CorMedix Announces Strategic Minority Investment in Talphera

Rhea-AI Summary

CorMedix (NASDAQ:CRMD) has announced a strategic $5 million minority investment in Talphera (NASDAQ:TLPH), acquiring 9,090,909 shares at $0.55 per share. The investment is part of Talphera's private placement financing to fund its Phase 3 study of Niyad™, a breakthrough-designated anticoagulant for extracorporeal circuits.

As part of the deal, CorMedix receives exclusive first negotiation rights for a potential Talphera acquisition, with a 60-day exclusive period following Phase 3 results. Additionally, CorMedix gains the right to nominate one director to Talphera's board. Niyad targets an estimated 165,000 acute kidney injury patients annually who receive CRRT treatment and cannot tolerate heparin.

Positive

• None.

Negative

• Significant investment in early-stage company with pending Phase 3 trial results
• Risk of trial failure or regulatory rejection for Niyad
• Limited 60-day window for exclusive acquisition negotiations post-trial results

Insights

Biotech Investment Strategist

CorMedix's $5M strategic investment in Talphera provides acquisition option for promising renal therapy; strengthens acute care portfolio positioning.

CorMedix has made a $5 million strategic minority investment in Talphera, acquiring 9,090,909 shares at $0.55 per share. This calculated move gives CorMedix two significant strategic advantages: an exclusive first-negotiation right for potentially acquiring Talphera after its Phase 3 results are announced, and the ability to nominate a director to Talphera's board.

The investment targets Talphera's lead product Niyad™, a nafamostat formulation being developed as an anticoagulant for extracorporeal circuits with FDA Breakthrough Device Designation. Niyad addresses a critical unmet need in continuous renal replacement therapy (CRRT) for patients who cannot tolerate standard heparin anticoagulation. The addressable market is substantial, with an estimated 165,000 acute kidney injury patients annually receiving CRRT treatments lasting 5-7 days.

This transaction represents a dual-purpose strategy for CorMedix: it secures a potential acquisition pathway while enabling Talphera to complete its pivotal NEPHRO CRRT study and prepare for commercial launch. The investment aligns perfectly with CorMedix's stated business development approach of targeting undervalued, synergistic assets that complement its focus on acute care specialty products.

If Niyad achieves FDA approval (potentially in 2026), it would become the first FDA-approved regional anticoagulant for CRRT, establishing a new standard of care in this niche but vital hospital acute care segment. For CorMedix, this represents a thoughtful portfolio expansion opportunity with controlled financial exposure while maintaining optionality on full acquisition based on clinical trial outcomes.

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

FAQ

What is the value of CorMedix's investment in Talphera (TLPH)?

CorMedix invested $5 million to acquire 9,090,909 shares at $0.55 per share as part of Talphera's private placement financing.

What rights did CorMedix (CRMD) receive in the Talphera investment?

CorMedix received exclusive first negotiation rights for potential acquisition with a 60-day window after Phase 3 results, plus the right to nominate one board director.

What is Talphera's Niyad product and its market potential?

Niyad is a breakthrough-designated anticoagulant for CRRT, targeting approximately 165,000 annual patients with acute kidney injury who cannot tolerate heparin.

When is the potential FDA approval expected for Talphera's Niyad?

Talphera is targeting potential FDA approval for Niyad in 2026, pending successful completion of its Phase 3 NEPHRO CRRT trial.

How many patients will be enrolled in Talphera's Phase 3 NEPHRO CRRT trial?

The Phase 3 trial aims to enroll and evaluate 70 adult patients undergoing continuous renal replacement therapy who cannot tolerate heparin or are at risk for bleeding.