Core Insights - Soligenix, Inc. has received orphan drug designation from the FDA for dusquetide, the active ingredient in SGX945, for the treatment of Behçet's Disease, which provides seven years of market exclusivity upon final approval [1][2][3] Group 1: Orphan Drug Designation - The U.S. Orphan Drug Act aims to encourage the development of therapies for rare diseases affecting fewer than 200,000 people in the U.S. [2] - Orphan drug designation offers financial and regulatory benefits, including government grants for clinical trials and waivers of FDA user fees [2] Group 2: Behçet's Disease Overview - Behçet's Disease affects approximately 18,000 people in the U.S., 50,000 in Europe, and up to 1 million worldwide, representing a significant unmet medical need [3][10] - The disease is characterized by symptoms such as mouth sores, skin rashes, genital sores, and eye inflammation, severely impacting patients' quality of life [9][11] Group 3: Dusquetide's Mechanism and Efficacy - Dusquetide is an innate defense regulator (IDR) that modulates the immune response to promote anti-inflammatory and tissue healing effects [4] - In a Phase 2a study, dusquetide showed a 40% improvement in the number of ulcers compared to placebo, which is comparable to the 37% improvement seen with apremilast [6] Group 4: Clinical Study Results - Dusquetide demonstrated safety and tolerability in a Phase 1 study with 84 healthy volunteers and positive efficacy in over 350 subjects with oral mucositis due to chemoradiation therapy [5] - The Phase 2a study for Behçet's Disease indicated that SGX945 was well-tolerated with no treatment-related adverse events, unlike common side effects associated with apremilast [7][6] Group 5: Intellectual Property and Development - Soligenix holds a strong intellectual property position for the IDR technology platform, including composition of matter for dusquetide [8] - The company is also developing other products, including HyBryte™ for cutaneous T-cell lymphoma and SGX942 for oral mucositis [12]

Part I - FINANCIAL INFORMATION [Item 1 - Condensed Consolidated Financial Statements (unaudited)](index=4&type=section&id=Item%201%20-%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements for the periods ended June 30, 2025 [Financial Statements](index=4&type=section&id=Financial%20Statements) The financial statements show a decrease in cash and total assets, a widening net loss, and negative operating cash flow Condensed Consolidated Balance Sheet Highlights (as of June 30, 2025) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $5,097,670 | $7,819,514 | | **Total current assets** | $5,320,452 | $8,828,630 | | **Total assets** | $5,760,647 | $8,966,483 | | **Total current liabilities** | $3,629,107 | $4,848,412 | | **Total liabilities** | $3,931,696 | $4,848,412 | | **Total shareholders' equity** | $1,828,951 | $4,118,071 | Condensed Consolidated Statement of Operations Highlights | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Total revenues** | $0 | $119,371 | | **Research and development** | $3,618,694 | $1,596,198 | | **General and administrative** | $2,171,693 | $2,265,568 | | **Loss from operations** | $(5,790,387) | $(3,861,766) | | **Net loss** | $(5,653,244) | $(3,559,829) | | **Basic and diluted net loss per share** | $(1.79) | $(3.71) | Condensed Consolidated Statement of Cash Flows Highlights (Six Months Ended June 30, 2025) | Metric | Amount | | :--- | :--- | | **Net cash used in operating activities** | $(4,588,835) | | **Net cash used in investing activities** | $(3,313) | | **Net cash from financing activities** | $1,870,304 | | **Net decrease in cash** | $(2,721,844) | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business segments, debt repayment, equity transactions, and a substantial doubt about its ability to continue as a going concern - The company has two active business segments: **Specialized BioTherapeutics**, focused on rare diseases like CTCL with its HyBryte™ product, and **Public Health Solutions**, which develops government-funded vaccines and therapeutics like RiVax®[18](index=18&type=chunk)[19](index=19&type=chunk)[21](index=21&type=chunk) - Management has concluded there is **substantial doubt about the company's ability to continue as a going concern**, with cash projected to fund operations only through the first quarter of 2026[24](index=24&type=chunk)[25](index=25&type=chunk)[26](index=26&type=chunk) - In February 2025, the company **fully repaid all outstanding obligations** under its convertible debt agreement with Pontifax and terminated the loan agreement[62](index=62&type=chunk) - During the six months ended June 30, 2025, the company sold **978,105 shares of common stock** through its At-The-Market (ATM) facility, which was fully utilized as of July 1, 2025[64](index=64&type=chunk)[67](index=67&type=chunk) [Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202%20-%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operational results, product development progress, and reiterates the 'going concern' warning [Business Overview and Strategy](index=27&type=section&id=Business%20Overview%20and%20Strategy) The company's strategy centers on advancing its HyBryte™ and synthetic hypericin platforms while seeking non-dilutive funding for its Public Health Solutions portfolio - The primary strategic focus is on the execution of the second confirmatory **Phase 3 FLASH2 clinical trial for HyBryte™ in CTCL**, with top-line results anticipated in the second half of 2026[91](index=91&type=chunk)[96](index=96&type=chunk) - The company plans to expand its pipeline by advancing **SGX302 (synthetic hypericin) into a Phase 2a trial for psoriasis** and **SGX945 (dusquetide) into a Phase 2a trial for Behçet's Disease**[92](index=92&type=chunk)[96](index=96&type=chunk) - A key part of the strategy is to continue seeking **government and non-governmental funding** for its Public Health Solutions programs and to explore strategic alternatives[94](index=94&type=chunk)[96](index=96&type=chunk) [Product Candidates in Development](index=30&type=section&id=Product%20Candidates%20in%20Development) This section details progress across the pipeline, including the HyBryte™ Phase 3 trial, SGX945 proof-of-concept, and advancements in Public Health Solutions vaccines - **HyBryte™ (CTCL):** Following an FDA refusal to file the initial NDA, the company is proceeding with a second, EMA-aligned **Phase 3 trial (FLASH2)**, with top-line results expected in H2 2026[118](index=118&type=chunk)[123](index=123&type=chunk)[128](index=128&type=chunk) - **SGX945 (Behçet's Disease):** The company completed a **Phase 2a proof-of-concept study** in July 2025, successfully demonstrating the biological efficacy of dusquetide in treating aphthous ulcers[163](index=163&type=chunk)[166](index=166&type=chunk) - **Filovirus Vaccines (SuVax™/MarVax™):** The company received **orphan drug designation** for its vaccine candidates against Sudan ebolavirus and Marburg marburgvirus in April 2024[181](index=181&type=chunk)[183](index=183&type=chunk)[186](index=186&type=chunk) - **RiVax® (Ricin Vaccine):** The ricin vaccine candidate has received both **Orphan Drug and Fast Track designations** from the FDA and could qualify for a biodefense Priority Review Voucher (PRV)[194](index=194&type=chunk)[196](index=196&type=chunk) [Results of Operations](index=59&type=section&id=Results%20of%20Operations) The company's net loss widened significantly for the six months ended June 30, 2025, driven primarily by increased research and development expenses Comparison of Operating Results (Six Months Ended June 30) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | **Net Loss** | $5,653,244 | $3,559,829 | +$2,093,415 | | **R&D Expenses** | $3,618,694 | $1,596,198 | +$2,022,496 | | **G&A Expenses** | $2,171,693 | $2,265,568 | -$93,875 | [Liquidity and Capital Resources](index=59&type=section&id=Liquidity%20and%20Capital%20Resources) The company has limited cash, sufficient only through Q1 2026, and has issued a 'going concern' warning while actively seeking new capital - The company reported **cash and cash equivalents of $5,097,670** as of June 30, 2025, down from $7,819,514 at the end of 2024[207](index=207&type=chunk) - A **'going concern' warning** has been issued, as current resources are expected to last only through Q1 2026[210](index=210&type=chunk) - The company's plans to secure liquidity include raising additional capital, applying for government grants, and pursuing partnerships; its **ATM facility was fully utilized** on July 1, 2025[211](index=211&type=chunk)[214](index=214&type=chunk)[215](index=215&type=chunk) [Item 3 - Quantitative and Qualitative Disclosures About Market Risk](index=65&type=section&id=Item%203%20-%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risks from interest rate and foreign exchange fluctuations are considered immaterial - The company's main market risk exposures are **interest income sensitivity and foreign exchange rates**, which are not considered material[231](index=231&type=chunk) [Item 4 - Controls and Procedures](index=65&type=section&id=Item%204%20-%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls - As of June 30, 2025, the company's management concluded that its **disclosure controls and procedures were effective**[233](index=233&type=chunk) - **No material changes** in internal controls over financial reporting were identified during the last fiscal quarter[234](index=234&type=chunk) Part II - OTHER INFORMATION [Item 1 - Legal Proceedings](index=66&type=section&id=Item%201%20-%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company has **no material legal proceedings** to report[236](index=236&type=chunk) [Item 1A - Risk Factors](index=66&type=section&id=Item%201A%20-%20Risk%20Factors) The company highlights a substantial risk of shareholder dilution from outstanding warrants, options, and future equity issuances - Shareholders face **substantial dilution risk** from outstanding securities, including **1,467,581 common stock warrants** and approximately **112,332 options** as of August 7, 2025[239](index=239&type=chunk)[240](index=240&type=chunk) - An additional **5,929,412 shares of common stock are available for future issuance** under the 2025 Equity Incentive Plan, which could further dilute existing shareholders[240](index=240&type=chunk) [Item 2 - Unregistered Sales of Equity Securities and Use of Proceeds](index=67&type=section&id=Item%202%20-%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported a small, unregistered issuance of common stock to a vendor in March 2025 - On March 14, 2025, the company issued **12,346 shares of common stock** to a vendor in a transaction exempt from SEC registration[242](index=242&type=chunk) [Item 5 - Other Information](index=67&type=section&id=Item%205%20-%20Other%20Information) The company's Chief Medical Officer retired and transitioned to a consulting role - **Dr. Richard Straube**, the company's Chief Medical Officer, retired effective August 12, 2025[244](index=244&type=chunk) - Following his retirement, Dr. Straube entered into a **one-year consulting agreement** to serve as the company's Consulting Chief Medical Officer[244](index=244&type=chunk)[246](index=246&type=chunk) [Item 6 - Exhibits](index=68&type=section&id=Item%206%20-%20Exhibits) This section lists filed exhibits, including a key consulting agreement and required officer certifications - Exhibits filed include the **consulting agreement with Dr. Richard Straube**, CEO/CFO certifications, and XBRL interactive data files[248](index=248&type=chunk)

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]

NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) -- via InvestorWire — Soligenix Inc. (NASDAQ: SNGX) today announces its placement in an editorial published by NetworkNewsWire ("NNW"), one of 70+ brands within the Dynamic Brand Portfolio@IBN (InvestorBrandNetwork), a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. To view the full publication, “Clinical Progress in Rare Disease Signals Long-Term Revenue Potent ...

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]