Core Insights - Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, reporting recent accomplishments and financial results for Q2 2025 [1][10] Recent Accomplishments - The company is confident in its late-stage rare disease pipeline, with key milestones expected, including top-line results from a Phase 2a clinical trial for mild-to-moderate psoriasis with SGX302 by year-end [2] - Successful completion of a Phase 2a proof of concept study for SGX945 in Behçet's Disease, demonstrating biological efficacy [2][9] - Ongoing clinical updates for the extended HyBryte™ treatment for early-stage cutaneous T-cell lymphoma (CTCL) and plans for a Phase 3 study [2] Financial Results - No revenue was reported for Q2 2025, consistent with minimal revenue in Q2 2024 [4] - Net loss for Q2 2025 was $2.7 million, or ($0.82) per share, compared to a net loss of $1.6 million, or ($1.31) per share in Q2 2024, primarily due to increased operating expenses [5] - Research and development expenses rose to $1.7 million in Q2 2025 from $0.5 million in Q2 2024, driven by costs related to clinical trials [6] - General and administrative expenses decreased to $1.1 million in Q2 2025 from $1.2 million in Q2 2024 [7] - Cash position as of June 30, 2025, was approximately $5.1 million, excluding $1.4 million received via the ATM facility on July 1, 2025 [7] Strategic Focus - The company is evaluating strategic options, including partnerships, mergers, acquisitions, government grants, and financing opportunities to advance its late-stage pipeline [2]

Core Insights - Soligenix Inc. is advancing its late-stage therapy HyBryte for cutaneous T-cell lymphoma (CTCL), a rare cancer primarily affecting older adults, with a global market estimated at nearly $1 billion, 70% of which is in the U.S. [1] - HyBryte has received orphan drug designations in the U.S. and Europe, as well as FDA Fast Track status, and has shown statistically significant results in just six weeks during its initial phase 3 trial [1][2] - A second confirmatory phase 3 study, FLASH2, is currently underway, with top-line results expected in 2026 [1] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs, particularly through its Specialized BioTherapeutics segment [3] - The company is also developing synthetic hypericin for psoriasis and has other programs targeting inflammatory diseases and Behçet's disease [3] - The Public Health Solutions segment includes vaccine candidates for ricin toxin, filoviruses, and COVID-19, supported by government grants and contracts [4]

Company Overview - Soligenix Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs [5] - The company is advancing its HyBryte(TM) platform, a novel therapy for cutaneous T-cell lymphoma (CTCL), primarily affecting older adults [4][5] - Soligenix has established U.S.-based manufacturing for HyBryte's active ingredient, showcasing domestic innovation [4] Industry Context - The aging American population is leading to an increase in chronic and rare diseases, with over 30 million Americans affected by rare diseases [3] - There is a growing need for accurate diagnoses and effective treatments, particularly as many rare conditions lack FDA-approved therapies [3] - The Trump administration's initiatives aim to improve access to treatments and accelerate medical innovation in this sector [4] Product Development - The Specialized BioTherapeutics segment is moving towards potential commercialization of HyBryte(TM) after successful completion of the second Phase 3 study [5] - Other development programs include synthetic hypericin for psoriasis and dusquetide for inflammatory diseases [5] - The Public Health Solutions segment includes vaccine candidates for ricin toxin, filoviruses, and COVID-19, supported by government grants [6]

Company Overview - Soligenix Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs [4] - The company is advancing its HyBryte(TM) platform, a novel therapy for treating cutaneous T-cell lymphoma (CTCL), primarily affecting older adults [3][4] - Successful U.S.-based manufacturing of HyBryte's active ingredient has been established, positioning the company for significant impact in the healthcare sector [3] Product Development - The Specialized BioTherapeutics segment is moving towards potential commercialization of HyBryte(TM) after completing the second Phase 3 study, with regulatory approvals anticipated [4] - Other development programs include synthetic hypericin (SGX302) for psoriasis, and dusquetide (SGX942) for inflammatory diseases, including oral mucositis in head and neck cancer [4] - The Public Health Solutions segment includes vaccine candidates such as RiVax(R) for ricin toxin, and CiVax(TM) for COVID-19, supported by government grants and contracts [5] Market Context - The aging U.S. population is facing increasing challenges from chronic and rare diseases, with over 30 million Americans affected by rare diseases [2] - The Trump administration's initiatives aim to improve access to treatments and accelerate medical innovation in response to this healthcare crisis [2]

Core Insights - Soligenix, Inc. has completed a Phase 2a proof of concept study for SGX945 (dusquetide) in treating Behçet's Disease, demonstrating biological efficacy [1][5] - The study showed that SGX945 had comparable outcomes to apremilast, the only approved drug for oral ulcers in Behçet's Disease, with a 40% improvement in ulcer count compared to placebo [3][4] - SGX945 was well-tolerated with no treatment-related adverse events, contrasting with common side effects associated with apremilast [4][5] Study Design and Results - The Phase 2a study was an open-label trial involving 8 patients with mild to moderate Behçet's Disease, receiving SGX945 as a twice-weekly intravenous infusion for 4 weeks [6] - The primary endpoint was the area under the curve (AUC) for the mean number of ulcers over time, with SGX945 showing a 40% improvement compared to placebo, while apremilast showed a 37% improvement [3][4] - Improvements in oral pain were also noted, with 7 out of 8 patients reporting benefits from SGX945 treatment [4][5] Future Development Plans - The company plans to reformulate SGX945 for home-based treatment using subcutaneous injection, aiming to enhance patient convenience and compliance [5] - There is an intention to conduct a follow-on placebo-controlled Phase 2 study to further explore SGX945's benefits in Behçet's Disease [6] - The company is looking to expand dusquetide's development into other innate immune-related inflammatory conditions as part of its long-term strategy [5] Market Context - Behçet's Disease is a chronic condition affecting approximately 1 million people worldwide, with significant unmet medical needs for effective treatments [6][11] - Current treatments, including apremilast, have limitations such as high costs and side effects, highlighting the potential market opportunity for SGX945 [12]

Core Insights - Soligenix, Inc. is focused on developing and commercializing products for rare diseases with unmet medical needs, with a promising late-stage pipeline and potential strategic options including partnerships and M&A opportunities [1][3] Financial Overview - The company has sufficient capital and cash runway to meet its goals into Q1 2026, with expected peak annual net sales of HyBryte™ in the U.S. exceeding $90 million and a total addressable worldwide CTCL market estimated at over $250 million annually [2][13] - The total addressable worldwide psoriasis market opportunity with SGX302 is estimated to exceed $1 billion annually, while SGX945 in Behçet's Disease (BD) has a market opportunity of approximately $200 million annually, leading to potential global annual sales of around $2 billion [2][11] Clinical Development - The confirmatory Phase 3 FLASH2 study for HyBryte™ is ongoing, with top-line results expected in the second half of 2026, and enrollment is on track [4][5] - The ongoing Phase 2a study of SGX302 in mild-to-moderate psoriasis has shown promising results, with previous cohorts demonstrating biologic activity and early clinical success [7][10] - A pilot Phase 2a proof of concept clinical trial for SGX945 in Behçet's Disease is expected to yield top-line results in Q3 2025 [11] Market Potential - Psoriasis affects approximately 60-125 million people globally, with the global treatment market valued at around $30 billion in 2023 and projected to reach $58-67 billion by 2030 [8][9] - Behçet's Disease is an orphan disease with around 18,000 known cases in the U.S. and 50,000 in Europe, impacting the quality of life for patients [12] Manufacturing and Partnerships - The company has successfully transferred the manufacturing of synthetic hypericin to a U.S. facility, optimizing the process for larger batch production [10] - Soligenix is actively pursuing partnerships in ex-U.S. markets to enhance its marketing authorizations for HyBryte™ and explore other potential cutaneous indications [6][14]

Core Viewpoint - Soligenix, Inc. has successfully completed the transfer of synthetic hypericin active ingredient manufacturing to the U.S., optimizing a scalable production process for its topical drug products HyBryte™ and SGX302, aimed at treating cutaneous T-cell lymphoma (CTCL) and psoriasis respectively [1][2]. Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs, particularly HyBryte™ for CTCL and SGX302 for psoriasis [15]. - The company is advancing its clinical programs and aims for potential commercialization worldwide following successful clinical trials [2][15]. Product Details - HyBryte™ is a first-in-class photodynamic therapy using synthetic hypericin, which is activated by safe visible light, targeting malignant T-cells in skin lesions [3]. - The treatment has shown significant anti-proliferative effects and has received orphan drug and fast track designations from the FDA and EMA [3][8]. Clinical Trial Results - The Phase 3 FLASH trial enrolled 169 patients, demonstrating a 16% response rate for HyBryte™ compared to 4% for placebo in the first treatment cycle [4]. - In the second treatment cycle, a 40% response rate was observed among patients receiving 12 weeks of HyBryte™ treatment [5]. - The third optional treatment cycle showed that 49% of patients who received HyBryte™ throughout all cycles had a positive treatment response [7]. Future Development - A second Phase 3 trial, FLASH2, is expected to begin before the end of 2024, replicating the successful design of the first trial with an extended treatment duration [9]. - The FDA has indicated that a longer duration comparative study may be preferred, and discussions are ongoing to address their feedback [9]. Financial Support - The FDA awarded a $2.6 million Orphan Products Development grant to support an investigator-initiated study evaluating HyBryte™ for expanded treatment in early-stage CTCL patients [11].

Core Insights - Soligenix, Inc. is advancing HyBryte™ (synthetic hypericin) as a potential new therapy for early-stage cutaneous T-cell lymphoma (CTCL), specifically targeting mycosis fungoides (MF), the most common form of CTCL [1][7] - The company emphasizes the urgent need for safer and more effective therapies for CTCL, as there has not been a new FDA-approved skin-directed therapy in over 10 years [3][4] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs, including HyBryte™ for CTCL and other therapeutic programs [7] - The company is also involved in vaccine development for biodefense and infectious diseases, supported by government funding [8] Clinical Development - Dr. Ellen Kim, the Lead Principal Investigator, highlighted the promising clinical results from ongoing Phase 3 FLASH studies, noting that participants have experienced positive outcomes with no serious adverse events leading to dropouts [3][4] - HyBryte™ operates through a unique mechanism that does not damage DNA, theoretically reducing the risk of skin cancer compared to traditional phototherapy [4] Research and Future Directions - Dr. Kim expressed excitement about the open enrollment in HyBryte™ clinical trials, emphasizing the critical role of patient participation in advancing new therapies [6] - The company aims to seek regulatory approvals for HyBryte™ following the successful completion of its second Phase 3 study [7]

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]