Relmada Therapeutics(RLMD) - 2025 Q2 - Quarterly Report

PART I - FINANCIAL INFORMATION 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 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 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] - 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] Unaudited Condensed Consolidated Statements of Operations 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] Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity 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] Unaudited Condensed Consolidated Statements of Cash Flows 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] - 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] Notes to Unaudited Condensed Consolidated Financial Statements 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 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][22] - The Esmethadone program was terminated effective July 7, 2025, and the psilocybin (REL-P11) program was terminated effective May 12, 2025[23] - 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] - 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] - 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][26] NOTE 2 - GOING CONCERN 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] - 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] - 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] NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES 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][50] - 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] - 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][54] - 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][58] 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 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] NOTE 5 - ACCRUED EXPENSES 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] NOTE 6 - STOCK APPRECIATION RIGHTS 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] - The total liability for cash-settled SARs was $32,116 as of June 30, 2025[77] - 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] - 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] NOTE 7 - STOCKHOLDERS' EQUITY 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] - 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][85] - From January 1 to June 30, 2025, 3,103,567 options were issued with a weighted average exercise price of $0.65[87] - 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] 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 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][111] - 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] - 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][101] - 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] NOTE 9 - OTHER POSTRETIREMENT BENEFIT PLAN 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] - 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] NOTE 10 - SEGMENT REPORTING 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] 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 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] - All material obligations under the esmethadone license agreement will cease 90 days after the termination notice[111] ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION 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 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] - 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][115] Strategic Business Review and New Approach 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][119] - 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] Key Upcoming Anticipated Milestones 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] - NDV-01 Twelve-month data from ongoing Phase 2 NMIBC Study – Year end 2025[120] - NDV-01 United States Investigative New Drug clearance – 1st Half 2026[120] - Sepranolone - Initiation of clinical trial in PWS – 1st Half 2026[120] Our Development Programs 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][123] - 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][125] - 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][128][129] - 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][134] Our Corporate History and Background 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] - 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] Business Strategy 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] Intellectual Property Portfolio and Market Exclusivity 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] - 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] Key Strengths 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] - Experienced management team with considerable drug development expertise[142] - Multiple potential bladder cancer related indications for NDV-01[142] - Extensive safety database for Sepranolone and promising efficacy signal in Tourette Syndrome[142] - Substantial and growing IP portfolio for both Sepranolone and NDV-01[142] - Scientific support of leading experts[142] Results of Operations (Three Months Ended June 30, 2025 versus June 30, 2024) 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][148] - 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][148] - 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] Results of Operations (Six Months Ended June 30, 2025 versus June 30, 2024) 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][155] - 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][155] - 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] 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] - The company projects insufficient liquidity to sustain operations for one year, raising substantial doubt about its ability to continue as a going concern[157] - Management is evaluating financing strategies, including equity or debt sales, or strategic collaborations, but cannot assure securing additional financing on favorable terms[158] 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 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] Commitments and Contingencies 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] Critical Accounting Policies and Estimates 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] ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 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] ITEM 4. CONTROLS AND PROCEDURES 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] - No material changes in internal control over financial reporting occurred during the six months ended June 30, 2025[170] PART II - OTHER INFORMATION 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 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] ITEM 1A. RISK FACTORS 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] ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS 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] ITEM 3. DEFAULTS UPON SENIOR SECURITIES Relmada reports no defaults upon senior securities during the period - There were no defaults upon senior securities during the reporting period[176] ITEM 4. MINE SAFETY DISCLOSURES This item is not applicable to Relmada Therapeutics, Inc - Mine Safety Disclosures are not applicable to the registrant[177] ITEM 5. OTHER INFORMATION 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] - On May 12, 2025, Relmada terminated its License Agreement with Arbormentis LLC, ending its participation in the psilocybin development program[179] ITEM 6. EXHIBITS 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] - Inline XBRL documents (Instance, Taxonomy Extension Schema, Calculation Linkbase, Definition Linkbase, Label Linkbase, Presentation Linkbase) are filed herewith[181] 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]