Relmada (NASDAQ: RLMD) boosts cash with $160M PIPE and NDV-01 data
Rhea-AI Filing Summary
Relmada Therapeutics reported a first quarter 2026 net loss of $19.1M, with operating expenses of $19.5M. Research and development was $8.1M and general and administrative expenses were $11.4M.
After a $160M PIPE financing that generated roughly $150M in net proceeds, cash, cash equivalents and short-term investments rose to $235.3M as of March 31, 2026, and management states this should fund operations through 2029. Common shares outstanding increased to 104.9 million.
The company highlighted Phase 2 data for NDV-01 in high-risk non-muscle invasive bladder cancer, showing a 95% anytime complete response rate and 76% 12‑month complete response rate among 38 efficacy-evaluable patients, with no progressions to muscle-invasive disease or cystectomies reported. A BCG-unresponsive subgroup showed similar durability. Safety appeared manageable, with no grade 3 or higher treatment-related adverse events and no treatment discontinuations for safety.
Relmada has written FDA feedback supporting two registrational pathways for NDV-01 and plans to initiate the Phase 3 RESCUE program and a Phase 2 study of sepranolone in Prader‑Willi syndrome in mid‑2026. A provisional NDV‑01 patent filing could support protection into 2047.
Positive
- $160M PIPE financing (about $150M net) boosted cash, cash equivalents and short-term investments to $235.3M as of March 31, 2026, and management indicates this cash runway extends through 2029, supporting multiple late-stage clinical programs.
- NDV-01 Phase 2 data in high-risk non-muscle invasive bladder cancer showed a 95% anytime complete response rate and 76% 12‑month complete response rate among 38 efficacy-evaluable patients, with no muscle-invasive progressions or cystectomies reported and no grade ≥3 treatment-related adverse events.
- Regulatory clarity was strengthened by written FDA feedback agreeing on two NDV-01 registrational development pathways, and a provisional NDV-01 patent filing could support intellectual property protection into 2047.
Negative
- None.
Insights
Relmada pairs strong NDV‑01 data with a major cash raise, extending runway into late-stage trials.
Relmada Therapeutics delivered encouraging Phase 2 NDV‑01 results in high‑risk non‑muscle invasive bladder cancer. Among 38 efficacy‑evaluable patients, anytime complete response reached 95%, with a 76% 12‑month complete response rate and an estimated 83% 12‑month complete response by Kaplan–Meier, without observed progression to muscle‑invasive disease or radical cystectomy in the dataset presented.
The safety profile looked manageable: 63% of treated patients reported treatment‑related events, mainly dysuria, but there were no grade ≥3 treatment‑related adverse events and no safety‑driven discontinuations. Written FDA feedback aligns on two registrational pathways, including a single‑arm second‑line BCG‑unresponsive cohort and a randomized adjuvant intermediate‑risk cohort, which could support broad non‑muscle invasive bladder cancer positioning if replicated in Phase 3.
Financially, the $160M PIPE, yielding about $150M net, lifted cash, cash equivalents and short‑term investments to $235.3M as of March 31, 2026. Management indicates this funds operations through 2029, which is a long runway for a clinical‑stage company planning multiple registrational studies and a Phase 2 Prader‑Willi syndrome trial. The trade‑off is a larger share count at 104.9 million, but the scale of funding and clinical optionality justify viewing the event as net positive.
8-K Event Classification
Key Figures
Key Terms
non-muscle invasive bladder cancer medical
BCG-unresponsive medical
complete response medical
disease free survival medical
Prader-Willi syndrome medical
Private Securities Litigation Reform Act of 1995 regulatory
Earnings Snapshot
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 May 12, 2026, Relmada Therapeutics, Inc. (the “Company”) issued a press release providing a corporate update and reporting its financial results for the three months ended March 31, 2026. The Company also announced that it would conduct a conference call and audio webcast on Tuesday, May 12, 2026, at 4:30 PM EST / 1:30 PM PST, to discuss the update and results. The Company’s complete unaudited condensed consolidated financial statements and notes thereto as of March 31, 2026, and December 31, 2025, and for the three months ended March 31, 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 May 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 May 12, 2026, regarding corporate update and full year 2025 financial results | |
| 99.2* | Corporate Presentation dated May 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: May 12, 2026 | RELMADA THERAPEUTICS, INC. | |
| By: | /s/ Sergio Traversa | |
| Name: | Sergio Traversa | |
| Title: | Chief Executive Officer | |
2
Exhibit 99.1
Relmada Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update
| ● | Positive 12-Month Phase 2 data for NDV-01 demonstrated a 95% complete response (CR) rate at any time and a durable 76% CR rate at 12 months in high-risk non-muscle invasive bladder cancer (NMIBC), and a 94% CR rate at any time and a durable 80% CR rate at 12 months in the BCG-unresponsive subpopulation, reinforcing best-in-class potential in NMIBC |
| ● | On track to initiate Phase 3 RESCUE registrational program in second line (2L) BCG-unresponsive and adjuvant intermediate-risk NMIBC in mid-2026 |
| ● | Filed provisional patent application with the USPTO in April 2026 covering NDV-01 pharmaceutical formulations and methods of treatment; if issued, patents claiming priority to the provisional filing would have a term until April 2047 |
| ● | Relmada will feature two NDV-01 presentations at the American Urological Association Annual Meeting (AUA2026), highlighting the 12-month Phase 2 data and the Phase 3 RESCUE program design and rationale |
| ● | Cash balance of $234.0 million as of March 31, 2026 expected to fund operations through 2029, including completion of the NDV-01 Phase 3 RESCUE program |
| ● | Management to host a conference call and webcast today at 4:30 PM ET |
CORAL GABLES, FL – May 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 first quarter ended March 31, 2026 and provided a corporate update.
“We made significant progress in the first quarter, highlighted by the robust 12-month Phase 2 data for NDV-01 in NMIBC and the successful completion of a $160 million PIPE financing, which has well-capitalized our balance sheet to fund the NDV-01 RESCUE Phase 3 program through completion,” said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics. “We remain on track to file the NDV-01 IND and initiate the Phase 3 RESCUE registrational program in mid-2026 – a milestone that would mark a major inflection point for Relmada and for the patients we aim to serve. We believe NDV-01 has the potential to be a best-in-class therapy for patients with NMIBC and remain focused on maximizing its potential for success. To this end, in April, we filed a provisional patent application in the U.S. directed to formulations and methods of treatment for NDV-01. This application, if issued, could form the basis for worldwide patent filings, and have a term into 2047.”
“The AUA2026 Annual Meeting provides an important opportunity to introduce NDV-01 to the broader urologic community,” said Raj S. Pruthi, MD, Chief Medical Officer – Urology of Relmada Therapeutics. “Our presentations will highlight the 12-month Phase 2 data generated to date for NDV-01, including observed complete responses and safety findings. We will also be sharing the design and rationale for the Phase 3 RESCUE program. NDV-01 is a sustained-release gemcitabine and docetaxel (Gem/Doce) designed to support streamlined, in-office administration in less than five minutes. We believe AUA2026 provides an important national forum to increase awareness and engagement within the investigator community as we approach the initiation of the RESCUE program in mid-2026.”
Upcoming AUA2026 Presentations and NDV-01 Phase 2 Data Highlights:
Relmada will present two abstracts at AUA2026 including: (1) NDV-01 Phase 2 data (12-month follow-up), and (2) the Phase 3 RESCUE program design (Clinical Trials in Progress session). The presentations are intended to raise awareness of NDV-01 and build investigator interest in the RESCUE registrational program. Key data to be highlighted include:
| ● | 95% complete response (CR) rate at any time and durable 76% CR rate at 12 months in high-risk NMIBC patients |
| ● | 94% CR rate at any time and durable 80% CR rate at 12 months in BCG-unresponsive NMIBC patients |
| ● | 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 |
NDV-01 Intellectual Property:
In April 2026, Relmada filed a provisional patent application with the United States Patent and Trademark Office (USPTO) directed to pharmaceutical formulations and methods of treatment related to NDV-01. The provisional filing has the potential to form the basis for a comprehensive world-wide patent filing program for NDV-01. If issued, patents claiming priority to the provisional filing will be expected to have a term until April 2047.
Expected Upcoming Relmada Milestones:
| ● | NDV-01 United States IND filing – 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 – YE 2026 |
Financial Results
First Quarter 2026 Financial Results
| ● | Research and development expense for the three months ended March 31, 2026, totaled $8.1 million, compared to $12.0 million for the three months ended March 31, 2025, a decrease of $3.9 million. The decrease was primarily attributable to non-recurring costs associated with the acquisition of sepranolone and the license agreement of NDV-01 recognized in 2025. This 2026 decrease was partially offset by increased costs related to the start-up of the Phase 3 NDV-01 trials and Phase 2b sepranolone study and additional R&D personnel. |
2
| ● | General and administrative expense for the three months ended March 31, 2026, totaled $11.4 million compared to $6.3 million for the three months ended March 31, 2025, an increase of approximately $5.1 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 March 31, 2026, totaled $15.1 million compared to $18.1 million for the three months ended March 31, 2025. |
| ● | The net loss for the three months ended March 31, 2026, was $19.1 million, or $0.22 per basic and diluted share, compared with a net loss of $17.6 million, or $0.58 per basic and diluted share, for the three months ended March 31, 2025. |
| ● | The Company’s balance of $234.0 million in cash, cash equivalents, and short-term investments, includes net proceeds of approximately $150 million from the private placement financing announced March 9, 2026. This compares 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 March 31, 2026, 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 May 7, 2026 |
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: Tuesday, May 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://www.relmada.com/investors/ir-calendar.
About NDV-01
NDV-01 is a ready-to-use, sustained-release intravesical 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 controlled drug release over approximately 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. It is encompassed by multiple patent applications that if issued, could provide protection until 2047.
3
About the NDV-01 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. Patients were evaluated at 3-month intervals using cystoscopy and cytology, with biopsies performed at the treating physician’s discretion. Time-to-event endpoints, including complete response (CR) and event free survival (EFS) rates, were analyzed as landmark events and using Kaplan–Meier (KM) analysis. The primary efficacy endpoints are safety and CR rate at 12 months, and secondary efficacy endpoints are duration of response (DOR) and EFS. Treatment-related adverse events (TRAEs) were graded according to CTCAE v5.0 (Common Terminology Criteria for Adverse Events, version 5.0).
About the NDV-01 Phase 3 RESCUE Registrational Pathways:
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. IND filing and program initiation remain on track for mid-2026.
Registration Pathway 1 – An open-label 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.
Registrational Pathway 2 – An open label randomized controlled trial in intermediate-risk NMIBC of adjuvant therapy following TURBT (Transurethral Resection of Bladder Tumor, NDV-01 vs. observation). There are no approved adjuvant treatments for 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).
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.
4
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 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, 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, 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 | ||||||||
| March 31, | As of | |||||||
| 2026 (Unaudited) | December 31, 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 9,776,400 | $ | 3,496,540 | ||||
| Short-term investments | 224,186,743 | 89,509,710 | ||||||
| Prepaid expenses | 1,380,151 | 977,721 | ||||||
| Total current assets | 235,343,294 | 93,983,971 | ||||||
| Other assets | 19,500 | 19,500 | ||||||
| Total assets | $ | 235,362,794 | $ | 94,003,471 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,731,401 | $ | 1,568,944 | ||||
| Accrued expenses | 7,160,233 | 4,861,583 | ||||||
| Total current liabilities | 12,891,634 | 6,430,527 | ||||||
| Stock appreciation rights | 3,738,583 | 1,060,931 | ||||||
| Total liabilities | 16,630,217 | 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, 150,000,000 shares authorized, 104,890,223 and 73,333,622 shares issued and outstanding, respectively | 104,890 | 73,333 | ||||||
| Additional paid-in capital | 935,946,841 | 784,705,878 | ||||||
| Accumulated deficit | (717,319,154 | ) | (698,267,198 | ) | ||||
| Total stockholders’ equity | 218,732,577 | 86,512,013 | ||||||
| Total liabilities and stockholders’ equity | $ | 235,362,794 | $ | 94,003,471 | ||||
6
Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
| Three months ended | ||||||||
| March 31, | ||||||||
| 2026 | 2025 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 8,087,845 | $ | 11,951,023 | ||||
| General and administrative | 11,373,909 | 6,267,412 | ||||||
| Total operating expenses | 19,461,754 | 18,218,435 | ||||||
| Loss from operations | (19,461,754 | ) | (18,218,435 | ) | ||||
| Other income: | ||||||||
| Interest/investment income, net | 959,762 | 440,287 | ||||||
| Realized (loss)/gain on short-term investments | (9,867 | ) | 62,952 | |||||
| Unrealized (loss)/gain on short-term investments | (540,097 | ) | 155,731 | |||||
| Total other income, net | 409,798 | 658,970 | ||||||
| Net loss | $ | (19,051,956 | ) | $ | (17,559,465 | ) | ||
| Loss per common share – basic and diluted | $ | (0.22 | ) | $ | (0.58 | ) | ||
| Weighted average number of common shares outstanding – basic and diluted | 86,596,873 | 30,408,890 | ||||||
7
Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(Unaudited)
| Three months ended March 31, 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 | ||||||||||
| Three months ended March 31, 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 | ||||||||||
8
Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)
| Three months ended | ||||||||
| March 31, | ||||||||
| 2026 | 2025 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (19,051,956 | ) | $ | (17,559,465 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 956,186 | 3,572,769 | ||||||
| Stock appreciation rights compensation | 2,677,652 | 3,038 | ||||||
| Issuance of restricted common stock | - | 905,226 | ||||||
| Realized loss/(gain) on short-term investments | 9,867 | (62,952 | ) | |||||
| Unrealized loss/(gain) on short-term investments | 540,097 | (155,731 | ) | |||||
| Change in operating assets and liabilities: | ||||||||
| Prepaid expenses | (402,430 | ) | 290,051 | |||||
| Accounts payable | 1,762,457 | (2,865,553 | ) | |||||
| Accrued expenses | (1,559,361 | ) | (2,194,416 | ) | ||||
| Net cash used in operating activities | (15,067,488 | ) | (18,067,033 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of short-term investments | (149,517,480 | ) | (487,916 | ) | ||||
| Sale of short-term investments | 14,290,483 | 15,847,629 | ||||||
| Net cash (used in)/provided by investing activities | (135,226,997 | ) | 15,359,713 | |||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of common stock | 159,999,996 | - | ||||||
| Payment of fees for issuance of common stock | (3,360,000 | ) | - | |||||
| ATM Fees | (65,651 | ) | - | |||||
| Net cash provided by financing activities | 156,574,345 | - | ||||||
| Net increase/(decrease) in cash and cash equivalents | 6,279,860 | (2,707,320 | ) | |||||
| Cash and cash equivalents at beginning of the period | 3,496,540 | 3,857,026 | ||||||
| Cash and cash equivalents at end of the period | $ | 9,776,400 | $ | 1,149,706 | ||||
| Non-cash investing and financing activities: | ||||||||
| Cashless exercise of warrants for common stock | (2,082 | ) | - | |||||
| Fees for issuance of common stock included in accounts payable | 2,400,000 | - | ||||||
| Fees for issuance of common stock included in accrued expenses | 3,858,011 | |||||||
9
Exhibit 99.2
Unlocking Life Changing Therapies May 2026 C O R P O R A T E O V E R V I E W
©2026 R elm ada - Al l ri ghts r eserved 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 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 R elm ada - Al l ri ghts r eserved Investment Thesis 3 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 R elm ada - Al l ri ghts r eserved Innovative Pipeline of Potential High-Value Assets 4 Candidate / Indication Phase 1 Phase 2 Phase 3 Status / Potential Next Steps NDV-011 High-Risk NMIBC (Study TRCG-001) 2026: Present data at upcoming medical meetings, continue enrollment NDV-01 Intermediate-Risk NMIBC (RESCUE Cohort 1) Mid-2026: Initiate RESCUE Phase 3 registrational Cohort 1 NDV-01 2L BCG-Unresponsive (RESCUE Cohort 2A)2 Mid-2026: Initiate RESCUE Phase 3 registrational Cohort 2A NDV-01 2L BCG-Unresponsive (RESCUE Cohort 2B)3 Mid-2026: Initiate RESCUE Phase 2 exploratory Cohort 2B Sepranolone Prader-Willi Syndrome (PWS) Mid-2026: Initiate Phase 2 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 appr oval. NMIBC: Non-muscle invasive bladder cancer; BCG: Bacillus Calmette-Guérin; 2L: Second Line Focused on programs with positive proof-of-concept data MID-2026 MID-2026 MID-2026 MID-2026
©2026 R elm ada - Al l ri ghts r eserved 5 NDV-01 A sustained-release intravesical formulation of gemcitabine/docetaxel (Gem/Doce) for patients with NMIBC, with positive Phase 2a data1 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 R elm ada - Al l ri ghts r eserved Our Focus: Non-Muscle Invasive Bladder Cancer (NMIBC) 6 1. Shih K et al. Aging Dis. 2021. 2. Aldousari S et al. Can Urol Assoc J. 2013. 80% of new cases1,2 20% 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
©2026 R elm ada - Al l ri ghts r eserved NMIBC Represents Multi-Billion Dollar Market Opportunity 7 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 ~ 68,000 ~85,000 ~744,000 ~ 54,400 Key Highlights High incidence1 4.2% of all new cancer cases in the US High recurrence5 ~30%-61% of high-risk patients recur within one year. Multiple treatment courses High cost Complex treatment pathways $6.5B total annual cost (U.S.)10 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) New bladder cancer cases2 71-97% 5-year overall survival, 8% with advanced disease3 US prevalence of Bladder Cancer1 (Overall Bladder Cancer) NMIBC cancer cases (80% of bladder cancers)4,6,8,9 50-80% recurrence rate (over five years)5
©2026 R elm ada - Al l ri ghts r eserved Potential 2L NDV-01 Usage * NMIBC Patient Journey 8 Initial Testing Urologist performs cystoscopy and urine cytology. TURBT TURBT to stage, risk-stratify, and treat disease. Symptoms Patient presents to physician; most common presenting symptom is hematuria (blood in urine). Risked-Based Therapies Adjuvant therapy (chemotherapy, immunotherapy, systemic therapy) based on patients risk category. 4 Low-Risk Intermediate-Risk High-Risk BCG-Unresponsive 1 2 3 (*) Initial NDV-01 Registrational Pathways 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 5 Ongoing Surveillance Regular cystoscopy and urine cytology (up to every 3 months) to monitor for recurrence/progression. Perioperative Chemotherapy Perioperative Chemotherapy Perioperative Chemotherapy Intravesical BCG Intravesical Chemotherapy/BCG * Perioperative Chemotherapy Disease Recurrence Immunotherapy, Intravesical Chemotherapy, and Systemic Therapies
©2026 R elm ada - Al l ri ghts r eserved Systemic Therapy Overview of NMIBC Treatment Landscape 9 Intravesical Chemotherapy Gene Therapy/ Immunotherapy TURBT Surgery 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 Approved and emerging treatments Complications (>15%)1 OR procedure under anesthesia Patient burden Emerging dataset Conventional Chemotherapies: mitomycin, gemcitabine, Gem/Doce Sustained-Release: NDV-01 (Gem/Doce), INLEXZO (gemcitabine), ZUSDURI (mitomycin) Risk of recurrence (50-80%)2 Supply issues Complex handling requirements BCG, Adstiladrin®, Anktiva®, Cretostimogene, TARA-002, EG- 70, TAR-210 (FGFR inhibitor) Risk of recurrence Risk of immune-mediated or systemic side effects KEYTRUDA® (anti-PD1), Sasanlimab (anti-PD1), TYRA-300 (oral FGFR3)
©2026 R elm ada - Al l ri ghts r eserved The Burden of Recurrences and TURBT is High 10 • Complication rate > 15%2 • Grade 3/4 complication rate = 9.4%3 • Readmission rate = 5%4 • Procedural Cost = $7,000-$10,0005, 7 • Worsening mental health, physical health and lower urinary tract symptom scores6 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 • 5-year risk of initial recurrence: 54.4%. After initial recurrence 60.1% of patients had a second recurrence by 2 years • After 2nd recurrence, 51.5% of patients had a 3rd recurrence by 3 years Frequent recurrences for IR NMIBC patients: ~ 1 recurrence / year1 Increased risk of progression with more recurrences1 Recurrences typically require TURBT Invasive OR procedure with anesthesia • The 5-year risk of progression: 9.5%, 21.9%, and 37.9% for patients with 1, 2, and 3+ recurrences, respectively
©2026 R elm ada - Al l ri ghts r eserved Gem/Doce Combination Stands Out in Urology Times Survey1 11 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? 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. Clinical trial Nogapendekin alfa inbakicept (ANKTIVA®) Pembrolizumab (KEYTRUDA®) Intravesical chemotherapy Mitomycin-C Nogapendekin alfa inbakicept (ANKTIVA®) Nadofaragene Firadenovec (ADSTILADRIN®) Gemcitabine plus docetaxel (Gem/Doce) Gemcitabine Nadofaragene firadenovec (ADSTILADRIN®) 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100%
©2026 R elm ada - Al l ri ghts r eserved vs. <5 minutes for NDV-01 Significant Issues with Conventional Gem/Doce Intravesical Therapy for NMIBC 12 NMIBC: Non-muscle invasive bladder cancer; Gem/Doce: Gemcitabine plus Docetaxel 4-hour total procedure time First administration Preparation by specialized pharmacy ~60-120 min dwell time Second administration ~90-120 min dwell time 30 min break vs. NDV-01 comes ready for use in two pre-filled plastic syringes Requires specialized pharmacy preparation vs. NDV-01 which provides the opportunity for community urologist to deliver Gem/Doce Utilization concentrated in academic setting vs. NDV-01 which provides sustained release of Gem/Doce for up to 10 days Limited drug exposure and dwell time
©2026 R elm ada - Al l ri ghts r eserved NDV-01 - Targeted Sustained-Release Intravesical Gem/Doce 13 Diffusion through pores Diffusion through the polymer Osmotic pumping Erosion Bladder-targeted solid matrix enables prolonged tumor exposure to the cytotoxic drug combination via multiple delivery modalities
©2026 R elm ada - Al l ri ghts r eserved NDV-01 in-vitro Drug Concentrations Show Continuous & Optimized Drug Release 14 • 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. 0 10 20 30 40 50 60 70 80 90 100 0 20 40 60 80 100 120 140 160 180 200 Release, % Time (hours) Gemcitabine Release % Docetaxel Release % 0 5 10 15 20 25 30 0 500 1000 1500 2000 2500 3000 0 20 40 60 80 100 120 140 160 180 200 Docetaxel Gemcitabine Time (hours) Gem, µg/ml DCTX, µg/ml NDV-01 Gem/Doce Concentration Over Time NDV-01 Cumulative Release Profile Experimental overview: 12g NDV-01 with 10% gemcitabine, 0.25% docetaxel formulation was instilled into 10ml artificial urine (AU F) 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 determin ed by HPLC
©2026 R elm ada - Al l ri ghts r eserved NDV-01: Clinically De-Risked with Clear Competitive Advantages 15 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. Inlexzo 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 R elm ada - Al l ri ghts r eserved 16 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 R elm ada - Al l ri ghts r eserved Inclusion Criteria Purpose Primary Endpoint Secondary Endpoint Exploratory Study Design 17 ONGOING TRCG-011 STUDY • High-risk disease with CIS, Ta/T 1 tumors1, 2 • BCG-naive, BCG- unresponsive, intolerant and experienced patients Evaluate the potential of NDV-01 as a safe and effective treatment for patients with high-risk NMIBC • Safety • CR Rate at 12 months • DOR • EFS • PK 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 Follow up to 24 months Urinary cytology Cystoscopy Upper tract imaging TURBT or bladder biopsy if necessary N=70 High-risk NMIBC Intravesical NDV-01 Induction 6 biweekly instillations Maintenance Monthly instillations
©2026 R elm ada - Al l ri ghts r eserved Demographic Data 18 ONGOING TRCG-011 STUDY Characteristics N=48 % Age Median (range) 75 (52-93) yr Sex Male 42 87.5% Female 6 12.5% BCG doses Median BCG doses (range) 9 (3-23) BCG-status BCG-naive 23 47.9% BCG-exposed 5 10.4% BCG-unresponsive 20 41.7% Stage CIS +/- Ta/T1 12 25.0% Ta HG 29 60.4% T1 HG 7 14.6% BCG: Bacillus Calmette-Guérin; CIS: Carcinoma In Situ; Ta: Noninv asive papillary carcinoma; T1: Tumor invades lamina propria; HG: High grade
©2026 R elm ada - Al l ri ghts r eserved 01-002 CIS BCG-UR 01-007 T1 BCG-exposed 01-009 T1 BCG-UR 01-010 T1 BCG-naive 01-011 T1+CIS BCG-naive 01-013 Ta BCG-exposed 01-014 Ta BCG-naive 01-015 Ta BCG-naive 01-020 Ta BCG-UR 01-022 Ta BCG-naive 01-023 Ta BCG-naive 01-024 Ta BCG-naive 01-025 Ta BCG-naive 01-027 Ta BCG-UR 01-028 Ta BCG-UR 01-004 CIS BCG-naive 01-021 Ta BCG-UR 01-026 Ta BCG-UR 01-005 T1+CIS BCG-UR 01-003 CIS BCG-naive 01-030 Ta BCG-UR Pending 01-019 Ta BCG-UR Discontinued 01-032 Ta BCG-UR Pending 01-034 T1+CIS BCG-UR Pending 01-035 Ta BCG-UR Pending 01-018 Ta BCG-exposed Discontinued 01-029 Ta BCG-UR Discontinued 01-033 T1 BCG-naive Discontinued 01-036 Ta BCG-UR Pending 01-037 Ta BCG-exposed Pending 01-038 Ta BCG-naive Pending 01-039 Ta BCG-naive Pending 01-042 Ta+CIS BCG-naive Pending 01-043 Ta+CIS BCG-UR Pending 01-045 T1 BCG-naive Pending 01-046 Ta BCG-UR Pending 01-044 Ta BCG-naive Pending 01-001 T1 BCG-naive Discontinued 01-047 Ta BCG-naive Pending 01-049 Ta BCG-naive Pending 01-050 Ta BCG-naive Pending 01-051 Ta BCG-exposed Pending 01-052 Ta BCG-naive Pending 01-054 CIS BCG-UR Pending 01-055 CIS BCG-UR Pending 01-059 CIS BCG-UR Pending 01-060 T1 BCG-naive Pending 01-062 CIS BCG-naive Pending 3 months 6 months 9 months Patient # 12 months NDV-01 Provided Durable Response Over Time 19 ONGOING TRCG-011 STUDY Stage BCG status Discontinued 95% Anytime CR rate 87% 3-month CR rate 86% 6-month CR rate 85% 9-month CR rate CR: Complete response; BCG: Bacillus Calmette-Guérin; BCG-UR: BCG-unresponsive; KM: Kaplan-Meier analysis 76% 12-month CR rate CR Non-CR Re-induced Ongoing
©2026 R elm ada - Al l ri ghts r eserved Efficacy Results 20 ONGOING TRCG-011 STUDY n/N % Anytime 36/38 95% 3-month 33/38 87% 6-month 25/29 86% 9-month 22/26 85%* 12-month 19/25 76%* 12-month KM analysis - 83% • 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 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 n/N % Anytime 16/17 94% 3-month 14/17 82% 6-month 12/14 86% 9-month 10/11 91% 12-month 8/10 80% 12-month KM analysis - 84% • n = 20 patients dosed in BCG-UR subpopulation • BCG-UR defined by FDA definition2 BCG-UR Subpopulation (Complete Response) Efficacy Evaluable Patients1 (Complete Response)
©2026 R elm ada - Al l ri ghts r eserved Treatment-Related AE and Tolerability 21 ONGOING TRCG-011 STUDY 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 R elm ada - Al l ri ghts r eserved BCG-Unresponsive NMIBC: The Presence of CIS Does NOT Impact Gem/Doce RFS1 22 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 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)
©2026 R elm ada - Al l ri ghts r eserved 23 Recurrent / Endovesical / Surgery-sparing / Combination therapy for / Urothelial cancer / Effectiveness Phase 3 Program
©2026 R elm ada - Al l ri ghts r eserved Two Independent NDV-01 Approval Pathways Provide Significant Market Opportunity 24 PHASE 3 RESCUE TRIAL 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; ~75k patients/annually in US1 – with ~35%2 of intermediate-risk patients receiving adjuvant therapy post-TURBT Registrational Pathway 2 Open label randomized controlled trial in intermediate-risk NMIBC – adjuvant therapy following TURBT (NDV-01 vs. observation) ~5k patients/annually in US1 – based on 12-month CR rates of 19%-46%3 for 1L BCG-unresponsive therapies Registrational Pathway 1 Single-arm trial in 2L BCG-unresponsive NMIBC with CIS who are refractory to approved or developmental 1L therapies
©2026 R elm ada - Al l ri ghts r eserved Cohort 2A: 2L BCG-Unresponsive NMIBC 25 PHASE 3 RESCUE TRIAL Open-label, single-arm study to evaluate safety and efficacy of NDV-01 in BCG-UR refractory to first-line therapy Study design Inclusion Criteria Purpose • HR BCG-UR with CIS refractory to first-line therapy • Safety and efficacy of NDV-01 in patients with HR BCG-UR with CIS Secondary Endpoint Primary Endpoint Other • CR anytime • Safety • DOR • PFS • RFS amongst responders • PK 1. BCG-Unresponsive patients with CIS +/- Ta/T1 disease. Phase 3 Cohort 2A is a registrational cohort intended for regulatory appro val. 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 Intravesical NDV-01 Induction 6 biweekly instillations Maintenance Monthly instillations Follow up to 24 months Urinary cytology Cystoscopy TURBT or bladder biopsy if necessary Cohort 2A1 (Registrational; N=87) HR BCG-UR NMIBC with CIS refractory to 1st line therapy
©2026 R elm ada - Al l ri ghts r eserved Cohort 1: Adjuvant Intermediate-Risk NMIBC 26 PHASE 3 RESCUE TRIAL Registrational Randomized study of TURBT + NDV-01 vs. TURBT in IR NMIBC Inclusion Criteria Primary Endpoint • IR NMIBC • IBCG risk factors ≥ 1 • DFS* • Safety Intravesical NDV-01 Induction 6 biweekly instillations + maintenance Observation Option to have Induction with NDV-01 with recurrence Follow up to 24 months Urinary cytology Cystoscopy Upper tract imaging TURBT or bladder biopsy if necessary 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 Cohort 1 (Registrational; N=276) TURBT within 12 weeks (+/- single-dose peri-operative chemotherapy) Study design *DFS = time from randomization to the date of the first documented recurrence/progression. Stratification Factors: • LG vs. HG • Single-dose peri-operative chemotherapy: yes vs. no Secondary Endpoint • HG-RFS • PFS • QOL
©2026 R elm ada - Al l ri ghts r eserved Expecting to Advance NDV-01 Towards Registration-Track Studies in Mid-2026 27 Interim Phase 3 2L BCG-Unresponsive 3-month Data Initial 3-month CR data + safety Mid 2026 YE 2026 BCG: Bacillus Calmette-Guérin (BCG); NMIBC: No muscle invasive bladder cancer; IR: Intermediate Risk Initiate Phase 3 RESCUE Trial Target two independent registrational pathways: • 2L BCG-Unresponsive NMIBC patients • Adjuvant Intermediate-Risk NMIBC patients
©2026 R elm ada - Al l ri ghts r eserved Sepranolone A novel candidate, with potential to overcome the challenges of current therapies for compulsivity disorders 28
©2026 R elm ada - Al l ri ghts r eserved Sepranolone Has the Potential to Normalize GABAA Receptor Activity 29 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 R elm ada - Al l ri ghts r eserved OCD is characterized by intrusive, unwanted thoughts (obsessions) and repetitive behaviors (compulsions) US prevalence 8.2M people4 Neurological disorder characterized by repetitive, involuntary tics, with childhood onset US prevalence 350-450K children and adults3 Neurological disorder that causes involuntary, rhythmic shaking. Primarily notice during voluntary movements US prevalence 6.4 MM people2 Genetic disorder often defined by persistent hunger and overeating Global prevalence 350-400K people1 Positive Phase 2 Data and Unique MOA Give Sepranolone Broad Potential 30 Prader-Willi Syndrome Essential Tremors Tourette Syndrome Obsessive- Compulsive Disorder and related disorders 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 R elm ada - Al l ri ghts r eserved Sepranolone: Highlights & Development Value 31 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 mid-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 R elm ada - Al l ri ghts r eserved Expecting to Advance Sepranolone Towards Phase 2 Study in Prader-Willi Syndrome in Mid-2026 32 Initiation of Pilot Phase 2 study in Prader-Willi Syndrome Focus on evaluating early proof-of-concept PWS: Prader-Willi syndrome Mid 2026
©2026 R elm ada - Al l ri ghts r eserved 33 Corporate Summary
©2026 R elm ada - Al l ri ghts r eserved Financial Overview 34 Gross proceeds from PIPE (net ~$150M million) Provides cash runway through 2029 Cash, cash equivalents & short-term investments As of March 31, 2025 Common shares outstanding ~127.9 million as converted – includes ~15.0M outstanding options (weighted average exercise price of $12.51/share) and ~8.0M outstanding warrants $234.0 million1 $160 million PIPE2 ~104.9 million3 1. As of March 31, 2026 – Includes net proceeds of ~$150M from PIPE on March 9, 2026 ; 2. On March 9, 2026; 3. As of March 31, 2026
Thank You!
Appendix
©2026 R elm ada - Al l ri ghts r eserved Gem/Doce combination has been embraced by the urologic oncology community 37 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 cystectomy7, 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 R elm ada - Al l ri ghts r eserved Cohort 2B: 2L BCG-Unresponsive NMIBC 38 Open-label, single-arm study to evaluate safety and efficacy of NDV-01 in BCG-UR refractory to first-line therapy Study design PHASE 3 RESCUE TRIAL Inclusion Criteria Purpose • HR BCG-UR papillary only refractory to first-line therapy • Safety and efficacy of NDV-01 in patients with HR BCG-UR with CIS Secondary Endpoint Primary Endpoint Other • CR anytime • Safety • DOR • PFS • RFS amongst responders • PK 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 Intravesical NDV-01 Induction 6 biweekly instillations Maintenance Monthly instillations Follow up to 24 months Urinary cytology Cystoscopy TURBT or bladder biopsy if necessary Cohort 2B1 (Exploratory; N=30) HR BCG-UR NMIBC papillary only refractory to 1st line therapy
©2026 R elm ada - Al l ri ghts r eserved Sepranolone Has the Potential to Normalize GABAA Receptor Activity 39 GABA PAM https://asarinapharma.com/sepranolone/how-does-sepranolone-work/
©2026 R elm ada - Al l ri ghts r eserved Management 40 Leadership Sergio Traversa Chief Executive Officer Maged Shenouda Chief Financial Officer Chuck Ence Chief Accounting and Compliance Officer Paul Kelly Chief Operating Officer Raj S. Pruthi, MD Chief Medical Officer Charles J. Casamento Chairman of the Board John Glasspool Director Fabiana Fedeli Director Sergio Traversa Chief Executive Officer Board of Directors Paul Kelly Chief Operating Officer