On November 4, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in predictive computational drug target discovery powered by AI/ML, reported that Compugen management will participate in a fireside chat at the upcoming Stifel 2025 Healthcare Conference in New York City. The fireside chat will take place on Tuesday November 11, 2025, at 3:20-3:50 PM ET.

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A live webcast will be accessible on the Investor Relations section of the Compugen website at www.cgen.com. A replay will also be available following the live event.

(Press release, Compugen, NOV 4, 2025, View Source [SID1234659393])

On November 4, 2025 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) ("Actinium" or the "Company"), a leader in the development of differentiated targeted radiotherapies, reported that new preclinical data for its lead antibody radioconjugate program, ATNM‑400, will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place December 10‑14, 2025 in San Antonio, Texas.

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Title: Anti‑tumor activity of ATNM‑400, a first‑in‑class Actinium‑225 antibody radioconjugate, in tamoxifen and trastuzumab resistant breast cancer models

Abstract Number: 2069
Presentation Number: PS4‑04‑26
Date/Time: Thursday, December 11, 2025, 5:00 PM–6:30 PM CT
Session: Poster Session 4

The ATNM-400 data presentation at SABCS follows prostate cancer data presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting, NSCLC data was presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), from which key findings are summarized below.

ATNM ‑ 400: Program and Multi-Indication Opportunity Overview

ATNM-400 is a first-in-class antibody-radioconjugate powered by Actinium-225 (Ac-225), designed to deliver potent alpha-particle radiation directly to tumor cells. The therapy’s high linear energy transfer (LET) enables precise tumor cell killing with minimal off-target exposure, while its target – a disease-driving protein linked to resistance and poor prognosis – is overexpressed across multiple solid tumors, including prostate, lung, and breast cancers.

Preclinical studies show ATNM-400 delivers best-in-class efficacy, overcomes resistance to, and synergizes with, standard-of-care therapies, supporting broad development as a monotherapy, combination, or treatment alternative across multiple solid tumors.

Prostate Cancer Data Highlights

Superior efficacy and durability vs 177Lu-PSMA-617 (active agent in Pluvicto), 225Ac-PSMA-617, and ARPI enzalutamide (active agent in Xtandi), with durable tumor control beyond 100 days.
Improved overall survival compared to 177Lu-PSMA-617 and enzalutamide.
Overcomes resistance to these standard-of-care agents, showing sustained tumor control and survival benefit in 177Lu-PSMA-617 and enzalutamide resistant prostate cancer models.
Synergy with ARPI therapy as the ATNM-400 target is upregulated after enzalutamide; combination achieved complete tumor regression in 40% of animals.
PSMA-independent activity enables treatment of patient populations not eligible for or progressing on 177Lu-PSMA-617.
NSCLC Data Highlights

3–5x greater tumor growth inhibition vs. front-line osimertinib (Tagrisso, AstraZeneca) and EGFR tyrosine kinase inhibitor (TKI), second-line Dato-DXd (Datroway, AstraZeneca/Daiichi Sankyo) a Trop-2 ADC, and third-line amivantamab (Rybrevant, Johnson & Johnson) an EGFR-cMET bispecific. Combined 2024 sales of these agents exceeded $7B.
Target upregulation following EGFR inhibition; ATNM-400 + osimertinib achieved complete tumor regression in 100% of tumor-bearing animals demonstrating synergy of the combination.
Clinical rationale for combination supported by a study that showed EBRT or external-beam radiotherapy + osimertinib improved PFS to 32.2 months vs. 20 months with osimertinib alone (Sampath et al.1, Lancet eClinicalMedicine, 2025). ATNM-400 has the potential to deliver precision targeted, powerful alpha radiation via Ac-225 which on a per-cell basis is ~4–8x more biologically lethal than diffuse, low-energy EBRT beams. Clinically, this may translate to higher response rates, lower toxicity, and entry into previously untreatable market segments when osimertinib is combined with EBRT.
ATNM-400 Data Afford Development Opportunities in High-Value, Unmet Need Indications

The data package for ATNM‑400 across breast cancer, prostate cancer and NSCLC underscores Actinium’s intention to demonstrate the potential for this radiotherapy candidate to address unmet needs in high‑value cancer segments. Data from preclinical studies thus far show ATNM-400 delivers best-in-class efficacy, overcomes resistance to, and synergizes with, standard-of-care therapies, supporting broad development as a monotherapy, combination, or treatment alternative across solid tumors. Key development opportunities based on the data include:

Breast Cancer: Potential in hormone‑resistant (tamoxifen) and HER2‑resistant (trastuzumab) patients, which represents a significant therapeutic opportunity with the HER2-targeted therapy Herceptin (Roche and biosimilars) generating approximately $4.0 billion in sales in 2024.

Prostate Cancer: Broad use potential as a monotherapy, combination, or follow-on to ARPIs and PSMA radioligands; opportunity in the $10 billion ARPI market and Pluvicto non-responders or relapses who on balance might be expected to outnumber the patients treated with Pluvicto which generated $1.7 billion in revenue over the last twelve months.

Non-Small Cell lung Cancer: Superior anti-tumor activity compared to the leading first, second and third-Line approved EGFR mutant therapies that generated sales of over $7.0 billion in 2024 and mechanistic synergy with first-line therapy osimertinib, which accounted for approximately $6.6 billion in sales in 2024.

Sandesh Seth, Chairman and CEO of Actinium Pharmaceuticals, commented, "We’re excited to present ATNM-400’s breast cancer data at SABCS which expands our demonstration of its potential across multiple solid tumors. The strong single-agent efficacy of ATNM-400 and its ability to overcome resistance when coupled with enzalutamide (Xtandi) in prostate cancer and osimertinib (TAGRISSO) in lung cancer showcases Actinium’s capability for innovation by exploiting the power of a radiotherapeutic directed to a target linked to resistance and poor prognosis. We believe that this program has the potential to meaningfully improve outcomes for patients with difficult-to-treat cancers and look forward to the data at SABCS".

About ATNM-400

ATNM-400 is a highly innovative, first-in-class, and multi-indication Actinium-225 (Ac-225) targeted radiotherapy candidate in development for prostate cancer, non-small cell lung cancer (NSCLC) and breast cancer. ATNM-400 is highly differentiated in prostate cancer as it targets a distinct non-PSMA protein strongly implicated in prostate cancer disease biology including progression and treatment resistance. Unlike 177Lu-PSMA-617, the active agent in Pluvicto and the majority of radiotherapies under development, which rely on PSMA targeting, ATNM-400 is designed to maintain efficacy in low-PSMA or high-PSMA resistant disease, a major unmet clinical need as up to 30% of patients do not respond to PSMA radioligand therapies and up to 60% of patients have at least one PSMA-negative tumor lesion. Ac-225 delivers high-linear-energy-transfer alpha particles that induce irreparable double-strand DNA breaks, offering superior potency over beta emitters like Lutetium-177 (177Lu), and has a shorter tissue path length that may reduce off-target toxicity. The receptor specifically targeted by ATNM-400 continues to be expressed at a high level even after androgen receptor inhibitor (ARPI) and ATNM-400 has shown to overcome resistance to the ARPI therapy enzalutamide and work synergistically in combination with enhanced tumor control including complete tumor regression. In NSCLC, ATNM-400 has shown superior efficacy compared to approved first, second- and third-line EGFR therapies including small molecules, antibody drug conjugates and bispecific antibodies that is synergistic with osimertinib, an EGFR tyrosine kinase inhibitor (TKI) that is a standard of care therapy approved for treatment of patients in the frontline setting and is also able to overcome osimertinib resistance.

Prostate cancer is the most commonly diagnosed cancer in men, with ~1.5 million new cases globally and over 313,000 expected in the U.S. in 2025. While early-stage disease is typically managed with surgery, radiation, and ARPI therapy, up to 20% of cases progress to mCRPC – a lethal stage with limited treatment options. Targeted radiotherapy is a growing field in prostate cancer, dominated by PSMA-targeting agents like Pluvicto, which had sales of over $1.3 billion in 2024, yet up to 30% of patients either lack or have no PSMA expression and virtually all patients develop resistance to Pluvicto within 1-year. In the U.S., 40,000–60,000 mCRPC patients annually progress after ARPI therapy with approximately 35% of patients progressing within 1-year. As a class, ARPI therapies had sales of over $10.0 billion in 2024 including enzalutamide (Xtandi) that led the class with sales of over $5.9 billion in 2024, highlighting a significant unmet need. Lung cancer is the leading cause of cancer deaths and there are there are over 200,000 new cases expected in the U.S. in 2025 and over 2 million cases globally. NSCLC accounts for approximately 85% of all lung cancer cases. EGFR targeting therapies including front-line osimertinib (Tagrisso, AstraZeneca) an EGFR tyrosine kinase inhibitor (TKI), second-line Dato-DXd (Datroway, AstraZeneca/Daiichi Sankyo) a Trop-2 ADC, and third-line amivantamab (Rybrevant, Johnson & Johnson) an EGFR-cMET bispecific had sales of approximately $7 billion in 2024 with the EGFR TKI Osimertinib (TAGRISSO, AstraZeneca) generating sales of $6.6 billion in 2024. Breast cancer is the most diagnosed cancer among woman in the United States with approximately 316,950 women expected to be diagnosed with the disease in 2025 according to the National Cancer institute. It is estimated that approximately 200,000 women are living with metastatic breast cancer in 2025, which is expected to grow to 250,000 in 2030. Of those diagnosed, hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer accounts for 70-75% of breast cancer, representing the largest subtype. In this setting, tamoxifen and trastuzumab (Herceptin, Roche and biosimilars) generated sales of approximately $4.0 billion in 2024. Across prostate cancer, NSCLC and breast cancer, ATNM-400 has demonstrated treatment paradigm changing potential in these indications, which have over 800,000 new cases in the U.S. alone.

(Press release, Actinium Pharmaceuticals, NOV 4, 2025, View Source [SID1234659392])

On November 4, 2025 AVEO Oncology, an LG Chem company (AVEO), and HiberCell, Inc. (HiberCell) reported that the companies have entered into an exclusive development and option agreement to develop HiberCell’s first-in-human human protein kinase RNA-like endoplasmic reticulum kinase (PERK) inhibitor, HC-5404, alone and in combination with AVEO’s potent and selective vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), FOTIVDA (tivozanib). FOTIVDA is an anti-angiogenic agent approved by the U.S. Food and Drug Administration in March of 2021 for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. Pre-clinical studies of HC-5404 in multiple solid tumor models, including gastric cancer and RCC, suggest the potential for enhanced anti-tumor efficacy when combined with an anti-angiogenic agent.

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Under the terms of the agreement, AVEO is responsible for conducting initial stage clinical development. During the Phase 2 clinical trial, AVEO will have the option to obtain an exclusive license for the development, manufacturing, and commercialization of HC-5404 in all therapeutic indications worldwide for an undisclosed option fee. In addition, if AVEO exercises its option, HiberCell will be eligible to receive milestone payments and royalties for global net sales of HC-5404, contingent upon successful development and commercialization.

"AVEO and LG Chem are excited to enter into this collaboration with HiberCell to advance the development of this first-in-human PERK inhibitor and to expand on our commitment to RCC patients," said Michael P. Bailey, President and CEO of AVEO. "HC-5404 has shown promising activity combined with VEGFR TKIs which makes pairing it with tivozanib in RCC a logical first phase of development. The combinability with our current portfolio in RCC, coupled with the opportunity to expand to other oncology indications, make this collaboration an important step in our vision to become a global leader in oncology."

"We are excited to be partnering with AVEO to help us explore the combination activity of HC-5404 and tivozanib in metastatic renal cell carcinoma," said Steven Gillis, Ph.D., Chairman and acting Chief Executive Officer at HiberCell. "AVEO brings considerable scientific and clinical development capabilities across oncology, including significant expertise in renal cell carcinoma. This collaboration is an important step in assessing the combination of HC-5404 and tivozanib in RCC and may inform broader development across multiple tumor types."

About FOTIVDA (tivozanib)
FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021, for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies, based on data from the TIVO-3 trial comparing FOTIVDA to sorafenib. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner Recordati UK Ltd. for the treatment of adult patients with advanced RCC. FOTIVDA was discovered by Kyowa Kirin.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTION

Hypertension was reported in 45% of patients (22% ≥ Grade 3). Hypertensive crises were reported in 0.8% of patients. Do not initiate FOTIVDA in patients with uncontrolled hypertension. Monitor for hypertension and treat as needed. Reduce the FOTIVDA dose for persistent hypertension not controlled by anti-hypertensive medications. Discontinue FOTIVDA for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Cardiac failures were reported in 1.6% of patients (1% ≥ Grade 3); 0.6% of events were fatal. Monitor for signs or symptoms of cardiac failure during treatment with FOTIVDA. Manage with dose interruption, dose reduction, or discontinuation.

Cardiac ischemia were reported in 3.2% of patients; 0.4% of events were fatal. Arterial thromboembolic events were reported in 2.0% of patients, including death due to ischemic stroke (0.1%). Closely monitor patients at risk for, or who have a history of these events. Discontinue FOTIVDA in patients who develop severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thrombotic Events (VTE) were reported in 2.4% of patients, including 0.3% fatal events. Closely monitor patients who are at increased risk for these events. Discontinue in patients who develop serious VTEs.

Hemorrhagic Events were reported in 11% of patients; 0.2% of events were fatal. Use FOTIVDA with caution in patients who are at risk for or who have a history of bleeding.

Proteinuria was reported in 8% of patients (2% = Grade 3). Monitor during treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or interrupt treatment. Discontinue in patients who develop nephrotic syndrome.

Gastrointestinal (GI) Perforation including fatal cases, has been reported in patients receiving FOTIVDA. Monitor for symptoms of GI perforation or fistula formation periodically throughout treatment with FOTIVDA. Permanently discontinue FOTIVDA in patients who develop severe or life-threatening GI perforation.

Thyroid Dysfunction events were reported in 11% of patients (0.3% ≥ Grade 3). Monitor thyroid function before and during treatment with FOTIVDA.

Wound Healing Complications: Withhold FOTIVDA for at least 24 days prior to elective surgery and do not administer for at least 2 weeks after major surgery and until adequate wound healing is observed.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) can occur with FOTIVDA. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue if signs or symptoms of RPLS occur.

Embryo-fetal Toxicity: FOTIVDA can cause fetal harm. Advise patients of the potential risk to a fetus, to avoid becoming pregnant and to use contraception during treatment and for one month after the last dose of FOTIVDA. Advise males with female partners of reproductive potential to use effective contraception during treatment and for one month after the last dose of FOTIVDA.

Allergic Reaction to Tartrazine: FOTIVDA 0.89 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS

Common adverse reactions include fatigue/asthenia, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis.

Serious adverse reactions include bleeding (3.5%), venous thromboembolism (3.5%), arterial thromboembolism (2.9%), acute kidney injury (2.3%), and hepatobiliary disorders (2.3%).

DRUG INTERACTIONS

Avoid coadministration with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Advise women not to breastfeed during treatment and for at least 1 month after the last dose.

The recommended dosage for patients with end-stage renal disease has not been established.

Reduce the FOTIVDA dose for patients with moderate hepatic impairment. The recommended dosage in patients with severe hepatic impairment has not been established.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for FOTIVDA (tivozanib).

(Press release, AVEO, NOV 4, 2025, View Source [SID1234659391])

On November 4, 2025 OmniAb, Inc. (NASDAQ: OABI) reported financial results for the three and nine months ended September 30, 2025, and provided operating and partner program updates.

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"Throughout the third quarter we continued to execute on our strategic initiatives while further demonstrating the value of our proprietary technology platform to a growing base of partners. The number of new program additions so far this year has significantly outpaced last year, bolstering our partnered pipeline and creating potential sources of enduring value within our portfolio. Importantly, OmniAb’s innovative technology platform and operational model allow for partner and program additions within an increasingly efficient and lean cost structure," said Matt Foehr, Chief Executive Officer of OmniAb. "In August we completed a private placement and strengthened our balance sheet while continuing to expand our suite of leading-edge technologies. We look forward to next month’s launch of OmniUltra, an important new technology that we expect will expand our platform and open new business opportunities."

Third Quarter 2025 Financial Results

Revenue for the third quarter of 2025 was $2.2 million, compared with $4.2 million for the same period in 2024, with the decrease primarily related to lower milestone revenue and a decline in service revenue associated with the completion of work on certain small molecule ion channel programs earlier this year.

Research and development expense was $10.4 million for the third quarter of 2025, compared with $13.3 million for the same period in 2024, with the decrease primarily due to lower personnel expenses related to reduced share-based compensation expense and headcount, and lower external expenses associated with small molecule ion channel programs. General and administrative expense was $6.8 million for the third quarter of 2025, compared with $7.1 million for the same period in 2024, with the decrease primarily due to lower legal fees and share-based compensation expense.

Net loss for the third quarter of 2025 was $16.5 million, or $0.14 per share, compared with a net loss of $16.4 million, or $0.16 per share, for the same period in 2024.

Nine Months Ended September 30, 2025 Financial Results

Revenue for the nine months ended September 30, 2025 was $10.3 million, compared with $15.6 million for the same period in 2024. The decline in license and milestone revenue was primarily due to lower milestone revenue, and service revenue declined primarily as a result of the completion or discontinuation of certain small molecule ion channel programs and the acceleration of revenue in the prior-year period from one of the discontinued programs. These decreases were offset by $0.7 million in xPloration revenue reflecting the sale of an instrument and related consumables.

Cost of xPloration revenue was $0.3 million for the nine months ended September 30, 2025 and consisted of direct costs associated with the sale of the xPloration instrument and associated consumables. Research and development expense was $33.8 million for the nine months ended September 30, 2025, compared with $41.8 million for the same period in 2024, primarily due to lower personnel expenses and lower external expenses associated with ion channel programs and contract research costs. General and administrative expense was $22.4 million for the nine months ended September 30, 2025, compared with $23.4 million for the same period in 2024 with the decrease primarily due to lower legal fees and share-based compensation expense. Other operating income, net for the nine months ended September 30, 2025 was $2.7 million and reflected a gain of $3.0 million from the sale of a small molecule Kv7.2 program to Angelini and a $0.9 million reduction in contingent liabilities attributed to changes in certain ion channel programs, partially offset by the $1.0 million contingent liability adjustment associated with the Angelini program. Other operating income, net during the nine months ended September 30, 2024 was $2.3 million and included a $2.4 million reduction in contingent liabilities primarily attributed to changes in ion channel programs.

Net loss for the nine months ended September 30, 2025 was $50.6 million, or $0.46 per share, compared with a net loss of $49.0 million, or $0.48 per share, for the same period in 2024.

As of September 30, 2025, OmniAb had cash, cash equivalents and short-term investments of $59.5 million. In August, OmniAb raised $30 million from a private placement of common stock, with net proceeds to the Company of approximately $28 million.

2025 Financial Guidance

OmniAb now expects 2025 revenue to be in the range of $18 million to $22 million, and operating expense to be in the range of $82 million to $86 million. In addition, OmniAb continues to expect 2025 cash use to be lower than cash use in 2024, excluding financings. The Company expects to end the year with cash between $52 million and $56 million. The 2025 full year effective tax rate is expected to be approximately 0%.

Third Quarter 2025 and Recent Business Highlights

During the third quarter of 2025, OmniAb entered into new license agreements, including with A*Star and University of Leeds, and recently with Dana-Farber Cancer Institute, Inc. As of September 30, 2025, the Company had 104 active partners and 399 active programs, including 32 OmniAb-derived programs in clinical development or being commercialized.

OmniAb continued to expand its intellectual property portfolio with the issuance of a U.S. patent related to its new OmniUltra technology, a transgenic chicken that produces a cow-like antibody with an exceptionally long third heavy-chain complementarity-determining region (CDRH3). The Company plans to launch this new proprietary discovery platform in December 2025 at the Antibody Engineering & Therapeutics (AET) conference in San Diego.

In addition, OmniAb and GSK published a paper titled "Voltage sensor interaction site for a selective small molecule Nav1.1 sodium channel potentiator that enhances firing of fast-spiking interneurons" in the October 2025 edition of Molecular Pharmacology. The paper highlights the potential for Nav1.1 as a therapeutic target for seizure disorders.

Business and partner highlights from the third quarter of 2025 and recent weeks included the following:

Batoclimab & IMVT-1402

In September, Immunovant presented an abstract at the 2025 Annual Meeting of the American Thyroid Association with six-month off-treatment data in uncontrolled Graves’ disease (GD) patients treated with batoclimab for 24 weeks. Of the 21 patients who entered the six-month off-treatment follow-up period, ~80% (17/21) demonstrated response, resulting in normal thyroid function (T3 and T4 less than the upper limit of normal) at the end of the six-month follow-up period. Of the 17 responders to therapy, ~50% (8/17) achieved anti-thyroid drug free remission at six months following the end of batoclimab treatment. Safety and tolerability were observed to be consistent with prior batoclimab studies.
Immunovant’s lead compound IMVT-1402 has two ongoing potentially registrational trials in GD and are currently enrolling patients, with topline readouts expected in 2027.
Zimberelimab

Arcus Biosciences presented the first overall survival (OS) results from Arm A1 of the Phase 2 EDGE-Gastric study at the European Society for Medical Oncology 2025 Congress. Anti-TIGIT domvanalimab plus anti-PD-1 zimberelimab and chemotherapy demonstrated 26.7 months of median OS as first-line treatment of unresectable or advanced gastroesophageal adenocarcinomas.
SAL003

China’s National Medical Products Administration accepted Shenzhen Salubris Pharmaceuticals’ SAL003 New Drug Application as a Class 1 therapeutic biological. SAL003 is a recombinant fully‑human anti‑PCSK9 monoclonal antibody designed for the treatment of hypercholesterolemia and mixed dyslipidemia.
Mipletamig

Aptevo Therapeutics announced a 100% remission rate in Cohort 3 of its Phase 1b/2 RAINIER trial evaluating mipletamig, a first-in-class CD123 x CD3 bispecific antibody, in combination with venetoclax + azacitidine for newly diagnosed patients with acute myeloid leukemia unfit for intensive chemotherapy. Aptevo also reported that no dose-limiting toxicities or cytokine release syndrome have been observed in the RAINIER trial, or among any frontline patients treated with mipletamig to date.
Sugemalimab

CStone Pharmaceuticals and Istituto Gentili entered into an exclusive partnership to commercialize sugemalimab across 23 countries in Western Europe and the United Kingdom.
CStone also announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion, recommending the approval of sugemalimab as monotherapy for the treatment of unresectable stage III non-small cell lung cancer in adults with PD-L1 expression on ≥1% of tumor cells and no sensitizing EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemotherapy.
RNDO-564

Rondo Therapeutics’ abstract titled "Comprehensive Characterization of RNDO-564, a First-in-Class CD28 x Nectin-4 Bispecific Antibody for the Treatment of Solid Tumors" was accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) on November 7, 2025.
Conference Call and Webcast

OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (800) 549 8228 using the conference ID 92631. Slides, as well as the live and replay webcast, are available at View Source

(Press release, OmniAb, NOV 4, 2025, View Source [SID1234659390])

On November 4, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported a business update on its lead asset TG4050 developed from its myvac platform, upcoming plans, and its financial position as of September 30, 2025.

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TG4050 – INTV: New Data presented at SITC (Free SITC Whitepaper) supports TG4050’s potential role in preventing cancer relapse

Transgene and its partner NEC1 will jointly present a poster on additional immunological data profiling the neoantigen-specific T-cell response after treatment with TG4050 in head and neck cancer at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

Comprehensive immunogenicity data confirm the ability of TG4050 monotherapy to induce neoantigen-specific cytotoxic CD8+ T-cell responses capable of targeting and eliminating tumor cells – see press release. These CD8+ T cells target multiple neoantigens encoded in the vaccine, have tissue resident cytosignature, and are still detectable up to two years after the start of TG4050 treatment. Overall, these data support the TG4050 mechanism of action that resulted in the reduction of risk of relapse observed in the randomized Phase I study.

These data have been generated from the randomized Phase I part of the ongoing Phase I/II trial evaluating TG4050 as a single agent in the adjuvant treatment of HPV-negative HNSCC, in patients that are in complete response following surgery and adjuvant (chemo-)radiotherapy.

These results follow the positive randomized Phase I data presented in a rapid oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO Annual Meeting – see press release).

The SITC (Free SITC Whitepaper) abstract is available both on the SITC (Free SITC Whitepaper) and Transgene websites. The poster presentation will take place on November 8 at the Conference and will be available on Transgene’s website following the presentation.

Transgene will host a webcast (in English) to discuss the SITC (Free SITC Whitepaper) data on November 14, 2025, from 10:00 a.m. to 11:00 a.m. ET (16:00 to 17:00 CET). The webcast and the replay will be available here and on Transgene‘s website.

Transgene expects to complete the randomization of patients with operable HNSCC in the Phase II part of the trial by early 2026. First immunogenicity data from this Phase II part are expected to be available in H2 2026. The first efficacy data (2-year disease-free survival, DFS) will become available as soon as all patients are evaluable for two-year DFS with either an event (relapse or death) or 2-year follow-up whichever occurs first.

Transgene is currently evaluating the most efficient regulatory pathway to accelerate the development of its lead asset, TG4050, with the goal of bringing it to patients with operable HNSCC as quickly as possible.

myvac platform: Potential to reduce the risk of relapse across multiple operable solid tumors

Transgene’s INTV platform, myvac, could be applied across a range of solid tumors where in many cases a significant unmet medical need remains. In parallel, Transgene is initiating start-up activities for a potential new Phase I trial in a second indication in an early treatment setting, with the aim of initiating once all conditions are met.

BT-001 (oncolytic virus – intratumoral administration): Updated Phase I/II data presented at ESMO (Free ESMO Whitepaper) 2025 demonstrated positive antitumoral activity

Transgene and BioInvent presented a poster on updated clinical results showing the positive antitumoral activity of BT-001 in patients with advanced refractory tumors at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting – see press release.

These updated data from the Phase I trial (NCT04725331) evaluating BT-001 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab)2 showed positive local, abscopal and sustained antitumoral activity in injected and non-injected lesions. Immune-mediated tumor shrinkage is consistent with the mechanistic hypothesis that BT-001, in combination with pembrolizumab, turns "cold" tumors into immunologically active ones.

The poster is available on Transgene’s website.

Transgene and BioInvent are exploring clinical development opportunities for intratumoral administration of BT-001 in collaboration with clinicians.

Key financial elements

In millions of euros Q3
2025 2024
Research Tax Credit 5.8 4.8
Revenue from collaborative and licensing agreements 0.1 -
Other income 0.3 0.2
Operating income 6.13 5.0

During the third quarter of 2025, the Research Tax Credit increased to €5.8 million compared to €4.8 million for the same period in 2024, reflecting the progress of the ongoing Phase II part of the clinical trial evaluating TG4050 in head and neck cancer, with sustained patient enrollment and related expenses, including the manufacturing of individualized batches.

As of September 30, 2025, Transgene had €12.8 million in cash, compared to €16.7 million as of December 31, 2024.

Over the first nine months of 2025, Transgene’s net cash burn4 was €28.8 million (including the prefinancing of the 2024 Research Tax Credit for €5.2 million in June 2025) compared to €31.3 million for the same period in 2024.

Business funded until the end of December 2026

In March 2025, the Company signed a new amendment to the current account advance agreement with its major shareholder TSGH (Institut Mérieux), which increased the total amount of the facility by €15 million to €48 million. As of September 30, 2025, the Company has drawn down €35.5 million from this facility.

With this credit facility and the support of TSGH (Institut Mérieux), Transgene is able to fund its business until the end of December 2026, enabling the Company to deliver significant news flow on its myvac platform over the next 12 months.

(Press release, Transgene, NOV 4, 2025, View Source [SID1234659389])