AUSTIN, Texas, Aug. 08, 2025 (GLOBE NEWSWIRE) -- via IBN – NetworkNewsAudio announces the Audio Press Release (APR) titled “Late-Stage Pipeline Wins Boost Investor Confidence in High-Growth Therapeutic Areas,” featuring Soligenix Inc. (NASDAQ: SNGX). To hear the NetworkNewsAudio version, visit https://nnw.fm/Tflrp To read the original editorial, visit https://nnw.fm/JoDGY Soligenix Inc. is advancing HyBryte, its late-stage therapy for cutaneous T-cell lymphoma (CTCL), a rare and chronic cancer that primaril ...

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 ...

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]

Core Insights - The interim results from an FDA-funded study indicate that HyBryte™ shows a rapid response and strong safety profile in treating early-stage cutaneous T-cell lymphoma (CTCL), with 75% of patients achieving "Treatment Success" after 18 weeks of treatment [1][2][3] Company Overview - Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs, particularly in the area of CTCL [16][17] - The company is advancing HyBryte™ (SGX301), a novel photodynamic therapy utilizing synthetic hypericin, which has received orphan drug and fast track designations from the FDA [5][11] Study Details - The ongoing open-label, investigator-initiated study (IIS) has enrolled nine patients, with six out of eight evaluable patients achieving a predefined "Treatment Success" [2][3] - The study is designed to evaluate the efficacy of HyBryte™ over a treatment period of up to 54 weeks, with a focus on the cumulative mCAILS score [4][12] Treatment Efficacy - In the first Phase 3 FLASH study, HyBryte™ demonstrated a 16% response rate for at least a 50% reduction in lesions compared to 4% in the placebo group, indicating significant efficacy [6][7] - The second open-label treatment cycle showed a 40% response rate among patients treated for 12 weeks, further supporting the efficacy of extended treatment [7][8] Safety Profile - HyBryte™ has been reported to have a benign safety profile, with no significant systemic absorption and a mechanism of action that avoids DNA damage, making it a safer alternative to current therapies [9][10] - The treatment has been well tolerated across multiple cycles, with 66% of patients opting to continue treatment in the optional safety cycle [8][9] Future Developments - A confirmatory Phase 3 study, FLASH2, is expected to begin before the end of 2024, aiming to replicate the successful design of the first FLASH study and enroll approximately 80 subjects [11][12] - The study will assess the efficacy of HyBryte™ over an extended 18-week treatment period, with ongoing discussions with the FDA regarding study design [11][12] Financial Support - The FDA has awarded a grant of up to $2.6 million to support the investigator-initiated study evaluating HyBryte™ for expanded treatment options, including home use [13]

Core Insights - Soligenix Inc. is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs [1][5] - The company has selected IBN to lead its corporate communications efforts, leveraging IBN's extensive distribution network to enhance visibility [1][4] Company Overview - Soligenix operates through two main segments: Specialized BioTherapeutics, which targets oncology and inflammation therapies, and Public Health Solutions, which focuses on vaccines and therapeutics for biothreats and infectious diseases [2] - The company is advancing multiple late-stage clinical programs, including HyBryte™ (SGX301) for cutaneous T-cell lymphoma, and other candidates for psoriasis (SGX302), oral mucositis (SGX942), and Behçet's disease (SGX945) [2][5] Public Health Initiatives - The Public Health Solutions segment includes development programs for vaccines against ricin poisoning (RiVax®), Ebola (SuVax™), and Marburg (MarVax™), supported by approximately $60 million in non-dilutive government grants and contracts [3][6] - The vaccine development utilizes proprietary heat stabilization technology known as ThermoVax® [6] Strategic Partnerships - IBN will utilize its investor-focused distribution network, which includes over 5,000 syndication outlets and a large social media following, to increase awareness for Soligenix [4][5] - IBN has over 19 years of experience and has assisted more than 500 client partners, positioning it to effectively reach a broad audience [5]

Core Viewpoint - The combination of the COVID adenovirus vaccine and CiVax™ shows broader protection against COVID-19 variants compared to a two-shot mRNA vaccination series, indicating potential advantages in vaccine efficacy and distribution logistics [1][2]. Group 1: CiVax™ Vaccine Development - CiVax™ is a heat-stable subunit vaccine candidate for COVID-19, demonstrating broad immune responses in preclinical studies with mice and non-human primates [2][4]. - The vaccine can be stored at ambient temperatures and requires only reconstitution with sterile water before use, simplifying global vaccination efforts [2][3]. - Development of CiVax™ was partially funded by a $1.5 million Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) [5]. Group 2: Technological Advancements - The ThermoVax® platform has successfully stabilized vaccines for various pathogens, enhancing the standard protein subunit vaccination technology [2][9]. - CiVax™ has shown efficacy as a booster after other primary vaccinations against COVID-19, providing broad immune coverage [4][2]. Group 3: Collaboration and Research - The development of CiVax™ is a result of collaboration with Axel Lehrer, PhD, from the University of Hawaiʻi at Mānoa, focusing on heat-stable vaccines for both COVID-19 and filoviruses [2][3]. - The research emphasizes the need for robust technology platforms to rapidly develop vaccines for emerging infectious diseases, as demonstrated by the COVID-19 pandemic [6].