chunk)[369](index=369&type=chunk) Common Stock Price Range (SNGX) | Period | High ($) | Low ($) | | :--- | :--- | :--- | | **Year Ended Dec 31, 2023** | | | | First Quarter | 129.57 | 28.00 | | Second Quarter | 67.20 | 10.26 | | Third Quarter | 11.86 | 6.73 | | Fourth Quarter | 32.00 | 6.08 | | **Year Ended Dec 31, 2024** | | | | First Quarter | 19.20 | 8.89 | | Second Quarter | 14.92 | 2.50 | | Third Quarter | 14.83 | 1.83 | | Fourth Quarter | 4.87 | 2.65 | - The company has never paid cash dividends and does not intend to in the foreseeable future, retaining earnings for business operations[370](index=370&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=105&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In FY2024, net loss increased to $8.3 million due to lower grant revenue and a 58% rise in R&D expenses to $5.2 million, with cash at $7.8 million, raising going concern doubts beyond 2025 Financial Performance (2024 vs. 2023) | Metric | 2024 ($) | 2023 ($) | Change (%) | | :--- | :--- | :--- | :--- | | **Revenues** | 119,371 | 839,359 | -86% | | **Gross Profit** | 0 | 97,311 | -100% | | **R&D Expenses** | 5,223,589 | 3,312,699 | +58% | | **G&A Expenses** | 4,215,908 | 4,482,552 | -6% | | **Net Loss** | 8,266,576 | 6,140,730 | +35% | - The increase in R&D expenses was primarily due to preliminary costs for initiating the Phase 2 Behçet's Disease study and the second confirmatory Phase 3 CTCL trial[399](index=399&type=chunk) - As of December 31, 2024, cash and cash equivalents totaled **$7.8 million**, with management expressing substantial doubt about the company's ability to continue as a going concern beyond the end of **2025** without additional financing[411](index=411&type=chunk)[412](index=412&type=chunk) R&D Expenses by Program (2024 vs. 2023) | Program | 2024 Expense ($) | 2023 Expense ($) | | :--- | :--- | :--- | | RiVax® and ThermoVax® | 253,994 | 133,186 | | SGX942 (Dusquetide) | (330,257) | (28,570) | | HyBryte™ (SGX301) | 4,691,803 | 2,698,609 | | Other | 608,049 | 509,474 | | **Total** | **5,223,589** | **3,312,699** | [Financial Statements and Supplementary Data](index=124&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements for 2024 and 2023, including balance sheets, statements of operations, and cash flows, along with notes and the auditor's report from Cherry Bekaert LLP - The independent auditor's report from Cherry Bekaert LLP expresses substantial doubt about the company's going concern ability due to recurring losses and negative operating cash flows[658](index=658&type=chunk) Consolidated Balance Sheet Highlights (as of Dec 31) | Account | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | **Cash and cash equivalents** | 7,819,514 | 8,446,158 | | **Total Assets** | 8,966,483 | 9,797,326 | | **Total Liabilities** | 4,848,412 | 7,274,904 | | **Total Shareholders' Equity** | 4,118,071 | 2,522,422 | Consolidated Statement of Operations Highlights (Year Ended Dec 31) | Account | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | **Total Revenues** | 119,371 | 839,359 | | **Loss from Operations** | (9,439,497) | (7,697,940) | | **Net Loss** | (8,266,576) | (6,140,730) | | **Basic and Diluted Net Loss Per Share** | (4.98) | (12.66) | [Controls and Procedures](index=124&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2024, with no material changes identified - Management concluded that the company's disclosure controls and procedures were effective as of **December 31, 2024**[443](index=443&type=chunk) - Based on a COSO framework assessment, management concluded that internal control over financial reporting was effective as of **December 31, 2024**[446](index=446&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=126&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section details biographical information for directors and executive officers, board structure, risk oversight, committee compositions, and adopted corporate governance policies - Dr. Christopher J. Schaber serves as both Chairman of the Board and CEO, a structure deemed in the company's best interest[451](index=451&type=chunk)[465](index=465&type=chunk) - The Board of Directors has three standing committees: Audit, Compensation, and Nominating and Corporate Governance, with independent director members[472](index=472&type=chunk)[473](index=473&type=chunk) - The company adopted a Nasdaq-compliant clawback policy in **2023** to recover excess incentive-based compensation from executive officers upon accounting restatement[482](index=482&type=chunk) [Executive Compensation](index=135&type=section&id=Item%2011.%20Executive%20Compensation) This section details Named Executive Officer compensation for 2023-2024, including CEO Christopher J. Schaber's total compensation of $832,627 in 2024, and outlines employment agreements and equity award practices Summary Compensation for Named Executive Officers | Name | Position | Year | Salary ($) | Bonus ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **Christopher J. Schaber** | CEO & President | 2024 | 540,255 | 108,051 | 148,950 | 832,627 | | | | 2023 | 519,476 | 72,727 | 75,482 | 700,484 | | **Jonathan Guarino** | CFO & Senior VP | 2024 | 254,800 | 42,806 | 66,200 | 399,177 | | | | 2023 | 245,000 | 31,605 | 45,289 | 354,693 | - The Compensation Committee engaged Setren & Associates, Inc. in **2024** to review and recommend on the executive compensation program[483](index=483&type=chunk)[485](index=485&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=144&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 14, 2025, directors and executive officers collectively owned 2.67% of common stock, with no 5%+ beneficial owners, and 5,770,122 shares available under the 2015 Equity Incentive Plan - As of March 14, 2025, all directors and executive officers as a group beneficially owned **86,401 shares**, representing **2.67%** of the class[509](index=509&type=chunk) - The company is not aware of any person beneficially owning more than **5%** of its outstanding common stock as of the reporting date[508](index=508&type=chunk) - As of December 31, 2024, **5,770,122 shares** were available for future issuance under the company's 2015 Equity Incentive Plan[512](index=512&type=chunk)[514](index=514&type=chunk) [Principal Accountant Fees and Services](index=148&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Cherry Bekaert LLP billed $214,463 in 2024 and $59,870 in 2023 exclusively for audit services, all pre-approved by the audit committee Accountant Fees Billed | Fee Category | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Audit Fees | 214,463 | 59,870 | | **Total** | **214,463** | **59,870** | - All fees paid to the principal accountant were exclusively for audit services, with no fees billed for tax or other services[521](index=521&type=chunk)[522](index=522&type=chunk)[523](index=523&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=148&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists consolidated financial statements and a comprehensive index of exhibits, including corporate governance documents, material contracts, and certifications - Lists all financial statements included in the filing, starting on page **F-1**[526](index=526&type=chunk) - Includes a detailed index of exhibits filed with the 10-K, such as corporate governance documents, material contracts, and executive employment agreements[527](index=527&type=chunk)[529](index=529&type=chunk)[532](index=532&type=chunk)

Core Viewpoint - Soligenix, Inc. is focused on advancing its clinical programs and achieving significant development milestones, particularly in the treatment of rare diseases with unmet medical needs, while managing its financial resources effectively [2][9]. Recent Accomplishments - The company has opened patient enrollment for its confirmatory Phase 3 study evaluating HyBryte™ in early-stage cutaneous T-cell lymphoma (CTCL) and has reported positive interim results from an open-label study of HyBryte™ [7][9]. - Formation of a European Medical Advisory Board to provide strategic guidance for the ongoing clinical studies [7]. Financial Results - For the year ended December 31, 2024, Soligenix reported revenues of $0.1 million, a decrease from $0.8 million in the previous year, primarily due to timing issues with government grant funding [4]. - The net loss for the year was $8.3 million, or ($4.98) per share, compared to a net loss of $6.1 million, or ($12.66) per share, in the prior year, influenced by a reverse stock split and increased research and development expenses [5][6]. - Research and development expenses rose to $5.2 million from $3.3 million, driven by costs related to new clinical trials [6]. Cash Position - As of December 31, 2024, the company had approximately $7.8 million in cash, which is expected to support operations through 2025 while exploring various strategic options for funding [2][8].

Core Insights - Soligenix, Inc. is presenting findings on the efficacy of HyBryte™ (synthetic hypericin) for treating cutaneous T-cell lymphoma (CTCL) and psoriasis at two major dermatology conferences in March 2025 [1][4][6] Group 1: Clinical Findings - Recent supportive studies indicate that longer treatment times with HyBryte™ improve efficacy, with a study showing a 40% response rate in patients treated for 12 weeks compared to a 4% response in the placebo group [5][11] - The Phase 3 FLASH trial demonstrated that 16% of patients receiving HyBryte™ achieved at least a 50% reduction in lesions, significantly higher than the 4% in the placebo group [10] - HyBryte™ has shown a statistically significant improvement in treating both plaque and patch lesions of CTCL, with response rates of 42% and 37% respectively [11] Group 2: Safety and Regulatory Status - HyBryte™ has received orphan drug and fast track designations from the FDA, indicating its potential as a safe and effective treatment for CTCL [9] - The treatment mechanism of HyBryte™ is not associated with DNA damage, making it a safer alternative compared to current therapies that carry significant side effects [13] - The FDA awarded a $2.6 million Orphan Products Development grant to support the evaluation of HyBryte™ for expanded treatment in early-stage CTCL patients [17] Group 3: Market Potential - The global psoriasis treatment market was valued at approximately $15 billion in 2020 and is projected to reach as much as $40 billion by 2027, indicating significant commercial potential for HyBryte™ in treating psoriasis [23] - CTCL affects approximately 31,000 individuals in the U.S. and 38,000 in Europe, highlighting a substantial patient population for potential treatment [19] Group 4: Company Overview - Soligenix, Inc. focuses on developing products for rare diseases with unmet medical needs, including HyBryte™ for CTCL and SGX302 for psoriasis [24]

Core Viewpoint - Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs, and it will present at the BIO CEO & Investor Conference on February 10-11, 2025 [1]. Company Overview - Soligenix is developing HyBryte™ (SGX301), a novel photodynamic therapy for cutaneous T-cell lymphoma (CTCL), and is seeking regulatory approvals following the successful completion of its second Phase 3 study [3]. - The company is also expanding its synthetic hypericin (SGX302) into psoriasis and developing dusquetide (SGX942) for inflammatory diseases, including oral mucositis in head and neck cancer, and SGX945 for Behçet's Disease [3]. - The Public Health Solutions segment includes the development of RiVax®, a ricin toxin vaccine, and vaccines targeting filoviruses and COVID-19, utilizing the ThermoVax® heat stabilization technology [4]. Conference Participation - Registered attendees of the BIO CEO & Investor Conference can schedule one-on-one meetings with Soligenix management through the conference scheduling platform [2].

PRINCETON, N.J., Jan. 16, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Company will deliver a corporate presentation at the upcoming conferences below. Sequire Investor Summit, held January 21 to 23 at Condado Vanderbilt, Puerto Rico. For more information about the Sequire Investor Summit, please re ...