On November 12, 2026 Theriva Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported financial results for the third quarter ended September 30, 2026, and provided a corporate update.

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"We are pleased with the clinical progress achieved this quarter," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Patient enrollment and dosing in the VIRAGE2 trial is progressing well, and we anticipate completing enrollment by the end of the fourth quarter of this year. The VIRAGE2 trial is a crucial step in the clinical advancement of VCN-01 as we evaluate a dosing regimen that is intended to maximize its potential clinical benefit in different cancer therapy combinations. The publication of detailed analyses of the results from the VIRAGE study in Nature Medicine was a gratifying validation of VCN-01’s novel mode of action and therapeutic potential in metastatic pancreatic ductal adenocarcinoma (PDAC). The recently signed asset sale agreement for SYN-004 (ribaxamase) and the related portfolio of antibiotic-degrading enzymes to Biossil Labs Inc. demonstrates our commitment to deriving value from our legacy microbiome programs while continuing to focus on the development of our lead program VCN-01. In parallel, we continue to evaluate strategic alternatives intended to maximize value for our stockholders."

Recent Highlights and Anticipated Milestones

VCN-01

Metastatic PDAC:

Two thirds of the target number of patients (4) have been dosed and enrollment is ongoing in the VIRAGE2 Phase 2a clinical trial evaluating the feasibility of more frequent repeated dosing of VCN-01 in combination with standard-of-care chemotherapy in first-line metastatic PDAC patients (EUCT: 2026-525566-21-00; NCT07701486).
The VIRAGE2 trial builds on feedback from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) recognizing improved survival outcomes in the VIRAGE2 trial in metastatic PDAC patients receiving 2 doses of VCN-01 administered 3-months apart.
The VIRAGE2 trial is designed to evaluate the safety and feasibility of administering at least 3 doses of VCN-01 given approximately 2 months apart in combination with standard-of-care chemotherapy. The trial is expected to enroll 6 evaluable patients.
VIRAGE2 is expected to complete enrollment in Q4 2026, with initial pharmacodynamic and safety/tolerability data anticipated by Q3 2027.
Results from the VIRAGE2 study, if successful, are expected to inform the VCN-01 dosing regimen for future clinical trials evaluating VCN-01 in different cancer therapy combinations, including a potential pivotal Phase 3 clinical trial in metastatic PDAC.
The detailed analyses of results from the VIRAGE Phase 2b trial evaluating VCN-01 in combination with gemcitabine/nab-paclitaxel standard-of-care chemotherapy in metastatic PDAC were recently published in Nature Medicine. The article is entitled "Intravenous hyaluronidase-expressing oncolytic adenovirus with chemotherapy in metastatic pancreatic cancer: a randomised phase 2b trial" and can be read here.
The published analyses of data from the VIRAGE trial highlighted that repeated dosing of VCN-01 in combination with gemcitabine/nab-paclitaxel chemotherapy was well-tolerated, with improved overall survival, progression-free survival and duration of response compared with chemotherapy alone.
Improved survival outcomes were observed in patients treated with two doses of VCN-01 (given 3 months apart) without increased toxicity, providing the rationale for evaluating more frequent administration of additional VCN-01 doses in the VIRAGE2 trial.
Data from the published analyses are consistent with the immune-mediated mechanism of action for VCN-01 that may enhance the anti-tumor effects of a range of coadministered pancreatic cancer therapies.
Retinoblastoma:

Discussions with key opinion leaders and the FDA are on-going regarding the design of a proposed Phase 2/3 clinical trial of intravitreal VCN-01 in combination with intravitreal topotecan in children with retinoblastoma with vitreous seeds that are refractory/resistant to the use of current intravitreal chemotherapy.
The proposed protocol builds on compelling Phase 1 clinical data in this ultra rare pediatric population for which there is no current treatment.
A Type C meeting completed with the FDA on August 31, 2026, provided guidance on the FDA’s current expectations for a clinical trial in this patient population, including proposed endpoints and statistical considerations. The FDA encouraged further discussion of the trial design with them, and additional interactions with the FDA are anticipated in Q1 2027.
VCN-01 has Orphan Drug Designation from the FDA, Orphan Medicinal Product Designation from the EMA and Rare Pediatric Disease Designation from the FDA for the treatment of retinoblastoma; if a Biologics License Application (BLA) for VCN-01 for the treatment of retinoblastoma is approved by the FDA by September 30, 2029, the Company may be eligible to receive a Priority Review Voucher.
SYN-004

Theriva completed the sale of Theriva’s portfolio of antibiotic-degrading enzymes, including SYN-004 (ribaxamase), SYN-007 (reformulated ribaxamase), and SYN-006 (carbapenemase), pursuant to an asset sale agreement with Biossil Labs Inc. ("Biossil").
Biossil acquired all rights, title and interest in SYN-004, SYN-007 and SYN-006, and assumed all responsibility and costs for development and commercialization of the assets.
Under the terms of the agreement, the Company received a $350,000 upfront payment upon closing and is eligible for an aggregate of up to $3 million in regulatory milestones and up to $88 million in sales milestones, as well as single-digit royalties on net product sales (capped at $250 million).
Concurrent with the Biossil asset sale, Theriva amended its Asset Purchase Agreement with PREV ABR LLC (from 2012) under which the Company originally acquired SYN-004 (ribaxamase) and the related product portfolio. Per the terms of the amendment, Theriva paid PREV ABR $140,000 upon receipt of the $350,000, and will be required to pay PREV 50% of future regulatory and sales milestone payments, 33⅓% of royalty payments received by Theriva, and 50% of other consideration received by Theriva in relation to the transferred assets, up to an aggregated total of $13 million.
Third Quarter Ended September 30, 2026 Financial Results

General and Administrative Expenses

General and administrative expenses decreased to $923,000 for the three months ended September 30, 2026, from $1.9 million for the three months ended September 30, 2025. This decrease of 51% primarily reflects a $841,000 decrease in the fair value of contingent consideration recognized in the three months ended September 30, 2026, compared to a $633,000 increase recognized in the same period in 2025, partially offset by a current year increase in legal fees. The charge related to stock-based compensation expense was $119,000 for the three months ended September 30, 2026, compared to $118,000 for the three months ended September 30, 2025.

Research and Development Expenses

Research and development expenses decreased to $612,000 for the three months ended September 30, 2026, from approximately $2.6 million for the three months ended September 30, 2025. This decrease of 76% is primarily the result of lower direct expenses related to the completion of the VCN-01 Phase 2b PDAC clinical trial, lower direct expenses related to VCN-01 manufacturing activities, lower direct clinical trial expenses related to the paused Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, lower expenses related to SYN-020, partially offset by expenses associated with the conduct of the VIRAGE2 Phase 2a study in metastatic PDAC patients evaluating more frequent VCN-01 dosing for a longer period.

Other Income/Expense

Other income was $64,000 for the three months ended September 30, 2026, compared to other income of $79,000 for the three months ended September 30, 2025. Other income for the three months ended September 30, 2026 is comprised of interest income of $64,000. Other income for the three months ended September 30, 2025 is primarily comprised of interest income of $65,000 and an exchange gain of $14,000.

Cash and Cash Equivalents

Cash and cash equivalents totaled $8.5 million as of September 30, 2026, a decrease of $4.6 million from December 31, 2025. During the year ended December 31, 2025, and nine months ended September 30, 2026, the primary use of cash was for working capital requirements and operating activities, which resulted in a net loss of $23.7 million and $6.7 million for the year ended December 31, 2025, and the nine months ended September 30, 2026, respectively.

(Press release, Theriva Biologics, NOV 12, 2026, View Source [SID1234674706])

On November 12, 2026 Obsidian Therapeutics, Inc. ("Obsidian") (Nasdaq: OBX), a clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered tumor-infiltrating lymphocyte (TIL) cell therapies, reported financial results for the third quarter ended September 30, 2026, highlighting recent progress and business updates.

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"2026 has been a transformative year so far for Obsidian. In the third quarter, we closed an oversubscribed $350 million financing, completed our transaction with Galera Therapeutics, and debuted on Nasdaq as a publicly traded company," said Madan Jagasia, M.D., Chief Executive Officer of Obsidian. "We have made substantial progress advancing amsoki-cel, with enrollment ongoing in the registration-enabling immune checkpoint inhibitor-resistant advanced melanoma cohort of our Agni-01 study. The updated data we presented at SITC (Free SITC Whitepaper) further strengthen our belief in the program, highlighting amsoki-cel’s consistent, favorable safety profile and encouraging clinical activity in patients with advanced melanoma, including an objective response rate of 67%, median progression-free survival of 8.3 months, and median duration of response not yet reached at median study follow-up of 14.3 months. We remain on track to complete enrollment in the registration-enabling cohort by the end of the first quarter of 2027 and report topline data by year-end 2027."

Third Quarter 2026 and Recent Updates

Amsokigene autoleucel (amsoki-cel, formerly OBX-115)

Enrollment in the registration-enabling cohort of the Phase 1/2 Agni-01 multicenter study of amsoki-cel in patients with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma is expected to be completed by the end of the first quarter of 2027, with topline data expected by the end of 2027.
The Company announced initiation of enrollment in August 2026. The single-arm registration-enabling cohort is part of the ongoing Agni-01 study (NCT06060613), which is a multicenter Phase 1/2 study, designed to further evaluate the safety and efficacy of amsoki-cel at the recommended phase 2 dose (RP2D) in patients with ICI-resistant advanced melanoma. The primary endpoint is objective response rate (ORR) as measured per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by a blinded independent central review (BICR).
Updated amsoki-cel results presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting continued to suggest encouraging efficacy, durable clinical benefit and a consistent, favorable safety profile in patients with ICI-resistant advanced melanoma. The presentation included updated efficacy data from the single-arm, open-label Phase 1/2 Agni-01 multicenter study as of a September 25, 2026, data cutoff in 15 patients treated at the RP2D. Additional data included pooled safety data across 37 patients from the Phase 1 first-in-human (FIH) single-center study and the Phase 1/2 Agni-01 multicenter study as of a May 5, 2026, data cutoff.
In the efficacy set (n=15), a 67% ORR, per RECIST v1.1, was observed, including 2 confirmed complete responses (CR) and 8 confirmed partial responses (PR). 2 of the 8 patients who achieved a PR demonstrated a 100% reduction in the sum of diameters (SOD) of target lesions. Data demonstrated a durable clinical benefit, including 5 of 10 responses ongoing as of the median 14.3-month study follow-up, median progression-free survival (PFS) of 8.3 months, and 33% of all treated patients (5/15) remained in deep, ongoing response at the 12-month post-infusion landmark. The median duration of response (mDOR) was not reached.
In the pooled safety set (n=37), there were no dose-limiting toxicities (DLT), treatment-related mortality (TRM), immune effector cell-associated neurotoxicity syndrome (ICANS) or ICU transfers, and the majority of non-hematologic treatment-emergent adverse events (TEAEs) occurring in ≥30% of patients were Grade 2 or less, with one reported Grade 3 cytokine release syndrome (CRS).
The Company also announced a publication in Nature Medicine summarizing safety and efficacy data as of a May 5, 2026, data cutoff from the FIH and ongoing Agni-01 studies. The publication, "Regulatable Membrane-Bound IL-15 Engineered TIL Cell Therapy for Immune Checkpoint Inhibitor-Resistant Advanced Melanoma: Pooled Analysis of Phase 1 and 1/2 Trials," is available online here.
Obsidian is also investigating amsoki-cel in patients with non-small cell lung cancer (NSCLC) in the Agni-01 trial. NSCLC Phase 1 data are expected in the first half of 2027.
Corporate Updates

Obsidian completed its transaction with Galera Therapeutics and began trading on Nasdaq on August 4, 2026, under the ticker symbol "OBX." The Company also closed a previously announced oversubscribed private placement of $350 million in gross proceeds.
In November 2026, Obsidian appointed Mark Reisenauer to the Board of Directors. Mr. Reisenauer brings more than 30 years of experience successfully commercializing and launching products in the oncology space. Most recently, he served as Chief Executive Officer and a director of Assertio, which was acquired by Zydus Lifesciences. Previously, he served as President of U.S. Commercial at Astellas Pharmaceuticals Inc., where he grew sales to nearly $5 billion while overseeing Marketing, Sales, Policy and Government Affairs and Market Access teams. Earlier in his career, he served as Senior Vice President and Chief Commercial Officer at Micromet, Inc., which was acquired by Amgen, where he led commercial launch activities and pipeline development. He also held senior roles at Abbott Laboratories, where he led global commercialization, licensing, and R&D strategy for oncology products and co-chaired the Oncology Therapeutic Executive Committee.
Third Quarter 2026 Financial Results

Cash, cash equivalents, and marketable securities were $324.4 million as of September 30, 2026. Obsidian expects that its current cash, cash equivalents, and marketable securities will support planned operations into the second half of 2028.
Research and development expenses were $27.5 million for the three months ended September 30, 2026.
General and administrative expenses were $10.3 million for the three months ended September 30, 2026.
Acquired in-process research and development expense associated with the Galera transaction was $15.1 million for the three months ended September 30, 2026.
Net loss was $50.7 million, or $1.23 per basic and diluted share, for the three months ended September 30, 2026.

(Press release, Obsidian Therapeutics, NOV 12, 2026, View Source [SID1234674705])

On November 12, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve outcomes for patients with cancer, reported financial results for the third quarter ended September 30, 2026, and provided a corporate update.

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"During the quarter we continued to execute well and make significant progress across the business, as we build the foundation to potentially become a commercial-stage biopharma company," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. "On the clinical side, we were honored to have had three posters accepted for presentation at SITC (Free SITC Whitepaper), featuring data on aglatimagene in localized prostate cancer and non-small cell lung cancer, and linoserpaturev in recurrent high-grade glioma. Together, the new biomarker data provide mechanistic support for the systemic effect and long-term clinical outcomes observed in our phase 3 trial of aglatimagene in patients with intermediate- to high-risk localized prostate cancer."

Dr. Tak continued, "On the corporate side, we continued to build commercial-stage company capabilities. We appointed Martine Zimmermann, a regulatory and quality leader with more than 30 years of experience, to our Board, and Maria Ostrovsky, who has supported multiple oncology launches and strategic partnerships, as Candel’s General Counsel. Both bring expertise that is highly relevant as we prepare for BLA submission and potential future launch. We believe we are well positioned to execute our operating plan into Q2 2028."

Third Quarter 2026 & Recent Highlights

Aglatimagene besadenovec – Prostate Cancer

The Company continues to advance its BLA readiness work, including Chemistry, Manufacturing, and Controls (CMC) and clinical modules.
Biodistribution and shedding data from the ongoing PrTK05 phase 2 trial in patients with intermediate-risk localized prostate cancer remain on track.
Process validation campaign for drug substance and drug product has been executed at our contract development and manufacturing organization. Validation batches are currently undergoing testing and are intended for commercial use, pending BLA approval.
Clinical material has been produced using the new process.
The Company announced novel immunological biomarker data from the ongoing phase 2 PrTK05 trial (NCT07332000) in patients with intermediate-risk localized prostate cancer and presented a late-breaking poster at the SITC (Free SITC Whitepaper) 2026 Annual Meeting (November 2026). See link to poster presentation.
Key findings included:
Increase in CD8+ cytotoxic T cells, central memory T cells, and effector memory T cells (all p<0.05) at the 2-6-week assessments after the first aglatimagene treatment. Increase in activated, proliferating CD8+ Ki67+ GZMB+ T cells (p<0.0001) 2-3 weeks after the first injection that remained above baseline through Weeks 16-18. Importantly, no increase in any of these cell populations was observed after SoC alone.
Increase in serum levels of granzyme A, granzyme B, and perforin 2-3 weeks after the first injection of aglatimagene (p<0.05).
Together, these results suggest systemic immune activation following intraprostatic administration of aglatimagene, consistent with previous observations in glioblastoma, pancreatic cancer, and NSCLC.
Additional shedding data presented at SITC (Free SITC Whitepaper) demonstrated transient detection of aglatimagene vector DNA in peripheral blood after intraprostatic administration of aglatimagene and clearance in urine samples at weeks 16-18. These findings are consistent with transient systemic biodistribution and shedding following administration.
The Company presented new biomarker data from its completed phase 3 clinical trial of aglatimagene in patients with localized intermediate- to high-risk prostate cancer at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2026 in September 2026.

AI-enabled digital pathology analysis performed on tumor biopsies evaluable for digital analysis (622 pre-treatment and 427 post-treatment collected more than two years after completion of radiation), demonstrated that aglatimagene plus EBRT significantly increased intratumoral lymphocyte infiltration and remodeled the tumor microenvironment compared with placebo plus EBRT. Among those patients with residual tumor, aglatimagene increased lymphocyte infiltration within tumor regions and enhanced lymphocyte-tumor engagement.
Aglatimagene significantly increased overall lymphocytic fraction compared to control (p=0.048), with both arms showing immune activation from radiation therapy (p<0.001) (calculated in all digital-pathology evaluable biopsies; 622 pre-treatment biopsies and 427 post-treatment biopsies analyzed).
In paired biopsies from patients with residual tumor (n=108; aglatimagene n=62, control n=46), aglatimagene significantly increased intratumoral lymphocyte fraction (p=0.006), lymphocyte-tumor enrichment (p=0.003), and lymphocyte-tumor mixing (p<0.001).
The Company previously reported that two years after treatment, 80% of evaluable aglatimagene patients (n=167) had negative prostate biopsies versus 63% of control patients (n=62) (p=0.0018).
Data from the PrTK03 trial demonstrated that with follow-up through March 15, 2026 (median, 58.0 months), patients with intermediate-risk disease treated with aglatimagene plus EBRT experienced a 41% reduction in the risk of prostate cancer recurrence or prostate cancer-specific death versus placebo plus EBRT (p=0.0034). As previously described, exploratory, descriptive analyses after extended follow-up of these patients showed 52% improvement in the time to biochemical failure, 49% reduction in the time to salvage anticancer therapy, and 90% improvement in the time to metastasis after aglatimagene treatment vs. placebo.
The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of localized prostate cancer. The phase 3 clinical trial of aglatimagene in localized prostate cancer was conducted under a Special Protocol Assessment with respect to certain aspects of the study design, agreed with the FDA.
• Aglatimagene besadenovec – Non-Small Cell Lung Cancer

The Company announced the publication of the phase 2a clinical trial results (NCT04495153) of aglatimagene plus valacyclovir in patients with stage III/IV NSCLC who had shown an inadequate response to immune checkpoint inhibitors (ICI) in the Journal for ImmunoTherapy of Cancer.
The trial demonstrated a median overall survival (mOS) of 24.5 months in the evaluable population, substantially exceeding historical benchmarks for standard-of-care docetaxel chemotherapy in this patient population.
The Company presented additional data at the SITC (Free SITC Whitepaper) 2026 Annual Meeting, during a poster presentation titled, "Multi-omics analyses reveal intratumoral and systemic immune activation to aglatimagene besadenovec + valacyclovir related to improved survival in patients with progressive NSCLC despite ICI treatment."
In progressive non-squamous NSCLC, longitudinal immune changes in peripheral blood and tumor tissue and specific multi-omic features were associated with survival beyond 24 months.
Integrated biomarker analyses demonstrated broadening of the T-cell repertoire diversity over time, alongside enhanced intratumoral immune activity, including increased tissue expression of genes associated with cytotoxic T-cell activation. Increases in CD40L, NCR1, CXCL5 and granzyme B, as well as antigen-presenting cell- and monocyte/macrophage-rich tumor niches that occurred after aglatimagene treatment were associated with longer survival.
As previously announced, the Company initiated the first clinical trial site of the global pivotal phase 3 clinical trial (AURORA) (NCT07660094), which is evaluating aglatimagene plus valacyclovir in combination with continued pembrolizumab in patients with metastatic non-squamous NSCLC whose disease has progressed despite treatment with pembrolizumab and platinum-based chemotherapy.
The randomized, open-label AURORA trial is expected to enroll patients with metastatic stage IV non-squamous NSCLC across approximately 150 sites worldwide, randomized 1:1 to receive either two courses of aglatimagene plus valacyclovir with continued pembrolizumab or standard-of-care docetaxel chemotherapy.
The study’s primary endpoint is overall survival, with secondary endpoints including safety and quality-of-life assessments (NSCLC-SAQ and EORTC QLQ-30).
The FDA previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC.

• Linoserpaturev – Recurrent high-grade glioma

The Company presented updated overall survival data from the single-administration and repeat-dosing cohorts of its phase 1b clinical trial of linoserpaturev (NCT03152318) in patients with rHGG in a poster presentation at the SITC (Free SITC Whitepaper) 2026 Annual Meeting.
In Arms A+B, 50 patients received 51 intratumoral injections, including one patient who received two injections. mOS was 12.0 months (95% CI, 8.3–14.4), with a median follow-up of 68.6 months. Durable long-term survival was observed in a subset of patients, with 11 of 50 patients (22%) alive at 18 months, 8 of 50 (16%) at 24 months, 5 of 50 (10%) at 36 months, and 2 of 50 (4%) at 48 months, as of the August 14, 2026 data cutoff.
In Arm C, 12 patients received repeated administrations of linoserpaturev, with up to six administrations. mOS was 14.3 months (95% CI, 8.9 months to not reached) with a median follow-up of 15.3 months. Five of 12 patients remained alive at efficacy cutoff on July 13, 2026. The Arm C survival data remain immature, with six patients having only recently initiated treatment and therefore having limited follow-up at the data cutoff.
The Company also presented data demonstrating that linoserpaturev could potentially be combined with vascular endothelial growth factor blockade to overcome hypoxia-associated immune suppression in glioblastoma.

Recent Corporate Events
In September 2026, the Company appointed Martine Zimmermann, PharmD, to its Board of Directors, effective September 8, 2026. Dr. Zimmermann brings more than 30 years of global regulatory affairs and quality expertise across all phases of drug development. She recently served as Executive Vice President, Head of Regulatory Affairs, Quality and Alliance Management at Inventiva S.A., and previously held senior regulatory leadership roles at Ipsen Biopharmaceuticals and Alexion Pharma International.
In October 2026, the Company appointed Maria Ostrovsky, JD, as General Counsel, effective November 3, 2026. Ms. Ostrovsky brings 20 years of legal experience, primarily in the life sciences industry, with expertise spanning corporate governance, strategic partnerships, regulatory compliance, and commercialization. Most recently, she served as Senior Vice President, General Counsel and Chief Compliance Officer at Deciphera Pharmaceuticals, where she built the healthcare compliance program and contributed to two global product launches. Her appointment strengthens the Company’s legal and compliance capabilities and supports its strategic partnering efforts.

Financial Results for the Third Quarter Ended September 30, 2026

Research and Development Expenses: Research and development expenses were $15.6 million for the third quarter of 2026 compared to $8.5 million for the third quarter of 2025. The increase was primarily due to higher clinical trial and manufacturing costs, in support of the Company’s aglatimagene programs, and an increase in employee-related expenses. Research and development expenses included a non-cash stock compensation expense of $1.0 million for the third quarter of 2026, as compared to a non-cash stock compensation expense of $0.5 million for the third quarter of 2025.

General and Administrative Expenses: General and administrative expenses were $7.4 million for the third quarter of 2026, compared to $4.7 million for the third quarter of 2025. The increase was primarily due to an increase in employee-related expenses and higher commercial readiness costs. General and administrative expenses included non-cash stock compensation expense of $1.7 million for the third quarter of 2026, as compared to a non-cash stock compensation expense of $0.6 million for the third quarter of 2025.

Net Loss: Net loss for the third quarter of 2026 was $21.9 million compared to net loss of $11.3 million for the third quarter of 2025 and included net other income of $1.1 million and $1.9 million, respectively. The decrease in net other income was primarily related to an increase in interest expense, which was partially offset by higher interest income.

Cash Position: Cash and cash equivalents, as of September 30, 2026, were $203.1 million compared to $119.7 million as of December 31, 2025. Based on current operating plans, the Company expects that its existing cash and cash equivalents, as of September 30, 2026, will be sufficient to fund operations into Q2 2028.

About aglatimagene besadenovec

Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. The Company completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) with results published in the Journal for ImmunoTherapy of Cancer, and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the FDA and published in The Lancet Oncology. The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority for any use.

About linoserpaturev

Linoserpaturev is a first-in-class, replication-competent, next-generation oncolytic herpes simplex virus-1 (HSV-1) immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. In October 2023, the Company announced that Nature published results from the ongoing clinical trial where linoserpaturev was reported to be generally well-tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single linoserpaturev injection in this therapy-resistant condition.1 The Company and academic collaborators are currently supported by Break Through Cancer to evaluate the effects of repeated linoserpaturev injections in patients with recurrent glioblastoma in an expansion cohort from the phase 1b clinical trial. In October 2025, an original manuscript, published in Science Translational Medicine reported collected findings from a comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of linoserpaturev in arm C. Lastly, in February 2026, Cell published an original manuscript showing that a single linoserpaturev treatment triggered persistent T-cell infiltration and antitumor immunity against glioblastoma, with key immune features associated with longer survival. Linoserpaturev previously received Fast Track Designation and Orphan Drug Designation for the treatment of recurrent high-grade glioma (rHGG) from the FDA.

(Press release, Candel Therapeutics, NOV 12, 2026, View Source [SID1234674704])

On November 12, 2026 NuCana plc (NASDAQ: NCNA) ("NuCana" or the "Company") reported financial results for the third quarter ended September 30, 2026 and provided an update on the development of its two lead anti-cancer product candidates, NUC-7738 and NUC-3373.

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"NuCana’s priorities are to define the next stage of clinical development for NUC-7738 in melanoma following the anticipated December announcement of the Phase 2 NuTide:701 expansion study results and latest translational data," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "Recruitment is complete in our Phase 2 expansion cohort of NuTide:701, evaluating NUC-7738 in combination with Keytruda (pembrolizumab) in patients with PD-1 inhibitor-resistant metastatic melanoma. We plan to present these results and the latest translational data at the ESMO (Free ESMO Whitepaper) Immuno-Oncology & Advanced Therapies Congress 2026, taking place December 14-16 in London. Following clearance of our Investigational New Drug application ("IND") earlier this year, we are continuing our dialogue with the U.S. Food and Drug Administration (the "FDA") regarding a potential registrational strategy for NUC-7738 in melanoma. The grant of a European composition-of-matter patent for NUC-7738 further strengthens our intellectual property position, building on similar patents in the United States and China."

Mr. Griffith continued, "We believe we have established a clear development pathway for NUC-3373 through an extensive AI-enabled analysis of proprietary data from more than 800 cancer cell lines alongside large public datasets. We believe this work has further characterized NUC-3373’s mechanism of action and differentiation from 5-fluorouracil (5-FU), supporting its greater anti-cancer activity in preclinical models compared with 5-FU and enabling us to prioritize tumor types, identify potential biomarkers of sensitivity and select rational combination strategies for further evaluation. The next phase of testing is now under way in cancer cell lines and our in-house patient-derived organoid models, which is intended to validate these findings and help guide the selection of potential future clinical development opportunities. This work gives us a focused basis for advancing NUC-3373 in settings where its differentiated biology may offer the greatest potential to benefit patients."

Mr. Griffith concluded, "With cash resources anticipated to fund our planned operations into 2029, we are focused on delivering the NUC-7738 Phase 2 expansion results, defining its potential registrational strategy and advancing the preclinical validation of NUC-3373. We are excited by the opportunities ahead and look forward to updating shareholders on these priorities."

2026 Anticipated Milestones

NUC-7738

Announce final data from the Phase 2 expansion study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant melanoma;
Obtain regulatory guidance from the FDA regarding a potential registrational strategy for NUC-7738 in melanoma; and
Advance evaluation of additional indications and combination strategies.

NUC-3373

Complete evaluation of optimal combinations and indications to inform potential future clinical studies of NUC-3373.

Third Quarter 2026 Financial Highlights and Cash Position

As at September 30, 2026, NuCana had cash and cash equivalents of £18.3 million compared to £19.5 million at June 30, 2026 and £24.3 million at December 31, 2025. NuCana anticipates its cash and cash equivalents at September 30, 2026 will be sufficient to fund its planned operations into 2029.

NuCana reported a net loss of £1.6 million for the quarter ended September 30, 2026, as compared to a net loss of £0.3 million for the quarter ended September 30, 2025. Basic and diluted loss per ordinary share was £0.00 for the quarter ended September 30, 2026, as compared to a loss per ordinary share of £0.00 for the comparable quarter ended September 30, 2025.

NuCana reported a net loss of £8.6 million for the nine months ended September 30, 2026, as compared to a net loss of £26.9 million for the nine months ended September 30, 2025. The net loss for the nine months ended September 30, 2026 and for the comparable period included the following non-cash or non-recurring items:

Share-based payment expenses of £3.3 million (2025: £9.1 million);
Professional fees of £nil (2025: £1.4 million) relating to the issue of warrants; and
Finance expense of £nil (2025: £12.6 million) relating to the non-cash loss on fair value revaluation of the warrants issued in the May 2025 financing; partly offset by
Total other income of £nil (2025: £2.7 million).

Basic and diluted loss per ordinary share was £0.00 for the nine months ended September 30, 2026, as compared to a loss per ordinary share of £0.00 for the comparable nine months ended September 30, 2025.

(Press release, Nucana, NOV 12, 2026, View Source [SID1234674703])

On November 12, 2026 Takeda (TSE:4502/NYSE:TAK) reported it will present research across a range of hematologic cancers and blood disorders at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 12–15, 2026, in New Orleans, Louisiana. Data from more than 20 presentations will expand the body of evidence supporting Takeda’s approved and investigational medicines.

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"Our data at ASH (Free ASH Whitepaper) this year, including new analyses showing how MIMRYLO reduced symptom and treatment burden in polycythemia vera in clinical studies, focus on supporting a more patient-centered treatment experience," said Awny Farajallah, MD, FACP, Chief Medical Officer at Takeda. "These findings, alongside early insights on our investigational medicines elritercept and mezagitamab, reflect Takeda’s commitment to advancing science and evidence generation across hematologic cancers and blood disorders."

New Evidence in Hematologic Cancers Prioritizes Patient Experience Alongside Outcomes
Key presentations in oncology will feature new analyses of MIMRYLO (rusfertide), a first-in-class hepcidin mimetic approved by the U.S. Food and Drug Administration for the treatment of erythrocytosis in adults with polycythemia vera (PV). The data being presented at ASH (Free ASH Whitepaper) include an analysis demonstrating improvement in patient-reported symptoms and post hoc analyses of efficacy and safety outcomes across key patient subgroups. Real-world evidence on the burden of phlebotomy in PV, underscoring the need for alternative therapies, will also be presented.

Additionally, an oral presentation will feature data from the ongoing Phase 2 open-label ascending dose study (NCT04419649) evaluating elritercept (TAK-226), an investigational therapy being studied for anemia associated with myelodysplastic syndrome (MDS) and myelofibrosis (MF). This analysis includes broad lower-risk MDS patient populations, including patients with ring sideroblast (RS)-negative disease and high transfusion burden. These data highlight the potential for elritercept to deliver durable responses and improve quality of life outcomes.

New Findings on Platelet Counts and PROs in a Rare, Immune-mediated Bleeding Disorder
Results from a post hoc analysis of Phase 2 data will highlight an association between platelet counts (≥100,000/µL) and beneficial patient-reported outcomes (PROs) in people living with persistent/chronic primary ITP. ITP is a rare immune-mediated bleeding disorder that causes low platelet counts and an increased risk of bleeding, which can have a debilitating impact on patients. The data are from a multicenter, randomized, double-blind study (NCT04278924) of mezagitamab, an investigational anti-CD38 monoclonal antibody. In the study, PROs were measured using the ITP Patient Assessment Questionnaire (ITP-PAQ), a validated disease-specific instrument to assess symptoms, function and health-related quality of life. Observations from the post hoc analysis indicate that platelet counts ≥100,000/μl were associated with higher scores on ITP-PAQ across multiple domains compared to platelets <30,000/μl, suggesting an association between higher platelet counts and better health-related quality of life.

Elritercept and mezagitamab are investigational medicines that have not been approved by any health authority.

Additional presentations will provide updated evidence for Takeda’s portfolio of approved treatments in lymphoma, leukemia and blood disorders.

MIMRYLO (rusfertide) IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
New or Worsening Thrombocytosis: MIMRYLO may increase platelet counts in patients with PV. Platelet counts generally plateaued on treatment by Week 8. After initiating MIMRYLO and during dose modifications, monitor CBC every 2 to 4 weeks or as clinically indicated. Platelet elevations associated with MIMRYLO may require cytoreductive therapy initiation, modification, or MIMRYLO dose modifications or discontinuation.
Injection-Site Reactions: Injection site reactions (including Grade 3 reactions) have been reported in patients treated with MIMRYLO. The most common injection site reactions reported were erythema, pruritus, pain, and swelling. Use ice, topical corticosteroid creams, antihistamines or analgesics, as needed, to treat injection site pain and swelling.
Embryo-Fetal Toxicity: Based on findings from animal reproduction studies, MIMRYLO may cause fetal harm when administered to a pregnant woman. Advise patients to stop taking MIMRYLO if they become pregnant.
ADVERSE REACTIONS
The most common (>15%) adverse reactions were injection site reactions (56%) and anemia (16%).

USE IN SPECIFIC POPULATIONS
Lactation: Because of the potential for serious adverse reactions in the breastfed child, including impaired iron absorption, advise patients not to breastfeed during treatment with MIMRYLO and for 30 days after the final treatment.
Females and Males of Reproductive Potential
Pregnancy Testing: Prior to initiating MIMRYLO, pregnancy testing is recommended for females of reproductive potential.
Contraception: Advise female patients of reproductive potential to use effective contraception during treatment with MIMRYLO and for at least 30 days after the final dose of MIMRYLO.
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-662-8532 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see MIMRYLO (rusfertide) full Prescribing Information.

About MIMRYLO (rusfertide)
MIMRYLO is a first-in-class subcutaneous treatment that mimics the action of hepcidin, a natural hormone that regulates iron homeostasis and erythrocytosis. By targeting the underlying mechanism of iron dysregulation in polycythemia vera, MIMRYLO aims to reduce excess red blood cell production and help patients maintain hematocrit control. MIMRYLO is administered once weekly via subcutaneous injection. Protagonist discovered MIMRYLO and led its development through Phase 3. Takeda has exclusive global development and commercialization rights for MIMRYLO.

About Elritercept
Elritercept is a novel investigational TGF-β ligand trap designed to restore effective hematopoiesis by addressing dysregulated activin signaling. Elritercept is currently being evaluated in three ongoing Phase 3 clinical trials: RENEW and ELRiSE MDS in patients with anemia associated with myelodysplastic syndromes (MDS), and ELRiSE MF in patients with anemia associated with myelofibrosis (MF). The U.S. Food and Drug Administration has granted Fast Track designation for the development of elritercept for very low-, low- and intermediate-risk MDS. Takeda holds rights to develop, manufacture and commercialize elritercept worldwide outside of mainland China, Hong Kong and Macau through an exclusive licensing agreement with Keros Therapeutics.

About Mezagitamab
Mezagitamab is an investigational, fully human anti-CD38 IgG1 monoclonal antibody that depletes cells with high CD38 expression, including plasma cells, plasmablasts and natural killer cells. In ITP, targeting these antibody-producing cells has the potential to reduce pathogenic autoantibody production, which may support improvements in platelet response and platelet counts to clinically meaningful levels. The safety and efficacy of mezagitamab is currently under investigation in a pivotal Phase 3 clinical trial. The U.S. Food and Drug Administration has granted mezagitamab Orphan Drug Designation for the treatment of ITP, Fast Track Designation for chronic/persistent ITP and Breakthrough Designation for the treatment of adult patients with chronic ITP who have had an insufficient response to previous treatment.

(Press release, Takeda, NOV 12, 2026, View Source;utm_term=&utm_content=1033477&utm_id=9b2de23c-1b8d-432e-89da-925d65f93d07&sfmc_activityid=01bf63e4-57d1-4bca-96c8-9dad86fbb8f4&utm_medium=email&utm_campaign=PressReleases_EN_Automated_Gray_700px_Email1&sfmc_journey_id=9b2de23c-1b8d-432e-89da-925d65f93d07&sfmc_journey_name=rPse_seRelsa_eNEL_naJ_uonrye2_20_4rPdo&sfmc_activity_id=01bf63e4-57d1-4bca-96c8-9dad86fbb8f4&sfmc_activity_name=rPseRsleaees_sNEA_tumotadeG_ar_y07p0_xmEia1l&sfmc_asset_id=1033477&sfmc_channel=email [SID1234674702])