RELMADA THERAPEUTICS, INC.
For the period ended Jun 30, 2026. Filed Aug 6, 2026.
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.
Jun 30, 2026 · Filed Aug 6, 2026
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 2026-03-31; filed 2026-05-12.
0001213900-26-055059
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001213900-26-086151
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 86 previous paragraphs and 96 current paragraphs.
59 unchanged; 24 reworded; 10 added; 2 removed; 1 previous and 3 current paragraphs rearranged.
Tables are not compared: 28 previous and 44 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 (10)
Current report
Relmada expects to file a United States IND application for NDV-01 with the FDA by year-end 2026.
Current report
Relmada expects to file a United States IND application for sepranolone with the FDA by year-end 2026.
Current report
Results of Operations
Current report
Research and Development Expense
Current report
Research and development expense for the six months ended June 30, 2026 was approximately $16,481,600 compared to $14,770,400 for the six months ended June 30, 2025, an increase of approximately $1,711,200. The increase was primarily due to:
Current report
General and Administrative Expense
Current report
General and administrative expense for the six months ended June 30, 2026 was approximately $17,991,100 compared to $13,669,300 for the six months ended June 30, 2025, an increase of approximately $4,321,800. The increase was primarily due to:
Current report
Other Income
Current report
Interest / investment income was approximately $3,261,200 and $761,700 for the six months ended June 30, 2026 and 2025, respectively. The increase was due to higher average investment balance. Realized loss on short-term investments was approximately $47,200 for the six months ended June 30, 2026 compared to a realized gain of approximately $110,200 for the six months ended June 30, 2025. Unrealized loss on short-term investments was approximately $707,400 for the six months ended June 30, 2026 compared to an unrealized gain of $141,900 for the six months ended June 30, 2025.
Removed paragraphs (2)
Previous report
Relmada expects to initiate a Phase 2 pilot study of sepranolone in PWS in mid-2026.
Reworded paragraphs (24)
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 in late 2024 and early 2025. 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 terminating further work on esmethadone (d-methadone, dextromethadone or REL-1017). Hence we accelerated ongoing efforts to augment our development pipeline while diversifying its risk, which culminated in the licensing of NDV-01, a novel delivery formulation of a chemotherapy regimen widely 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. We substantially redesigned our development programs following a comprehensive strategic review in late 2024 and early 2025. 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 terminating further work on esmethadone (d-methadone, dextromethadone or REL-1017). Hence we accelerated ongoing efforts to augment our development pipeline while diversifying its risk, which culminated in the licensing of NDV-01, a novel, sustained-release, delivery formulation of a chemotherapy regimen widely 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.
Previous wording
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 in Israel to assess its safety and efficacy in patients with aggressive forms of NMIBC. We intend to develop NDV-01 for two separate indications: (1) the treatment of high-risk, 2nd line Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC and (2) the treatment of intermediate risk patients in the adjuvant setting. We expect to initiate Phase 3 programs for each indication mid-2026.
Current wording
Currently, our lead product candidate, NDV-01, is a novel, sustained-release formulation of gemcitabine and docetaxel, with the potential to be a best-in-class intravesical treatment across the NMIBC disease spectrum. NDV-01 is currently in a Phase 2 clinical trial in Israel to assess its safety and efficacy in patients with aggressive forms of NMIBC. We intend to develop NDV-01 for two separate indications: (1) the treatment of high-risk, 2nd line Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC and (2) the treatment of intermediate risk NMIBC patients in the adjuvant setting. We expect to file an United States Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) by year-end 2026. Subsequently, upon IND clearance, we anticipate initiation of Phase 3 programs for each indication.
Previous wording
Our second product, sepranolone is a novel neurosteroid epimer of allopregnanolone. Sepranolone is being developed for the potential treatment of PWS, with additional potential indications in TS, essential tremor and other diseases related to excessive GABAergic activity. We expect to initiate a Phase 2b study in PWS mid-2026.
Current wording
Our second product, sepranolone is a novel neurosteroid epimer of allopregnanolone. Sepranolone is being developed for the potential treatment of PWS, with additional potential indications in TS, essential tremor and other diseases related to excessive GABAergic activity. We expect to file an IND application with the FDA by year-end 2026. Upon IND clearance, we anticipate initiation of a Phase 2b study in PWS..
Previous 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.
Current wording
On March 25, 2025, Relmada announced the in-license agreement from Trigone Pharma Ltd. (Trigone) of NDV-01, a novel, sustained-release, delivery formulation of a widely used chemotherapeutic regimen used to treat NMIBC.
Previous wording
We expect multiple key milestones over the next 12 months. These include:
Current wording
We expect several key milestones over the next upcoming months. These include:
Previous wording
NDV-01, our lead program, was in-licensed on March 24, 2025, NDV-01, is a novel intravascular 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 and for patients that do not respond adequately to BCG. 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, intravesical delivery technology designed for the long-acting, sustained-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 and for patients that do not respond adequately to BCG. 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
NDV-01 is formulated as a controlled-release intravesical therapy containing gemcitabine and docetaxel. By maintaining continuous drug exposure within the bladder, NDV-01 may optimize local efficacy while minimizing systemic absorption and associated side effects. Unlike conventional intravesical instillations, which result in fluctuating drug levels, NDV-01 provides a continuous release of both agents over 10 days. This sustained delivery may improve cancer cell eradication and reduce recurrence risk while lowering the frequency of administration.
Current wording
NDV-01 is formulated as a sustained-release intravesical therapy containing gemcitabine and docetaxel. By maintaining continuous drug exposure within the bladder, NDV-01 may optimize local efficacy while minimizing systemic absorption and associated side effects. Unlike conventional intravesical instillations, which result in fluctuating drug levels, NDV-01 provides a continuous release of both agents over 10 days. This sustained delivery may improve cancer cell eradication and reduce recurrence risk while lowering the frequency of administration.
Previous wording
NDV-01 is currently in a Phase 2 clinical trial evaluating its safety and efficacy in patients with aggressive NMIBC. The Phase 2 study is a single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with High Grade-NMIBC. Patients are treated with NDV-01 in a biweekly induction phase, followed by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated. The primary efficacy endpoints are safety and complete response rate (Complete Response Rate at 12 months), and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS).
Current wording
NDV-01 is currently in a Phase 2 clinical trial evaluating its safety and efficacy in patients with aggressive NMIBC. The Phase 2 study is a single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with High Risk-NMIBC. Patients are treated with NDV-01 in a biweekly induction phase, followed by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated. The primary efficacy endpoints are safety and complete response rate (Complete Response Rate at 12 months), and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS).
Previous wording
The Company also previously announced the successful completion and receipt of written feedback from a Type B pre-IND submissions with the U.S. Food and Drug Administration (FDA) regarding the planned Phase 3 program for NDV-01 in NMIBC patients. Relmada secured FDA alignment on certain key elements of the planned Phase 3 pivotal program for NDV-01, expected to begin in mid-2026, and incorporating two studies for two separate indications:
Current wording
The Company also previously announced the successful completion and receipt of written feedback from a Type B pre-IND submissions with the FDA regarding the planned Phase 3 program for NDV-01 in NMIBC patients. Relmada secured FDA alignment on certain key elements of the planned Phase 3 pivotal program for NDV-01, expected to begin by year-end 2026, and incorporating two studies for two separate indications:
Previous wording
About the Planned High-Grade Registrational Study
Current wording
About the Planned High-Risk Registrational Study
Previous wording
The planned pivotal Phase 3 study in 2nd-line, refractory, high-grade BCG-unresponsive NMIBC with CIS will be an open-label, single-arm trial evaluating:
Current wording
The planned pivotal Phase 3 study in 2nd-line, high risk, BCG-unresponsive NMIBC with CIS will be an open-label, single-arm trial evaluating:
Previous wording
We have not generated revenues and do not anticipate generating revenues for the foreseeable future. We had a net loss of approximately $19,052,000 for the three months ended March 31, 2026. At March 31, 2026, we had an accumulated deficit of approximately $717,319,200.
Current wording
We have not generated revenues and do not anticipate generating revenues for the foreseeable future. We had a net loss of approximately $31,966,100 for the six months ended June 30, 2026. At June 30, 2026, we had an accumulated deficit of approximately $730,233,300.
Previous 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.
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 sustained-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 March 31, 2026 was approximately $8,087,800 compared to $11,951,000 for the three months ended March 31, 2025, a decrease of approximately $3,863,200. The change was primarily driven by:
Current wording
Research and development expense for the three months ended June 30, 2026 was approximately 8,393,800 compared to $2,819,400 for the three months ended June 30, 2025, an increase of approximately $5,574,400. The change was primarily driven by:
Previous wording
General and administrative expense for the three months ended March 31, 2026 was approximately $11,373,900 compared to $6,267,400 for the three months ended March 31, 2025, an increase of approximately $5,106,500. The change was primarily due to:
Current wording
General and administrative expense for the three months ended June 30, 2026 was approximately $6,617,200 compared to $7,401,900 for the three months ended June 30, 2025, a decrease of approximately $784,700. The change was primarily due to:
Previous wording
Interest/investment income was approximately $959,800 and $440,300 for the three months ended March 31, 2026 and 2025, respectively. The increase was due to higher average investment balance. Realized loss on short-term investments was approximately $9,900 and realized gain on short-term investments was approximately $63,000 for the three months ended March 31, 2026 and 2025, respectively. Unrealized loss on short-term investments and unrealized gain on short-term investments for the three months ended March 31, 2026 and 2025 was approximately $540,100 and $155,700, respectively.
Current wording
Interest/investment income was approximately $2,301,400 and $321,500 for the three months ended June 30, 2026 and 2025, respectively. The increase was due to higher average investment balance. Realized loss on short-term investments was approximately $37,300 for the three months ended June 30, 2026 compared to a realized gain of $47,200 for the three months ended June 30, 2025. Unrealized loss on short-term investments was approximately $167,300 and $13,800 for the three months ended June 30, 2026 and 2025.
Previous wording
The net loss for the Company for the three months ended March 31, 2026 and 2025 was approximately $19,052,000 and $17,559,500 respectively. The Company had loss per share, basic and diluted of $0.22 and $0.58 for the three months ended March 31, 2026 and 2025, respectively.
Current wording
The net loss for the Company for the three months ended June 30, 2026 and 2025 was approximately $12,914,200 and $9,866,400, respectively. The Company had loss per share basic and diluted of $0.11 and $0.30 for the three months ended June 30, 2026 and 2025, respectively.
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 three months ended March 31, 2026, the Company incurred a net loss of $19,051,956 and had negative operating cash flows of $15,067,488.
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 six months ended June 30, 2026, the Company incurred a net loss of $31,966,141 and had negative operating cash flows of $24,673,921.
Previous wording
For the three months ended March 31, 2026, cash used in operating activities was $15,067,488 primarily due to the net loss of $19,051,956 offset by non-cash stock-based compensation charges of $956,186 and stock appreciation rights compensation of $2,677,652. There were realized and unrealized losses on short-term investments of $9,867 and $540,097, respectively. In addition, there was an increase in operating assets and liabilities of $199,334.
Current wording
For the six months ended June 30, 2026, cash used in operating activities was $24,673,921 primarily due to the net loss of $31,966,141 offset by non-cash stock-based compensation charges of $1,859,089 and stock appreciation rights compensation of $4,019,150. There were realized and unrealized losses on short-term investments of $47,162 and $707,354, respectively. In addition, there was an increase in operating assets and liabilities of $659,465.
Previous wording
For the three months ended March 31, 2025, cash used in operating activities was $18,067,033 primarily due to the net loss of $17,559,465 offset by non-cash stock-based compensation charges of $3,572,769 and stock appreciation rights compensation of $3,038. There were realized and unrealized gains on short-term investments of $62,952 and $155,731, respectively. In addition, there was an increase in operating assets and liabilities of $4,769,918.
Current 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,,021,222 and stock appreciation rights compensation of $27,649 and proceeds from the issuance of restricted common stock of $905,226. 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 $4,745,009.
Previous wording
For the three months ended March 31, 2026, cash used in investing activities was $135,226,997 due to $149,517,480 of purchases of short-term investments offset by $14,290,483 of sales of short-term investments.
Current wording
For the six months ended June 30, 2026, cash used in investing activities was $117,641,611, due to $174,270,466 of purchases of short-term investments offset by $56,628,855 of sales of short-term investments.
Previous wording
For the three months ended March 31, 2025, cash provided by investing activities was $15,359,713 due to $487,916 of purchases of short-term investments offset by $15,847,629 of sales of short-term investments.
Current 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.
Previous wording
For the three months ended March 31, 2026, net cash from financing activities totaled $156,574,345 due to proceeds from the issuance of common stock for $159,999,996 offset by fees for issuance of common stock of $3,360,000 and ATM fees of $65,651.
Current wording
Net cash provided by financing activities for the six months ended June 30, 2026 was $150,153,362 due to proceeds from the issuance of common stock for $159,999,996, proceeds from options exercised for common stock of $101,497, and proceeds from warrants exercised for common stock of $1,683 offset by fees for issuance of common stock of $9,817,890 and ATM fees of $131,924.
Previous wording
Net cash provided by financing activities for the three months ended March 31, 2025 was $0.
Current wording
Net cash used in financing activities for the six months ended June 30, 2025 was $73,021 related to ATM fees.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
For the Six Months Ended June 30, 2026 versus June 30, 2025
Current report — wording carried from elsewhere
The net loss for the Company for the six months ended June 30, 2026 and 2025 was approximately $31,966,100 and $27,425,900 respectively. The Company had loss per share, basic and diluted of $0.32 and $0.86 for the six months ended June 30, 2026 and 2025, respectively.
Current report — wording carried from elsewhere
The Company did not provide for income taxes for the six months ended June 30, 2026 and 2025, since there was a loss and a full valuation allowance against all deferred tax assets.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION