Core Insights - Inhibrx Biosciences, Inc. will host a live webcast on October 23, 2025, to present topline results from the ChonDRAgon study of ozekibart (INBRX-109) for advanced chondrosarcoma [1] - The company will also provide updates on ongoing trials of ozekibart in combination therapies for colorectal cancer and Ewing sarcoma [1] Company Overview - Inhibrx is a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology and rare diseases [1][5] - The company utilizes diverse protein engineering methods to create novel biologic therapeutic candidates [5] Product Information - Ozekibart (INBRX-109) is a tetravalent death receptor 5 (DR5) agonist antibody designed to induce tumor-biased cell death [3] - The FDA granted Fast Track designation for ozekibart in January 2021 and orphan drug designation in November 2021 for chondrosarcoma [3] Clinical Trials - A Phase 2 trial of ozekibart in metastatic, unresectable conventional chondrosarcoma was initiated in June 2021 [4] - Ongoing Phase 1/2 trials are investigating ozekibart in combination with FOLFIRI for colorectal cancer and with irinotecan/temozolomide for Ewing sarcoma [4]

Core Insights - Urica Therapeutics, a subsidiary of Fortress Biotech, has initiated Phase 3 trials for dotinurad, a new oral treatment for gout, marking a significant advancement in its clinical development program [1][3] Group 1: Clinical Trials - The RUBY study will evaluate dotinurad's safety and efficacy in approximately 500 patients with hyperuricemia associated with gout, with participants receiving the drug once daily for up to 64 weeks [4] - The TOPAZ study will assess dotinurad in about 250 patients with tophaceous gout, with a treatment duration of up to 76 weeks [5] Group 2: Market Context - Gout is a prevalent form of inflammatory arthritis caused by excess uric acid, leading to severe pain and inflammation, with a significant treatment gap for patients not responding to first-line therapies [6] - There are currently no suitable second-line treatment options available in the U.S. or E.U., highlighting a critical unmet need in the market [6] Group 3: Company Developments - Fortress Biotech has achieved significant milestones, including two FDA approvals and a substantial acquisition, enhancing its portfolio and potential revenue streams [3] - Urica holds a minority equity position in Crystalys and is entitled to a 3% royalty on future net sales of dotinurad, indicating a strategic financial interest in the drug's success [3]

Core Viewpoint - Urica Therapeutics, a subsidiary of Fortress Biotech, has initiated two Phase 3 clinical trials for dotinurad, a new oral treatment for gout, which could address significant unmet medical needs in this area [1][3]. Clinical Trials - The RUBY study will evaluate dotinurad's safety and efficacy in approximately 500 patients with hyperuricemia associated with gout, with participants receiving the drug once daily for up to 64 weeks [4]. - The TOPAZ study will assess dotinurad in about 250 patients with tophaceous gout, with a treatment duration of up to 76 weeks [5]. Company Developments - Fortress Biotech's Executive Chairman highlighted the initiation of these trials as a major milestone, building on recent successes including two FDA approvals and a significant acquisition [3]. - Fortress received approximately $28 million upfront from the acquisition of Checkpoint Therapeutics by Sun Pharma, with potential future payments and royalties [3]. Market Context - Gout is characterized by painful inflammation due to excess uric acid, and there is a notable treatment gap for patients who do not respond to first-line therapies [6]. - Current treatment options in the U.S. and E.U. are limited, indicating a critical need for new therapies like dotinurad [6]. Company Overview - Fortress Biotech focuses on acquiring and advancing biopharmaceutical assets to enhance shareholder value through various revenue streams [7]. - The company has a diverse portfolio, including eight marketed products and multiple development programs across therapeutic areas such as oncology and rare diseases [8].

Core Insights - Palisade Bio, Inc. has successfully closed an underwritten public offering, raising approximately $138 million to support the Phase 2 clinical development of PALI-2108 for Ulcerative Colitis [1][2] Group 1: Offering Details - The offering consisted of 197,154,844 shares of common stock priced at $0.70 per share [3] - The offering was led by B Group Capital and Columbia Threadneedle Investments, with participation from several notable investors [1] Group 2: Use of Proceeds - Proceeds from the offering will be utilized to advance the clinical development program for PALI-2108, which targets significant unmet medical needs in inflammatory bowel disease (IBD) [2] Group 3: Company Overview - Palisade Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases [6]

Core Insights - Kiniksa Pharmaceuticals reported a strong commercial performance in Q2 2025, with ARCALYST net product revenue reaching $156.8 million, reflecting a 52% year-over-year growth [1][2][8] - The company has raised its 2025 ARCALYST net sales guidance to between $625 million and $640 million, up from a previous range of $590 million to $605 million [2][13] - Kiniksa is advancing its clinical pipeline, with the initiation of the Phase 2/3 clinical trial for KPL-387 in recurrent pericarditis, expecting data in the second half of 2026 [4][15] Financial Performance - Total revenue for Q2 2025 was $156.8 million, compared to $108.6 million in Q2 2024 [8][22] - The net income for Q2 2025 was $17.8 million, a significant improvement from a net loss of $3.9 million in Q2 2024 [13][22] - Operating expenses for Q2 2025 totaled $136.6 million, up from $108.7 million in Q2 2024, with collaboration expenses increasing due to ARCALYST profitability [8][22] Product and Pipeline Updates - ARCALYST has been prescribed by over 3,475 prescribers for recurrent pericarditis, with an average treatment duration of approximately 30 months [7] - As of Q2 2025, about 15% of the target 14,000 multiple-recurrence patients are actively receiving ARCALYST treatment [7] - KPL-387 is in the dose-focusing portion of its Phase 2/3 trial, with plans for a pivotal trial to follow [4][15] Cash Position - Kiniksa's cash balance increased by $39.4 million in Q2 2025, reaching $307.8 million, with no debt reported [1][13][23] - The company expects to maintain a cash flow positive operating plan on an annual basis [13]

Financial Performance - As of March 31, 2025, the company had cash and cash equivalents and short-term deposits of $1,018 thousand, a decrease from $1,964 thousand as of March 31, 2024 [3] - Revenues for the three months ended March 31, 2025, totaled $586 thousand, reflecting a year-over-year increase driven by a higher number of contracts executed in the CDMO business [7] - R&D expenses for the same period amounted to $1,296 thousand, down from $1,568 thousand in 2024, primarily due to lower wages and reduced direct R&D expenses [7] - Marketing, general and administrative expenses were $500 thousand, slightly up from $484 thousand in the same period last year [7] - The net loss for the three months ended March 31, 2025, was $1,557 thousand, an improvement from a net loss of $2,159 thousand for the same period in 2024 [7] Business Overview - Scinai Immunotherapeutics Ltd. is a biopharmaceutical company focused on developing innovative biological drug candidates for inflammation and immunology-related diseases [4] - The company operates two business units: one for in-house development of biological therapeutic products and another as a boutique CDMO providing various drug development services [4] - The CDMO unit began generating revenues in the second quarter of 2024, with full-year revenues for 2024 reported at $658 thousand [7]

Table of Contents THE SECURITIES ACT OF 1933 SOLIGENIX, INC. (Exact Name of Registrant as Specified in Its Charter) As filed with the Securities and Exchange Commission on March 15, 2024. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER (Primary Standard Industrial Classification Code Number) Delaware 2834 41-1505029 (I.R.S. Employer Identification Number) Soligenix, Inc. 29 Emmons Drive, Suite B-10 Princeton, New Jersey 08540 ( ...