Relmada Therapeutics (RLMD) is a clinical-stage pharma company with no commercialized products and a $141 million market cap. RLMD has shown strong technical momentum, gaining 440% since August. Shares have a 100% “Buy” technical opinion from Barchart. Despite technical strength, RLMD lacks revenue, faces pipeline setbacks, and is rated “Hold” on Wall Street. Author’s Note: Investments are judged by revenue, earnings, cash flow, and dividends – that’s Investing 101. This company was founded in 200 ...

Financial Data and Key Metrics Changes - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments of approximately $13.9 million, down from $44.9 million as of December 31, 2024, excluding net proceeds of approximately $94 million from a recent $100 million underwritten offering [19][20] - The net loss for Q3 2025 was $10.1 million, or $0.30 per share, compared to a net loss of $21.7 million, or $0.72 per share for Q3 2024 [22] Business Line Data and Key Metrics Changes - Research and development expenses for Q3 2025 totaled $4 million, a decrease of $7.1 million from $11.1 million in Q3 2024, primarily due to lower study costs [21] - General and administrative expenses for Q3 2025 were $6.3 million, down from $11.9 million in Q3 2024, driven by a decrease in stock-based compensation and administrative expenses [22] Market Data and Key Metrics Changes - The company is developing NDV-01 for non-muscle-invasive bladder cancer (NMIBC), which affects about 68,000 new patients annually in the U.S. and has a prevalence of approximately 744,000 patients [4][9] - Sopranalone is being developed for Prader-Willi syndrome, which has a U.S. prevalence of approximately 20,000 patients [5] Company Strategy and Development Direction - The company aims to advance two late-stage clinical programs: NDV-01 for NMIBC and Sopranalone for Prader-Willi syndrome, with both expected to initiate studies in the first half of 2026 [6][19] - The FDA has aligned on key elements of the phase 3 program for NDV-01, allowing for two distinct registrational tracks, which is seen as a significant de-risking milestone [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the NDV-01 clinical development program based on positive nine-month results and constructive discussions with the FDA [17] - The company is well-capitalized following a recent $100 million financing, which is expected to support operations into 2028 [6][20] Other Important Information - The company has established a clinical advisory board for NDV-01, chaired by a renowned urologic oncologist, to provide guidance for the pivotal program [8] - The company plans to initiate a proof of concept study for Sopranalone in the first half of 2026 [19] Q&A Session Summary Question: Can you help us understand the market opportunity for the two indications and the sequence of studies? - The refractory second-line BCG unresponsive population is about 8,000 patients annually, while the intermediate-risk population is estimated at 80,000 patients, with over half likely to receive adjuvant therapy [25][27] - Both trials are planned to start in Q2 2026, with the refractory study expected to provide three-month data by Q4 2026 and top-line data by Q2 2028 [29] Question: What potential pricing could look like? - Current therapies set a benchmark around $700,000 for the first year, and the company will base pricing on data and market reception [30][32] Question: How does the product's ease of use open up the market? - The new formulation allows for a five-minute installation without the need for specialized pharmacies, making it more accessible for community urologists [34][35] Question: What if the BRIDGE study succeeds? - If the BRIDGE study shows that gemcitabine and docetaxel are non-inferior to BCG, it could significantly expand the market opportunity for the product, especially in off-label use [36][38]

Exhibit 99.1 Relmada Therapeutics Reports Third Quarter 2025 Financial Results and Provides Key Clinical, Regulatory, and Corporate Updates Positive 9-month follow-up data for NDV-01 showed a 92% overall response rate at any time in non-muscle invasive bladder cancer (NMIBC), with favorable overall safety Secured FDA alignment on key elements of Phase 3 program with two independent paths for approval in two separate NMIBC indications: High-risk 2 line BCG-unresponsive, and Intermediate-risk patients in the ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________________ to ___________________________ Commission File Number: 000- 55347 RELMADA THERAPEUTICS, INC. (Exact name of registrant as specified in its c ...

Positive 9-month follow-up data for NDV-01 showed a 92% overall response rate at any time in non-muscle invasive bladder cancer (NMIBC), with favorable overall safety Secured FDA alignment on key elements of Phase 3 program with two independent paths for approval in two separate NMIBC indications: High-risk 2nd line BCG-unresponsive, and Intermediate-risk patients in the adjuvant setting; Studies expected to begin H1 2026 Completed $100M underwritten offering of common stock and pre-funded warrants on Novem ...

Core Insights - Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies for oncology and central nervous system conditions [2] - The company plans to host a conference call and webcast on November 13, 2025, to discuss its financial results for Q3 2025 and recent business progress [1] Company Overview - Relmada's lead candidates, NDV-01 and sepranolone, are in mid-stage clinical development and aim to address significant unmet medical needs [2] - The company is advancing therapies that could transform treatment options in their targeted areas [2] Conference Call Details - The conference call is scheduled for November 13, 2025, at 4:30 PM ET [1][3] - Participants can access the call via US and international dial-in numbers, and a replay will be available on the company's website [3]

Core Points - Relmada Therapeutics, Inc. has announced the pricing of an underwritten offering of 40,142,000 shares of common stock at $2.20 per share, along with pre-funded warrants to purchase up to 5,315,000 shares at $2.199 each, aiming for gross proceeds of approximately $100 million before expenses [1][2][3] Group 1 - The offering is expected to close on November 5, 2025, subject to customary closing conditions [1] - Major investors in the offering include Janus Henderson Investors, Ferring Ventures SA, and OrbiMed among others [1] - Jefferies and Leerink Partners are acting as joint book-running managers, with Mizuho as a book-runner for the offering [2] Group 2 - The net proceeds will be used for working capital, clinical studies for regulatory approvals, and further development of product candidates [3] - The company may also invest in or acquire synergistic companies and engage in licensing activities related to current and future product candidates [3] Group 3 - The securities were offered under a shelf registration statement declared effective by the SEC on September 12, 2024, with a final prospectus supplement to be filed [4]

Core Insights - Relmada Therapeutics announced positive 9-month follow-up safety and efficacy data for NDV-01 in non-muscle invasive bladder cancer (NMIBC), achieving a 92% overall response rate [1][3] - The FDA provided feedback supporting two potential registrational trials for NDV-01, one for 2nd line refractory BCG-unresponsive NMIBC and another for intermediate-risk NMIBC [1][4] - The company plans to initiate Phase 3 pivotal programs for NDV-01 in the first half of 2026 [2][8] FDA Meeting Outcomes - The FDA confirmed that no additional non-clinical studies are required for the 505(b)(2) New Drug Application (NDA) [4] - A single-arm trial for high-grade, 2nd line BCG-unresponsive NMIBC patients is considered acceptable by the FDA [4] - A randomized controlled trial proposal for intermediate-risk NMIBC was also deemed generally acceptable [4] Clinical Results - The 9-month follow-up data showed a complete response rate of 92% (23/25) for all patients, with 84% (21/25) at 3 months and 87% (20/23) at 6 months [3][5] - In the BCG-unresponsive subpopulation, the complete response rates were 91% (10/11) at any time, 82% (9/11) at 3 months, and 78% (7/9) at 6 months [6][12] Safety Profile - No new safety signals were reported, with no patients experiencing Grade 3 treatment-related adverse events (AEs) [11] - Among 36 enrolled patients, 61% experienced treatment-related AEs, primarily transient dysuria (62%) [11] Product Overview - NDV-01 is a sustained-release formulation of gemcitabine and docetaxel designed for intravesical administration, allowing for gradual drug release over 10 days [8] - The product is convenient to administer in-office, requiring less than 10 minutes and no specialized equipment [8] Market Opportunity - NMIBC accounts for 75-80% of all bladder cancer cases, with a significant market opportunity due to high recurrence rates and limited treatment options [9]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Click Holdings Limited (CLIK) is up 81% at $11.17 [3] - Avidity Biosciences, Inc. (RNA) is up 43% at $70.72 [3] - Dyne Therapeutics, Inc. (DYN) is up 37% at $23.58 [3] - Zenas BioPharma, Inc. (ZBIO) is up 21% at $29.00 [3] - ProPetro Holding Corp. (PUMP) is up 18% at $7.47 [3] - PepGen Inc. (PEPG) is up 17% at $5.35 [3] - Unusual Machines, Inc. (UMAC) is up 15% at $14.85 [3] - Semler Scientific, Inc. (SMLR) is up 14% at $27.32 [3] - ETHZilla Corporation (ETHZ) is up 13% at $20.51 [3] - Relmada Therapeutics, Inc. (RLMD) is up 13% at $2.38 [3] Premarket Losers - Smart Logistics Global Limited (SLGB) is down 37% at $3.21 [4] - MaxsMaking Inc. (MAMK) is down 22% at $4.08 [4] - Prenetics Global Limited (PRE) is down 14% at $14.40 [4] - United States Antimony Corporation (UAMY) is down 14% at $10.22 [4] - NeurAxis, Inc. (NRXS) is down 12% at $3.01 [4] - Obook Holdings Inc. (OWLS) is down 9% at $11.39 [4] - Qualigen Therapeutics, Inc. (QLGN) is down 9% at $3.30 [4] - Critical Metals Corp. (CRML) is down 8% at $13.70 [4] - Neuphoria Therapeutics Inc. (NEUP) is down 8% at $5.73 [4] - Beam Therapeutics Inc. (BEAM) is down 7% at $25.86 [4]

Core Viewpoint - Relmada Therapeutics has appointed Dr. Max Kates to its Clinical Advisory Board to support the development of NDV-01 for non-muscle invasive bladder cancer (NMIBC), with the Phase 3 program expected to begin in the first half of 2026 [2][3]. Company Overview - Relmada Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapies for oncology and central nervous system conditions [11]. - The company's lead candidates, NDV-01 and sepranolone, are advancing through mid-stage clinical development [11]. NDV-01 Development - NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel, designed for the treatment of NMIBC, allowing for gradual drug release over 10 days [8][9]. - The formulation aims to enhance local exposure while minimizing systemic toxicity and is convenient to administer in-office [9]. - NDV-01 has the potential to serve as a frontline or salvage therapy for NMIBC, which represents 75-80% of all bladder cancer cases [10]. Market Opportunity - NMIBC is associated with a high recurrence rate of 50-80% over five years, with over 744,000 prevalent cases in the U.S., indicating a significant market opportunity for NDV-01 [10]. Dr. Max Kates' Role - Dr. Kates brings extensive experience from chairing the Phase 3 BRIDGE trial and has a strong background in urologic oncology, which will be beneficial for the design and conduct of the NDV-01 Phase 3 program [3][5]. - His expertise includes advancements in surgical innovation and novel therapies for bladder cancer, which will contribute to the real-world applicability of NDV-01 [3][5].