On November 4, 2025 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported that an abstract regarding azer-cel has been selected for oral presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held from 6-9 December 2025 in Orlando, Florida.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The ASH (Free ASH Whitepaper) Annual Meeting is the world’s premier event in malignant and non-malignant haematology, attracting more than 30,000 clinicians, scientists, and industry representatives from over 100 countries. Each year, the meeting highlights the most significant scientific and clinical advances in the field, with oral abstracts representing the highest tier of accepted submissions.

Imugene’s abstract, titled "Azer-cel, an allogeneic (allo) CD19 CAR T, in combination with low-dose interleukin-2 (IL-2) demonstrates clinical activity in patients with large B-cell lymphoma (LBCL) who relapsed after autologous (auto) CAR T", has been selected for presentation within the session "Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Next Generation CAR-T Clinical Trials in Relapsed/Refractory B-cell NonHodgkin Lymphoma and Multiple Myeloma."

The oral presentation will take place on Saturday 6 December 2025, from 2:30pm to 2:45pm US Eastern Time in West Hall D2 of the Orange County Convention Center.

The abstract published overnight includes clinical activity and safety data from the Company’s azer-cel (allogeneic CD19 CAR T) program, evaluating the combination with low-dose IL-2 in patients with relapsed or refractory large B-cell lymphoma (LBCL) following prior autologous CAR T-cell therapy. The abstract is linked on Imugene’s website at View Source

Imugene’s Managing Director and Chief Executive Officer, Leslie Chong, said: "We are honoured that azer-cel has been selected for oral presentation at ASH (Free ASH Whitepaper), it being the world’s leading haematology conference. This puts a spotlight on the growing clinical interest in allogeneic CAR T approaches and represents an exciting opportunity to share new insights from our ongoing study with the global haematology community."

(Press release, Imugene, NOV 4, 2025, View Source [SID1234659294])

On November 4, 2025 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the third quarter of 2025, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the third quarter of 2025, Exelixis gained momentum in the cabozantinib franchise and delivered on critical strategic priorities across the research & development portfolio," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "The cabozantinib franchise continued to outperform with sustained growth in renal cell carcinoma and neuroendocrine tumors, where CABOMETYX built on its position as the leading oral therapy for new patient market share in second-line and later settings. In October, we presented the detailed positive results from the STELLAR-303 pivotal trial evaluating zanzalintinib in combination with atezolizumab in advanced colorectal cancer at the 2025 European Society for Medical Oncology Congress, along with a simultaneous publication in The Lancet. Based on these results, we intend to complete the submission of our first new drug application for zanzalintinib in the U.S. before year-end. We also made strong progress across the range of ongoing and planned zanzalintinib pivotal trials, as well as the four ongoing phase 1 clinical studies from our early-stage pipeline where we’re looking to profile and move the most promising candidates into full development. I want to thank the entire Exelixis team for their collective efforts and unwavering commitment as we work toward our goals of improving standards of care and helping more patients with cancer."

Third Quarter 2025 Financial Results
Total revenues for the quarter ended September 30, 2025 were $597.8 million, as compared to $539.5 million for the comparable period in 2024.
Total revenues for the quarter ended September 30, 2025 included net product revenues of $542.9 million, as compared to $478.1 million for the comparable period in 2024. The increase in net product revenues was primarily due to an increase in sales volume.
Collaboration revenues, composed of license revenues and collaboration services revenues, were $54.8 million for the quarter ended September 30, 2025, as compared to $61.5 million for the comparable period in 2024. The decrease in collaboration revenues was primarily related to lower milestone-related revenues recognized in the quarter and lower development cost reimbursements earned, partially offset by higher royalty revenues for the sales of cabozantinib outside the U.S. generated by Exelixis’ collaboration partner Ipsen Pharma SAS (Ipsen).
Research and development expenses for the quarter ended September 30, 2025 were $199.2 million, as compared to $222.6 million for the comparable period in 2024. The decrease in research and development expenses was primarily related to decreases in clinical trial costs and license and other collaboration costs.
Selling, general and administrative expenses for the quarter ended September 30, 2025 were $123.7 million, as compared to $111.8 million for the comparable period in 2024. The increase in selling, general and administrative expenses was primarily related to increases in stock-based compensation and consulting and outside services.
Provision for income taxes for the quarter ended September 30, 2025 was $58.8 million, as compared to $36.8 million for the comparable period in 2024.
Restructuring expenses for the quarter ended September 30, 2025 were $19.8 million. The restructuring expenses primarily consist of severance and employee-related costs. In August 2025, Exelixis’ Board of Directors authorized a corporate reorganization plan (the Plan) to reorganize the Company’s workforce and close the office located in King of Prussia, Pennsylvania. In connection with the Plan, the Company estimates that it will incur aggregate charges of approximately $20.5 million. The majority of these costs were incurred in the third quarter of 2025. The Plan was implemented in the third quarter of fiscal year 2025 and is expected to be substantially completed by the end of fiscal year 2025.
Impairment of long-lived assets for the quarter ended September 30, 2024 of $51.7 million was related to the non-cash asset impairment charge to certain of Exelixis’ leased facilities.
GAAP net income for the quarter ended September 30, 2025 was $193.6 million, or $0.72 per share, basic and $0.69 per share, diluted, as compared to GAAP net income of $118.0 million, or $0.41 per share, basic and $0.40 per share, diluted, for the comparable period in 2024. GAAP net income per share for the quarter ended September 30, 2025 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended September 30, 2025, as compared to the comparable period in 2024, as a result of the stock repurchase programs.

(Press release, Exelixis, NOV 4, 2025, View Source [SID1234659354])

On November 4, 2025 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported results for the third quarter of 2025 and reaffirmed its outlook for solid profitable growth while raising its profitability targets.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

QIAGEN reaffirmed its FY 2025 outlook for net sales growth of about 4-5% CER (about 5-6% CER core sales excluding divestments) and raised its adjusted diluted EPS target to about $2.38 CER (previously about $2.35 CER). QIAGEN also expects an adjusted operating income margin of about 29.5% (about 30% CER) in 2025 while absorbing headwinds from currency movements and tariffs.

QIAGEN also announced two strategic initiatives to strengthen its Sample technologies portfolio and enhance shareholder value. The acquisition of Parse Biosciences provides entry into the rapidly growing single-cell market. QIAGEN also announced plans to complete a $500 million synthetic share repurchase in early January 2026 to further increase shareholder returns, bringing total returns to more than $1 billion since 2024 and well ahead of its 2028 goal.

"QIAGEN continues to deliver in a challenging environment, with another quarter of results above our outlook and among the fastest growth rates in the industry," said Thierry Bernard, CEO of QIAGEN. "We are pleased with the sustained growth from QIAstat-Dx and QuantiFERON, along with solid momentum in Sample technologies as we prepare to launch three new instruments. The acquisition of Parse Biosciences is an excellent strategic fit, strengthening our leadership in Sample technologies by providing access to the high-growth single-cell market and the ability to offer solutions to drive large-scale AI-driven biology. It reflects our commitment to invest in innovation offering accretive returns and expand our addressable markets. As we update our targets for 2025, we are moving ahead on our ambitions to deliver solid profitable growth," he said.

"Our strong profitability and cash generation are allowing QIAGEN to step up shareholder returns," said Roland Sackers, CFO of QIAGEN. "With the execution of the $500 million repurchase in January 2026 that shareholders approved at our last Annual General Meeting, we are returning more than $1 billion to shareholders well ahead of our 2028 goal. We remain focused on generating the highest returns and are reviewing how to increase this target while also strengthening our portfolio through organic investments and targeted acquisitions such as Parse. We anticipate that our ongoing capital allocation decisions will bring our leverage ratio toward the industry average of about 2x in 2026."

Please find the full press release incl. tables as a PDF for download at the top of this page.

Investor presentation and conference call

A conference call is scheduled for Wednesday, November 5, 2025, at 15:30 Frankfurt Time / 14:30 London Time / 9:30 New York Time. A live audio webcast will be available in the Investor Relations section of the QIAGEN website (www.qiagen.com), with a recording accessible after the event. The accompanying presentation will be published in advance under "Events and Presentations" in the same section.

(Press release, Qiagen, NOV 4, 2025, View Source;EPS-Target-Announces-Parse-Acquisition-and-500-Million-Share-Repurchase/default.aspx [SID1234659370])

On November 4, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, reported it will jointly present additional immunological data profiling the immune response after treatment with the individualized neoantigen therapeutic vaccine (INTV) TG4050 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The conference will be held in National Harbor, Maryland, USA, from November 5 to 9, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Comprehensive immunogenicity data confirm TG4050’s ability to induce neoantigen-specific cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, thereby contributing to the prevention of cancer relapse, when used as monotherapy.

Prof. Le Tourneau, MD, PhD, Medical Oncologist at Gustave Roussy, and Principal Investigator, commented: "These new immunological data provide compelling evidence confirming TG4050’s mechanism of action. They also offer a clear rationale for the sustained prevention of relapses, which is a critical outcome for long-term patient benefit."

Data presented at SITC (Free SITC Whitepaper) demonstrate that TG4050 in monotherapy induces a potent CD8+ T cell response consistent with durable anti-tumor immunity:

Vaccine-induced cytotoxic CD8+ T cells display effector phenotype biomarkers even one year after the end of treatment, suggesting potential long-term effector functions.
CD8+ T cells express high levels of cytotoxic and tissue-resident biomarkers, suggesting that these cells are effective at killing cancer cells and likely to be found not only in the blood but also in tissues, where they are designed to be able to scout for and eliminate tumor cells.
The abstract is available on both the new windowSITC and PDFTransgene websites. The poster presentation will take place on November 8 and will be available that day on both the SITC (Free SITC Whitepaper) and Transgene’s websites.

Dr. Emmanuelle Dochy, MD, Chief Medical Officer of Transgene, said: "We are extremely proud to present new immunological data that further characterize the CD8+ T cell responses against the selected neoantigens. These translational data confirm that the vaccine selected neoantigens that induce an efficient immune response. TG4050 is currently being evaluated in the Phase II part of our ongoing Phase I/II study. The first immunogenicity data from this Phase II part are expected to be available in the second half of 2026."

Motoo Nishihara, Corporate EVP and CTO, at NEC, added: "These findings highlight the strong potential of NEC’s AI-driven platform in enabling the development of individualized neoantigen therapeutic vaccines. The confirmation of the mechanism of action and evidence of durable relapse prevention mark important milestones that reinforce our dedication to revolutionizing cancer treatment through cutting-edge AI innovation."

Transgene and NEC previously shared data (see PDFpress release) illustrating that CD8+ T cells specific to tumor neoantigens have been detected in patients treated with TG4050. These cells target multiple neoantigens encoded in the vaccine and their responses persist for up to two years after the start of the treatment.

New data provide key mechanistic insights into how TG4050 induces and sustains potent, CD8+ T cell responses in operable HNSCC* patients

Comprehensive immunogenicity data demonstrate TG4050’s ability to induce neoantigen-specific cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, supporting its potential to reduce risk of relapse

Conference call scheduled on November 14 at 4 p.m. CET (in English). See details below.

Strasbourg, France & Tokyo, Japan, November 4, 2025, 5:45 p.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, will jointly present additional immunological data profiling the immune response after treatment with the individualized neoantigen therapeutic vaccine (INTV) TG4050 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The conference will be held in National Harbor, Maryland, USA, from November 5 to 9, 2025.

Comprehensive immunogenicity data confirm TG4050’s ability to induce neoantigen-specific cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, thereby contributing to the prevention of cancer relapse, when used as monotherapy.

Prof. Le Tourneau, MD, PhD, Medical Oncologist at Gustave Roussy, and Principal Investigator, commented: "These new immunological data provide compelling evidence confirming TG4050’s mechanism of action. They also offer a clear rationale for the sustained prevention of relapses, which is a critical outcome for long-term patient benefit."

Data presented at SITC (Free SITC Whitepaper) demonstrate that TG4050 in monotherapy induces a potent CD8+ T cell response consistent with durable anti-tumor immunity:

Vaccine-induced cytotoxic CD8+ T cells display effector phenotype biomarkers even one year after the end of treatment, suggesting potential long-term effector functions.
CD8+ T cells express high levels of cytotoxic and tissue-resident biomarkers, suggesting that these cells are effective at killing cancer cells and likely to be found not only in the blood but also in tissues, where they are designed to be able to scout for and eliminate tumor cells.
The abstract is available on both the new windowSITC and PDFTransgene websites. The poster presentation will take place on November 8 and will be available that day on both the SITC (Free SITC Whitepaper) and Transgene’s websites.

Dr. Emmanuelle Dochy, MD, Chief Medical Officer of Transgene, said: "We are extremely proud to present new immunological data that further characterize the CD8+ T cell responses against the selected neoantigens. These translational data confirm that the vaccine selected neoantigens that induce an efficient immune response. TG4050 is currently being evaluated in the Phase II part of our ongoing Phase I/II study. The first immunogenicity data from this Phase II part are expected to be available in the second half of 2026."

Motoo Nishihara, Corporate EVP and CTO, at NEC, added: "These findings highlight the strong potential of NEC’s AI-driven platform in enabling the development of individualized neoantigen therapeutic vaccines. The confirmation of the mechanism of action and evidence of durable relapse prevention mark important milestones that reinforce our dedication to revolutionizing cancer treatment through cutting-edge AI innovation."

Transgene and NEC previously shared data (see PDFpress release) illustrating that CD8+ T cells specific to tumor neoantigens have been detected in patients treated with TG4050. These cells target multiple neoantigens encoded in the vaccine and their responses persist for up to two years after the start of the treatment.

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 (4 p.m. to 5 p.m. CET).

Webcast link to English language conference call:
new windowView Source

(Press release, Transgene, NOV 4, 2025, View Source [SID1234659388])

On November 4, 2025 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported a financial update and announced its cash position as of September 30, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"MaaT Pharma is actively executing its financing strategy, building on the momentum of our outstanding Phase 3 results with Xervyteg in acute Graft-versus Host disease patients. With funding secured through February 2026, we are leveraging a balanced mix of dilutive and non-dilutive sources to support our development programs and preserve shareholder value. The recent partnership with Clinigen and the loan agreement with the European Investment Bank are key milestones in this strategy, providing capital-efficient solutions we intend to build upon to sustain our growth throughout 2026," said Eric Soyer, Chief Financial Officer of MaaT Pharma.

Corporate and Financing Update

In July 2025, the Company announced that it has secured a €37.5 million, 4-tranche loan financing from the European Investment Bank (EIB). The financing will support the advancement of its late-stage hemato-oncology clinical programs including the lead-asset Xervyteg, currently under regulatory review by the European Medicines Agency (EMA) for the treatment of acute Graft-versus-Host disease (aGvHD), and the second drug candidate, MaaT033, currently being evaluated in a Phase 2b randomized controlled trial in improving survival for patients receiving allo-HSCT.
The Company announces the successful drawdown in October 2025 of Tranche A for an amount of €3.5 million, together with the issuance, in accordance with the terms of the 24th resolution of the shareholders’ meeting held on June 20, 2025 and Articles L. 228-91 and seq. of the French Commercial Code, of 468,772 warrants to the EIB with an exercise price of 4.5898€, as per the Loan and Warrant agreements with the EIB. The Tranche A loan is payable over two years after a grace period of 4 years, and bears an interest rate of 7% per annum.
In July 2025, the Company announced the signature of an exclusive license and distribution agreement with Clinigen, the global pathfinder accelerating access to critical medicines and a leading European player in hospital distribution and market access, to support market access to Xervyteg for 3rd-line aGvHD patients across Europe, should the submission for Marketing Authorisation be successful. With this partnership, MaaT Pharma demonstrates its capability to supply products to pharmaceutical companies, including those specializing in rare diseases while ensuring commercial scale-up.
The Company received an upfront payment of €10.5 million in July 2025 and may receive up to an additional €18 million, including €12 million upon Marketing Authorization approval and €6 million in commercial milestones. The Company is also eligible for royalty payments on net sales, with a rate in the mid-thirties, as well as recurring cash flows under the supply agreement, with products being sold to the partner at a pre-agreed price.
In September 2025, MaaT Pharma has been awarded the Innovative Company label ("Entreprise Innovante") by Bpifrance.
Cash position1

As of September 30, 2025, total cash and cash equivalents were EUR 22.4 million, as compared to EUR 15.0 million as of June 30, 2025, and EUR 20.2 million as of December 31, 2024.
The Company believes it has sufficient cash to cover its current operating needs and development programs until the end of February 2026.
Revenues in Q3 20251

MaaT Pharma reported revenues from France from its Early Access Program of EUR 1.0 million for the quarter ended September 30, 2025, a 56% increase over the third quarter of 2024. Total revenues for the first nine months of 2025 amounted to EUR 3.4 million compared with EUR 2.3 million for the same period of 2024, a year-over-year increase of 45%1, reflecting the continued demand from the medical community for MaaT Pharma’s drug candidate Xervyteg(MaaT013).
Upcoming financial communication*

March 30th, 2026 – Q4 and Full year 2025 financial results
*Indicative calendar that may be subject to change.

Upcoming investor and medical conferences participation

November 5-9, 2025 – 40th Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in National Harbor, MD, USA
November 19-21, 2025 – Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) annual meeting in Geneva, Switzerland
November 25, 2025 – Investir Day event in Paris, France
December 6-9, 2025 – 67th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in Orlando, Fl, USA

(Press release, MaaT Pharma, NOV 4, 2025, View Source [SID1234659404])