Relmada Reports 2025 Financials and Clinical Advancements
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5 days ago
0mins
Should l Buy RLMD?
Source: NASDAQ.COM
- Promising Clinical Data: Relmada's bladder cancer candidate NDV-01 demonstrated a 95% complete response rate in the latest 12-month Phase 2 data, with an 80% rate in BCG-unresponsive patients, indicating its potential in treating non-muscle invasive bladder cancer and likely broad adoption in community urology practices.
- FDA Registration Pathways Confirmed: The company confirmed two Phase 3 registrational pathways for NDV-01 with the FDA, targeting intermediate-risk NMIBC and second-line BCG-unresponsive patients, with studies expected to start in mid-2026 and initial data anticipated by year-end 2026, marking significant clinical development progress.
- Improved Financials: In Q4 2025, Relmada reported a net loss of $19.9 million, or $0.27 per share, reflecting a decrease in losses, although cash used in operating activities reached $14.6 million, indicating ongoing pressure from R&D investments.
- Funding Secured Through 2029: With the completion of a $160 million PIPE financing, Relmada expects to be funded through 2029, supporting the Phase 3 program for NDV-01 and other R&D initiatives, enhancing market confidence in its long-term growth prospects.
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Analyst Views on RLMD
Wall Street analysts forecast RLMD stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 6.100
Low
9.00
Averages
9.50
High
10.00
Current: 6.100
Low
9.00
Averages
9.50
High
10.00
About RLMD
Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for central nervous system (CNS) and metabolic disorders. The Company is focused on the development of esmethadone (d-methadone, dextromethadone, REL-1017), an N-methyl-D-aspartate (NMDA) receptor antagonist. Esmethadone, an isomer of methadone, is a new chemical entity (NCE) that potentially addresses areas of high unmet medical need in the treatment of CNS diseases and other disorders. The Company’s lead program, REL-1017, is a NCE and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. Its lead product candidate, esmethadone, is being developed as a rapidly acting, oral agent for the treatment of depression and other potential indications. Sepranolone is its phase IIb ready neurosteroid developed for the potential treatment of Tourette syndrome and other compulsive disorders.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Relmada Therapeutics Stock Rises After Piper Sandler Coverage Launch
- Analyst Coverage Initiation: Piper Sandler initiated coverage on Relmada Therapeutics (RLMD) with an Overweight rating, arguing that the stock has yet to reflect the full potential of its lead cancer candidate NDV-01, resulting in a price increase on Tuesday.
- Drug Development Progress: NDV-01, currently in mid-stage development for non-muscle invasive bladder cancer, combines chemotherapy agents gemcitabine and docetaxel, expected to provide significant therapeutic advantages in the market.
- Market Potential Assessment: Analyst Kelsey Goodwin noted that despite the current stock price not reflecting NDV-01's value in the large NMIBC market, the drug's gradual release design and high translatability of existing evidence lay a solid foundation for future success.
- Target Price Setting: The analyst set a $12 per share target for RLMD, assuming 20% and 15% peak market shares for NDV-01 in BCG-unresponsive high-risk and intermediate-risk NMIBC, with probabilities of success at 35% and 25%, respectively.
See More
Relmada Reports 2025 Financials and Clinical Advancements
- Promising Clinical Data: Relmada's bladder cancer candidate NDV-01 demonstrated a 95% complete response rate in the latest 12-month Phase 2 data, with an 80% rate in BCG-unresponsive patients, indicating its potential in treating non-muscle invasive bladder cancer and likely broad adoption in community urology practices.
- FDA Registration Pathways Confirmed: The company confirmed two Phase 3 registrational pathways for NDV-01 with the FDA, targeting intermediate-risk NMIBC and second-line BCG-unresponsive patients, with studies expected to start in mid-2026 and initial data anticipated by year-end 2026, marking significant clinical development progress.
- Improved Financials: In Q4 2025, Relmada reported a net loss of $19.9 million, or $0.27 per share, reflecting a decrease in losses, although cash used in operating activities reached $14.6 million, indicating ongoing pressure from R&D investments.
- Funding Secured Through 2029: With the completion of a $160 million PIPE financing, Relmada expects to be funded through 2029, supporting the Phase 3 program for NDV-01 and other R&D initiatives, enhancing market confidence in its long-term growth prospects.
See More
Relmada Therapeutics Financial Report Analysis
- Financial Overview: As of December 31, 2025, Relmada Therapeutics reported a cash balance of $93 million, and despite net proceeds of approximately $94 million from a stock offering, the company faced a net loss of $19.9 million, indicating increasing financial pressure.
- R&D Expense Trends: Research and development expenses for Q4 2025 were $8.1 million, down from $11 million in Q4 2024, suggesting potential challenges in maintaining R&D momentum after completing two Phase 3 trials.
- Rising Administrative Costs: General and administrative expenses rose to $12.3 million in Q4 2025 from $8.1 million in Q4 2024, an increase of $4.2 million primarily due to higher compensation costs, which may impact overall profitability.
- Future Growth Potential: Relmada plans to initiate a Phase 3 rescue program for bladder cancer and a Phase 2 proof of concept trial for Prader-Willi syndrome, indicating a robust pipeline and significant future growth potential in oncology.
See More
Relmada (RLMD) Q4 2025 Earnings Call Transcript
See More
Relmada Therapeutics Q4 Earnings Call Highlights
- NDV-01 Clinical Data: NDV-01 demonstrated a 76% complete response rate at 12 months in its Phase 2 trial for non-muscle invasive bladder cancer, with an 80% response rate in BCG-unresponsive patients, indicating strong efficacy in high-risk populations and potential for future market adoption.
- Registration Trial Plans: Relmada plans to initiate the RESCUE program in mid-2026 across approximately 80 North American sites, with initial data expected by the end of 2026, which will provide critical insights for the company's future in bladder cancer treatment.
- Financial Position Update: As of the end of 2025, Relmada reported approximately $93 million in cash, along with net proceeds from recent financings totaling around $160 million, which are expected to fund operations through 2029, demonstrating robust financial management.
- R&D Expense Changes: The company reported R&D expenses of $8.1 million for Q4 2025, down from $11 million in Q4 2024, primarily due to the completion of two Phase 3 trials, reflecting an optimization in resource allocation for research and development activities.
See More
Relmada Therapeutics Q4 Earnings Report Analysis
- Disappointing Earnings: Relmada Therapeutics reported a Q4 GAAP EPS of -$0.27, missing expectations by $0.13, indicating challenges in profitability that could undermine investor confidence.
- Decline in R&D Spending: Research and development expenses for the three months ended December 31, 2025, totaled $8.1 million, down $2.9 million from $11.0 million in the same period of 2024, reflecting a contraction in investment that may hinder future product development.
- Increase in Administrative Costs: General and administrative expenses rose to $12.3 million in Q4 2025, compared to $8.1 million in Q4 2024, an increase of approximately $4.2 million, indicating cost pressures in operational management that could impact overall profitability.
- Market Reaction Outlook: Given the earnings miss, investors may adopt a cautious stance towards Relmada's future performance, potentially affecting its stock price trajectory and fundraising capabilities.
See More
Relmada Therapeutics Stock Rises After Piper Sandler Coverage Launch
- Analyst Coverage Initiation: Piper Sandler initiated coverage on Relmada Therapeutics (RLMD) with an Overweight rating, arguing that the stock has yet to reflect the full potential of its lead cancer candidate NDV-01, resulting in a price increase on Tuesday.
- Drug Development Progress: NDV-01, currently in mid-stage development for non-muscle invasive bladder cancer, combines chemotherapy agents gemcitabine and docetaxel, expected to provide significant therapeutic advantages in the market.
- Market Potential Assessment: Analyst Kelsey Goodwin noted that despite the current stock price not reflecting NDV-01's value in the large NMIBC market, the drug's gradual release design and high translatability of existing evidence lay a solid foundation for future success.
- Target Price Setting: The analyst set a $12 per share target for RLMD, assuming 20% and 15% peak market shares for NDV-01 in BCG-unresponsive high-risk and intermediate-risk NMIBC, with probabilities of success at 35% and 25%, respectively.
See More
Relmada Reports 2025 Financials and Clinical Advancements
- Promising Clinical Data: Relmada's bladder cancer candidate NDV-01 demonstrated a 95% complete response rate in the latest 12-month Phase 2 data, with an 80% rate in BCG-unresponsive patients, indicating its potential in treating non-muscle invasive bladder cancer and likely broad adoption in community urology practices.
- FDA Registration Pathways Confirmed: The company confirmed two Phase 3 registrational pathways for NDV-01 with the FDA, targeting intermediate-risk NMIBC and second-line BCG-unresponsive patients, with studies expected to start in mid-2026 and initial data anticipated by year-end 2026, marking significant clinical development progress.
- Improved Financials: In Q4 2025, Relmada reported a net loss of $19.9 million, or $0.27 per share, reflecting a decrease in losses, although cash used in operating activities reached $14.6 million, indicating ongoing pressure from R&D investments.
- Funding Secured Through 2029: With the completion of a $160 million PIPE financing, Relmada expects to be funded through 2029, supporting the Phase 3 program for NDV-01 and other R&D initiatives, enhancing market confidence in its long-term growth prospects.
See More
Relmada Therapeutics Financial Report Analysis
- Financial Overview: As of December 31, 2025, Relmada Therapeutics reported a cash balance of $93 million, and despite net proceeds of approximately $94 million from a stock offering, the company faced a net loss of $19.9 million, indicating increasing financial pressure.
- R&D Expense Trends: Research and development expenses for Q4 2025 were $8.1 million, down from $11 million in Q4 2024, suggesting potential challenges in maintaining R&D momentum after completing two Phase 3 trials.
- Rising Administrative Costs: General and administrative expenses rose to $12.3 million in Q4 2025 from $8.1 million in Q4 2024, an increase of $4.2 million primarily due to higher compensation costs, which may impact overall profitability.
- Future Growth Potential: Relmada plans to initiate a Phase 3 rescue program for bladder cancer and a Phase 2 proof of concept trial for Prader-Willi syndrome, indicating a robust pipeline and significant future growth potential in oncology.
See More
Relmada (RLMD) Q4 2025 Earnings Call Transcript
See More
Relmada Therapeutics Q4 Earnings Call Highlights
- NDV-01 Clinical Data: NDV-01 demonstrated a 76% complete response rate at 12 months in its Phase 2 trial for non-muscle invasive bladder cancer, with an 80% response rate in BCG-unresponsive patients, indicating strong efficacy in high-risk populations and potential for future market adoption.
- Registration Trial Plans: Relmada plans to initiate the RESCUE program in mid-2026 across approximately 80 North American sites, with initial data expected by the end of 2026, which will provide critical insights for the company's future in bladder cancer treatment.
- Financial Position Update: As of the end of 2025, Relmada reported approximately $93 million in cash, along with net proceeds from recent financings totaling around $160 million, which are expected to fund operations through 2029, demonstrating robust financial management.
- R&D Expense Changes: The company reported R&D expenses of $8.1 million for Q4 2025, down from $11 million in Q4 2024, primarily due to the completion of two Phase 3 trials, reflecting an optimization in resource allocation for research and development activities.
See More
Relmada Therapeutics Q4 Earnings Report Analysis
- Disappointing Earnings: Relmada Therapeutics reported a Q4 GAAP EPS of -$0.27, missing expectations by $0.13, indicating challenges in profitability that could undermine investor confidence.
- Decline in R&D Spending: Research and development expenses for the three months ended December 31, 2025, totaled $8.1 million, down $2.9 million from $11.0 million in the same period of 2024, reflecting a contraction in investment that may hinder future product development.
- Increase in Administrative Costs: General and administrative expenses rose to $12.3 million in Q4 2025, compared to $8.1 million in Q4 2024, an increase of approximately $4.2 million, indicating cost pressures in operational management that could impact overall profitability.
- Market Reaction Outlook: Given the earnings miss, investors may adopt a cautious stance towards Relmada's future performance, potentially affecting its stock price trajectory and fundraising capabilities.
See More
