Incyclix Bio Establishes Steering Committee of Leading Breast Cancer Experts to Guide INX-315 Clinical Development

On November 5, 2026 Incyclix Bio, LLC, a next-generation cell cycle control company developing INX-315, a novel, potent and selective CDK2 inhibitor for the treatment of advanced and resistant cancer, reported the formation of a Steering Committee of leading breast cancer experts to guide the continued clinical development of INX-315. The committee will be chaired by Seth Wander, MD, Ph.D., Director of Translational Research for the Breast Oncology Program and Director of Precision Medicine at the Termeer Center for Targeted Therapies at Massachusetts General Hospital.

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"Drug resistance remains a significant challenge in breast cancer care, leaving many patients with limited treatment options," said Dr. Wander. "Encouraging data from the ongoing INX-315-01 clinical trial underscore the potential of CDK2 inhibition to address treatment resistance in patients with advanced or metastatic breast cancer. I look forward to collaborating with my fellow committee members and the Incyclix team to advance the clinical development of INX-315 for these patients."

Additional members of the Steering Committee include:

Sheheryar Kabraji, BMBCh, Associate Professor of Oncology, Chief of Breast Medicine and Director of Breast Translational Research at Roswell Park Comprehensive Cancer Center in Buffalo, NY
Antoinette Tan, MD, MHSc, Chief of Breast Medical Oncology and Co-Director of the Phase I Program at Atrium Health Levine Cancer Institute, Wake Forest University School of Medicine, NC
Philippe Aftimos, MD, Medical Oncologist and Clinical Trials Development Leader at Institut Jules Bordet in Brussels, Belgium
Sarah Premji, MD, Assistant Director of Breast Cancer Research at Sarah Cannon Research Institute in Nashville, TN
Cynthia Ma, MD, Ph.D., Professor of Medicine in the Division of Oncology and Clinical Director of the Breast Cancer Program at Washington University School of Medicine in St. Louis, MO
"We are highly encouraged by the emerging clinical profile of INX-315 in breast cancer and have assembled this distinguished group of experts to help guide the program’s next phase of development," said Patrick Roberts, Pharm.D., Ph.D., Chief Executive Officer and Co-Founder of Incyclix Bio. "Their collective clinical and research expertise will be invaluable as we advance INX-315 and evaluate its potential to address treatment resistance in patients with advanced or metastatic breast cancer following CDK4/6 inhibitor therapy, an area of significant unmet need."

Despite advances in treatment, patients with advanced or metastatic breast cancer whose disease progresses following CDK4/6 inhibitor therapy continue to face limited treatment options. Incyclix’s ongoing Phase 1/2 clinical trial (NCT05735080) is evaluating INX-315 in patients with CDK4/6 inhibitor (CDK4/6i) resistant estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) breast cancer. The Steering Committee will provide strategic guidance on the program’s continued clinical development, including preparations for a potential pivotal trial expected to initiate in 2027.

The INX-315-01 trial is also evaluating INX-315 in patients with CCNE1-amplified ovarian cancer.

(Press release, Incyclix Bio, NOV 5, 2026, View Source [SID1234674369])

NeOnc Reports Third Quarter 2026 Financial Results and Highlights Recent Corporate and Clinical Progress

On November 5, 2026 NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) ("NeOnc" or the "Company"), a clinical-stage biopharmaceutical company developing therapies for central nervous system (CNS) cancers, reported financial results for the third quarter ended September 30, 2026, and highlighted recent corporate and clinical progress, including the upcoming presentation of data from its NEO100 and NEO212 programs at the Society for Neuro-Oncology Annual Meeting.

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Amir F. Heshmatpour, Executive Chairman, President and Chief Executive Officer, commented:

"The third quarter marked a period of meaningful progress for NeOnc, strengthening our clinical programs, our balance sheet and our international presence. In August, we were pleased to report positive topline Phase 2a results for intranasal NEO100 in recurrent IDH1-mutant high-grade glioma. The study met its primary endpoint, an important milestone that supports the potential of our intranasal approach to directly address delivery across the blood-brain barrier, one of the greatest challenges in treating brain cancer. Additionally, during the quarter, NEO212 continued to advance toward Phase 2 development, and we look forward to sharing data from both programs at the Society for Neuro-Oncology Annual Meeting on November 13.

"Alongside these clinical achievements, we strengthened the financial and strategic foundation that supports them. In September, we raised $15 million from new and existing healthcare-focused institutional investors and used a portion of the proceeds to redeem all of our Series A Convertible Preferred Stock in cash, eliminating its potential dilution for our shareholders. At the same time, our net loss for the quarter was $4.4 million, down from $8.6 million in the third quarter of 2025, and total operating expenses declined to $5.8 million from $6.9 million.

"In October, we were honored to enter into a memorandum of understanding (MoU) with the Department of Health – Abu Dhabi to advance research and clinical capability in CNS oncology in the Emirate of Abu Dhabi. The MoU creates a framework to bring NeOnc’s development expertise together with the Emirate’s healthcare capabilities, and we are proud to work alongside the Department of Health to address the needs of patients with complex and rare brain cancers, including children.

"Finally, we were delighted to welcome Nasim Shomali and Ali Alabedin to our Board of Directors, whose expertise in corporate planning, banking and international markets deepens the Board as NeOnc grows. We thank our patients, investigators, partners and shareholders for their support, and we are encouraged by the work ahead as we strive to bring new approaches to patients with brain cancer."

Third Quarter and Recent Highlights

Society for Neuro-Oncology Annual Meeting

NEO100 and NEO212 Data Presentations: Data from both of NeOnc’s clinical programs will be presented in two posters on Friday, November 13, 2026, at the 31st Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO) at the Pennsylvania Convention Center in Philadelphia. Thomas C. Chen, MD, PhD, will present updated results from the Phase 1/2a study and compassionate use experience with intranasal NEO100 in recurrent WHO Grade III/IV IDH1-mutant astrocytoma (Abstract CTNI-26). Josh Neman, PhD, will present Phase 1 safety, pharmacokinetic and early activity data for oral NEO212 in TMZ-resistant recurrent glioblastoma and brain metastases (Abstract CTNI-27).
NEO100 Clinical Progress

Positive Topline Phase 2a Results: In August, the Company reported positive topline results from the Phase 2a portion of NEO100-01, evaluating intranasal NEO100 in patients with recurrent IDH1-mutant high-grade glioma. The study met its primary endpoint, with six-month progression-free survival of 48.9% versus a pre-specified 20% benchmark for standard of care (p = 0.0047). Median overall survival was 26.09 months, with overall survival rates of 60.9% at 12 months and 54.1% at 24 months. No major toxicities were reported, and adverse events were predominantly low grade.
Compassionate Use in Abu Dhabi: In October, the Company reported that, according to his treating physicians, a critically ill three-year-old boy with an aggressive brain tumor treated with investigational NEO100 under NeOnc’s Compassionate Care program in Abu Dhabi began breathing independently without ventilator support and moving his legs. These observations involve a single patient and do not establish that NEO100 caused the improvement.
NEO212 Development

FDA Written Feedback on CMC Development: In July, the Company received written feedback from the FDA on the chemistry, manufacturing and controls program for NEO212 and the planned transition from a capsule to a tablet formulation, which NeOnc is incorporating into its NEO212 development plan.
Abu Dhabi

Memorandum of Understanding with the Department of Health – Abu Dhabi: In October, NeOnc and the Department of Health – Abu Dhabi signed a memorandum of understanding to collaborate on CNS oncology research, clinical development methods, real-world evidence, and training and capacity-building, and to explore proposed clinical collaboration and a potential regional presence for NeOnc, subject to separate agreements and approvals. The MoU builds on the Investigational New Drug authorizations the Department of Health – Abu Dhabi granted for NEO100 and NEO212 in June 2026.
Abu Dhabi Future Health Summit: Mr. Heshmatpour spoke on October 22 on "The Investment Lens: Banking on Prediction" panel at the Abu Dhabi Future Health Summit 2026, addressing the financing of clinical development, international collaboration and biomarker-informed drug development.
Corporate and Financial

$15 Million Registered Direct Offering: On September 10, 2026, the Company closed a registered direct offering priced at-the-market under Nasdaq rules with new and existing healthcare-focused institutional investors for gross proceeds of approximately $15 million, before deducting placement agent fees and other offering expenses. Roth Capital Partners and A.G.P./Alliance Global Partners acted as co-placement agents.
Redemption of Series A Convertible Preferred Stock: In September, the Company redeemed all 6,000 outstanding shares of its Series A Convertible Preferred Stock for approximately $5.8 million in cash, a discount to the aggregate stated value of $6.0 million, using a portion of the offering proceeds. No shares of common stock were issued in the redemption, eliminating the potential dilution associated with the preferred stock.
Insider Purchases: Following the Phase 2a results, Mr. Heshmatpour and Dr. Chen purchased a combined 160,016 shares of NeOnc common stock for approximately $629,000 in open-market transactions using personal funds.
Board Appointments: The Company appointed Nasim Shomali to its Board of Directors, effective July 1, 2026, following the resignation of Ming-Fu (Alan) Chiang, MD, PhD, MBA, in June 2026. The Company also appointed Ali Alabedin, Head of Islamic Banking Group at First Abu Dhabi Bank, to its Board of Directors, effective October 9, 2026. Mr. Alabedin succeeds Steven L. Giannotta, MD, who will continue to serve on NeOnc’s Scientific Advisory Board.
National Television: Mr. Heshmatpour and Dr. Chen were featured on Health Uncensored with Dr. Drew on Fox Business Network, discussing NeOnc’s approach to reaching brain tumors without surgery or systemic chemotherapy.
Financial Results for Q3 2026

Cash position: As of September 30, 2026, the Company had cash and cash equivalents of approximately $6.2 million, compared with approximately $2.0 million as of June 30, 2026. The increase primarily reflects net proceeds of approximately $13.9 million from the September registered direct offering, partially offset by the approximately $5.8 million cash redemption of the Series A Convertible Preferred Stock and cash used in operations. The Company also maintained an undrawn $10.0 million line of credit with HCWG, a related party, subject to the terms of the facility, and approximately $73.8 million remained available under its at-the-market offering program with BTIG, LLC and A.G.P./Alliance Global Partners.
G&A expenses: General and administrative expenses decreased to $0.6 million from $0.9 million in Q3 2025, reflecting the reversal of previously accrued compensation, lower business development costs and lower travel expenses, partially offset by continued advertising, marketing and investor relations costs.
R&D expenses: Research and development expenses were $1.3 million, compared with $0.7 million in Q3 2025. The increase reflects NeOnc’s continued investment in clinical execution, including the addition of clinical trial sites, drug-product manufacturing to support ongoing and planned clinical trials, the NEO100-03 pediatric trial, patient recruitment, data-lock and analysis activities for the NEO100 Phase 2a study, and design of the Phase 2a trial of NEO212, partially offset by the reversal of previously accrued laboratory fees.
Net loss: Net loss was $4.4 million in Q3 2026, compared with $8.6 million in Q3 2025. The 49% decrease was driven primarily by lower non-cash stock-based compensation expense, lower operating expenses, lower interest expense on the convertible promissory notes repaid in January 2026, and a noncash gain on the change in fair value of the Series A derivative liability. Net loss attributable to common stockholders was $7.3 million, or $(0.28) per basic and diluted share, compared with $8.6 million, or $(0.45) per basic and diluted share, in Q3 2025. Net loss attributable to common stockholders in Q3 2026 included $2.8 million of noncash deemed dividends related to the redemption of the Series A Convertible Preferred Stock and a down-round adjustment of previously issued warrants. Total operating expenses were $5.8 million, compared with $6.9 million in Q3 2025, and included approximately $0.3 million of noncash stock-based compensation. Excluding this noncash expense, total operating expenses were approximately $5.6 million. A reconciliation of this non-GAAP measure is provided below.
Nine-month results: Net loss for the nine months ended September 30, 2026, was $27.5 million, compared with $46.6 million for the same period in 2025. Net cash used in operating activities was $16.8 million for the nine months ended September 30, 2026, and 2025. The difference between cash used in operations and the net loss for the period primarily reflects non-cash charges, including $8,651,875 of stock-based compensation.
Reconciliation of GAAP Total Operating Expenses to Non-GAAP Total Operating Expenses Excluding Stock-Based Compensation (unaudited)

Three Months
Ended
September 30,
2026
GAAP total operating expenses $ 5,834,350
Less: Non-cash stock-based compensation expense (267,565 )
Non-GAAP total operating expenses excluding stock-based compensation $ 5,566,785

About NEO100

NEO100 is a highly purified form of perillyl alcohol administered intranasally. Its delivery approach is designed to provide a non-invasive route to the brain. NEO100 remains investigational, and its safety and efficacy have not been established.

About NEO212

NEO212 is an investigational oral conjugate of temozolomide and NEO100. It is being studied for CNS cancers, including recurrent glioblastoma. Preclinical studies support further evaluation of its potential activity and delivery characteristics; clinical efficacy and safety have not been established. NEO212 is being developed under an FDA investigational new drug application.

(Press release, Neonc, NOV 5, 2026, https://www.globenewswire.com/news-release/2026/11/05/3396510/0/en/neonc-reports-third-quarter-2026-financial-results-and-highlights-recent-corporate-and-clinical-progress.html [SID1234674368])

Elevar Therapeutics Announces FDA PDUFA Date for Resubmitted New Drug Application for Rivoceranib in Combination With Camrelizumab for Use as a First-line Systemic Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

On November 5, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients with cancer, reported the U.S. Food and Drug Administration (FDA) acknowledged receipt of the resubmission of a new drug application (NDA) for its investigational drug rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, an anti-PD-1 antibody, as a first-line systemic treatment for unresectable or metastatic hepatocellular carcinoma (uHCC). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 9, 2027. HCC is the most common type of liver cancer.

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On Oct. 9, 2026, Elevar resubmitted the NDA for rivoceranib, while Hengrui Pharma resubmitted a biologics license application (BLA) for camrelizumab. The FDA will review the applications under an integrated review process for the two-drug combination regimen. The resubmission includes Elevar’s and Hengrui Pharma’s response to previously raised concerns by the FDA in its Complete Response Letter issued in July 2026.

"The results from the CARES-310 study support our continued evaluation of the combination of camrelizumab and rivoceranib as a potential first-line therapy to improve outcomes for patients facing limited treatment options in unresectable hepatocellular carcinoma, which we continue to keep top of mind while navigating the regulatory landscape," said Dong-Gun Kim, chief executive officer of Elevar Therapeutics. "We are pleased to receive classification of this NDA resubmission, jointly with Hengrui’s BLA resubmission for camrelizumab and will work closely with the FDA as it reviews the applications."

The NDA is based on the global Phase 3 CARES-310 study, in which first-line camrelizumab plus rivoceranib combination therapy achieved a median overall survival of 23.8 months in patients with unresectable or metastatic HCC, compared to sorafenib’s mOS of 15.2 months (HR = 0.64, 95% CI 0.52 – 0.79, P< 0.0001). Results observed across multiple patient subgroups were generally consistent. In December 2025, the final analysis was published in The Lancet Oncology, a leading international medical journal. In addition, prior to regulatory approval, the combination regimen was included as a first-line treatment option for advanced HCC in the 2025 Barcelona Clinic Liver Cancer treatment strategy and European Society for Medical Oncology guidelines in recognition of the treatment’s clinical relevance. However, rivoceranib and camrelizumab are investigational in the United States and have not been approved by the FDA, so their safety and effectiveness for the proposed indication have not yet been established.

"Hepatocellular carcinoma remains a major cause of cancer-related mortality worldwide," said Arndt Vogel, M.D., Ph.D., scientist in the Division of Gastroenterology and Hepatology at Toronto General Hospital Research Institute, and a medical oncologist at the UHN-Princess Margaret Cancer Centre at the University of Toronto. "Despite advances in treatment, there remains a need for additional therapeutic options for patients with advanced HCC. The clinical development program evaluating camrelizumab plus rivoceranib includes the global Phase 3 CARES-310 study, as well as studies across multiple stages of HCC and in combination with locoregional therapies. The FDA’s continued review represents an important regulatory milestone as the potential role of this investigational combination in HCC continues to be evaluated."

For more information about the combination of camrelizumab and rivoceranib, visit ElevarTX.com.

About Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the most common type of liver cancer and most frequently develops in people with chronic underlying liver inflammation, which may be from viral and non-viral causes. HCC typically has a poor prognosis with limited treatment options and continues to be a diagnosis with an ongoing urgent medical need. More than 800,000 people worldwide are diagnosed with liver cancer each year and it is also a leading cause of cancer deaths, accounting for more than 700,000 annually, according to the American Cancer Society.

About Rivoceranib

Rivoceranib, an oral small-molecule tyrosine kinase inhibitor (TKI), is a highly selective inhibitor of vascular endothelial growth factor receptors (VEGFRs), a primary pathway for tumor angiogenesis. VEGFR inhibition is a clinically validated target to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Several clinical studies were completed in patients with uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf). Rivoceranib, under the name apatinib (Aitan), was the first TKI approved in gastric cancer in China (October 2014). It was also approved in China in combination with camrelizumab as a first-line treatment for unresectable or metastatic HCC (January 2023). The drug has been studied in more than 6,000 patients worldwide across multiple tumor types. Orphan drug designations have been granted for gastric cancer (U.S., EU and South Korea), adenoid cystic carcinoma (U.S.) and uHCC (U.S. and EU). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Hengrui Pharma is the license-holder of rivoceranib in the Chinese territory.

About Camrelizumab

Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid cancers. Camrelizumab is developed by Hengrui Pharma. Under the brand name AiRuiKa, Camrelizumab is currently approved for 10 indications in China, covering lung cancer, liver cancer, esophageal cancer, nasopharyngeal cancer, and cervical cancer. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021 and by the EMA in August 2024. In October 2023, Elevar licensed camrelizumab in combination with rivoceranib for HCC for commercialization from Hengrui Pharma worldwide excluding Greater China and South Korea.

(Press release, Elevar Therapeutics, NOV 5, 2026, View Source [SID1234674367])

IN8bio Reports Third Quarter 2026 Financial Results and Recent Business Highlights

On November 5, 2026 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies and T cell engagers (TCEs) for cancer and autoimmune diseases, reported financial results and business highlights for the third quarter ended September 30, 2026.

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"This quarter we continued to build upon our deep expertise in γδ T cells, officially welcoming Dr. Polyakova to the team and making progress with our proprietary TCE platform," said William Ho, CEO and co-founder of IN8bio. "It’s also exciting to see the external recognition that the unique properties of γδ T cells and their tissue-specific distribution, "may offer a unique opportunity to eliminate pathogenic cells more precisely and deeply in target organs" as stated in the Nature Reviews article. We believe this platform has the potential to enable a new class of therapeutics for autoimmune diseases and oncology, and we are excited to present our initial animal data by year-end."

Third Quarter 2026 Business Highlights

Strengthened Research and Development Leadership

Oxana Polyakova, Ph.D., joined IN8bio as Senior Vice President of Research & Development in September 2026, bringing 20 years of experience in γδ T cell biology, immunology, oncology, TCE and biologics development.
Dr. Polyakova joins IN8bio from LAVA Therapeutics, a clinical-stage immuno-oncology company developing bispecific γδ T cell engagers, where she served as Chief Scientific Officer (CSO). She previously also served as CSO at LIfT Biosciences. She was Scientific Founder and Head of Discovery at Adaptate Biotherapeutics, a γδ TCE focused spinout of GammaDelta Therapeutics, which was acquired by Takeda. At Adaptate, she designed and led its R&D strategy, established its laboratories and built its R&D team which has a program currently in the clinic. Dr. Polyakova served as the Protein and Molecular Leader at GammaDelta Therapeutics Limited that was also acquired by Takeda.
She will help lead R&D efforts to accelerate IN8bio’s γδ TCE pipeline toward clinical development.

Publication of INB-200 Phase 1 Data in GBM

In July 2026, IN8bio announced the publication of peer-reviewed clinical data from the Phase 1 trial of INB-200 (DeltEx DRI) in patients with newly diagnosed GBM in the Journal of Clinical Oncology(JCO), titled "Intracranial injection of ex vivo expanded and activated gamma-delta T cells engineered with a MGMT-expressing lentivector in patients with primary glioblastoma."

Advancing γδ T Cell Engager Platform (INB-619)

Continued advancing proprietary INB-600 platform of novel pan-γδ TCEs designed to selectively engage and expand γδ T cells to eliminate disease-associated target cells while potentially improving tolerability compared with conventional CD3-targeting TCEs.
Advancing INB-619 through preclinical studies for potential applications in oncology and autoimmune diseases.
INB-619 was included in a review of next-generation immune cell engagers for B cell depletion in autoimmune disease published in Nature Reviews Drug Discovery in October 2026, which noted its ability to activate and expand both tissue-resident Vδ1 and circulating Vδ2 γδ T cells in vitro.
Remain on track to report initial in vivo preclinical data for INB-619 by year-end 2026.
Third Quarter 2026 Financial Highlights

Research and Development (R&D) expenses: R&D expenses were $2.6 million for the three months ended September 30, 2026, compared with $2.1 million for the comparable prior year period. This amount includes non-cash items such as stock-based compensation (SBC) and depreciation of $0.4 million for the three months ended September 30, 2026. The increase was due primarily to preclinical costs associated with the Company’s T cell engager platform.
General and administrative (G&A) expenses: G&A expenses were $2.1 million for the three months ended September 30, 2026, compared with $1.9 million for the comparable prior year period. This amount includes non-cash items such as SBC and depreciation of $0.3 million for the three months ended September 30, 2026. The increase was due primarily to higher spending on professional services.
Net loss: The Company reported a net loss of $4.6 million, or $0.24 per basic and diluted common share, for the three months ended September 30, 2026, compared with a net loss of $3.9 million, or $0.85 per basic and diluted common share, for the comparable prior year period.
Cash position: As of September 30, 2026, the Company had cash of $14.0 million, compared with $10.7 million as of September 30, 2025.

(Press release, In8bio, NOV 5, 2026, View Source [SID1234674366])

Perspective Therapeutics Presents Encouraging Incremental Data and Analyses from Phase 1/2a Trial of [212Pb]Bamzireotide Navoxetan (VMT-α-NET) in Advanced SSTR2 Expressing NETs

On November 5, 2026 Perspective Therapeutics, Inc. ("Perspective," the "Company," "we," "us," and "our") (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced systemic treatments for cancers, reported incremental data and analyses from its ongoing Phase 1/2a clinical trial of [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2) expressing neuroendocrine tumors (NETs). These analyses were presented today in an oral presentation at the 2026 North American Neuroendocrine Tumors Society (NANETS) Multidisciplinary NET Medical Symposium taking place November 5-7, 2026 in Las Vegas, Nevada.

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The NANETS presentation provided incremental data and analyses following the Company’s rapid oral presentation on October 23, 2026 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026. Additional data were presented on 57 patients with gastroenteropancreatic (GEP) NETs whose target lesions all express SSTR2 who are enrolled in Cohorts 1-3 of the trial. Among these 57 patients: progression free survival (PFS) was 75% at 18 months; disease control was observed in 35 (92%) of 38 Cohort 2 patients and all 17 (100%) patients in Cohort 3; and responses were seen in 14 (37%) of 38 Cohort 2 patients and in 8 (47%) of 17 Cohort 3 patients.

"Deeper analyses of the substantial bamzireotide dataset are providing important insights into its clinical profile and its potential to benefit patients relative to an approved radiotherapy as shown in that therapy’s U.S. package insert of 13% ORR and ~65% PFS at 18 months," said Markus Puhlmann, MD, Perspective’s Chief Medical Officer. "We are pleased to see a stronger signal in a subgroup of interest, specifically GEP-NETs patients whose target lesions all express SSTR2. Meanwhile, bamzireotide remains well-tolerated, with low incidence of high-grade adverse events. Long-term safety follow-up is ongoing, and these findings continue to be evaluated against natural history for organ function and pre-existing conditions of each patient."

"These analyses support bringing bamzireotide expeditiously to patients, especially GEP-NETs patients whose target lesions all express SSTR2," said Thijs Spoor, Perspective’s Chief Executive Officer. "We are incorporating these findings as a potential enrichment strategy into ongoing discussions with regulators on the design of a registration enabling study, and are targeting an end-of-Phase 2 meeting in the first quarter of 2027. FDA feedback and completion of the necessary clinical, regulatory, and operational activities are expected to enable initiation of the Phase 3 study in 2027."

NANETS presentation highlights rationale for enrichment strategy
Across Cohorts 1-3 of the ongoing Phase 1/2 dose finding study, 68 patients received at least one treatment of bamzireotide. These patients received at least one treatment across three dose cohorts of up to 10 mCi, 20 mCi, and 24 mCi, respectively, split into four doses administered every eight weeks. Patients were followed for a median of 128 weeks in Cohort 1, 76 weeks in Cohort 2, and 34 weeks in Cohort 3, as of September 10, 2026.

Efficacy: Durable ongoing disease control and robust anti-tumor activities in all three cohorts across multiple patient populations

GEP-NET SSTR2-positive in all target lesions* All patients who received at least one treatment
Cohort 2
(n=38) Cohort 3
(n=17) Cohorts 1- 3
(n=57) Cohort 2
(n=46) Cohort 3
(n=20) Cohorts 1- 3
(n=68)
Objective response rate 14 of 38
(37%) 8 of 17
(47%) 22 of 57
(39%) 15 of 46
(33%) 10 of 20
(50%) 25 of 68
(37%)
Disease control rate 35 of 38
(92%) 17 of 17 (100%) 54 of 57
(95%) 41 of 46
(89%) 19 of 20
(95%) 62 of 68
(91%)
Landmark PFS at

6 months
90% 94% 91% 83% 90% 85%
12 months
76% 78% 78% 71% 77% 74%
18 months
73% NE 75% 69% NE 72%

*Retrospective subgroup analysis
Objective response rate includes confirmed and initial responses that have not yet been confirmed. All patients with unconfirmed initial responses remain in study and are expected to receive subsequent tumor assessment. Disease control rate includes complete response, partial response, and stable disease.

Findings from 57 GEP-NET patients in Cohorts 1-3 whose target lesions all express SSTR2

Durable disease control: Disease control rate was 92% for Cohort 2 and 100% for Cohort 3. PFS rate was 91% at six months, 78% at 12 months, and 75% at 18 months across Cohorts 1, 2 and 3.
Robust tumor responses: 14 out of 38 (37%) Cohort 2 patients experienced confirmed response as their best responses. A further 11 patients with stable disease in Cohort 2 remain in study as of September 10, 2026. In Cohort 3, 8 out of 17 patients experienced an initial response; five of those responses were confirmed. All three patients with responses pending confirmation remain in study and are expected to receive subsequent tumor assessments. A further 8 patients with stable disease in Cohort 3 remain in study as of September 10, 2026.
Safety: No dose-limiting toxicities and no discontinuations due to adverse events

Across all 68 patients who received at least one bamzireotide treatment:

Bamzireotide continues to be well-tolerated. There were no reports of dose-limiting toxicities, no treatment-related discontinuations, and no serious adverse events related to study medication during the treatment emergent adverse event window.

Low incidence of high-grade TEAEs were observed, all of which were Grade 3 (20 out of 68 patients, or 29%). No Grade 4 or 5 events were reported.

Low incidence of high-grade hematologic TEAEs were observed, all of which were Grade 3 (five out of 68 patients, or 7.4%). No intervention required for lymphopenia. No myelodysplastic syndrome reported to date.

Renal tolerability has remained acceptable, with ongoing follow-up. Grade 3 renal events were rare during ongoing study follow up, possibly not drug related. Two patients (3%) experienced Grade 3 renal events, both acute kidney injuries. One patient experienced the event approximately two years after their final treatment; the investigator assessed the event to be possibly related and the event is ongoing. For the second patient, the investigator assessed the event to be unlikely related to bamzireotide treatment, and the event has resolved.

In addition, a creatinine level elevation to above 2 mg/dL was reported in one patient. This event occurred after the patient discontinued bamzireotide treatment without completing all four planned doses due to disease progression, and during a subsequent post-progression systemic therapy.
Upcoming conference presentation. The Company will exhibit a poster on bamzireotide at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium on November 20, 2026.

About [²¹²Pb]VMT-α-NET
Perspective designed [212Pb]VMT-α-NET to target somatostatin receptor subtype 2 (SSTR2), and to deliver the alpha-emitting radioisotope lead-212, or ²¹²Pb, to tumor sites expressing SSTR2. The Company is conducting a multi-center, open-label, dose-escalation and dose-expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive tumors who have not received prior radiopharmaceutical therapies (RPT).

About Neuroendocrine Tumors
Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs, and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or non-pancreatic neuroendocrine tumors. According to cancer.net, it is estimated that more than 12,000 people in the United States are diagnosed with a NET each year. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors, and as a result, there are over 250,000 people living with this diagnosis.

(Press release, Perspective Therapeutics, NOV 5, 2026, View Source [SID1234674365])