Relmada Therapeutics Updates Shareholders on Growth and Outlook

Insights from Relmada Therapeutics' CEO to Shareholders

In a recent communication from Relmada Therapeutics, Inc. (NASDAQ: RLMD), CEO Sergio Traversa offered an encouraging update on the company's progress as 2025 enters its second half. Relmada, a pioneering biotechnology firm dedicated to developing groundbreaking therapies aimed at oncology-related and central nervous system conditions, is on a trajectory of significant advancement.

Transformational Year Highlight

The year 2025 stands out as a truly transformative era for Relmada Therapeutics. As we navigate through this pivotal period, we are excited to share the strides we've made and express gratitude to our shareholders for their unwavering support.

Strategic Review and Portfolio Enhancement

An essential component of our growth strategy was undertaken earlier this year through a thorough strategic review. This review reinforced Relmada's commitment to providing life-altering treatments while expanding our diverse portfolio. As a result of this analysis, we are proud to announce the addition of two innovative Phase 2 product candidates—key contributors to enhancing Relmada's long-term value.

Product Candidates

The first candidate, NDV-01, is a sustained-release formulation of gemcitabine and docetaxel currently in development for treating non-muscle invasive bladder cancer (NMIBC). Meanwhile, sepranolone is being developed as a potential therapeutic solution for compulsive disorders, including conditions like Prader-Willi Syndrome (PWS).

Promising Outcomes for NDV-01

Our recent six-month follow-up data from the Phase 2 study of NDV-01 revealed exceptional outcomes, boasting a 91% complete response rate at varying treatment intervals. These results build upon the positive data shared at the most recent American Urological Association Annual Meeting, positioning NDV-01 as a groundbreaking, bladder-sparing option for those afflicted with NMIBC—a condition impacting approximately 600,000 individuals across the U.S.

Future Phase 3 Trial Preparations

We are preparing for a Phase 3 registrational trial slated to kick off in the first half of 2026. Critical preparatory activities are in motion, including essential regulatory filings and scaling up our manufacturing capabilities.

Reinforcing the NDV-01 Initiative

To bolster the NDV-01 program, we have welcomed two esteemed experts in the field of bladder cancer:

Expertise Addition

Dr. Raj S. Pruthi has taken on the role of Chief Medical Officer for Oncology, while Dr. Yair Lotan will be the Chair of our Clinical Advisory Board. Their expertise is expected to be instrumental as we move forward into late-stage development.

Sepranolone Development and Milestones

Turning our attention to sepranolone, our proof-of-concept data has been promising, particularly for Tourette’s syndrome, indicating that this therapy may offer substantial benefits for individuals with various compulsive disorders. We are planning to launch a Phase 2 study focused on PWS within the first half of 2026.

Preparation for Future Trials

To facilitate this, our team is engaging with regulatory bodies and ramping up manufacturing processes to ensure we are well-prepared for this critical step.

Key Milestones Ahead

Both NDV-01 and sepranolone have important milestones on the horizon:

• NDV-01
• Phase 2 nine-month results expected in Q4 2025, followed by twelve-month results in Q1 2026.
• Product supply scale-up slated for the second half of 2025.
• U.S. IND clearance anticipated in the first half of 2026.
• Commencement of Phase 3 registrational trial targeted for early 2026.

• Sepranolone
• Ongoing FDA dialogues and related manufacturing activities planned for later in 2025.
• Initiation of the Phase 2 PWS study expected in early 2026.

Looking Towards the Future

As we advance into autumn, optimism pervades our outlook for Relmada's future. The positive trajectories for both NDV-01 and sepranolone, alongside our enhanced team expertise, strategically positions us for sustained value creation through meticulous execution and efficient development practices.

On behalf of our dedicated team, I extend our heartfelt thanks for the trust and confidence you place in us. We eagerly anticipate sharing our journey and updates with you in the months to come.

Sincerely,
Sergio Traversa
Chief Executive Officer
Relmada Therapeutics, Inc.

About Relmada Therapeutics, Inc.

Relmada Therapeutics is dedicated to the development of transformative therapies that address significant unmet medical needs in oncology and central nervous system disorders. Our lead candidates, NDV-01 and sepranolone, are progressing through vital mid-stage clinical development phases.

If you seek additional details about our work and progress, please visit www.relmada.com.

Frequently Asked Questions

What updates did Relmada Therapeutics share with shareholders?

Relmada shared insights into their strategic initiatives, product developments, and upcoming milestones in their recent CEO letter.

What are NDV-01 and sepranolone?

NDV-01 is a drug for treating non-muscle invasive bladder cancer, while sepranolone targets compulsive disorders like Prader-Willi Syndrome.

When will the Phase 3 trial for NDV-01 start?

The Phase 3 registrational trial for NDV-01 is expected to begin in the first half of 2026.

Who are the new experts added to Relmada's team?

Dr. Raj S. Pruthi will serve as Chief Medical Officer for Oncology, and Dr. Yair Lotan has joined as Chair of the Clinical Advisory Board.

What is the focus of Relmada Therapeutics?

Relmada focuses on developing innovative therapies for oncology-related and central nervous system conditions, aiming to fulfill significant unmet medical needs.

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