Relmada Therapeutics(US:RLMD)2023-11-08 21:05PART I - FINANCIAL INFORMATION Unaudited Condensed Consolidated Financial Statements The company reported a reduced net loss for the nine months ended September 30, 2023, with total assets decreasing due to lower short-term investments and cash used in operations Condensed Consolidated Balance Sheets As of September 30, 2023, total assets decreased to $109.1 million from $152.9 million at year-end 2022, primarily due to reduced short-term investments Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | Sep 30, 2023 ($) | Dec 31, 2022 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | $6,698,599 | $5,395,905 | | Short-term investments | $99,568,502 | $142,926,781 | | Total current assets | $109,101,138 | $152,870,304 | | Total assets | $109,148,853 | $152,905,179 | | Total current liabilities | $8,422,218 | $12,468,877 | | Accumulated deficit | $(535,737,523) | $(462,110,935) | | Total stockholders' equity | $100,726,635 | $140,436,302 | Unaudited Condensed Consolidated Statements of Operations For Q3 2023 and the nine-month period, the company reported a reduced net loss, primarily driven by a significant decrease in research and development expenses Operating Results (Unaudited) | Metric | Q3 2023 ($) | Q3 2022 ($) | Nine Months 2023 ($) | Nine Months 2022 ($) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $10,454,072 | $30,529,108 | $40,055,287 | $86,454,632 | | General and administrative | $12,238,566 | $8,208,053 | $36,817,686 | $36,092,024 | | Total operating expenses | $22,692,638 | $38,737,161 | $76,872,973 | $122,546,656 | | Net loss | $(22,002,058) | $(39,418,707) | $(73,626,588) | $(119,099,458) | | Loss per common share | $(0.73) | $(1.31) | $(2.45) | $(4.04) | Unaudited Condensed Consolidated Statements of Cash Flows For the nine months ended September 30, 2023, net cash used in operating activities decreased, while investing activities provided significant cash, with no financing activities in the current period Cash Flow Summary (Unaudited, Nine Months Ended Sep 30) | Activity | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(41,409,492) | $(67,918,717) | | Net cash provided by investing activities | $42,712,186 | $21,389,056 | | Net cash provided by financing activities | $0 | $44,610,591 | | Net increase/(decrease) in cash | $1,302,694 | $(1,919,070) | | Cash and cash equivalents at end of period | $6,698,599 | $42,524,369 | Notes to Unaudited Condensed Consolidated Financial Statements The notes detail the company's clinical-stage biotechnology business, key accounting policies, liquidity assessment, and significant license agreements with associated future payment obligations - The company is a clinical-stage biotechnology company focused on developing esmethadone (REL-1017), an NMDA receptor antagonist for CNS diseases19 - Management believes existing cash, cash equivalents, and short-term investments are sufficient to fund operations and capital expenditures for at least 12 months from the financial statement issuance date24 - The company has license agreements that include future obligations for milestone payments up to $160 million and low single-digit royalties on net sales for the Arbormentis program, and up to 12% royalties for the Wonpung agreement7277 Stock-Based Compensation Expense (Nine Months Ended Sep 30) | Expense Category | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Research and development | $5,463,100 | $5,674,600 | | General and administrative | $28,453,800 | $26,894,200 | | Total | $33,916,900 | $32,568,800 | Management's Discussion and Analysis of Financial Condition and Results of Operation Management discusses the status of clinical programs, including ongoing Phase 3 trials and a new Phase 1 initiative, alongside financial performance showing a reduced net loss primarily due to lower R&D expenses Business Overview and Program Updates Relmada, a clinical-stage biotech, continues advancing esmethadone (REL-1017) Phase 3 trials despite prior endpoint misses, with promising long-term study results and a new psilocybin program initiating Phase 1 - The RELIANCE I and RELIANCE III studies for esmethadone (REL-1017) did not achieve their primary endpoints in late 20229899 - The company plans to complete enrollment for the RELIANCE II and RELIGHT Phase 3 trials in the first and second half of 2024, respectively117 - A new program for a non-psychedelic, low-dose modified-release psilocybin formulation for metabolic indications is planned to enter a Phase 1 trial in early 2024106117 - The Phase 3 long-term, open-label study (Study 310) of REL-1017 showed that patients experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms over one year101 Results of Operations For the nine months ended September 30, 2023, the company reported a reduced net loss, primarily driven by a significant decrease in research and development expenses following trial completions Comparison of Operating Expenses (Nine Months Ended Sep 30) | Expense Category | 2023 ($) | 2022 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Research and development | $40,055,287 | $86,454,632 | $(46,399,345) | | General and administrative | $36,817,686 | $36,092,024 | $725,662 | | Total operating expenses | $76,872,973 | $122,546,656 | $(45,673,683) | - The decrease in R&D expense was primarily due to a $35.3 million reduction in study costs associated with the completion of RELIANCE I and III trials136137 - The increase in G&A expense was mainly due to a $1.6 million increase in stock-based compensation136137 Net Loss and Loss Per Share (Nine Months Ended Sep 30) | Metric | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Net Loss | $(73,626,600) | $(119,099,500) | | Loss per Share | $(2.45) | $(4.04) | Liquidity and Capital Resources As of September 30, 2023, the company held $106.3 million in cash and investments, with management asserting sufficient liquidity for at least the next 12 months despite cash used in operations - The company had cash, cash equivalents, and short-term investments totaling $106,267,101 as of September 30, 2023141 - Net cash used in operating activities was $41,409,492 for the nine months ended September 30, 2023141143 - Management believes existing cash and investments will fund operations for at least 12 months from the issuance of the financial statements142 Quantitative and Qualitative Disclosures About Market Risk The company reported no material changes to its market risk exposures since the last annual report - There have been no material changes to the company's market risk exposures since the last annual report152 Controls and Procedures Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures are effective as of September 30, 2023153 - No material changes to internal control over financial reporting occurred during the nine months ended September 30, 2023154 PART II - OTHER INFORMATION Legal Proceedings The company is not aware of any legal proceedings likely to have a material adverse effect on its business or financial condition - The company is currently not aware of any legal proceedings that would likely have a material adverse effect on its business157 Risk Factors No material changes to risk factors have occurred since the last annual report on Form 10-K - No material changes to risk factors have occurred since the Form 10-K for the year ended December 31, 2022158 Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities during the period - None159 Exhibits This section lists exhibits filed with the quarterly report, including CEO and CFO certifications and Inline XBRL documents - Exhibits filed include Sarbanes-Oxley certifications and Inline XBRL data files163