Relmada Therapeutics(RLMD) - 2025 Q2 - Quarterly Results

Executive Summary & Recent Developments Relmada Therapeutics reported Q2 2025 financial results and positive 6-month follow-up data for NDV-01 in bladder cancer Q2 2025 Financial Results and Corporate Update Relmada Therapeutics reported its financial results for the second quarter ended June 30, 2025, alongside 6-month follow-up data from its Phase 2 study of NDV-01 in bladder cancer and a general corporate and pipeline update - Relmada Therapeutics, Inc. (Nasdaq: RLMD) reported financial results for Q2 2025, announced 6-month follow-up data for NDV-01 in bladder cancer, and provided a corporate and pipeline update[2] NDV-01 6-Month Follow-up Safety and Efficacy Data The 6-month follow-up data for NDV-01 in non-muscle invasive bladder cancer (NMIBC) demonstrated impressive efficacy with a high overall response rate and good safety profile, reinforcing its potential as a durable treatment - NDV-01 showed a 91% overall response rate at any time in non-muscle invasive bladder cancer, with good overall safety[1] NDV-01 Phase 2 Study: Baseline Characteristics (n=29) | Table 1: Baseline characteristics (n=29) | | | :--- | :--- | | Gender | n (%) | | Male | 24 (83%) | | Female | 5 (17%) | | Median Age (years) (range) | 73 (54-93) | | Median BCG Doses (range) | 6 (0-18) | | ● BCG-naïve (n (%)) | 12 (41%) | | ● BCG exposed (n (%)) | 4 (14%) | | ● BCG unresponsive (n (%)) | 13 (45%) | | Stage (n (%)) | | | Pure CIS | 3 (10%) | | Ta/T1 + CIS | 4 (14%) | | Ta | 18 (62%) | | T1 | 4 (14%) | NDV-01 Phase 2 Study: Clinical Results (Response Data) | | Table 2: Clinical Results (Response Data) | | :--- | :--- | | Complete Response | % (n/N) | | Anytime | 91% (21/23) | | 3 months | 83% (19/23) | | 6 months | 90% (19/21) | - The 91% CR rate at any time point following NDV-01 treatment, combined with previously reported 3-month results, increases confidence in NDV-01 as a potential durable treatment for bladder cancer[5] Pipeline Highlights Relmada's pipeline features NDV-01 for bladder cancer, progressing to Phase 3, and sepranolone for Prader-Willi Syndrome, preparing for Phase 2 NDV-01 NDV-01 is a sustained-release intravesical formulation of gemcitabine and docetaxel (Gem/Doce) being developed for High-Grade/Intermediate-Grade Non-Muscle Invasive Bladder Cancer (HG-NMIBC), with promising clinical data and plans for Phase 3 initiation - NDV-01 is a sustained-release intravesical formulation of gemcitabine and docetaxel (Gem/Doce) for HG-NMIBC[6][8] - The U.S. market opportunity for NMIBC is estimated at ~600,000 prevalent cases[8] Clinical Data and Safety Profile NDV-01 demonstrated a complete response at 9 months with no progression to muscle invasive disease or severe treatment-related adverse events - One subject reached the 9-month assessment and had a complete response (CR)[7] - No patient had progression to muscle invasive disease or underwent a radical cystectomy[7] - No patient experienced >= Grade 3 Treatment-Related Adverse Events (TRAE) or discontinued treatment due to AEs[7] Development Status and Next Steps The Phase 2 study is actively enrolling, with FDA interactions and product supply scale-up planned for 2H 2025, leading to Phase 3 initiation in 1H 2026 - The Phase 2 single-arm study is actively enrolling[8] - FDA interactions and product supply scale-up are expected in 2H 2025[8] - Initiation of a Phase 3 registration-track study is planned for 1H 2026[8] Sepranolone Sepranolone, a first-in-class GABAA Modulating Steroid Antagonist (GAMSA), is being prepared for Phase 2 initiation in Prader-Willi Syndrome (PWS) and targets other compulsivity-related disorders - Sepranolone is a first-in-class GABAA Modulating Steroid Antagonist (GAMSA)[9] Indications and Market Opportunity Sepranolone targets Prader-Willi Syndrome, Tourette Syndrome, and other compulsivity-related disorders, with PWS having an estimated US prevalence of 20,000 patients - Indications include Prader-Willi Syndrome (PWS), Tourette Syndrome (TS), Essential Tremor, and other compulsivity-related disorders[13] - US prevalence for PWS, an orphan disease, is estimated at 20,000 patients[13] Development Status and Next Steps The company is preparing for Phase 2 initiation in PWS, with FDA engagement and manufacturing activities planned for 2H 2025, and study launch in 1H 2026 - The company is currently preparing for Phase 2 initiation in PWS[13] - FDA engagement and manufacturing activities are planned for 2H 2025[13] - A Phase 2 study launch in PWS is planned for 1H 2026[13] Financial Performance Overview Relmada reported reduced R&D and G&A expenses, leading to a lower net loss and improved loss per share for Q2 and 1H 2025 Three Months Ended June 30, 2025 Results For the second quarter of 2025, Relmada reported a significant reduction in R&D and G&A expenses, leading to a lower net loss and improved loss per share compared to the prior year Key Financial Highlights (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | R&D Expense | $2.8 million | $10.7 million | ↓ 73.8% | | G&A Expense | $7.4 million | $8.1 million | ↓ 8.6% | | Net Loss | $9.9 million | $17.8 million | ↓ 44.4% | | Loss per share | $0.30 | $0.59 | ↓ 49.2% | - R&D expense decrease primarily due to wind-down of REL-1017 trial costs and lower stock-based compensation, partially offset by increased R&D employee compensation[13] - G&A expense decrease primarily due to lower stock-based compensation, partially offset by increased G&A employee compensation and consulting services expenses[13] Six Months Ended June 30, 2025 Results For the first half of 2025, Relmada continued to reduce R&D and G&A expenses, resulting in a decreased net loss and improved loss per share, while managing cash usage from operations Key Financial Highlights (Six Months Ended June 30) | Metric | 1H 2025 | 1H 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | R&D Expense | $14.7 million | $24.0 million | ↓ 38.75% | | G&A Expense | $13.7 million | $17.8 million | ↓ 23.0% | | Net Cash Used in Operations | $24.5 million | $26.3 million | ↓ 6.8% | | Net Loss | $27.4 million | $39.6 million | ↓ 30.8% | | Loss per share | $0.86 | $1.31 | ↓ 34.4% | - R&D expense decrease reflects reduced REL-1017 trial costs and lower stock-based compensation, partially offset by increased costs for NDV-01 and sepranolone acquisitions and R&D employee compensation[13] - G&A expense decrease primarily due to lower stock-based compensation and reduced use of consulting services, partially offset by increased G&A employee compensation[13] - Cash, Equivalents & Short-Term Investments stood at $20.6 million as of June 30, 2025, down from $44.9 million at year-end 2024[13] - Shares Outstanding were 33,191,622 as of August 4, 2025[13] Conference Call and Webcast Details Relmada hosted a conference call and webcast on August 7, 2025, to discuss Q2 2025 results and pipeline progress, with replay available Conference Call and Webcast Relmada hosted a conference call and webcast on August 7, 2025, to discuss its Q2 2025 results and pipeline progress, with replay available online - A conference call was held on August 7, 2025, at 4:30 PM ET to discuss Q2 2025 results and pipeline progress[11] - A replay of the webcast is available on the Investors section of the Relmada website[12] - Dial-in numbers: U.S. 1-877-407-0792, International 1-201-689-8263; Conference ID: 13754263[13] Detailed Financial Statements This section presents the condensed consolidated balance sheets, statements of operations, and cash flows for Relmada Therapeutics Condensed Consolidated Balance Sheets The condensed consolidated balance sheets show a decrease in total assets and stockholders' equity as of June 30, 2025, compared to December 31, 2024, primarily driven by a reduction in cash, cash equivalents, and short-term investments Condensed Consolidated Balance Sheets | | As of June 30, 2025 (Unaudited) | As of December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $1,353,351 | $3,857,026 | | Short-term investments | $19,266,190 | $41,052,356 | | Prepaid expenses | $474,628 | $886,461 | | Total current assets | $21,094,169 | $45,795,843 | | Other assets | $21,975 | $21,975 | | Total assets | $21,116,144 | $45,817,818 | | Liabilities and Stockholders' Equity | | | | Accounts payable | $1,361,911 | $4,130,563 | | Accrued expenses | $3,772,636 | $6,160,827 | | Total current liabilities | $5,134,547 | $10,291,390 | | Stock appreciation rights | $32,116 | $4,467 | | Total liabilities | $5,166,663 | $10,295,857 | | Stockholders' Equity | | | | Common stock | $33,191 | $30,174 | | Additional paid-in capital | $684,224,232 | $676,373,822 | | Accumulated deficit | $(668,307,942) | $(640,882,035) | | Total stockholders' equity | $15,949,481 | $35,521,961 | | Total liabilities and stockholders' equity | $21,116,144 | $45,817,818 | Condensed Consolidated Statements of Operations The condensed consolidated statements of operations show a significant reduction in operating expenses and net loss for both the three and six months ended June 30, 2025, compared to the same periods in 2024, primarily driven by lower R&D and G&A costs Condensed Consolidated Statements of Operations (Unaudited) | | Three months ended June 30, | Six months ended June 30, | | :--- | :--- | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Operating expenses: | | | | | | Research and development | $2,819,377 | $10,721,089 | $14,770,400 | $24,026,395 | | General and administrative | $7,401,929 | $8,097,695 | $13,669,342 | $17,780,249 | | Total operating expenses | $10,221,306 | $18,818,784 | $28,439,742 | $41,806,644 | | Loss from operations | $(10,221,306) | $(18,818,784) | $(28,439,742) | $(41,806,644) | | Other (expenses) income: | | | | | | Interest/investment income, net | $321,458 | $963,013 | $761,745 | $2,018,901 | | Realized (loss) gain on short-term investments | $47,203 | $133,114 | $110,156 | $186,247 | | Unrealized (loss) gain on short-term investments | $(13,797) | $(45,465) | $141,934 | $5,248 | | Total other income | $354,864 | $1,050,662 | $1,013,835 | $2,210,396 | | Net loss | $(9,866,442) | $(17,768,122) | $(27,425,907) | $(39,596,248) | | Loss per common share – basic and diluted | $(0.30) | $(0.59) | $(0.86) | $(1.31) | | Weighted average number of common shares outstanding – basic and diluted | 33,191,622 | 30,174,202 | 31,807,943 | 30,153,186 | Condensed Consolidated Statements of Changes in Stockholders' Equity The condensed consolidated statements of changes in stockholders' equity reflect the impact of stock-based compensation, issuance of restricted common stock, ATM expenses, and net losses on the total equity for the periods ended June 30, 2025, and 2024 Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) | | Common Stock Shares | Par Value | Additional Paid-in Capital | Accumulated Deficit | Total | | :--- | :--- | :--- | :--- | :--- | :--- | | Balance – December 31, 2024 | 30,174,202 | $30,174 | $676,373,822 | $(640,882,035) | $35,521,961 | | Stock based compensation | - | - | $3,572,769 | - | $3,572,769 | | Issuance of Restricted Common Stock | 3,017,420 | $3,017 | $902,209 | - | $905,226 | | Net loss | - | - | - | $(17,559,465) | $(17,559,465) | | Balance – March 31, 2025 | 33,191,622 | $33,191 | $680,848,800 | $(658,441,500) | $22,440,491 | | Stock based compensation | - | - | $3,448,453 | - | $3,448,453 | | ATM Expenses | - | - | $(73,021) | - | $(73,021) | | Net loss | - | - | - | $(9,866,442) | $(9,866,442) | | Balance – June 30, 2025 | 33,191,622 | $33,191 | $684,224,232 | $(668,307,942) | $15,949,481 | | | | | | | | | Balance – December 31, 2023 | 30,099,203 | $30,099 | $646,229,824 | $(560,902,681) | $85,357,242 | | Stock based compensation | - | - | $8,295,468 | - | $8,295,468 | | Options exercised for common stock | 74,999 | $75 | $246,672 | - | $246,747 | | ATM Expenses | - | - | $(25,000) | - | $(25,000) | | Net loss | - | - | - | $(21,828,126) | $(21,828,126) | | Balance – March 31, 2024 | 30,174,202 | $30,174 | $654,746,964 | $(582,730,807) | $72,046,331 | | Stock based compensation | - | - | $7,213,419 | - | $7,213,419 | | Net loss | - | - | - | $(17,768,122) | $(17,768,122) | | Balance – June 30, 2024 | 30,174,202 | $30,174 | $661,960,383 | $(600,498,929) | $61,491,628 | Condensed Consolidated Statements of Cash Flows The condensed consolidated statements of cash flows indicate a net decrease in cash and cash equivalents for the six months ended June 30, 2025, primarily due to cash used in operating activities, partially offset by cash provided by investing activities Condensed Consolidated Statements of Cash Flows (Unaudited) | | Six months ended June 30, | | :--- | :--- | | | 2025 | 2024 | | Cash flows from operating activities | | | | Net loss | $(27,425,907) | $(39,596,248) | | Adjustments to reconcile net loss to net cash used in operating activities: | | | | Stock-based compensation | $7,926,448 | $15,508,887 | | Realized (gain) on short-term investments | $(110,156) | $(186,247) | | Unrealized (gain) on short-term investments | $(141,934) | $(5,248) | | Change in operating assets and liabilities: | | | | Prepaid expenses and other assets | $411,834 | $637,035 | | Accounts payable | $(2,768,652) | $668,559 | | Accrued expenses | $(2,388,191) | $(3,326,511) | | Stock appreciation rights compensation | $27,649 | - | | Net cash (used in) operating activities | $(24,468,909) | $(26,299,773) | | Cash flows from investing activities | | | | Purchase of short-term investments | $(809,375) | $(8,313,312) | | Sale of short-term investments | $22,847,630 | $32,386,030 | | Net cash provided by investing activities | $22,038,255 | $24,072,718 | | Cash flows from financing activities | | | | Proceeds from options exercised for common stock | - | $246,747 | | ATM Expenses | $(73,021) | $(25,000) | | Net cash (used in)/provided by financing activities | $(73,021) | $221,747 | | Net (decrease)/increase in cash and cash equivalents | $(2,503,675) | $(2,005,308) | | Cash and cash equivalents at beginning of the period | $3,857,026 | $4,091,568 | | Cash and cash equivalents at end of the period | $1,353,351 | $2,086,260 | Product Candidate and Indication Background This section provides detailed information on NDV-01 and sepranolone, their clinical studies, and the diseases they target About NDV-01 NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel designed for non-muscle invasive bladder cancer, offering enhanced local exposure, minimal systemic toxicity, and convenient in-office administration - NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce) for non-muscle invasive bladder cancer[15] - It is designed for bladder retention and gradual drug release over 10 days, creating a soft matrix that enhances local exposure while minimizing systemic toxicity[15] - NDV-01 is convenient to administer in-office in less than 10 minutes, without anesthesia or specialized equipment, and is protected by patents through 2038[15] About the Phase 2 Study (NDV-01) The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center trial evaluating the safety and efficacy of NDV-01 in patients with HG-NMIBC, with primary endpoints of safety and complete response rate at 12 months - The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center study[16] - It evaluates the safety and efficacy of NDV-01 in patients with High-Grade Non-Muscle Invasive Bladder Cancer (HG-NMIBC)[16] - Patients receive biweekly induction followed by monthly maintenance for up to one year, with primary efficacy endpoints being safety and complete response rate (CRR) at 12 months[16] About Non-Muscle Invasive Bladder Cancer (NMIBC) NMIBC accounts for approximately 75% of all bladder cancer cases, characterized by high recurrence rates and a significant market opportunity due to over 600,000 prevalent cases in the U.S. and limited treatment options - NMIBC represents ~75% of all bladder cancer cases and is associated with high recurrence (50–75% over 7 years)[17] - There are over 600,000 prevalent cases in the U.S. and limited treatment options, indicating a significant market opportunity[17] - NDV-01 has the potential to serve as a frontline or salvage therapy across multiple NMIBC subtypes[17] About Sepranolone and GABA Modulation Sepranolone, a synthetic isoallopregnanolone, is a selective GABAA receptor modulator that antagonizes allopregnanolone (ALLO) to target disorders linked to excess GABAergic activity, demonstrating an excellent safety profile in over 335 patients - Sepranolone is a synthetic isoallopregnanolone that selectively modulates GABAA receptors by antagonizing allopregnanolone (ALLO) without disrupting GABA signaling[18] - It targets disorders linked to excess GABAergic activity, such as Prader-Willi syndrome, Tourette syndrome, and Obsessive-Compulsive Disorder (OCD)[18] - Over 335 patients have been treated with sepranolone in clinical trials to date, showing an excellent safety profile[18] About Prader-Willi Syndrome (PWS) Prader-Willi Syndrome (PWS) is a rare genetic disorder affecting approximately 20,000 patients in the US, characterized by neurodevelopmental and behavioral complications, with current treatments only addressing symptoms rather than the underlying pathology - PWS is a rare genetic disorder caused by chromosomal deletions on chromosome 15, leading to neurodevelopmental and behavioral complications[19] - US prevalence is estimated to be 20,000 patients[19] - Current treatments address symptoms but do not modify the underlying neurobehavioral pathology[19] About Relmada Therapeutics, Inc. Relmada Therapeutics is a clinical-stage biotechnology company developing transformative therapies for oncology and CNS conditions Company Overview Relmada Therapeutics is a clinical-stage biotechnology company dedicated to developing transformative therapies for oncology-related and central nervous system conditions, with lead candidates NDV-01 and sepranolone progressing through mid-stage clinical development - Relmada Therapeutics is a clinical-stage biotechnology company[20] - The company focuses on developing transformative therapies for oncology-related and central nervous system conditions[20] - Lead candidates NDV-01 and sepranolone are advancing through mid-stage clinical development to address significant unmet needs[20] Forward-Looking Statements This section provides a disclaimer regarding future-oriented statements, highlighting inherent risks and the company's non-obligation to update them Disclaimer on Forward-Looking Statements This section provides a safe harbor for forward-looking statements, emphasizing that such statements are based on current expectations and are subject to risks, uncertainties, and assumptions that could cause actual results to differ materially, and Relmada undertakes no obligation to update them - The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements[22] - Statements are based on management's current expectations and beliefs, subject to risks, uncertainties, and assumptions that could cause actual results to differ materially[22] - Relmada undertakes no obligation to publicly update any forward-looking statement, and readers are cautioned that not all risks can be predicted or identified[22] Investor and Media Contacts This section provides contact information for investor relations and media inquiries Contact Information Contact details are provided for investor relations and corporate communications for media inquiries - Investor Contact: Brian Ritchie, LifeSci Advisors, britchie@lifesciadvisors.com[23] - Media Inquiries: Corporate Communications, media@relmada.com[23]