On November 5, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported the publication of two abstracts accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting, to be held 5–9 November 2025 in National Harbor, MD, USA.

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The mitazalimab abstract presents new data from the OPTIMIZE-1 trial in metastatic pancreatic cancer, further characterizing efficacy, safety, and biomarker responses at two dose levels. These findings strengthen the clinical rationale for selecting the 900 μg/kg dose in the planned Phase 3 study and the exposure-response data further supports mitazalimab contribution to the clinical benefits observed in OPTIMIZE-1. Alligator will also present preclinical data on ATOR-4066, a bispecific antibody targeting CD40 and CEACAM5, demonstrating immune activation and remodeling of the tumor microenvironment.

Mitazalimab presentation details
Title: CD40 agonist mitazalimab + mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma: dose characterization based on exposure response and biomarker analysis from the OPTIMIZE-1 study
Abstract number: 530
Time: Saturday, 8 November 2025
Presenter: Yago Pico de Coaña, Medical Science Director, Alligator Bioscience

Key findings:

Improved survival outcomes at 6 months:
PFS: 50.8% vs. 38.7%
OS: 89.5% vs. 69.4%
Manageable safety profile: Safety was manageable across both dose levels, with the increased rate of adverse events in the 900 μg/kg group attributed to extended treatment exposure
Biomarker analyses: Greater immune activation at 900 μg/kg, including higher levels of Ki67+ T cells, a marker of actively dividing and proliferating immune cells
Dose selection for Phase 3: Data support 900 μg/kg as the recommended dose for the planned Phase 3 study in metastatic pancreatic cancer
ATOR-4066 presentation details
Title: ATOR-4066, a bispecific antibody targeting CD40 and CEACAM5, induces potent anti-tumor activity that associates with activated intra-tumoral immune cells and disassembly of extracellular tumor matrix
Abstract number: 940
Time: Saturday, 8 November 2025
Presenter: Hampus Andersson, Industrial PhD student, Alligator Bioscience

Key findings:

Localized immune activation: Enhanced dendritic cell and macrophage activation, uptake of tumor antigens, and priming of neoantigen-specific T cells
Potent anti-tumor activity: Superior efficacy compared to CD40 monospecific antibodies in preclinical tumor models
Tumor microenvironment remodeling: Downregulation of extracellular matrix (ECM) organization genes and upregulation of ECM disassembly pathways, correlating with increased immune cell infiltration
"The new OPTIMIZE-1 data provide important validation of mitazalimab’s therapeutic potential in metastatic pancreatic cancer and further strengthen the rationale for the planned Phase 3 study using the 900 μg/kg dose level," said Søren Bregenholt, CEO of Alligator Bioscience. "This is a significant milestone for Alligator as we prepare mitazalimab for late-stage development. In addition, we are pleased to share encouraging preclinical results for ATOR-4066, underscoring the breadth and innovation of our pipeline."

(Press release, Alligator Bioscience, NOV 5, 2025, View Source [SID1234659455])

On November 5, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported the completion of patient enrollment of SAFFRON, a global Phase III study of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) for the treatment of patients with epidermal growth factor receptor ("EGFR")-mutated, MET-overexpressed and/or amplified, locally advanced or metastatic non-small cell lung cancer ("NSCLC") following progression on treatment with TAGRISSO. The last patient was randomized on October 31, 2025.

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This combination represents a promising, chemotherapy-free, all-oral treatment option following progression on an EGFR tyrosine kinase inhibitor ("TKI"), and was granted approval in China in June 2025 based on the results of the SACHI randomized Phase III trial. ORPATHYS is an oral, potent and highly selective MET TKI being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. TAGRISSO is a third-generation, irreversible EGFR TKI.

SAFFRON is a global Phase III, open-label, randomized, multicenter study to investigate the efficacy and safety of ORPATHYS administered orally in combination with TAGRISSO versus platinum-based doublet chemotherapy in participants with EGFR-mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on first- or second-line treatment with TAGRISSO as the most recent therapy. The primary endpoint of the study is progression free survival (PFS) as assessed by blinded independent central review (BICR) according to RECIST 1.1 criteria. Other endpoints include overall survival (OS), objective response rate ("ORR"), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety. This study randomized 338 patients, screened from over 230 sites across 29 countries. Additional details may be found at clinicaltrials.gov, using identifier NCT05261399.

Topline results from the SAFFRON study are estimated to be reported in the first half of 2026, followed by submission of results for presentation at an appropriate medical congress. If favorable, the results could support global regulatory filings for the ORPATHYS and TAGRISSO combination.

About NSCLC and MET aberrations
Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths.[1] Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.[2] The majority of NSCLC patients (approximately 75%) are diagnosed with advanced disease, and approximately 10-15% of NSCLC patients in the US and Europe and up to 40-50% of patients in Asia have EGFR-mutated ("EGFRm") NSCLC.[3],[4],[5],[6],[7]

MET is a tyrosine kinase receptor that has an essential role in normal cell development. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is one of the mechanisms of de novo or acquired resistance to EGFR TKI for metastatic EGFRm NSCLC.[8],[9]

About ORPATHYS
ORPATHYS (savolitinib) is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

ORPATHYS is approved in China and is marketed by AstraZeneca for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alterations, representing the first selective MET inhibitor approved in China. ORPATHYS is also approved in China for the treatment of patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR tyrosine kinase inhibitor therapy, in combination with TAGRISSO.

It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.

About TAGRISSO
TAGRISSO (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. TAGRISSO (40mg and 80mg once-daily oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO as a treatment for patients across multiple stages of EGFRm NSCLC.

There is an extensive body of evidence supporting the use of TAGRISSO in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease.

In late-stage disease, TAGRISSO demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. TAGRISSO is also being investigated in this setting in combination with ORPATHYS (savolitinib) in the SAFFRON Phase III trial and in combination with DATROWAY (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

TAGRISSO also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, TAGRISSO is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

About ORPATHYS and TAGRISSO Combination Development in EGFR-mutated NSCLC
This combination represents a promising chemotherapy-free oral treatment strategy to address mechanisms of resistance in this setting. Among patients who experience disease progression following treatment with a third-generation EGFR TKI, approximately 15-50% present with MET aberration, depending on the sample type, detection method and assay cut-off used. TAGRISSO is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Treatment with ORPATHYS in combination with TAGRISSO has been studied extensively in these patients in the TATTON study (NCT02143466) and the SAVANNAH single-arm Phase II study (NCT03778229). Strong data from SAVANNAH presented at the 2025 European Lung Cancer Congress (ELCC) demonstrated high, clinically meaningful and durable ORR, with consistent safety results. The encouraging results led to the initiation of several randomized Phase III trials in this setting including the SACHI trial in China (NCT05015608) and the global SAFFRON trial (NCT05261399), as well as the SANOVO trial in China (NCT05009836).

SACHI: This Phase III trial in China evaluated the combination of ORPATHYS and TAGRISSO compared to platinum-based doublet chemotherapy for the treatment of patients with EGFRm, MET-amplified locally advanced or metastatic NSCLC following progression on treatment with an EGFR TKI. Results were presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. The treatment combination received approval in China in June 2025.

SAFFRON: This ongoing global Phase III trial is to evaluate the combination of ORPATHYS and TAGRISSO compared to platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following progression on treatment with TAGRISSO. This received Fast Track Designation from the US Food and Drug Administration (FDA) and enrollment was completed in October 2025. We look forward to completing this trial to support potential US and other global registration filings.

SANOVO: This ongoing Phase III trial in China is to evaluate the combination of ORPATHYS and TAGRISSO compared to TAGRISSO monotherapy in previously untreated patients with locally advanced or metastatic NSCLC with EGFRm and MET overexpression. Enrollment was completed in August 2025.

(Press release, Hutchison China MediTech, NOV 5, 2025, https://www.hutch-med.com/saffron-global-phiii-enrollment-completion/ [SID1234659385])

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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])