ZyVersa Therapeutics Releases Mid-Year Shareholder Letter Highlighting Recent Corporate Developments And R&D Progress Including Closing Two Financial Transactions Providing Access To $12M In Capital

 ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA, "ZyVersa"))), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, announces that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, has issued a mid-year Shareholder Letter to update investors on recent corporate developments and to highlight near-term value-building R&D milestones for second half of 2025. The full text of the letter follows.

A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER

Dear Shareholders:

Over my 40-year career, I've seen the full arc of biotech—celebrated successes and weathered setbacks. Today's biotech environment ranks among the most challenging we've faced: capital markets remain tight, sector valuations are compressed, major exchanges are underperforming, and investor sentiment is cautious. Yet history teaches us that it's in these moments—when others pull back—that focused, disciplined companies with sound science and strong leadership can chart a breakthrough course.

At ZyVersa, we believe we are exceptionally positioned to do just that. Our pipeline is advancing. Our science is differentiated. Our mission—to deliver transformative therapies for patients with serious unmet needs—has never been more urgent. But to realize this potential, your continued support is essential.

We remain deeply committed to executing with discipline and urgency. In a market that rewards resilience, ZyVersa is staying the course—with focus, strategic clarity, and resolve. Together, we can build long-term value for patients, the healthcare system, and our shareholders.

I am pleased to announce that in Q2-2025, we closed two financing transactions providing access to $12 million in capital to advance our R&D initiatives. On July 8, 2025, we closed a $2M warrant inducement transaction from a current investor, and on June 25, 2025, we closed a Share Purchase Agreement for up to $10 Million in Partnership with Williamsburg Venture Holdings. This increased capital supports advancement of our key development programs targeting kidney and inflammatory diseases to value-building inflection points over the next several months.

Cholesterol Efflux Mediator™ VAR 200 for Kidney Diseases

VAR 200 uniquely targets a neglected pathway leading to development and progression of kidney diseases—accumulation of excess lipids in the kidneys' filtration system that causes kidney damage, inflammation, and fibrosis leading to kidney dysfunction. Our lead indication for VAR 200 is rare kidney disease, focal segmental glomerulosclerosis ("FSGS"), with potential indication expansion into rare kidney disease, Alport syndrome, and diabetic kidney disease (DKD). Prior to initiating a Phase 2a trial in patients with FSGS, we initiated a small open-label Phase 2a trial in patients with DKD mid-June 2025, in which we expect to obtain patient proof-of-concept data more quickly than in an FSGS trial. This will enable assessment of drug effects as patients proceed through treatment and will provide insights for developing a larger Phase 2a/b protocol in patients with FSGS. Preliminary data are expected to be reported in Q4-2025, with final results anticipated in H1-2026.

Based on the unique mechanism of action of VAR 200, we provided drug and regulatory support under FDA-authorized Emergency Compassionate Use to treat a patient at the University of Miami Miller School of Medicine who has ApoCII amyloidosis, a very rare disease which mainly affects the kidney. Emergency Compassionate Use was authorized because the patient has no other effective treatment options to treat her serious condition.

There is a tremendous unmet need for effective renal drug therapies and innovation in this space is not just a medical imperative, it's a market opportunity with transformative potential.

• Kidney disease, which affects over 850 million people globally, has limited treatment options and none modify the disease which continues to progress, ultimately to kidney failure requiring dialysis or transplant for survival.
• Two million patients worldwide are living with kidney failure, which negatively impacts quality of life and increases mortality risk.
• In the US, kidney disease consumes around 25% of Medicare spending—over $130 billion annually.
  
   

The good news is that regulators recognize that kidney disease is one of the most pressing global health challenges, and they are taking steps to reduce drug development barriers to motivate investment in innovation.

• The FDA and EMA are actively supporting innovation in kidney disease with accelerated pathways for rare and serious diseases.
• Initiatives like PARASOL are expected to shorten the time and reduce the number of patients required for clinical trials, while enabling greater interaction with regulatory authorities.

Investors are increasingly recognizing that first-in-class kidney drug therapies, like SGLT2 inhibitors, have blockbuster potential, and can build franchises—not just single assets.