FDA written feedback supports: - a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS - a randomized vs observation single trial in intermediate-risk NMIBC in the adjuvant setting Phase 3 program expected to initiate in 1H 2026 CORAL GABLES, Fla., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorde ...

Upgrades - Bradesco BBI upgraded Volaris (VLRS) to Outperform from Neutral with a price target of $12 [2] - Loop Capital upgraded Ollie's Bargain Outlet (OLLI) to Buy from Hold with a price target of $135, increased from $130, citing underestimated comp potential in fiscal 2026 [2] - Raymond James upgraded Cummins (CMI) to Outperform from Market Perform with a price target of $585, noting a change in sentiment for the second half of 2026 despite a cautious near-term outlook [3] Downgrades - Janney Montgomery Scott downgraded Heritage Commerce (HTBK) to Neutral from Buy with a fair value estimate of $14 following an acquisition agreement with CVB Financial (CVBF) [4] - William Blair downgraded Clearwater Analytics (CWAN) to Market Perform from Outperform without a price target after a take-private deal at $24.55 per share [5] - Raymond James double downgraded Sealed Air (SEE) to Market Perform from Strong Buy without a price target, indicating reduced odds for a topping bid after the conclusion of the "go-shop" period [6] - Citi downgraded Amicus (FOLD) to Neutral from Buy with a price target of $14.50, down from $17, after BioMarin announced an acquisition for $4.8 billion or $14.50 per share [6] Initiations - Wells Fargo initiated coverage of Arcellx (ACLX) with an Overweight rating and a price target of $100, viewing its anti-cel as a future pillar in multiple myeloma treatment [7] - Jefferies initiated coverage of BlackSky (BKSY) with a Buy rating and a price target of $23, projecting sales to double to $211 million by 2028 [7] - BTIG initiated coverage of Invivyd (IVVD) with a Buy rating and a price target of $10, highlighting its effective antibody production [7] - Jefferies initiated coverage of Relmada Therapeutics (RLMD) with a Buy rating and a price target of $9, noting a transformation towards oncology and neuro pipeline [7] - Seaport Research initiated coverage of MasterCraft Boat (MCFT) with a Neutral rating and no price target, expressing caution due to competitive pressures in the marine industry [7]

Core Insights - Relmada Therapeutics is advancing NDV-01, a sustained release intravesical formulation of gemcitabine/docetaxel, into Phase 3 studies for non-muscle invasive bladder cancer (NMIBC) in H1 2026, targeting high-risk and intermediate-risk NMIBC patients, which account for approximately 80% of new NMIBC cases annually in the U.S. [1][2][9] Company Overview - Relmada Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapies for oncology and central nervous system conditions, with NDV-01 as a lead candidate [10]. Product Details - NDV-01 is designed for bladder retention and gradual drug release over 10 days, enhancing local exposure while minimizing systemic toxicity. It is a ready-to-use formulation that can be administered in-office without the need for anesthesia or specialized equipment [5]. Clinical Study Information - The ongoing Phase 2 study of NDV-01 is an open-label, single-arm trial evaluating safety and efficacy in patients with high-grade NMIBC, with primary endpoints including safety and complete response rate at 12 months [6]. Market Opportunity - NMIBC represents 75-80% of all bladder cancer cases, with a high recurrence rate of 50-80% over five years. With over 744,000 prevalent cases in the U.S. and limited treatment options, the market potential for NDV-01 is significant [9]. Upcoming Presentation - A poster highlighting the 6-month follow-up data from the Phase 2 trial will be presented at the Society of Urologic Oncology 26 Annual Meeting on December 4, 2025 [1][8].

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]

Clinical Development - NDV-01 program achieved a 92% overall response rate at any time in non-muscle invasive bladder cancer (NMIBC) with favorable safety[1] - FDA alignment secured for Phase 3 program with two independent paths for approval in high-risk BCG-unresponsive and intermediate-risk NMIBC settings[5] - Expected milestones include the initiation of Phase 3 trials for NDV-01 in high-risk and intermediate-risk NMIBC in the first half of 2026[14] - Sepranolone's Phase 2 proof of concept clinical trial for Prader-Willi Syndrome is also expected to initiate in the first half of 2026[14] Financial Performance - 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 in Q3 2024[14] - Net loss for the nine months ended September 30, 2025, was $37,517,403, a reduction of 38.7% compared to a net loss of $61,322,218 for the same period in 2024[29] - Total operating expenses for the nine months ended September 30, 2025, were $38,767,088, down 40.3% from $64,815,482 for the same period in 2024[29] - Cash and cash equivalents at the end of the period were $1,384,484, down from $3,857,026 at the beginning of the period, indicating a decrease of 64.1%[33] - Net cash used in operating activities for the nine months ended September 30, 2025, was $31,190,765, a reduction of 27.0% from $42,956,164 for the same period in 2024[33] Expenses - R&D expenses for Q3 2025 were $4.0 million, down from $11.1 million in Q3 2024, primarily due to reduced trial costs[14] - General and administrative expenses for the nine months ended September 30, 2025, were $19,960,421, down 32.8% from $29,639,951 for the same period in 2024[29] - The company incurred stock-based compensation expenses of $11,534,002 for the nine months ended September 30, 2025, compared to $23,458,012 for the same period in 2024, a decrease of 50.8%[33] - G&A expenses for Q3 2025 were $6.3 million, down from $11.9 million in Q3 2024, mainly due to lower stock-based compensation[14] Assets and Equity - Cash, equivalents, and short-term investments totaled $13.9 million as of September 30, 2025, down from $44.9 million at December 31, 2024[14] - Total current assets decreased from $45,795,843 as of December 31, 2024, to $14,854,269 as of September 30, 2025, representing a decline of approximately 67.6%[27] - Stockholders' equity decreased from $35,521,961 as of December 31, 2024, to $9,465,539 as of September 30, 2025, a decline of approximately 73.3%[27] Shares Outstanding - Shares outstanding were 73,333,622 as of November 10, 2025[14] - The company reported a weighted average number of common shares outstanding of 32,274,238 for the nine months ended September 30, 2025, compared to 30,160,242 for the same period in 2024, reflecting an increase of 7.0%[29]

Financial Performance - Relmada reported a net loss of approximately $37.5 million for the nine months ended September 30, 2025, with an accumulated deficit of about $678.4 million[147]. - The net loss for the three months ended September 30, 2025, was approximately $10.09 million, compared to a net loss of $21.73 million for the same period in 2024, representing a decrease of about 53%[156]. - The net loss for the nine months ended September 30, 2025, was approximately $37.52 million, compared to $61.32 million for the same period in 2024, a decrease of about 39%[163]. - The company incurred negative operating cash flows of $31.19 million for the nine months ended September 30, 2025, compared to $42.96 million for the same period in 2024, a reduction of about 27%[170]. - The company reported a decrease in interest/investment income to approximately $247,000 for the three months ended September 30, 2025, down from $856,500 in 2024, a decline of about 71%[155]. - The company had a cash decrease of $2.47 million for the nine months ended September 30, 2025, compared to a decrease of $2.61 million for the same period in 2024[170]. - The company expects to incur additional losses until it can generate significant revenue from the commercialization of its product candidates[167]. Research and Development - The lead product NDV-01 is currently in a Phase 2 clinical trial for aggressive non-muscle invasive bladder cancer (NMIBC), with a complete response rate of 92% at any time and 85% at nine months[139][138]. - Sepranolone, a novel neurosteroid, is expected to initiate a Phase IIb study in Prader-Willi Syndrome in the first half of 2026[125][132]. - The company plans to initiate Phase III programs for NDV-01 targeting high-risk, second-line BCG-unresponsive NMIBC and intermediate-risk patients in the adjuvant setting in the first half of 2026[143]. - NDV-01 allows for a single administration in less than 10 minutes, providing sustained localized chemotherapy for up to 10 days, enhancing therapeutic effects while improving patient convenience[134][135]. - In a Phase 2a study, Sepranolone demonstrated a 28% reduction in tic severity as measured by the YGTSS scoring system, with no off-target CNS effects observed[131][130]. - The ongoing Phase 2 study of NDV-01 involved 36 patients, with 61% experiencing treatment-related adverse events, primarily transient dysuria[138]. Intellectual Property - The company has over 40 issued patents related to Sepranolone and more than 10 issued patents related to NDV-01, potentially providing market exclusivity beyond 2030 and 2038, respectively[149][150]. Strategic Changes - Relmada has restructured its development strategy to focus on acquiring new candidates while pausing work on esmethadone, aiming to diversify its development pipeline[122]. - The FDA has provided feedback indicating that a single-arm trial for NDV-01 in BCG-unresponsive patients may be acceptable, with further discussions planned[141]. Expenses - Research and development expenses for the three months ended September 30, 2025, decreased to approximately $4.04 million from $11.15 million for the same period in 2024, a reduction of about 64%[154]. - General and administrative expenses for the three months ended September 30, 2025, decreased to approximately $6.29 million from $11.86 million for the same period in 2024, a reduction of about 53%[154]. - For the nine months ended September 30, 2025, research and development expenses were approximately $18.81 million, down from $35.18 million in 2024, a decrease of about 53%[161]. Financing Activities - The company closed an underwritten offering of 40,142,000 shares at an offering price of $2.20 per share, generating net proceeds of approximately $94 million[168].

Core Insights - Relmada Therapeutics reported a 92% overall response rate for NDV-01 in non-muscle invasive bladder cancer (NMIBC) with favorable safety data [1][3][5] - The company secured FDA alignment on key elements of its Phase 3 program for NDV-01, which includes two independent paths for approval targeting high-risk and intermediate-risk NMIBC patients [1][3][8] - Relmada completed a $100 million underwritten offering to support its operations and planned studies into 2028 [1][3][12] Clinical Results - NDV-01 demonstrated a 92% complete response rate at any time point, with 84% at 3 months, 87% at 6 months, and 85% at 9 months [5][6] - In the BCG-unresponsive subpopulation, the complete response rate was 91% at any time point [7] - No patients progressed to muscle-invasive disease or underwent radical cystectomy [6] FDA Alignment and Study Design - FDA indicated that a single-arm trial may be acceptable for high-risk, 2nd line BCG-unresponsive patients [5][8] - For intermediate-risk NMIBC, a randomized study design post-TURBT was deemed generally acceptable [5][8] - No further non-clinical studies are required to support a 505(b)(2) New Drug Application [5] Financial Results - For Q3 2025, Relmada reported a net loss of $10.1 million, or $0.30 per share, compared to a net loss of $21.7 million, or $0.72 per share in Q3 2024 [13][28] - Research and development expenses were $4.0 million, down from $11.1 million in Q3 2024 [12][28] - General and administrative expenses decreased to $6.3 million from $11.9 million in Q3 2024 [12][28] Upcoming Milestones - NDV-01 twelve-month data from the ongoing Phase 2 NMIBC study is expected in Q1 2026 [12] - Initiation of Phase 3 trials for NDV-01 in high-risk and intermediate-risk settings is anticipated in the first half of 2026 [12][8] - A Phase 2 trial for sepranolone in Prader-Willi Syndrome is also set to begin in the first half of 2026 [12]

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]