Relmada preliminary Q3 net loss widens to $13.9M
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Relmada Therapeutics (RLMD) reported preliminary, unaudited third-quarter 2026 results. Net loss was $13.9 million, versus $10.1 million in the 2025 quarter; research and development expense was $9.2 million, versus $4.0 million. Cash, cash equivalents and short-term investments were $202.1 million as of September 30, 2026.
In the ongoing Phase 2 NDV-01 study in high-risk non-muscle-invasive bladder cancer, 12 of 14 evaluable patients who had a complete response at month 12 and continued in the study remained in response at month 18 (86%); two patients progressed to muscle-invasive disease at month 15, and no patients had undergone radical cystectomy through month 18. In the 51-patient efficacy-evaluable group, 48 of 51 (94%) had a complete response at any time; at month 12, 24 of 31 (77%) did. Relmada says NDV-01 and sepranolone IND submissions remain on track by year-end 2026. It expects to begin NDV-01’s Phase 3 SPECTRUM program and sepranolone’s Phase 2b Prader-Willi syndrome study upon IND clearance; it also reports FDA alignment on two independent NDV-01 registrational pathways.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- None.
Negative
- Moderate pointQuarterly net loss was $13.9 million, versus $10.1 million in 2025.
8-K Event Classification
Key Figures
Key Terms
Investigational New Drug (IND) regulatory
non-muscle invasive bladder cancer (NMIBC) medical
complete response (CR) medical
intravesical co-formulation medical
chemistry, manufacturing and controls (CMC) technical
registrational pathways regulatory
Earnings Snapshot
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were RLMD’s third-quarter 2026 financial results?
What did RLMD report from NDV-01’s 18-month Phase 2 results?
What are RLMD’s planned SPECTRUM registrational cohorts?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of
earliest event reported):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone
number, including area code: (
| (Former name or former address, if changed since last report) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of exchange on which registered | ||
| The |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 12, 2026, Relmada Therapeutics, Inc. (the “Company”) issued a press release providing a corporate update and reporting its financial results for the third fiscal quarter ended September 30, 2026. (These results are preliminary and unaudited.) The Company also announced that it would conduct a conference call and audio webcast on Thursday, November 12, 2026, at 4:30 PM EST / 1:30 PM PST, to discuss the update and results. The Company’s complete unaudited financial statements and notes thereto as of, and for the three and nine months ended, September 30, 2026 and 2025, will be contained in its Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 2.02 by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02 of this Current Report on Form 8-K, including the information set forth in Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 7.01 Regulation FD Disclosure.
On November 12, 2026, the Company updated its corporate presentation, a copy of which is furnished herewith as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including the information set forth in Exhibit 99.2, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1* | Press release dated November 12, 2026, regarding corporate update and third quarter 2026 financial results | |
| 99.2* | Corporate Presentation dated November 12, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
| * | Furnished herewith |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: November 12, 2026 | RELMADA THERAPEUTICS, INC. | |
| By: | /s/ Sergio Traversa | |
| Name: | Sergio Traversa | |
| Title: | Chief Executive Officer | |
2
Exhibit 99.1
Relmada Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Update
| ● | NDV-01 CMC program on track to submit the IND by year-end 2026, with initiation of the registrational Phase 3 SPECTRUM program upon IND clearance |
| ● | Long-term extension NDV-01 Phase 2 data demonstrate continued durability of response: 86% of 12-month complete responders remained in complete response at 18 months, with no Grade ≥3 treatment-related adverse events or discontinuations |
| ● | Registrational Phase 3 program renamed SPECTRUM; two independent registrational pathways in NMIBC remain unchanged |
| ● | Cash, cash equivalents and short-term investments of approximately $202.1 million as of September 30, 2026, expected to fund operations through 2029 |
CORAL GABLES, Fla., Nov. 12, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today reported financial results for the third quarter ended September 30, 2026, and provided a business update, including 18-month results from the NDV-01 Phase 2 study, the registrational Phase 3 SPECTRUM program, and continued progress toward the planned year-end 2026 Investigational New Drug (IND) submission for NDV-01 and sepranolone.
“Relmada has made significant progress in advancing the NDV-01 CMC program and remains on track to submit the NDV-01 IND by year-end 2026. Furthermore, we have established a manufacturing plan to provide uninterrupted clinical supply through the completion of the Phase 3 SPECTRUM program,” said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics.
“Initial 18-month results from the ongoing NDV-01 Phase 2 study demonstrate extended durability of complete response and continued favorable tolerability,” added Bipin Dalmia, Chief Business Officer of Relmada Therapeutics. “Our Phase 3 program remains unchanged, with two independent registrational pathways in NMIBC, and we have renamed it SPECTRUM to reflect the potential breadth of NDV-01 across the NMIBC disease spectrum. We expect to begin the SPECTRUM program upon IND clearance.”
CMC and Manufacturing Update
NDV-01: NDV-01 CMC program is on track for IND submission by year-end 2026, with initiation of the registrational Phase 3 SPECTRUM program upon IND clearance. Furthermore, we have established a manufacturing plan to provide uninterrupted clinical supply through completion of the Phase 3 SPECTRUM program.
Sepranolone: The Company is finalizing the stability testing of the pre-filled syringe (PFS) delivery system to enable sepranolone IND submission, which is on track for year-end 2026. We expect to start the Phase 2b trial in Prader-Willi Syndrome upon IND clearance.
NDV-01 Clinical Update
Phase 2 Study: Initial 18-month results from the ongoing Phase 2 TRGC-011 study of NDV-01 in high-risk NMIBC continue to support extended durability of NDV-01 complete responses and continued favorable tolerability profile.
| ● | Initial 18-month durability results: 23 patients in complete response (CR) at 12 months continued into the long-term extension (LTE). 86% (12/14) of evaluable patients who reached 18 months remained in CR. In the BCG-unresponsive subgroup, 11 patients continued into the LTE, and 88% (7/8) of evaluable patients who reached 18 months remained in CR. Two BCG-naïve patients (T1 at study entry) progressed to muscle-invasive disease (T2a) at the Month 15 assessment. |
| ● | Updated 12-month efficacy results: Among 51 evaluable patients, the anytime CR rate was 94% (48/51) and the 12-month CR rate was 77% (24/31). In the BCG-unresponsive subgroup, the anytime CR rate was 96% (22/23) and 12-month CR rate was 73% (11/15). Through 12-months, both progression-free and cystectomy-free survival was 100%. |
| ● | Safety and tolerability: To date, there were no Grade ≥3 treatment-related adverse events (TRAEs), no treatment-related serious adverse events, and no treatment-related discontinuations. |
Phase 3 SPECTRUM Program: The NDV-01 Phase 3 program remains unchanged and is designed to pursue two independent registrational pathways in NMIBC:
| 1. | A single-arm study in second-line (2L) high-risk BCG-unresponsive carcinoma in situ (CIS) ± Ta/T1 (Cohort 2UC), together with a separate single-arm 2L high-risk BCG-unresponsive Ta/T1 w/o CIS exploratory cohort (Cohort 2UP). |
| 2. | A randomized study evaluating NDV-01 as adjuvant therapy following transurethral resection of bladder tumor (TURBT) versus observation in low-grade intermediate-risk NMIBC (Cohort IRA). |
The Company has changed the name of its Phase 3 program from RESCUE to SPECTRUM to better reflect the potential breadth of NDV-01 across the entire NMIBC disease spectrum. Clinical trial sites are engaged and preparing to initiate patient enrollment upon IND clearance.
Anticipated Upcoming Milestones
NDV-01:
| ● | NDV-01 United States IND submission – By year-end 2026 |
| ● | NDV-01 Phase 3 SPECTRUM program initiation – Upon IND clearance |
Sepranolone:
| ● | Sepranolone United States IND submission – By year-end 2026 |
| ● | Sepranolone Phase 2b initiation in Prader-Willi Syndrome – Upon IND clearance |
2
Financial Results
Third Quarter 2026 Financial Results
| ● | Research and development expense for the three months ended September 30, 2026, totaled $9.2 million, compared to $4.0 million for the three months ended September 30, 2025, an increase of $5.2 million. The increase was primarily attributable to higher NDV-01 and sepranolone study preparation costs, increased manufacturing and drug storage costs and higher employee compensation, partially offset by lower stock-based compensation. |
| ● | General and administrative expense for the three months ended September 30, 2026, totaled $3.9 million compared to $6.3 million for the three months ended September 30, 2025, a decrease of approximately $2.4 million. The decrease was primarily driven by lower stock-based compensation and lower stock appreciation rights expense, partially offset by higher employee compensation and consulting services. |
| ● | Net cash used in operating activities for the three months ended September 30, 2026, totaled $12.6 million compared to $6.7 million for the three months ended September 30, 2025. |
| ● | The net loss for the three months ended September 30, 2026, was $13.9 million, or $0.12 per basic and diluted share, compared with a net loss of $10.1 million, or $0.30 per basic and diluted share, for the three months ended September 30, 2025. |
| ● | As of September 30, 2026, the Company’s cash, cash equivalents, and short-term investments totaled $202.1 million, compared to cash, cash equivalents, and short-term investments of approximately $93.0 million at December 31, 2025. |
| ● | The Company’s current cash, cash equivalents, and short-term investments as of September 30, 2026, are expected to provide sufficient resources to fund Company operations through 2029, including completion of the two registrational cohorts of the NDV-01 Phase 3 SPECTRUM program. |
| ● | The Company had 106,694,846 shares outstanding, as of November 10, 2026. |
Nine Months Ended September 30, 2026 Financial Results
| ● | Research and development expense for the nine months ended September 30, 2026, totaled $25.7 million, compared to $18.8 million for the nine months ended September 30, 2025, an increase of $6.9 million. The increase was primarily attributable to increased manufacturing and drug storage costs, higher employee compensation and higher stock appreciation rights expense, partially offset by lower study costs and lower stock-based compensation. |
| ● | General and administrative expense for the nine months ended September 30, 2026, totaled $21.9 million compared to $20.0 million for the nine months ended September 30, 2025, an increase of approximately $1.9 million. The increase was primarily driven by higher employee compensation, stock appreciation rights expense and consulting services, partially offset by lower stock-based compensation. |
| ● | Net cash used in operating activities for the nine months ended September 30, 2026, totaled $37.3 million compared to $31.2 million for the nine months ended September 30, 2025. |
| ● | The net loss for the nine months ended September 30, 2026, was $45.8 million, or $0.44 per basic and diluted share, compared with a net loss of $37.5 million, or $1.16 per basic and diluted share, for the nine months ended September 30, 2025. |
Conference Call and Webcast Information
Relmada will host a conference call and webcast today at 4:30 PM ET to discuss recent business progress and financial results.
Date: Thursday, November 12, 2026 at 4:30 PM ET
Participant Dial-in (US): 1-800-717-1738
Participant Dial-in (International): 1-646-307-1865
Webcast Access: Click Here
A replay of the webcast will be available in the Investors section of the Relmada website at https://ir.relmada.com/investors/events/.
3
About NDV-01
NDV-01 is a novel, sustained-release, intravesical co-formulation of gemcitabine and docetaxel (Gem/Doce) being developed for the treatment of non-muscle invasive bladder cancer (NMIBC). The formulation is engineered to provide prolonged bladder retention and sustained drug release for up to 10 days. By forming a soft intravesical matrix, NDV-01 is designed to increase local drug exposure while limiting systemic toxicity. The treatment can be administered conveniently in an office setting in under 5 minutes without the need for anesthesia or specialized equipment. NDV-01 is encompassed by multiple patent applications that if issued, could provide protection until 2047.
About the NDV-01 Phase 3 SPECTRUM Registrational Pathways:
Relmada has received written FDA feedback confirming alignment on two registrational pathways for NDV-01, including study design, patient populations, and primary endpoints. The Company expects to submit an IND by year-end 2026 and initiate the Phase 3 SPECTRUM program upon IND clearance.
About NMIBC
NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence rates (50–80% over 5 years) and disease progression in a subset of these patients. With 63,000 incident NMIBC cases per year in the U.S. and limited treatment options, the market opportunity is significant. High-risk BCG-unresponsive disease represents the biggest unmet need in NMIBC, with limited and suboptimal bladder-sparing treatment options. While four therapies are FDA-approved for first line BCG-unresponsive disease, there are no approved therapies in the second line or later. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies and patients with recurrence must undergo repeated surgical resections. NDV-01 has the potential to serve as a foundational intravesical therapy across the NMIBC disease spectrum.
About Sepranolone and GABA Modulation
Sepranolone, a synthetic isoallopregnanolone, selectively modulates GABAA receptors by antagonizing allopregnanolone (ALLO), without disrupting GABA signaling. It targets disorders linked to excess GABAergic activity such as Prader-Willi syndrome (PWS), Tourette syndrome, and obsessive-compulsive disorder (OCD). More than 335 patients have been treated with sepranolone in clinical trials to date, with a favorable safety profile. The Company is on track to submit the sepranolone IND by year-end 2026 and expects to initiate the Phase 2 study in Prader-Willi syndrome upon IND clearance.
About Prader-Willi Syndrome (PWS)
PWS is a rare genetic disorder caused by chromosomal deletions on chromosome 15, leading to neurodevelopmental and behavioral complications. Global prevalence is estimated to be 350,000-400,000 patients. Current treatments address symptoms but do not modify the underlying neurobehavioral pathology.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology and central nervous system conditions. Its lead candidates, NDV-01 and sepranolone, are advancing through clinical development with the potential to address significant unmet needs.
For more information, visit www.relmada.com
4
Forward-Looking Statements:
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as “if”, “may”, “expects”, “anticipates”, “believes”, “will”, “will likely result”, “will continue”, “plans to”, “potential”, “promising”, and similar expressions. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential for Relmada’s product candidates to fail to progress, potential for Phase 2 NDV-01 data to fail to continue to deliver positive results supporting further development, potential for clinical trials to fail to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of interim or top-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to continue to secure FDA agreement on the regulatory path for NDV-01 and/or sepranolone, potential changes to the design, size or timing of the Phase 3 SPECTRUM studies, including as a result of updated treatment guidelines or third-party clinical data, or that future NDV-01 and/or sepranolone clinical results will be acceptable to the FDA, failure to successfully execute manufacturing and CMC activities for NDV-01 and/or sepranolone, including GMP manufacture of clinical trial material, manufacturing scale-up, process validation, timing of completion of manufacturing activities, and regulatory acceptance of manufacturing-related submissions, failure to secure adequate NDV-01 and/or sepranolone drug supply, failure of pending patent applications to result in issued patents, or issued patents being challenged and invalidated by third parties or not providing us with any competitive advantages, the Company’s cash runway and sufficiency of the Company’s cash resources and uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials, and the other risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein are not a complete list.
Investor Contact:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com
Media Inquiries:
Corporate Communications
media@relmada.com
5
Relmada Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| As of | ||||||||
| September 30, | As of | |||||||
| 2026 (Unaudited) | December 31, 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 5,720,325 | $ | 3,496,540 | ||||
| Short-term investments | 196,402,988 | 89,509,710 | ||||||
| Other receivable | 10,912 | — | ||||||
| Prepaid expenses | 2,915,011 | 977,721 | ||||||
| Total current assets | 205,049,236 | 93,983,971 | ||||||
| Other assets | 247,379 | 19,500 | ||||||
| Total assets | $ | 205,296,615 | $ | 94,003,471 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,538,585 | $ | 1,568,944 | ||||
| Accrued expenses | 5,237,116 | 4,861,583 | ||||||
| Total current liabilities | 7,775,701 | 6,430,527 | ||||||
| Stock appreciation rights | 3,783,853 | 1,060,931 | ||||||
| Total liabilities | 11,559,554 | 7,491,458 | ||||||
| Commitments and Contingencies (See Note 8) | ||||||||
| Stockholders’ Equity: | ||||||||
| Preferred stock, $0.001 par value, 200,000,000 shares authorized, none issued and outstanding | — | — | ||||||
| Class A convertible preferred stock, $0.001 par value, 3,500,000 shares authorized, none issued and outstanding | — | — | ||||||
| Common stock, $0.001 par value, 200,000,000 and 150,000,000 shares authorized, respectively, 106,694,846 and 73,333,622 shares issued and outstanding, respectively | 106,695 | 73,333 | ||||||
| Additional paid-in capital | 937,725,893 | 784,705,878 | ||||||
| Accumulated deficit | (744,095,527 | ) | (698,267,198 | ) | ||||
| Total stockholders’ equity | 193,737,061 | 86,512,013 | ||||||
| Total liabilities and stockholders’ equity | $ | 205,296,615 | $ | 94,003,471 | ||||
6
Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
| Three months ended | Nine months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 9,217,440 | $ | 4,036,267 | $ | 25,699,073 | $ | 18,806,667 | ||||||||
| General and administrative | 3,878,983 | 6,291,079 | 21,870,130 | 19,960,421 | ||||||||||||
| Total operating expenses | 13,096,423 | 10,327,346 | 47,569,203 | 38,767,088 | ||||||||||||
| Loss from operations | (13,096,423 | ) | (10,327,346 | ) | (47,569,203 | ) | (38,767,088 | ) | ||||||||
| Other (expenses) income: | ||||||||||||||||
| Interest/investment income, net | 2,274,541 | 247,013 | 5,535,697 | 1,008,758 | ||||||||||||
| Realized (loss) gain on short-term investments | (435,122 | ) | (81,438 | ) | (482,284 | ) | 28,717 | |||||||||
| Unrealized (loss) gain on short-term investments | (2,605,184 | ) | 70,275 | (3,312,539 | ) | 212,210 | ||||||||||
| Total other (expense) income – net | (765,765 | ) | 235,850 | 1,740,874 | 1,249,685 | |||||||||||
| Net loss | $ | (13,862,188 | ) | $ | (10,091,496 | ) | $ | (45,828,329 | ) | $ | (37,517,403 | ) | ||||
| Loss per common share – basic and diluted | $ | (0.12 | ) | $ | (0.30 | ) | $ | (0.44 | ) | $ | (1.16 | ) | ||||
| Weighted average number of common shares outstanding – basic and diluted | 112,437,710 | 33,191,622 | 103,745,599 | 32,274,238 | ||||||||||||
7
Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Changes in Stockholders’ Equity
(Unaudited)
| Three and Nine months ended September 30, 2026 | ||||||||||||||||||||
| Common Stock | Additional Paid-in | Accumulated | ||||||||||||||||||
| Shares | Par Value | Capital | Deficit | Total | ||||||||||||||||
| Balance – December 31, 2025 | 73,333,622 | $ | 73,333 | $ | 784,705,878 | $ | (698,267,198 | ) | $ | 86,512,013 | ||||||||||
| Stock based compensation | — | — | 956,186 | — | 956,186 | |||||||||||||||
| Proceeds from issuance of common stock, net | 29,474,569 | 29,475 | 150,352,510 | — | 150,381,985 | |||||||||||||||
| ATM Fees | — | — | (65,651 | ) | — | (65,651 | ) | |||||||||||||
| Cashless exercise of pre-funded warrants for common stock | 2,082,032 | 2,082 | (2,082 | ) | — | — | ||||||||||||||
| Net loss | — | — | — | (19,051,956 | ) | (19,051,956 | ) | |||||||||||||
| Balance – March 31, 2026 | 104,890,223 | 104,890 | 935,946,841 | (717,319,154 | ) | 218,732,577 | ||||||||||||||
| Stock based compensation | — | — | 902,903 | — | 902,903 | |||||||||||||||
| ATM fees | — | — | (66,273 | ) | — | (66,273 | ) | |||||||||||||
| Stock issuance costs | — | — | (199,879 | ) | — | (199,879 | ) | |||||||||||||
| Exercise of pre-funded warrants for common stock | 1,682,500 | 1,683 | — | — | 1,683 | |||||||||||||||
| Options exercised | 97,123 | 97 | 101,400 | — | 101,497 | |||||||||||||||
| Net loss | — | — | — | (12,914,185 | ) | (12,914,185 | ) | |||||||||||||
| Balance – June 30, 2026 | 106,669,846 | 106,670 | 936,684,992 | (730,233,339 | ) | 206,558,323 | ||||||||||||||
| Stock based compensation | — | — | 1,023,176 | — | 1,023,176 | |||||||||||||||
| Options exercised | 25,000 | 25 | 17,725 | — | 17,750 | |||||||||||||||
| Net loss | — | — | — | (13,862,188 | ) | (13,862,188 | ) | |||||||||||||
| Balance – September 30, 2026 | 106,694,846 | $ | 106,695 | $ | 937,725,893 | $ | (744,095,527 | ) | $ | 193,737,061 | ||||||||||
| Three and Nine months ended September 30, 2025 | ||||||||||||||||||||
| Common Stock | Additional Paid-in | Accumulated | ||||||||||||||||||
| Shares | Par Value | Capital | Deficit | Total | ||||||||||||||||
| Balance – December 31, 2024 | 30,174,202 | $ | 30,174 | $ | 676,373,822 | $ | (640,882,035 | ) | $ | 35,521,961 | ||||||||||
| Stock-based compensation | — | — | 3,572,769 | — | 3,572,769 | |||||||||||||||
| Issuance of Restricted Common Stock | 3,017,420 | 3,017 | 902,209 | — | 905,226 | |||||||||||||||
| Net loss | — | — | — | (17,559,465 | ) | (17,559,465 | ) | |||||||||||||
| Balance – March 31, 2025 | 33,191,622 | 33,191 | 680,848,800 | (658,441,500 | ) | 22,440,491 | ||||||||||||||
| Stock-based compensation | — | — | 3,448,453 | — | 3,448,453 | |||||||||||||||
| ATM Expenses | — | — | (73,021 | ) | — | (73,021 | ) | |||||||||||||
| Net loss | — | — | — | (9,866,442 | ) | (9,866,442 | ) | |||||||||||||
| Balance – June 30, 2025 | 33,191,622 | 33,191 | 684,224,232 | (668,307,942 | ) | 15,949,481 | ||||||||||||||
| Stock-based compensation | — | — | 3,607,554 | — | 3,607,554 | |||||||||||||||
| Net loss | — | — | — | (10,091,496 | ) | (10,091,496 | ) | |||||||||||||
| Balance – September 30, 2025 | 33,191,622 | $ | 33,191 | $ | 687,831,786 | $ | (678,399,438 | ) | $ | 9,465,539 | ||||||||||
8
Exhibit 99.2
Unlocking Life Changing Therapies Corporate Overview | November 2026
©2026 Relmada - All rights reserved Disclosures 2 The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This presentation contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "if", "may", "expects", "anticipates", "believes", "will", "will likely result", "will continue", "plans to", "potential", "promising", and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential for Phase 2 NDV-01 data to fail to continue to deliver positive results supporting further development, potential for clinical trials to fail to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of interim or top-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to secure FDA agreement on the regulatory path for sepranolone, and NDV-01, or that future sepranolone, or NDV-01 clinical results will be acceptable to the FDA, failure to secure adequate sepranolone, or NDV-01 drug supply, risks related to the manufacture of NDV-01, including chemistry, manufacturing and controls (CMC) activities and reliance on third-party manufacturers, potential changes to the design of the Phase 3 SPECTRUM program, including as a result of updated clinical practice guidelines or FDA feedback, the Company's cash runway and sufficiency of the Company's cash resources and uncertainties inherent in estimating the Company's cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials, and the other risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein are not a complete list. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
©2026 Relmada - All rights reserved The Promise of NDV-01: Gem/Doce Reimagined TM 3 Novel, patented, sustained release, ready-to-use Gem/Doce co-formulation administered in <5 minutes Strong physician familiarity with conventional Gem/Doce Sustained release for up to 10 days extends local drug exposure Biodegradable matrix without added procedural or tolerability burden Ready-to-use (RTU) product designed for ease of adoption and broad utilization 94% Anytime CR1 77% 12-month landmark CR1 Interim P2 data1 in HR NMIBC build on over a decade of compelling clinical evidence with conventional Gem/Doce FDA aligned Phase 3 program with two independent registrational cohorts 1. Interim results from ongoing phase 2 trial in HR NMIBC through Month 12. CR: Complete response; BCG: Bacillus Calmette-Guérin; BCG-UR: BCG-Unresponsive; NMIBC: Non-muscle invasive bladder cancer; DC: Discontinuations; RTU: Ready to use; DC: Discontinuation; TRAE: Treatment-related adverse event NDV-01 holds the potential to be the best-in-class intravesical treatment across the NMIBC disease spectrum Two Independent Registrational Cohorts 2UC: 2L HR BCG-UR CIS ± Ta/T1 (single arm; N=87) IRA: IR Adjuvant vs. Observation (randomized 1:1; N=276, under review) Exploratory Cohort 2UP: 2L HR BCG-UR Ta/T1 w/o CIS (single arm; N=50) 0% Grade ≥ 3 TR AEs & DCs1 100% Progression Free Survival1 100% Cystectomy Free Survival1
©2026 Relmada - All rights reserved Anticipated Milestones 4 Candidate / Indication Phase 1 Phase 2 Phase 3 Status / Potential Next Steps NDV-011 High-Risk NMIBC (Study TRGC-011) 4Q26: Continued enrollment and long- term follow-up NDV-01 2L HR BCG-Unresponsive CIS ± Ta/T1 (SPECTRUM Cohort 2UC)2 YE26: Submit the NDV-01 IND Upon IND Clearance: Initiate SPECTRUM Phase 3 registrational Cohort 2UC NDV-01 Intermediate-Risk NMIBC Adjuvant (SPECTRUM Cohort IRA) Upon IND Clearance: Initiate SPECTRUM Phase 3 registrational Cohort IRA NDV-01 2L HR BCG-Unresponsive Ta/T1 w/o CIS (SPECTRUM Cohort 2UP)3 Upon IND Clearance: Initiate SPECTRUM Phase 2 exploratory Cohort 2UP Sepranolone Prader-Willi Syndrome (PWS) YE26: Submit the Sepranolone IND Upon IND Clearance: Initiate Phase 2b study 1. NDV-01: A sustained-release intravesical formulation of gemcitabine/docetaxel (Gem/Doce); 2. BCG-Unresponsive patients with CIS +/- Ta/T1 disease; Phase 3 Cohort 2UC is a registrational cohort intended for regulatory approval. 3. BCG-Unresponsive patients with high-grade Ta/T1 disease. Cohort 2UP is an exploratory cohort and not intended for regulatory approval. NMIBC: Non-muscle invasive bladder cancer; BCG: Bacillus Calmette-Guérin; 2L: Second Line. Focused on programs with positive proof-of-concept data Upon IND Clearance Upon IND Clearance Upon IND Clearance Upon IND Clearance
©2026 Relmada - All rights reserved ©2026 Relmada - All rights reserved NDV-01 A novel, sustained-release, intravesical co-formulation of gemcitabine/docetaxel (Gem/Doce) being developed for patients with NMIBC NMIBC: Non-muscle invasive bladder cancer. The graphic is for artistic purposes only, not a factual representation 5
©2026 Relmada - All rights reserved Our Focus: Non-Muscle Invasive Bladder Cancer (NMIBC) 6 Flaig TW, Spiess PE, Abern M, et al. Bladder Cancer, Version 1.2026, NCCN Clinical Practice Guidelines In Oncology. J Natl Compr Canc Netw. 2026;24(5):186-203. doi:10.6004/jnccn.2026.0022 75% of new cases1,2 25% of new cases1,2 Muscle-invasive Non-muscle invasive NMIBC • Papillary tumors: non-invasive projections from the bladder surface • Carcinoma in situ (CIS): flat, aggressive cancer that is often unresectable MIBC • Tumors have invaded bladder muscle with or without lymph node involvement • Tumors may have spread to nearby organs but are not growing into the pelvic or abdominal wall 75% of new cases 25% of new cases
©2026 Relmada - All rights reserved Intravesical Chemotherapy is a Recommended Treatment in Intermediate and High-Risk NMIBC 7 Based on NCCN Guidelines Version 3.2026, FDA product labels; * Intravesical immunotherapy includes gene therapy that causes interferon production; NMIBC: Non-muscle invasive bladder cancer; BCG: Bacillus Calmette Guérin; TURBT: Trans Urethral Resection of Bladder Tumor; CR: Complete Response; RFS: Recurrence Free Survival; 1L: First Line; 2L: Second Line Intravesical Immunotherapy* Cystectomy Unmet Needs • Risk of progression to muscle-invasive and metastatic disease • High morbidity of radical cystectomy • Limited efficacy and durability of bladder-sparing therapies • High treatment burden (tolerability, frequency, duration, procedural) • Complex workflow integration Unmet Needs • High recurrence rate • Repeat TURBTs • Progression to HR disease 4 FDA-approved therapies in 1L after BCG failure, but nothing approved in 2L or later Preferred first option Systemic Immunotherapy ± Intravesical BCG Low Risk Intermediate Risk (~60k/yr including recurrent) High Risk (~25k/yr incident patients) Intravesical Chemotherapy Intravesical Chemotherapy (mitomycin, gemcitabine, sequential gemcitabine/docetaxel) Surveillance ± perioperative chemo Surveillance BCG Unmet Needs • Repeated surveillance
©2026 Relmada - All rights reserved Most Common Intravesical Therapy in BCG-Unresponsive NMIBC Conventional Gem/Doce is Favored by Urologists Despite Operational Challenges 8 Operational Inefficiencies 1. Derived from Urology Times: Survey on Treatment Patterns and Preferences in Non–Muscle Invasive Bladder Cancer, June 2025, based on responses from 42 practicing physicians (Saylor, Benjamin P. "Survey: New NMIBC Treatments Face Slow Uptake." Urology Times, 17 July 2025. NMIBC: Non-muscle invasive bladder cancer; Gem/Doce: Gemcitabine plus Docetaxel Limited Drug Exposure Suboptimal dwell time inside the bladder reduces efficacy Specialized Pharmacy Requires hazardous drug hood and personal protect equipment Academic Concentration Treatment remains largely limited to academic centers meeting prerequisites Specialized pharmacy preparation ~60-120 min dwell time Drain bladder and administer Doce Administer Gemcitabine ~90-120 min dwell time Mitomycin-C Nogapendekin alfa inbakicept Nadofaragene Firadenovec Gem/Doce Gemcitabine 0% 50% HCPs and Patients Choose Gem/Doce
©2026 Relmada - All rights reserved vs. NDV-01 which provides sustained release of Gem/Doce for up to 10 days NDV-01 Addresses Significant Issues with Conventional Gem/Doce 9 NMIBC: Non-muscle invasive bladder cancer; Gem/Doce: Gemcitabine plus Docetaxel vs. <5 minutes in office procedure for NDV-01 vs. NDV-01 comes in prefilled syringes ready to use without need for specialized preparation/storage/handling vs. NDV-01 which provides the opportunity for broad utilization of Gem/Doce across the NMIBC disease spectrum Limited drug exposure and dwell time Up to 4-hour total conventional Gem/Doce procedure time Requires specialized pharmacy preparation Utilization concentrated in academic setting Conventional Gem/Doce Issue NDV-01 Solution
©2026 Relmada - All rights reserved NDV-01: Novel Sustained-Release Intravesical Gem/Doce 10 Hydrophilic Carbomer Gel Instilled into an empty bladder via standard catheter. Forms a scaffold for the NDV-01 Gem/Doce matrix. Hydrophobic NDV-01 Matrix Soft spherical matrix containing Gem/Doce forms within the bladder. The matrix gradually releases the chemotherapy co- formulation into the bladder for up to 10 days. How NDV-01 Works NMIBC: Non-muscle invasive bladder cancer; Gem/Doce: Gemcitabine plus Docetaxel Gel A Gel B Gel B = 15 mL sterile Gem/Doce gel Commercial Target Product Profile Gel A = 60 mL sterile Carbomer gel Ready to Use = no specialized preparation, storage, handling, disposal requirements
©2026 Relmada - All rights reserved WHY IT'S A DURABLE, ATTRACTIVE MARKET Large and recurring ~63,000 new NMIBC patients/yr on top of a ~575–610K prevalent pool; high recurrence means patients cycle through multiple lines of therapies for years. The opportunity is also shifting earlier Novel agents are pushing up the disease sequence into the underserved high- risk BCG-naïve, BCG-exposed "gray zone", and intermediate-risk disease. Premium pricing is established Approved novel agents already command ~$129K–$690K per patient/year, with broad payer coverage and J-codes – the category supports specialty economics. Community-driven, office-based ~80% of NMIBC is managed in community urology – a channel that would welcome a simple, ready-to-use in-office intravesical product over complex modalities, BCG-dependent, or device- / infusion-based regimens. Clinical patterns trending toward bladder-sparing therapy, increasing later-line treatment volumes A Large, Durable NMIBC Market – Opportunity Remains for Potential Best-in-Class Therapy US disease burden funnel A durable, attractive market Patient estimates by risk group do not reflect the 2026 guideline updates that redefine intermediate and high-risk disease for HG Ta tumors. Incidence: 84,530 new US bladder-cancer cases (SEER 2026), ~75% NMIBC (NCCN); Prevalence: 763,031 living with bladder cancer in the US (SEER 2023); NMIBC ~75–80% of that. Risk-tier figures are approximate estimates including 40% HR and 30% IR; BCG-unresponsive is a downstream failure state that includes multiple lines of treatment, not incident diagnosis and includes patients intolerant to BCG. 84,530 ~63,000 ~20K ~25K >25K ~10× incidence Living with NMIBC ~575–610K A durable, recurring prevalent pool 11
©2026 Relmada - All rights reserved 12 Phase 2 Study for High-Risk NMIBC An open-label, single-arm, single-center Phase 2 study (TRGC-011) to evaluate safety and efficacy of NDV-01 in HR NMIBC patients (NCT06663137) HR: High Risk; NMIBC: Non-muscle invasive bladder cancer
©2026 Relmada - All rights reserved Inclusion Criteria Primary Endpoint Secondary Endpoints Study Design 13 ONGOING TRGC-011 STUDY • High-risk NMIBC • BCG-naive, BCG-exposed, and BCG-unresponsive patients • Safety • CR Rate at anytime • CR Rate at 12 months • HG-RFS • PK (exploratory) NMIBC: Non-muscle invasive bladder cancer; CR: Complete Response; DOR: Duration of Response; HG-RFS: High Grade – Recurrence Free Survival; PK: Pharmacokinetics; BCG: Bacillus Calmette- Guérin Long-Term Extension 2-Year Maintenance Monthly instillations N=70 High-risk NMIBC Core Study, 12 Months Induction 6 biweekly instillations Maintenance Monthly instillations Efficacy Assessment • CR = negative cystoscopy and negative urine cytology • Biopsy if indicated • Assessed every 3 months
©2026 Relmada - All rights reserved Demographic Data 14 ONGOING TRGC-011 STUDY Efficacy-evaluable Cohort 1 patients (N=51): treated patients with ≥1 NDV-01 dose(s) post-baseline response assessment. Prior BCG doses among patients with prior BCG. BCG: Bacillus Calmette-Guérin; CIS: Carcinoma In Situ; Ta: Noninvasive papillary carcinoma; T1: Tumor invades lamina propria; HG: High grade Characteristics N=51 % Age Median (range) 72 (52–93) yr Sex Male 43 84.3% Female 8 15.7% BCG doses Median BCG doses (range) 12 (1–18) BCG-status BCG-naive 24 47.1% BCG-exposed 4 7.8% BCG-unresponsive 23 45.1% Stage CIS +/- Ta/T1 16 31.4% Ta HG 29 56.9% T1 HG 6 11.8%
©2026 Relmada - All rights reserved Complete Response (CR) Through 12 Months 15 ONGOING TRGC-011 STUDY n/N % Anytime 48/51 94% 3-month 45/51 88% 6-month 38/46 83% 9-month 33/38 87% 12-month 24/31 77% • 3 of 6 patients re-induced after a 3-month non-CR achieved CR at Month 6 • 100% Progression free survival: No patients progressed to muscle-invasive or metastatic bladder cancer through Month 12 • 100% Cystectomy free survival: No patients underwent a radical cystectomy through Month 12 1. Efficacy-evaluable patients (N=51): treated patients with ≥1 NDV-01 dose(s) post-baseline response assessment. Rates include CRs after re-induction; a missed assessment between two CRs is counted as CR. Data cut 12-Oct-2026; preliminary. CR: Complete response; BCG: Bacillus Calmette-Guérin; BCG-UR: BCG-Unresponsive. Overall Population1 (n=51; CR) n/N % Anytime 22/23 96% 3-month 20/23 87% 6-month 16/21 76% 9-month 13/16 81% 12-month 11/15 73% BCG-UR Subpopulation1 (n=23; CR) • 2 of 3 patients re-induced after a 3-month non-CR achieved CR at Month 6
©2026 Relmada - All rights reserved Extended Durability in 12-Month Complete Responders 16 ONGOING TRGC-011 STUDY n/N % 15-month 15/18 83% 18-month 12/14 86% • 1 patient with 12-month CR did not enter Long Term Extension (LTE) • n = 23 patients in LTE (18 evaluable at Month 15; 14 at Month 18) • 12 of 14 patients (86%) remained in CR at Month 18 • 2 patients progressed to muscle-invasive bladder cancer (T2a) at the Month 15 assessment: – 1 BCG-Naïve (T1) – 1 BCG-Naïve (CIS+T1) • No patients underwent a radical cystectomy through Month 18 1. Patients in CR at the 12-month landmark who continued on study beyond 12 months. Data cut 12-Oct-2026; preliminary. LTE: Long-term extension; CR: Complete Response; BCG-UR: BCG-unresponsive. Overall Population LTE1 (n=23; CR) n/N % 15-month 8/9 89% 18-month 7/8 88% BCG-UR Subpopulation LTE1 (n=11; CR) • n = 11 BCG-UR patients in LTE (9 evaluable at Month 15; 8 at Month 18) • 7 of 8 patients (88%) remained in CR at Month 18
©2026 Relmada - All rights reserved Treatment-Related AEs and Tolerability 17 ONGOING TRGC-011 STUDY 35 of 51 patients (69%) had a TRAE No ≥ Grade 3 TRAEs and no treatment-related SAEs No patients discontinued due to TRAEs • 55% transient uncomfortable urination (dysuria) • 22% hematuria • 16% urinary urgency / frequency TRAE: Treatment-related (related or possibly related) adverse event; AE: Adverse event; SAE: Serious adverse event. Cohort 1 efficacy-evaluable patients (N=51); preliminary.
©2026 Relmada - All rights reserved 18
©2026 Relmada - All rights reserved SPECTRUM Phase 3 Program Built on Two Independent FDA Registrational Pathways 19 PHASE 3 SPECTRUM TRIAL NMIBC: non-muscle invasive bladder cancer; BCG: Bacillus Calmette-Guérin; BCG-UR: BCG-unresponsive; CIS: carcinoma in situ; HR: high risk; IR: intermediate risk; 1L: first-line; 2L: second-line Registrational cohorts Each designed to independently support potential FDA regulatory approvals Planned exploratory cohort Evidence generation; not for registration 2UC N=87 High Risk Second-line (2L) BCG-Unresponsive CIS ± Ta/T1 Single arm IRA N=276 (under review) Intermediate Risk Adjuvant versus Observation Randomized 1:1 2UP N=50 2L HR BCG-UR Ta/T1 w/o CIS (papillary only) Single arm
©2026 Relmada - All rights reserved Inclusion Criteria Primary Endpoint Key Secondary Endpoints Cohorts 2UC/2UP: 2L BCG-Unresponsive NMIBC 20 PHASE 3 SPECTRUM TRIAL • HR BCG-UR NMIBC with CIS ± Ta/T1 • Failed one or two lines of 1L BCG-UR therapy • CR rate at anytime (2UC) • HG-RFS (2UP) • Safety • 12-Month DOR • PFS • HG-RFS • CFS • QOL • PK (exploratory) 1. BCG-Unresponsive patients with CIS +/- Ta/T1 disease; Phase 3 Cohort 2UC is a registrational cohort intended for regulatory approval. 2. BCG-Unresponsive patients with high-grade Ta/T1 disease. Cohort 2UP is an exploratory cohort and not intended for regulatory approval. NMIBC: Non-muscle invasive bladder cancer; BCG: Bacillus Calmette-Guérin; 2L: Second Line Registrational cohort designed to support potential FDA approval. CIS: carcinoma in situ; HR: high risk; BCG-UR: BCG-unresponsive; CR: complete response; DOR: duration of response; PFS: progression-free survival; RFS: recurrence-free survival; PK: pharmacokinetics. 2-Year Maintenance Monthly instillations 5-Year Follow-Up N=871 2L BCG-UR CIS ± Ta/T1 Core Study, 12 Months Induction / Re-induction 6 biweekly instillations Maintenance Monthly instillations Registrational open-label, single-arm trial Efficacy Assessment • CR = negative cystoscopy and negative urine cytology • Biopsy if indicated • Assessed every 3 months N=502 2L BCG-UR Ta/T1 (Papillary Only)
©2026 Relmada - All rights reserved Inclusion Criteria Primary Endpoint Key Secondary Endpoints Cohort IRA: Adjuvant Intermediate-Risk NMIBC 21 PHASE 3 SPECTRUM TRIAL • IR NMIBC (no high-grade) • ≥1 IBCG risk factor • TURBT within 12 weeks (± single-dose peri-operative chemotherapy) • DFS* • Safety • HG-RFS • PFS • QOL *DFS = time from randomization to the first documented recurrence or progression. Sample size under review. DFS: disease-free survival; HG-RFS: high-grade recurrence-free survival; IBCG: International Bladder Cancer Group; IR: intermediate risk; PFS: progression-free survival; QOL: quality of life; TURBT: transurethral resection of bladder tumor 5-Year Follow-Up N=276 (under review) Adjuvant IR NMIBC TURBT + NDV-01 Induction + monthly maintenance (1-year) TURBT + Observation NDV-01 cross-over option Stratification • 1-2 vs 3+ IBCG risk factors • Single-dose peri-operative chemotherapy (yes vs. no) Registrational Randomized (1:1) Trial – TURBT + NDV-01 vs. TURBT + Observation
©2026 Relmada - All rights reserved On Track to Submit NDV-01 IND by Year-End 2026 and Initiate Phase 3 SPECTRUM Upon IND Clearance 22 PHASE 3 SPECTRUM TRIAL Initiate Phase 3 SPECTRUM Program Two independent registrational pathways: • 2L BCG-Unresponsive NMIBC patients • Adjuvant Intermediate-Risk NMIBC patients YE26 Upon IND Clearance BCG: Bacillus Calmette-Guérin (BCG); NMIBC: Non-muscle invasive bladder cancer; NDV-01 United States IND Submission
©2026 Relmada - All rights reserved ©2026 Relmada - All rights reserved NDV-01 Market Opportunity 23
©2026 Relmada - All rights reserved SPECTRUM Registrational + Potential Lifecycle Expansion Opportunity 24 1. Based on Internal estimates.* Includes recurrent patients. 0 50,000 100,000 150,000 Number of US Patients/yr ~12k 2L+ BCG-UR ~60k Intermediate Risk* ~80k Potential Lifecycle Expansion Opportunity ~150k+ Total1 SPECTRUM 2UC/2UP + IRA Cohorts Potential lifecycle expansion
©2026 Relmada - All rights reserved ©2026 Relmada - All rights reserved Sepranolone A novel GAMSA, with potential to overcome the challenges of current therapies for compulsivity disorders 25 GAMSA: a GABA-A modulating steroid antagonist. The graphic is for artistic purposes only, not a factual representation
©2026 Relmada - All rights reserved Sepranolone Has the Potential to Normalize GABAA Receptor Activity 26 GABA (Υ-aminobutyric acid) is the primary neurotransmitter, involved in anxiety and compulsive disorders1,2 Allopregnanolone (ALLO) typically enhances GABAA calming effects3, 4 In some individuals, ALLO exacerbates anxiety and compulsivity5, 6 Sepranolone normalizes GABAA receptor activity without interfering in GABA signaling7,8 1. Nuss P et al. Neuropsychiatr Dis Treat. 2015. 2. Möhler H. Neuropharmacology. 2012. 3. Belelli D et al. Nat Rev Neurosci. 2005. 4. Majewska MD et al. Science. 1986. 5. Girdler SS et al. Biol Psychiatry. 2001. 6. Bixo M et al. Br J Psychiatry. 2025. 7. Bixo M et al. Psychoneuroendocrinology. 2017. 8. Bäckström T et al. Psychoneuroendocrinology. 2021. GABAA: Υ-aminobutyric acid type A; ALLO: Allopregnanolone
©2026 Relmada - All rights reserved Sepranolone: Highlights & Development Value 27 Differentiated therapeutic candidate for compulsivity-related disorders, supported by positive proof-of-concept data in Tourette's syndrome Phase 2b study in Prader-Willi syndrome (PWS) – a rare genetic disorder affecting 350,000–400,000 individuals worldwide – planned pending IND clearance Program readiness: Regulatory engagement and manufacturing operations are actively underway, supporting efficient trial initiation Orphan/rare disease incentives: Potential for orphan drug designation, including regulatory exclusivity, accelerated approval pathways, and enhanced commercial positioning Strategic investor value: Clear development milestones, potential for first- in-class differentiation, and meaningful opportunity in a high-unmet-need rare disease
©2026 Relmada - All rights reserved On Track to Submit Sepranolone IND by Year-End 2026 and Initiate Phase 2b Trial in PWS Upon IND Clearance 28 Initiation of Phase 2b study in Prader-Willi Syndrome Focus on evaluating early proof-of-concept YE26 Upon IND Clearance PWS: Prader-Willi syndrome Sepranolone United States IND Submission
©2026 Relmada - All rights reserved ©2026 Relmada - All rights reserved Corporate Summary 29
©2026 Relmada - All rights reserved Financial Overview 30 $202.1 million1 ~106.7 million1 1. As of September 30, 2026; ~127.9M as converted – includes ~14.9M outstanding options (weighted average exercise price of $12.58/share) and ~6.3M outstanding warrants Common shares outstanding Cash, cash equivalents & short-term investments As of September 30, 2026
Thank You!