RELMADA THERAPEUTICS, INC. Annual Report - How They Did This Year

Hey there! Thinking about RELMADA THERAPEUTICS, INC.? This guide explains their past year's performance simply, helping you decide if it fits your investments.

We have fresh information from their latest annual report (for the year ended December 31, 2025). Let's dive in!

1. What does this company do and how did they perform this year?

RELMADA THERAPEUTICS, INC. (or "Relmada") is a biotech company testing new drugs. They find and create new medicines. No drugs are approved for sale yet. You can find them on NASDAQ under RLMD.

Last year (late 2024 and early 2025) brought big changes for Relmada. They completely changed their strategy. They reviewed all their drug projects. Then they decided to totally change their direction. This involved:

• Stopping their previous main drug programs: Relmada stopped developing esmethadone (REL-1017) in July 2025. This was their main drug for major depression. They made this choice after a strategic review. High costs and challenges in late-stage trials likely played a role, or the drug's effectiveness or safety might not have met new goals. They also ended a psilocybin program (REL-P11) in May 2025. This marked a big shift from their old focus areas.
• Buying and licensing new drug candidates: Relmada quickly brought in two new potential drugs. This replaced the programs they stopped. It showed a fast shift to new opportunities and drug areas.

So, their "performance" this year wasn't about drug sales. Instead, they completely changed their research and development plans. They aimed to set up the company for long-term success with new assets.

2. Financial performance - money earned, profit, growth

Relmada is a clinical-stage company. They have no approved products for sale yet. So, they earn no money from drug sales. They are not making a profit from sales. They also have no sales or marketing team. There are no products to promote.

Their financial health depends on raising money and managing operating costs. Research and development (R&D) costs are their main expense, which are typically high for a biotech company running trials. Investors closely watch these numbers, along with cash reserves, to understand their "cash runway" – how long they can operate without more funding.

3. Major wins and challenges this year

This year brought both big challenges and exciting new paths:

Challenges:

• Program Terminations: The biggest challenge was stopping their main drug, esmethadone (REL-1017). They also ended the REL-P11 program. This means the programs didn't meet new goals for effectiveness, safety, or market potential, or they faced big development problems. This led to shifting resources.

Major Wins (New Direction):

• New Drug Candidates: They licensed NDV-01 (for bladder cancer) from Trigone Pharma in March 2025. They also bought sepranolone (for brain disorders) from Asarina Pharma in February 2025. These two drugs are now Relmada's main focus.
• Positive NDV-01 Phase 2 Data: For NDV-01, their main drug for bladder cancer (NMIBC), they reported good 12-month data. This came from a Phase 2 study, showing safety and effectiveness.
  • Safety: No new safety issues arose in 48 patients. No severe side effects were reported. No patients stopped treatment due to side effects. About 63% of patients had mild to moderate side effects. These were mainly uncomfortable urination (54%), positive urine culture (8%), and blood in urine (8%).
  • Effectiveness (Complete Response Rate): The drug worked very well. 95% of patients had a complete response at some point. Importantly, 76% of patients still had a complete response at 12 months. This was 83% using a statistical method that accounts for patients who left or hadn't reached 12 months. Even in tough cases (cancer not responding to standard BCG treatment), 80% had a complete response at 12 months, which was 84% statistically.
  • No Progression: No patients' cancer spread to muscle. None needed bladder removal surgery. This shows a big clinical benefit.
• FDA Alignment for NDV-01: The FDA gave positive feedback to Relmada about their plans for NDV-01's next stage (Phase 3 trials). This agreement reduces risk and clarifies the path to approval. The FDA agreed Relmada can use existing safety data for NDV-01's parts. This is very important as it suggests a 505(b)(2) approval path, which could speed up development and approval by using findings from already approved drugs.
• Positive Sepranolone Phase 2a Data: Sepranolone targets brain conditions. A Phase 2a study in Tourette Syndrome (TS) showed good results:
  • It cut tic severity by 28% versus standard care. This shows a meaningful clinical effect.
  • Patients reported 69% better quality of life. This is a key patient-reported result.
  • It also greatly reduced the urge to tic. Clinicians saw better overall improvement.
  • No major brain side effects appeared. The drug was generally well-tolerated. This is crucial for brain treatments.

4. Key risks that could hurt the stock price

Investing in a biotech company like Relmada has big risks. These risks are even bigger because of their current stage:

• No Approved Products: Relmada has no products making money right now. Their value and future depend on successfully developing NDV-01 and sepranolone, securing regulatory approval, and achieving sales. This means a single drug's success or failure can greatly change the company's value.
• Clinical Trial Failures: Even with good Phase 2 data, Phase 3 trials could fail. They might not meet goals, show safety issues, or prove effective enough for approval. Clinical trials cost a lot and take time. A Phase 3 failure would be a big problem. It could end a program and cause investors to lose much money.
• Regulatory Hurdles: Getting FDA approval is long, complex, and costly. Success is not guaranteed, even with good clinical data. The FDA might ask for more studies, express concerns about manufacturing, or add rules that limit sales potential.
• Competition: The drug industry is very competitive. Other companies might develop better treatments for bladder cancer or brain disorders. New drug markets also face price pressure. Generic versions become available after patents expire.
• Funding: Relmada needs constant, large funding. This pays for trials, research, and daily operations. If they can't raise enough money easily, programs could slow down, be cut back, or even stopped. Raising money often means issuing new shares, which means more shares issued, reducing your ownership percentage and value.
• Rapidly Changing Environment: The biotech world changes fast. New science, changing rules, and market demands always affect drug development. Relmada must adapt fast. This can create more risks and uncertainties.

5. Competitive positioning

Relmada's new drugs look promising against competitors. This is especially true given today's market:

• NDV-01 (Bladder Cancer): This drug uses a new way to deliver chemotherapy directly into the bladder. It uses existing drugs like gemcitabine and docetaxel. It aims to be more convenient, offering one quick dose. Current treatments often need many steps. NDV-01 might keep drugs in the bladder longer, which could make it work better. This is a big advantage. There's a global shortage of BCG. BCG is a long-used, effective treatment for bladder cancer (NMIBC). This shortage has lasted since 2019. This shortage created a big need for other effective treatments. NDV-01 could fill this important market gap.
• Sepranolone (Neurological Disorders): This is a "new neurosteroid." It works uniquely to normalize brain activity. Good results in the Tourette Syndrome study suggest it. It could be a new, effective option for conditions with too much brain activity. It might have fewer side effects than current treatments. Existing drugs often cause big brain-related side effects. This could be a key advantage in brain disorder treatment.

6. Leadership or strategy changes

This year brought a major strategy change for Relmada. The company "substantially redesigned" its drug programs in late 2024 and early 2025. They completely shifted from old drugs like esmethadone (REL-1017) and REL-P11. Now they focus on NDV-01 and sepranolone, which they bought or licensed. This decisive shift shows a flexible leadership team that adapts to new science, market chances, or past program issues. This proves they actively manage their drug pipeline.

7. Future outlook

Relmada has a clear plan for the near future. Several key goals are expected around mid-2026 and year-end 2026. These will greatly impact the company's value.

• NDV-01 (Bladder Cancer):
  • They expect FDA approval to start US clinical trials by mid-2026. This is called IND clearance. This is a vital regulatory step, as human trials cannot start in the US without it.
  • They plan to start two Phase 3 trials for NDV-01 by mid-2026: One trial is for high-risk bladder cancer patients who didn't respond to other treatments (BCG-unresponsive NMIBC). The other is for intermediate-risk bladder cancer. Starting Phase 3 trials is a big step forward, meaning the drug is closer to being sold.
  • They expect initial 3-month data from the high-risk Phase 3 trial by year-end 2026. This data is highly awaited and could show early signs of the drug's effectiveness for a critical patient group.
• Sepranolone (Neurological Disorders):
  • They expect to start a Phase 2 trial for sepranolone in Prader-Willi Syndrome (PWS) by mid-2026. This expands its potential uses beyond Tourette Syndrome. They also explore its use for Tourette Syndrome and essential tremor, suggesting a wider focus on brain disorders.

These milestones are crucial. They will shape the company's future value and path. Success could create significant value.

8. Market trends or regulatory changes affecting them

• BCG Shortage: There's a global shortage of BCG. BCG is a long-used, effective treatment for bladder cancer (NMIBC). This market trend could greatly help NDV-01. If NDV-01 works as a good alternative, it could fill a critical medical need. The BCG shortage makes this need worse, which could speed up NDV-01's use and market reach.
• FDA Pathway (505(b)(2)): The FDA agreed Relmada can use existing safety data for NDV-01's parts. This is a very good regulatory step. This suggests NDV-01 might qualify for a 505(b)(2) approval path. This path lets a new drug application (NDA) use the FDA's past findings about safety and effectiveness for an approved drug. This could simplify development, reduce the need for many early safety studies, and ultimately shorten time and cost to market. This is faster than creating a new drug from scratch.

Relmada is in a critical transition phase, having pivoted to new drug candidates with promising early data and clear regulatory pathways. Your investment decision will hinge on their ability to execute on upcoming clinical milestones and secure the necessary funding to bring these new therapies to market.