Core Viewpoint - Soligenix, Inc. is expanding its European Medical Advisory Board to enhance strategic guidance for the Phase 3 study of HyBryte™ in treating cutaneous T-cell lymphoma (CTCL), with top-line results expected in the second half of 2026 [1][2]. Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, particularly through its Specialized BioTherapeutics segment [20]. - The company is advancing HyBryte™ (SGX301), a novel photodynamic therapy utilizing synthetic hypericin, aimed at treating CTCL [20]. Clinical Study Details - The confirmatory Phase 3 study, named FLASH2, will enroll approximately 80 patients and is designed to replicate the successful elements of the previous Phase 3 FLASH trial, which showed a 49% treatment response rate [15]. - The FLASH2 study will extend the double-blind, placebo-controlled assessment to 18 weeks, with the primary endpoint assessed at the end of this period [15]. Advisory Board Expansion - The European Medical Advisory Board now includes five esteemed dermatologists, enhancing the company's expertise in clinical strategies and regulatory interactions [2][3][4][7][8]. - The board members are recognized leaders in the field of dermatology and CTCL, contributing valuable insights for the upcoming clinical study [2][3][4][7][8]. Treatment Mechanism and Efficacy - HyBryte™ employs synthetic hypericin activated by visible light, which penetrates deeper into the skin compared to ultraviolet light, potentially treating more severe skin conditions [9]. - In previous studies, HyBryte™ demonstrated a statistically significant improvement in lesion reduction compared to placebo, with a 16% response rate in the first treatment cycle [10]. Safety Profile - HyBryte™ is noted for its safety, with no systemic absorption and a mechanism of action that does not involve DNA damage, making it a safer alternative to existing therapies [14]. - The treatment has been well tolerated across multiple cycles, with a significant portion of patients opting to continue treatment in the optional safety cycle [13]. Market Context - CTCL is a rare form of non-Hodgkin's lymphoma affecting approximately 31,000 individuals in the U.S. and 38,000 in Europe, with no current cure available [19][18]. - The company aims to address the significant safety risks associated with existing treatments, positioning HyBryte™ as a potentially safer and effective option for patients [14].

Core Viewpoint - Soligenix, Inc. has successfully closed a public offering, raising approximately $7.5 million, which extends its cash runway through the end of 2026 to support key development milestones in its biopharmaceutical projects [1][3]. Funding and Financial Details - The company sold 5,555,560 shares of common stock and warrants at a combined price of $1.35 per share [1]. - The warrants have an exercise price of $1.35 per share, are immediately exercisable, and will expire five years from the issuance date [1]. - The net proceeds from the offering will be allocated to research and development, commercialization activities, working capital, and general corporate purposes [3]. Existing Warrants Amendment - Certain existing warrants from May 2023, April 2024, and July 2024 will be amended to have a reduced exercise price of $1.35 per share, aligning their expiration with the new warrants sold in the offering [2]. Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs [6]. - The company is advancing its Specialized BioTherapeutics segment, particularly HyBryte™ (SGX301), aimed at treating cutaneous T-cell lymphoma, and is seeking regulatory approvals following successful Phase 3 study results [6]. - The Public Health Solutions segment includes vaccine development programs for ricin toxin, filoviruses, and COVID-19, supported by government funding [7].

Core Viewpoint - Soligenix, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $7.5 million to fund research, development, and general corporate purposes [3]. Group 1: Offering Details - The company is offering 5,555,560 shares of common stock and warrants to purchase an equal number of shares at a combined price of $1.35 per share and warrant [1]. - The existing warrants will be amended to have a reduced exercise price of $1.35 per share and will expire in line with the new warrants [2]. - The closing of the offering is expected around September 29, 2025, pending customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for research and development, commercialization activities, working capital, and general corporate purposes [3]. Group 3: Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs [7]. - The company is advancing HyBryte™ (SGX301) for the treatment of cutaneous T-cell lymphoma and has completed a second Phase 3 study [7]. - Other development programs include treatments for psoriasis, inflammatory diseases, and a ricin toxin vaccine candidate [8].

Core Insights - Soligenix, Inc. has appointed Dr. Tomas J. Philipson as a Strategic Advisor, bringing extensive experience in U.S. economic and healthcare policy to the company [1][2][3] - The company is advancing its lead product candidate, HyBryte, which is currently in a confirmatory Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma (CTCL) [3][9] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs [15] - The company’s Specialized BioTherapeutics segment is working on HyBryte, a novel photodynamic therapy utilizing synthetic hypericin for CTCL treatment [15] Product Details - HyBryte (SGX301) is a first-in-class photodynamic therapy that uses safe, visible light for activation, targeting malignant T-cells in skin lesions [4] - The treatment has shown significant efficacy in clinical trials, with a 16% response rate in the first treatment cycle compared to 4% in the placebo group [5] - In the second treatment cycle, a 40% response rate was observed among patients receiving 12 weeks of HyBryte treatment [6] Clinical Trials - The first Phase 3 FLASH trial enrolled 169 patients, demonstrating statistically significant improvements in lesion reduction [5] - A second confirmatory Phase 3 trial, FLASH2, is expected to begin before the end of 2024, aiming to replicate the successful design of the first trial [9][10] - The FDA has awarded a $2.6 million Orphan Products Development grant to support an investigator-initiated study of HyBryte for early-stage CTCL [12] Market Context - CTCL is a rare form of non-Hodgkin's lymphoma affecting approximately 31,000 individuals in the U.S. and 38,000 in Europe, with no current cure available [14][13] - The safety profile of HyBryte is a significant advantage, as it is not associated with DNA damage, unlike many existing therapies [8]

Group 1 - The article does not provide any specific content or data related to a company or industry [1]

Core Viewpoint - Soligenix, Inc. has demonstrated the extended stability of its ebolavirus vaccines using the ThermoVax® platform, maintaining potency after two years at high temperatures, which is crucial for deployment in virus-endemic regions and for pandemic preparedness [1][2]. Group 1: Vaccine Stability and Efficacy - The bivalent and trivalent vaccines, targeting Zaire ebolavirus, Sudan ebolavirus, and Marburg marburgvirus, showed no change in potency after two years of storage at 40°C (104°F) [1]. - The vaccines have exhibited broad immune responses in mice and up to 100% protection in non-human primates [2][3]. - The ThermoVax® platform enhances the stability of vaccines, making them competitive with other technologies that require stringent cold-storage [2][3]. Group 2: Vaccine Development and Manufacturing - The filovirus vaccines are subunit protein vaccines developed in collaboration with Dr. Axel Lehrer, utilizing a robust protein manufacturing process [3][4]. - The vaccines are designed to be heat-stable and can be lyophilized, allowing for easy reconstitution with water prior to use [3]. - The adjuvant used in the vaccines has been tested in Phase 1 and Phase 2 clinical studies, supporting its safety and efficacy [4]. Group 3: Regulatory and Market Position - Soligenix has received Orphan Drug Designation from the FDA for its filovirus vaccines, providing market exclusivity and various financial benefits [5]. - The company is positioned to leverage government grants and regulatory advantages to support clinical trials and potential market entry [5]. Group 4: Public Health Context - Filoviruses, including Ebola and Marburg, have high mortality rates and limited treatment options, highlighting the need for effective vaccines [6][7]. - Recent outbreaks of Sudan and Marburg viruses underscore the importance of developing vaccines that can be stored and distributed easily in affected regions [6][7].

Company Overview - Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs [3] - The company has a Specialized BioTherapeutics segment that is advancing HyBryte™ (SGX301), a novel photodynamic therapy for cutaneous T-cell lymphoma (CTCL), towards potential commercialization following the successful completion of a second Phase 3 study [3] - Other development programs include SGX302 for psoriasis, SGX942 for inflammatory diseases, and SGX945 for Behçet's Disease [3] Public Health Solutions - The Public Health Solutions segment includes the development of RiVax®, a ricin toxin vaccine candidate, and vaccines targeting filoviruses and COVID-19 [4] - The vaccine programs utilize the proprietary ThermoVax® technology and have received support from government grants and contracts from agencies such as NIAID, DTRA, and BARDA [4] Upcoming Events - Christopher J. Schaber, Ph.D., President and CEO of Soligenix, will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, with an on-demand presentation available on September 5, 2025 [1] - Key management members will hold one-on-one meetings throughout the conference, and registered attendees can schedule meetings via the conference platform [2]

Core Viewpoint - Soligenix, Inc. has seen a significant increase in stock price following the U.S. FDA granting orphan drug designation to dusquetide for Behçet's Disease, supported by recent positive clinical trial results demonstrating efficacy and safety [1][6]. Company Summary - The orphan drug designation provides Soligenix with a seven-year market exclusivity upon final FDA approval, along with various financial and regulatory benefits such as government grants for clinical trials, waiver of FDA user fees for New Drug Application submission, and certain tax credits [3]. - Dusquetide has shown safety and tolerability in a Phase 1 study involving 84 healthy volunteers, and positive efficacy results in Phase 2 and 3 studies with over 350 subjects suffering from oral mucositis due to chemoradiation therapy for head and neck cancer [6]. - The stock price of Soligenix has increased by 67.29%, reaching $4.65 at the time of publication [7]. Industry Summary - Behçet's Disease is a rare inflammatory disorder affecting up to 18,000 people in the U.S., 50,000 in Europe, 350,000 in Turkey, and potentially one million people worldwide, characterized by painful sores and eye inflammation [4]. - The U.S. Orphan Drug Act aims to encourage the development of therapies for rare diseases, providing incentives for companies like Soligenix to invest in these areas [2].

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)