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Relmada Therapeutics (RLMD)
NASDAQ:RLMD
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Relmada Therapeutics
(NASDAQ:RLMD)
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Rating:57Neutral
Price Target:
$3.50
▼(-44.00% Downside)
Action:ReiteratedDate:12/30/25
The score is held back primarily by weak financial performance (no revenue, ongoing large losses, and sustained cash burn with a shrinking equity base). Offsetting this, recent communications were notably positive with strong NDV-01 clinical results, FDA alignment, and a $100M raise extending runway into 2028, while technicals also show improving price momentum; valuation remains difficult to support given negative earnings and no dividend.
Positive Factors
NDV-01 Phase 2 Efficacy
A 92% Phase 2 response materially raises the probability NDV-01 can reach approval and become a meaningful clinical asset. Durable, high efficacy strengthens partner interest, supports favorable label potential and pricing discussions, and meaningfully de-risks the core oncology program long-term.
Regulatory Alignment
FDA alignment on Phase 3 design and acceptance of two registrational tracks reduces regulatory uncertainty and shortens the path to approval. This structural de-risking improves trial planning, investor and partner confidence, and the likelihood of efficient global development and commercialization planning.
Extended Runway from Financing
The $100M underwritten financing extends operational runway into 2028, materially reducing near-term funding pressure. This allows execution of pivotal trials, strategic hires and program investments without immediate dilutive raises, supporting continuity of development through key inflection points.
Negative Factors
No Commercial Revenue
Reporting zero revenue means the company lacks product cashflows and must rely on external financing or partnerships. Over the medium term this structurally increases execution risk: program failures or adverse funding conditions could halt development and threaten corporate viability.
Persistent Cash Burn
Sustained negative operating and free cash flow (~$40M TTM) creates persistent financing needs. Heavy burn increases the frequency and size of capital raises, raising dilution risk, distracting management, and limiting optionality to fund new programs or absorb trial delays or unexpected costs.
Eroded Equity Cushion
Equity erosion from roughly $208M to about $9.5M TTM materially shrinks the capital cushion. This reduces balance-sheet flexibility, increases reliance on market financing, and leaves little room to absorb trial setbacks or invest in parallel opportunities without heavy dilution.
Relmada Therapeutics (RLMD) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$458.34M
Dividend YieldN/A
Average Volume (3M)2.25M
Price to Earnings (P/E)―
Beta (1Y)1.66
Revenue GrowthN/A
EPS Growth37.37%
CountryUS
Employees17
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.27
Shares Outstanding73,333,626
10 Day Avg. Volume5,558,413
30 Day Avg. Volume2,253,406
Financial Highlights & Ratios
PEG Ratio0.00
Price to Book (P/B)0.00
Price to Sales (P/S)0.00
P/FCF Ratio0.00
Enterprise Value/Market Cap0.99
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/Ebitda-11.80
Forecast
1Y Price Target
$12.50Price Target Upside100.00% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering4
EPS Forecast (FY)-0.59
Revenue Forecast (FY)N/A
Relmada Therapeutics Business Overview & Revenue Model
Company DescriptionRelmada Therapeutics, Inc., a clinical-stage biotechnology company, focuses on developing various products for the treatment of central nervous system (CNS) diseases and other disorders. Its lead product candidate is Esmethadone (d-methadone, dextromethadone, and REL-1017), a new chemical entity and N-methyl-D-aspartate receptor antagonist that is in Phase 3 clinical trials for the adjunctive or monotherapy treatment of major depressive disorder in adults. The company was founded in 2004 and is headquartered in Coral Gables, Florida.
How the Company Makes MoneyRelmada Therapeutics primarily generates revenue through strategic partnerships, collaborations, and funding related to the research and development of its pipeline therapies. As a clinical-stage company, Relmada does not yet have products on the market generating sales revenue. Instead, it relies on investments, grants, and milestone payments from partners who are interested in the potential of its drug candidates. These collaborations can involve licensing agreements or co-development arrangements, which provide financial support for the ongoing development of their therapies. The company's future revenue streams are expected to depend on the successful clinical trials and subsequent commercialization of its lead candidates, particularly if regulatory approvals are obtained.
Relmada Therapeutics Earnings Call Summary
Earnings Call Date:Mar 19, 2026
(Q4-2025)
| Next Earnings Date:May 13, 2026
Earnings Call Sentiment Positive
The call conveyed strong clinical and corporate progress: compelling Phase II 12-month efficacy and a favorable safety profile for NDV-01, FDA-aligned Phase III plans with two registrational pathways, a strengthened leadership team, and substantial financing that extends runway through 2029. Offsetting items include higher G&A and operating cash burn, a modestly larger net loss in Q4, competitive enrollment risks in a crowded NMIBC landscape, and limited subgroup sizes in the Phase II dataset which introduce some uncertainty. On balance, the positives—particularly the best-in-class efficacy signals, regulatory alignment, and significant financing—outweigh the near-term financial and competitive challenges.Q4-2025 Updates
Positive Updates
Strong 12-Month Phase II Efficacy for NDV-01
NDV-01 demonstrated a 12-month complete response (CR) rate of 76% in the Phase II study and an 80% 12-month CR in the BCG-unresponsive population. CR anytime was 95% in the overall population (n=38) and 94% in the BCG-unresponsive subgroup.
Favorable Safety Profile
No patients progressed to muscle-invasive disease, no radical cystectomies occurred, no grade 3 or higher treatment-related adverse events were observed, no treatment interruptions or discontinuations due to adverse events, and most treatment-related adverse events were grade 1.
Regulatory Alignment and Planned Phase III RESCUE Program
Company achieved FDA alignment on a two-pathway registrational strategy (intermediate-risk adjuvant post-TURBT and second-line BCG-unresponsive). Expect U.S. IND clearance and initiation of the Phase III RESCUE program in mid-2026; plan to run ~80 sites in North America.
Potential Large Addressable Populations
Estimated U.S. patient populations: ~70,000–75,000 intermediate-risk patients for adjuvant use post-TURBT and ~5,000 BCG-unresponsive second-line patients, supporting potential commercial opportunity if approved.
Significant Financing and Extended Runway
Closed a $160 million private financing on March 9, 2026 (net proceeds ~ $150M). Company had $93M cash at December 31, 2025 (up from ~$45M at Dec 31, 2024), and management expects these funds plus existing cash to provide runway through 2029 and through completion of the planned NDV-01 Phase III program.
Pipeline Progress: Cipranolone PoC in Prader-Willi
Cipranolone (GABA-modulating steroid antagonist) has prior proof-of-concept in Tourette syndrome; company planning to initiate a proof-of-concept Phase II study in Prader-Willi syndrome in mid-2026 and is engaged with FDA on trial design.
Leadership and Scientific Support Strengthened
Appointment of Dr. Raj S. Pruthi as Chief Medical Officer, Oncology, and establishment of a scientific advisory board with recognized urologic oncology experts to support NDV-01 development.
Planned Data Readouts and Disclosure Cadence
Updated 12-month Phase II data accepted for presentation at AUA; plan to report initial three-month response data from the Phase III BCG-unresponsive study by end of 2026 and provide additional updates at roughly three-month intervals (3-, 6-, 9-, 12-month follow-ups).
Negative Updates
Rising Operating and G&A Costs
General and administrative expense for Q4 2025 was $12.3M versus $8.1M in Q4 2024, an increase of $4.2M (≈51.9%), primarily driven by higher compensation costs.
Increased Operating Cash Burn
Net cash used in operating activities for Q4 2025 was $14.6M versus $8.8M in Q4 2024, an increase of $5.8M (≈65.9%), reflecting higher near-term spend on program start-ups and operations.
Net Loss Widened Slightly
Net loss for Q4 2025 was $19.9M (loss per share $0.27) vs. $18.7M (loss per share $0.06) for Q4 2024 — an increase in net loss of ~$1.2M (≈6.4%).
R&D Expense Decline Largely Program-Specific
R&D expense for Q4 2025 decreased to $8.1M from $11.0M in Q4 2024 (a decrease of $2.9M, ≈26.4%), driven by completion of two Phase III trials for REL-1017 — offset partially by start-up costs for NDV-01 and cipranolone, signaling shifting program spend rather than lower pipeline investment overall.
Competitive and Crowded NMIBC Landscape
NMIBC is a congested space with multiple active trials and recent approvals; potential enrollment competition and market adoption risk exist despite company belief that NDV-01's in-office, sustained-release profile is a recruitment/commercial advantage.
Small Phase II Subgroup Sizes and Uncertainties
Some subgroup results come from small patient counts (e.g., four CIS patients), limiting statistical robustness. FDA has not specified a minimum durability threshold for approval, adding some regulatory uncertainty about required follow-up duration.
Market Adoption Requires Education
Only ~35% of intermediate-risk patients historically receive adjuvant therapy today; commercial uptake may require market-building and physician/patient education despite potential clinical benefit.
Company Guidance
The company guided that it will initiate the Phase III RESCUE program for NDV‑01 in mid‑2026 (after U.S. IND clearance) at an estimated ~80 North American sites with two FDA‑aligned registrational pathways: a randomized adjuvant intermediate‑risk post‑TURBT study (target two‑year RFS ~75%, event‑driven with ~128 events; U.S. population ~70,000–75,000/year) and a single‑arm BCG‑unresponsive second‑line CIS/refractory study (U.S. population ~5,000/year) with CR anytime as the primary endpoint and initial 3‑month response data expected by the end of 2026 and subsequent ~3‑month cadence updates (3, 6, 9, 12 months); they reported Phase II 12‑month results showing a 76% 12‑month CR (80% in BCG‑unresponsive), 95% CR anytime (n=38) and 94% CR anytime in BCG‑unresponsive, with no progression to muscle‑invasive disease, no radical cystectomies, no grade ≥3 treatment‑related AEs and mostly grade‑1 AEs; cipranolone PoC in Prader‑Willi is planned to begin mid‑2026; financially, cash was $93M at 12/31/2025 (including ~ $94M net from a Nov 2025 offering), the company completed a $160M private financing (net ≈ $150M) on Mar 9, 2026 expected to fund operations through 2029 and completion of Phase III, and Q4 2025 results included R&D expense $8.1M (vs $11.0M prior year), G&A $12.3M (vs $8.1M), net cash used in operations $14.6M (vs $8.8M), and net loss $19.9M (‑$0.27 per share) vs $18.7M (‑$0.06) in Q4 2024.Relmada Therapeutics Financial Statement Overview
Summary
Financials reflect a pre-revenue, cash-burning biotech profile: zero revenue, persistent large net losses, and consistently negative operating/free cash flow. The debt-free balance sheet is a positive, but equity has fallen sharply, signaling erosion of the capital cushion and ongoing funding risk despite some improvement in the pace of losses/cash burn.Income Statement
RLMD reports zero revenue across the annual periods shown and in TTM (Trailing-Twelve-Months), with persistent large operating losses and net losses (TTM net loss of about $56M; 2024 net loss about $80M). Losses improved versus 2022–2023, but profitability remains deeply negative and there is no visible top-line traction in the provided data, keeping earnings quality and operating leverage weak.8
Very Negative
Balance Sheet
The company shows no debt, which reduces financial risk and limits balance-sheet leverage concerns. However, equity has fallen sharply (from about $208M in 2021 to about $9.5M in TTM), reflecting sustained losses and a materially thinner capital cushion; returns on equity are strongly negative across periods, signaling ongoing value erosion despite the debt-free structure.28
Negative
Cash Flow
Cash burn remains heavy, with negative operating cash flow and negative free cash flow in every period shown (TTM operating/free cash flow around -$40M; 2024 around -$52M). While burn improved versus 2022 and is better than 2024 in TTM, free cash flow growth is negative in TTM and cash generation is not yet supported by revenue, leaving funding needs and runway risk as key concerns.10
Very Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| EBITDA | -38.53M | 0.00 | -83.89M | 4.91M | -161.25M | -125.70M |
| Net Income | -56.17M | 0.00 | -79.98M | -98.79M | -157.04M | -125.75M |
Balance Sheet | ||||||
| Total Assets | 14.88M | 94.00M | 45.82M | 97.55M | 152.91M | 223.33M |
| Cash, Cash Equivalents and Short-Term Investments | 13.89M | 93.01M | 44.91M | 96.32M | 148.32M | 211.91M |
| Total Debt | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Total Liabilities | 5.41M | 7.49M | 10.30M | 12.19M | 12.47M | 15.06M |
| Stockholders Equity | 9.47M | 86.51M | 35.52M | 85.36M | 140.44M | 208.26M |
Cash Flow | ||||||
| Free Cash Flow | -39.99M | 0.00 | -51.76M | -51.66M | -103.80M | -91.87M |
| Operating Cash Flow | -39.99M | 0.00 | -51.76M | -51.66M | -103.80M | -91.87M |
| Investing Cash Flow | 40.14M | -48.14M | 51.56M | 50.45M | 19.73M | -54.12M |
| Financing Cash Flow | -245.51K | 93.56M | -40.34K | -98.46K | 45.02M | 187.94M |
Relmada Therapeutics Technical Analysis
Positive
6.25
Price Trends
4.50
Positive
4.16
Positive
2.63
Positive
Market Momentum
0.58
Negative
62.40
Neutral
50.87
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For RLMD, the sentiment is Positive. The current price of 6.25 is above the 20-day moving average (MA) of 5.33, above the 50-day MA of 4.50, and above the 200-day MA of 2.63, indicating a bullish trend. The MACD of 0.58 indicates Negative momentum. The RSI at 62.40 is Neutral, neither overbought nor oversold. The STOCH value of 50.87 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for RLMD.
Relmada Therapeutics Risk Analysis
Relmada Therapeutics disclosed 82 risk factors in its most recent earnings report. Relmada Therapeutics reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Relmada Therapeutics Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
60 Neutral | $200.98M | -2.24 | -103.99% | ― | 250.00% | 15.15% | |
57 Neutral | $458.34M | ― | -269.50% | ― | ― | 37.37% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
44 Neutral | $39.32M | -1.37 | -122.43% | ― | -100.00% | -8.30% | |
42 Neutral | $81.01M | -1.14 | -305.39% | ― | -90.18% | -17.93% |
* Healthcare Sector Average
RLMD
Relmada Therapeutics
6.25
5.95
1983.33%
XBIT
XBiotech
2.35
-1.10
-31.88%
PRLD
Prelude Therapeutics
3.19
2.45
331.08%
SPRB
Spruce Biosciences
59.05
33.85
134.31%
HOWL
Werewolf Therapeutics
0.81
-0.28
-25.69%
Relmada Therapeutics Corporate Events
Executive/Board Changes
Relmada Therapeutics Amends Executive Employment Agreements
Neutral
Dec 15, 2025
On December 12, 2025, Relmada Therapeutics‘ Board of Directors approved amended employment agreements for its executive officers, effective January 1, 2026. The agreements include salary increases for executives and detailed severance packages in cases of termination, highlighting the company’s commitment to retaining key leadership during potential changes in control.
The most recent analyst rating on (RLMD) stock is a Buy with a $10.00 price target. To see the full list of analyst forecasts on Relmada Therapeutics stock, see the RLMD Stock Forecast page.
Business Operations and StrategyFinancial DisclosuresPrivate Placements and Financing
Relmada Therapeutics Reports Q3 2025 Financial Results
Positive
Nov 13, 2025
Relmada Therapeutics reported its third-quarter 2025 financial results and provided updates on its NDV-01 program for non-muscle invasive bladder cancer (NMIBC). The company announced positive 9-month follow-up data for NDV-01, showing a 92% complete response rate, and secured FDA alignment on key elements of its Phase 3 program. Additionally, Relmada completed a $100 million underwritten offering to support its operations into 2028, which will help advance the NDV-01 registrational studies and the development of sepranolone for Prader-Willi Syndrome.
The most recent analyst rating on (RLMD) stock is a Hold with a $1.00 price target. To see the full list of analyst forecasts on Relmada Therapeutics stock, see the RLMD Stock Forecast page.
Private Placements and Financing
Relmada Therapeutics Announces $100M Stock Offering
Neutral
Nov 5, 2025
On November 4, 2025, Relmada Therapeutics announced the pricing of a $100 million underwritten offering of common stock and pre-funded warrants. The proceeds from this offering are intended to support working capital, corporate purposes, and further development of product candidates, as well as potential investments or acquisitions in synergistic technologies. The offering is expected to close on November 5, 2025, and includes participation from notable investors such as Janus Henderson Investors and OrbiMed.
The most recent analyst rating on (RLMD) stock is a Hold with a $1.00 price target. To see the full list of analyst forecasts on Relmada Therapeutics stock, see the RLMD Stock Forecast page.
Business Operations and StrategyFinancial DisclosuresProduct-Related Announcements
Relmada Therapeutics Receives FDA Feedback on NDV-01 Trials
Positive
Nov 4, 2025
On November 4, 2025, Relmada Therapeutics announced FDA feedback on its proposed NDV-01 Phase III trials and shared nine-month safety and efficacy data for its Phase II study in high-risk NMIBC patients. The FDA’s feedback suggests a single-arm trial may be acceptable for BCG-unresponsive patients, and a randomized study for intermediate-risk NMIBC patients is generally acceptable, pending further discussions. The nine-month data showed no new safety signals and a high complete response rate among patients. The company also reported preliminary financial information, indicating approximately $13.9 million in cash and investments as of September 30, 2025.
The most recent analyst rating on (RLMD) stock is a Hold with a $1.00 price target. To see the full list of analyst forecasts on Relmada Therapeutics stock, see the RLMD Stock Forecast page.
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.