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Soligenix(SNGX) - 2024 Q4 - Annual Report
2025-03-21 20:05
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)
Soligenix Announces Recent Accomplishments and Year End 2024 Financial Results
Prnewswire· 2025-03-21 11:30
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].
HyBryte™ Treatment Studies Presented at Two Medical Conferences in March
Prnewswire· 2025-03-06 12:30
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]
Soligenix to Present at BIO CEO & Investor Conference
Prnewswire· 2025-02-04 12:30
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].
Soligenix to Present at Upcoming Investor Conferences
Prnewswire· 2025-01-16 12:30
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 ...
HyBryte™ Expanded Treatment Continues to Demonstrate Positive Outcomes in Early-Stage Cutaneous T-Cell Lymphoma
Prnewswire· 2025-01-14 12:30
Core Viewpoint - Soligenix, Inc. has received a $2.6 million FDA Orphan Products Development grant to support an investigator-initiated study evaluating the extended use of HyBryte™ for treating early-stage cutaneous T-cell lymphoma (CTCL), showing promising initial results with over 70% of patients achieving treatment success [1][12]. 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, which includes HyBryte™ for CTCL [15]. - The company is advancing its product pipeline, including potential treatments for psoriasis and inflammatory diseases, alongside its vaccine programs targeting bioterror threats and COVID-19 [16]. Study Details - The ongoing open-label study has enrolled nine patients, with five achieving "Treatment Success," defined as a ≥50% improvement in the mCAILS score [1]. - The study allows for treatment over 12 months with twice-weekly dosing, and initial results indicate that HyBryte™ is safe and well-tolerated [1][12]. - The Phase 3 FLASH study previously demonstrated a 16% treatment response rate for HyBryte™ compared to 4% for placebo, with a statistically significant p-value of 0.04 [5]. Treatment Efficacy - In the second treatment cycle of the FLASH study, a 40% response rate was observed among patients treated for 12 weeks, significantly higher than the placebo group [6]. - The third optional treatment cycle showed that 66% of patients opted to continue treatment, with 49% demonstrating a positive response [7]. Safety Profile - HyBryte™ has a favorable safety profile, not associated with DNA damage, making it a safer alternative to existing therapies that carry significant side effects [8]. - The treatment's mechanism avoids the risks of secondary malignancies, which are common with current therapies for CTCL [8]. Regulatory and Future Studies - The FDA and EMA require a second successful Phase 3 trial for marketing approval, with the FLASH2 study expected to begin before the end of 2024 [9][10]. - The FLASH2 study will replicate the successful design of the first FLASH study, extending treatment duration to 18 weeks to assess efficacy in a real-world setting [10].
Soligenix Initiates Confirmatory Phase 3 Clinical Trial of HyBryte™ for the Treatment of Cutaneous T-Cell Lymphoma
Prnewswire· 2024-12-16 12:30
Core Viewpoint - Soligenix, Inc. has initiated patient enrollment for its confirmatory Phase 3 study, FLASH2, to evaluate HyBryte™ in treating cutaneous T-cell lymphoma (CTCL), building on previous successful studies [1][9]. Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, including HyBryte™ for CTCL [14]. - The company is also developing other products, including SGX302 for psoriasis and SGX942 for inflammatory diseases [14][15]. Product Details - HyBryte™ (SGX301) is a novel photodynamic therapy using synthetic hypericin activated by safe visible light, targeting malignant T-cells in CTCL [3][4]. - The treatment avoids risks associated with DNA-damaging drugs and has shown significant anti-proliferative effects on malignant T-cells [3][8]. Clinical Study Insights - The FLASH2 study will enroll approximately 80 subjects with early-stage CTCL, extending the treatment duration to 18 weeks of continuous therapy [2][9]. - In the previous Phase 3 FLASH study, a treatment response of 49% was observed in patients completing 18 weeks of therapy [5][9]. - The FLASH2 study aims to replicate the successful design of the first FLASH study while providing a more prolonged treatment assessment [9][10]. Regulatory and Funding Support - HyBryte™ has received orphan drug and fast track designations from the FDA and orphan designation from the EMA [4]. - The FDA awarded a $2.6 million Orphan Products Development grant to support the evaluation of HyBryte™ for early-stage CTCL treatment [11]. 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 [12][13]. - The disease's treatment landscape is motivated by safety concerns, as existing therapies often have significant side effects [8].
HyBryte™ Clinical Results Demonstrate Continued Improvement Post-Treatment
Prnewswire· 2024-12-02 12:30
Significant Efficacy against Plaque Lesions Also Demonstrated with HyBryte™PRINCETON, N.J., Dec. 2, 2024 /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 analysis of the post-treatment data from the open-label study (protocol HPN-CTCL-04) comparing HyBryte™ (synthetic hypericin) to Valchlor® (mechlorethamine) has ...
Soligenix Announces Formation of European Medical Advisory Board for Cutaneous T-Cell Lymphoma
Prnewswire· 2024-11-19 12:30
Phase 3 clinical study of HyBryte™ in CTCL initiating in 2024PRINCETON, N.J., Nov. 19, 2024 /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 the formation of a European Medical Advisory Board (MAB) to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 multicen ...
Soligenix Initiates a Phase 2 Clinical Trial of SGX945 (dusquetide) for the treatment of Behçet's Disease
Prnewswire· 2024-11-14 12:15
Study DUS-AUBD-01 opens patient enrollmentPRINCETON, N.J., Nov. 14, 2024 /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 it has opened patient enrollment for its Phase 2 study (protocol number DUS-AUBD-01) evaluating SGX945 (dusquetide) in the treatment of Behçet's Disease."We are pleased to have received FDA cl ...