Relmada Therapeutics (Nasdaq: RLMD) details Q2 2026 loss and NDV-01 Phase 3 path
Rhea-AI Filing Summary
Relmada Therapeutics reported Q2 2026 results and a business update centered on its oncology and CNS pipeline. For the three months ended June 30, 2026, it recorded a net loss of $12,914,185 on $8,393,789 in research and development expenses. Cash, cash equivalents and short‑term investments totaled $217.7 million as of June 30, 2026, and the company raised $159,999,996 from common stock issuance during the first half.
Lead candidate NDV‑01, a sustained‑release intravesical gemcitabine/docetaxel therapy for non‑muscle invasive bladder cancer, showed Phase 2a data in high‑risk patients with high complete response rates. Efficacy‑evaluable participants achieved complete response rates of 95% anytime and 76% at 12 months, with no progression to muscle‑invasive disease or radical cystectomy reported. In a BCG‑unresponsive subgroup, complete response rates were 94% anytime and 80% at 12 months. The company expects to file an NDV‑01 IND by year‑end 2026 and to initiate the Phase 3 RESCUE registrational program after IND clearance. Relmada also plans a year‑end 2026 IND filing for sepranolone, aiming to start a Phase 2 trial in Prader‑Willi syndrome.
Positive
- $217.7 million in cash, cash equivalents and short-term investments as of June 30, 2026, with management stating this capital is expected to fund operations through completion of the NDV-01 Phase 3 RESCUE program.
Negative
- None.
Filing Explained
By June 30, 2026, issued shares reached 106.7 million after financing and equity-linked exercises, reducing existing holders’ ownership percentages absent offsets.
The August 6 Form 8-K furnishes second-quarter results and a corporate update; its disclosed equity activity is completed issuance and warrant exercise, leaving
That compares with
The equity roll-forward records
A pre-funded warrant converts into shares at a nominal exercise price; the filing’s June 30 balance sheet separately reports
8-K Event Classification
Key Figures
Key Terms
non-muscle invasive bladder cancer (NMIBC) medical
BCG-unresponsive medical
intravesical medical
GABAA receptors medical
Prader-Willi Syndrome (PWS) medical
Earnings Snapshot
Management stated that capital is expected to fund operations through completion of the Phase 3 RESCUE program for NDV-01.
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What were Relmada Therapeutics (RLMD) key financial results for Q2 2026?
How is Relmada (RLMD) advancing NDV-01 and what are the next regulatory steps?
What Phase 2a efficacy has NDV-01 shown in high-risk NMIBC for Relmada (RLMD)?
What are the plans for Relmada Therapeutics (RLMD) sepranolone program?
How does Relmada (RLMD) describe its funding outlook for NDV-01 development?
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):
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telephone number, including area code: (
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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) |
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| 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:
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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 August 6, 2026, Relmada Therapeutics, Inc. (the “Company”) issued a press release providing a corporate update and reporting its financial results for the three months ended June 30, 2026. The Company also announced that it would conduct a conference call and audio webcast on Thursday, August 6, 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 June 30, 2026, and December 31, 2025, and for the three and six months ended June 30, 2026 and 2025, will be contained in its Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 2.02 by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02 of this Current Report on Form 8-K, including the information set forth in Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 7.01 Regulation FD Disclosure.
On August 6, 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 August 6, 2026, regarding a corporate update and reporting its financial results for the three and six months ended June 30, 2026 | |
| 99.2* | Corporate Presentation dated August 6, 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: August 6, 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 Second Quarter 2026 Financial Results and Provides Business Update
| ● | Advancing NDV-01 toward IND filing expected by year-end 2026 with GMP manufacturing of clinical trial material underway. Initiation of the Phase 3 RESCUE registrational program upon IND clearance. |
| ● | Sepranolone IND filing expected by year-end 2026 and initiation of Phase 2 proof-of-concept study in Prader-Willi Syndrome upon IND clearance. |
| ● | Strengthened the leadership team with appointment of Bipin Dalmia as Chief Business Officer. |
| ● | Added to the Russell 2000® and Russell 3000® Indexes effective June 26, 2026. |
| ● | Cash balance of $217.7 million as of June 30, 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 – August 6, 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 second quarter ended June 30, 2026, and provided a business update.
“Relmada has entered a critical execution phase as we prepare NDV-01 for registrational development. With FDA alignment, a robust clinical dataset, an experienced leadership team, and capital expected to fund operations through completion of the Phase 3 RESCUE program, we believe the Company is well positioned to create significant long-term value,” said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics. “Our immediate priority is manufacturing execution for NDV-01. Bringing a novel, sustained-release therapy of this kind into registrational development requires careful execution, and we are focused on completing the remaining activities needed to support the IND filing.”
Manufacturing and CMC Update
The Company is advancing manufacturing and chemistry, manufacturing, and controls (CMC) activities to support planned IND filings for both NDV-01 and sepranolone by year-end 2026. Each program is progressing along its own development path.
NDV-01: Manufacturing and CMC activities supporting the planned NDV-01 IND submission are ongoing. The Company expects to submit the NDV-01 IND by year-end 2026 and initiate the Phase 3 RESCUE registrational program upon IND clearance. Clinical trial sites are engaged and prepared to begin enrollment following IND clearance.
Sepranolone: Formulation development for sepranolone is complete, and the Company is finalizing the pre-filled syringe delivery system. This is the remaining step ahead of the sepranolone IND submission, which is expected by year-end 2026. The company expects to initiate the Phase 2 proof-of-concept study in Prader-Willi Syndrome following IND clearance.
Corporate Update
During the quarter, Relmada strengthened its leadership team with the appointment of Bipin Dalmia, PhD, MBA, as Chief Business Officer. He brings nearly three decades of biopharmaceutical leadership experience spanning business development, portfolio strategy, commercial planning, and uro-oncology, including leadership of the U.S. launch, indication expansion, global commercialization, and long-term manufacturing strategy for the first FDA-approved intravesical gene therapy for NMIBC.
“Since joining Relmada, I have become increasingly convinced that NDV-01 represents one of the most compelling opportunities in NMIBC,” said Bipin Dalmia, Chief Business Officer of Relmada Therapeutics. “As the NMIBC treatment landscape continues to evolve, patients and physicians are seeking therapies that deliver meaningful efficacy and durability without compromising convenience, tolerability, or ease of use. As we advance toward registrational development, NDV-01’s highly differentiated profile and potential applicability across multiple patient populations position it to become a foundational and best-in-class intravesical therapy across the NMIBC disease spectrum.”
Expected Upcoming Relmada Milestones:
NDV-01:
| ● | NDV-01 United States IND filing – By YE26 |
| ● | NDV-01 Phase 3 RESCUE program initiation – Upon IND Clearance |
Sepranolone:
| ● | Sepranolone United States IND filing – By YE26 |
| ● | Sepranolone Phase 2 initiation in Prader-Willi Syndrome – Upon IND Clearance |
Financial Results
Second Quarter 2026 Financial Results
| ● | Research and development expense for the three months ended June 30, 2026, totaled $8.4 million, compared to $2.8 million for the three months ended June 30, 2025, an increase of $5.6 million. The increase was primarily attributable to higher NDV-01 and sepranolone study costs and increased manufacturing and drug storage costs, partially offset by lower employee compensation. |
| ● | General and administrative expense for the three months ended June 30, 2026, totaled $6.6 million compared to $7.4 million for the three months ended June 30, 2025, a decrease of approximately $0.8 million. The decrease was primarily driven by lower stock-based compensation and lower employee compensation, partially offset by higher stock appreciation rights expense and consulting services. |
2
| ● | Net cash used in operating activities for the three months ended June 30, 2026, totaled $9.6 million compared to $6.4 million for the three months ended June 30, 2025. |
| ● | The net loss for the three months ended June 30, 2026, was $12.9 million, or $0.11 per basic and diluted share, compared with a net loss of $9.9 million, or $0.30 per basic and diluted share, for the three months ended June 30, 2025. |
| ● | As of June 30, 2026, the Company’s cash, cash equivalents, and short-term investments balance were $217.7 million, compared to cash, cash equivalents, and short-term investments of approximately $93.0 million at December 31, 2025. |
| ● | The Company’s current cash, cash equivalents, and short-term investments as of June 30, 2026, are expected to provide sufficient resources to fund Company operations through 2029, including completion of the Phase 3 NDV-01 RESCUE program. |
| ● | The Company had 106,669,846 shares outstanding, as of August 4, 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: Thursday, August 6, 2026 at 4:30 PM ET |
| ● | Participant Dial-in (US): 1-800-717-1738 |
| ● | Participant Dial-in (International): 1-646-307-1865 |
| ● | Webcast Access: Click Here |
A replay of the webcast will be available in the Investors section of the Relmada website at https://ir.relmada.com/investors/events/.
About NDV-01
NDV-01 is a novel, 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 sustained 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. NDV-01 is encompassed by multiple patent applications that if issued, could provide protection until 2047.
About the NDV-01 Phase 3 RESCUE Registrational Pathways:
Relmada has received written FDA feedback confirming alignment on two registrational development pathways for NDV-01, including study design, patient populations, and primary endpoints. The Company expects to submit an IND by year-end 2026 and initiate the Phase 3 RESCUE program upon IND clearance.
3
About NMIBC
NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence rates (50 – 80% over 5 years) and disease progression in a subset of these patients. With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. High-risk BCG-unresponsive disease represents the biggest unmet need in NMIBC, with limited and suboptimal bladder-sparing treatment options. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies and patients with recurrence must undergo repeated surgical resections. NDV-01 has the potential to serve as a foundational frontline or salvage therapy across the NMIBC disease spectrum.
About Sepranolone and GABA Modulation
Sepranolone, a synthetic isoallopregnanolone, selectively modulates GABAA receptors by antagonizing allopregnanolone (ALLO), without disrupting GABA signaling. It targets disorders linked to excess GABAergic activity such as Prader-Willi Syndrome (PWS), Tourette Syndrome, and Obsessive-Compulsive Disorder (OCD). More than 335 patients have been treated with sepranolone in clinical trials to date, with an excellent safety profile. The Company expects to submit an IND by year-end 2026 and initiate the Phase 2 study in Prader-Willi syndrome upon IND clearance.
About Prader-Willi Syndrome (PWS)
PWS is a rare genetic disorder caused by chromosomal deletions on chromosome 15, leading to neurodevelopmental and behavioral complications. Global prevalence is estimated to be 350,000-400,000 patients. Current treatments address symptoms but do not modify the underlying neurobehavioral pathology.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology and central nervous system conditions. Its lead candidates, NDV-01 and sepranolone, are advancing through clinical development with the potential to address significant unmet needs.
For more information, visit www.relmada.com
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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 successfully execute manufacturing and CMC activities for NDV-01 and/or sepranolone, including GMP manufacture of clinical trial material, manufacturing scale-up, process validation, timing of completion of manufacturing activities, and regulatory acceptance of manufacturing-related submissions, failure to secure adequate NDV-01 and/or sepranolone drug supply, failure of pending patent applications to result in issued patents, or issued patents being challenged and invalidated by third parties or not providing us with any competitive advantages, the Company’s cash runway and sufficiency of the Company’s cash resources and uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials, and the other risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein are not a complete list.
Investor Contact:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com
Media Inquiries:
Corporate Communications
media@relmada.com
5
Relmada Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| As of | ||||||||
| June 30, | As of | |||||||
| 2026 (Unaudited) | December 31, 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 11,334,370 | $ | 3,496,540 | ||||
| Short-term investments | 206,396,805 | 89,509,710 | ||||||
| Other receivable | 10,912 | - | ||||||
| Prepaid expenses | 1,297,590 | 977,721 | ||||||
| Total current assets | 219,039,677 | 93,983,971 | ||||||
| Other assets | 19,500 | 19,500 | ||||||
| Total assets | $ | 219,059,177 | $ | 94,003,471 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,409,190 | $ | 1,568,944 | ||||
| Accrued expenses | 5,011,583 | 4,861,583 | ||||||
| Total current liabilities | 7,420,773 | 6,430,527 | ||||||
| Stock appreciation rights | 5,080,081 | 1,060,931 | ||||||
| Total liabilities | 12,500,854 | 7,491,458 | ||||||
| Commitments and Contingencies (See Note 8) | ||||||||
| Stockholders’ Equity: | ||||||||
| Preferred stock, $0.001 par value, 200,000,000 shares authorized, none issued and outstanding | - | - | ||||||
| Class A convertible preferred stock, $0.001 par value, 3,500,000 shares authorized, none issued and outstanding | - | - | ||||||
| Common stock, $0.001 par value, 200,000,000 shares authorized, 106,669,846 and 73,333,622 shares issued and outstanding, respectively | 106,670 | 73,333 | ||||||
| Additional paid-in capital | 936,684,992 | 784,705,878 | ||||||
| Accumulated deficit | (730,233,339 | ) | (698,267,198 | ) | ||||
| Total stockholders’ equity | 206,558,323 | 86,512,013 | ||||||
| Total liabilities and stockholders’ equity | $ | 219,059,177 | $ | 94,003,471 | ||||
6
Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
| Three months ended | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 8,393,789 | $ | 2,819,377 | $ | 16,481,634 | $ | 14,770,400 | ||||||||
| General and administrative | 6,617,238 | 7,401,929 | 17,991,147 | 13,669,342 | ||||||||||||
| Total operating expenses | 15,011,027 | 10,221,306 | 34,472,781 | 28,439,742 | ||||||||||||
| Loss from operations | (15,011,027 | ) | (10,221,306 | ) | (34,472,781 | ) | (28,439,742 | ) | ||||||||
| Other (expenses) income: | ||||||||||||||||
| Interest/investment income, net | 2,301,394 | 321,458 | 3,261,156 | 761,745 | ||||||||||||
| Realized (loss) gain on short-term investments | (37,294 | ) | 47,203 | (47,162 | ) | 110,156 | ||||||||||
| Unrealized (loss) gain on short-term investments | (167,258 | ) | (13,797 | ) | (707,354 | ) | 141,934 | |||||||||
| Total other income | 2,096,842 | 354,864 | 2,506,640 | 1,013,835 | ||||||||||||
| Net loss | $ | (12,914,185 | ) | $ | (9,866,442 | ) | $ | (31,966,141 | ) | $ | (27,425,907 | ) | ||||
| Loss per common share – basic and diluted | $ | (0.11 | ) | $ | (0.30 | ) | $ | (0.32 | ) | $ | (0.86 | ) | ||||
| Weighted average number of common shares outstanding – basic and diluted | 112,375,941 | 33,191,622 | 99,327,509 | 31,807,943 | ||||||||||||
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Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(Unaudited)
| Three and Six months ended June 30, 2026 | ||||||||||||||||||||
| Common Stock | Additional Paid-in | Accumulated | ||||||||||||||||||
| Shares | Par Value | Capital | Deficit | Total | ||||||||||||||||
| Balance – December 31, 2025 | 73,333,622 | $ | 73,333 | $ | 784,705,878 | $ | (698,267,198 | ) | $ | 86,512,013 | ||||||||||
| Stock based compensation | - | - | 956,186 | - | 956,186 | |||||||||||||||
| Proceeds from issuance of common stock, net | 29,474,569 | 29,475 | 150,352,510 | - | 150,381,985 | |||||||||||||||
| ATM Fees | - | - | (65,651 | ) | - | (65,651 | ) | |||||||||||||
| Cashless exercise of pre-funded warrants for common stock | 2,082,032 | 2,082 | (2,082 | ) | - | - | ||||||||||||||
| Net loss | - | - | - | (19,051,956 | ) | (19,051,956 | ) | |||||||||||||
| Balance – March 31, 2026 | 104,890,223 | 104,890 | 935,946,841 | (717,319,154 | ) | 218,732,577 | ||||||||||||||
| Stock based compensation | - | - | 902,903 | - | 902,903 | |||||||||||||||
| ATM fees | - | - | (66,273 | ) | - | (66,273 | ) | |||||||||||||
| Stock issuance costs | - | - | (199,879 | ) | - | (199,879 | ) | |||||||||||||
| Exercise of pre-funded warrants for common stock | 1,682,500 | 1,683 | - | - | 1,683 | |||||||||||||||
| Options exercised | 97,123 | 97 | 101,400 | - | 101,497 | |||||||||||||||
| Net loss | - | - | - | (12,914,185 | ) | (12,914,185 | ) | |||||||||||||
| Balance – June 30, 2026 | 106,669,846 | $ | 106,670 | $ | 936,684,992 | $ | (730,233,339 | ) | $ | 206,558,323 | ||||||||||
| Three and Six months ended June 30, 2025 | ||||||||||||||||||||
| Common Stock | Additional Paid-in | Accumulated | ||||||||||||||||||
| Shares | Par Value | Capital | Deficit | Total | ||||||||||||||||
| Balance – December 31, 2024 | 30,174,202 | $ | 30,174 | $ | 676,373,822 | $ | (640,882,035 | ) | $ | 35,521,961 | ||||||||||
| Stock based compensation | - | - | 3,572,769 | - | 3,572,769 | |||||||||||||||
| Issuance of Restricted Common Stock | 3,017,420 | 3,017 | 902,209 | - | 905,226 | |||||||||||||||
| Net loss | - | - | - | (17,559,465 | ) | (17,559,465 | ) | |||||||||||||
| Balance – March 31, 2025 | 33,191,622 | 33,191 | 680,848,800 | (658,441,500 | ) | 22,440,491 | ||||||||||||||
| Stock based compensation | - | - | 3,448,453 | - | 3,448,453 | |||||||||||||||
| ATM Expenses | - | - | (73,021 | ) | - | (73,021 | ) | |||||||||||||
| Net loss | - | - | - | (9,866,442 | ) | (9,866,442 | ) | |||||||||||||
| Balance – June 30, 2025 | 33,191,622 | $ | 33,191 | $ | 684,224,232 | $ | (668,307,942 | ) | $ | 15,949,481 | ||||||||||
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Relmada Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)
| Six months ended June 30, | ||||||||
| 2026 | 2025 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (31,966,141 | ) | $ | (27,425,907 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 1,859,089 | 7,021,222 | ||||||
| Stock appreciation rights compensation | 4,019,150 | 27,649 | ||||||
| Issuance of restricted common stock | - | 905,226 | ||||||
| Realized loss/(gain) on short-term investments | 47,162 | (110,156 | ) | |||||
| Unrealized loss/(gain) on short-term investments | 707,354 | (141,934 | ) | |||||
| Change in operating assets and liabilities: | ||||||||
| Prepaid expenses and other assets | (319,869 | ) | 411,834 | |||||
| Accounts payable | 840,246 | (2,768,652 | ) | |||||
| Accrued expenses | 150,000 | (2,388,191 | ) | |||||
| Other receivable | (10,912 | ) | - | |||||
| Net cash used in operating activities | (24,673,921 | ) | (24,468,909 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of short-term investments | (174,270,466 | ) | (809,375 | ) | ||||
| Sale of short-term investments | 56,628,855 | 22,847,630 | ||||||
| Net cash (used in)/provided by investing activities | (117,641,611 | ) | 22,038,255 | |||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of common stock | 159,999,996 | - | ||||||
| Payment of fees for issuance of common stock | (9,817,890 | ) | - | |||||
| Proceeds from options exercised for common stock | 101,497 | - | ||||||
| Proceeds from warrants exercised for common stock | 1,683 | - | ||||||
| ATM fees | (131,924 | ) | (73,021 | ) | ||||
| Net cash provided/(used in) by financing activities | 150,153,362 | (73,021 | ) | |||||
| Net increase/(decrease) in cash and cash equivalents | 7,837,830 | (2,503,675 | ) | |||||
| Cash and cash equivalents at beginning of the period | 3,496,540 | 3,857,026 | ||||||
| Cash and cash equivalents at end of the period | $ | 11,334,370 | $ | 1,353,351 | ||||
| Non-cash investing and financing activities | ||||||||
| Cashless exercise of warrants for common stock | $ | (2,082 | ) | - | ||||
9
Exhibit 99.2
Unlocking Life Changing Therapies Corporate Overview | August 2026
©2026 Relmada - All rights reserved Disclosures 2 The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This 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 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 Relmada - All rights reserved 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) 2H26: Continued enrollment and long-term follow-up By YE26: File NDV-01 IND NDV-01 Intermediate-Risk NMIBC (RESCUE Cohort 1) Upon IND Clearance: Initiate RESCUE Phase 3 registrational Cohort 1 NDV-01 2L BCG-Unresponsive (RESCUE Cohort 2A)2 Upon IND Clearance: Initiate RESCUE Phase 3 registrational Cohort 2A NDV-01 2L BCG-Unresponsive (RESCUE Cohort 2B)3 Upon IND Clearance: Initiate RESCUE Phase 2 exploratory Cohort 2B Sepranolone Prader-Willi Syndrome (PWS) By YE26: File Sepranolone IND Upon IND Clearance: Initiate Phase 2 study 1. NDV-01: A sustained-release intravesical formulation of gemcitabine/docetaxel (Gem/Doce); 2. BCG-Unresponsive patients with CIS +/- Ta/T1 disease; Phase 3 Cohort 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 Focused on programs with positive proof-of-concept data Upon IND Clearance Upon IND Clearance Upon IND Clearance Upon IND Clearance
©2026 Relmada - All rights reserved NDV-01 A sustained-release intravesical formulation of gemcitabine/docetaxel (Gem/Doce) for patients with NMIBC, with positive Phase 2a data1 5 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 NMIBC Represents Multi-Billion Dollar Market Opportunity 6 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 Relmada - All rights reserved Potential 2L NDV-01 Usage * NMIBC Patient Journey 7 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 Relmada - All rights reserved Systemic Therapy Overview of NMIBC Treatment Landscape 8 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 Relmada - All rights reserved Gem/Doce Combination Stands Out in Urology Times Survey1 9 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 Relmada - All rights reserved vs. <5 minutes for NDV-01 Significant Issues with Conventional Gem/Doce Intravesical Therapy for NMIBC 10 NMIBC: Non-muscle invasive bladder cancer; Gem/Doce: Gemcitabine plus Docetaxel vs. NDV-01 comes ready for use in two pre-filled plastic syringes vs. NDV-01 which provides the opportunity for community urologist to deliver Gem/Doce vs. NDV-01 which provides sustained release of Gem/Doce for up to 10 days 4-hour total conventional Gem/Doce procedure time Requires specialized pharmacy preparation Utilization concentrated in academic setting Limited drug exposure and dwell time
©2026 Relmada - All rights reserved NDV-01 - Targeted Sustained-Release Intravesical Gem/Doce 11 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 Relmada - All rights reserved NDV-01 in-vitro Drug Concentrations Show Continuous & Optimized Drug Release 12 • 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 100ml artificial urine (AUF) and kept in an orbital shaker incubator at 370C, 20 rpm. 87ml of the AUF sample was withdrawn twice a day and replaced by 85ml of fresh AUF. The drugs concertation in the UAF was quantitatively determined by HPLC
©2026 Relmada - All rights reserved NDV-01: Clinically De-Risked with Clear Competitive Advantages 13 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 Relmada - All rights reserved 14 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 Inclusion Criteria Purpose Primary Endpoint Secondary Endpoint Exploratory Study Design 15 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 Relmada - All rights reserved Demographic Data 16 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: Noninvasive papillary carcinoma; T1: Tumor invades lamina propria; HG: High grade
©2026 Relmada - All rights reserved 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 17 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 Relmada - All rights reserved Efficacy Results 18 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 Relmada - All rights reserved Treatment-Related AE and Tolerability 19 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 Relmada - All rights reserved 20 Recurrent / Endovesical / Surgery-sparing / Combination therapy for / Urothelial cancer / Effectiveness Phase 3 Program
©2026 Relmada - All rights reserved Two Independent NDV-01 Approval Pathways Provide Significant Market Opportunity 21 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 Relmada - All rights reserved Cohort 2A: 2L BCG-Unresponsive NMIBC 22 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 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 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 Relmada - All rights reserved Cohort 1: Adjuvant Intermediate-Risk NMIBC 23 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 Relmada - All rights reserved Expect to File NDV-01 IND By YE26 and Initiate Phase 3 RESCUE Program Upon IND Clearance 24 Initiate Phase 3 RESCUE Trial Target two independent registrational pathways: • 2L BCG-Unresponsive NMIBC patients • Adjuvant Intermediate-Risk NMIBC patients YE26 Upon IND Clearance BCG: Bacillus Calmette-Guérin (BCG); NMIBC: No muscle invasive bladder cancer; IR: Intermediate Risk NDV-01 United States IND Filing
©2026 Relmada - All rights reserved Sepranolone A novel candidate, with potential to overcome the challenges of current therapies for compulsivity disorders 25
©2026 Relmada - All rights reserved Sepranolone Has the Potential to Normalize GABAA Receptor Activity 26 GABA (Υ-aminobutyric acid) is the primary neurotransmitter, involved in anxiety and compulsive disorders1,2 Allopregnanolone (ALLO) typically enhances GABAA calming effects3, 4 In some individuals, ALLO exacerbates anxiety and compulsivity5, 6 Sepranolone normalizes GABAA receptor activity without interfering in GABA signaling7,8 1. Nuss P et al. Neuropsychiatr Dis Treat. 2015. 2. Möhler H. Neuropharmacology. 2012. 3. Belelli D et al. Nat Rev Neurosci. 2005. 4. Majewska MD et al. Science. 1986. 5. Girdler SS et al. Biol Psychiatry. 2001. 6. Bixo M et al. Br J Psychiatry. 2025. 7. Bixo M et al. Psychoneuroendocrinology. 2017. 8. Bäckström T et al. Psychoneuroendocrinology. 2021. GABAA: Υ-aminobutyric acid type A; ALLO: Allopregnanolone
©2026 Relmada - All rights reserved 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 27 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 Relmada - All rights reserved Sepranolone: Highlights & Development Value 28 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 Relmada - All rights reserved Expect to File Sepranolone IND By YE26 and Initiate Phase 2 Trial in PWS Upon IND Clearance 29 Initiation of Phase 2 study in Prader-Willi Syndrome Focus on evaluating early proof-of-concept YE26 Upon IND Clearance PWS: Prader-Willi syndrome Sepranolone United States IND Filing
©2026 Relmada - All rights reserved Corporate Summary 30
©2026 Relmada - All rights reserved Financial Overview 31 $217.7 million1 ~106.7 million1 1. As of June 30, 2026; ~127.9M as converted – includes ~14.9M outstanding options (weighted average exercise price of $12.58/share) and ~6.3M outstanding warrants Common shares outstanding Cash, cash equivalents & short-term investments As of June 30, 2026
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