Soligenix(US:SNGX)2025-08-14 20:05Part I - FINANCIAL INFORMATION Item 1 - Condensed Consolidated Financial Statements (unaudited) This section presents the unaudited condensed consolidated financial statements for the periods ended June 30, 2025 Financial Statements 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 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®181921 - 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 2026242526 - In February 2025, the company fully repaid all outstanding obligations under its convertible debt agreement with Pontifax and terminated the loan agreement62 - 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, 20256467 Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's financial condition, operational results, product development progress, and reiterates the 'going concern' warning Business Overview and Strategy 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 20269196 - 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 Disease9296 - 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 alternatives9496 Product Candidates in Development 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 2026118123128 - 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 ulcers163166 - Filovirus Vaccines (SuVax™/MarVax™): The company received orphan drug designation for its vaccine candidates against Sudan ebolavirus and Marburg marburgvirus in April 2024181183186 - 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)194196 Results of Operations 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 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 2024207 - A 'going concern' warning has been issued, as current resources are expected to last only through Q1 2026210 - 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, 2025211214215 Item 3 - Quantitative and Qualitative Disclosures About Market Risk 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 material231 Item 4 - Controls and Procedures 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 effective233 - No material changes in internal controls over financial reporting were identified during the last fiscal quarter234 Part II - OTHER INFORMATION Item 1 - Legal Proceedings The company is not currently a party to any material legal proceedings - The company has no material legal proceedings to report236 Item 1A - Risk Factors 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, 2025239240 - 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 shareholders240 Item 2 - Unregistered Sales of Equity Securities and Use of Proceeds 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 registration242 Item 5 - Other Information 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, 2025244 - Following his retirement, Dr. Straube entered into a one-year consulting agreement to serve as the company's Consulting Chief Medical Officer244246 Item 6 - Exhibits 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 files248