CorMedix Announces Strategic Minority Investment in Talphera

BERKELEY HEIGHTS, N.J., Sept. 08, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that it has made a $5 million strategic minority equity investment in Talphera, Inc. (Nasdaq: TLPH), acquiring 9,090,909 shares at an at-market price of $0.55 per share as part of Talphera’s concurrently announced private placement financing. Talphera expects to use the proceeds of the equity financing to fund the completion of its ongoing Phase 3 registrational study for Niyad™ and for pre-launch preparations.

Talphera is a specialty pharmaceutical company developing Niyad, a lyophilized formulation of nafamostat which is currently being studied as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (“FDA”). Talphera’s randomized, double-blind, registrational study of Niyad, NEPHRO CRRT, aims to enroll and evaluate 70 adult patients undergoing continuous renal replacement therapy (“CRRT”), who cannot tolerate heparin or are at risk for bleeding. An estimated 165,000 acute kidney injury patients receive an average 5 to 7 day course of CRRT in the hospital ICU setting in a given year.

In connection with the equity investment, Talphera has granted CorMedix (1) the exclusive right of first negotiation for a potential acquisition of the company with a 60 day exclusive negotiation period following completion and announcement of its Phase 3 study results for Niyad, and (2) the right to nominate one member to Talphera’s Board of Directors.

“We are excited to announce this strategic investment and agreement with Talphera, as we see Niyad as a potential significant improvement above the current standard of care in CRRT,” said Joseph Todisco, CEO of CorMedix. “The investment in Talphera is consistent with our business development strategy to invest in highly synergistic and undervalued assets. We look forward to building a relationship with Talphera as it advances Niyad toward a potential approval in 2026.”

Vince Angotti, Talphera CEO, stated. “We appreciate the interest CorMedix has in Talphera and the support from a company that has quickly established itself as a leader in acute care specialty products. The completion of this financing with CorMedix as well as other high quality institutional investors further validates the potential value of Niyad to become a new standard of care in the hospital acute care market. If approved, Niyad would become the first available FDA-approved regional anticoagulant for CRRT.”

About CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath^® (taurolidine and heparin) for the prevention of catheter related bloodstream infections in patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products including MINOCIN^® (minocycline), REZZAYO™ (rezafungin), VABOMERE^® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA^® (delafloxacin), and KIMYRSA^® (oritavancin), as well as TOPROL-XL^® (metoprolol succinate).

CorMedix has ongoing clinical studies for DefenCath^® in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop DefenCath^® as a catheter lock solution for use in other patient populations. REZZAYO™ is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplantation. The completion of the Phase III study for REZZAYO™ is expected in 1H 2026. For more information visit: www.cormedix.com or www.melinta.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements, including, but not limited to statements regarding Talphera providing a synergistic investment opportunity; the anticipated benefits of CorMedix’s investment in Talphera; Talphera’s expected use of the proceeds of CorMedix’s investment; statements regarding Talphera’s potential completion of the CRRT study by the end of 2025; Talphera’s expectation and ability to obtain approval of the Niyad PMA in the second half of 2026; and expectations regarding the use of Niyad in the hospital setting. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix and in the Quarterly Report on Form 10-Q for the quarter ended, on June 30, 2025. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Forward-looking statements involve estimates, expectations, projections, goals, forecasts, assumptions, risks and uncertainties. Actual outcomes or results may differ from anticipated results, sometimes materially. Factors that could cause actual results to differ include, but are not limited to: Talphera’s ability to obtain regulatory approvals for its developmental product candidates; Talphera’s liquidity and its ability to maintain capital resources sufficient to conduct the required clinical studies; general economic conditions that are less favorable than expected; geopolitical developments and additional changes in international trade policies and relations, including tariffs; and the ability of our products and product candidates to compete effectively against current and future competitors.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.