On November 4, 2026 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported it will present clinical data from the Phase 1b/2 study of OP-3136 in combination with fulvestrant, the Phase 1b/2 study of palazestrant in combination with everolimus, and the Phase 1b study of palazestrant in combination with atirmociclib in poster presentations at the San Antonio Breast Cancer Symposium (SABCS) taking place December 8-11 in San Antonio, TX.

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Poster Presentation Details
Title: A phase 1 study of OP-3136, a novel oral selective KAT6A/B inhibitor, as monotherapy and in combination with endocrine therapy (ET) in estrogen receptor-positive (ER+), human epidermal growth factor-2-negative (HER2-) advanced breast cancer (ABC)
Abstract Number: 3363
Presentation Number: P1-4-16
Date/Time: Wednesday, December 9, 2026, 12:30 PM – 2:00 PM CT/11:30 AM – 1:00 PM ET

Title: Palazestrant (OP-1250) in combination with everolimus, a phase 1b/2 study, in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) advanced or metastatic breast cancer
Abstract Number: 813
Presentation Number: P4-13-28
Date/Time: Thursday, December 10, 2026, 5:00 PM – 6:30 PM CT/6:00 PM – 7:30 PM ET

Title: Palazestrant (OP-1250) in combination with atirmociclib, a phase 1b study, in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) advanced or metastatic breast cancer
Abstract Number: 811
Presentation Number: PS10-11
Date/Time: Friday, December 11, 2026, 7:00 AM – 8:30 AM CT/8:00 AM – 9:30 AM ET

Additional information can be found on the SABCS website. A copy of the posters will be made available on the Publications page of Olema’s website in alignment with the SABCS 2026 embargo policy.

(Press release, Olema Oncology, NOV 4, 2026, https://www.globenewswire.com/news-release/2026/11/04/3395781/0/en/olema-oncology-to-present-combination-data-from-the-palazestrant-and-op-3136-programs-at-the-2026-san-antonio-breast-cancer-symposium.html [SID1234674239])

On November 4, 2026 Zelluna (OSE: ZLNA), a clinical-stage company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported its results for the third quarter 2026.

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Webcast scheduled for 5 November 2026 at 09:00 (CET). Link to webcast here.

Operational Highlights:

ZIMA-101 recruitment and dosing on track: Two of the three patients required at Dose Level 1 have now been successfully dosed, the second following the reporting period, with dosing of a third patient planned during Q4 2026 to complete this dose level. More than 30 patients have been screened for HLA-A2 and/or MAGE-A4 expression, with potential patients identified across all four target indications (ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma and head and neck cancer), demonstrating strong clinical site engagement and supporting continued recruitment momentum. Subject to completion of Dose Level 1 and a favourable subsequent safety review by the Independent Data Monitoring Committee (IDMC), Zelluna expects to begin and complete recruitment and dosing at Dose Level 2, representing a threefold increase in the administered cell dose compared with Dose Level 1, during Q1 through early Q2 2027.
No dose-limiting toxicities to date: ZI-MA4-1 has been well tolerated, with no dose-limiting toxicities reported in the two patients treated. On 17 August 2026, the Independent Data Monitoring Committee (IDMC) completed its planned safety review of the first patient and recommended continued recruitment at Dose Level 1.
Initial observations from patient samples: Preliminary blood measurements indicate cell kinetics consistent with expectations, alongside early changes in circulating pro-inflammatory immune markers following ZI-MA4-1 infusion. Clinical follow-up is ongoing, including further tumour imaging assessments and the collection and analysis of translational data from patients treated at Dose Level 1.
External clinical evidence supports TCR-NK therapeutic potential: Researchers at MD Anderson Cancer Center have reported a complete response in a heavily pre-treated multiple myeloma patient treated with an independently developed TCR-NK therapy. While generated in a different disease setting, this provides an encouraging external clinical demonstration that the TCR-NK approach can deliver anti-tumour activity in late-stage cancer patients.
Awarded NOK 15.6 million grant by the Research Council of Norway to further advance TCR-NK manufacturing: Following the reporting period, on 4 November 2026, Zelluna was awarded NOK 15.6 million in a grant by the Research Council of Norway. Funding will enable further manufacturing development and support Zelluna’s commercial strategy to make off-the-shelf TCR-NK cell therapies broadly accessible to patients with solid cancers. The award, which is subject to final contract negotiations, follows another grant awarded by the Research Council of Norway in June 2026 earlier this year to support the ZIMA-101 clinical programme.
Manufacturing process successfully executed at new CDMO: Following the reporting period, an initial manufacturing run was successfully completed at Zelluna’s new CDMO, an important step towards establishing manufacturing capabilities at the new facility and highlighting the potential transferability of Zelluna’s manufacturing process across sites, an important TCR-NK platform attribute supporting future scalability, manufacturing flexibility and cost efficiency. Analytical and functional characterisation of the resulting product is ongoing.
ZIMA-101 featured at leading international oncology conferences: Following the reporting period, the design of the ongoing ZIMA-101 Phase 1 study of ZI-MA4-1 was presented by Professor Fiona Thistlethwaite, Chief Investigator of the study at The Christie NHS Foundation Trust, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 in Madrid. A further poster presentation outlining the design of the study is scheduled for the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2026.
Martin Welschof elected as new Board member: At an Extraordinary General Meeting held on 9 September 2026, Martin Welschof, CEO of BioInvent International AB, was elected as a new member of the Board, replacing Hans Ivar Robinson, who has stepped down from the Board. Martin Welschof has previously served as CEO of Affitech A/S and Opsona Therapeutics, holds a PhD in recombinant antibody technology and brings extensive international experience from executive leadership in clinical-stage and listed biotechnology companies.
Financial Highlights Q3 2026:

Total operating expenses: MNOK 28.8 in Q3 2026 and MNOK 69.2 YTD
Total loss: MNOK 29.0 in Q3 2026 and MNOK 69.0 YTD
Cash and cash equivalents: MNOK 60.4 as of 30 September 2026
Net negative cash flow from operations: MNOK 25.5 in Q3 2026
Financial runway: Into Q3 2027
Expected grants and tax credits: SkatteFUNN tax credits of MNOK 5.2 related to 2025 expected in Q4 2026, as well as the first payments under the MNOK 16 grant awarded by the Research Council of Norway in June 2026, with the remainder expected in 2027
Share issue to Inven2: On 4 August 2026, 446,752 new shares were issued at NOK 19.78 per share to settle EUR 791,666.70 under the option and license agreement with Inven2, triggered by the dosing of the first patient

"The third quarter marked Zelluna’s transition into a clinical-stage biotechnology company. We have now treated two patients in ZIMA-101, with no dose-limiting toxicities reported to date. Recruitment is on track, supported by strong engagement from our clinical sites and investigators driving continued progress towards completion of our first dose cohort and preparations for dose escalation.

Our immediate priority is to complete Dose Level 1 and progress towards a threefold higher dose, subject to independent safety review. This will be an important next step in exploring the therapeutic potential of TCR-NK for patients with solid tumours. We are also encouraged by emerging external clinical evidence, including the complete response reported with an independent TCR-NK therapy, demonstrating the potential of this approach to deliver meaningful anti-tumour activity in patients. With our differentiated platform, continued clinical execution, and sustained strategic interest in off-the-shelf cell therapies we believe Zelluna is well positioned to create value for patients and shareholders as clinical data builds" says CEO Namir Hassan.

"It is encouraging to see the progress in recruitment to the ZIMA-101 study, with patients being identified across several solid tumour indications. As an early-phase clinical trial evaluating a novel TCR-NK cell therapy, our initial focus is on establishing safety and progressing through dose escalation. We look forward to building on this early experience as the study advances." Prof. Fiona Thistlethwaite, Chief Investigator, ZIMA-101.

Outlook

Zelluna enters the final quarter of 2026 with encouraging initial clinical observations and recruitment and dosing progressing on track in the first-in-human ZIMA-101 study. The Company’s immediate priority is to complete Dose Level 1 and advance to Dose Level 2, where recruitment and dosing are expected to take place from Q1 through early Q2 2027, subject to completion of Dose Level 1 and a favourable subsequent IDMC safety review. The encouraging initial observations at the lowest planned dose level support continued dose escalation. Ongoing clinical and translational assessments of patients treated at Dose Level 1, together with data from higher dose levels, are expected to build a more comprehensive understanding of the safety and therapeutic potential of ZI-MA4-1. In parallel, Zelluna continues to strengthen its manufacturing capabilities and advance its TCR-NK pipeline, including the evaluation of AI-engineered TCR candidates targeting KKLC1. Zelluna’s cash position is expected to fund planned operations into the third quarter of 2027.

The quarterly report and presentation materials will be made publicly available on the Zelluna website at 07:00 CET on 5 November 2026. The Company will host a webcast on 5 November at 09:00 CET, and questions can be submitted during the event. The webcast recording will remain available on the Company’s website after the event.

(Press release, Zelluna Immunotherapy, NOV 4, 2026, View Source [SID1234674238])

On November 4, 2026 Polaris Rx reported that it has been selected by Bristol Myers Squibb to dispense ZENBEXUS (iberdomide), the first cereblon E3 ligase modulator (CELMoD) therapy approved by the U.S. Food and Drug Administration (FDA). ZENBEXUS is approved, in combination with daratumumab and hyaluronidase-fihj and dexamethasone, for adults with multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.1

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Multiple myeloma is a blood cancer of the plasma cells in the bone marrow. The American Cancer Society estimates about 36,000 Americans will be diagnosed in 2026, and about 10,850 will die from the disease. Most patients are 65 or older at diagnosis, with an average age of 69. Many patients see their cancer return or stop responding to treatment, making new options for relapsed disease critical.2

ZENBEXUS is the first drug in a new class called cereblon-modulating protein degraders. It is supplied in 0.75 mg and 1 mg strengths.1 The FDA granted ZENBEXUS accelerated approval on August 13, 2026, based on the Phase 3 EXCALIBER-RRMM trial, which compared the ZENBEXUS regimen (n=207) against daratumumab, bortezomib and dexamethasone (n=213). In the study, 41 percent of patients taking the ZENBEXUS combination reached a complete response with no detectable cancer cells, known as minimal residual disease (MRD)-negative complete response. It is the first new multiple myeloma drug approved by the FDA based directly on MRD. Continued approval may depend on confirmatory trial results.3

"Polaris Rx is proud to be among a select group of pharmacies extending access to ZENBEXUS, the first therapy of its kind for patients with relapsed multiple myeloma," said Eric Sredzinski, PharmD, Chief Strategy Officer of Polaris Rx. "Because ZENBEXUS is taken at home, our pharmacists and patient-support teams can help patients stay on track between clinic visits. We’re excited to help bring this new option to patients and the care teams who support them."

(Press release, PolarisRx, NOV 4, 2026, View Source [SID1234674237])

On November 4, 2026 Chengdu Zenitar Biomedical Technology Co., Ltd. (Zenitar) reported it is developing flonoltinib maleate (FM), a first-in-class oral JAK2/FLT3/CDK6 inhibitor for myeloproliferative neoplasms (MPNs), including myelofibrosis (MF) and polycythemia vera (PV).

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Zenitar launched randomized Phase 2 FM-MF-02 (NCT07750574) in the US, Canada and Brazil to select Phase 3 dose for JAKi-naïve and refractory MF. Randomized FMF-02 (NCT06457425) met its week-24 endpoints: superior SVR35 and TSS50 with FM 50/100mg versus ruxolitinib; previous data presented orally at ASH (Free ASH Whitepaper)24 (#486) and ASH (Free ASH Whitepaper)25 (#908). ASH (Free ASH Whitepaper) 2026 presence covers FMF-02 long-term follow-up (oral presentation, #411, December 12, 4:30pm) and refractory PV Phase 2 data (poster, #3765, December 13, 6pm), both in Session 634.

"Over the 15 years since the initial FDA approval of Ruxolitinib, JAKi have markedly improved the prognosis of many patients with MF. The long-term data show significant room for improvement for this key therapeutic class in terms of both efficacy and tolerability" said Dr. Andrew Kuykendall, Moffitt Cancer Center and principal investigator of the FM-MF-02 study. "The initial data from the randomized FMF-02 study presented at the ASH (Free ASH Whitepaper) meeting last year was very encouraging. The presentation on long-term follow up of this study at this year’s meeting is eagerly awaited. On the FM-MF-02 study, patients with MF and an inadequate response to prior JAKi are randomized to various FM regimens, including both of those (50mg/100mg) reported to be superior to Ruxolitinib in the FMF-02 study, and a third intermediate (75mg) dose. "This study will help define the best FM dosing regimen to take forward in registration studies of FM randomized against approved JAKi for patients with MF. I am very excited about leading it and to working closely with my colleagues on its conduct and generation of key data."

"It is clear that JAK inhibitors have made a substantial difference in the quality and length of life of patients with MF. It is equally clear that there are significant limitations to the currently approved generation of JAKi" said Raajit Rampal, Director of the Myeloproliferative Neoplasms Program, Memorial Sloan Kettering Cancer Center. "Investigation of the biology of MF and of clinical resistance to JAKi in MF has identified several new candidate therapeutic targets in MF/MPN, including cyclin-dependent kinase 6 (CDK6). FM represents a novel drug that combines more specific targeting of JAK2 with CDK6 inhibition. FM-MF-02 is an important milestone study that demonstrates further proof-of-concept that this mechanism-based targeting can extend benefits to patients with MF beyond those observed with a first-generation JAKi such as ruxolitinib. FM is now well-positioned for pivotal registrational studies, and to potentially change currents standards of care."

"There are significant unmet needs for the majority of our patients with MF, the most important of which is the prospect of cure with tolerable therapies. This is a very exciting time for developmental therapeutics in MF as we have agents with diverse modes of action under clinical investigation. I expect JAKi to remain as a cornerstone of MF-therapy and thus the data generated on FM to date is particularly important," said Claire Harrison, Professor of Myeloproliferative Neoplasms from Guy’s and St Thomas NHS Foundation Trust, and Chair of the FM Scientific Advisory Board. "We need next generation JAKi to further alter the disease course in MF. I found the initial report at to 2025 ASH (Free ASH Whitepaper) meeting on the randomized FMF-02 study very intriguing with superiority to Ruxolitinib reported with both FM regimens across a meaningful clinical and molecular spectrum of patients with MF. The conduct of definitive regulatory studies of FM is an urgent necessity, and the FM-MF-02 study is a very important step on that path. Personally, I am very interested in moving rapidly to clinical studies of FM in combination with novel agents with non-JAKi modes of action for patients with MF and in the evolving data on FM for patients with advanced PV which will also be shared at the ASH (Free ASH Whitepaper) meeting this year."

"Our investigator’s satisfaction with the positive data from the prior FMF-02 randomized study of FM versus Ruxolitinib in patients with MF encouraged us to very rapidly advance to the international randomized FM-MF-02 study" said Professor Lijuan Chen, Zenitar Chairman, CEO & CSO. "FM’s clinical success as a highly selective JAK2 inhibitor with unique FLT3 and CDK6 inhibitory activity is very important for patients with MF who need substantial improvements in efficacy over that offered by first generation JAKi. As a FIC clinically important molecule FM validates the AI-driven, structure-based development programs that have generated Zenitar’s broad pipeline. We are excited to again share data on FM with the global community at the ASH (Free ASH Whitepaper) meeting. Our expanding rapid conduct of registrational studies is key to getting our agents to patients in need and we are committed to the optimal conduct of these studies with our investigators around the world."

(Press release, Zenitar Biomedical, NOV 4, 2026, View Source [SID1234674236])

On November 4, 2026 Orca Bio, a commercial-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported that new clinical data will be presented in four poster sessions at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 12-15 in New Orleans, LA, with one additional abstract accepted for online publication. The presentations will include two-year follow-up of TREGZI from the pivotal Phase 3 Precision-T trial, as well as data from ongoing studies evaluating Orca-T and the company’s next-generation candidate, Orca-Q.

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"Orca Bio is committed to advancing the science and body of evidence that support the value and potential of high-precision therapies in blood cancers," said J. Scott McClellan, MD, Ph.D., chief development officer of Orca Bio. "We look forward to sharing our data presentations at ASH (Free ASH Whitepaper), highlighting the results from the two-year follow up from the TREGZI pivotal trial, Precision-T, along with data exploring the benefit of Orca-T and Orca-Q across a range of transplant settings and patient types."

The ASH (Free ASH Whitepaper) abstracts are now available at www.hematology.org. Details of the Orca Bio poster presentations follow:

Poster Session: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Toxicities: Poster I
Title: Trial in Progress: A Phase 2 Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome (SERENE-T)
Publication Number: 2457
Date and Time: December 12, 2026 at 5:30 PM – 7:30 PM CST
Location: Ernest N. Morial Convention Center – Hall F

Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I
Title: Clinical Overview of Acute GVHD Events with Orca-T Compares to Conventional Allograft with tac/MTX in Phase 3 Precision-T trial
Publication Number: 2485
Date and Time: December 12, 2026 at 5:30 PM – 7:30 PM CST
Location: Ernest N. Morial Convention Center – Hall F

Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster II
Title: Preliminary Outcomes of Reduced Intensity Conditioning or Nonmyeloablative Conditioning with Orca-Q in Matched Related and Matched Unrelated Donors
Publication Number: 4244
Date and Time: December 13, 2026 at 6:00 PM – 8:00 PM CST
Location: Ernest N. Morial Convention Center – Hall F

Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster II
Title: ACCESS-T: A Phase 1 Trial of Orca-T with Dual-Agent Tacrolimus/Ruxolitinib Prophylaxis for Myeloablative HLA-Mismatched Allogeneic HCT
Publication Number: 4227
Date and Time: December 13, 2026 at 6:00 PM – 8:00 PM CST
Location: Ernest N. Morial Convention Center – Hall F

Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III
Title: Two-Year Follow-Up of Orca-T Compared to Conventional Allogeneic Hematopoietic Stem Cell Transplant Demonstrates Durable Survival Outcomes: Updated Results from the Precision-T Phase 3 Trial
Publication Number: 5992
Date and Time: December 14, 2026 at 6:00 PM – 8:00 PM CST
Location: Ernest N. Morial Convention Center – Hall F

Online Publication Only: Impact of Federal Eligibility Criteria for Donors on Post-Transplant Outcomes in the Orca-T Phase 3 Precision-T Trial
Publication Number: 8384

About TREGZI

TREGZI is the first-and-only FDA approved precision-cell therapy for allogeneic transplant in adults with hematologic malignancies to improve survival free of cGVHD. It is indicated for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host-disease-free survival, in the treatment of adults with hematological malignancies.

TREGZI is a personalized treatment manufactured for each individual patient using living cells from a matched donor. TREGZI uses hematopoietic stem and progenitor cells (HSPCs) to reconstitute the immune system, highly purified regulatory T cells (Tregs) to suppress GVHD and conventional T cells (Tcons) to accelerate immune reconstitution and produce graft-versus-leukemia (GVL) activity.

The FDA approval of TREGZI was based on the results of Precision-T, a randomized, open-label, multi-center study that evaluated the safety, efficacy and tolerability of TREGZI compared with conventional allogeneic hematopoietic stem cell transplant (alloHSCT).

Click here for Important Safety Information.

About Orca-Q

Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy under evaluation in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical and mismatched donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform.

(Press release, Orca Bio, NOV 4, 2026, View Source [SID1234674235])