Relmada (NASDAQ: RLMD) narrows 2025 loss, funds NDV-01 Phase 3 push
Rhea-AI Filing Summary
Relmada Therapeutics reported audited 2025 results and a major strategic shift toward oncology, led by NDV-01 for non-muscle invasive bladder cancer. For 2025, the company recorded a net loss of $57.4 million, an improvement from $80.0 million in 2024, as total operating expenses fell to $59.1 million from $83.9 million. Research and development spending declined to $26.9 million and general and administrative costs to $32.2 million.
Total assets rose to $94.0 million as of December 31, 2025, driven by cash and short-term investments of about $94.0 million and common shares outstanding increasing to 73.3 million. A separate $160 million PIPE financing and the year-end balance sheet underpin management’s view that cash resources should fund operations through 2029.
Clinically, 12‑month Phase 2a data for NDV‑01 showed high complete response rates in high‑risk NMIBC, including a 3‑month complete response in 95% of evaluable patients and 76% at 12 months, with no Grade 3 or higher treatment‑related adverse events and no treatment‑related discontinuations. The FDA has agreed to two registrational pathways for NDV‑01, and Relmada plans to start the Phase 3 RESCUE program and a Phase 2b trial of sepranolone in Prader‑Willi syndrome in mid‑2026.
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Insights
Relmada de-risks its lead asset and extends cash runway while remaining loss-making.
Relmada Therapeutics narrowed its annual net loss to $57.4M from $80.0M as operating expenses fell to $59.1M. Research and development dropped sharply, reflecting a more focused pipeline centered on NDV‑01 and sepranolone rather than broad program spending.
Year-end assets increased to $94.0M, backed by cash and short-term investments around that level, and a separate $160M PIPE financing is highlighted as supporting cash runway through 2029. This improves funding visibility for the planned Phase 3 RESCUE trials and the Phase 2b Prader‑Willi study, though dilution is the trade-off.
Clinically, NDV‑01’s Phase 2a data in high‑risk NMIBC show strong 3‑ and 12‑month complete response rates with no ≥ Grade 3 treatment‑related adverse events and no treatment‑related discontinuations. FDA alignment on two registrational pathways reduces regulatory uncertainty, but actual approval will hinge on Phase 3 RESCUE outcomes and the ability to replicate durability and safety at larger scale.
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FORM
CURRENT REPORT
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Item 2.02 Results of Operations and Financial Condition.
On March 19, 2026, Relmada Therapeutics, Inc. (the “Company”) issued a press release providing a corporate update and reporting its financial results for the fiscal year ended December 31, 2025. The Company also announced that it would conduct a conference call and audio webcast on Thursday, March 19, 2026, at 4:30 PM EST / 1:30 PM PST, to discuss the update and results. The Company’s complete audited financial statements and notes thereto as of, and for the years ended, December 31, 2025 and 2024, will be contained in its Annual Report on Form 10-K 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 March 19, 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 March 19, 2026, regarding corporate update and full year 2025 financial results | |
| 99.2* | Corporate Presentation dated March 19, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
| * | Furnished herewith |
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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: March 19, 2026 | RELMADA THERAPEUTICS, INC. | |
| By: | /s/ Sergio Traversa | |
| Name: | Sergio Traversa | |
| Title: | Chief Executive Officer | |
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Exhibit 99.1
Relmada Therapeutics Reports Fourth Quarter and Full Year 2025 Results and Provides Business Update
| ● | Positive 12-month Phase 2 data for NDV-01 in non-muscle invasive bladder cancer (NMIBC) demonstrated a 95% complete response (CR) rate at any time and a durable 76% CR rate at 12 months, with favorable safety profile |
| ● | Completed an oversubscribed $160 million PIPE financing led by leading healthcare investors in March 2026, strengthens balance sheet to support NDV-01 Phase 3 development |
| ● | On track to initiate Phase 3 RESCUE registrational program in second line (2L) BCG-unresponsive and adjuvant intermediate-risk NMIBC in mid-2026 |
| ● | Cash balance of $93.0 million as of December 31, 2025, plus gross proceeds of $160 million from March 2026 PIPE expected to fund operations through 2029, including completion of the NDV-01 RESCUE program |
| ● | Management to host a conference call and webcast today at 4:30 PM ET |
CORAL GABLES, FL – March 19, 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 audited financial results for the fourth quarter and full year ended December 31, 2025 and provided a corporate update highlighting significant progress across its pipeline.
“This has truly been a transformational year for Relmada, marked by significant progress with our lead program NDV-01”, said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics. “Our recently reported 12-month data for NDV-01 demonstrated durable complete responses with a favorable safety profile, reinforcing the program’s potential to become a best-in-class therapy for patients with non-muscle invasive bladder cancer. With a successful $160M PIPE financing and regulatory alignment with the FDA on two registrational pathways, we believe that we are well positioned to advance NDV-01 into the Phase 3 RESCUE program in mid-2026. Our team is now focused on executing this plan and initiating the RESCUE registrational program as we work to bring NDV-01 to patients as efficiently as possible.”
“NDV-01’s compelling efficacy, durability, and favorable safety profile, combined with operational ease-of-use are the cornerstone of its differentiated product profile and best-in-class potential” said Raj S. Pruthi, MD, Chief Medical Officer-Oncology of Relmada Therapeutics. “We continue to be encouraged by the high response rates and durable clinical benefit observed through 12 months, including in the BCG-unresponsive population, alongside a favorable safety profile with no ≥ Grade 3 treatment-related adverse events and no treatment-related discontinuations. Our clinical program builds on the urologic oncology community’s comfort with conventional Gem/Doce’s efficacy and safety profile with a sustained release product that could provide physicians and patients with a streamlined, less than 5-minute in-office procedure. These results reinforce our confidence as we advance NDV-01 into the Phase 3 RESCUE registrational program in mid-2026.”
Highlights of the 12-month follow-up data from the ongoing Phase 2 study of NDV-01:
In the 12-month follow-up of the Phase 2a study (March 9, 2026 Company press release) treatment with NDV-01 produced:
| ● | Durable 76% complete response (CR) rate at 12 months with 95% CR rate at any time in high-risk NMIBC |
| ● | BCG-unresponsive patients achieved an 80% CR rate at 12 months and 94% CR rate at any time |
| ● | No patient had progression to muscle-invasive disease, and no patient underwent a radical cystectomy |
| ● | Favorable overall tolerability – no ≥ Grade 3 treatment-related adverse events and no treatment-related discontinuations or dose interruptions. |
Phase 3 RESCUE Registrational Pathways:
As previously disclosed in the Company’s January 12, 2026 regulatory update, Relmada has received written feedback from the U.S. Food and Drug Administration (FDA) confirming alignment on two registrational development pathways for NDV-01, including study design, patient populations and primary endpoints.
Registrational Pathway 1 – An open label randomized controlled trial in intermediate-risk NMIBC of adjuvant therapy following TURBT (NDV-01 vs. observation). There are no approved treatments for adjuvant intermediate risk NMIBC, which we estimate affect ~75,000 patients/year in the US. The primary endpoint of the study is disease free survival (DFS).
Registration Pathway 2 – A single-arm trial in second line (2L) BCG-unresponsive NMIBC with carcinoma in situ (CIS) patients who are currently refractory to approved or developmental therapies. Patients with BCG-unresponsive NMIBC with CIS who fail first line (1L) therapies, which we estimate to affect ~5,000 patients/year in the US, have few, if any, effective treatment alternatives to radical cystectomy. The primary endpoint of the study is complete response (CR) rate at any time.
Expected Upcoming Relmada Milestones:
| ● | NDV-01 United States IND clearance – Mid-2026 |
| ● | NDV-01 Phase 3 RESCUE Program initiation – Mid-2026 |
| ● | Sepranolone Phase 2 initiation in Prader-Willi syndrome – Mid-2026 |
| ● | Initial 3-month NDV-01 data from Phase 3 2L BCG-unresponsive study expected by YE 2026 |
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Financial Results
Fourth Quarter 2025 Financial Results
| ● | Research and development expense for the three months ended December 31, 2025, totaled $8.1 million, compared to $11.0 million for the three months ended December 31, 2024, a decrease of $2.9 million. The decrease was primarily driven by a decrease in study costs associated with the completion of two Phase 3 trials for REL-1017, partially offset by increased costs related to the start-up the Phase 3 NDV-01 trials and Phase 2b sepranolone study and additional R&D personnel. |
| ● | General and administrative expense for the three months ended December 31, 2025, totaled $12.3 million compared to $8.1 million for the three months ended December 31, 2024, an increase of approximately $4.2 million. The increase was primarily driven by an increase in compensation costs partially offset by a decrease in stock based compensation costs. |
| ● | Net cash used in operating activities for the three months ended December 31, 2025, totaled $14.6 million compared to $8.8 million for the three months ended December 31, 2024. |
| ● | The net loss for the three months ended December 31, 2025, was $19.9 million, or $0.27 per basic and diluted share, compared with a net loss of $18.6 million, or $0.62 per basic and diluted share, for the three months ended December 31, 2024. |
Twelve Month Ended December 31, 2025 Financial Results
| ● | Research and development (R&D) expense for the 12 months ended December 31, 2025, totaled $26.9 million, compared to $46.2 million for the 12 months ended December 31, 2024, a decrease of $19.3 million. The decrease was primarily driven by a decrease in study costs associated with completion and conclusion of two Phase 3 trials for REL-1017, partially offset by increased costs related to the acquisition of NDV-01 and sepranolone, as well as the start-up of the Phase 3 NDV-01 trials and Phase 2b sepranolone study. |
| ● | General and administrative (G&A) expense for the 12 months ended December 31, 2025, totaled $32.2 million compared to $37.7 million for the 12 months ended December 31, 2024, a decrease of approximately $5.5 million. The decrease was primarily driven by a decrease in stock-based compensation expense and lower professional fees, partially offset by an increase in personnel-related costs. |
| ● | Net cash used in operating activities for the 12 months ended December 31, 2025, totaled $45.8 million compared to $51.8 million for the 12 months ended December 31, 2024. |
| ● | The net loss for the 12 months ended December 31, 2025, was $57.4 million, or $1.45 per basic and diluted share, compared with a net loss of $80.0 million, or $2.65 per basic and diluted share, for the 12 months ended December 31, 2024. |
| ● | The Company’s cash balance of $93.0 million in cash, cash equivalents, and short-term investments, includes net proceeds of approximately $94 million from an underwritten stock offering announced November 5, 2025. This compares to cash, cash equivalents, and short-term investments of approximately $44.9 million at December 31, 2024. |
| ● | On March 9, 2026, the Company announced a private financing with gross proceeds of $160 million. This financing, along with the cash, cash equivalents, and short-term investments as of December 31, 2025, is expected to provide sufficient resources to fund Company operations through 2029, including completion of the Phase 3 NDV-01 RESCUE program. |
| ● | The Company had 104,890,223 shares outstanding, as of March 16, 2026 |
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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.
Conference Call and Webcast Information:
| ● | Date: Thursday, March 19, 2026 at 4:30 PM ET |
| ● | Participant Dial-in (US): 1-877-407-0792 |
| ● | Participant Dial-in (International): 1-201-689-8263 |
| ● | Webcast Access: Click Here |
A replay of the webcast will be available in the Investors section of the Relmada website at https://www.relmada.com/investors/ir-calendar.
About NDV-01
NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. The NDV-01 formulation is ready to use, convenient to administer in-office in less than 5 minutes and does not require anesthesia or specialized equipment. It is protected by patents through 2038.
About the Phase 2 Study
The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with high-grade non-muscle invasive bladder cancer (HG-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 (CRR) at 12 months, and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS).
About NMIBC
NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence (50 – 80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. High-grade BCG-unresponsive disease represents one of the most difficult-to-treat NMIBC subtypes, with limited bladder-sparing options. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.
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, Tourette syndrome, and Obsessive-Compulsive Disorder (OCD). More than 335 patients have been treated with sepranolone in clinical trials to date, with an excellent safety profile.
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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 mid-stage clinical development with the potential to address significant unmet needs.
For more information, visit www.relmada.com
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 progress, including the potential for Phase 2 NDV-01 data to continue to deliver positive results supporting further development, potential for clinical trials 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, or that future NDV-01 and/or sepranolone clinical results will be acceptable to the FDA, failure to secure adequate NDV-01 and/or sepranolone drug supply, 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
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Relmada Therapeutics, Inc.
Condensed Consolidated Balance Sheets (Audited)
| As of | As of | |||||||
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,496,540 | $ | 3,857,026 | ||||
| Short-term investments | 89,509,710 | 41,052,356 | ||||||
| Prepaid expenses | 977,721 | 886,461 | ||||||
| Total current assets | 93,983,971 | 45,795,843 | ||||||
| Other assets | 19,500 | 21,975 | ||||||
| Total assets | $ | 94,003,471 | $ | 45,817,818 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,568,944 | $ | 4,130,563 | ||||
| Accrued expenses | 4,861,583 | 6,160,827 | ||||||
| Total current liabilities | 6,430,527 | 10,291,390 | ||||||
| Stock appreciation rights | 1,060,931 | 4,467 | ||||||
| Total liabilities | 7,491,458 | 10,295,857 | ||||||
| Commitments and Contingencies (Note 10) | ||||||||
| 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, 150,000,000 shares authorized, 73,333,622 and 30,174,202 shares issued and outstanding, respectively | 73,333 | 30,174 | ||||||
| Additional paid-in capital | 784,705,878 | 676,373,822 | ||||||
| Accumulated deficit | (698,267,198 | ) | (640,882,035 | ) | ||||
| Total stockholders’ equity | 86,512,013 | 35,521,961 | ||||||
| Total liabilities and stockholders’ equity | $ | 94,003,471 | $ | 45,817,818 | ||||
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Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Audited)
| 2025 | 2024 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 26,879,146 | $ | 46,175,512 | ||||
| General and administrative | 32,221,054 | 37,715,524 | ||||||
| Total operating expenses | 59,100,200 | 83,891,036 | ||||||
| Loss from operations | (59,100,200 | ) | (83,891,036 | ) | ||||
| Other income (expenses): | ||||||||
| Interest/investment income, net | 1,395,989 | 3,530,021 | ||||||
| Realized (loss) gain on short-term investments | (79,207 | ) | 374,926 | |||||
| Unrealized gain on short-term investments | 398,255 | 6,735 | ||||||
| Total other income (expenses), net | 1,715,037 | 3,911,682 | ||||||
| Net loss | $ | (57,385,163 | ) | $ | (79,979,354 | ) | ||
| Net loss per common share – basic and diluted | $ | (1.45 | ) | $ | (2.65 | ) | ||
| Weighted average number of common shares outstanding – basic and diluted | 39,479,694 | 30,163,751 | ||||||
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Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(Audited)
| Common Stock | Additional Paid-in | Accumulated | ||||||||||||||||||
| Balance – December 31, 2023 | 30,099,203 | $ | 30,099 | $ | 646,229,824 | $ | (560,902,681 | ) | $ | 85,357,242 | ||||||||||
| Stock-based compensation expense | - | - | 30,184,414 | - | 30,184,414 | |||||||||||||||
| Net proceeds from cash exercise option | 74,999 | 75 | 246,672 | - | 246,747 | |||||||||||||||
| ATM fees | - | - | (287,088 | ) | - | (287,088 | ) | |||||||||||||
| Net loss | - | - | - | (79,979,354 | ) | (79,979,354 | ) | |||||||||||||
| Balance – December 31, 2024 | 30,174,202 | 30,174 | 676,373,822 | (640,882,035 | ) | 35,521,961 | ||||||||||||||
| Stock-based compensation expense | - | - | 13,905,181 | - | 13,905,181 | |||||||||||||||
| Issuance of restricted common stock | 3,017,420 | 3,017 | 902,209 | - | 905,226 | |||||||||||||||
| Net proceeds from cash exercise options | 40,142,000 | 40,142 | 93,597,687 | - | 93,637,829 | |||||||||||||||
| ATM fees | - | - | (73,021 | ) | - | (73,021 | ) | |||||||||||||
| Net loss | - | - | - | (57,385,163 | ) | (57,385,163 | ) | |||||||||||||
| Balance – December 31, 2025 | 73,333,622 | $ | 73,333 | $ | 784,705,878 | $ | (698,267,198 | ) | $ | 86,512,013 | ||||||||||
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Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows (Audited)
| 2025 | 2024 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (57,385,163 | ) | $ | (79,979,354 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 13,905,181 | 30,184,414 | ||||||
| Stock appreciation rights compensation | 1,056,464 | 4,467 | ||||||
| Issuance of restricted common stock | 905,226 | - | ||||||
| Realized (gain) loss on short-term investments | 79,207 | (374,926 | ) | |||||
| Unrealized gain on short-term investments | (398,255 | ) | (6,735 | ) | ||||
| Change in operating assets and liabilities: | ||||||||
| Prepaid expenses and other assets | (88,785 | ) | 319,746 | |||||
| Accounts payable | (2,561,619 | ) | 624,554 | |||||
| Accrued expenses | (1,299,244 | ) | (2,527,964 | ) | ||||
| Net cash used in operating activities | (45,786,988 | ) | (51,755,798 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of short-term investments | (83,828,576 | ) | (12,079,628 | ) | ||||
| Sale of short-term investments | 35,690,270 | 63,641,225 | ||||||
| Net cash (used in)/provided by investing activities | (48,138,306 | ) | 51,561,597 | |||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of common stock, net | 93,637,829 | - | ||||||
| Payment of ATM fees | (73,021 | ) | (287,088 | ) | ||||
| Proceeds from options exercised for common stock | - | 246,747 | ||||||
| Net cash provided by/(used in) financing activities | 93,564,808 | (40,341 | ) | |||||
| Net decrease in cash and cash equivalents | (360,486 | ) | (234,542 | ) | ||||
| Cash and cash equivalents at beginning of the year | 3,857,026 | 4,091,568 | ||||||
| Cash and cash equivalents at end of the year | $ | 3,496,540 | $ | 3,857,026 | ||||
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Exhibit 99.2
Exhibit 99.2 C O R P O R A T E O V E R V I E W Unlocking Life Changing Therapies March 2026
Disclosures 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 Phase 2 NDV - 01 data to continue to deliver positive results supporting further development, potential for clinical trials 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, 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 should not be 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 2
Investment Thesis Innovative pipeline of potential high - value assets , led by NDV - 01 for non - muscle invasive bladder cancer (NMIBC) NDV - 01, a late - stage sustained - release Gem/Doce with attractive commercial profile and well - defined regulatory pathway Improvement vs. conventional Gem/Doce , positioning NDV - 01 as a next - generation standard - of - care driven by ease and speed of administration, extended tumor exposure and physician familiarity Proven efficacy of conventional Gem/Doce supported by positive clinical response and tolerability profile for NDV - 01 reduce mechanistic and regulatory risk Experienced leadership team supported by leading urology KOLs with direct NMIBC trial and practice experience ©2026 Relmada - All rights reserved 3
Innovative Pipeline of Potential High - Value Assets Focused on programs with positive proof - of - concept data Candidate / Indication Phase 1 Phase 2 Phase 3 Status / Potential Next Steps NDV - 01 1 High - Risk NMIBC (Study TRCG - 001) 2026 : Present data at upcoming medical meetings, continue enrollment NDV - 01 Mid - 2026 : Initiate RESCUE Phase 3 registrational Cohort 1 Intermediate - Risk NMIBC (RESCUE Cohort 1) MID - 2026 NDV - 01 2L BCG - Unresponsive (RESCUE Cohort 2A) 2 Mid - 2026 : Initiate RESCUE Phase 3 registrational Cohort 2A MID - 2026 NDV - 01 2L BCG - Unresponsive (RESCUE Cohort 2B) 3 Mid - 2026: Initiate RESCUE Phase 2 exploratory Cohort 2B MID - 2026 Sepranolone Prader - Willi Syndrome (PWS) Mid - 2026 : Initiate Phase 2b study 2026/27 : Identify next Indication 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 2A is a registrational cohort intended for regulatory approval. 3. BCG - Unresponsive patients with high - grade Ta/T1 disease. Cohort 2B is an exploratory cohort and not intended for regulatory approval. NMIBC: Non - muscle invasive bladder cancer; BCG: Bacillus Calmette - Guérin; 2L: Second Line ©2026 Relmada - All rights reserved 4
NDV - 01 A sustained - release intravesical formulation of gemcitabine/docetaxel (Gem/Doce) for patients with NMIBC, with positive Phase 2a data 1 1. Relmada press release March 9, 2025 NMIBC: Non - muscle invasive bladder cancer. The graphic is for artistic purposes only, not a factual representation ©2026 Relmada - All rights reserved 5
Our Focus: Non - Muscle Invasive Bladder Cancer (NMIBC) 80% 20% of new cases 1,2 of new cases 1,2 Non - muscle invasive Muscle - invasive NMIBC MIBC • Tumors have invaded bladder muscle with or • Papillary tumors: non - invasive without lymph node involvement projections from the bladder surface • Tumors may have spread to nearby organs but are • Carcinoma in situ (CIS): flat, aggressive not growing into the pelvic or abdominal wall cancer that is often unresectable 1. Shih K et al. Aging Dis. 2021. 2. Aldousari S et al. Can Urol Assoc J. 2013. ©2026 Relmada - All rights reserved 6
NMIBC Represents Multi - Billion Dollar Market Opportunity US prevalence of Bladder Cancer 1 (Overall Bladder Cancer ) New bladder cancer cases 2 71 - 97% 5 - year overall survival, 8% with advanced disease 3 ~744,000 ~85,000 Key Highlights High incidence 1 4.2% of all new cancer cases in the US High recurrence 5 ~30% - 61% of high - risk patients recur within one year. ~ 68,000 ~ 54,400 Multiple treatment courses High cost NMIBC cancer cases (80% of bladder cancers) 4,6,8,9 50 - 80% recurrence rate (over five years) 5 Intermediate - risk and high - risk have increased risk of recurrence and progression (Intermediate - risk represents 45% 6, 7 and high - risk represents 35% 7 of NMIBC cases) Complex treatment pathways $6.5B total annual cost (U.S.) 10 1. National Cancer Institute (SEER). Cancer Stat Facts: Bladder Cancer. 2. American Cancer Society. Key Statistics for Bladder Cancer. 3. National Cancer Institute. Bladder Cancer Survival Data. 4. American Urological Association / SUO. NMIBC Guidelines (2024 Amendment). 5. Białek et al. EORTC Bladder Cancer Recurrence Calculator. 2024. 6. Seo et al. J Prev Med Public Health. 2018. 7. Nielsen et al. Cancer. 2013. 8. Shih K et al. Aging Dis. 2021. 9. Aldousari et al. Can Urol Assoc J. 2013. 10. Clark O et al. Pharmacoecon Open. 2024. NMIBC: Non - muscle invasive bladder cancer ©2026 Relmada - All rights reserved 7
NMIBC Patient Journey (*) Initial NDV - 01 Registrational Pathways Risked - Based Therapies 4 Adjuvant therapy (chemotherapy, immunotherapy, systemic therapy) based on patients risk category. Symptoms 1 Patient presents to Low - Risk Intermediate - Risk High - Risk BCG - Unresponsive physician; most common presenting symptom is hematuria (blood in urine). Perioperative Chemotherapy Perioperative Chemotherapy Perioperative Chemotherapy Perioperative Chemotherapy Initial Testing Intravesical BCG Immunotherapy, Intravesical Chemotherapy, and Intravesical 2 3 Chemotherapy/BCG * Urologist performs cystoscopy and urine cytology. Systemic Therapies Ongoing Surveillance 5 TURBT Regular cystoscopy and urine cytology (up to every 3 months) to monitor for recurrence/progression. TURBT to stage, risk - stratify, and treat disease. Disease Recurrence Potential 2L NDV - 01 Usage * Based on AUA/SUO Practice Guidelines, 2024 (Event April 28, 2025 (Holzbeierlein et al. (“Diagnosis and Treatment of Non - Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment”). NMIBC: Non - muscle invasive bladder cancer; BCG: Bacillus Calmette Guérin; TURBT: Trans Urethral Resection of Bladder Tumor; 2L: Second - line ©2026 Relmada - All rights reserved 8
Overview of NMIBC Treatment Landscape Approved and emerging treatments TURBT Surgery Intravesical Chemotherapy Gene Therapy/ Immunotherapy Systemic Therapy Complications (>15%) 1 Emerging dataset Risk of recurrence (50 - 80%) 2 Supply issues Risk of recurrence OR procedure under anesthesia Conventional Chemotherapies : mitomycin, gemcitabine, Gem/Doce Risk of immune - mediated or systemic side effects Complex handling requirements Patient burden Sustained - Release : NDV - 01 (Gem/Doce), INLEXZO (gemcitabine), ZUSDURI (mitomycin) KEYTRUDA® (anti - PD1), Sasanlimab (anti - PD1), TYRA - 300 (oral FGFR3) BCG, Adstiladrin®, Anktiva®, Cretostimogene, TARA - 002, EG - 70, TAR - 210 (FGFR inhibitor) Relmada internal market research, 2025. 1. Pycha A et al. Urology. 2003. 2. Białek, Ł. (2024, August 1). EORTC Bladder Cancer Recurrence and Progression Calculator . Omni Calculator. NMIBC: Non - muscle invasive bladder cancer; TURBT: Transurethral resection of bladder tumor; BCG: Bacillus Calmette - Guérin ©2026 Relmada - All rights reserved 9
The Burden of Recurrences and TURBT is High Frequent recurrences for IR NMIBC patients: ~ 1 recurrence / year 1 Recurrences typically require TURBT Invasive OR procedure with anesthesia • Complication rate > 15% 2 • 5 - year risk of initial recurrence: 54.4%. After initial recurrence 60.1% of patients had a second recurrence by 2 years • Grade 3/4 complication rate = 9.4% 3 • Readmission rate = 5% 4 • Procedural Cost = $7,000 - $10,000 5, 7 • Worsening mental health, physical health and lower urinary tract symptom scores 6 • After 2nd recurrence, 51.5% of patients had a 3rd recurrence by 3 years Increased risk of progression with more recurrences 1 • The 5 - year risk of progression: 9.5%, 21.9%, and 37.9% for patients with 1, 2, and 3+ recurrences, respectively 1. Sharma V et al. Urology. 2023. 2 . Pycha A et al. Urology. 2003. 3. Bansal A et al. Indian J Urol. 2016. 4. Jindal T et al. Curr Urol. 2023. 5. MediGence TURBT cost data. 6. Lee LJ et al. Clinicoecon Outcomes Res. 2020. 7. Kokkotos F et al. J Clin Oncol. 2022 ©2026 Relmada - All rights reserved 10
Gem/Doce Combination Stands Out in Urology Times Survey 1 What is your preferred treatment for patients with BCG - unresponsive NMIBC? When selecting intravesical therapy after BCG - unresponsive NMIBC, which agent do you most commonly use? Gemcitabine plus docetaxel (Gem/Doce) Intravesical chemotherapy Nadofaragene firadenovec (ADSTILADRIN®) Gemcitabine Nadofaragene Firadenovec (ADSTILADRIN®) Clinical trial Pembrolizumab (KEYTRUDA®) Mitomycin - C Nogapendekin alfa inbakicept (ANKTIVA®) Nogapendekin alfa inbakicept (ANKTIVA®) 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% 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. ©2026 Relmada - All rights reserved 11
Significant Issues with Conventional Gem/Doce Intravesical Therapy for NMIBC Preparation by specialized pharmacy First administration 4 - hour total procedure time vs. <5 minutes for NDV - 01 Requires specialized pharmacy preparation vs. NDV - 01 comes ready for use in two pre - filled plastic syringes ~60 - 120 min dwell time 30 min break vs. NDV - 01 which provides the opportunity for community urologist to deliver Gem/Doce Utilization concentrated in academic setting Second administration ~90 - 120 min dwell time vs. NDV - 01 which provides sustained release of Gem/Doce for up to 10 days Limited drug exposure and dwell time NMIBC : Non - muscle invasive bladder cancer; Gem/Doce : Gemcitabine plus Docetaxel 12 ©2026 Relmada - All rights reserved
NDV - 01 - Targeted Sustained - Release Intravesical Gem/Doce Bladder - targeted solid matrix enables prolonged tumor exposure to the cytotoxic drug combination via multiple delivery modalities Diffusion through pores Diffusion through the polymer Osmotic pumping Erosion ©2026 Relmada - All rights reserved 13
NDV - 01 in - vitro Drug Concentrations Show Continuous & Optimized Drug Release NDV - 01 Gem/Doce Concentration Over Time NDV - 01 Cumulative Release Profile 3000 30 25 20 15 10 5 100 90 80 70 60 50 40 30 20 10 Gem, µg/ml DCTX, µg/ml 2500 2000 1500 1000 500 0 Gemcitabine Release % Docetaxel Release % 0 0 0 20 40 60 80 100 120 140 160 180 200 0 20 40 60 80 100 120 140 160 180 200 Time (hours) Time (hours) • In - vitro profiles demonstrate stable and predictable drug levels, minimizing peaks and troughs associated with systemic side effects. • Controlled drug exposure can potentially enhance anti - tumor activity while reducing the frequency of administration, enabling biweekly dosing. Experimental overview: 12g NDV - 01 with 10% gemcitabine, 0.25% docetaxel formulation was instilled into 10ml artificial urine (AUF) and kept in an orbital shaker incubator at 370C, 20 rpm. The AUF sample was withdrawn twice a day and replaced by fresh AUF. The drugs concertation in the UAF was quantitatively determined by HPLC ©2026 Relmada - All rights reserved 14
NDV - 01: Clinically De - Risked with Clear Competitive Advantages Ready for Use: Rapid, Office - Based Administration NDV - 01 comes as two prefilled syringes instilled in < 5 minutes Convenience: Unlocks Community - Based Treatment In - office administration by MA/RN/LPN without specialized infusion infrastructure, supporting broad adoption in community urology practices where ~80% of NMIBC patients are treated Derisked Based on Conventional Gem/Doce Usage Conventional Gem/Doce is a well - understood and most commonly used in academic practice , providing familiarity and supporting a lower - risk clinical and regulatory pathway Prolonged Intravesical Tumor Exposure NDV - 01 delivers continuous intravesical Gem/Doce inside the bladder enabling sustained tumor exposure Favorable Safety & Clearance Profile The NDV - 01 biodegradable polymer gradually disintegrates and is safely excreted in urine , vs. Inlexz which requires device extraction Relmada internal market research 2025. NMIBC: Non - muscle invasive bladder cancer; Gem/Doce : Gemcitabine plus Docetaxel; MA: Medical assistant; RN: Registered Nurse; LPN: Licensed practical ©2026 Relmada - All rights reserved 15
Study TRCG - 011 for High - Risk NMIBC An open - label, single - arm, single - center Phase 2a study 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 16
ONGOING TRCG - 011 STUDY Study Design Inclusion Criteria Primary Endpoint Secondary Endpoint Exploratory Purpose • High - risk disease with Evaluate the potential of NDV - 01 as a safe and effective treatment for patients with high - risk NMIBC • Safety • DOR • PK CIS, Ta/T 1 tumors 1, 2 • CR Rate at 12 months • EFS • BCG - naive, BCG - unresponsive, intolerant and experienced patients Intravesical NDV - 01 Follow up to 24 months Induction 6 biweekly instillations N=70 Urinary cytology Cystoscopy Upper tract imaging High - risk NMIBC Maintenance Monthly instillations TURBT or bladder biopsy if necessary 1. The American Cancer Society. Bladder Cancer Stages. American Cancer Society, 12, Mar, 2024; 2. Holzbeierlein, Jeffrey M., et al. “Diagnosis and Treatment of Non - Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment.” The Journal of Urology, vol. 211, no. 4, Jan. 2024. CIS : Carcinoma In Situ; Ta : Noninvasive papillary carcinoma; T1: Tumor invades lamina propria; NMIBC: Non - muscle invasive bladder cancer; CR: Complete Response; DOR: Duration of Response; EFS: Event Free Survival; PK: Pharmacokinetics; TURBT: Transurethral resection of bladder tumor BCG: Bacillus Calmette - Guérin ©2026 Relmada - All rights reserved 17
ONGOING TRCG - 011 STUDY Demographic Data Characteristics N=48 % Age Median (range) Sex 75 (52 - 93) yr Male 42 6 87.5% 12.5% Female BCG doses Median BCG doses (range) BCG - status BCG - naive BCG - exposed BCG - unresponsive Stage 9 (3 - 23) 23 5 47.9% 10.4% 41.7% 20 CIS +/ - Ta/T1 Ta HG 12 29 7 25.0% 60.4% 14.6% T1 HG BCG: Bacillus Calmette - Guérin; CIS: Carcinoma In Situ; Ta: Noninvasive papillary carcinoma; T1: Tumor invades lamina propria ; HG: High grade ©2026 Relmada - All rights reserved 18
ONGOING TRCG - 011 STUDY NDV - 01 Provided Durable Response Over Time Patient # Stage BCG status 3 months 6 months 9 months 12 months 01 - 002 01 - 007 01 - 009 01 - 010 01 - 011 CIS T1 T1 T1 T1+CIS Ta Ta Ta Ta Ta Ta Ta Ta Ta Ta CIS Ta BCG - UR BCG - exposed BCG - UR BCG - naive BCG - naive BCG - exposed BCG - naive BCG - naive BCG - UR BCG - naive BCG - naive BCG - naive BCG - naive BCG - UR BCG - UR BCG - naive BCG - UR BCG - UR BCG - UR BCG - naive BCG - UR BCG - UR BCG - UR BCG - UR BCG - UR BCG - exposed BCG - UR BCG - naive BCG - UR BCG - exposed BCG - naive BCG - naive BCG - naive BCG - UR 01 - 013 01 - 014 01 - 015 01 - 020 01 - 022 01 - 023 01 - 024 01 - 025 01 - 027 01 - 028 01 - 004 01 - 021 01 - 026 01 - 005 01 - 003 01 - 030 01 - 019 01 - 032 01 - 034 01 - 035 01 - 018 01 - 029 01 - 033 01 - 036 01 - 037 01 - 038 01 - 039 01 - 042 01 - 043 01 - 045 01 - 046 01 - 044 01 - 001 01 - 047 01 - 049 01 - 050 01 - 051 01 - 052 01 - 054 01 - 055 01 - 059 01 - 060 01 - 062 Ta T1+CIS CIS Ta Ta Ta T1+CIS Ta Ta Ta T1 Ta Ta Ta Ta Ta+CIS Ta+CIS T1 Ta Ta T1 Ta Ta Ta Ta Ta CIS CIS CIS T1 Discontinued Pending Discontinued Pending Pending Pending Discontinued Discontinued Discontinued Pending Pending Pending Pending Pending Pending Pending Pending Pending Discontinued BCG - naive BCG - UR CR BCG - naive BCG - naive BCG - naive BCG - naive BCG - naive BCG - exposed BCG - naive BCG - UR BCG - UR BCG - UR BCG - naive BCG - naive Non - CR Re - induced Ongoing Pending Pending Pending Pending Pending Pending Pending Pending Pending Pending CIS 95% 87% 3 - month CR rate 86% 6 - month CR rate 85% 9 - month CR rate 76% 12 - month CR rate Anytime CR rate CR : Complete response; BCG: Bacillus Calmette - Guérin; BCG - UR: BCG - unresponsive; KM: Kaplan - Meier analysis ©2026 Relmada - All rights reserved 19
ONGOING TRCG - 011 STUDY Efficacy and Tolerability Efficacy Evaluable Patients 1 (Complete Response) BCG - UR Subpopulation (Complete Response) n/N 36/38 33/38 25/29 22/26 19/25 - % n/N 16/17 14/17 12/14 10/11 8/10 - % Anytime 95% 87% 86% 85%* 76%* 83% Anytime 94% 82% 86% 91% 80% 84% 3 - month 3 - month 6 - month 6 - month 9 - month 9 - month 12 - month 12 - month 12 - month KM analysis 12 - month KM analysis • • • No patient had progression to muscle invasive disease No patient underwent a radical cystectomy 10 patients awaiting 3 - month response assessment – Including 3 BCG - unresponsive CIS patients • • n = 20 patients dosed in BCG - UR subpopulation BCG - UR defined by FDA definition 2 1. Efficacy evaluable patients (n=38) includes patients with at least 3 - month follow - up assessment. *Includes patients with CR after re - induction. 80% CR rate after re - induction; 2. https://www.fda.gov/media/101468/download ; BCG: Bacillus Calmette - Guérin; BCG - UR: BCG - unresponsive; KM: Kaplan - Meier analysis ©2026 Relmada - All rights reserved 20
ONGOING TRCG - 011 STUDY Treatment - Related AE and Tolerability No patient had ≥ Grade 3 TRAE No patients discontinued treatment due to AEs Of the 48 patients who received ≥ 1 dose of NDV - 01, 30 (63%) had a TRAE • 54% transient uncomfortable urination (dysuria) • 8% asymptomatic positive urine culture • 8% hematuria TRAE: Treatment - related adverse events; AE: Adverse events ©2026 Relmada - All rights reserved 21
BCG - Unresponsive NMIBC: The Presence of CIS Does NOT Impact Gem/Doce RFS 1 Steinberg et al. (2020): n=276; heavily - pre - treated with BCG 12 - month RFS: • Any CIS = 60% • HG papillary alone = 61% Cox regression analysis for risk factors: • Presence of CIS does NOT Impact RFS (p=0.15) 1. As demonstrated by third - party data: Steinberg et al. J Urol. 2020;203:902 – 909; BCG: Bacillus Calmette - Guérin; CIS : carcinoma in situ; RFS: recurrence - free survival; HG: High grade ©2026 Relmada - All rights reserved 22
Phase 3 Program R ecurrent / E ndovesical / S urgery - sparing / C ombination therapy for / U rothelial cancer / E ffectiveness ©2026 Relmada - All rights reserved 23
PHASE 3 RESCUE TRIAL Two Independent NDV - 01 Approval Pathways Provide Significant Market Opportunity Registrational Pathway 2 Registrational Pathway 1 Open label randomized controlled trial in intermediate - risk NMIBC – adjuvant therapy following TURBT (NDV - 01 vs. observation) Single - arm trial in 2L BCG - unresponsive NMIBC with CIS who are refractory to approved or developmental therapies ~75k patients/annually in US 1 – with ~35% 2 of intermediate - risk patients receiving adjuvant therapy post - TURBT ~5k patients/annually in US 1 – based on 12 - month CR rates of 19% - 46% 3 for 1L BCG - unresponsive therapies 1. Based on Internal estimates. 2. Grabe - Heyne et al. Front Oncol. 2023. 3. FDA approval summaries; company disclosures; published clinical trial data. NMIBC: Non - muscle invasive bladder cancer; BCG: Bacillus Calmette - Guérin (BCG); TURBT: Transurethral Resection of Bladder Tumor; CIS : carcinoma in situ; 1L: first - line; 2L: second - line; CR : Complete Response; ©2026 Relmada - All rights reserved 24
PHASE 3 RESCUE TRIAL Cohort 2A: 2L BCG - Unresponsive NMIBC Open - label, single - arm study to evaluate safety and efficacy of NDV - 01 in BCG - UR refractory to first - line therapy Inclusion Criteria Purpose Primary Endpoint Secondary Endpoint Other • HR BCG - UR with CIS refractory to first - line therapy • Safety and efficacy of NDV - 01 in patients with HR BCG - UR with CIS • CR anytime • Safety • DOR • PK • PFS • RFS amongst responders Study design Intravesical NDV - 01 Follow up to 24 months Cohort 2A 1 (Registrational; N=87) Induction 6 biweekly instillations Urinary cytology Cystoscopy TURBT or bladder biopsy if necessary HR BCG - UR NMIBC with CIS refractory to 1 st line therapy Maintenance Monthly instillations 1. BCG - Unresponsive patients with CIS +/ - Ta/T1 disease. Phase 3 Cohort 2A is a registrational cohort intended for regulatory approval. 2. BCG - Unresponsive patients with high - grade Ta/T1 disease. Phase 2 Cohort 2B is an exploratory cohort and not intended for regulatory approval. HR: High risk; CIS: Carcinoma In Situ; CR: Complete Response; DOR: Duration of Response; RFS: Recurrence Free Survival; PFS: Progression Free Survival; PK: Pharmacokinetics; TURBT: Transurethral resection of bladder tumor; BCG: Bacillus Calmette - Guérin BCG - UR: BCG - unresponsive ©2026 Relmada - All rights reserved 25
PHASE 3 RESCUE TRIAL Cohort 1: Adjuvant Intermediate - Risk NMIBC Registrational Randomized study of TURBT + NDV - 01 vs. TURBT in IR NMIBC Inclusion Criteria Primary Endpoint Secondary Endpoint • IR NMIBC DFS* • HG - RFS • PFS • • • IBCG risk factors ≥ 1 Safety • QOL Study design Intravesical NDV - 01 Induction 6 biweekly instillations + maintenance Follow up to 24 months Cohort 1 (Registrational; N=276) Urinary cytology Cystoscopy Upper tract imaging TURBT within 12 weeks (+/ - single - dose peri - operative chemotherapy) TURBT or bladder biopsy if necessary Observation Option to have Induction with NDV - 01 with recurrence Stratification Factors: • LG vs. HG • Single - dose peri - operative chemotherapy: yes vs. no *DFS = time from randomization to the date of the first documented recurrence/progression. DFS: Disease Free Survival; IR: Immediate Risk; HG - RFS: High Grade Recurrence Free Survival; PFS: Progression Free Survival; QOL: Quality of Life Metrics; TURBT : Transurethral resection of bladder tumor; IBCG: International Bladder Cancer Group; LG: Low grade; HG : High grade ©2026 Relmada - All rights reserved 26
Expecting to Advance NDV - 01 Towards Registration - Track Studies in Mid - 2026 Initiate Phase 3 RESCUE Trials Target two independent registrational pathways: • 2L BCG - Unresponsive NMIBC patients Mid 2026 • Adjuvant Intermediate - Risk NMIBC patients Interim Phase 3 2L BCG - Unresponsive 3 - month Data Initial 3 - month CR data + safety Q4 2026 BCG: Bacillus Calmette - Guérin (BCG); NMIBC: No muscle invasive bladder cancer; IR: Intermediate Risk ©2026 Relmada - All rights reserved 27
Sepranolone A novel candidate, with potential to overcome the challenges of current therapies for compulsivity disorders ©2026 Relmada - All rights reserved 28
Sepranolone Has the Potential to Normalize GABA A Receptor Activity GABA ( Υ - aminobutyric acid) is the primary neurotransmitter, involved in anxiety and compulsive disorders 1,2 In some individuals, ALLO exacerbates anxiety and Sepranolone Allopregnanolone normalizes GABA A receptor activity without interfering in GABA signaling 7,8 (ALLO) typically enhances GABA calming effects 3, 4 A compulsivity 5, 6 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. GABA : Υ - aminobutyric acid type A; A ALLO: Allopregnanolone ©2026 Relmada - All rights reserved 29
Positive Phase 2 Data and Unique MOA Give Sepranolone Broad Potential Neurological disorder characterized by repetitive, involuntary tics, with childhood onset Genetic disorder often defined by persistent hunger and overeating Prader - Willi Syndrome Tourette Syndrome Global prevalence 350 - 400K people 1 US prevalence 350 - 450K children and adults 3 Neurological disorder that causes involuntary, rhythmic shaking. Primarily notice during voluntary movements OCD is characterized by intrusive, unwanted thoughts (obsessions) and repetitive behaviors (compulsions) Obsessive - Compulsive Disorder and related Essential Tremors US prevalence 6.4 MM people 2 disorders US prevalence 8.2M people 4 1. Scheimann AO. UpToDate. 2023. 2. Crawford S et al. Neurology. 2020. 3. Tinker SC et al. Psychiatry Res. 2022. 4. International OCD Foundation epidemiology data. PWS: Prader - Willi syndrome; ET: Essential Tremor; OCD: Obsessive Compulsive Disorder ©2026 Relmada - All rights reserved 30
Sepranolone: Highlights & Development Value Differentiated therapeutic candidate for compulsivity - related disorders, supported by positive proof - of - concept data in Tourette’s syndrome Phase 2 study in Prader - Willi syndrome (PWS) planned for H1 2026, targeting a rare genetic disorder affecting 350,000 – 400,000 individuals worldwide Program readiness: Regulatory engagement and manufacturing activities 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 visibility 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 31
Expecting to Advance Sepranolone Towards Phase 2 Study in Prader - Willi Syndrome in Mid - 2026 Mid 2026 Initiation of Pilot Phase 2 study in Prader - Willi Syndrome Focus on evaluating early proof - of - concept PWS: Prader - Willi syndrome ©2026 Relmada - All rights reserved 32
Corporate Summary ©2026 Relmada - All rights reserved 33
Financial Overview $160 million PIPE 2 $93.0 million ~104.8 million 3 1 Cash, cash Gross proceeds from PIPE Common equivalents & short - term investments shares outstanding (net ~$150M million) ~127.9 million as converted – includes 15M outstanding options (weighted average exercise price of $12.51/share) and ~8.0M outstanding warrants As of December 31, 2025 Provides cash runway through 2029 1. As of December 31, 2025; 2. On March 9, 2026; 3. Includes 29.5 million shares issued for PIPE on March 9, 2025 34 ©2026 Relmada - All rights reserved
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Appendix
Gem/Doce combination has been embraced by the urologic oncology community Effective salvage treatment for patients who have failed or are intolerant to BCG with reported 2 - year RFS ~50% 1, 2, 3 Gem/Doce is an effective alternative first - line agent in high - risk BCG naïve patients with 2 - year RFS of 82% 4 Gem/Doce use expanding into intermediate - risk and low - grade tumors with reported 2 - year RFS of 70 - 80% 5, 6 Gem/Doce avoids/delays radical cystectomy 7, 8 Large ongoing cooperative “BRIDGE” study (n=870) evaluating Gem/Doce combination vs. BCG (NCT05538663) 1. Steinberg RL et al. J Urol. 2020; 2. Garneau CA et al. Can Urol Assoc J. 2024; 3. Yim K et al. Urol Oncol. 2023; 4. McElree IM et al. J Urol. 2022; 5. McElree IM et al. Urol Oncol. 2023; 6. Tan WS et al. Eur Urol Oncol. 2023; 7. Chevuru PT et al. Urol Oncol. 2023; 8. Narayan VM et al. J Urol. 2024. 9 . Steinberg RL et al. J Urol. 2019; RFS: Relapse Free Survival; BCG: Bacillus Calmette - Guérin; NMIBC: Non - muscle invasive bladder cancer; Gem/Doce : Gemcitabine plus Docetaxel ©2026 Relmada - All rights reserved 37
PHASE 3 RESCUE TRIAL Cohort 2B: 2L BCG - Unresponsive NMIBC Open - label, single - arm study to evaluate safety and efficacy of NDV - 01 in BCG - UR refractory to first - line therapy Inclusion Criteria Purpose Primary Endpoint Secondary Endpoint Other • HR BCG - UR papillary only refractory to • Safety and efficacy of NDV - 01 in patients with HR BCG - UR with CIS • CR anytime • Safety • DOR • PK • PFS first - line therapy • RFS amongst responders Study design Intravesical NDV - 01 Follow up to 24 months Cohort 2B 1 (Exploratory; N=30) Induction 6 biweekly instillations Urinary cytology Cystoscopy HR BCG - UR NMIBC papillary only refractory to 1 st line therapy TURBT or bladder biopsy if necessary Maintenance Monthly instillations 1. BCG - Unresponsive patients with high - grade Ta/T1 disease. Phase 2 Cohort 2B is an exploratory cohort and not intended for regulatory approval. CR: Complete Response; DOR: Duration of Response; RFS: Recurrence Free Survival; PFS: Progression Free Survival; BCG - UR: BCG - unresponsive ©2026 Relmada - All rights reserved 38
Sepranolone Has the Potential to Normalize GABA A Receptor Activity PAM GABA https://asarinapharma.com/sepranolone/how - does - sepranolone - work/ ©2026 Relmada - All rights reserved 39
Management Leadership Board of Directors Sergio Traversa Maged Shenouda Chuck Ence Chief Accounting and Charles J. Casamento John Glasspool Fabiana Fedeli Chief Executive Officer Chief Financial Officer Chairman of the Board Director Director Compliance Officer Paul Kelly Chief Operating Officer Raj S. Pruthi, MD Chief Medical Officer Sergio Traversa Chief Executive Officer Paul Kel ly Chief Operating Officer ©2026 Relmada - All rights reserved 40
FAQ
How did Relmada Therapeutics (RLMD) perform financially in 2025?
What is the cash and balance sheet position of Relmada Therapeutics (RLMD)?
What recent clinical data did Relmada report for NDV-01 in NMIBC?
What regulatory progress has Relmada made for NDV-01?
What upcoming milestones did Relmada Therapeutics outline?
How is Relmada expanding beyond NDV-01 with sepranolone?
Filing Exhibits & Attachments
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