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].

Group 1: AI Investment Opportunity - Artificial intelligence is identified as the greatest investment opportunity of our lifetime, with a strong emphasis on the urgency to invest now [1][13] - Wall Street is investing hundreds of billions into AI, but there is a critical question regarding the energy supply needed to support this technology [2][6] - AI data centers consume massive amounts of energy, comparable to the energy needs of small cities, leading to concerns about power grid strain and rising electricity prices [2][3] Group 2: Company Overview - A specific company is highlighted as a key player in the AI energy sector, owning critical energy infrastructure assets that are essential for meeting the increasing energy demands of AI [3][7] - This company is positioned to benefit from the surge in demand for electricity driven by AI data centers, making it a unique investment opportunity [3][8] - The company is debt-free and has a significant cash reserve, equating to nearly one-third of its market capitalization, which provides financial stability [8][10] Group 3: Market Position and Growth Potential - The company plays a pivotal role in U.S. LNG exportation and is well-positioned to capitalize on the onshoring trend driven by tariffs [5][7] - It is capable of executing large-scale engineering, procurement, and construction projects across various energy sectors, including nuclear energy [7][8] - The company also holds a substantial equity stake in another AI-related venture, providing indirect exposure to multiple growth engines in the AI sector [9][10] Group 4: Investment Appeal - The stock is described as undervalued, trading at less than 7 times earnings, which presents a compelling investment opportunity [10][11] - The company is generating real cash flows and is not reliant on speculative growth, making it a solid investment choice [11][12] - The influx of talent into the AI sector ensures continuous innovation, further enhancing the investment potential in AI-related companies [12][14]

Summary of Relmada Therapeutics Conference Call Company Overview - **Company Name**: Relmada Therapeutics - **Ticker Symbol**: RLMD - **Public Listing**: NASDAQ since 2019, public since 2014 - **Focus Area**: Central nervous system and oncology, specifically bladder cancer treatment [2][3] Key Developments - **Strategic Shift**: The company has adopted a new strategy to lower risk while maintaining upside potential, leading to the acquisition of two programs [3] - **NDB-01**: The most advanced program, focusing on non-muscle invasive bladder cancer, which constitutes about 75% of bladder cancer cases [4][5] - **Sopranolol**: An early-stage program for treating compulsive disorders, with potential applications in Tourette's syndrome and Prader-Willi syndrome [25][26] Bladder Cancer Insights - **Prevalence**: Bladder cancer accounts for 1 in 25 cancers in the U.S., with approximately 70,000 to 80,000 new cases annually [5][6] - **Patient Demographics**: Primarily affects older men, with an average disease duration of around 10 years [5] - **Recurrence Rate**: High recurrence, with 50% of patients experiencing recurrence within one year and 70-80% within two years [6] Treatment Landscape - **Current Treatments**: Include surgery (TURBT), BCG immunotherapy, and chemotherapy [7][9] - **Challenges with BCG**: BCG is difficult to tolerate and has been in shortage for several years [9] - **Emerging Chemotherapy**: The combination of gemcitabine and docetaxel (referred to as Gendoza) is effective but has limitations in administration and preparation [12][13] NDB-01 Advantages - **Delivery Method**: NDB-01 is an extended-release gel that allows for easier administration of chemotherapy directly in the bladder [14][15] - **Efficacy**: Early data shows a 90% cancer-free rate at six months in the ongoing phase 2 study [19][20] - **Market Position**: Competes with products from Johnson & Johnson and UroGen, which have higher treatment costs [21][22][23] Financial Overview - **Cash Position**: As of the end of Q2, the company had $20.6 million in cash and equivalents [28] - **Share Structure**: 33.2 million shares outstanding, indicating a clean balance sheet [28] - **Future Financing**: The company acknowledges the need for future financing to support clinical trials but does not anticipate immediate needs [41] Market Potential - **Treatment Costs**: UroGen's treatment costs $21,000 per treatment, while Johnson & Johnson's is $69,000, indicating a significant market opportunity for NDB-01 [22][23] - **Annual Procedures**: There are approximately 100,000 surgeries annually for non-muscle invasive bladder cancer in the U.S., suggesting substantial revenue potential [23] Conclusion - **Regulatory Path**: Plans to discuss with the FDA in Q4 and aim to start registration studies in Q2 2026 [24] - **Insider Confidence**: Recent insider buying by executives indicates confidence in the company's future [45][46] This summary encapsulates the key points from the Relmada Therapeutics conference call, highlighting the company's strategic direction, product developments, market landscape, and financial positioning.

Core Points - Relmada Therapeutics, Inc. has regained compliance with Nasdaq's $1.00 minimum bid price requirement as of September 15, 2025 [1][2] - The company achieved the required minimum closing bid price of $1.00 for at least 10 consecutive business days, specifically on September 12, 2025 [2] - Relmada is now fully compliant with all Nasdaq continued listing requirements and will continue to be traded under the ticker "RLMD" [2] Company Overview - Relmada Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapies for oncology-related and central nervous system conditions [2] - The company's lead candidates, NDV-01 and sepranolone, are currently advancing through mid-stage clinical development [2]

Core Insights - Relmada Therapeutics has experienced a transformational year in 2025, with significant progress in its clinical development and strategic initiatives [1] Strategic Review and Portfolio Expansion - A comprehensive strategic review was completed, reaffirming the mission to develop life-changing treatments and diversify the portfolio [2] - Two new Phase 2 product candidates were added, enhancing the long-term value proposition of the company [2] NDV-01 Development - NDV-01 has shown a 91% complete response rate in a Phase 2 study for non-muscle invasive bladder cancer (NMIBC), affecting approximately 600,000 patients in the U.S. [2] - Preparations are underway to initiate a Phase 3 registrational trial in the first half of 2026, including regulatory filings and manufacturing scale-up [3][8] - The NDV-01 program is further supported by the addition of two experts in bladder cancer to the team [4] Sepranolone Advancement - Positive proof-of-concept data in Tourette's syndrome indicates potential for sepranolone in treating compulsive disorders [5] - A Phase 2 study for sepranolone in Prader-Willi Syndrome (PWS) is planned to begin in the first half of 2026, targeting a rare genetic disorder affecting 350,000–400,000 people worldwide [5][13] Key Upcoming Milestones - Upcoming milestones include Phase 2 results for NDV-01 in Q4 2025 and Q1 2026, product supply scale-up in the second half of 2025, and U.S. IND clearance in the first half of 2026 [8] - The initiation of the Phase 3 registrational trial for NDV-01 is also scheduled for the first half of 2026 [8] Company Outlook - The company remains optimistic about its future, with the progress of NDV-01 and sepranolone, alongside a strengthened team, positioning it well for value creation [9]

Financial Data and Key Metrics Changes - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments of approximately $20.6 million, down from $44.9 million as of December 31, 2024 [22] - Cash used in operations in Q2 2025 was $6.4 million, compared to $13.3 million for the same period in 2024 [22] - The net loss for Q2 2025 was $9.9 million or $0.30 per share, compared to a net loss of $17.8 million or $0.59 per share for Q2 2024 [24] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2025 totaled $2.8 million, down from $10.7 million in Q2 2024, primarily due to lower study costs from the wind down of clinical trials for REL-ten seventeen [23] - General and administrative expenses for Q2 2025 were $7.4 million, compared to $8.1 million in Q2 2024, driven by a decrease in stock-based compensation [24] Market Data and Key Metrics Changes - The company is focusing on two product candidates: NDV-one for non-muscle invasive bladder cancer and sopranolone for compulsivity disorders, targeting significant and underserved markets [6][20] - NDV-one has shown a complete response rate of 91% at any time point following treatment in high-risk patients [14] Company Strategy and Development Direction - The company aims to initiate a Phase III study for NDV-one in 2026 and a proof of concept study for sopranolone in Prader Willi syndrome also in 2026 [18][27] - The management team has expanded with the addition of experts in bladder cancer and urologic oncology, which is expected to enhance the company's strategic objectives [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of NDV-one as a promising treatment for non-muscle invasive bladder cancer, with plans to engage with the FDA regarding trial design [18][36] - The company believes that the recent approval of a competitor's product sets a precedent for their own approach in the market [33] Other Important Information - The company reported a clean balance sheet and a strong cash position, which positions it well for future value-creating steps [27] - Management emphasized the importance of upcoming milestones and the disciplined development strategy to enhance the long-term value proposition [22] Q&A Session Summary Question: How do recent data and competitor approvals affect NDV-one's strategy? - Management acknowledged the opportunity in both high-grade and low-grade non-muscle invasive bladder cancer, noting the significant efficacy data for high-grade disease while also considering the larger market for low-grade patients [31][33] Question: What are the goals for the upcoming FDA meeting? - The main goal is to discuss the viability of a single-arm open-label study for chemoablation, similar to the path taken by a competitor [36] Question: How should R&D expenses be viewed going forward? - R&D expenses have decreased due to a lack of patient enrollment, but costs will rise again as the company prepares to start new trials [41]

[Executive Summary & Recent Developments](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Developments) 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](index=1&type=section&id=Q2%202025%20Financial%20Results%20and%20Corporate%20Update) 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](index=2&type=chunk) [NDV-01 6-Month Follow-up Safety and Efficacy Data](index=1&type=section&id=NDV-01%206-Month%20Follow-up%20Safety%20and%20Efficacy%20Data) 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](index=1&type=chunk) 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](index=5&type=chunk) [Pipeline Highlights](index=2&type=section&id=Pipeline%20Highlights) 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](index=2&type=section&id=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](index=6&type=chunk)[8](index=8&type=chunk) - The U.S. market opportunity for NMIBC is estimated at **~600,000 prevalent cases**[8](index=8&type=chunk) [Clinical Data and Safety Profile](index=2&type=section&id=Clinical%20Data%20and%20Safety%20Profile) 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](index=7&type=chunk) - No patient had progression to muscle invasive disease or underwent a radical cystectomy[7](index=7&type=chunk) - No patient experienced >= Grade 3 Treatment-Related Adverse Events (TRAE) or discontinued treatment due to AEs[7](index=7&type=chunk) [Development Status and Next Steps](index=2&type=section&id=Development%20Status%20and%20Next%20Steps) 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](index=8&type=chunk) - FDA interactions and product supply scale-up are expected in **2H 2025**[8](index=8&type=chunk) - Initiation of a Phase 3 registration-track study is planned for **1H 2026**[8](index=8&type=chunk) [Sepranolone](index=3&type=section&id=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](index=9&type=chunk) [Indications and Market Opportunity](index=3&type=section&id=Indications%20and%20Market%20Opportunity) 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](index=13&type=chunk) - US prevalence for PWS, an orphan disease, is estimated at **20,000 patients**[13](index=13&type=chunk) [Development Status and Next Steps](index=3&type=section&id=Development%20Status%20and%20Next%20Steps) 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](index=13&type=chunk) - FDA engagement and manufacturing activities are planned for **2H 2025**[13](index=13&type=chunk) - A Phase 2 study launch in PWS is planned for **1H 2026**[13](index=13&type=chunk) [Financial Performance Overview](index=3&type=section&id=Financial%20Performance%20Overview) 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](index=3&type=section&id=Three%20Months%20Ended%20June%2030%2C%202025%20Results) 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](index=13&type=chunk) - G&A expense decrease primarily due to lower stock-based compensation, partially offset by increased G&A employee compensation and consulting services expenses[13](index=13&type=chunk) [Six Months Ended June 30, 2025 Results](index=3&type=section&id=Six%20Months%20Ended%20June%2030%2C%202025%20Results) 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](index=13&type=chunk) - 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](index=13&type=chunk) - 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](index=13&type=chunk) - Shares Outstanding were **33,191,622** as of August 4, 2025[13](index=13&type=chunk) [Conference Call and Webcast Details](index=3&type=section&id=Conference%20Call%20and%20Webcast%20Details) 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](index=3&type=section&id=Conference%20Call%20and%20Webcast) 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](index=11&type=chunk) - A replay of the webcast is available on the Investors section of the Relmada website[12](index=12&type=chunk) - Dial-in numbers: U.S. **1-877-407-0792**, International **1-201-689-8263**; Conference ID: **13754263**[13](index=13&type=chunk) [Detailed Financial Statements](index=7&type=section&id=Detailed%20Financial%20Statements) This section presents the condensed consolidated balance sheets, statements of operations, and cash flows for Relmada Therapeutics [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) 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](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=5&type=section&id=Product%20Candidate%20and%20Indication%20Background) This section provides detailed information on NDV-01 and sepranolone, their clinical studies, and the diseases they target [About NDV-01](index=5&type=section&id=About%20NDV-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](index=15&type=chunk) - 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](index=15&type=chunk) - 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](index=15&type=chunk) [About the Phase 2 Study (NDV-01)](index=5&type=section&id=About%20the%20Phase%202%20Study%20(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](index=16&type=chunk) - It evaluates the safety and efficacy of NDV-01 in patients with High-Grade Non-Muscle Invasive Bladder Cancer (HG-NMIBC)[16](index=16&type=chunk) - 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](index=16&type=chunk) [About Non-Muscle Invasive Bladder Cancer (NMIBC)](index=5&type=section&id=About%20Non-Muscle%20Invasive%20Bladder%20Cancer%20(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](index=17&type=chunk) - There are over **600,000 prevalent cases** in the U.S. and limited treatment options, indicating a significant market opportunity[17](index=17&type=chunk) - NDV-01 has the potential to serve as a frontline or salvage therapy across multiple NMIBC subtypes[17](index=17&type=chunk) [About Sepranolone and GABA Modulation](index=5&type=section&id=About%20Sepranolone%20and%20GABA%20Modulation) 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](index=18&type=chunk) - It targets disorders linked to excess GABAergic activity, such as Prader-Willi syndrome, Tourette syndrome, and Obsessive-Compulsive Disorder (OCD)[18](index=18&type=chunk) - Over **335 patients** have been treated with sepranolone in clinical trials to date, showing an excellent safety profile[18](index=18&type=chunk) [About Prader-Willi Syndrome (PWS)](index=5&type=section&id=About%20Prader-Willi%20Syndrome%20(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](index=19&type=chunk) - US prevalence is estimated to be **20,000 patients**[19](index=19&type=chunk) - Current treatments address symptoms but do not modify the underlying neurobehavioral pathology[19](index=19&type=chunk) [About Relmada Therapeutics, Inc.](index=5&type=section&id=About%20Relmada%20Therapeutics%2C%20Inc.) Relmada Therapeutics is a clinical-stage biotechnology company developing transformative therapies for oncology and CNS conditions [Company Overview](index=5&type=section&id=Company%20Overview) 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](index=20&type=chunk) - The company focuses on developing transformative therapies for oncology-related and central nervous system conditions[20](index=20&type=chunk) - Lead candidates NDV-01 and sepranolone are advancing through mid-stage clinical development to address significant unmet needs[20](index=20&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) 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](index=6&type=section&id=Disclaimer%20on%20Forward-Looking%20Statements) 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](index=22&type=chunk) - 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](index=22&type=chunk) - 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](index=22&type=chunk) [Investor and Media Contacts](index=6&type=section&id=Investor%20and%20Media%20Contacts) This section provides contact information for investor relations and media inquiries [Contact Information](index=6&type=section&id=Contact%20Information) Contact details are provided for investor relations and corporate communications for media inquiries - Investor Contact: Brian Ritchie, LifeSci Advisors, britchie@lifesciadvisors.com[23](index=23&type=chunk) - Media Inquiries: Corporate Communications, media@relmada.com[23](index=23&type=chunk)

[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This part details Relmada Therapeutics' unaudited condensed consolidated financial statements and related notes for the periods ended June 30, 2025 and 2024 [ITEM 1. FINANCIAL STATEMENTS](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) This section presents Relmada Therapeutics' unaudited condensed consolidated financial statements and detailed notes for the periods ended June 30, 2025 and 2024 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of Relmada's financial position, detailing assets, liabilities, and equity as of June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheets (June 30, 2025 vs. December 31, 2024) | Metric | June 30, 2025 (Unaudited) (USD) | December 31, 2024 (USD) | | :-------------------------- | :------------------------ | :------------------ | | Cash and cash equivalents | $1,353,351 | $3,857,026 | | Short-term investments | $19,266,190 | $41,052,356 | | Total current assets | $21,094,169 | $45,795,843 | | Total assets | $21,116,144 | $45,817,818 | | Total current liabilities | $5,134,547 | $10,291,390 | | Total liabilities | $5,166,663 | $10,295,857 | | Total stockholders' equity | $15,949,481 | $35,521,961 | - Total assets decreased by approximately **53.9%** from **$45.8 million** at December 31, 2024, to **$21.1 million** at June 30, 2025, primarily driven by a significant reduction in cash and short-term investments[9](index=9&type=chunk) - Total current liabilities decreased by approximately **50.1%** from **$10.3 million** at December 31, 2024, to **$5.1 million** at June 30, 2025[9](index=9&type=chunk) [Unaudited Condensed Consolidated Statements of Operations](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) This section details Relmada's financial performance, including operating expenses, net loss, and loss per share for the three and six months ended June 30, 2025 and 2024 Condensed Consolidated Statements of Operations (Three Months Ended June 30) | Operating Expense | June 30, 2025 (USD) | June 30, 2024 (USD) | Change (YoY) (%) | | :---------------- | :------------ | :------------ | :----------- | | R&D | $2,819,377 | $10,721,089 | -73.7% | | G&A | $7,401,929 | $8,097,695 | -8.59% | | Total | $10,221,306 | $18,818,784 | -45.7% | | Net Loss | $(9,866,442) | $(17,768,122) | -44.4% | | Loss per share | $(0.30) | $(0.59) | -49.2% | Condensed Consolidated Statements of Operations (Six Months Ended June 30) | Operating Expense | June 30, 2025 (USD) | June 30, 2024 (USD) | Change (YoY) (%) | | :---------------- | :------------ | :------------ | :----------- | | R&D | $14,770,400 | $24,026,395 | -38.5% | | G&A | $13,669,342 | $17,780,249 | -23.1% | | Total | $28,439,742 | $41,806,644 | -32.0% | | Net Loss | $(27,425,907) | $(39,596,248) | -30.7% | | Loss per share | $(0.86) | $(1.31) | -34.4% | - Net loss significantly decreased by **44.4%** for the three months ended June 30, 2025, and by **30.7%** for the six months ended June 30, 2025, compared to the same periods in 2024, primarily due to reduced operating expenses[12](index=12&type=chunk) [Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) This section outlines the changes in Relmada's stockholders' equity, reflecting the impact of net loss, stock-based compensation, and other equity transactions for the six months ended June 30, 2025 Changes in Stockholders' Equity (Six Months Ended June 30, 2025) | Item | Amount (USD) | | :------------------------ | :----------- | | Balance – Dec 31, 2024 | $35,521,961 | | Stock based compensation | $7,021,222 | | Issuance of Restricted Common Stock | $905,226 | | ATM Expenses | $(73,021) | | Net loss | $(27,425,907)| | Balance – June 30, 2025 | $15,949,481 | - Total stockholders' equity decreased from **$35.5 million** at December 31, 2024, to **$15.9 million** at June 30, 2025, primarily due to the net loss incurred during the period, partially offset by stock-based compensation and issuance of restricted common stock[15](index=15&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents Relmada's cash flow activities, including operating, investing, and financing, for the six months ended June 30, 2025 and 2024 Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30) | Cash Flow Activity | June 30, 2025 (USD) | June 30, 2024 (USD) | | :------------------------ | :------------ | :------------ | | Operating activities | $(24,468,909) | $(26,299,773) | | Investing activities | $22,038,255 | $24,072,718 | | Financing activities | $(73,021) | $221,747 | | Net (decrease)/increase | $(2,503,675) | $(2,005,308) | | Cash & equivalents at end | $1,353,351 | $2,086,260 | - Net cash used in operating activities decreased from **$26.3 million** in H1 2024 to **$24.5 million** in H1 2025, primarily due to a lower net loss[18](index=18&type=chunk) - Cash provided by investing activities decreased from **$24.1 million** in H1 2024 to **$22.0 million** in H1 2025, mainly due to lower sales of short-term investments[18](index=18&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures for the financial statements, covering accounting policies, specific line items, and other relevant financial information [NOTE 1 - BUSINESS](index=8&type=section&id=NOTE%201%20-%20BUSINESS) Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing NDV-01 for non-muscle invasive bladder cancer and Sepranolone for neurological disorders. The company terminated its Esmethadone and psilocybin (REL-P11) programs in July and May 2025, respectively. Relmada also acquired Sepranolone for €3 million and licensed NDV-01 for a $3.5 million upfront payment and 3,017,420 shares of common stock, with potential milestones up to $200 million - Relmada is a clinical-stage biotechnology company developing NDV-01 for non-muscle invasive bladder cancer (NMIBC) and Sepranolone for Prader-Willi Syndrome, Tourette Syndrome, and other GABAergic activity-related diseases[21](index=21&type=chunk)[22](index=22&type=chunk) - The Esmethadone program was terminated effective July 7, 2025, and the psilocybin (REL-P11) program was terminated effective May 12, 2025[23](index=23&type=chunk) - The company acquired Sepranolone from Asarina Pharma AB for a total purchase price of **€3,000,000**, with **$2,756,000** paid on February 5, 2025[28](index=28&type=chunk) - Relmada entered an exclusive license agreement with Trigone for NDV-01, making a **$3,500,000** upfront payment and issuing **3,017,420** shares of common stock (**10%** of outstanding shares) for worldwide rights (excluding Israel, India, South Africa)[29](index=29&type=chunk) - The company received a Nasdaq notification for not maintaining a minimum bid price of **$1** per share and was granted an extension until January 19, 2026, to regain compliance after transferring its listing to the Nasdaq Capital Market[25](index=25&type=chunk)[26](index=26&type=chunk) [NOTE 2 - GOING CONCERN](index=9&type=section&id=NOTE%202%20-%20GOING%20CONCERN) Relmada has incurred significant losses and negative operating cash flows since inception, with a net loss of $27.4 million and negative operating cash flows of $24.5 million for the six months ended June 30, 2025. The company projects insufficient liquidity to sustain operations for one year, raising substantial doubt about its ability to continue as a going concern. Management is evaluating financing strategies but cannot assure their success or favorable terms - The Company incurred a net loss of **$27,425,907** and had negative operating cash flows of **$24,468,909** for the six months ended June 30, 2025[33](index=33&type=chunk) - Relmada projects insufficient liquidity to sustain its operations through one year following the date of financial statement issuance, raising substantial doubt about its ability to continue as a going concern[33](index=33&type=chunk) - Management is evaluating financing strategies, including equity or debt sales, or strategic collaborations, but there are no assurances of securing additional financing on favorable terms[34](index=34&type=chunk) [NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=9&type=section&id=NOTE%203%20-%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines Relmada's significant accounting policies, including the basis of presentation, principles of consolidation, use of estimates, and treatment of cash, short-term investments, patents, leases, fair value measurements, income taxes, research and development costs, stock-based compensation, and net loss per common share. It also details the adoption of recent accounting standards (ASU 2023-07, ASU 2023-09) and the evaluation of upcoming standards (ASU 2024-03, ASU 2025-03, ASU 2025-04) - Short-term investments, consisting of mutual funds, were valued at **$19,266,190** at June 30, 2025, and are classified as Level 1 inputs within the fair value hierarchy[42](index=42&type=chunk)[50](index=50&type=chunk) - The company recorded an unrealized loss of **$13,797** for the three months ended June 30, 2025, and an unrealized gain of **$141,934** for the six months ended June 30, 2025, on short-term investments[50](index=50&type=chunk) - Stock appreciation rights (SARs) liability is classified within Level 3 of the fair value hierarchy, valued at **$32,116** as of June 30, 2025, using a Black-Scholes model with specific unobservable inputs[53](index=53&type=chunk)[54](index=54&type=chunk) - The company expenses all research and development costs as incurred and has recognized a full valuation allowance against its net deferred tax assets due to the uncertainty of realization[56](index=56&type=chunk)[58](index=58&type=chunk) Anti-Dilutive Securities (Common Stock Equivalent Shares) | Security | June 30, 2025 (Shares) | June 30, 2024 (Shares) | | :------------------ | :------------ | :------------ | | Stock options | 14,158,927 | 13,052,592 | | Common stock warrants | 750,908 | 1,813,455 | | Total | 14,909,835 | 14,866,047 | [NOTE 4 - PREPAID EXPENSES](index=15&type=section&id=NOTE%204%20-%20PREPAID%20EXPENSES) This note details the composition and changes in Relmada's prepaid expenses, including insurance and research and development, as of June 30, 2025, and December 31, 2024 Prepaid Expenses (June 30, 2025 vs. December 31, 2024) | Category | June 30, 2025 (USD) | December 31, 2024 (USD) | | :------------------- | :------------ | :---------------- | | Insurance | $68,000 | $403,100 | | Research and Development | $307,100 | $391,200 | | Other | $99,500 | $92,200 | | Total | $474,600 | $886,500 | - Total prepaid expenses decreased by approximately **46.4%** from **$886,500** at December 31, 2024, to **$474,600** at June 30, 2025, primarily due to a significant reduction in prepaid insurance[73](index=73&type=chunk) [NOTE 5 - ACCRUED EXPENSES](index=15&type=section&id=NOTE%205%20-%20ACCRUED%20EXPENSES) This note outlines the breakdown and changes in Relmada's accrued expenses, including research and development, professional fees, and bonuses, as of June 30, 2025, and December 31, 2024 Accrued Expenses (June 30, 2025 vs. December 31, 2024) | Category | June 30, 2025 (USD) | December 31, 2024 (USD) | | :------------------- | :------------ | :---------------- | | Research and development | $1,890,500 | $4,514,800 | | Professional fees | $257,000 | $362,600 | | Accrued bonus | $1,035,900 | $732,300 | | Accrued vacation | $509,800 | $421,700 | | Other | $79,400 | $129,400 | | Total | $3,772,600 | $6,160,800 | - Total accrued expenses decreased by approximately **38.7%** from **$6,160,800** at December 31, 2024, to **$3,772,600** at June 30, 2025, mainly driven by a reduction in accrued research and development costs[74](index=74&type=chunk) [NOTE 6 - STOCK APPRECIATION RIGHTS](index=15&type=section&id=NOTE%206%20-%20STOCK%20APPRECIATION%20RIGHTS) During the first six months of 2025, Relmada issued 775,000 cash-settled Stock Appreciation Rights (SARs) with exercise prices ranging from $0.45 to $0.67, vesting over four years. The total SARs liability at June 30, 2025, was $32,116, with $24,611 in compensation expense recognized for the period. The company has approximately $440,800 in unrecognized compensation expense related to unvested SARs - **775,000** cash-settled SARs were issued during the six months ended June 30, 2025, with exercise prices from **$0.45** to **$0.67** and a **10-year** term, vesting over **4** years[75](index=75&type=chunk) - The total liability for cash-settled SARs was **$32,116** as of June 30, 2025[77](index=77&type=chunk) - Compensation expense related to cash-settled SARs for the six months ended June 30, 2025, was **$24,611**, allocated to R&D (**$24,439**) and G&A (**$172**)[77](index=77&type=chunk) - Unrecognized compensation expense for unvested SARs is approximately **$440,800**, to be recognized over a weighted average remaining service period of **3.72** years[78](index=78&type=chunk) [NOTE 7 - STOCKHOLDERS' EQUITY](index=16&type=section&id=NOTE%207%20-%20STOCKHOLDERS'%20EQUITY) Relmada issued 3,017,420 shares of restricted common stock in Q1 2025 as part of the Trigone Pharma license agreement, recognizing $905,226 in R&D compensation expense. The company's 2021 Equity Incentive Plan was amended in May 2025 to increase available shares by 2,000,000, bringing the combined plan total to 15,052,942 options or stock awards. During H1 2025, 3,103,567 options were issued, and 631,905 warrants expired. Total stock-based compensation expense for H1 2025 was $7,926,400, a decrease from $15,508,900 in H1 2024 - **3,017,420** shares of restricted common stock were issued during the six months ended June 30, 2025, related to the Trigone Pharma license agreement, resulting in **$905,226** of R&D compensation expense[80](index=80&type=chunk) - The 2021 Equity Incentive Plan was amended in May 2025 to increase available shares by **2,000,000**, bringing the combined total for all plans to **15,052,942** options or other stock awards[84](index=84&type=chunk)[85](index=85&type=chunk) - From January 1 to June 30, 2025, **3,103,567** options were issued with a weighted average exercise price of **$0.65**[87](index=87&type=chunk) - Unrecognized stock-based compensation expense for unvested stock options is approximately **$11.2 million**, to be recognized over a weighted average remaining service period of **2.98** years[89](index=89&type=chunk) Stock-Based Compensation Expense by Class (Six Months Ended June 30) | Expense Class | June 30, 2025 (USD) | June 30, 2024 (USD) | | :------------------------ | :------------ | :------------ | | Research and development | $1,236,200 | $3,279,300 | | General and administrative| $6,690,200 | $12,229,600 | | Total | $7,926,400 | $15,508,900 | [NOTE 8 - COMMITMENTS AND CONTINGENCIES](index=18&type=section&id=NOTE%208%20-%20COMMITMENTS%20AND%20CONTINGENCIES) Relmada has ongoing commitments under various license agreements. It continues to pay $45,000 quarterly to Inturrisi/Manfredi for esmethadone rights, despite terminating the program in July 2025. The psilocybin license with Arbormentis LLC was terminated in May 2025. A new exclusive license for NDV-01 with Trigone involves an upfront payment, equity issuance, and potential milestone payments up to $200 million plus a 3% royalty on net sales. The company also has lease obligations for office space and is not currently aware of any material legal proceedings - Relmada pays **$45,000** every three months to Inturrisi/Manfredi for esmethadone rights, an obligation that will cease **90** days after the July 7, 2025, termination notice[95](index=95&type=chunk)[111](index=111&type=chunk) - The license agreement with Arbormentis, LLC for the psilocybin development program was terminated on May 12, 2025, with all obligations ceasing **90** days after the notice[98](index=98&type=chunk) - The exclusive license agreement with Trigone for NDV-01 includes an upfront payment of **$3,500,000**, issuance of **3,017,420** common shares, potential development, regulatory, and commercial milestones up to **$200 million**, and a **3%** royalty on net sales[100](index=100&type=chunk)[101](index=101&type=chunk) - Lease expense for office space was approximately **$98,500** for the six months ended June 30, 2025, down from **$122,100** in the prior year[104](index=104&type=chunk) [NOTE 9 - OTHER POSTRETIREMENT BENEFIT PLAN](index=20&type=section&id=NOTE%209%20-%20OTHER%20POSTRETIREMENT%20BENEFIT%20PLAN) Relmada participates in a multiemployer 401(k) plan, matching 100% of the first 3% of employee contributions and 50% of contributions between 3% and 5%. The company's contribution expense for the six months ended June 30, 2025, was approximately $100,700, an increase from $69,400 in the prior year - Relmada matches **100%** of the first **3%** of employee 401(k) contributions and **50%** of contributions between **3%** and **5%**[106](index=106&type=chunk) - The company's 401(k) contribution expense was approximately **$100,700** for the six months ended June 30, 2025, compared to **$69,400** for the same period in 2024[107](index=107&type=chunk) [NOTE 10 - SEGMENT REPORTING](index=20&type=section&id=NOTE%2010%20-%20SEGMENT%20REPORTING) Relmada operates as a single reportable segment: clinical stage drug development. The Chief Operating Decision-Maker (CODM) assesses performance and allocates resources based on research and development operating expenses. The company's operating expenses for this segment decreased significantly for both the three and six months ended June 30, 2025, compared to 2024 - Relmada's operations constitute a single reportable segment: clinical stage drug development[109](index=109&type=chunk) Clinical Stage Drug Development Operating Expenses (Three Months Ended June 30) | Expense Category | June 30, 2025 (USD) | June 30, 2024 (USD) | | :--------------------------- | :------------ | :------------ | | Clinical Study Expense | $779,600 | $1,587,500 | | Other Research Expense | $702,200 | $6,239,500 | | Manufacturing & Drug Storage | $81,600 | $681,500 | | Compensation Expense | $1,062,700 | $632,600 | | Stock-based Compensation | $193,300 | $1,580,000 | | Total R&D Expense | $2,819,400 | $10,721,100 | Clinical Stage Drug Development Operating Expenses (Six Months Ended June 30) | Expense Category | June 30, 2025 (USD) | June 30, 2024 (USD) | | :--------------------------- | :------------ | :------------ | | Clinical Study Expense | $8,740,200 | $4,760,100 | | Other Research Expense | $2,533,200 | $13,306,300 | | Manufacturing & Drug Storage | $237,200 | $974,000 | | Pre-clinical Expense | $- | $33,700 | | Compensation Expense | $1,996,100 | $1,673,000 | | Stock-based Compensation | $1,263,700 | $3,279,300 | | Total R&D Expense | $14,770,400 | $24,026,400 | [NOTE 11 - SUBSEQUENT EVENTS](index=20&type=section&id=NOTE%2011%20-%20SUBSEQUENT%20EVENTS) On July 7, 2025, Relmada formally terminated its License Agreement with Dr. Charles E. Inturrisi and Dr. Paolo Manfredi, ending its esmethadone development program. All material obligations under this agreement will cease 90 days after the notice date - On July 7, 2025, Relmada terminated the License Agreement for the esmethadone development program with Dr. Charles E. Inturrisi and Dr. Paolo Manfredi[111](index=111&type=chunk) - All material obligations under the esmethadone license agreement will cease **90** days after the termination notice[111](index=111&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION](index=21&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATION) This section provides management's perspective on Relmada's financial condition and operational results, highlighting a strategic shift towards new development candidates (NDV-01 and Sepranolone) following the termination of the Esmethadone and psilocybin programs. It details key financial performance metrics, including a significant reduction in net loss and operating expenses, and addresses the company's liquidity challenges and going concern risk. Upcoming milestones for its new programs are also outlined [Business Overview](index=21&type=section&id=Business%20Overview) This section provides an overview of Relmada Therapeutics, Inc.'s strategic shift in its development programs, focusing on new candidates after terminating previous ones - Relmada Therapeutics, Inc. is a clinical-stage biotechnology company that has substantially redesigned its development programs in late 2024 and early 2025[114](index=114&type=chunk) - The company acquired Sepranolone and in-licensed NDV-01, while terminating the Esmethadone (REL-1017) program effective July 7, 2025, and the psilocybin (REL-P11) program effective May 12, 2025[114](index=114&type=chunk)[115](index=115&type=chunk) [Strategic Business Review and New Approach](index=22&type=section&id=Strategic%20Business%20Review%20and%20New%20Approach) This section outlines Relmada's refined strategy, emphasizing novel therapeutic solutions, market opportunities, IP protection, and pipeline diversification through recent acquisitions - Relmada's refined strategy focuses on advancing novel therapeutic solutions, addressing unmet medical needs, targeting large market opportunities, strengthening IP protection, leveraging development expertise, diversifying the pipeline, prioritizing mid- to late-stage programs, accelerating market entry, pursuing cost-effective development, and implementing a targeted commercialization strategy[116](index=116&type=chunk)[119](index=119&type=chunk) - Since January 1, 2025, the company has successfully closed two important transactions: the NDV-01 in-licensing and Sepranolone acquisition, aligning with its new strategy[117](index=117&type=chunk) [Key Upcoming Anticipated Milestones](index=22&type=section&id=Key%20Upcoming%20Anticipated%20Milestones) This section lists Relmada's anticipated milestones for its NDV-01 and Sepranolone development programs, including clinical data releases and trial initiations - NDV-01 Nine-month data from ongoing Phase 2 NMIBC Study – 2nd Half 2025[120](index=120&type=chunk) - NDV-01 Twelve-month data from ongoing Phase 2 NMIBC Study – Year end 2025[120](index=120&type=chunk) - NDV-01 United States Investigative New Drug clearance – 1st Half 2026[120](index=120&type=chunk) - Sepranolone - Initiation of clinical trial in PWS – 1st Half 2026[120](index=120&type=chunk) [Our Development Programs](index=24&type=section&id=Our%20Development%20Programs) This section details Relmada's key development programs, Sepranolone and NDV-01, highlighting their therapeutic targets, mechanisms, and promising clinical data - Sepranolone, a novel neurosteroid, is being developed for Prader-Willi Syndrome, Tourette Syndrome, and other diseases related to excessive GABAergic activity, targeting specific GABAA receptor subtypes (alpha-2 and alpha-4)[122](index=122&type=chunk)[123](index=123&type=chunk) - Phase 2a study data for Sepranolone showed competitive tic reduction (**28%** by YGTSS, p=**0.051**) and improved quality of life in Tourette Syndrome, with no CNS off-target or systemic side effects[124](index=124&type=chunk)[125](index=125&type=chunk) - NDV-01 is a novel intravesical delivery technology for gemcitabine and docetaxel, designed for sustained, localized chemotherapy for up to **10** days in non-muscle invasive bladder cancer (NMIBC), addressing limitations of conventional administration[127](index=127&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk) - Initial positive **6-month** follow-up data from the Phase 2 study of NDV-01 in aggressive NMIBC showed a **90%** complete response rate at **6** months (**19/21** patients), with no progression to muscle invasive disease or Grade **3+** treatment-related adverse events[133](index=133&type=chunk)[134](index=134&type=chunk) [Our Corporate History and Background](index=26&type=section&id=Our%20Corporate%20History%20and%20Background) This section provides Relmada's corporate background as a clinical-stage biotechnology company, noting its history of net losses and accumulated deficit without generating revenue - Relmada is a clinical-stage biotechnology company developing NCEs and novel drug products for cancer, neurological disorders, and other diseases[135](index=135&type=chunk) - The company has not generated revenues and does not anticipate doing so in the foreseeable future, reporting a net loss of approximately **$27.4 million** for the six months ended June 30, 2025, and an accumulated deficit of approximately **$668.3 million**[137](index=137&type=chunk) [Business Strategy](index=27&type=section&id=Business%20Strategy) Relmada's business strategy focuses on leveraging its expertise to identify, develop, and commercialize product candidates with significant market potential for unmet medical needs - Relmada's strategy is to leverage its industry experience and development expertise to identify, develop, and commercialize product candidates with significant market potential that address unmet medical needs[138](index=138&type=chunk) [Intellectual Property Portfolio and Market Exclusivity](index=27&type=section&id=Intellectual%20Property%20Portfolio%20and%20Market%20Exclusivity) This section highlights Relmada's extensive intellectual property portfolio, including over 40 patents for Sepranolone and over 10 for NDV-01, providing market exclusivity beyond 2030 and 2038, respectively - Relmada holds over **40** issued patents and pending applications for Sepranolone, potentially providing coverage beyond **2030** for various uses including compulsive behaviors[139](index=139&type=chunk) - The company also has over **10** issued patents and pending applications for NDV-01, covering formulations and controlled release methods for bladder cancer, potentially extending coverage beyond **2038**[140](index=140&type=chunk) [Key Strengths](index=27&type=section&id=Key%20Strengths) This section outlines Relmada's core strengths, including compelling product opportunities, an experienced management team, diverse indications, strong efficacy signals, and a robust IP portfolio - Compelling lead product opportunities in NDV-01 and Sepranolone[142](index=142&type=chunk) - Experienced management team with considerable drug development expertise[142](index=142&type=chunk) - Multiple potential bladder cancer related indications for NDV-01[142](index=142&type=chunk) - Extensive safety database for Sepranolone and promising efficacy signal in Tourette Syndrome[142](index=142&type=chunk) - Substantial and growing IP portfolio for both Sepranolone and NDV-01[142](index=142&type=chunk) - Scientific support of leading experts[142](index=142&type=chunk) [Results of Operations (Three Months Ended June 30, 2025 versus June 30, 2024)](index=28&type=section&id=Results%20of%20Operations%20(Three%20Months%20Ended%20June%2030,%202025%20versus%20June%2030,%202024)) This section analyzes Relmada's operating results for the three months ended June 30, 2025, compared to 2024, highlighting significant reductions in R&D and G&A expenses, leading to a decreased net loss Operating Expenses (Three Months Ended June 30) | Expense Category | June 30, 2025 (USD) | June 30, 2024 (USD) | Increase (Decrease) (USD) | | :------------------------ | :------------ | :------------ | :------------------ | | Research and development | $2,819,377 | $10,721,089 | $(7,901,712) | | General and administrative| $7,401,929 | $8,097,695 | $(695,766) | | Total | $10,221,306 | $18,818,784 | $(8,597,478) | - Research and development expense decreased by approximately **$7.9 million** (**73.7%**) due to the winding down of REL-1017 studies, lower stock-based compensation, and reduced manufacturing costs, partially offset by increased compensation for R&D employees[144](index=144&type=chunk)[148](index=148&type=chunk) - General and administrative expense decreased by approximately **$0.7 million** (**8.6%**) due to lower stock-based compensation, partially offset by increased compensation for G&A employees and consulting services[144](index=144&type=chunk)[148](index=148&type=chunk) - Net loss for the three months ended June 30, 2025, was **$9,866,400**, a decrease from **$17,768,100** in the prior year, resulting in a loss per share of **$0.30** compared to **$0.59**[146](index=146&type=chunk) [Results of Operations (Six Months Ended June 30, 2025 versus June 30, 2024)](index=30&type=section&id=Results%20of%20Operations%20(Six%20Months%20Ended%20June%2030,%202025%20versus%20June%2030,%202024)) This section analyzes Relmada's operating results for the six months ended June 30, 2025, compared to 2024, showing decreased R&D and G&A expenses, leading to a reduced net loss Operating Expenses (Six Months Ended June 30) | Expense Category | June 30, 2025 (USD) | June 30, 2024 (USD) | Increase (Decrease) (USD) | | :------------------------ | :------------ | :------------ | :------------------ | | Research and development | $14,770,400 | $24,026,395 | $(9,255,995) | | General and administrative| $13,669,342 | $17,780,249 | $(4,110,907) | | Total | $28,439,742 | $41,806,644 | $(13,366,902) | - Research and development expense decreased by approximately **$9.3 million** (**38.5%**) due to the wind-down of REL-1017 studies, lower stock-based compensation, and reduced manufacturing/pre-clinical costs, partially offset by costs associated with Sepranolone and NDV-01 acquisitions and increased R&D compensation[151](index=151&type=chunk)[155](index=155&type=chunk) - General and administrative expense decreased by approximately **$4.1 million** (**23.1%**) due to lower stock-based compensation and consulting services, partially offset by increased G&A employee compensation[151](index=151&type=chunk)[155](index=155&type=chunk) - Net loss for the six months ended June 30, 2025, was **$27,425,900**, a decrease from **$39,596,200** in the prior year, resulting in a loss per share of **$0.86** compared to **$1.31**[153](index=153&type=chunk) [Liquidity](index=32&type=section&id=Liquidity) This section addresses Relmada's liquidity challenges, including continuous losses and negative operating cash flows, raising substantial doubt about its ability to continue as a going concern - Relmada has incurred continuous losses and negative operating cash flows, with a net loss of **$27.4 million** and negative operating cash flows of **$24.5 million** for the six months ended June 30, 2025[157](index=157&type=chunk) - The company projects insufficient liquidity to sustain operations for one year, raising substantial doubt about its ability to continue as a going concern[157](index=157&type=chunk) - Management is evaluating financing strategies, including equity or debt sales, or strategic collaborations, but cannot assure securing additional financing on favorable terms[158](index=158&type=chunk) Selected Cash Flow Information (Six Months Ended June 30) | Cash Flow Activity | June 30, 2025 (USD) | June 30, 2024 (USD) | | :------------------------ | :------------ | :------------ | | Cash used in operating | $(24,468,909) | $(26,299,773) | | Cash provided by investing| $22,038,255 | $24,072,718 | | Cash (used in)/provided by financing | $(73,021) | $221,747 | | Net decrease in cash | $(2,503,675) | $(2,005,308) | [Effects of Inflation](index=33&type=section&id=Effects%20of%20Inflation) This section explains that Relmada's monetary assets are not directly affected by inflation, but rising expenses could impact resource utilization - Relmada's assets are primarily monetary (cash and investments) and not directly affected by inflation, but inflation can increase expenses such as employee compensation and contract services, impacting resource utilization[163](index=163&type=chunk) [Commitments and Contingencies](index=33&type=section&id=Commitments%20and%20Contingencies) This section states that there have been no material changes to the risk factors related to commitments and contingencies since the prior annual report - There have been no material changes to the risk factors related to commitments and contingencies previously disclosed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024[164](index=164&type=chunk) [Critical Accounting Policies and Estimates](index=33&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section indicates that management continuously reviews its estimates, and currently, no estimates involve a high level of uncertainty in the unaudited condensed consolidated financial statements - Management continuously reviews its estimates, and currently, none of the Company's estimates and assumptions used in the unaudited condensed consolidated financial statements involve a high level of estimation uncertainty[166](index=166&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=34&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) There have been no material changes to Relmada's exposures to market risks since the disclosures in its annual Form 10-K for the year ended December 31, 2024 - No material changes to market risk exposures have occurred since the disclosures in the annual Form 10-K for the year ended December 31, 2024[168](index=168&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=34&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Relmada's management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025. There were no material changes in internal control over financial reporting during the six months ended June 30, 2025 - Relmada's disclosure controls and procedures were evaluated and deemed effective as of June 30, 2025[169](index=169&type=chunk) - No material changes in internal control over financial reporting occurred during the six months ended June 30, 2025[170](index=170&type=chunk) [PART II - OTHER INFORMATION](index=35&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This part covers other information not included in the financial statements, such as legal proceedings, risk factors, equity sales, and exhibits [ITEM 1. LEGAL PROCEEDINGS](index=35&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) Relmada is not currently aware of any legal proceedings or potential claims that would likely have a material adverse effect on its business, financial condition, operating results, or cash flows - The Company is not aware of any legal proceedings or potential claims that would have a material adverse effect on its business, financial condition, operating results, or cash flows[173](index=173&type=chunk) [ITEM 1A. RISK FACTORS](index=35&type=section&id=ITEM%201A.%20RISK%20FACTORS) There have been no material changes to the risk factors previously disclosed in Relmada's Form 10-K for the year ended December 31, 2024 - No material changes to the risk factors have occurred since the disclosures in the annual Form 10-K for the year ended December 31, 2024[174](index=174&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=35&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) Relmada reports no unregistered sales of equity securities or use of proceeds during the period - There were no unregistered sales of equity securities or use of proceeds during the reporting period[175](index=175&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=35&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) Relmada reports no defaults upon senior securities during the period - There were no defaults upon senior securities during the reporting period[176](index=176&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=35&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to Relmada Therapeutics, Inc - Mine Safety Disclosures are not applicable to the registrant[177](index=177&type=chunk) [ITEM 5. OTHER INFORMATION](index=35&type=section&id=ITEM%205.%20OTHER%20INFORMATION) No directors or executive officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter. The company formally terminated its License Agreement with Arbormentis LLC for the psilocybin development program on May 12, 2025 - No directors or executive officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarterly period[178](index=178&type=chunk) - On May 12, 2025, Relmada terminated its License Agreement with Arbormentis LLC, ending its participation in the psilocybin development program[179](index=179&type=chunk) [ITEM 6. EXHIBITS](index=36&type=section&id=ITEM%206.%20EXHIBITS) This section lists the exhibits filed with the Form 10-Q, including certifications from the CEO and CFO (pursuant to Sections 302 and 906 of Sarbanes-Oxley Act) and various Inline XBRL documents - Exhibits include certifications of the Chief Executive Officer and Principal Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[181](index=181&type=chunk) - Inline XBRL documents (Instance, Taxonomy Extension Schema, Calculation Linkbase, Definition Linkbase, Label Linkbase, Presentation Linkbase) are filed herewith[181](index=181&type=chunk) [SIGNATURES](index=37&type=section&id=SIGNATURES) The report is duly signed on behalf of Relmada Therapeutics, Inc. by Sergio Traversa, Chief Executive Officer, and Maged Shenouda, Chief Financial Officer, on August 7, 2025 - The report was signed by Sergio Traversa, Chief Executive Officer, and Maged Shenouda, Chief Financial Officer, on August 7, 2025[186](index=186&type=chunk)

Core Insights - Relmada Therapeutics reported a 91% overall response rate for NDV-01 in non-muscle invasive bladder cancer during a 6-month follow-up of a Phase 2 study, indicating strong efficacy and safety [1][3][4] - The company is preparing to initiate a Phase 3 registration trial for NDV-01 in the first half of 2026 and plans to start a Phase 2 study for sepranolone in Prader-Willi syndrome in the same timeframe [1][5] Clinical Results - The Phase 2 study of NDV-01 involved 29 patients, with a median age of 73 years. The study reported a complete response rate of 91% at any time point, 83% at 3 months, and 90% at 6 months [2][3] - No patients progressed to muscle invasive disease or underwent radical cystectomy, and no patients experienced Grade 3 treatment-related adverse events [3][4] Pipeline Developments - NDV-01 is a sustained-release formulation of gemcitabine and docetaxel, designed for intravesical administration, which enhances drug retention and minimizes systemic toxicity [10][12] - Sepranolone is a first-in-class GABAA Modulating Steroid Antagonist targeting disorders linked to excess GABAergic activity, with plans for further clinical development [5][13] Financial Performance - For the second quarter ended June 30, 2025, Relmada reported a net loss of $9.9 million, or $0.30 per share, compared to a net loss of $17.8 million, or $0.59 per share, in the same period of the previous year [5][24] - Research and development expenses were $2.8 million for the quarter, down from $10.7 million in Q2 2024, primarily due to reduced trial costs [5][24] Market Opportunity - The U.S. market for high-grade/intermediate-grade non-muscle invasive bladder cancer is significant, with approximately 600,000 prevalent cases, highlighting the potential for NDV-01 as a frontline or salvage therapy [7][12] - Prader-Willi syndrome, targeted by sepranolone, has an estimated U.S. prevalence of 20,000 patients, representing an orphan disease market [7][14]

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 August 7, 2025, to discuss its financial results for Q2 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 August 7, 2025, at 4:30 PM ET [3] - Dial-in numbers for participants include 1-877-407-0792 for US and 1-201-689-8263 for international callers [3] - Webcast access will be available through the company's investor relations section [1][3]