NDV-01 hits 76% 12-month CR as Relmada (RLMD) secures $160M PIPE
Rhea-AI Filing Summary
Relmada Therapeutics entered into a private placement securities purchase agreement with institutional and accredited investors for approximately $160.0 million, selling 29,474,569 common shares at $4.75 and pre-funded warrants for 4,210,527 shares at $4.749 with a $0.001 exercise price. Closing is expected on March 11, 2026, and proceeds are earmarked for working capital and to advance research and development of its product candidates. Investors receive registration rights for resale and liquidated damages if registration timelines are missed.
The company also reported 12‑month interim Phase 2 NDV‑01 data in high‑risk non‑muscle invasive bladder cancer, showing a 12‑month complete response rate of 76% overall and 80% in the BCG‑unresponsive subgroup, with no progression to muscle‑invasive disease or radical cystectomies. These results support moving NDV‑01 into the Phase 3 RESCUE registrational program across both adjuvant intermediate‑risk and second‑line BCG‑unresponsive settings.
Positive
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Insights
Relmada raises $160M alongside strong NDV‑01 Phase 2 data.
Relmada Therapeutics secured commitments for a
Concurrently, 12‑month interim Phase 2 data for NDV‑01 in high‑risk NMIBC showed a 12‑month complete response rate of
Together, a sizable equity financing and encouraging durability and safety data meaningfully strengthen both the balance sheet and the development narrative for NDV‑01. Actual long‑term impact will depend on executing the Phase 3 design described and maintaining similar efficacy and tolerability in larger, multi‑center settings.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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Item 1.01 Entry into a Material Definitive Agreement.
On March 9, 2026, Relmada Therapeutics, Inc. (the “Company”) entered into a Securities Purchase Agreement (the “Purchase Agreement”) for a private placement (the “Private Placement”) with certain institutional and accredited investors (each, a “Purchaser” and collectively, the “Purchasers”). The closing of the Private Placement (the “Closing”) is expected to occur on March 11, 2026, subject to the satisfaction of customary closing conditions.
Pursuant to the Purchase Agreement, the Purchasers have agreed to purchase, for an aggregate purchase price of approximately $160.0 million, an aggregate of (i) 29,474,569 shares (“Shares”) of the Company’s common stock, par value $0.001 per share (the “Common Stock”), at a price of $4.75 per Share and (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 4,210,527 shares of Common Stock (the “Pre-Funded Warrant Shares”) at a price of $4.749 per Pre-Funded Warrant, which represents the per share purchase price for the Shares less the $0.001 per share exercise price for each such Pre-Funded Warrant. The Company intends to use the net proceeds from the Private Placement for working capital and general corporate purposes, which includes the advancement of research and development of its product candidates.
Each of the Pre-Funded Warrants is immediately exercisable, has an exercise price of $0.001 and may be exercised at any time after the date of issuance. A holder of Pre-Funded Warrants may not exercise its Pre-Funded Warrant if the holder, together with its affiliates, would beneficially own more than 9.99% (or, at the election of the purchaser, 4.99%) of the number of shares of the Common Stock outstanding immediately after giving effect to such exercise. A holder of Pre-Funded Warrants may increase or decrease this percentage not in excess of 9.99% by providing at least 61 days’ prior notice to the Company.
Also on March 9, 2026, the Company entered into a Registration Rights Agreement (the “Registration Rights Agreement”) with the Purchasers. Pursuant to the Registration Rights Agreement, the Company has agreed to prepare and file, as promptly as reasonably practicable and in any event no later than the later of (x) 45 days after the Closing and (y) one business day after the Company files its Annual Report on Form 10-K for the year ended December 31, 2025 (the “Filing Deadline”), one or more registration statements with the Securities and Exchange Commission (the “SEC”) to register for resale the Shares and the Pre-Funded Warrant Shares, and to cause the applicable registration statements to become effective within the time periods set forth in the Registration Rights Agreement (the “Effectiveness Deadline”). The Company has granted the Purchasers customary indemnification rights in connection with the Registration Rights Agreement. The Purchasers have also granted the Company customary indemnification rights in connection with the Registration Rights Agreement.
In the event the registration statement has not been filed by the Filing Deadline or has not been declared effective by the SEC by the Effectiveness Deadline, subject to certain limited exceptions, the Company has agreed to make pro rata payments to each Purchaser as liquidated damages in an amount equal to 1.0% of the aggregate amount paid pursuant to the Purchase Agreement by such Purchaser, per 30-day period or pro rata for any portion thereof for each such 30-day period during which such event continues, subject to certain caps set forth in the Purchase Agreement.
The Purchase Agreement contains customary representations, warranties and covenants that were made solely for the benefit of the parties to the Purchase Agreement. Such representations, warranties and covenants (i) are intended as a way of allocating risk between the parties to the Purchase Agreement and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company.
The Company has engaged Jefferies LLC, Leerink Partners LLC, Piper Sandler & Co. and Mizuho Securities USA LLC as placement agents for the Private Placement. The Company has agreed to pay customary placement fees and reimburse certain expenses of the placement agents.
The foregoing is only a summary of the terms of the Purchase Agreement, the Registration Rights Agreement and the Pre-Funded Warrants issued under the Purchase Agreement, does not purport to be complete and is qualified in its entirety by reference to the full text of (i) the form of the Purchase Agreement, a copy of which is attached as Exhibit 10.1 to this Current Report on Form 8-K, (ii) the form of the Registration Rights Agreement, a copy of which is attached as Exhibit 10.2 to this Current Report on Form 8-K, and (iii) the form of Pre-Funded Warrant issued under the Purchase Agreement, a copy of which is attached as Exhibit 4.1 to this Current Report on Form 8-K, and are incorporated herein by reference.
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Item 3.02. Unregistered Sales of Equity Securities.
The disclosure regarding the securities to be sold and issued under the Purchase Agreement as set forth under Item 1.01 of this report is incorporated by reference under this Item 3.02.
The securities described above under Item 1.01 have not been registered under the Securities Act of 1933, as amended (the “Securities Act”). Based in part upon the representations of the Purchasers in the Purchase Agreement, the Company relied on the exemption afforded by Section 4(a)(2) under the Securities Act.
Neither this Current Report on Form 8-K nor any exhibit attached hereto is an offer to sell or the solicitation of an offer to buy any securities of the Company.
Item 7.01 Regulation FD Disclosure.
On March 9, 2026, the Company issued a press release announcing NDV-01 12-month Phase 2 data. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Also on March 9, 2026, the Company issued a press release announcing the Private Placement. A copy of the press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K.
Also on March 9, 2026, the Company made available a presentation relating to NDV-01 12-month Phase 2 data. A copy of the presentation is furnished as Exhibit 99.3 to this Current Report on Form 8-K.
The information contained in Item 7.01 of this Current Report on Form 8-K and in Exhibits 99.1, 99.2 and 99.3 attached hereto will not be treated as “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. This information will not be incorporated by reference into any filing under the Securities Act or into another filing under the Exchange Act, unless that filing expressly incorporates this information by reference.
Item 8.01. Other Events.
On March 9, 2026, the Company announced 12-month interim data from its ongoing Phase 2 trial evaluating NDV-01 in patients with high-risk non-muscle invasive bladder cancer (“NMIBC”). The Phase 2 trial of NDV-01 demonstrated a 12-month complete response (“CR”) rate of 76% with a favorable safety profile. A 12-month CR rate of 80% was achieved in the Bacillus Calmette-Guérin (“BCG”)-unresponsive population, one of the most difficult-to-treat segments of NMIBC. Taken together, these findings support the potential best-in-class profile of NDV-01 and support advancement into the Phase 3 RESCUE registrational program evaluating NDV-01 in both second line (“2L”) BCG-unresponsive and adjuvant intermediate-risk NMIBC.
Highlights of the 12-month follow-up data from the Ongoing Phase 2 study of NDV-01:
| Clinical Results (Response Data) | |
| Complete Response | |
| Anytime | 95% (36/38) |
| 3 month | 87% (33/38) |
| 6 month | 86% (25/29) |
| 9 month | 85% (22/26) |
| 12 month | 76% (19/25) |
| 12-month KM analysis | 83% |
| N=48 patients dosed in overall population; KM: Kaplan-Meier analysis | |
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Efficacy in BCG-Unresponsive Subpopulation**:
| Clinical Results (Response Data) | |
| Complete Response | |
| Anytime | 94% (16/17) |
| 3 month | 82% (14/17) |
| 6 month | 86% (12/14) |
| 9 month | 91% (10/11) |
| 12 month | 80% (8/10) |
| 12-month KM analysis | 84% |
| N=20 patients dosed in BCG-UR subpopulation; ** BCG-UR defined by FDA definition; BCG-UR: Bacillus Calmette-Guérin (BCG) – Unresponsive; KM: Kaplan-Meier analysis | |
| ● | No patient had progression to muscle-invasive disease |
| ● | No patient underwent a radical cystectomy |
| ● | No patients had a ≥ Grade 3 treatment related adverse event (“TRAE”) |
| ● | No patients discontinued treatment due to adverse event (“AE”) |
| ● | Of the 48 patients who received ≥ 1 dose, 30 (63%) experienced a treatment-related AEs. |
| ● | Among treatment-related AEs, |
| o | 54% were transient uncomfortable urination (dysuria, <24 hours, Grade 1) |
| o | 8% had an asymptomatic positive urine culture |
| o | 8% had hematuria |
Phase 3 RESCUE Registrational Pathways:
Registrational Pathway 1 – An open label randomized controlled trial in intermediate-risk NMIBC of adjuvant therapy following TURBT (NDV-01 vs. observation). There are no approved treatments for adjuvant intermediate risk NMIBC, which we estimate affects approximately 75,000 patients per year in the United States.
| ● | Primary endpoint: Disease Free Survival (“DFS”) |
| ● | Key secondary endpoints: High-grade recurrence free survival (“HG-RFS”), progression free survival (“PFS”), quality of life (“QOL”) metrics |
Registration Pathway 2 – A single-arm trial in 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 the Company estimates to affect approximately 5,000 patients per year in the United States, have few, if any, effective treatment alternatives to radical cystectomy.
| ● | Primary endpoint: CR rate at any time |
| ● | Key secondary endpoint: Duration of response (“DOR”), PFS, recurrence free survival (“RFS”) amongst responders |
Expected Upcoming NDV-01 Milestones:
| ● | NDV-01 United States IND clearance – Mid-2026 |
| ● | Phase 3 RESCUE Program Initiation – Mid-2026 |
| ● | Initial 3-month results from Phase 3 2L BCG-unresponsive study expected by year-end 2026 |
Statements contained in this Current Report on Form 8-K regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may involve risks and uncertainties, such as statements related to the Company’s ability to complete the Private Placement, the anticipated proceeds to be received in the Private Placement, the expected timing of the closing of the Private Placement, the intended use of proceeds from the Private Placement and the Company’s plans and expectations with respect to its product candidates. The risks and uncertainties involved include the risks detailed from time to time in the Company’s SEC filings, including in its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 27, 2025.
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Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 4.1 | Form of Pre-Funded Warrant. | |
| 10.1* | Form of Purchase Agreement, dated March 9, 2026, by and among the Company and the Purchasers | |
| 10.2 | Form of Registration Rights Agreement, dated March 9, 2026, by and among the Company and the Purchasers | |
| 99.1 | Press Release, dated March 9, 2026, announcing NDV-01 12-month Phase 2 data. | |
| 99.2 | Press Release, dated March 9, 2026, announcing the Private Placement. | |
| 99.3 | NDV-01 12-month Phase 2 data Presentation. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
| * | Schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the SEC upon request. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: March 9, 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 12-Month Phase 2 Interim Data for NDV-01 in Non-Muscle Invasive Bladder Cancer
| ● | Durable 76% complete response (CR) rate at 12 months with 95% CR rate at any time in high-risk NMIBC |
| ● | BCG-unresponsive patients achieved an 80% CR rate at 12 months and 94% CR rate at any time |
| ● | Tolerability profile remains favorable – no ≥ Grade 3 treatment-related adverse events and no treatment-related discontinuations |
| ● | Data reinforces advancement of NDV-01 into Phase 3 RESCUE registrational program in second line (2L) BCG-unresponsive and adjuvant intermediate-risk NMIBC in mid-2026 |
CORAL GABLES, FL – March 9 2026 (GlobeNewswire) – 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 announced 12-month interim data from its ongoing Phase 2 trial evaluating NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC).
The Phase 2 trial of NDV-01 demonstrated a 12-month complete response (CR) rate of 76% with a favorable safety profile. Notably, a 12-month CR rate of 80% was achieved in the BCG-unresponsive population, one of the most difficult-to-treat segments of NMIBC. Taken together, these findings support the potential best-in-class profile of NDV-01 and support advancement into the Phase 3 RESCUE registrational program evaluating NDV-01 in both 2L BCG-unresponsive and adjuvant intermediate-risk NMIBC.
“These 12-month data show the potential durability of NDV-01’s clinical response profile while continuing to demonstrate a clean safety profile” said Raj S. Pruthi, MD, Chief Medical Officer-Oncology of Relmada Therapeutics. “Importantly, we continue to observe strong responses in patients with BCG-unresponsive disease, with no progression to muscle-invasive disease and no patients requiring radical cystectomy. We believe these interim results provide meaningful clinical validation of the program and support advancing NDV-01 into the registrational Phase 3 RESCUE program with two separate registrational pathways: 2L BCG-unresponsive and adjuvant intermediate-risk, which we expect to initiate in mid-2026.”
“I am highly encouraged by NDV-01’s high response rates, 12-month durability and favorable tolerability profile. Building on the clinical community’s familiarity with conventional Gem/Doce, these Phase 2 results provide robust validation of NDV-01’s novel sustained release formulation. In addition, NDV-01’s less than 5-minute administration simplifies dosing for clinical staff, supporting broad adoption in community urology practices where ~80% of NMIBC patients are treated – and potentially offering a significantly more streamlined user experience than currently approved therapies,” said Max Kates, MD, Director of Urologic Oncology at Johns Hopkins and Relmada Clinical Advisor.
Highlights of the 12-month follow-up data from the Ongoing Phase 2 study of NDV-01:
| Clinical Results (Response Data) | |
| Complete Response | |
| Anytime | 95% (36/38) |
| 3 month | 87% (33/38) |
| 6 month | 86% (25/29) |
| 9 month | 85% (22/26) |
| 12 month | 76% (19/25) |
| 12-month KM analysis | 83% |
| N=48 patients dosed in overall population; KM: Kaplan-Meier analysis | |
Efficacy in BCG-Unresponsive Subpopulation**:
|
Clinical Results (Response Data) | |
| Complete Response | |
| Anytime | 94% (16/17) |
| 3 month | 82% (14/17) |
| 6 month | 86% (12/14) |
| 9 month | 91% (10/11) |
| 12 month | 80% (8/10) |
| 12-month KM analysis | 84% |
| N=20 patients dosed in BCG-UR subpopulation; ** BCG-UR defined by FDA definition; BCG-UR: Bacillus Calmette-Guérin (BCG) – Unresponsive; KM: Kaplan-Meier analysis | |
| ● | No patient had progression to muscle-invasive disease |
| ● | No patient underwent a radical cystectomy |
| ● | No patients had a ≥ Grade 3 treatment related adverse event (TRAE) |
| ● | No patients discontinued treatment due to AEs |
| ● | Of the 48 patients who received ≥ 1 dose, 30 (63%) experienced a treatment-related adverse event (AE). |
| ● | Among treatment-related AEs, |
| o | 54% were transient uncomfortable urination (dysuria, <24 hours, Grade 1) |
| o | 8% had an asymptomatic positive urine culture |
| o | 8% had hematuria |
Phase 3 RESCUE Registrational Pathways:
Registrational Pathway 1 – An open label randomized controlled trial in intermediate-risk NMIBC of adjuvant therapy following TURBT (NDV-01 vs. observation). There are no approved treatments for adjuvant intermediate risk NMIBC, which we estimate affects ~75,000 patients/year in the US.
| ● | Primary endpoint: Disease Free Survival (DFS) |
| ● | Key secondary endpoints: High-grade recurrence free survival (HG-RFS), progression free survival (PFS), quality of life (QOL) metrics |
2
Registration Pathway 2 – A single-arm trial in second line (2L) BCG-unresponsive NMIBC with carcinoma in situ (CIS) patients who are currently refractory to approved or developmental therapies. Patients with BCG-unresponsive NMIBC with CIS who fail first line (1L) therapies, which we estimate to affect ~5,000 patients/year in the US, have few, if any, effective treatment alternatives to radical cystectomy.
| ● | Primary endpoint: Complete response (CR) rate at any time |
| ● | Key secondary endpoint: Duration of response (DOR), progression free survival (PFS), recurrence free survival (RFS) amongst responders |
Expected Upcoming NDV-01 Milestones:
| ● | NDV-01 United States IND clearance – Mid-2026 |
| ● | Phase 3 RESCUE Program Initiation – Mid-2026 |
| ● | Initial 3-month results from Phase 3 2L BCG-unresponsive study expected by YE 2026 |
About NDV-01
NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. The NDV-01 formulation is ready to use, convenient to administer in-office in approximately 5 minutes and does not require anesthesia or specialized equipment. It is protected by patents through 2038.
About the Phase 2 Study
The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with HG-NMIBC. Patients are treated with NDV-01 in a biweekly induction phase, followed by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated. The primary efficacy endpoints are safety and complete response rate (CRR) at 12 months, and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS).
About NMIBC
NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence (50 – 80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. High-grade BCG-unresponsive disease represents one of the most difficult-to-treat NMIBC subtypes, with limited bladder-sparing options. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.
About 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
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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 progress, including the potential for Phase 2 NDV-01 data to continue to deliver positive results supporting further development, potential for clinical trials to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to continue to secure FDA agreement on the regulatory path for NDV-01 and/or sepranolone, or that future NDV-01 and/or sepranolone clinical results will be acceptable to the FDA, failure to secure adequate NDV-01 and/or sepranolone drug supply, the Company’s cash runway and sufficiency of the Company’s cash resources and uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials, and the other risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein are not a complete list.
Investor Contact:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com
Media Inquiries:
Corporate Communications
media@relmada.com
4
Exhibit 99.2
Relmada Therapeutics Announces Oversubscribed $160.0 Million Private Placement Financing
CORAL GABLES, Fla., March 9, 2026 /GlobeNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system indications, today announced that it has entered into a securities purchase agreement for a private investment in public equity (“PIPE”) financing that is expected to result in gross proceeds of approximately $160.0 million to the Company, before placement agent fees and offering expenses. The PIPE financing included participation from Venrock Healthcare Capital Partners, Commodore Capital, Janus Henderson Investors, RA Capital Management, Balyasny Asset Management, OrbiMed, Spruce Street Capital, Squadron Capital Management, Columbia Threadneedle Investments, Adage Capital Management, Marshall Wace, Braidwell LP, Great Point Partners, LLC and Eventide Asset Management.
Pursuant to the terms of the securities purchase agreement, Relmada is selling an aggregate of (i) 29,474,569 shares of its common stock (“Common Stock”) at a purchase price of $4.75 per share and (ii) pre-funded warrants to purchase 4,210,527 shares of Common Stock at a purchase price of $4.749 per pre-funded warrant. The pre-funded warrants have an exercise price of $0.001 per share. The PIPE financing is expected to close on or about March 11, 2026, subject to satisfaction of customary closing conditions.
Relmada intends to use the net proceeds from the PIPE financing, together with existing cash, cash equivalents, and short-term investments, for working capital and general corporate purposes, which includes the advancement of research and development of its product candidates.
Jefferies, Leerink Partners, Piper Sandler and Mizuho are acting as placement agents for the PIPE financing.
The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Concurrently with the execution of the securities purchase agreement, Relmada and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of Common Stock and the Common Stock issuable upon exercise of the pre-funded warrants, in each case sold in the PIPE financing.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Relmada Therapeutics, Inc.
Relmada 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.
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, including but not limited to statements regarding Relmada’s ability to complete the PIPE financing, the anticipated proceeds to be received in the PIPE financing, the expected timing of the closing of the PIPE financing and the expected use of the proceeds from the PIPE financing. 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 “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 the 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 considered a complete list.
Investor Contact:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com
Media Inquiries:
Corporate Communications
media@relmada.com
Source: Relmada Therapeutics
Exhibit 99.3
NDV - 01 12 - Month Phase 2 Data March 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 27 A of the Securities Act of 1933 and Section 21 E 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 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 .
©2026 Relmada - All rights reserved Inclusion Criteria • High - risk disease with CIS, Ta/T 1 tumors 1, 2 • BCG - naive, BCG - unresponsive, intolerant and experienced patients Purpose Evaluate the potential of NDV - 01 as a safe and effective treatment for patients with high - risk NMIBC Primary Endpoint • Safety • CR Rate at 12 months Secondary Endpoint Exploratory • PK TRCG - 011 for High - Risk NMIBC Study Design 3 • DOR • EFS 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, pp. 533 – 38, doi:10.1097/ju.0000000000003846. 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 4 % N=48 Characteristics Age 75 (52 - 93) yr Median (range) Sex 87.5% 42 Male 12.5% 6 Female BCG doses 9 (0 - 23) Median BCG doses (range) BCG - status 47.9% 23 BCG - naive 10.4% 5 BCG - exposed 41.7% 20 BCG - unresponsive Stage 25.0% 12 CIS +/ - Ta/T1 60.4% 29 Ta HG 14.6% 7 T1 HG BCG: Bacillus Calmette - Guérin; CIS: Carcinoma In Situ; Ta: Noninvasive papillary carcinoma; T1: Tumor invades lamina propria ; HG: High grade
©2026 Relmada - All rights reserved 45. T1 BCG - naive Pending 46. 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 59. CIS BCG - UR Pending 60. T 1 BCG - naive Pending 01 - 062 CIS BCG - naive Pending 12 months NDV - 01 Provided Durable Response Over Time 5 Patient # Stage BCG status 3 months 6 months 9 months 01 - 002 CIS BCG - UR 01 - 007 T1 BCG - exposed 9. T1 BCG - UR 10. T1 BCG - naive 11. T1+CIS BCG - naive 13. Ta BCG - exposed 14. Ta BCG - naive 15. Ta BCG - naive 01 - 020 Ta BCG - UR 22. Ta BCG - naive 23. Ta BCG - naive 24. Ta BCG - naive 25. Ta BCG - naive 27. Ta BCG - UR 28. 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 34. T1+CIS BCG - UR Pending 35. Ta BCG - UR Pending 01 - 018 Ta BCG - exposed Discontinued 01 - 029 Ta BCG - UR Discontinued 01 - 033 T1 BCG - naive Discontinued 36. Ta BCG - UR Pending 37. Ta BCG - exposed Pending 38. Ta BCG - naive Pending 39. Ta BCG - naive Pending 42. Ta+CIS BCG - naive Pending 43. Ta+CIS BCG - UR Pending 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 and Tolerability 6 % n/N 95% 36/38 Anytime 87% 33/38 3 - month 86% 25/29 6 - month 85% 22/26 9 - month 76% 19/25 12 - month 83% - 12 - month KM analysis • No patient had progression to muscle invasive disease • No patient underwent a radical cystectomy • 10 patients awaiting 3 - month response assessment – Including 3 BCG - unresponsive CIS patients 1. Efficacy evaluable patients (n=38) includes patients with at least 3 month follow - up assessment. *Includes patients with CR after re - induction. 60% 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 94% 16/17 Anytime 82% 14/17 3 - month 86% 12/14 6 - month 91% 10/11 9 - month 80% 8/10 12 - month 84% - 12 - month KM analysis • n = 20 patients dosed in BCG - UR subpopulation • BCG - UR defined by FDA definition 2 BCG - UR Subpopulation (Complete Response) Efficacy Evaluable Patients 1 (Complete Response)
©2026 Relmada - All rights reserved Treatment - Related AE and Tolerability 7 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 • 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) BCG - Unresponsive NMIBC: The Presence of CIS Does NOT Impact Gem/Doce RFS 1 8 1. As demonstrated by third - party data: Steinberg et al. J Urol. 2020;203:902 – 909; BCG: Bacillus Calmette - Guérin; CIS : carcinoma in situ; RFS: recurrence - free survival; HG: High grade
©2026 Relmada - All rights reserved Two Independent NDV - 01 Approval Pathways Provide Significant Market Opportunity 10 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 US 1 – with ~35% 2 of intermediate - risk patients receiving adjuvant therapy post - TURBT Registrational Pathway 1 Open label randomized controlled trial in intermediate - risk NMIBC – adjuvant therapy following TURBT (NDV - 01 vs. observation) ~5k patients/annually in US 1 – based on 12 - month CR rates of 19% - 46% 3 for 1L BCG - unresponsive therapies Registrational Pathway 2 Single - arm trial in 2L BCG - unresponsive NMIBC with CIS who are refractory to approved or developmental therapies R ecurrent / E ndovesical / S urgery - sparing / C ombination therapy for / U rothelial cancer / E ffectiveness
©2026 Relmada - All rights reserved Cohort 1: Adjuvant Intermediate - Risk NMIBC 11 Registrational Randomized study of TURBT + NDV - 01 vs. TURBT in IR NMIBC Inclusion Criteria • IR NMIBC • IBCG risk factors ≥ 1 Primary Endpoint • 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. PHASE 3 RESCUE TRIAL Stratification Factors: • LG vs. HG • Single - dose peri - operative chemotherapy: yes vs. no Secondary Endpoint • HG - RFS • PFS • QOL
©2026 Relmada - All rights reserved Cohort 2A: 2L BCG - Unresponsive NMIBC 12 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 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 2A 1 (Registrational; N=87) HR BCG - UR NMIBC with CIS refractory to 1 st line therapy
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