On November 4, 2025 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system indications, reported the pricing of its underwritten offering of 40,142,000 shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to 5,315,000 shares of common stock. The shares of common stock are being sold at an offering price of $2.20 per share, and the pre-funded warrants are being sold at an offering price of $2.199 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. The gross proceeds to Relmada from the offering, before deducting underwriting discounts and commissions and other expenses payable by Relmada, and excluding the exercise of any pre-funded warrants, are expected to be approximately $100 million. The offering is expected to close on November 5, 2025, subject to customary closing conditions. Investors in the offering included Janus Henderson Investors, Ferring Ventures SA, Squadron Capital Management, Marshall Wace, Spruce Street Capital, OrbiMed, Columbia Threadneedle Investments and Driehaus Capital Management.

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Jefferies and Leerink Partners are acting as joint book-running managers for the offering. Mizuho is acting as book-runner for the offering.

Relmada intends to use the net proceeds from the offering, together with existing cash, cash equivalents, and short-term investments, for working capital and general corporate purposes, which includes, without limitation, clinical studies required to gain regulatory approvals, implementation of adequate systems and controls to allow for regulatory approvals, further development of its product candidates, investing in or acquiring companies that are synergistic with or complementary to its technologies, licensing activities related to its current and future product candidates, the development of emerging technologies, investing in or acquiring companies that are developing emerging technologies, licensing activities, or the acquisition of other businesses.

The securities described above were offered by Relmada pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was declared effective by the Securities and Exchange Commission ("SEC") on September 12, 2024. A final prospectus supplement describing the terms of the offering will be filed with the SEC. Copies of the final prospectus supplement and the accompanying base prospectus, when available, may also be obtained by request by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, or by telephone at (877) 821-7388, or by e-mail at [email protected]; Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525 ext. 6105, or by emailing [email protected]; or Mizuho Securities USA LLC, Attention: Equity Capital Markets Desk, at 1271 Avenue of the Americas, New York, New York 10020, or by email at [email protected].

This press release is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of any securities of Relmada, 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.

(Press release, Relmada Therapeutics, NOV 4, 2025, View Source [SID1234661916])

On November 4, 2025 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system indications, reported the receipt of written minutes from a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the planned Phase 3 program for NDV-01 in non-muscle invasive bladder cancer (NMIBC) patients. The Company will be requesting follow-up meetings with FDA to discuss each development path. Relmada secured FDA alignment on certain key elements of the planned Phase 3 pivotal program for NDV-01, expected to begin in H1 2026 and incorporating two independent studies for approval in two separate indications:

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High-grade, 2nd line BCG-unresponsive NMIBC patients
Intermediate risk NMIBC in the adjuvant setting
Key Outcomes from the FDA Type B pre-IND meeting (specific study design details to be further discussed with the agency):

In high-grade, 2nd line BCG-unresponsive setting, the FDA stated that a single arm trial might be acceptable in a more refractory patient population.
In the intermediate risk NMIBC setting, the FDA agreed that a proposal to randomize patients post-TURBT to adjuvant NDV-01 vs observation, evaluating a time-to-event endpoint, is generally acceptable.
Further non-clinical studies are not required. FDA indicated that no further non-clinical studies are required to support a 505(b)(2) New Drug Application (NDA).
"The positive outcome of our Type B meeting and alignment with the FDA on the Phase 3 pivotal program mark a key milestone for Relmada and NDV-01," said Raj Pruthi, MD, Chief Medical Officer – Urology, Relmada Therapeutics. "We believe the FDA’s guidance provides a path to advance NDV-01 for patients with NMIBC who currently have limited options. We believe a single-arm registrational study in high-grade, refractory BCG-unresponsive patients offers a rapid route to potential approval, while alignment on a separate second pivotal study in intermediate-risk NMIBC could enable an additional indication and broader clinical adoption."

Sergio Traversa, Chief Executive Officer of Relmada Therapeutics, stated: "We added NDV-01 to our portfolio based on its strong potential to transform the treatment of NMIBC. The outcome of our Type B meeting with the FDA further reinforces our confidence in the path forward and in NDV-01’s potential to become a best-in-class, durable, ready and easy-to-use, in-office, bladder-sparing therapy. We look forward to initiating the Phase 3 programs in the first half of 2026."

Also, Relmada announced 9-month follow-up data from the Phase 2 study of NDV-01 in non-muscle invasive bladder cancer.

Highlights of the 9-month follow-up data and updated 3-month and 6-month data from the Phase 2 study of NDV-01:

Clinical Results (Response Data)
Complete Response % (n/N)
Anytime 92% (23/25)
3 months 84% (21/25)
6 months 87% (20/23)*
9 months 85% (17/20)*
*Includes patients with CR after re-induction. 60% CR rate after re-induction.

Two subjects have reached 12-month assessment, and both have a CR
No patient had progression to muscle invasive disease
No patient underwent a radical cystectomy
No new safety signals in terms of type, number, or degree of AEs — with no patients having a >= Grade 3 TRAE and no patients discontinued treatment due to AEs
36 enrolled patients (receiving >= 1 dose), of which 22 (61%) experienced a treatment-related AE. Among treatment-related AEs, 62% were transient uncomfortable urination (dysuria), 9% were asymptomatic positive urine culture and 7% were hematuria.
Efficacy in BCG-Unresponsive Subpopulation**:

Clinical Results (Response Data)
Complete Response % (n/N)
Anytime 91% (10/11)
3 months 82% (9/11)
6 months 78% (7/9)
9 months 88% (7/8)
n = 18 patients dosed in BCG-UR subpopulation
BCG-UR defined by FDA definition**
BCG-UR, Bacillus Calmette-Guérin (BCG) – Unresponsive

**View Source

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 tumor exposure. NDV-01 is ready to use, convenient to administer in-office in less than 10 minutes, and does not require preparation, anesthesia or specialized equipment.

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. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.

(Press release, Relmada Therapeutics, NOV 4, 2025, View Source [SID1234661915])

On November 4, 2025 Leidos Holdings, Inc. reported financial results for the third quarter of fiscal year 2025, highlighted by robust earnings and revenue growth.

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"Leidos continues to deliver exceptional results through the strength of our portfolio of mission-critical work as well as the innovation, agility, and discipline of our talented workforce," said Leidos Chief Executive Officer Tom Bell. "Despite the government shutdown, we are raising our 2025 earnings and margin guidance and holding firm on our 2025 revenue and cash guidance. Moreover, we are optimistic about our future given our alignment with the priorities of the administration and confidence that our customers will move out aggressively in search of smarter and more efficient outcomes for the nation."

(Press release, Leidos, NOV 4, 2025, View Source [SID1234661778])

On November 4, 2025 Defence Therapeutics Inc. ("Defence" or the "Company"), a leading biotechnology company specialized in drug delivery technologies, reported at the World ADC Conference in San Diego, USA, highly encouraging results from its latest preclinical in vivo study evaluating Accum-Kadcyla, a novel version of Genentech/Roche’s marketed ADC Kadcyla (ado-trastuzumab emtansine), in mouse models of HER2-positive breast cancer.

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Study Results: 20-Fold Increased Potency at Equivalent Dose

In the comparative in vivo study, Accum-Kadcyla demonstrated a ~20-fold higher anti-tumor efficacy than Kadcyla alone when administered at the same dose (0.5 mg/kg). Tumor growth was significantly halted in the Accum-Kadcyla-treated group, resulting in a durable and near-complete response in most mice while Kadcyla at the same dose (0.5 mg/kg) had no effect on tumor growth. Importantly, 100% of the animals survived throughout the duration of the study with no signs of toxicity, underscoring the excellent tolerability of the treatment.

Implications for Patients and the Industry

These results confirm that Defence’s Accum platform can dramatically enhance the intracellular delivery and potency of ADCs by overcoming endosomal entrapment—a known bottleneck in ADC performance. By increasing the therapeutic payload’s reach inside cancer cells, Accum enables a more efficient drug release and tumor killing, even at lower doses.

This finding is particularly meaningful for patients: the ability to achieve the same or better efficacy at reduced doses translates into a potential reduction in toxicity and side effects, addressing one of the main limitations of current ADC therapies. Practically, it could potentially bring this current second line of treatment to a first line of treatment for the benefit of the patients.

Dr. Maxime Parisotto, Chief Scientific Officer of Defence Therapeutics, commented:

"These results further validate the power of Accum as a transformative technology for ADCs. By amplifying the potency of a clinically proven ADC like Kadcyla by 20 times at the same dose, we demonstrate that Accum can unlock a new generation of safer and more effective targeted therapies for cancer patients."

Next Steps and Commercial Outlook

Following these promising results, Defence Therapeutics plans to expand its Accum-ADC program to additional HER2-positive and HER2-low tumor models and to advance discussions with potential pharmaceutical partners.

(Press release, Defence Therapeutics, NOV 4, 2025, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-demonstrates-strong-preclinical-in-vivo-efficacy-results-evaluating-accum-kadcyla-in-breast-cancer-models [SID1234659633])

On November 4, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that the Company will be showing evidence of strong immune system engagement inducing potent anti-cancer cell activity of its next generation Bria-OTS+ platform in preclinical models at a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40 th Anniversary Annual Meeting, to be held November 7-9, 2025, in National Harbor, MD. The details are listed below.

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Title: Redefining Cancer Vaccines: Bria-OTS+ Integrates Trained Innate Immunity and Adaptive Memory to Overcome Immune Resistance
Abstract Number: 353
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center
Date: Friday, November 7, 2025
Time : 12:15-1:45 PM, and 5:35-7 PM ET

"We are very excited with this opportunity to showcase the activity of our novel Bria-OTS+ platform which is designed to reinvigorate the body’s immune system to powerfully and selectively attack cancer cells while sparing normal tissues," commented Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer.

"We will present extensive immune system activation and cytotoxicity data at the upcoming poster session on November 7, 2025. Our data further validates the promise of our personalized cancer immunotherapy platform in advancing new treatments for cancer," stated Dr. William V. Williams, BriaCell’s President and CEO. "We look forward to evaluating these encouraging results in upcoming clinical studies of Bria-BRES+ for breast cancer and Bria-PROS+ for prostate cancer, as we strive to bring new hope to patients with unmet medical needs."

(Press release, BriaCell Therapeutics, NOV 4, 2025, View Source [SID1234659459])