Core Insights - CorMedix Therapeutics reported preliminary unaudited financial results for Q4 and FY 2025, with Q4 net revenue of approximately $127 million and FY 2025 net revenue of approximately $310 million, alongside a pro forma net revenue of approximately $400 million for FY 2025 [1][3] - The company expects Q4 2025 adjusted EBITDA to be between $77 million and $81 million, and reported unaudited cash and short-term investments of approximately $148 million as of December 31, 2025 [1][3] Financial Performance - Preliminary unaudited net revenue for Q4 2025 is approximately $127 million, while FY 2025 net revenue is approximately $310 million [1] - FY 2025 pro forma net revenue is approximately $400 million [1] - Expected Q4 adjusted EBITDA is between $77 million and $81 million [1] - As of December 31, 2025, unaudited cash and short-term investments are approximately $148 million [1] Business Updates - CorMedix anticipates clinical data from the Phase 3 ReSPECT study of REZZAYO® in Q2 2026 [1] - The ongoing Phase 3 study of taurolidine/heparin catheter lock solution in TPN patients is expected to complete enrollment in early 2027 [1] - Strong utilization and patient growth for DefenCath® is noted among outpatient dialysis organization customers [1] Revenue Guidance - FY 2026 revenue guidance is set at $300 million to $320 million, including $150 million to $170 million for DefenCath [1] - DefenCath revenue guidance for 2026 is heavily weighted towards H1 2026, with expectations of modest utilization growth [1] - For FY 2027, CorMedix estimates DefenCath sales in the range of $100 million to $140 million, assuming maintenance of current outpatient dialysis utilization [1] Operational Synergies - The company has operationalized synergies of approximately $35 million on a full-year run rate basis related to the acquisition of Melinta [1] - Estimated FY 2026 operating expenses are projected to be between $145 million and $160 million, excluding non-cash items and one-time expenses [1] Future Events - CorMedix will hold an Analyst Day on February 10, 2026, to provide insights on its key pipeline assets and future strategic direction [2][3]

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on October 20, 2025 Registration No. 333-287675 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 TVARDI THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 75-3175693 (Primary Standard Industrial Classification Code Number) (I.R.S. Emp ...

Table of Contents As filed with the Securities and Exchange Commission on October 7, 2025 Registration No. 333-287675 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 TVARDI THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 75-3175693 (I.R.S. Empl ...

Core Viewpoint - Soligenix, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $7.5 million to fund research, development, and general corporate purposes [3]. Group 1: Offering Details - The company is offering 5,555,560 shares of common stock and warrants to purchase an equal number of shares at a combined price of $1.35 per share and warrant [1]. - The existing warrants will be amended to have a reduced exercise price of $1.35 per share and will expire in line with the new warrants [2]. - The closing of the offering is expected around September 29, 2025, pending customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for research and development, commercialization activities, working capital, and general corporate purposes [3]. Group 3: Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs [7]. - The company is advancing HyBryte™ (SGX301) for the treatment of cutaneous T-cell lymphoma and has completed a second Phase 3 study [7]. - Other development programs include treatments for psoriasis, inflammatory diseases, and a ricin toxin vaccine candidate [8].

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]

As filed with the Securities and Exchange Commission on March 26, 2025. Registration No. 333-286072 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GRI BIO, INC. (Exact name of registrant as specified in its charter) Delaware 2834 82-4369909 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) Ad ...

Table of Contents As filed with the Securities and Exchange Commission on January 23, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT Under The Securities Act Of 1933 AARDVARK THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) 4370 La Jolla Village Drive, Suite 1050 San Diego, CA 92122 (858) 225-7696 (Address, including zip code, and telepho ...

Table of Contents As filed with the Securities and Exchange Commission on March 14, 2024 Registration No. 333-276251 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 PRE-EFFECTIVE AMENDMENT NO. 3 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Spyre Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 46-4312787 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 221 Crescent Street Build ...

S-1 1 tenx_s1.htm FORM S-1 As filed with the U.S. Securities and Exchange Commission on December 1, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Tenax Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 26-2593535 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identi ...

Table of Contents As filed with the Securities and Exchange Commission on August 18, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 2834 (Primary Standard Industrial Classification Code Number) Alex Wilson, Chief Legal Officer c/o AEON Biopharma, Inc. 5 Park Plaza, Suite 1750 Irvine, California 92614 ...