Relmada Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Relmada Therapeutics, Inc. has filed its 2023 annual report detailing its financial performance and business operations.</b>

AI Summary

RELMADA THERAPEUTICS, INC. (RLMD) filed a Annual Report (10-K) with the SEC on March 19, 2024. Relmada Therapeutics, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The company is incorporated in Nevada and its principal executive offices are located in Coral Gables, Florida. Relmada Therapeutics, Inc. is registered under the standard industrial classification for Pharmaceutical Preparations. The company's common stock is traded on The NASDAQ Global Select Market under the symbol RLMD. The filing indicates Relmada Therapeutics, Inc. is a non-accelerated filer and a smaller reporting company.

Why It Matters

For investors and stakeholders tracking RELMADA THERAPEUTICS, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Relmada's financial health, operational status, and strategic direction for the fiscal year 2023, crucial for investors to assess the company's performance and future prospects. As a pharmaceutical preparations company, the details within this report are vital for understanding its regulatory compliance, research and development pipeline, and market positioning within the healthcare sector.

Risk Assessment

Risk Level: low — RELMADA THERAPEUTICS, INC. shows low risk based on this filing. The filing is a standard annual report (10-K) and does not contain immediate, significant negative financial or operational news, indicating a routine disclosure.

Analyst Insight

Investors should review the full 10-K filing for detailed financial statements, risk factors, and management's discussion and analysis to form an informed investment decision.

Key Numbers

• 2023 — Fiscal Year End (Reported fiscal year)
• 2024-03-19 — Filing Date (Date the 10-K was filed)
• 001-39082 — SEC File Number (Commission file number for the registrant)

Key Players & Entities

• RELMADA THERAPEUTICS, INC. (company) — Filer name
• RLMD (company) — Trading Symbol
• The NASDAQ Global Select Market (company) — Exchange where common stock is registered
• 2023 (date) — Fiscal year end
• 20240319 (date) — Filing date
• Nevada (jurisdiction) — State of incorporation
• Coral Gables, FL (location) — Principal executive offices

FAQ

Industry Context

Relmada Therapeutics operates within the pharmaceutical preparations industry, focusing on the development and commercialization of treatments.

Regulatory Implications

As a pharmaceutical company, Relmada is subject to extensive regulation by bodies such as the FDA, impacting its drug development, manufacturing, and marketing processes.

What Investors Should Do

1. Review the 'Risk Factors' section of the 10-K for potential challenges and uncertainties facing Relmada Therapeutics.
2. Analyze the 'Management's Discussion and Analysis of Financial Condition and Results of Operations' for detailed insights into the company's financial performance.
3. Examine any disclosures regarding clinical trials, regulatory approvals, or product pipeline developments within the business overview.

Year-Over-Year Comparison

This is the annual report for the fiscal year ended December 31, 2023, providing a comprehensive update compared to previous filings.

Key Financial Figures

• $0.001 — were 30,174,202 shares of common stock, $0.001 par value per share, outstanding. Doc
• $98,791,700 — uture. We had net loss of approximately $98,791,700 and $157,043,800 for the years ended De
• $157,043,800 — t loss of approximately $98,791,700 and $157,043,800 for the years ended December 31, 2023 a
• $560,902,700 — an accumulated deficit of approximately $560,902,700. Business Strategy Our strategy is t

Filing Documents

• f10k2023_relmadatherap.htm (10-K) — 913KB
• f10k2023ex23-1_relmada.htm (EX-23.1) — 2KB
• f10k2023ex31-1_relmada.htm (EX-31.1) — 11KB
• f10k2023ex31-2_relmada.htm (EX-31.2) — 11KB
• f10k2023ex32-1_relmada.htm (EX-32.1) — 5KB
• f10k2023ex32-2_relmada.htm (EX-32.2) — 5KB
• 0001213900-24-024013.txt (&nbsp;) — 4497KB
• rlmd-20231231.xsd (EX-101.SCH) — 45KB
• rlmd-20231231_cal.xml (EX-101.CAL) — 27KB
• rlmd-20231231_def.xml (EX-101.DEF) — 209KB
• rlmd-20231231_lab.xml (EX-101.LAB) — 409KB
• rlmd-20231231_pre.xml (EX-101.PRE) — 205KB
• f10k2023_relmadatherap_htm.xml (XML) — 372KB

Forward-Looking Statements

Forward-Looking Statements ii PART I 1.

Risk Factors

Risk Factors 13 1B. Unresolved Staff Comments 33 1C. Cybersecurity 33 2.

Properties

Properties 34 3.

Legal Proceedings

Legal Proceedings 34 4. Mine Safety Disclosures 34 PART II 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 35 6. [Reserved] 36 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 36 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 40 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 40 9. Changes in and Disagreements with Accountants on Accounting, and Financial Disclosure 40 9A.

Controls and Procedures

Controls and Procedures 40 9B. Other Information 41 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 42 PART III 10. Directors, Executive Officers, and Corporate Governance 43 11.

Executive Compensation

Executive Compensation 43 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 43 13. Certain Relationships and Related Transactions, and Director Independence 43 14. Principal Accounting Fees and Services 43 PART IV 15. Exhibits, Financial Statement Schedules, Signatures 44 i CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (this Report) contains forward looking statements that involve risks and uncertainties, principally in the sections entitled "Description of Business," "Risk Factors," and "Management's Discussion and Analysis of Financial Condition and Results of Operations." All statements other than statements of historical fact contained in this Report, including statements regarding future events, our future financial performance, business strategy and plans and objectives of management for future operations, are forward-looking "can," "continue," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "should," or "will" or the negative of these terms or other comparable terminology. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks outlined under "Risk Factors" or elsewhere in this Report, which may cause our or our industry's actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our business or the e

BUSINESS

ITEM 1. BUSINESS Business Overview Relmada Therapeutics, Inc. (Relmada, the Company, we or us) (a Nevada corporation), is a clinical-stage biotechnology company focused on the development of esmethadone (d-methadone, dextromethadone, REL-1017), an N-methyl-D-aspartate (NMDA) receptor antagonist. Esmethadone, an isomer of methadone, is a new chemical entity (NCE) that potentially addresses areas of high unmet medical need in the treatment of central nervous system (CNS) diseases and other disorders. Our lead product candidate, esmethadone, is being developed as a rapidly acting, oral agent for the treatment of depression and other potential indications. On October 15, 2019, we reported top-line data from study REL-1017-202. During late 2022, we announced RELIANCE I and III, both Phase 3 trials, did not achieve their primary endpoints. Relmada has completed its long term, open label study and plans to complete two additional ongoing adjunctive Phase 3 trials (RELIANCE II and RELIGHT). Relmada also intends, in 2024, to enter human studies of its proprietary, modified-release formulation of psilocybin (REL-P11) in doses that we believe are lower than those associated with psychedelic effects for metabolic indications. Phase 2 Clinical Trial In the REL-1017-202 study, 62 subjects, with an average age of 49.2 years, with an average Hamilton Depression Rating Scale score of 25.3 and an average Montgomery-Asberg Depression Rating Scale (MADRS) score of 34.0 (severe depression), were randomized. Other demographic characteristics were balanced across all arms. After an initial screening period, subjects were randomized to one of three arms: placebo, REL-1017 25 mg or REL-1017 50 mg, in addition to stable background antidepressant therapy. Subjects in the REL-1017 treatment arms received one loading dose of either 75 mg (25 mg arm) or 100 mg (50 mg arm) of REL-1017. Subjects were treated inpatient for 7 days and discharged home at Day 9. They returned for follow-up v

View Full Filing

View this 10-K filing on SEC EDGAR