Relmada Therapeutics, Inc. (RLMD) SEC Filings & Earnings Calls

Loss of key urology leadership could delay clinical programs.

“CMO – Urology departure without disclosed reason or successor.”

Clinical-stage pipeline risk

“Currently, none of our product candidates has been approved for sale in the United States or elsewhere. We have no commercial products nor do we have a sales or marketing infrastructure.” · word for word

Cash burn and future financing risk

“Beyond that point management will evaluate the size and scope of any subsequent trials that will affect the timing of additional financings through public or private sales of equity or debt securities or from bank or other loans or through strategic collaboration and/or licensing agreements.” · word for word

Clinical-stage company with no approved products; pipeline execution risk for NDV-01 and sepranolone.

“Advancing NDV-01 toward IND filing; Sepranolone IND filing expected by year-end 2026.”

Manufacturing and CMC execution risk for NDV-01 registrational program.

“Manufacturing and CMC activities supporting the planned NDV-01 IND submission are ongoing.” · word for word

No approved products; reliance on unproven pipeline

“Currently, none of our product candidates has been approved for sale in the United States or elsewhere.” · word for word

Cash burn and future dilution risk

“We have incurred losses and negative cash flows from operations since inception and expects to incur additional losses until such time that it can generate significant revenue.”

Clinical-stage biotech with no approved products; reliance on NDV-01 and sepranolone pipeline success.

“Clinical-stage biotechnology company; net loss of $19.1M in Q1 2026; no revenue mentioned.”

Clinical Trial Failure Risk

“The interim analysis of our former lead program in December 2024 was disappointing...the trial was unlikely to succeed.” · word for word

Dilution Risk from Share Authorization Increase

“To approve an amendment to our Articles of Incorporation, as amended, to increase the number of authorized shares of common stock from 150,000,000 to 200,000,000.” · word for word

Financing Dependency

“The Company will require substantial additional funding in order to develop and, if successful, commercialize our product candidates.”

Clinical-stage biotech with no approved products; reliance on NDV-01 success.

“Clinical-stage biotechnology company; NDV-01 is lead program; no approved products mentioned.”

High cash burn rate; net loss and negative operating cash flow.

“Net loss of $19.9M in Q4 2025; operating cash outflow $14.6M.”

No approved products or revenue

“Currently, none of our product candidates has been approved for sale in the United States or elsewhere. We have no commercial products, nor do we have a sales or marketing infrastructure.” · word for word

Clinical trial failure risk

“Risks related to clinical and regulatory matters include risks associated with clinical trials and the future ability to commercially market the product.” · word for word

Cash burn and need for additional capital

“We have not generated revenues and do not anticipate generating revenues for the foreseeable future.” · word for word

Dependence on NDV-01 and sepranolone

“Currently, our lead product, NDV-01... Our second product, sepranolone...”

Phase 3 trial execution risk; regulatory approval uncertainty.

“Phase 3 RESCUE program initiation expected mid-2026; initial results by YE 2026.”

Clinical and regulatory risk: Phase 3 trials may fail or face delays; FDA may not approve.

“Phase 3 trials expected to begin H1 2026; no guarantee of success.”

Financing risk: Company still loss-making; may need additional capital beyond 2028.

“Net loss of $12.9M in Q3 2025; cash runway into 2028 but no revenue.”

Going concern risk (alleviated)

“At September 30, 2025, the Company was projecting insufficient liquidity to sustain its operations through one year following the date that the financial statements are issued. ... As of the date of this report, Management believes that the Company’s existing cash and cash equivalents and short-term investments will enable it to fund operating expenses and c” · word for word

Clinical trial risk

“Currently, none of our product candidates has been approved for sale in the United States or elsewhere. We have no commercial products nor do we have a sales or marketing infrastructure.” · word for word

Dilution risk

“On November 5, 2025 the Company announced the closing of its underwritten offering of 40,142,000 shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to 5,315,000 shares of common stock.” · word for word

Dilution risk from large equity offering

“40,142,000 shares of common stock and pre-funded warrants for up to 5,315,000 shares”

Clinical trial and regulatory risk; no revenue or profitability.

“Potential failure to secure FDA agreement on regulatory path for sepranolone and NDV-01.” · word for word