RELMADA THERAPEUTICS, INC.
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 13, 2025
RLMD$3.90+3.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001213900-25-073073
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001213900-25-109983
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONThe 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 88 previous paragraphs and 90 current paragraphs.
52 unchanged; 24 reworded; 14 added; 12 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 48 previous and 39 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 (14)
Current report
Currently, our lead product, NDV-01 is a novel, controlled-release intravesical formulation of gemcitabine and docetaxel. NDV-01 is currently in a Phase 2 clinical trial to assess its safety and efficacy in patients with aggressive forms of non-muscle invasive bladder cancer (NMIBC). We intend to develop NDV-01 for the treatment of high-risk, 2nd line Bacillus Calmette-Guérin (BCG)*-unresponsive NMIBC and also in intermediate risk patients in the adjuvant setting. We expect to initiate Phase III programs for each indication in the first-half of 2026.
Current report
Our second product, Sepranolone is a novel neurosteroid epimer of allopregnanolone. Sepranolone is being developed for the potential treatment of Prader-Willi Syndrome, Tourette Syndrome, excessive tremor and other diseases related to excessive GABAergic activity. We expect to initiate a Phase IIb study in Prader-Willi Syndrome in the first-half of 2026.
Current report
Relmada expects to initiate a Phase II pilot study of Sepranolone in Prader Willi Syndrome in the 1 st half of 2026.
Current report
Nine-Month Safety and Efficacy Data
Current report
We obtained nine-month safety and efficacy data for our Phase II study of NDV-01 in high-risk NMIBC. Among 36 enrolled patients who received at least one dose, no new safety signals were observed with respect to the type, frequency or severity of adverse events. No patients experienced Grade ≥3 treatment-related adverse events, and no patients discontinued treatment due to adverse events. Of the 36 patients, 22 (61%) experienced a treatment-related adverse event. Among treatment-related adverse events, 62% were transient uncomfortable urination (dysuria), 9% were asymptomatic positive urine culture and 7% were hematuria. The below table summarizes the efficacy data from the study.
Current report
Two patients have reached the 12-month assessment, and both have a CR. No patient has progressed to muscle-invasive disease and no patient has undergone radical cystectomy. 11 patients are awaiting the three-month response assessment.
Current report
The Company also recently announced the successful completion and receipt of written minutes from a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the planned Phase 3 program for NDV-01 in non-muscle invasive bladder cancer (NMIBC) patients. Relmada secured FDA alignment on certain key elements of the planned Phase 3 pivotal program for NDV-01, expected to begin in H1 2026, and incorporating two studies in:
Current report
Following are the key outcomes from the FDA Type B pre-IND meeting (specific study design details to be further discussed with the agency):
Current report
FDA Feedback on proposed NDV-01 Phase III Trials
Current report
The FDA indicated that in the BCG-unresponsive setting, a single arm trial may be acceptable in a patient population refractory to other therapies, with the details of such a design to be discussed further with the FDA. The FDA also indicated that, a randomized, post-transurethral resection of the bladder tumor (“TURBT”) adjuvant study comparing NDV-01 to observation in intermediate risk NMIBC patients with a time-to-event primary endpoint is generally acceptable, subject to submission of the intended trial design and endpoint definition to the FDA in a meeting package. In addition, the FDA agreed with our proposal to rely on FDA’s prior findings of safety for Gemzar and Taxotere and published literature for the nonclinical safety assessment of NDV-01 because this is a proposed 505(b)(2) approval.
Current report
Based on this feedback, we requested Type B meetings with the FDA for the randomized intermediate-risk NMIBC trial and for the BCG-unresponsive trial. We have protocols in active development for both the single-arm study in BCG-unresponsive NMIBC with carcinoma in situ (CIS) who are refractory to other therapies, which would enroll approximately 100 patients, and the randomized intermediate-risk NMIBC trial, which would enroll approximately 266 patients.
Current report
We intend to develop NDV-01 for the treatment of high-risk, 2nd line BCG-unresponsive NMIBC and also in intermediate risk patients in the adjuvant setting. We expect to initiate Phase III programs for each indication in the first-half of 2026.
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, are approximately $94 million.
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 these unaudited condensed consolidated quarterly 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 September 30, 2025 and the Company has sufficient funds to maintain operations for at least 12 months from the issuance of these unaudited condensed consolidated financial statements.
Removed paragraphs (12)
Previous report
Strategic Business Review and New Approach
Previous report
Following a comprehensive evaluation of the Company’s business strategy and growth opportunities, management and the Board of Directors have implemented on an enhanced approach aimed at maximizing shareholder value.
Previous report
This refined strategy remains focus on:
Previous report
Key Strategic Priorities
Previous report
Under this 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. Since January 1, 2025, we have successfully closed two important transactions, NDV-01 in-licensing and Sepranolone acquisition, which align with our new strategy.
Previous report
Relmada is currently evaluating the nonclinical and clinical strategy for the development of Sepranolone.
Previous report
On April 28, 2025, the Company announced positive initial data from the Phase 2 study. As of the latest cut-off, a total of 26 patients had been enrolled: 20 patients had reached the 3-month assessment with 7 reaching the 6-month assessment.
Previous report
On August 7, 2025, the Company announced positive 6-month follow-up data from the Phase 2 study.
Previous report
Highlights of the 6-month follow-up data from the Phase 2 study:
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 concluded that management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern.
Reworded paragraphs (24)
Previous wording
Following the 2024 REL-1017 setback and subsequent post hoc analyses, the program has been terminated effective July 7, 2025.
Current wording
Following the 2024 REL-1017 setback and subsequent post hoc analyses, the program was terminated effective July 7, 2025.
Previous wording
We also had been developing REL-P11, a modified-release formulation of psilocybin, as an investigational agent for the treatment of metabolic disease. Effective May 12, 2025, this program has been terminated.
Current wording
We also had been developing REL-P11, a modified-release formulation of psilocybin, as an investigational agent for the treatment of metabolic disease. Effective May 12, 2025, this program was terminated.
Previous wording
On March 25, 2025, Relmada announced thein-license agreement from Trigone Pharma Ltd. (Trigone) of NDV-01, anovel delivery formulation of a widely used chemotherapeutic regimen used to treat NMIBC.
Current wording
On March 25, 2025, Relmada announced the in-license agreement from Trigone Pharma Ltd. (Trigone) of NDV-01, a novel delivery formulation of a widely used chemotherapeutic regimen used to treat NMIBC.
Previous wording
Our second program , in-licensed on March 24, 2025, NDV-01, is a novel intravesicular delivery technology designed for the long-acting, controlled release of gemcitabine and docetaxel. This combination therapy has gained significant interest as an alternative to Bacillus Calmette-Guérin (BCG) for treating NMIBC, especially given the global BCG shortage since 2019. Clinical studies have shown that gemcitabine and docetaxel achieve response rates and Recurrence-Free Survival comparable to or better than BCG. However, conventional administration is cumbersome, requiring sequential drug delivery over three to four hours, with limited tumor exposure time.
Current wording
NDV-01, our lead program, was in-licensed on March 24, 2025, NDV-01, is a novel intravesicular delivery technology designed for the long-acting, controlled release of gemcitabine and docetaxel. This combination therapy has gained significant interest as an alternative to BCG for treating NMIBC, especially given the global BCG shortage since 2019. Clinical studies have shown that gemcitabine and docetaxel achieve response rates and Recurrence-Free Survival comparable to or better than BCG. However, conventional administration is cumbersome, requiring sequential drug delivery over three to four hours, with limited tumor exposure time.
Previous wording
We are a clinical-stage, publicly traded 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, depression and other diseases.
Current wording
We are a clinical-stage, publicly traded 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 $27,425,900 for the six months ended June 30, 2025. At June 30, 2025, we had an accumulated deficit of approximately $668,308,000.
Current wording
We have not generated revenues and do not anticipate generating revenues for the foreseeable future. We had a net loss of approximately $37,517,400 for the nine months ended September 30, 2025. At September 30, 2025, we had an accumulated deficit of approximately $678,399,400.
Previous wording
Wehave more than 10 issued patents and pending patent applications related to NDV-01 for multiple uses, including formulations and methods for controlled release of therapeutics for treatment of diseases such as bladder cancer, potentially providing coverage beyond 2038.
Current wording
We have more than 10 issued patents and pending patent applications related to NDV-01 for multiple uses, including formulations and methods for controlled release of therapeutics for treatment of diseases such as bladder cancer, potentially providing coverage beyond 2038.
Previous wording
Research and development expense for the three months ended June 30, 2025 was approximately $2,819,400 compared to $10,721,100 for the three months ended June 30, 2024, a decrease of approximately $7,901,700. The change was primarily driven by:
Current wording
Research and development expense for the three months ended September 30, 2025 was approximately $4,036,300 compared to $11,149,100 for the three months ended September 30, 2024, a decrease of approximately $7,112,800. The change was primarily driven by:
Previous wording
General and administrative expense for the three months ended June 30, 2025 was approximately $7,401,900 compared to $8,097,700 for the three months ended June 30, 2024, a decrease of approximately $695,800. The change was primarily due to:
Current wording
General and administrative expense for the three months ended September 30, 2025 was approximately $6,291,100 compared to $11,859,700 for the three months ended September 30, 2024, a decrease of approximately $5,568,600. The change was primarily due to:
Previous wording
Interest / investment income was approximately $761,700 and $2,018,900 for the six months ended June 30, 2025 and 2024, respectively. The decrease was due to lower interest rates and investment yields. Realized gain on short-term investments was approximately $110,200 for the six months ended June 30, 2024 compared to a realized gain of approximately $186,200 for the six months ended June 30, 2024. Unrealized gain on short-term investments was approximately $141,900 and $5,200 for the six months ended June 30, 2025 and 2024, respectively.
Current wording
Interest/investment income was approximately $247,000 and $856,500 for the three months ended September 30, 2025 and 2024, respectively. The decrease was due to lower average investment balance. Realized loss on short-term investments was approximately $81,400 for the three months ended September 30, 2025 compared to a realized gain on short term investments of approximately $147,800 for the three months ended September 30, 2024. Unrealized gain on short-term investments was approximately $70,300 and $278,600 for the three months ended September 30, 2025 and 2024.
Previous wording
The net loss for the Company for the three months ended June 30, 2025 and 2024 was approximately $9,866,400 and $17,768,100, respectively. The Company had loss per share basic and diluted of $0.30 and $0.59 for the three months ended June 30, 2025 and 2024, respectively.
Current wording
The net loss for the Company for the three months ended September 30, 2025 and 2024 was approximately $10,091,500 and $21,726,000, respectively. The Company had loss per share basic and diluted of $0.30 and $0.72 for the three months ended September 30, 2025 and 2024, respectively.
Previous wording
For the Six Months Ended June 30, 2025 versus June 30, 2024
Current wording
For the Nine Months Ended September 30, 2025 versus September 30, 2024:
Previous wording
Research and development expense for the six months ended June 30, 2025 was approximately $14,770,400 compared to $24,026,400 for the six months ended June 30, 2024, a decrease of approximately $9,256,000. The decrease was primarily due to:
Current wording
Research and development expense for the nine months ended September 30, 2025 was approximately $18,806,700 compared to $35,175,500 for the nine months ended September 30, 2024, a decrease of approximately $16,368,800. The decrease was primarily due to:
Previous wording
General and administrative expense for the six months ended June 30, 2025 was approximately $13,669,300 compared to $17,780,200 for the six months ended June 30, 2024, a decrease of approximately $4,110,900. The decrease was primarily due to:
Current wording
General and administrative expense for the nine months ended September 30, 2025 was approximately $19,960,400 compared to $29,640,000 for the nine months ended September 30, 2024, a decrease of approximately $9,679,600. The decrease was primarily due to:
Previous wording
Interest/investment income was approximately $321,500 and $963,000 for the three months ended June 30, 2025 and 2024, respectively. The decrease was due to lower average investment balance. Realized gain on short-term investments was approximately $47,200 and $133,100 for the three months ended June 30, 2025 and 2024, respectively. Unrealized loss on short-term investments was approximately $13,800 and $45,500 for the three months ended June 30, 2025 and 2024.
Current wording
Interest / investment income was approximately $1,008,800 and $2,875,500 for the nine months ended September 30, 2025 and 2024, respectively. The decrease was due to lower interest rates and investment yields and a lower average balance. Realized gain on short-term investments was approximately $28,700 and $334,100 for the nine months ended September 30, 2025 and 2024, respectively. Unrealized gain on short-term investments was approximately $212,200 and $283,800 for the nine months ended September 30, 2025 and 2024, respectively.
Previous wording
The net loss for the Company for the six months ended June 30, 2025 and 2024 was approximately $27,425,900 and $39,596,200 respectively. The Company had loss per share, basic and diluted of $0.86 and $1.31 for the six months ended June 30, 2025 and 2024, respectively.
Current wording
The net loss for the Company for the nine months ended September 30, 2025 and 2024 was approximately $37,517,400 and $61,322,200 respectively. The Company had loss per share, basic and diluted of $1.16 and $2.03 for the nine months ended September 30, 2025 and 2024, respectively.
Previous wording
The Company did not provide for income taxes for the six months ended June 30, 2025 and 2024, since there was a loss and a full valuation allowance against all deferred tax assets.
Current wording
The Company did not provide for income taxes for the nine months ended September 30, 2025 and 2024, since there was a loss and a full valuation allowance against all deferred tax assets.
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 six months ended June 30, 2025, the Company incurred a net loss of $27,425,907 and had negative operating cash flows of $24,468,909. 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 unaudited 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 nine months ended September 30, 2025, the Company incurred a net loss of $37,517,403 and had negative operating cash flows of $31,190,765. 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.
Previous wording
For the six months ended June 30, 2025, cash used in operating activities was $24,468,909 primarily due to the net loss of $27,425,907 offset by non-cash stock-based compensation charges of $7,926,448. There were realized gains and unrealized gains on short-term investments of $110,156 and $141,934, respectively. In addition, there was an increase in operating assets and liabilities of $4,717,360.
Current wording
For the nine months ended September 30, 2025, cash used in operating activities was $31,190,765 primarily due to the net loss of $37,517,403 offset by non-cash stock-based compensation charges of $11,534,002 and fair value changes on stock appreciation rights of $216,640. There were realized gains and unrealized gains on short-term investments of $28,717 and $212,210, respectively. In addition, there was a decrease in operating assets and liabilities of $5,183,077.
Previous wording
For the six months ended June 30, 2024, cash used in operating activities was $26,299,773 primarily due to the net loss of $39,596,248 offset by non-cash stock-based compensation charges of $4,477,995. There were realized gains and unrealized gains on short-term investments of $186,247 and $5,248, respectively. In addition, there was an increase in operating assets and liabilities of $4,766,880.
Current wording
For the nine months ended September 30, 2024, cash used in operating activities was $42,956,164 due to the net loss of $61,322,218 offset by non-cash stock-based compensation charges of $23,458,012 and fair value changes on stock appreciation rights of $12,562. There were realized and unrealized gains on short-term investments of $334,082 and $283,803, respectively. In addition, there was a decrease in operating assets and liabilities of $4,486,635.
Previous wording
For the six months ended June 30, 2025, cash provided by investing activities was $22,038,255, due to $809,375 of purchases of short-term investments offset by $22,847,630 of sales of short-term investments.
Current wording
For the nine months ended September 30, 2025, cash provided by investing activities was $28,791,244, due to $1,043,307 of purchases of short-term investments offset by $29,834,551 of sales of short-term investments.
Previous wording
For the six months ended June 30, 2024, cash provided by investing activities was $24,072,718, due to $8,313,312 of purchases of short-term investments offset by $32,386,030 of sales of short-term investments.
Current wording
For the nine months ended September 30, 2024, cash provided by investing activities was $40,216,239, due to $11,424,986 of purchases of short-term investments offset by $51,641,225 of sales of short-term investments.
Previous wording
Net cash used by financing activities for the six months ended June 30, 2025 was $73,021 related to ATM expenses.
Current wording
Net cash used by financing activities for the nine months ended September 30, 2025 was $73,021 related to ATM expenses.
Previous wording
For the six months ended June 30, 2024, cash provided by financing activities was $221,747 due to proceeds from options exercised for common stock of $246,747 offset by ATM expenses of $25,000.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2024 was $132,146, due to proceeds from options exercised for common stock of $246,747 offset by ATM expenses of $114,601.