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RELMADA THERAPEUTICS, INC.

For the period ended Dec 31, 2025. Filed Mar 19, 2026.

View on SEC.gov

About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2025 · Filed Mar 19, 2026

RLMD$3.90+3.4%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-K

Period ended 2024-12-31; filed 2025-03-27.

0001013762-25-003426

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-K

Period ended 2025-12-31; filed 2026-03-19.

0001213900-26-031862

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 56 previous paragraphs and 49 current paragraphs.

31 unchanged; 13 reworded; 5 added; 11 removed; 1 previous and 0 current paragraphs rearranged.

Tables are not compared: 15 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (5)

Current report

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. In order to market and sell our products we must conduct clinical trials on patients and obtain regulatory approvals from appropriate regulatory agencies, like the FDA in the United States, and similar organizations elsewhere in the world.

Current report

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. The shares of common stock were sold at an offering price of $2.20 per share, and the pre-funded warrants were sold at an offering price of $2.199 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. The net proceeds to Relmada from the offering, before deducting other expenses payable by Relmada, and excluding the exercise of any pre-funded warrants, were approximately $94 million.

Current report

On March 9, 2026 the Company entered into a Private Investment in a Public Entity (PIPE) Purchase Agreement, the Purchasers agreed to purchase, for an aggregate purchase price of approximately $160.0 million, an aggregate of (i) 29,474,569 shares of the Company’s common stock, par value $0.001 per share, at a price of $4.75 per Share and (ii) pre-funded warrants to purchase up to 4,210,527 shares of common stock at a price of $4.749 per pre-funded warrant, which represents the per share purchase price for the common stock less the $0.001 per share exercise price for each such Pre-Funded Warrant.

Current report

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 capital expenditure requirements for at least 12 months from the issuance of its audited consolidated financial statements. 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. Any such expenditures related to any subsequent clinical trials will not be incurred until such additional financing is raised. As a result, the Company concluded that management’s plans alleviated substantial doubt about the Company’s ability to continue as a going concern as of December 31, 2025 and the Company has sufficient funds to maintain operations for at least 12 months from the issuance of these audited consolidated financial statements.

Current report

Net cash provided by financing activities for the year ended December 31, 2025, was $93,564,808 due to proceeds from the issuance of common stock for $93,637,829 offset by ATM fees of $73,021.
Removed paragraphs (11)

Previous report

We also had been developing REL-P11, a modified-release formulation of psilocybin, as an investigational agent for the treatment of metabolic disease. The REL-P11 program has successfully completed a Phase 1 safety study. However, in light of an ongoing strategic review of this business opportunity, the changing regulatory landscape for psychedelics, its early stage of development and the acquisition of new, more advanced product candidates, this program has also been paused.

Previous report

Since 2013, we had been developing esmethadone as our lead product candidate as an oral agent for the treatment of depression and other potential indications. In December 2024, we reported that the pre-planned interim analysis, conducted by the Independent Data Monitoring Committee (DMC), of Reliance II, our Phase 3 study of esmethadone as a potential adjunctive treatment for MDD, indicated that the study was futile and unlikely to meet the primary efficacy endpoint with statistical significance, and that we would pause the Reliance II and Relight Phase 3 studies of esmethadone.

Previous report

Following this 2024 REL-1017 setback, which we believe most likely resulted from an overwhelming placebo response—a trend that has become more common than exceptional in central nervous system (CNS) clinical trials—the program has been paused pending a comprehensive data review, after which we will make a decision regarding the future of this program.

Previous report

Following a comprehensive evaluation of the Company’s business strategy and growth opportunities, management and the Board of Directors have implemented a revised approach aimed at maximizing shareholder value. This refined strategy remains focused on:

Previous report

Under this updated approach, we will continue to emphasize:

Previous report

This strategic framework positions the Company for long-term growth while maintaining execution and financial prudence.

Previous report

We commenced a strategic review in December 2024 of our then existing development pipeline and the opportunities open to us given our core strengths in every aspect of drug development, with particular expertise in CNS. That process recently resulted in a series of transactions that have considerably expanded and strengthened Relmada’s potential to create shareholder value. Over the past three months, we have successfully closed two important transactions, NDV-01 in-licensing and Sepranolone acquisition, which align with our new strategy.

Previous report

In response to these conditions, management is currently evaluating the size and scope of any subsequent operations and clinical trials that will affect the timing to obtain the required funding of future operations. Financing strategies may include, but are not limited to, the public or private sale of equity or debt securities or from bank or other loans or through strategic collaboration and/or licensing agreements. There can be no assurances that the Company will be able to secure additional financing, or if available, that it will be sufficient to meet its needs or on favorable terms. Because management’s plans have not yet been finalized and are not within the Company’s control, the implementation of such plans cannot be considered probable. As a result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern.
Reworded paragraphs (13)

Previous wording

Relmada Therapeutics, Inc. (Relmada, the Company, we or us) (a Nevada corporation), is a publicly traded, clinical-stage biotechnology company. We substantially redesigned our development programs following a comprehensive strategic review occasioned by disappointing interim analysis results in December 2024 indicating that our then lead development candidate, esmethadone (d-methadone, dextromethadone, or REL-1017) for the adjunctive treatment of Major Depressive Disorder (MDD), was unlikely to succeed in its pivotal trial. We concluded in our review that the most promising path to create shareholder value was to lever our extensive drug development expertise and clinical operations capabilities by acquiring new development candidates, while pausing further work on REL-1017. Hence we accelerated ongoing efforts to augment our development pipeline while diversifying its risk, which culminated in the recently announced licensing of NDV-01, a novel delivery formulation of a widely used chemotheraphy regimen used to treat non muscle-invasive bladder cancer (NMIBC) that is currently in Phase 2, and the acquisition of Sepranolone, a Phase 2b-ready neurosteroid with potential applications in Prader-Willi syndrome (PWS), Tourette Syndrome (TS), essential tremor and other diseases related to excessive GABAergic activity.

Current wording

Relmada Therapeutics, Inc. (Relmada, the Company, we or us) (a Nevada corporation), is a publicly traded, clinical-stage biotechnology company developing NCEs and novel versions of drug products that potentially address areas of high unmet medical need in the treatment of cancer, neurological disorders, and other diseases.

Previous wording

We have not generated revenues and do not anticipate generating revenues for the foreseeable future. We had a net loss of approximately $79,979,400 and $98,791,700 for the years ended December 31, 2024 and 2023, respectively. At December 31, 2024, we have an accumulated deficit of approximately $640,882,000.

Current wording

We have not generated revenues and do not anticipate generating revenues for the foreseeable future. We had a net loss of approximately $57,385,200 for the year ended December 31, 2025. At December 31, 2025, we had an accumulated deficit of approximately $698,267,200.

Previous wording

Total research and development expense for the year ended December 31, 2024 was approximately $46,175,500, as compared to $54,807,400 for the same period of 2023, a decrease of $8,631,900. The decrease in research and development expense was primarily due to:

Current wording

Total research and development expense for the year ended December 31, 2025 was approximately $26,879,100, as compared to $46,175,500 for the same period of 2024, a decrease of $19,296,400. The decrease in research and development expense was primarily due to:

Previous wording

Total general and administrative expense for the year ended December 31, 2024 was approximately $37,715,500, as compared to $48,894,900 for the same period of 2023, a decrease of $11,179,400. The decrease in general and administrative expenses was primarily due to:

Current wording

Total general and administrative expense for the year ended December 31, 2025 was approximately $32,221,100, as compared to $37,715,500 for the same period of 2024, a decrease of $5,494,400. The decrease in general and administrative expenses was primarily due to:

Previous wording

Interest/investment income was approximately $3,530,000 for the year ended December 31, 2024 compared to approximately $5,151,700 for the same period of 2023, a decrease of $1,621,700. The decrease was primarily related to lower average investment balance during 2024 as compared to 2023.

Current wording

Interest/investment income was approximately $1,396,000 for the year ended December 31, 2025 compared to approximately $3,530,000 for the same period of 2024, a decrease of $2,134,000. The decrease was primarily related to lower average investment balance during 2025 as compared to 2024.

Previous wording

Realized gain on short-term investments was approximately $374,900 compared to a realized loss of approximately $4,064,400 for the same period of 2023, an increase of $4,439,300. The increase was related to the timing of the sales of short-term investments along with market conditions.

Current wording

Realized loss on short-term investments was approximately $79,200 for the year ended December 31, 2025 compared to a realized gain of approximately $374,900 for the year ended December 31, 2024, a decrease of $454,100. The decrease was related to the timing of the sales of short-term investments along with market conditions.

Previous wording

Unrealized gain on short-term investments was approximately $6,700 compared to approximately $3,823,200 for the same period of 2023, a decrease of $3,816,500. The decrease was related to the market conditions.** **

Current wording

Unrealized gain on short-term investments was approximately $398,300 for the year ended December 31, 2025 compared to approximately $6,700 for the year ended December 31, 2024, an increase of $391,600. The increase was related to the market conditions.

Previous wording

The Company recorded a net loss of approximately $79,979,400 and $98,791,700 or $2.65 and $3.28 per common share, basic and diluted, during the years ended December 31, 2024 and 2023, respectively, based on the factors described above.

Current wording

The Company recorded a net loss of approximately $57,385,200 and $79,979,400 or $1.45 and $2.65 per common share, basic and diluted, during the years ended December 31, 2025 and 2024, respectively, based on the factors described above.

Previous wording

As shown in the accompanying audited consolidated financial statements, the Company has 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 from the commercialization of its product candidates. During the twelve months ended December 31, 2024, the Company incurred a net loss of $79,979,354 and had negative operating cash flows of $51,755,798. Given the Company’s projected operating requirements and its existing cash and cash equivalents and short-term investments, the Company is projecting insufficient liquidity to sustain its operations through one year following the date that the financial statements are issued. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern.

Current wording

As shown in the accompanying audited consolidated financial statements, the Company has 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 from the commercialization of its product candidates. During the twelve months ended December 31, 2025, the Company incurred a net loss of $57,385,163 and had negative operating cash flows of $45,786,988.

Previous wording

For the year ended December 31, 2023, net cash used in operating activities was $51,659,206 primarily due to the net loss of $98,791,746. This was offset by non-cash expenses which primarily consisted of stock-based compensation of $43,811,149. There were realized losses and unrealized gains on short term investments of $4,064,391 and $3,823,234, respectively. In addition, there were increases in operating assets and liabilities for the year ended December 31, 2023 of $3,080,234.

Current wording

For the year ended December 31, 2025, net cash used in operating activities was $45,786,988 primarily due to the net loss of $57,385,163. This was offset by non-cash expenses which primarily consisted of stock-based compensation of $14,810,407 and stock appreciation rights compensation of $1,056,464. There were realized losses and unrealized gains on short term investments of $79,207 and $398,255, respectively. In addition, there were decreases in operating assets and liabilities for the year ended December 31, 2025 of $3,949,648.

Previous wording

For the year ended December 31, 2023, net cash provided by investing activities was $50,453,332, due to $90,463,532 of purchases of short term investments offset by $140,916,864 of sales of short term investments.

Current wording

For the year ended December 31, 2025, net cash used in investing activities was $48,138,306, due to $83,828,576 of purchases of short term investments offset by $35,690,270 of sales of short term investments.

Previous wording

For the year ended December 31, 2024, net cash provided by investing activities was $51,561,597, due to $12,079,628 of purchases of short term investments offset by $63,641,225 of sales of short term investments.

Current wording

For the year ended December 31, 2024, net cash provided by investing activities was $51,561,598, due to $12,079,628 of purchases of short term investments offset by $63,641,225 of sales of short term investments.

Previous wording

The Company is obligated to pay approximately $105,000 under 2 leases for office space over the next year.

Current wording

The Company is obligated to pay approximately $96,900 under 2 leases for office space over the next year.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

Net cash used in financing activities for the year ended December 31, 2023, was $98,463 due to ATM reactivation fees.