Core Viewpoint - Soligenix, Inc. has received orphan drug designation from the European Commission for SGX945, a treatment for Behçet's Disease, following positive Phase 2a clinical results demonstrating biological efficacy and safety [1][3] Group 1: Orphan Drug Designation - The European Commission granted orphan drug designation to dusquetide for Behçet's Disease, which provides a 10-year marketing exclusivity period in the EU after product approval [2] - Orphan designation offers incentives for protocol assistance from the EMA and direct access to the centralized authorization procedure [2] Group 2: Clinical Results and Efficacy - The Phase 2a study of SGX945 showed a 40% improvement in the mean number of ulcers compared to placebo, which is higher than the 37% improvement seen with apremilast in a Phase 3 study [6][7] - The improvement with SGX945 was sustained, showing a 32% improvement at Week 8 after treatment ended at Week 4, while apremilast showed a 41% improvement at Week 8 with continuous administration [6][7] Group 3: Patient Population and Unmet Need - Behçet's Disease affects approximately 18,000 people in the U.S., 50,000 in Europe, and up to 1 million people worldwide, indicating a significant unmet medical need [3][10] - The disease is characterized by painful symptoms that severely impact patients' quality of life, with no current cure available [9][11] Group 4: Mechanism of Action and Safety - Dusquetide, the active ingredient in SGX945, is an innate defense regulator that modulates the body's immune response to promote healing and reduce inflammation [4] - The drug has demonstrated safety and tolerability in a Phase 1 study with 84 healthy volunteers, and no treatment-related adverse events were reported in the Phase 2a study [5][7] Group 5: Intellectual Property and Development - Soligenix holds a strong intellectual property position for dusquetide and related analogs, which enhances its competitive edge in the market [8] - The company is also developing other products targeting rare diseases, indicating a diversified pipeline focused on unmet medical needs [12]

Rising to the Challenges of Rare Disease Treatment NASDAQ: SNGX March 27, 2026 Forward-Looking Statements This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products and product candidates and their development, regulatory approvals, ability to commercialize our products and product candidates and a ...

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 Investment & Growth Summit on March 2, 2026 [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 [1] - The company is also expanding its product pipeline, which includes SGX302 for psoriasis, dusquetide (SGX942) for inflammatory diseases, and SGX945 for Behçet's Disease [1] - 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 [1] Upcoming Events - Christopher J. Schaber, Ph.D., President & CEO of Soligenix, will deliver a corporate presentation at the BIO Investment & Growth Summit on March 2, 2026, in Miami Beach, Florida [1] Funding and Support - The development of Soligenix's vaccine programs has been supported by government grants and contracts from agencies such as NIAID, DTRA, and BARDA [1]

Core Insights - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, highlighting significant progress in its clinical pipeline and upcoming milestones for 2026 [1][2] Clinical Developments - Top-line results from the Phase 2a trial of SGX302 for mild-to-moderate psoriasis showed that the gel therapy was well tolerated, with one patient achieving "Almost Clear" status and over 50% improvement in PASI score [1] - The Phase 2a trial of SGX945 for Behçet's Disease demonstrated biological efficacy, with results comparable to apremilast, indicating potential for home-based treatment in future studies [1] - Ongoing studies for HyBryte™ in early-stage cutaneous T-cell lymphoma (CTCL) show promising results, with 75% of patients achieving "Treatment Success" after 18 weeks of treatment [1] Market Opportunities - Peak annual net sales for HyBryte™ in the U.S. are expected to exceed $90 million, with a total addressable worldwide CTCL market estimated at over $250 million annually [2] - The psoriasis market opportunity with SGX302 is projected to exceed $1 billion annually, while SGX945 for Behçet's Disease is estimated at approximately $200 million annually [2] - Overall, the potential for significant commercial returns across the rare disease pipeline is estimated at around $2 billion in global annual sales [2] Financial Position - As of September 30, 2025, the company reported approximately $10.5 million in cash, with additional non-dilutive funding of about $500 thousand from New Jersey's NOL sales program [2] - The company is focused on advancing its development programs and has sufficient capital to meet its goals through 2026 [2]

Core Insights - Soligenix, Inc. has published results from its Phase 2a study of SGX945 (dusquetide) for treating Behçet's Disease, indicating promising outcomes for patients with oral ulcers associated with the condition [1][2][5] Study Results - The Phase 2a study showed beneficial effects for 7 out of 8 patients over 4 weeks of treatment, with sustained improvements noted during the follow-up period [2][4] - SGX945 demonstrated a 40% improvement in the area under the curve (AUC) for the mean number of ulcers compared to placebo, while the approved drug apremilast showed a 37% improvement [3][9] - Improvements in oral pain were consistent with the AUC measurements, with 7 of 8 patients reporting benefits such as reduced duration and number of oral ulcers [4][9] Safety and Tolerability - SGX945 was well-tolerated with no treatment-related adverse events reported, contrasting with common side effects associated with apremilast, such as diarrhea (41%), nausea (19%), and headache (14%) [4][9] Future Development Plans - The company plans to reformulate SGX945 for home-based treatment via subcutaneous injection and aims to expand its development into other inflammatory conditions related to the innate immune system [5][10] - Soligenix holds a strong intellectual property position for dusquetide and has received Fast-Track and Orphan Drug designations from the FDA for its treatment of Behçet's Disease [10][12] Market Context - Behçet's Disease is a chronic condition affecting approximately 1 million people worldwide, with significant unmet medical needs, particularly in managing symptoms like oral ulcers [11][12] - Current treatments, including apremilast, require continuous administration and are associated with high costs and side effects, highlighting the potential market opportunity for SGX945 [14][15]

Core Insights - Soligenix Inc. is a late-stage biopharmaceutical company focused on developing therapies for rare diseases with significant unmet medical needs [3][4] - The U.S. healthcare system faces increasing challenges from chronic illnesses and rare disorders, particularly among older populations, with over 30 million Americans affected by rare diseases [2][3] - Soligenix is advancing several therapies, including HyBryte(TM) for cutaneous T-cell lymphoma, and is positioned to align with national healthcare goals under the current administration [3][4] Company Overview - Soligenix Inc. specializes in developing and commercializing products for rare diseases, with a focus on HyBryte(TM) as a novel photodynamic therapy for cutaneous T-cell lymphoma [4] - The company is also expanding its pipeline to include treatments for psoriasis and inflammatory diseases, as well as vaccine candidates for bioterrorism threats and COVID-19 [5] Industry Context - The increasing burden of rare diseases among aging populations highlights the urgent need for innovative treatments, as many conditions lack FDA-approved therapies [2][3] - The company's initiatives are supported by government grants and contracts from agencies such as NIAID, DTRA, and BARDA, indicating a strong alignment with public health objectives [5]

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]

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]