Perioperative Imfinzi approved in the US in novel regimen with neoadjuvant enfortumab vedotin for patients with muscle-invasive bladder cancer

On November 10, 2026 AstraZeneca reported that Imfinzi (durvalumab) in combination with enfortumab vedotin (EV) as neoadjuvant treatment, followed by Imfinzi monotherapy as adjuvant treatment after radical cystectomy (surgery to remove the bladder), has been approved in the US for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have refused cisplatin-based chemotherapy.

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The approval was granted by the Food and Drug Administration after securing Priority Review and was based on results from the VOLGA Phase III trial which were presented during a Presidential Symposium at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and simultaneously published in The New England Journal of Medicine.

In 2026, around 16,000 patients will be treated for MIBC in the United States.1 Approximately one in four patients with bladder cancer has muscle-invasive disease, where the tumour invades the muscle wall of the bladder, without distant metastases.2,3 As many as 50% of patients are ineligible for cisplatin-based chemotherapy due to impaired renal function or comorbidities.4,5 The standard treatment for these patients has historically been radical cystectomy alone, but despite undergoing this major surgery, patients experience high rates of recurrence and have a poor prognosis.4-6

Jonathan E. Rosenberg, MD, Chief of the Genitourinary Oncology Service at the Memorial Sloan Kettering Cancer Center and member of the VOLGA Steering Committee, said: "This approval brings the first perioperative immunotherapy regimen where enfortumab vedotin is administered only in the neoadjuvant setting to patients with muscle-invasive bladder cancer who are not candidates for cisplatin-based chemotherapy. The results of VOLGA show a statistically significant and clinically meaningful improvement in both event-free and overall survival along with a manageable safety profile. Based on this, the VOLGA regimen has the potential to become a new standard of care in this curative-intent setting."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "Today’s approval offers a novel Imfinzi-based regimen that almost halved the risk of disease recurrence and reduced the risk of death by 42 per cent in the VOLGA trial, allowing physicians to optimise treatment for patients in this curative-intent setting. As our third bladder cancer indication in two years, this approval reinforces Imfinzi as an immunotherapy backbone across muscle-invasive and non-muscle-invasive disease."

In the trial, patients were treated with three cycles of Imfinzi and EV before radical cystectomy, followed by nine cycles of Imfinzi adjuvant monotherapy. In a planned interim analysis, perioperative Imfinzi plus neoadjuvant EV demonstrated a 49% reduction in the risk of disease progression, recurrence, not undergoing surgery or death versus radical cystectomy with or without approved adjuvant treatment (based on an event-free survival [EFS] hazard ratio [HR] of 0.51; 95% confidence interval [CI] 0.38-0.67; p<0.0001). Estimated median EFS was not yet reached for the Imfinzi combination versus 12.1 months for the comparator arm. An estimated 64% of patients treated with the Imfinzi combination remained alive and event-free at two years compared to 45% in the comparator arm.

Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi combination reduced the risk of death by 42% compared to the comparator arm (based on an OS HR of 0.58; 95% CI 0.40-0.83; p=0.0027). Estimated median OS was not yet reached for the Imfinzi combination or comparator arm. An estimated 78% of patients treated with the Imfinzi combination were alive at two years compared to 69% in the comparator arm.

The safety and tolerability of Imfinzi plus EV was consistent with the known safety profiles of the individual medicines, with no new safety signals identified. Grade 3 and 4 adverse events due to any cause occurred in 64% of patients treated with the Imfinzi combination and 44% of patients in the comparator arm. Patient-reported quality of life was maintained after surgery in patients treated with the Imfinzi combination.

Regulatory applications are currently under review in the European Union (EU), Japan and several other countries based on the results of the VOLGA trial.

Imfinzi is approved in over 50 countries for patients with cisplatin-eligible MIBC based on the NIAGARA Phase III trial. Imfinzi in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy is approved in the US, Japan and other countries for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer, based on the POTOMAC Phase III trial. In July 2026, positive high-level results from the NILE Phase III trial showed Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS versus chemotherapy as 1st-line treatment for patients with PD-L1 high unresectable, locally advanced or metastatic urothelial cancer.

Notes

Bladder cancer
Bladder cancer is the 8th most common cancer in the world, with more than 635,000 cases diagnosed each year.7 The most common type is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.8

In 2025, the NIAGARA Phase III trial established a new standard of care in MIBC by adding perioperative Imfinzi to neoadjuvant cisplatin-based chemotherapy and radical cystectomy.9 However, up to half of patients are not eligible to receive cisplatin, and approximately 50% of MIBC patients who undergo bladder removal surgery experience disease recurrence. New treatment options that prevent both progression before surgery and recurrence after surgery are critically needed in this curative-intent setting.4,6

VOLGA
VOLGA is a Phase III, randomised, open-label, multi-centre global trial evaluating perioperative Imfinzi with or without Imjudo (tremelimumab) in combination with neoadjuvant EV as treatment for patients with MIBC undergoing radical cystectomy who are ineligible for or have refused cisplatin compared to radical cystectomy with or without approved adjuvant therapy. In the trial, 695 patients were randomised 1:1:1 to Arm 1 (three cycles of Imfinzi and EV, plus two cycles of Imjudo prior to surgery, followed by nine cycles of Imfinzi plus one cycle of Imjudo as adjuvant therapy), Arm 2 (three cycles of Imfinzi and EV prior to surgery, followed by nine cycles of Imfinzi adjuvant monotherapy) and Arm 3, the comparator arm.

The trial was conducted in 182 centres across 25 countries in Europe, North America, South America and Asia. Its dual primary endpoints are EFS, defined as the time from randomisation to first recurrence post-radical cystectomy, first progression in patients who did not undergo radical cystectomy, failure to undergo radical cystectomy in patients with residual disease or death due to any cause, for both experimental arms versus the comparator arm. Secondary endpoints include OS (Arm 1 vs. Arm 3 and Arm 2 vs. Arm 3), pathologic complete response, disease-free survival and pathologic downstaging across both experimental arms.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In addition to its bladder cancer indications, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage small cell lung cancer (SCLC) and in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC.

Imfinzi is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). It is also approved as a monotherapy in unresectable HCC in Japan, China and the EU, and in resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers in the US, EU and Japan. Additionally, in April 2026, Imfinzi in combination with Imjudo, lenvatinib and transarterial chemoembolisation (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival versus TACE alone for patients with unresectable HCC eligible for embolisation in the EMERALD-3 Phase III trial.

Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US, EU and China). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan.

Since the first approval in May 2017, an estimated 600,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers.

AstraZeneca in immuno-oncology (IO)
AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours.

AstraZeneca strives to redefine cancer care and help transform outcomes for patients with Imfinzi as a monotherapy and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers.

AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.

(Press release, AstraZeneca, NOV 13, 2026, View Source [SID1234674765])

Kura Oncology to Participate in Two Investor Conferences in November

On November 13, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, reported that management will present at the following investor conferences:

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UBS Global Biopharma London Conference
November 17, 2026
1:20 p.m. GMT/ 8:20 a.m. ET / 5:20 a.m. PT

Jefferies Global Healthcare Conference
November 18, 2026
2:30 p.m. GMT/ 9:30 a.m. ET / 6:30 a.m. PT

Live audio webcasts will be available in the Investors section of Kura’s website at View Source, with archived replays available following the events.

(Press release, Kura Oncology, NOV 13, 2026, View Source [SID1234674764])

Oncolytics Biotech® Announces Clinical Supply Agreement to Evaluate Pelareorep in Combination with LOQTORZI® (toripalimab-tpzi) in SCAC

On November 13, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported that it has entered into a clinical supply agreement with Coherus Oncology, Inc. ("Coherus") to evaluate Oncolytics’ investigational oncolytic virus immunotherapy, pelareorep, in combination with Coherus’ next-generation PD-1 inhibitor, LOQTORZI (toripalimab-tpzi), in a clinical study in patients with squamous cell anal carcinoma ("SCAC").

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The study is expected to be conducted at a premier cancer center in the United States, which will be named once the study commences, and is anticipated to begin in the first quarter of 2027. It is expected to enroll patients who have progressed on the current standard-of-care first-line treatment of chemotherapy and checkpoint inhibition. Importantly, there is no approved therapy for second-line patients in this indication.

Under the terms of the clinical supply agreement, Coherus will provide LOQTORZI to Oncolytics, which is expected to partner with the institution sponsoring the planned clinical study.

"This agreement supports a focused clinical evaluation of pelareorep with a marketed PD-1 inhibitor in a difficult-to-treat patient population," said Jared Kelly, Chief Executive Officer of Oncolytics. "The planned study is designed to build upon the previous efficacy signals pelareorep has shown in second-line or later SCAC patients while getting data in a patient population that has progressed on the new first-line standard of care. If the results are supportive, we believe SCAC could provide an important first step toward evaluating this combination more broadly across HPV-associated cancers."

Rationale for the Pelareorep and Toripalimab Combination

Pelareorep is designed to activate toll-like receptor 3, stimulating innate and adaptive antitumor immune responses, and to promote the formation of tertiary lymphoid structures within the tumor, which have been associated with improved responses to checkpoint inhibitor therapy. Through these mechanisms, pelareorep promotes tumor-directed T-cell activation and infiltration and induces inflammatory signaling within the tumor microenvironment. Recent translational data presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting showed that pelareorep combined with a checkpoint inhibitor increases human papillomavirus ("HPV")-16-specific T cell clones and tumor-infiltrating lymphocyte clones in SCAC patients. Toripalimab blocks the PD-1 pathway, a mechanism tumors can use to suppress activated T cells. The planned study will evaluate whether pelareorep-mediated immune activation can enhance the antitumor activity of PD-1 blockade in SCAC patients who have progressed on chemo-immunotherapy treatment.

SCAC is an HPV-associated cancer with limited treatment options for patients whose disease progresses after available therapy. Because HPV-associated tumors express viral antigens that may provide recognizable immune targets, the SCAC study may also inform a potential broader development strategy across HPV-associated cancers.

About Pelareorep
Pelareorep is an intravenously delivered, systemically active, investigational immunotherapy with a dual mechanism of action that selectively replicates in tumor cells while activating both innate and adaptive anti-tumor immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes. It has been administered to over 1,200 patients, and clinical studies have demonstrated pelareorep’s potential to enhance the activity of checkpoint inhibitors and other anti-cancer therapies across multiple solid tumor types.

About Toripalimab
LOQTORZI (toripalimab-tpzi) is a next-generation PD-1 inhibitor and is the only available FDA-approved treatment indicated in combination with chemotherapy for recurrent or metastatic nasopharyngeal carcinoma. It is also being developed for additional tumor types with the goal of serving as a PD-1 inhibitor backbone for future treatment combinations that may extend survival for patients.

(Press release, Oncolytics Biotech, NOV 13, 2026, View Source [SID1234674763])

Xenetic Biosciences Reports Third Quarter 2026 Financial Results and Highlights Strategic Business Updates

On November 13, 2026 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported financial results for the third quarter ended September 30, 2026, and highlighted its proposed share exchange transaction with Santersus AG ("Santersus"), which is expected to establish a Nasdaq-listed, clinical-stage company with a differentiated pipeline targeting neutrophil extracellular traps (NETs) across multiple high-value therapeutic indications.

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"This is a defining period for Xenetic as we work toward completing a transaction that we believe has the potential to fundamentally transform the Company’s clinical development profile and long-term value proposition," said James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic Biosciences. "Santersus is expected to bring an established clinical-stage platform, two FDA Breakthrough Device Designations and a pipeline targeting serious diseases with substantial unmet medical needs. Importantly, the proposed combined company would have multiple development programs and potential catalysts, including an ongoing pivotal sepsis study, planned advancement in lupus and an anticipated oncology clinical readout in 2027."

Mr. Parslow continued, "We believe the complementary nature of NucleoCapture and Xenetic’s DNase platform provides a differentiated opportunity to address NETs through distinct mechanisms, potentially expanding the therapeutic reach of the combined platform. Our focus remains on advancing the proposed transaction and positioning the combined organization to execute against its development priorities and build sustainable stockholder value."

Third Quarter 2026 and Recent Strategic Highlights

Initiated Clinical Evaluation of DNase I in Combination with CAR T-Cell Therapy: Announced the first patient dosed in an investigator-initiated, Phase I (NCT07361224) clinical study evaluating systemic recombinant human DNase I in combination with anti-CD19 CAR T-cell therapy in patients with large B-cell lymphoma (LBCL). The study is being conducted at Tel Aviv Sourasky University Medical Center in Israel in collaboration with PeriNess Ltd., with initial efficacy data expected in the second quarter of 2027.
Advanced Pre-Clinical Development Strategy in CAR T cell therapy: Research examines a self-reinforcing niche of therapy resistance created by extracellular chromatin and NETs released during CAR T-cell killing and its reversal by DNase I.
Announced Definitive Exchange Agreement with Santersus AG: Entered into a definitive share exchange agreement to, subject to Xenetic’s stockholder approval, acquire all of the outstanding share capital of Santersus AG in exchange for newly issued shares of Xenetic in an all-stock transaction (the "Proposed Transaction"). The Proposed Transaction is expected to create a Nasdaq-listed clinical-stage company focused on targeting neutrophil extracellular traps (NETs) across multiple therapeutic indications. After closing, the combined company is expected to continue to trade on the Nasdaq Capital Market as Santersus Bio, Inc., under new ticker symbol "SNTS".The Proposed Transaction has been unanimously approved by the Board of Directors of Santersus. Xenetic’s Board of Directors – acting on the unanimous recommendation of its independent Special Committee – has also approved the Proposed Transaction and recommends that Xenetic stockholders vote in favor of the Proposed Transaction. The Proposed Transaction is expected to close in the first quarter of 2027, subject to approval by Xenetic stockholders, the shares of Xenetic common stock issuable in the Proposed Transaction having been approved for listing on Nasdaq, the effectiveness of a resale registration statement on Form S-1 to be filed with the U.S. Securities and Exchange Commission ("SEC"), and the satisfaction or waiver of other customary closing conditions.
Summary of Financial Results for Third Quarter 2026

Royalty revenue for the three months ended September 30, 2026 decreased approximately 29% to approximately $0.7 million, compared to approximately $1.0 million for the comparable prior-year period. The decrease was primarily attributable to positive royalty adjustments recognized from certain countries during the third quarter of 2025 under the Company’s sublicense agreement with Takeda Pharmaceutical Co. Ltd.

Research and development expenses for the three months ended September 30, 2026 decreased approximately 31% to approximately $0.5 million, compared to approximately $0.8 million for the comparable prior-year period, primarily due to lower manufacturing development costs.

General and administrative expenses for the three months ended September 30, 2026 increased approximately 138% to approximately $1.9 million, compared to approximately $0.8 million for the comparable quarter of 2025. The increase was primarily attributable to higher legal and financial advisory expenses associated with the Proposed Transaction.

Net loss for the quarter ended September 30, 2026 was approximately $1.7 million, or $0.72 per basic and diluted share, compared to approximately $0.5 million, or $0.33 per basic and diluted share, for the same period in 2025.

Cash and cash equivalents totaled approximately $5.8 million as of September 30, 2026, compared to approximately $7.9 million as of December 31, 2025.

(Press release, Xenetic Biosciences, NOV 13, 2026, View Source [SID1234674755])

TuHURA Biosciences Reports Third Quarter 2026 Financial Results and Provides a Corporate Update

On November 13, 2026 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported financial results for the Company’s third quarter ended September 30, 2026, and provided a corporate update.

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"We continue to make significant progress across each of our programs. In October, we shared our first look at data from our open-label front line study of IFx-2.0 with Keytruda in patients with deep-seated metastatic Merkel cell carcinoma, which showed durable, major objective anti-tumor responses in the first three patients with all responses ongoing for more than six months," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. "Working collaboratively with the FDA, we received clearance to begin our Phase 1b study of TBS-2025, our VISTA-inhibiting antibody, in relapsed/refractory mutNPM1 acute myeloid leukemia (AML), a molecularly defined subset of AML where the presence of VISTA on leukemic cells is associated with poor response to therapy and survival."

Dr. Bianco continued, "We will have a strong presence again this year at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December with 3 poster presentations highlighting our Delta Opioid Receptor (DOR) technology. The ASH (Free ASH Whitepaper) scientific review committee recognized the importance of our discoveries of the central role the DOR plays in controlling proliferation, recruitment and immunosuppressive capabilities of MDSCs, the body’s main cell type for suppressing immune responses leading to acquired resistance to cancer immunotherapies."

"With meaningful progress having been made in each of our programs, we believe we are well positioned to deliver on several transformational potential milestones. Having continuing access to a $50mm credit facility from our largest shareholder has allowed us to fund operations in a non-dilutive manner benefiting shareholders as we continue driving towards these value-creating events," Dr. Bianco concluded.

Third Quarter and Recent Corporate Highlights:

•
Announced three poster presentations at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 12-15, 2026, in New Orleans. The posters highlight research on the role of the Delta Opioid Receptor (DOR) in controlling the immunosuppressive capabilities of myeloid-derived suppressor cells (MDSCs), and the data underscore the potential therapeutic breadth of DOR technology across MDSCs, T regs and M2 macrophages.

•
Provided a first look at data from its open-label study of IFx-2.0 as an adjunctive therapy to Keytruda in first line treatment of patients with deep seated metastatic Merkel Cell Carcinoma. Preliminary results demonstrated major objective partial responses in each of the first 3 patients, constituting major objective tumor responses, which are ongoing for more than six months.

•
Received a new U.S. Patent broadening coverage for its VISTA Inhibitor, TBS-2025. The patent extends coverage to include bispecific/multi-specific antibodies across all classes of human antibodies as well as coverage for methods of treatment that extend beyond cancer, expanding into new treatment areas like autoimmune disease and infection. The patent term extends to 2042, prior to any potential patent term adjustment and/or regulatory patent term extension.

•
Received key U.S. patent for its groundbreaking Delta Opioid Receptor (DOR) Antibody Drug Conjugate (ADC) technology. The patent discloses uses beyond ADCs, including autologous or allogeneic adoptive cellular immunotherapies like CAR-T, Tregs or TIL cell therapies. The term of the patent runs through 2043 before any patent term extension.

•
Well funded to achieve clinical goals. The Parkview loan facility contributed $5.6 million in non-dilutive financing during the quarter ended September 30, 2026. This facility allows the Company to operationally proceed on all fronts while maintaining shareholder value. This facility also allows the Company to focus exclusively on operational goals.

•
Received FDA "Study May Proceed" notice and IND clearance for the evaluation of its VISTA-Inhibiting Antibody in molecularly defined subsets of AML and other blood-related cancers. The IND allows the Company to examine TBS-2025 in a Phase 1b study evaluating the safety and potential efficacy of monotherapy at different doses in patients with relapsed/refractory (r/r) mutNPM1 AML who have failed to respond to or relapsed after Menin inhibitor therapy. If TBS-2025 results in encouraging response rates during the dose-optimization stage of the study, the Company will explore with the FDA the potential expansion of the trial in consideration for the opportunity for accelerated approval.

Currently Anticipated Milestones by Program

IFx-2.0 (Innate Immune Agonist)

•
2H 2026: Expect to receive orphan drug designation in MCC
•
1H2027: Expect preliminary results from front-line study IFX-2.0 with Keytruda when administered by CT or ultrasound-guided techniques to metastatic deep seated MCC
•
2H 2027: Expect to complete enrollment in the Company’s Phase 3 registrational front-line study of IFx-2.0 as adjunctive therapy to Keytruda in advanced or metastatic MCC

TBS-2025 (VISTA inhibiting mAb)

•
2H 2026: Expect to initiate a Phase 1b/2 trial of TBS-2025 VISTA inhibiting antibody in mutNPM1 r/r AML
•
1H 2027: Expect to receive orphan drug designation in AML
•
1H 2027: Expect preliminary safety and response data for VISTA in mutated NMP1 r/r AML

MDSC Inhibitors (Bi-specific ADCs)

•
2H 2026: Presentations at ASH (Free ASH Whitepaper)
•
2H 2026: Initiation of ADC in vivo POC studies

Summary of Financial Results for the Third Quarter 2026

Cash and cash equivalents of $1.9 million at September 30, 2026. The Company received $9.2 million in gross proceeds as of September 30, 2026, on the Parkview credit facility.

Research and development expenses were $3.7 million and $5.0 million for the 3 months ended September 30, 2026, and 2025, respectively. The decrease of $1.3 million was due to lower manufacturing costs, which are expected to resume in the next quarter with the start of the TBS-2025 clinical trial material manufacturing campaign.

General and administrative (G&A) expenses were $2.0 million and $1.6 million for the 3 months ended September 30, 2026, and 2025, respectively. The increase of $0.4 million was primarily due to increases in non-cash stock compensation expense and costs associated with being a public company.

Net cash outflows from operating activities were ($18.1) million and ($22.1) million for the 9 months ended September 30, 2026, and 2025, respectively.

Net cash flows from financing activities were $16.5 million and $13.4 million for the 9 months ended September 30, 2026, and 2025, respectively.

Total common shares outstanding were approximately 65.8 million at September 30, 2026.

(Press release, TuHURA Biosciences, NOV 13, 2026, View Source [SID1234674754])