Perioperative IMFINZI® (durvalumab) approved in the US in novel regimen with neoadjuvant enfortumab vedotin-ejfv for patients with muscle-invasive bladder cancer

Perioperative IMFINZI® (durvalumab) approved in the US in novel regimen with neoadjuvant enfortumab vedotin-ejfv for patients with muscle-invasive bladder cancer

Based on VOLGA Phase III trial data which showed a 49% reduction in risk of recurrence and a 42% reduction in risk of death, with a manageable safety profile

Approval reinforces potential of IMFINZI as an immunotherapy backbone across muscle-invasive and non-muscle-invasive bladder cancer​

WILMINGTON, Del.–(BUSINESS WIRE)–
AstraZeneca’s ​IMFINZI® (durvalumab)​ in combination with enfortumab vedotin-ejfv (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.

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) 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 tumor 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-ejfv 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-basedregimen that almost halved the risk of disease recurrence and reduced the risk of death by 42 percent in the VOLGA trial, allowing physicians to optimize 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 IMFINZIcombination 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 IMFINZIcombination or comparator arm. An estimated 78% of patients treated with the IMFINZIcombination 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.

IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI® (durvalumab) or IMJUDO® (tremelimumab-actl).

Severe and Fatal Immune-Mediated Adverse Reactions

Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and/or IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

  • IMFINZI as a Single Agent
    • In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions.

    • In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions.

    • The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions.

    • The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy.

  • IMFINZI with IMJUDO
    • Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.

  • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
    • Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions.

Immune-Mediated Colitis

IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.

  • IMFINZI as a Single Agent
    • Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.

  • IMFINZI with IMJUDO
    • Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO.

  • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
    • Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients.

Immune-Mediated Hepatitis

IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.

  • IMFINZI as a Single Agent
    • Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1.4%) adverse reactions.

  • IMFINZI with IMJUDO
    • Immune‑mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%), and Grade 3 (4.1%) adverse reactions.

  • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
    • Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.

Immune-Mediated Endocrinopathies

  • Adrenal Insufficiency:IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.
    • IMFINZI as a Single Agent
      • Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

    • IMFINZI with IMJUDO
      • Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

    • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
      • Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions.

  • Hypophysitis:IMFINZI and IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated.
    • IMFINZI as a Single Agent
      • Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI.

    • IMFINZI with IMJUDO
      • Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO.

    • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
      • Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.

  • Thyroid Disorders:IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.
    • IMFINZI as a Single Agent
      • Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

      • Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI.

      • Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

    • IMFINZI with IMJUDO
      • Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO.

      • Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

      • Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO.

    • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
      • Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy.

      • Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.

      • Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.

    • IMFINZI with Carboplatin and Paclitaxel
      • Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel.

  • Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated.
    • IMFINZI as a Single Agent
      • Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.

    • IMFINZI with IMJUDO
      • Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up.

    • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
      • Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions.

Immune-Mediated Nephritis with Renal Dysfunction

IMFINZI and IMJUDO can cause immune-mediated nephritis.

  • IMFINZI as a Single Agent
    • Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

  • IMFINZI with IMJUDO
    • Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions.

  • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
    • Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.

Immune-Mediated Dermatology Reactions

IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.

  • IMFINZI as a Single Agent
    • Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.

  • IMFINZI with IMJUDO
    • Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.

  • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
    • Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.

Immune-Mediated Pancreatitis

IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.

Other Immune-Mediated Adverse Reactions

The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI and IMJUDO or were reported with the use of other immune-checkpoint inhibitors.

  • Cardiac/vascular: Myocarditis, pericarditis, vasculitis.
  • Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.
  • Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.
  • Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.
  • Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica.
  • Endocrine: Hypoparathyroidism.
  • Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection.
  • Other:Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap Syndrome, reported as the co-occurrence of either two or all three adverse reactions.

Infusion-Related Reactions

IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.

  • IMFINZI as a Single Agent
    • Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.

  • IMFINZI with IMJUDO
    • Infusion-related reactions occurred in 2.6% (10/388) of patients receiving IMFINZI and IMJUDO.

  • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
    • Infusion-related reactions occurred in 2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.

  • IMFINZI with Enfortumab Vedotin-ejfv (EV)
    • Infusion-related reactions occurred in 1.3% (3/228) of patients receiving IMFINZI in combination with EV.

Complications of Allogeneic HSCT after IMFINZI

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.

Lactation

There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose.

Adverse Reactions

Unresectable Stage III NSCLC

  • In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonia (7%) and pneumonitis/radiation pneumonitis (3.4%).

  • In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms.

Resectable NSCLC

  • In patients with resectable NSCLC in the AEGEAN study, the most common adverse reactions (occurring in ≥20% of patients) were anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash.

  • In patients with resectable NSCLC in the neoadjuvant phase of the AEGEAN study receiving IMFINZI in combination with platinum-containing chemotherapy (n=401), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6.7% of patients. Serious adverse reactions occurred in 21% of patients. The most frequent (≥1%) serious adverse reactions were pneumonia (2.7%), anemia (1.5%), myelosuppression (1.5%), vomiting (1.2%), neutropenia (1%), and acute kidney injury (1%). Fatal adverse reactions occurred in 2% of patients, including death due to COVID-19 pneumonia (0.5%), sepsis (0.5%), myocarditis (0.2%), decreased appetite (0.2%), hemoptysis (0.2%), and death not otherwise specified (0.2%). Of the 401 IMFINZI-treated patients who received neoadjuvant treatment and 398 placebo-treated patients who received neoadjuvant treatment, 1.7% (n=7) and 1% (n=4), respectively, did not receive surgery due to adverse reactions.

  • In patients with resectable NSCLC in the adjuvant phase of the AEGEAN study receiving IMFINZI as a single agent (n=265), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 8% of patients. Serious adverse reactions occurred in 13% of patients. The most frequent serious adverse reactions reported in >1% of patients were pneumonia (1.9%), pneumonitis (1.1%), and COVID-19 (1.1%). Four fatal adverse reactions occurred during the adjuvant phase of the study, including COVID-19 pneumonia, pneumonia aspiration, interstitial lung disease, and aortic aneurysm.

Metastatic NSCLC

  • In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in ≥20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%).

  • In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. Serious adverse reactions occurred in 44% of patients, with the most frequent serious adverse reactions reported in at least 2% of patients being pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%). Fatal adverse reactions occurred in a total of 4.2% of patients.

Limited-stage Small Cell Lung Cancer

  • In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), the most common adverse reactions occurring in ≥20% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (38%) and fatigue (21%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis or radiation pneumonitis and pneumonia.

  • In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), IMFINZI was permanently discontinued due to adverse reactions in 16% of the patients receiving IMFINZI. Serious adverse reactions occurred in 30% of patients receiving IMFINZI. The most frequent serious adverse reactions reported in ≥1% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (12%) and pneumonia (5%). Fatal adverse reactions occurred in 2.7% of patients who received IMFINZI including pneumonia (1.5%), cardiac failure, encephalopathy, and pneumonitis (0.4% each).

Extensive-stage Small Cell Lung Cancer

  • In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (≥20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%).

  • In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy.

Locally Advanced or Metastatic Biliary Tract Cancers (BTCs)

  • In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in ≥20% of patients) were fatigue (42%), nausea (40%), constipation (32%), decreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia (20%).

  • In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 2% of patients were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%), and acute kidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic stroke (4 patients), sepsis (2 patients), and upper gastrointestinal hemorrhage (2 patients).

Unresectable Hepatocellular Carcinoma (HCC)

  • In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), the most common adverse reactions (occurring in ≥20% of patients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%), musculoskeletal pain (22%), and abdominal pain (20%).

  • In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%). Fatal adverse reactions occurred in 8% of patients who received IMFINZI and IMJUDO, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients.

Primary Advanced or Recurrent dMMR Endometrial Cancer

  • In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), the most common adverse reactions, including laboratory abnormalities (occurring in >20% of patients) were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea (59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation (39%), rash (39%), decreased magnesium (36%), increased ALT (32%), increased AST (30%), diarrhea (27%), vomiting (27%), cough (27%), decreased potassium (25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%), and decreased appetite (18%). The most common Grade 3 or 4 adverse reactions (≥3%) were constipation (4.5%) and fatigue (4.5%).

  • In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), permanent discontinuation of IMFINZI due to adverse reactions occurred in 11% of patients. Serious adverse reactions occurred in 30% of patients who received IMFINZI with carboplatin and paclitaxel; the most common serious adverse reactions (≥4%) were constipation (4.5%) and rash (4.5%).

BCG-Naive, High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

  • In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, the most common (≥20%) adverse reactions, including laboratory abnormalities were increased glucose (43%), increased AST (43%), increased lipase (42%), increased ALT (42%), increased GGT (40%), urinary tract infection (40%), increased potassium (39%), dysuria (37%), decreased hemoglobin (35%), hematuria (33%), increased serum creatinine (30%), musculoskeletal pain (28%), decreased lymphocytes (27%), urinary frequency (26%), decreased sodium (23%), fatigue (21%), rash (20%), and pyrexia (20%).

  • In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, permanent discontinuation of IMFINZI due to adverse reactions occurred in 18% of patients. The adverse reactions which resulted in permanent discontinuation of IMFINZI (≥1%) were hepatitis (1.8%), acute kidney injury (1.2%), and diarrhea (1.2%). Serious adverse reactions occurred in 32% of patients. The most common (≥1%) serious adverse reactions were urinary tract infection (4.5%), COVID (1.8%), hepatitis (1.5%), dysuria (1.2%), and prostate cancer (1.2%). Fatal adverse reactions occurred in 2.4% of patients who received IMFINZI in combination with BCG, including congestive cardiac failure (0.6%), COVID (0.3%), cardiovascular disorder (0.3%), dementia with Lewy bodies (0.3%), and pancreatic cancer (0.3%).

Muscle-Invasive Bladder Cancer (MIBC)

  • In patients with MIBC, the most common adverse reactions, including laboratory abnormalities, in the overall study (occurring in ≥20% of patients) were decreased hemoglobin, decreased neutrophils, increased blood creatinine, decreased sodium, nausea, increased ALT, decreased calcium, decreased platelets, fatigue, increased potassium, decreased lymphocytes, increased AST, constipation, decreased magnesium, decreased appetite, increased alkaline phosphatase, rash, pyrexia, diarrhea, vomiting, and abdominal pain.

  • In patients with MIBC in the neoadjuvant phase of the NIAGARA study receiving IMFINZI in combination with gemcitabine and cisplatin (n=530), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 9% of patients. Serious adverse reactions occurred in 24% of patients; the most frequent (≥1%) serious adverse reactions were pulmonary embolism (1.9%), febrile neutropenia (1.5%), acute kidney injury (1.3%), thrombocytopenia (1.3%), urinary tract infection (1.3%), and pneumonia (1.3%). Fatal adverse reactions occurred in 1.1% of patients including sepsis, myocardial infarction, and pulmonary embolism (0.2% each). One fatal adverse reaction of pneumonia was reported in 1 (0.2%) patient in the post-surgery phase before adjuvant treatment started. Of the 530 patients in the IMFINZI-treatment arm and 526 patients in the chemotherapy-treatment arm who received neoadjuvant treatment, 1 (0.2%) patient in each treatment arm did not receive surgery due to adverse reactions. The adverse reaction that led to cancellation of surgery in the IMFINZI treatment arm was interstitial lung disease.

  • In patients with MIBC in the adjuvant phase of the NIAGARA study receiving IMFINZI as a single agent (n=383), permanent discontinuation of adjuvant IMFINZI due to an adverse reaction occurred in 5% of patients. Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions (occurring in ≥1% of patients) were urinary tract infection (7%), acute kidney injury (3.7%), hydronephrosis (2.1%), pyelonephritis (2.1%), urosepsis (1.8%), and sepsis (1.6%). Fatal adverse reactions occurred in 1.8% of patients, including COVID-19, severe acute respiratory syndrome, cardiopulmonary failure, gastrointestinal hemorrhage, and chronic hepatic failure (0.3% each).

Cisplatin-ineligible/cisplatin-refusal MIBC

  • The most common adverse reactions (≥20%), including laboratory abnormalities, were increased AST, increased ALT, decreased hemoglobin, rash, increased creatinine, pruritus, decreased calcium, increased lipase, increased potassium, urinary tract infection, increased amylase, fatigue, decreased sodium, decreased lymphocytes, diarrhea, decreased leukocytes, constipation, decreased appetite, increased alkaline phosphatase, dysgeusia, nausea, peripheral neuropathy, musculoskeletal pain, and alopecia.

  • In patients with cisplatin-ineligible/cisplatin-refusal MIBC in the neoadjuvant phase of the VOLGA study receiving IMFINZI + EV (n=228), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 7% of patients. Serious adverse reactions occurred in 24% of patients; serious adverse reactions in ≥1% of patients included urinary tract infection (4.4%), rash (2.2%), pneumonia (1.3%), and multiple organ dysfunction syndrome (1.3%). Of the 228 patients in the IMFINZI + EV arm who received neoadjuvant treatment, two patients (0.9%) did not receive surgery due to an adverse reaction (pneumonia).

  • In patients with cisplatin-ineligible/cisplatin-refusal MIBC in the adjuvant phase of the VOLGA study receiving IMFINZI (n=157), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 11% of patients. Serious adverse reactions occurred in 35% of patients; serious adverse reactions in ≥1% of patients included urinary tract infection (11%), acute kidney injury (5%), sepsis, pneumonia, and septic shock (1.9% each), and hydronephrosis, inguinal hernia, decreased appetite, peripheral neuropathy, hypertension, and diarrhea (1.3% each).

Resectable Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJC)

  • In patients with resectable GC/GEJC, the most common adverse reactions in the overall study (occurring in ≥20% of patients) were diarrhea, nausea, peripheral neuropathy, fatigue, alopecia, decreased appetite, rash, abdominal pain, vomiting, musculoskeletal pain, pyrexia, and stomatitis.

  • In patients with resectable GC/GEJC in the neoadjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=475), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 2.5% of patients. Serious adverse reactions occurred in 21% of patients; the most frequent (≥2%) serious adverse reaction was diarrhea (2.5%). Deaths occurred in 1.9% of patients; deaths of ≥2 patients included septic shock (0.6%) and acute coronary syndrome (0.4%). Of the 475 patients in the IMFINZI + FLOT chemotherapy treatment arm and 469 patients in the placebo + FLOT chemotherapy treatment arm who received neoadjuvant treatment, 0.6% and 0.4% of patients, respectively, did not receive surgery due to adverse reactions, and 2.3% and 2.6% of patients, respectively, had a delay in surgery due to ARs.

  • In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=365), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 7% of patients. Serious adverse reactions occurred in 29% of patients; the most frequent (≥2%) serious adverse reaction was pneumonia (2.5%). Deaths occurred in 2.2% of patients; deaths of ≥2 patients included gastrointestinal perforation (0.5%) and COVID-19 (0.5%).

  • In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI alone (n=345), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6% of patients. Serious adverse reactions occurred in 14% of patients. Deaths occurred in 1.7% of patients; deaths of ≥2 patients included gastrointestinal perforation (0.6%) and COVID-19 (0.6%).

The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.

Indications:

IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.

IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).

IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).

IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-authorized test.

IMFINZI in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).

IMFINZI in combination with enfortumab vedotin-ejfv (EV) as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment after radical cystectomy, is indicated for the treatment of adult patients with MIBC who are ineligible for or who have refused cisplatin-based chemotherapy.

IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).

Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO.

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, randomized, open-label, multi-center global trial evaluating perioperative IMFINZI with or without tremelimumab-actl 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 randomized 1:1:1 to Arm 1 (three cycles of IMFINZI and EV, plus two cycles of tremelimumab-actl prior to surgery, followed by nine cycles of IMFINZI plus one cycle of tremelimumab-actl 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 centers across 25 countries in Europe, North America, South America and Asia. Its dual primary endpoints are EFS, defined as the time from randomization 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® (durvalumab)

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 tumor’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® (tremelimumab-actl) 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 chemoembolization (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 embolization in the EMERALD-3 Phase III trial.

IMFINZI in combination with chemotherapy followed byIMFINZI 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 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 withIMFINZI. As part of a broad development program, 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-tumor immune response and stimulate the body’s immune system to attack tumors.

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 program, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca.

Dr. Rosenberg has financial interests related to AstraZeneca.

References

  1. AstraZeneca PLC. Investor relations epidemiology spreadsheet. Available at: https://www.astrazeneca.com/investor-relations.html. Accessed November 2026.

  2. Burger M, et al. Epidemiology and Risk Factors of Urothelial Bladder Cancer. Eur Urol. 2013;63(2):234-241.

  3. National Collaborating Centre for Cancer. Bladder Cancer: Diagnosis and Management. London: National Institute for Health and Care Excellence (NICE). Available at: https://www.ncbi.nlm.nih.gov/books/NBK356289/. Accessed November 2026.

  4. Dash A, et al. Impact of renal impairment on eligibility for adjuvant cisplatin-based chemotherapy in patients​ with urothelial carcinoma of the bladder. Cancer. 2006;107(3):506-513.

  5. Galsky MD, et al. Treatment of patients with metastatic urothelial cancer “unfit” for cisplatin-based​ chemotherapy. J Clin Oncol. 2011;29(17):2432-2438.

  6. Holzbeierlein J, et al. Treatment of Non-Metastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/SUO Guideline (2017; Amended 2020, 2024). J Urol. 2024;212(1):3-10.

  7. World Health Organization. International Agency for Research on Cancer. Bladder Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/30-bladder-fact-sheet.pdf. Accessed November 2026.

  8. American Cancer Society. What Is Bladder Cancer? Available at: https://www.cancer.org/cancer/types/bladder-cancer/about/what-is-bladder-cancer.html. Accessed November 2026.

  9. AstraZeneca PLC. Imfinzi approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer. Available at: https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-for-bladder-cancer.html. Accessed November 2026.

US-117221 Last Updated 11/26

Media Inquiries

Lauren-Jei McCarthy

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US Media Mailbox: [email protected]

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INDUSTRY KEYWORDS: Oncology Health FDA General Health Clinical Trials Pharmaceutical Biotechnology

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Bloom Energy Supports Louisiana Disaster Relief Ahead of Texas-LSU Matchup

Bloom Energy Supports Louisiana Disaster Relief Ahead of Texas-LSU Matchup

BATON ROUGE, La.–(BUSINESS WIRE)–
As Baton Rouge gets ready for the Texas-LSU matchup, Bloom Energy is joining the community off the field to support two organizations making a difference for families across Louisiana.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261113756487/en/

On Friday, Bloom Energy visited Baton Rouge Fire Station 12 to recognize the work of the Baton Rouge Area Foundation and Civic Collaborative Foundation, two organizations helping strengthen communities and support Louisianans in times of need. As part of the event, Bloom Energy presented each organization with a $10,000 donation.

“Keeping communities safe depends on the people and organizations that strengthen them every day,” said Natalie Sunderland, Chief Marketing Officer at Bloom Energy. “For decades, the Baton Rouge Area Foundation and Civic Collaborative Foundation have stood alongside Louisiana families and helped communities rebuild and move forward. We’re proud to support their work and the lasting resilience they’re building across Baton Rouge and South Louisiana.”

“We’re so thankful for Bloom Energy’s generosity in Baton Rouge, and for the tireless dedication of first responders everywhere,” said Chris Meyer, president and CEO of the Baton Rouge Area Foundation and Civic Collaborative Foundation. “This grant will allow our community to better prepare for disasters before they happen and equip the brave men and women of the Baton Rouge Fire Department to respond more effectively.”

Among the largest community foundations in the country, the Baton Rouge Area Foundation seeks to improve the quality of life in greater Baton Rouge and across south Louisiana by supporting local nonprofits, engaging community leaders and partnering with others to create positive regional change.

Civic Collaborative Foundation, a Baton Rouge-based nonprofit that shares leadership and administrative support with the Baton Rouge Area Foundation, provides temporary relief to individuals and families facing financial hardship after natural and man-made disasters along the Gulf Coast and helps Louisiana communities prepare for and recover from disasters.

The donations reflect Bloom Energy’s commitment to supporting the communities it serves and partnering with local organizations that are helping build stronger, more resilient communities.

Bloom will also be on campus Saturday ahead of the Texas-LSU game as ESPN Radio’s College Football Campus Tour powered by Bloom Energy brings its live broadcast and interactive Fan Zone to Baton Rouge.

Upcoming Confirmed 2026 Tour Stops

  • November 14 – Baton Rouge, Louisiana | Texas at LSU

  • November 21 – Lincoln, Nebraska | Ohio State at Nebraska

  • November 28 – Nashville, Tennessee | Tennessee at Vanderbilt

About Bloom Energy

Bloom Energy empowers enterprises to meet soaring energy demands and responsibly take charge of their power needs. The company’s fuel cell systems provide ultra-reliable, clean and highly scalable onsite electricity for Fortune 500 customers around the world, including data centers, semiconductor manufacturing, large utilities and other commercial and industrial sectors, as well as mission-critical organizations in local communities, such as hospitals, college campuses and retailers. Headquartered in Silicon Valley, Bloom Energy employs more than 2,000 people worldwide and manufactures its systems in the United States. For more information, visit BloomEnergy.com.

Forward-Looking Statements

This press release contains certain forward-looking statements, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or our future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” “will” and “would” or the negative of these words or similar terms or expressions that concern Bloom’s expectations, strategy, priorities, plans or intentions. These forward-looking statements include, but are not limited to, the impact of the contribution to the Baton Rouge Area Foundation and Civic Collaborative Foundation. Readers are cautioned that these forward-looking statements are only predictions and may differ materially from actual future events or results due to a variety of factors, including, but not limited to, risks and uncertainties detailed in Bloom’s SEC filings. More information on potential risks and uncertainties that may impact Bloom’s business are set forth in Bloom’s periodic reports filed with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 9, 2026, its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026, June 30, 2026 and September 30, 2026, filed with the SEC on April 29, 2026, July 28, 2026 and October 22, 2026, respectively, as well as subsequent reports filed with or furnished to the SEC. Bloom assumes no obligation to, and does not intend to, update any such forward-looking statements.

Media Contact

Katja Gagen

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Organigram Provides NASDAQ Listing Update

Organigram Provides NASDAQ Listing Update

The Notification has no immediate effect on the listing or trading of the Company’s common shares on the Nasdaq Global Select Market.

TORONTO–(BUSINESS WIRE)–
Organigram Global Inc. (NASDAQ: OGI) (TSX: OGI) (the “Company” or “Organigram”), Canada’s #1 cannabis company by market share¹ and a growing global cannabis platform, today announced that on November 11, 2026, it received notification (the “Notification”) from The Nasdaq Stock Market LLC (“Nasdaq”) that it is not in compliance with the minimum bid price requirement under Nasdaq Listing Rule 5450(a)(1) for continued listing on the Nasdaq Global Select Market. The Notification was issued because the closing bid price of the Company’s common shares was below US$1.00 per share for 30 consecutive business days. Nasdaq Listing Rule 5450(a)(1) requires listed common shares to maintain a minimum bid price of US$1.00 per share (the “Minimum Bid Requirement”), while Nasdaq Listing Rule 5810(c)(3)(A) provides that a deficiency exists when the requirement is not met for 30 consecutive business days.

The Notification has no immediate effect on the listing or trading of the Company’s common shares on the Nasdaq Global Select Market. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 calendar days, until May 10, 2027, to regain compliance with the Minimum Bid Requirement. To regain compliance, the closing bid price of the Company’s common shares must be at least US$1.00 per share for a minimum of 10 consecutive business days during the compliance period, subject to Nasdaq’s discretion to extend this period.

If the Company does not regain compliance by May 10, 2027, it may be eligible for an additional 180-calendar-day compliance period, subject to satisfying applicable Nasdaq requirements, including transferring its listing to the Nasdaq Capital Market. If the Company does not qualify for an additional compliance period, its common shares may become subject to delisting proceedings, subject to applicable appeal rights.

The Company’s common shares are also listed on the Toronto Stock Exchange, and the Notification does not affect the Company’s listing or compliance status on that exchange.

About Organigram

Organigram Global Inc. is listed on the NASDAQ Global Select Market and TSX. The Company’s wholly owned subsidiary, Organigram Inc., is a licensed cultivator and processor. Through its acquisition of Sanity Group GmbH (“Sanity Group”), Organigram participates in the German medical cannabis market and other emerging markets within Europe. Organigram is focused on producing high-quality cannabis for adult consumers, as well as extending the Company’s global footprint. Organigram has also developed and acquired a portfolio of cannabis brands, including Edison, Big Bag O’ Buds, SHRED, Monjour, Tremblant, Collective Project, Trailblazer, BOXHOT and DEBUNK. Through its acquisition of Sanity Group, Organigram’s European brands include Vayamed, avaay, ZOIKS, Endosane Pharmaceuticals, VAAY, and Grashaus Projects. Organigram operates facilities in Moncton, New Brunswick and Lac Supérieur, Quebec, with a dedicated edibles manufacturing facility in Winnipeg, Manitoba. The Company also operates two additional cannabis processing facilities in Southwestern Ontario; one in Aylmer and the other in London. The facility in Aylmer houses best-in-class extraction capabilities, and is optimized for formulation refinement, post-processing of minor cannabinoids, and infused pre-roll production. The facility in London will be optimized for labelling, packaging, and national fulfillment. The Company is regulated by Health Canada under the Cannabis Act and the Cannabis Regulations.

For Investor enquiries:


Max Schwartz, Director of Investor Relations

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Cerenome Reports Third Quarter 2026 Financial Results and Business Highlights Featuring REYOBIQ ReSPECT- LM Data and CNSide Commercial and Reimbursement Progress

HOUSTON, Nov. 13, 2026 (GLOBE NEWSWIRE) — Cerenome, Inc. (Nasdaq: CNSY) (“Cerenome” or the “Company”), a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted radiopharmaceuticals, and artificial intelligence, announces financial results for the third quarter ended September 30, 2026, and provides an overview of recent business progress.

“Recognition of our first quarter of CNSide® diagnostic revenue and commercial payments beginning in October is a tremendous landmark,” said Marc H. Hedrick, M.D., Cerenome’s President and Chief Executive Officer. “Furthermore, our payer universe continues to expand with now about 80% of U.S. private payers representing approximately 190 million covered lives. Most recently, with Aetna coverage, it gives physicians an in-network option for both tumor cell enumeration and molecular profiling. In parallel, our growing commercial team is focused on helping more cancer centers use our test in patient care. In therapeutics, we materially advanced our two key programs by completing enrollment in our Phase 2 trial in adults with recurrent glioblastoma, opening up higher dose cohorts in the repeat dosing of REYOBIQ™ in patients with leptomeningeal metastases and reporting interim data in that trial.”

Q3 2026 AND RECENT HIGHLIGHTS


Corporate

  • During the quarter, Plus Therapeutics rebranded as Cerenome, and on August 3 its common stock began trading on Nasdaq under the symbol CNSY. The new name and brand reflect the Company’s focus on integrating CNS diagnostics, therapeutics, and data.
  • In November, Ron Andrews was appointed as Chief Business Officer to advance CNSide commercial adoption and strategic partnerships. Mr. Andrews continues to serve on the Company’s Board of Directors.


CNSide® CSF Assay Platform

  • The company submitted billing claims for approximately $1.55 million in gross billings at list prices and recognized $0.7 million in net diagnostic revenue in the quarter after estimated payer adjustments and price concessions.
  • Contracted coverage was expanded through agreements with Medical Mutual, Health Care Service Corporation and Blue Cross Blue Shield of Michigan.
  • Secured in-network agreements were also made with Florida Blue and Aetna. The Aetna agreement, effective November 1, is the first national CNSide payer agreement to include both tumor cell enumeration and molecular profiling. The Company’s aggregate contracted footprint now represents approximately 190 million covered lives.
  • The company entered into a collaboration with Genomic Testing Cooperative to add DNA and RNA profiling to CNSide. In July, the Company also highlighted updated NCCN CNS Cancers Guidelines recognizing a role for CSF analysis in the assessment of LM.
  • XiFin was selected for revenue cycle management and clearinghouse services, and Samantha Fowlkes was appointed as Vice President and Head of Commercial Sales for CNSide Diagnostics.
  • The Company is on track for Medicare reimbursement in 1st half of 2027 and is separately pursuing a coverage determination from Novitas Solutions.
  • CNSide CSF Molecular Profile tests were launched for solid tumors and hematologic malignancies. The test was available to order beginning October 12, providing DNA and RNA profiling from cerebrospinal fluid (CSF). CNSide can be ordered independently or alongside tumor cell enumeration.


REYOBIQ™ Development

  • The company presented interim Phase 1 ReSPECT-LM (multi-dose) findings at the Society of Neuro Oncology Annual meeting in November. The first 10 patients have been treated with repeated intraventricular doses of REYOBIQ, with no dose-limiting toxicities or treatment discontinuations due to adverse events reported. This highlights the potential for REYOBIQ to safely administer higher dose of tumor-destroying radiation (compared to single-dose study). Dose escalation is ongoing to identify a recommended multiple-dose regimen for a follow-on randomized study.
  • Also, enrollment was completed in the Phase 2 ReSPECT-GBM study in recurrent glioblastoma in October. Cerenome expects topline data in mid-2027 following additional patient follow-up, and plans to hold an End-of-Phase 2 meeting with the FDA thereafter.
  • Investigators reported preclinical data at the Rivkin Ovarian Cancer Research Symposium in October showing the active agent in REYOBIQ was associated with a new mechanism of action, namely positively impacting the tumor environment. The net effect described by investigators was administering REYOBIQ along with anti-PD-1 checkpoint blockade enhanced antitumor activity in these preclinical studies, opening up the possibility of novel combination therapies.
  • Investigators presented pharmacokinetic, dosimetry, and safety observations from the ReSPECT-LM program at the SNO/ASCO CNS Metastases Conference in August. A separate presentation examined the potential health economic impact of earlier detection of leptomeningeal metastases (LM) using CNSide.

THIRD QUARTER 2026 FINANCIAL RESULTS

  • Cash, cash equivalents and investments totaled $4.9 million as of September 30, 2026, compared with $8.6 million as of June 30, 2026. In September, the Company announced closing a senior secured financing facility up to $20 million with royalty-based repayments. In addition, the Company raised $3.8M under the Equity Distribution Agreement subsequent to the end of the quarter.
  • Total revenue was $0.7 million, consisting entirely of net diagnostic revenue.
  • Cost of revenue was $0.9 million. Research and development expense was $2.1 million, compared with $2.4 million a year earlier. Selling, general and administrative expense was $5.2 million, compared with $3.4 million a year earlier.
  • Operating loss was $7.5 million, compared with $4.5 million a year earlier. Net loss was $8.7 million, or $1.14 per share, compared with $4.4 million, or $1.03 per share, a year earlier.

ANTICIPATED MILESTONES AND OUTLOOK FOR 2027


CNSide Commercial Rollout

  • Expand CNSide adoption across cancer centers, build-out the field sales team, enhance the testing menu and build on existing payer collection experience across the CNSide test menu.


REYOBIQ Clinical Program

  • Continue dose escalation in LM Multi-dose study and follow patients in ReSPECT-GBM for the anticipated mid-2027 topline readouts from both trials.

Conference Call and Webcast

Cerenome will host a conference call and webcast Monday, November 16, 2026, at 8:30 a.m. Eastern Time to discuss third quarter results and provide a business update.

Webcast and Conference Call
Date/Time:   Monday, November 16, 2026 at 8:30 AM ET
Webcast:  
https://event.choruscall.com/mediaframe/webcast.html?webcastid=vTAb1pUs
Dial-in:   U.S.: 833-862-0853
International: 412-317-6789
    Please dial in 15 minutes before the start time.
     

Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.

About Leptomeningeal metastases (LM)

Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ™ (rhenium Re186 obisbemeda)

REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off-target risks and improve outcomes for CNS cancer patients versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials, respectively. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

About CNSide Diagnostics, LLC

CNSide Diagnostics, LLC is a wholly owned subsidiary of Cerenome, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.

About Cerenome

Cerenome (Nasdaq: CNSY) is a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted therapeutics, and artificial intelligence to improve outcomes for patients with central nervous system cancers. The CNSide® CSF diagnostics platform combines cellular and molecular testing to support the detection, characterization, and longitudinal assessment of cancers involving the CNS.

Its lead therapeutic platform, REYOBIQ™ (rhenium Re186 obisbemeda), is being evaluated in clinical trials for leptomeningeal metastases, recurrent glioblastoma, and pediatric brain cancers. The data & artificial intelligence platform is designed to integrate diagnostic, molecular, imaging, and clinical data into actionable insights that support precision oncology and therapeutic innovation.

By integrating commercial diagnostics, targeted therapeutics, proprietary longitudinal data, and artificial intelligence within a single organization, Cerenome is building a differentiated CNS oncology platform designed to improve patient care while creating long-term shareholder value. For more information, visit https://www.cerenome.com.

Forward-Looking Statements

This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments, and other factors they believe to be appropriate. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company’s ability to maintain the listing of its common stock on Nasdaq; expectations pertaining to 2027 milestones, its platform and its data strategy; the results of the Company’s research and development activities, including uncertainties relating to the continued clinical trials of its product candidates and therapies, and the timing and outcome of the ReSPECT-LM, ReSPECT-GBM, and ReSPECT-PBC trials; the Company’s liquidity position and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company; market conditions and product performance; challenges associated with radiotherapeutic manufacturing, production, and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and the continued success of CNSide CSF Assay, revenue and corporate profitability expectations including support reimbursements and payments for the CNSide CSF Assay, the development and utility of the CNSide CSF Assay, and expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates. This list of risks, uncertainties, and other factors is not complete. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions the Company might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Cerenome discusses some of these matters more fully, as well as certain risk factors that could affect its business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, Quarterly Reports on Form 10-Q for the three months ended March 31, 2026 and six-months ended June 30, 2026, and Current Reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations, and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

Investor Contact
CORE IR
[email protected]

(Financial Tables follow)

   
CERENOME, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(in thousands, except share and par value data)
 
   
       
    September 30, 2026     December 31, 2025  
Assets            
Current assets:            
Cash and cash equivalents   $ 879     $ 4,256  
Restricted cash and cash equivalents     —       4,502  
Accounts receivable, net     722       —  
Investments     3,992       4,356  
Inventory     235       —  
Other current assets     2,239       1,734  
Total current assets     8,067       14,848  
             
Property and equipment, net     1,349       257  
Grant receivable     1,761       322  
Operating lease right-of-use assets     29       70  
Goodwill     372       372  
Intangible assets, net     231       333  
Other assets     391       123  
Total assets   $ 12,200     $ 16,325  
Liabilities and Stockholders’ Equity            
Current liabilities:            
Accounts payable and accrued expenses   $ 8,210     $ 5,920  
Investor liability pursuant to Letter Agreement     —       4,502  
Convertible note     3,851       —  
Operating lease liability     30       56  
Deferred grant liability     927       927  
Line of credit     —       750  
Other current liabilities     105       159  
Total current liabilities     13,123       12,314  
             
Noncurrent operating lease liability     —       15  
Total liabilities     13,123       12,329  
             
Stockholders’ equity (deficit):            
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 1,952 shares issued and outstanding as of September 30, 2026 and December 31, 2025     —       —  
Common stock, $0.001 par value; 2,000,000,000 shares authorized; 7,890,305 and 5,557,371 shares issued as of September 30, 2026 and December 31, 2025, respectively; 7,879,968 and 5,547,034 shares outstanding as of September 30, 2026 and December 31, 2025, respectively     8       6  
Treasury stock (at cost), 10,337 shares as of September 30, 2026 and December 31, 2025     (500 )     (500 )
Additional paid-in capital     540,043       520,355  
Accumulated deficit     (540,474 )     (515,865 )
Total stockholders’ (deficit) equity     (923 )     3,996  
Total liabilities and stockholders’ equity (deficit)   $ 12,200     $ 16,325  

 
CERENOME, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(in thousands, except share and per share data)
 
 
    Three Months Ended September 30,     Nine Months Ended September 30,  
    2026     2025     2026     2025  
Grant revenue   $ –     $ 1,397     $ 1,439     $ 3,846  
Diagnostic revenue, net     722       —       722       —  
Total revenue     722       1,397       2,161       3,846  
Operating expenses:                        
Cost of revenue     912       —       912       —  
Research and development     2,107       2,436       9,237       5,438  
Selling, general and administrative     5,158       3,443       15,643       7,964  
Total operating expenses     8,177       5,879       25,792       13,402  
Operating loss     (7,455 )     (4,482 )     (23,631 )     (9,556 )
                         
Other income (expense):                        
Interest income     119       59       365       87  
Interest expense     (14 )     —       (36 )     (548 )
Financing expenses     (1,618 )     —       (1,618 )     (3,061 )
Warrant issuance costs     —       —       —       (964 )
Change in fair value of financial instruments     490       —       490       —  
Change in fair value of derivative instruments     —       —       —       (2,631 )
Other expense     (179 )     —       (179 )     —  
Total other income (expense)     (1,202 )     59       (978 )     (7,117 )
Net loss   $ (8,657 )   $ (4,423 )   $ (24,609 )   $ (16,673 )
                         
Per share information                        
Net loss per share of common stock – basic and diluted   $ (1.14 )   $ (1.03 )   $ (3.50 )   $ (7.21 )
Weighted average number of shares of common stock outstanding – basic and diluted     7,566,819       4,297,158       7,040,597       2,313,816  
                         

 
CERENOME, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

(in thousands)
 
    Nine Months Ended September 30,  
    2026     2025  
Cash flows from operating activities:            
Net loss   $ (24,609 )   $ (16,673 )
Adjustments to reconcile net loss to net cash used in operating activities:            
Depreciation and amortization     378       300  
Stock-based compensation expense     2,561       827  
Noncash financing expenses     1,618       3,061  
Noncash interest expense     22       —  
Loss on investments (Note 5)     179       —  
Change in fair value of financial instruments     (490 )     —  
Change in fair value of derivative instruments     —       2,631  
Accretion of discount on short-term investments     (18 )     (19 )
Operating lease right-of-use asset amortization     41       53  
Gain on sale of assets     —       (16 )
Increases (decreases) in cash caused by changes in operating assets and liabilities:            
Grant receivable     (1,439 )     571  
Accounts receivable     (722 )     —  
Other assets     (864 )     64  
Accounts payable and accrued expenses     2,491       (6,308 )
Change in operating lease liabilities     (41 )     (54 )
Other liabilities     (151 )     1,045  
Net cash used in operating activities     (21,044 )     (14,518 )
Cash flows from investing activities:            
Purchases of property and equipment     (1,368 )     (37 )
Proceeds from sale of property and equipment     —       30  
Purchase of intangible assets     —       (7 )
Purchase of short-term investments     (15,085 )     (11,068 )
Sales of short-term investments     10,691       —  
Redemption of short-term investments     4,597       11,305  
Net cash (used in) provided by investing activities     (1,165 )     223  
Cash flows from financing activities:            
Proceeds from convertible note and royalty obligation     3,000       —  
Payments for convertible note and royalty obligation transaction costs     (180 )     —  
Proceeds from credit facility     1,000       —  
Repayment of credit facility     (1,772 )     (3,292 )
Proceeds from issuance of notes payable and warrants     —       3,738  
Repayment of notes payable     —       (3,703 )
Proceeds from sale of common stock, pre-funded warrants and warrants     —       15,927  
Payment of financing costs     —       (2,250 )
Proceeds from sale of common stock under Lincoln Park Purchase Agreement     —       19,612  
Payment to investors pursuant to Letter Agreement     (4,502 )     (2,293 )
Proceeds from underwritten public offering     15,000       —  
Offering costs for sale of common stock     (1,362 )     (231 )
Proceeds from Distribution Agreement     3,337       —  
Payments for commissions and offering costs from Distribution Agreement     (191 )     —  
Net cash provided by financing activities     14,330       27,508  
Net change in cash, restricted cash and cash equivalents     (7,879 )     13,213  
Cash, restricted cash and cash equivalents at beginning of period     8,758       76  
Cash, restricted cash and cash equivalents at end of period   $ 879     $ 13,289  
             
Supplemental disclosure of cash flows information:            
Cash paid for interest   $ —     $ 539  
Supplemental schedule of non-cash investing and financing activities:            
Unpaid liability to investors pursuant to Letter Agreement (Note 13)   $ —     $ 6,391  
Exchange of warrants for notes payable   $ —     $ 3,694  
Redemption of notes by issuance of common stock, pre-funded warrants and warrants   $ —     $ 3,512  
Unpaid offering cost   $ 51     $ 252  



BeyondSpring Reports Third-Quarter 2026 Financial Results and Provides Corporate Update

FDA Fast Track Designation for Plinabulin plus docetaxel marks key regulatory milestone in DUBLIN-4 study population of Post-ICI Non-Squamous NSCLC with no actionable genomic alteration (AGA)

Strategic transaction with Biolin provides data from approximately half of DUBLIN-4’s 442 patients and supports the planned interim analysis at 221 PFS events

FLORHAM PARK, N.J., Nov. 13, 2026 (GLOBE NEWSWIRE) — BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage company developing innovative therapies for the treatment of cancer and other diseases, today announced its financial results for the quarter ended September 30, 2026, and provided a corporate update highlighting regulatory and strategic progress for Plinabulin and its global Phase 3 DUBLIN-4 trial.

“The third quarter marked an important regulatory and strategic step forward for Plinabulin,” said Min Qiu, Chief Executive Officer of BeyondSpring. “The FDA’s Fast Track designation underscores the significant unmet need for new treatment options for NSCLC patients without AGA and progressing after immune checkpoint inhibitor therapy, where docetaxel is still the standard of care.  Plinabulin has been shown to improve the tolerability and dose intensity of docetaxel and demonstrated a long-term survival benefit in the previous successful DUBLIN-3 study in second- and third-line EGFR wild-type NSCLC, published in The Lancet Respiratory Medicine in 2024.”

Mr. Qiu continued, “With an FDA-aligned Phase 3 design and a strategic transaction with Biolin to support approximately half of DUBLIN-4’s planned 442-patient enrollment, generating quality data from China, we remain focused on advancing the study toward its prespecified interim analysis at 221 progression-free survival events. We believe positive interim results could represent a significant value inflection point for BeyondSpring, as we continue to pursue financing and strategic opportunities to support global execution.”

Recent Regulatory, Clinical and Corporate Highlights

FDA Fast Track designation for Plinabulin plus docetaxel in post-ICI non-squamous NSCLC

  • The Company announced that the U.S. Food and Drug Administration granted Fast Track designation to Plinabulin plus docetaxel for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA), following prior anti-PD-(L)1 therapy and platinum-based chemotherapy.
  • The designated population corresponds to the second- or third-line patient population targeted in the global DUBLIN-4 trial. Fast Track designation may facilitate more frequent FDA interactions and, if applicable criteria are met, rolling review of a future application.

Strategic transaction to fund half of DUBLIN-4’s planned patient enrollment

  • The Company completed the sale of BeyondSpring Ltd., its wholly owned subsidiary that indirectly held the majority equity interest in Dalian Wanchunbulin Pharmaceuticals Ltd. (“Bulin”), to Biolin Investment Limited (“Biolin”) on September 30, 2026, pursuant to a definitive agreement among the parties.
  • As non-cash consideration, Biolin will support the funding of DUBLIN-4 clinical development activities conducted by Bulin at participating sites in China, which are expected to include enrollment of approximately 221 patients, or approximately half of the planned 442-patient global enrollment. BeyondSpring will receive access to clinical data generated from the China portion of the trial.

Third Quarter Financial Results

Continuing operations:

  • Research and development (R&D) expenses were $1.1 million for the quarter ended September 30, 2026, compared to $1.0 million for the quarter ended September 30, 2025. The increase of $0.1 million was primarily due to a $0.3 million increase in preclinical expenses related to Plinabulin treatment combination research in support of strategic business development and partnership initiatives, partially offset by lower patent-related legal services and drug manufacturing costs.
  • General and administrative (G&A) expenses were $1.0 million for the quarter ended September 30, 2026, compared to $0.7 million for the quarter ended September 30, 2025. The increase of $0.3 million was primarily due to an increase in legal fees related to financing activities and higher consulting expenses related to accounting advisory and audit services, partially offset by lower personnel-related and travel expenses.
  • Net loss was $2.1 million for the quarter ended September 30, 2026, compared to $1.6 million for the quarter ended September 30, 2025.
  • Cash, cash equivalents, and short-term investments were $0.6 million as of September 30, 2026, compared to $4.0 million as of December 31, 2025.

Year-to-Date Financial Results

Continuing operations:

  • Research and development (R&D) expenses were $3.1 million for the nine months ended September 30, 2026, compared to $2.7 million for the nine months ended September 30, 2025. The increase of $0.4 million was primarily due to expanded drug manufacturing activities and increased preclinical Plinabulin treatment combination research, partially offset by lower patent-related legal services and personnel-related expenses.
  • General and administrative (G&A) expenses were $2.7 million for the nine months ended September 30, 2026, compared to $3.2 million for the nine months ended September 30, 2025. The decrease of $0.5 million was primarily due to lower personnel-related expenses, mainly from lower incentive compensation and share-based compensation, as well as lower professional service expenses in legal advisory and lower travel and entertainment expenses.
  • Net loss was $5.7 million for the nine months ended September 30, 2026, compared to $5.8 million for the nine months ended September 30, 2025.

About BeyondSpring

BeyondSpring (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company developing first-in-class therapies for cancers with high unmet needs. Its lead asset, Plinabulin, has been studied in more than 700 cancer patients and is in late-stage development across multiple cancer indications. Plinabulin’s novel mechanism as a GEF-H1 agonist with dendritic cell maturation benefit supports both anticancer activity and immune modulation, offering a unique approach to resensitizing tumors that have progressed on checkpoint inhibitors. In addition, it has the potential to synergize with chemotherapy, antibody-drug conjugates (ADCs), radiation, and checkpoint inhibitors. BeyondSpring is also an early incubator of and maintains an equity interest in SEED Therapeutics, a clinical-stage targeted protein degradation molecular glue company with investments from Eli Lilly and Eisai. Learn more at beyondspringpharma.com.

About Plinabulin and the Clinical Rationale for the DUBLIN-4 Trial

Plinabulin is a late-stage, first-in-class investigational GEF-H1 agonist with a differentiated mechanism of action that includes dendritic cell maturation, anti-angiogenic activity and mitigation of chemotherapy-induced neutropenia. To date, more than 700 cancer patients have been treated with Plinabulin across multiple clinical programs in various cancer types, demonstrating an extensive clinical safety database.

The post-ICI setting remains difficult to treat: 12 Phase 3 trials evaluating different treatment approaches against docetaxel, including four involving ADCs, have failed to demonstrate an overall survival benefit over docetaxel.

In the Phase 3 DUBLIN-3 trial, published in The Lancet Respiratory Medicine in 2024, Plinabulin combined with docetaxel demonstrated a statistically significant improvement in OS in second- and third-line EGFR wild-type NSCLC vs. docetaxel alone (n=559), showing superior OS benefit in non-squamous patients (n=332, OS HR 0.72, p=0.0078). The combination also demonstrated statistically significant improvements compared to docetaxel alone, including doubling the 2-year and 3-year survival rates and improvements in PFS and ORR, while also significantly reducing grade 4 neutropenia (p<0.0001).

Importantly, a post hoc analysis of the DUBLIN-3 post-ICI subgroup showed a median OS of 15.8 months with Plinabulin plus docetaxel versus 11.7 months with docetaxel alone (HR 0.55), with ORR of 18.2% versus 8.0%, respectively. These findings support the clinical rationale for Plinabulin’s differentiated dendritic cell maturation mechanism and its further evaluation in DUBLIN-4.

This rationale was further supported by prospective data from the Phase 2 Study 303 (n=47), presented at ASCO 2026. In patients with NSCLC whose disease had progressed following PD-1 inhibitor treatment, the combination of Plinabulin, docetaxel and a PD-1 inhibitor demonstrated encouraging anticancer activity. With a median follow-up of 28.8 months, the Plinabulin combination showed a median PFS of 7.0 months, a disease control rate of 79.5%, and a confirmed ORR of 18.2%, with a 2-year OS rate of 58%, nearly double the historical rate reported with docetaxel in a similar patient population.

Investor Contact:
[email protected]

Media Contact:
[email protected]

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge, beliefs, and expectations regarding possible future events and are subject to risks, uncertainties, and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of a number of factors, including, but not limited to, the inability of Biolin and Bulin to perform their respective funding, clinical development, data generation and other obligations; delays or challenges in enrollment or execution of the China portion of DUBLIN-4; regulatory, data-transfer or human-genetic-resources requirements that may affect the transfer or use of China-generated clinical data; the inability of such data to support regulatory submissions outside Greater China; the possibility that the transaction may not achieve the anticipated benefits; the possibility that Fast Track designation may not result in a faster development or regulatory review process, and the fact that such designation does not increase the likelihood of regulatory approval; difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all; unexpected results from preclinical studies or clinical trials; the risk that preclinical results may not be predictive of clinical results; delays in, or failure to obtain, regulatory approvals; results that do not meet the Company’s expectations regarding the safety, efficacy, clinical utility, or regulatory pathway of the Company’s product candidates; increased competition in the market; the Company’s ability to meet Nasdaq’s continued listing requirements; and other risks described in BeyondSpring’s most recent Form 10-K and subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release, and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Financial Tables to Follow

BEYONDSPRING INC.
 
CONDENSED CONSOLIDATED BALANCE SHEETS
 
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
 
  As of  
  December 31,
2025
    September 30,
2026
 
    $       $  
          (Unaudited)  
Assets              
Current assets:              
Cash and cash equivalents   2,967       580  
Short term investments   1,000       –  
Advances to suppliers   105       112  
Prepaid expenses and other current assets   68       592  
Current assets of discontinued operations   16,742       –  
Total current assets   20,882       1,284  
               
Noncurrent assets:              
Property and equipment, net   155       117  
Operating right-of-use assets   278       88  
Long-term equity investment   –       18,373  
Other noncurrent assets   98       –  
Noncurrent assets of discontinued operations   4,520       –  
Total noncurrent assets   5,051       18,578  
               
Total assets   25,933       19,862  
               
Liabilities and equity              
               
Current liabilities:              
Accounts payable   256       743  
Accrued expenses   865       2,381  
Current portion of operating lease liabilities   307       79  
Other current liabilities   770       1,414  
Current liabilities of discontinued operations   11,378       –  
Total current liabilities   13,576       4,617  
               
Noncurrent liabilities:              
Other noncurrent liabilities   90       –  
Noncurrent liabilities of discontinued operations   36,257       –  
Total noncurrent liabilities   36,347       –  
               
Total liabilities   49,923       4,617  
               
               
               
Shareholders’ equity (deficit)              
Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 41,122,320 and 41,409,059 shares issued and outstanding as of December 31, 2025 and September 30, 2026, respectively)   4       4  
Additional paid-in capital   375,664       375,924  
Accumulated deficit   (408,431 )     (360,647 )
Accumulated other comprehensive income (loss)   602       (36 )
               
Total BeyondSpring Inc.’s shareholders’ (deficit) equity   (32,161 )     15,245  
Noncontrolling interests   8,171       –  
Total shareholders’ (deficit) equity   (23,990 )     15,245  
               
Total liabilities and shareholders’ (deficit) equity   25,933       19,862  
               

BEYONDSPRING INC.
 
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
 
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
 
(Unaudited)
 
  Three months ended

September 30,
    Nine months ended

September 30,
 
  2025     2026     2025     2026  
    $       $       $       $  
                               
Revenue   –       –       –       –  
                               
Operating expenses                              
Research and development   (968 )     (1,107 )     (2,667 )     (3,071 )
General and administrative   (672 )     (956 )     (3,188 )     (2,674 )
                               
Loss from operations   (1,640 )     (2,063 )     (5,855 )     (5,745 )
Foreign exchange gain (loss), net   1       (1 )     8       (2 )
Interest income   19       –       63       11  
                               
Loss before income tax   (1,620 )     (2,064 )     (5,784 )     (5,736 )
Income tax expenses   (2 )     –       (2 )     –  
                               
Net loss from continuing operations   (1,622 )     (2,064 )     (5,786 )     (5,736 )
                               
Discontinued operations                              
Loss from discontinued operations   (3,298 )     (1,015 )     (9,557 )     (9,425 )
Gain on sale of subsidiary interests   –       53,674       6,986       53,674  
Income tax expenses   (24 )     (103 )     (66 )     (395 )
Net income (loss) from discontinued operations   (3,322 )     52,556       (2,637 )     43,854  
                               
Net income (loss)   (4,944 )     50,492       (8,423 )     38,118  
Less: Net loss attributable to noncontrolling interests from discontinued operations   (3,404 )     (300 )     (9,554 )     (9,666 )
Net income (loss) attributable to BeyondSpring Inc.   (1,540 )     50,792       1,131       47,784  
                               
Earnings (loss) per share, basic and diluted                              
Continuing operations   (0.04 )     (0.05 )     (0.14 )     (0.14 )
Discontinued operations   0.00       1.29       0.17       1.30  
Basic and diluted earnings (loss) per share   (0.04 )     1.24       0.03       1.16  
                               
Weighted-average shares outstanding                              
Basic and diluted   40,317,266       41,119,820       40,316,639       41,119,820  
                               
Other comprehensive loss, net of tax of nil:                              
Foreign currency translation adjustment loss from continuing operations   –       –       –       –  
Foreign currency translation adjustment loss from discontinued operations   (183 )     (281 )     (711 )     (1,248 )
Comprehensive income (loss)   (5,127 )     50,211       (9,134 )     36,870  
Less: Comprehensive loss attributable to noncontrolling interests from continuing operations   –       –       –       –  
Less: Comprehensive loss attributable to noncontrolling interests from discontinued operations   (3,481 )     (490 )     (9,842 )     (10,276 )
Comprehensive income (loss) attributable to BeyondSpring Inc.   (1,646 )     50,701       708       47,146  
                               



Cheetah Net Supply Chain Service Inc. Announces Third Quarter 2026 Results and Provides Corporate Update

IRVINE, Calif., Nov. 13, 2026 (GLOBE NEWSWIRE) — Cheetah Net Supply Chain Service Inc. (“Cheetah” or the “Company”) (Nasdaq CM: CTNT), a provider of logistics and warehousing services and international trading services, today reported results for the quarter ended September 30, 2026 and provided a corporate update.

For the quarter ended September 30, 2026, the Company reported total revenue of $3,557,805, compared to $361,935 in the same period in 2025, representing an increase of $3,195,870, or 883.0%. The Company recorded an operating loss of $821,890 for the quarter ended September 30, 2026, compared to an operating loss of $1,564,479 in the same period in 2025, representing a decrease of $742,589, or 47.5%. The decrease was primarily due to an increase of $237,229 in gross profit and the absence of an impairment loss of $731,307 recognized in the same period in 2025, partially offset by an increase of $287,851 in general and administrative expenses compared to the same period in 2025. The Company recognized other expenses, net, of $1,726,105 for the quarter ended September 30, 2026, primarily attributable to a $2,783,884 loss resulting from the change in fair value of acquisition-related contingent consideration asset, partially offset by interest income of $398,232 and other income of $666,508. After accounting for an income tax provision of nil, the Company reported a net loss from continuing operations of $2,547,995, compared to net loss from continuing operations of $1,314,650 for the same period in 2025, representing an increase in net loss of $1,233,345, or 93.8%.

Tony Liu, Cheetah’s Chairman and CEO, commented: “The third quarter of 2026 marked an important step forward in the execution of our business diversification strategy. Following the acquisition of Super International Trading Limited in May, our international trading business demonstrated encouraging momentum, generating approximately $3.56 million in revenue during the quarter. This performance reflects the progress we have made in expanding our business platform and developing new sources of revenue.”

“While our logistics and warehousing business continues to face challenges arising from evolving global trade conditions and cross-border customer demand, we remain focused on optimizing our operating structure and allocating resources toward opportunities that we believe offer greater long-term growth potential. We are encouraged by the progress of our international trading business and will continue to focus on strengthening its operations, expanding business opportunities, and improving operational efficiency.”

“Looking ahead, we remain committed to disciplined capital allocation, prudent financial management, and the pursuit of strategic opportunities that complement our existing capabilities. We believe that our continued efforts to diversify our revenue streams and strengthen our operating platform will position the Company for sustainable long-term growth.”

Third Quarter 2026 Financial Results



Continuing operations – logistics and warehousing business

For the three months ended September 30, 2026, the Company reported revenue of $nil from its logistics and warehousing services segment, compared to $361,935 for the same period in 2025. The decrease was primarily due to the disposition of Edward and the expiration of TWEW’s legacy customer service contracts during late 2025 and early 2026, which were not renewed on their original terms. As of the date of this release, TWEW is renegotiating logistics and labor services arrangements with customers that had business relationships with TWEW prior to its acquisition, and letters of intent and draft contracts with certain of these customers are in the process of being executed.

The Company also reported cost of revenue of $nil and $317,757 for the three months ended September 30, 2026 and 2025, respectively, representing a decrease of $317,757, or 100.0%, consistent with the corresponding decline in revenue from Edward and TWEW.

Gross profit for the three months ended September 30, 2026, was $nil, a decrease of $44,178, or 100.0%, from $44,178 for the three months ended September 30, 2025.

General and administrative expenses for the Company’s continuing operations-logistics and warehousing services segment decreased by $90,368, or 84.1%, to $17,068 for the three months ended September 30, 2026 from $107,436 for the three months ended September 30, 2025. The decrease was mainly due to the disposal of Edward in 2026.



Continuing operations – international trading

For the three months ended September 30, 2026, the Company reported revenue of $3,557,805 from its international trading segment, all of which was generated by Super International Trading Limited (“Super International”), which we acquired on May 27, 2026. The increase was primarily due to the expansion of the Company’s international trading business following the acquisition of Super International.

The Company also reported cost of revenue of $3,276,398 and $nil for the three months ended September 30, 2026 and 2025, respectively, representing an increase of $3,276,398, all of which was attributable to Super International, consistent with the corresponding increase in international trading revenue.

Gross profit for the three months ended September 30, 2026 was $281,407, an increase of $281,407, from $nil for the three months ended September 30, 2025.

General and administrative expenses for the Company’s continuing operations – international trading segment increased to $23,349 for the three months ended September 30, 2026 from $nil for the three months ended September 30, 2025. The increase was mainly due to the commencement of the Company’s international trading operations following the acquisition of Super International on May 27, 2026.



Continuing operations – Corporate Unallocated Operating Adjustments

General and administrative expenses for the Company’s continuing operations- corporate unallocated operating adjustments segment increased by $354,870, or 51.1%, to $1,048,697 for the three months ended September 30, 2026 from $693,827 for the three months ended September 30, 2025. The increase was mainly due to travel and entertainment expenses and legal and accounting fees and other general and administrative expenses.

Share-based compensation expenses were $14,183 and $76,087 for the three months ended September 30, 2026 and 2025, respectively, representing a decrease of $61,904, or 81.4%.

Interest income from continuing operations was $398,232 for the three months ended September 30, 2026, compared to $244,776 for the three months ended September 30, 2025, representing an increase of $153,456 or 62.7%. The increase was primarily due to an increase in average outstanding loan balances as the Company made additional loans to third parties, resulting in higher interest income.

Interest expense incurred from our continuing operations was $6,961 for the three months ended September 30, 2026, which decreased by $888, or 11.3%, from $7,849 for the three months ended September 30, 2025, mainly due to the continued amortization of our long-term borrowings and lower credit card and premium finance interest.

Net other income from continuing operations was $666,508 for the three months ended September 30, 2026, compared to $12,902 for the three months ended September 30, 2025, representing an increase of $653,606, or 5,065.9%. The increase was primarily driven by higher foreign exchange gains resulting from currency rate fluctuations.

The Company’s receivable from withdrawal of investment deposit of $41,762,995 as of September 30, 2026, represents RMB 280,000,000 contributed by Naiside to a PRC investment fund in January 2026 and repayable in full by Shanghai Kesheng on or before December 30, 2026. The receivable is denominated in Renminbi and remeasured at each reporting date. For the three months ended September 30, 2026, the Company recognized an unrealized foreign exchange gain of $652,422 on this receivable. Excluding this non-cash gain, the Company’s loss from continuing operations before income taxes of $2,547,995 for the three months ended September 30, 2026 would have been approximately $3,200,417.

Other expense from the change in fair value of acquisition-related contingent consideration asset was $2,783,884 for the three months ended September 30, 2026, compared to $nil for the three months ended September 30, 2025.

As a result of the above factors, the Company had a net loss of $2,547,995 from continuing operations for the three months ended September 30, 2026, compared to a net loss of $1,314,650 for the same period of 2025.

Nine Months 2026 Financial Results



Continuing operations – logistics and warehousing business

For the nine months ended September 30, 2026, the Company reported revenue of $92,700 from its logistics and warehousing services segment, compared to $1,195,860 for the same period in 2025. The decrease was primarily due to the disposition of Edward and the expiration of TWEW’s legacy customer service contracts, as described above.

The Company also reported cost of revenue of $72,833 and $1,060,526 for the nine months ended September 30, 2026 and 2025, respectively, primarily reflecting labor and logistics costs for TWEW and ocean freight service costs incurred by Edward.

Gross profit for the nine months ended September 30, 2026, was $19,867, a decrease of $115,467, or 85.3%, from $135,334 for the nine months ended September 30, 2025.

General and administrative expenses for the Company’s continuing operations-logistics and warehousing services segment decreased by $179,749, or 50.8%, to $173,757 for the nine months ended September 30, 2026 from $353,506 for the nine months ended September 30, 2025. The decrease was mainly due to lower operating and administrative expenses following the disposal of Edward, as well as ongoing cost control initiatives.



Continuing operations – international trading

For the nine months ended September 30, 2026, the Company reported revenue of $4,426,714 from its international trading segment, of which $208,909, or 4.7%, was attributable to Cheetah, and $4,217,805, or 95.3%, was attributable to Super International, which the Company acquired on May 27, 2026. The increase was primarily due to the expansion of the Company’s international trading business following the acquisition of Super International.

The Company also reported cost of revenue of $4,125,807 and $nil for the nine months ended September 30, 2026 and 2025, respectively, representing an increase of $4,125,807 including $199,409 attributable to Cheetah and $3,926,398 attributable to Super International, consistent with the corresponding increase in international trading revenue.

Gross profit for the nine months ended September 30, 2026, was $300,907, an increase of $300,907, from $nil for the nine months ended September 30, 2025.

General and administrative expenses for the Company’s continuing operations-international trading segment increased to $43,433 for the nine months ended September 30, 2026 from $nil for the nine months ended September 30, 2025. The increase was mainly due to the acquisition of Super International.



Continuing operations – Corporate Unallocated Operating Adjustments

General and administrative expenses for the Company’s continuing operations- corporate unallocated operating adjustments segment increased by $275,462, or 12.2%, to $2,529,043 for the nine months ended September 30, 2026 from $2,253,581 for the nine months ended September 30, 2025. The increase was mainly due to an increase in travel and entertainment expenses and other general and administrative expenses.

Share-based compensation expenses were $42,547 and $102,716 for the nine months ended September 30, 2026 and 2025, respectively, representing a decrease of $60,169, or 58.6%.

Interest income from continuing operations was $814,069 for the nine months ended September 30, 2026, compared to $725,094 for the nine months ended September 30, 2025, representing an increase of $88,975 or 12.3%. The increase was primarily due to an increase in average outstanding loan balances as the Company made additional loans to third parties, resulting in higher interest income.

Interest expense incurred from our continuing operations was $21,460 for the nine months ended September 30, 2026, which decreased by $3,261, or 13.2%, from $24,721 for the nine months ended September 30, 2025, mainly due to lower average outstanding balances under long-term borrowings and premium finance arrangements.

Net other income from continuing operations was $1,669,286 for the nine months ended September 30, 2026, compared to $42,658 for the nine months ended September 30, 2025, representing an increase of $1,626,628, or 3,813.2%. The increase was primarily driven by higher foreign exchange gains resulting from currency rate fluctuations.

During the nine months ended September 30, 2026, the Company recognized an unrealized foreign exchange gain of approximately $1,631,708 related to the receivable arising from the withdrawal of the investment deposit. Excluding this non-cash gain, the Company would have incurred a loss from continuing operations before income taxes of approximately $4,719,313 for the nine months ended September 30, 2026.

Other expense from the change in fair value of acquisition-related contingent consideration asset was $2,783,884 for the nine months ended September 30, 2026, compared to $nil for the nine months ended September 30, 2025.

As a result of the above factors, the Company had a net loss of $3,093,215 from continuing operations for the nine months ended September 30, 2026, compared to a net loss of $2,581,087 for the same period of 2025.

Liquidity and Going Concern Considerations

The Company reported a net loss of approximately $3.1 million for the nine months ended September 30, 2026, and net cash used in operating activities of approximately $2.5 million. As the Company continues to integrate its newly acquired international trading business and develop its logistics and warehousing service business, the Company may continue to incur operating losses and generate negative cash flow. These factors were considered in management’s evaluation of the Company’s ability to continue as a going concern, together with the mitigating factors described below.

As of September 30, 2026, the Company had cash and cash equivalents of approximately $14.5 million and a working capital balance of $87.1 million. In addition, the Company had a receivable from withdrawal of investment deposit of $41.8 million and loans receivable from third parties of approximately $29.5 million, which can be sufficient for the Company to support its ongoing business operations and meet the obligations in the future.

Management has evaluated the Company’s ability to continue as a going concern in accordance with ASC 205-40, Presentation of Financial Statements – Going Concern. This evaluation considered the Company’s current financial condition, expected cash flows, obligations due within the next 12 months, and available sources of liquidity.

The Company is working to further improve its liquidity and capital sources primarily by generating cash from operations, pursuing debt financing, and, if needed, seeking financial support from its principal stockholder. If necessary to fully implement its business plan and sustain continued growth, the Company may seek additional equity financing from outside investors. Based on the current operating plan, management believes that the aforementioned measures collectively will provide sufficient liquidity to meet the Company’s liquidity and capital requirements for at least 12 months from the issuance date of its consolidated financial statements.

Forward-Looking Statements

This press release contains certain forward-looking statements, including statements that are predictive in nature. Forward-looking statements are based on the Company’s current expectations and assumptions. The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “anticipate,” “believe,” “continue,” “estimate,” “expect,” “future,” “intend,” “may,” “outlook,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in the Company’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K, under the caption “Risk Factors.”

For more information, please contact:

Cheetah Net Supply Chain Service Inc. 

Investor Relations

(949) 418-7804
[email protected]

CHEETAH NET SUPPLY CHAIN SERVICE INC.

(UNAUDITED) CONSOLIDATED BALANCE SHEETS

    September 30,   December 31,
    2026
  2025*
    (UNAUDITED)   (AUDITED)
ASSETS            
CURRENT ASSETS:            
Cash and cash equivalents   $ 14,464,614     $ 233,217  
Accounts receivable, net     419,529       6,540  
Loan receivable     29,471,513       7,430,111  
Other receivables, net     1,341,520       1,157,130  
Prepaid expenses and other current assets     1,026,988       238,648  
Receivable from withdrawal of investment deposit     41,762,995       —  
TOTAL CURRENT ASSETS     88,487,159       9,065,646  
NONCURRENT ASSETS:            
Property, plant, and equipment, net     303,167       358,868  
Operating lease right-of-use assets     414,992       1,165,517  
Intangibles, net     490,000       792,571  
Goodwill     2,665,654       475,862  
TOTAL NONCURRENT ASSETS     3,873,813       2,792,818  
TOTAL ASSETS   $ 92,360,972     $ 11,858,464  
             
LIABILITIES AND STOCKHOLDERS’ EQUITY            
CURRENT LIABILITIES:            
Accounts payable   $ 419,058     $ 32,762  
Current portion of long-term debt     37,750       35,902  
Loans payable from premium finance     123,516       82,650  
Due to a related party     10,745       5,204  
Operating lease liabilities, current     428,852       594,407  
Accrued liabilities and other current liabilities     343,781       594,693  
TOTAL CURRENT LIABILITIES     1,363,702       1,345,618  
NONCURRENT LIABILITIES:            
Long-term debt, net of current portion     542,618       572,653  
Operating lease liabilities, net of current portion     —       584,606  
TOTAL NONCURRENT LIABILITIES     542,618       1,157,259  
TOTAL LIABILITIES   $ 1,906,320     $ 2,502,877  
             
COMMITMENTS AND CONTINGENCIES     —       —  
             
STOCKHOLDERS’ EQUITY            
Common stock, $0.0001 par value, 2,200,000,000 and 1,000,000,000 shares authorized; 1,333,445 and 115 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively, including: *            
Class A common stock, $0.0001 par value, 2,000,000,000 shares and 891,750,000 shares authorized; 1,332,087 and 91 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively     133       —  
Class B common stock, $0.0001 par value, 200,000,000 shares and 108,250,000 shares authorized; 1,358 and 24 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively     —       —  
Additional paid-in capital     101,878,048       17,685,901  
Accumulated deficit     (11,423,529 )     (8,330,314 )
TOTAL STOCKHOLDERS’ EQUITY     90,454,652       9,355,587  
             
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY   $ 92,360,972     $ 11,858,464  

* Retrospectively restated for effect of the Company’s amended and restated articles of incorporation and bylaws and share reverse splits on April 20, 2026 (1-for-200) and September 21, 2026 (1-for-150).

CHEETAH NET SUPPLY CHAIN SERVICE INC.

(UNAUDITED) CONSOLIDATED STATEMENTS OF OPERATIONS

    For the Three Months Ended September 30,   For the Nine Months Ended September 30,
    2026
  2025*   2026
  2025*
    (Unaudited)   (Unaudited)   (Unaudited)   (Unaudited)
REVENUE   $ 3,557,805     $ 361,935     $ 4,519,414     $ 1,195,860  
                         
COST OF REVENUE     3,276,398       317,757       4,198,640       1,060,526  
                         
GROSS PROFIT     281,407       44,178       320,774       135,334  
                         
OPERATING EXPENSES                        
General and administrative expenses     1,089,114       801,263       2,746,233       2,607,087  
Impairment loss expenses     —       731,307       —       731,307  
Share-based compensation expenses     14,183       76,087       42,547       102,716  
TOTAL OPERATING EXPENSES     1,103,297       1,608,657       2,788,780       3,441,110  
                         
LOSS FROM OPERATIONS     (821,890 )     (1,564,479 )     (2,468,006 )     (3,305,776 )
                         
OTHER INCOME (EXPENSES)                        
Interest income     398,232       244,776       814,069       725,094  
Interest expenses     (6,961 )     (7,849 )     (21,460 )     (24,721 )
Loss on disposal of Edward     —       —       (297,610 )     —  
Other income     666,508       12,900       1,669,286       78,005  
Other expenses     —       2       —       (35,347 )
Other expense change in fair value of acquisition-related contingent consideration asset     (2,783,884 )     —       (2,783,884 )     —  
OTHER INCOME, NET     (1,726,105 )     249,829       (619,599 )     743,031  
                         
INCOME (LOSS) FROM CONTINUING OPERATIONS BEFORE INCOME TAXES     (2,547,995 )     (1,314,650 )     (3,087,605 )     (2,562,745 )
                         
Income tax     —       —       5,610       18,342  
                         
INCOME (LOSS) FROM CONTINUING OPERATIONS     (2,547,995 )     (1,314,650 )     (3,093,215 )     (2,581,087 )
                         
LOSS FROM DISCONTINUED OPERATIONS, NET OF TAX     —       —       —       —  
                         
NET INCOME (LOSS)   $ (2,547,995 )   $ (1,314,650 )   $ (3,093,215 )   $ (2,581,087 )
                         
Earnings (loss) from continuing operations per ordinary share – basic and diluted   $ (11.23 )   $ (12,170.24 )   $ (38.17 )   $ (23,897.33 )
Earnings (loss) from discontinued operations per ordinary share – basic and diluted   $ 0.00     $ 0.00     $ 0.00     $ 0.00  
Earnings (loss) per share – basic and diluted   $ (11.23 )   $ (12,170.24 )   $ (38.17 )   $ (23,897.33 )
Weighted average shares – basic and diluted     226,988       108       81,037       108  

* Certain reclassifications have been made to the financial statements for the period ended September 30, 2025, to conform to the presentation for the period ended September 30, 2026, with no effect on previously reported net income (loss).

CHEETAH NET SUPPLY CHAIN SERVICE INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

    Nine Months Ended September 30,
    2026
  2025
Net cash provided by (used in) operating activities   $ (2,543,247 )   $ 733,780  
Cash used in operations-continuing operations     (2,543,247 )     (1,806,721 )
Cash provided by operations-discontinued operations     —       2,540,501  
Net cash used in investing activities     (67,239,062 )     (2,214,816 )
Cash used in investing activities-continuing operations     (67,239,062 )     (2,214,816 )
Net cash provided by (used in) financing activities     84,022,934       (16,237 )
Cash provided by (used in) financing activities-continuing operations     84,022,934       (16,237 )
Effect of exchange rate fluctuation on cash     (9,228 )     3  
Net increase (decrease) in cash   $ 14,231,397     $ (1,497,270 )



Calidi Biotherapeutics Reports Third Quarter 2026 Financial Results and Recent Business Highlights

 –     Continued to advance the development of CLD-401 towards the clinic

–      Presented new CLD-401 data and in situ TCE platform advances at the ESMO Congress 2026

–      Received $1.2 million gross proceeds from at-the-market registered direct offering

–      Reduced general and administrative expenses by $1.0 million, or 39%, in the third quarter of 2026 versus the same period in the prior year

SAN DIEGO, Nov. 13, 2026 (GLOBE NEWSWIRE) — Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, today reported financial and operating results for the three months ended September 30, 2026, and reviewed recent business highlights.

“Throughout the third quarter, Calidi continued to advance its RedTail platform for systemic and local delivery and redefine the potential of oncolytic viruses and genetic medicine,” said Eric Poma, Ph.D., Calidi Biotherapeutics CEO. “In particular, CLD-401 demonstrated remarkable anti-tumor activity with systemic administration in syngeneic tumor models and continues to progress towards the clinic.”

Third Quarter 2026 and Recent Business Developments

  • Presented two posters at the European Society for Medical Oncology (ESMO) Congress 2026 on October 24, 2026. The presentations showcased new data from the Company’s RedTail platform, a systemically delivered virotherapy platform engineered to selectively target tumors, remodel the tumor microenvironment, and enable high-level expression of therapeutic genetic payloads directly within tumors.
    • Preclinical data on Calidi’s lead program, CLD-401, showed complete tumor eradication in 80% of EMT6 breast cancer tumor-bearing mice versus 0% in the control arm. CLD-401 was engineered for systemic delivery, and new data from an MB49 bladder cancer model show it retains antitumor activity with either systemic intravenous or localized intratumoral administration, supporting flexible delivery approaches across tumor accessibility and disease settings. 
    • Presented preclinical data from Calidi’s in situ T-cell engager (“TCE”) platform, including CLD-501, its TROP-2-targeted candidate, and CLD-502, its EpCAM-targeted candidate.   Following intravenous delivery, the platform generated approximately 10 ng/mL of EpCAM-targeted TCE directly within tumors, and both targeted TCEs demonstrated antigen-dependent, does-responsive T-cell mediated cytotoxicity.
  • Received $1.2 million gross proceeds from an at-the-market registered direct offering that closed on September 18, 2026.
  • Reduced general and administrative expenses by $1.0 million, or 39%, in the third quarter of 2026 versus the same period in the prior year. Reduced general and administrative expenses by $3.6 million, or 42%, in the nine months ended September 30, 2026, versus the same period in the prior year. On November 6, 2026, Calidi executed a restructuring plan, predominantly through a reduction in headcount, that is expected to save $3 million on an annualized basis to extend the Company’s cash runway to reduce costs, extend the Company’s operating runway, and preserve capital while pursuing additional financing. 

Third Quarter 2026 Financial
Results

Calidi reported a $3.6 million net loss attributable to common stockholders for the third quarter of 2026, compared to a net loss attributable to common stockholders of $10.8 million for the third quarter of 2025, which included a $5.7 million non-cash charge for a deemed dividend on warrants.  There was no such charge during the third quarter of 2026.

Research and development expenses were $2.7 million for the third quarter of 2026, compared to $2.4 million for the same quarter in 2025.

General and administrative expenses were $1.6 million for the third quarter of 2026, compared to $2.7 million for the same quarter in 2025.

The Company had $3.9 million in cash and $0.2 million in restricted cash as of September 30, 2026, compared with $5.6 million in cash and $0.2 million in restricted cash as of December 31. 2025.

About Calidi Biotherapeutics

Calidi Biotherapeutics (NYSE American: CLDI) is a biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. The Company’s proprietary RedTail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent genetic medicine(s) to metastatic locations.

CLD-401, the lead candidate from the RedTail platform, currently in IND-enabling studies, targets metastatic non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need. Calidi continues to advance its pipeline utilizing the RedTail platform including its novel approach to incorporate in situ T-cell engagers in solid tumors.

Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com.

Forward-Looking Statements

This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, the Company’s plans strategies, priorities and key operational initiatives for fiscal year 2026 and 2027, including the Company’s plan to dose the first patient in the second half of 2027, statements concerning key milestones, including certain pre-clinical data, planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates; and, with respect to the Company’s fiscal year 2026 and 2027 initiatives, including the timing and ability to open a phase 1 clinical study in the second half of 2027, the risk that actual results may differ materially due to, among other things, the timing, cost and results of research and development activities and preclinical studies; interactions with, and the timing and substance of feedback from, regulatory authorities (including that any preliminary interactions with the FDA may not be indicative of future outcomes or regulatory success); changes in applicable laws or regulations; manufacturing and supply chain matters; the availability of capital and other resources; and changes in business, market, economic or competitive conditions. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s annual report filed with the SEC on Form 10-K on March 27, 2026, as may be amended or supplemented by other reports we file with the SEC from time to time. We disclaim any obligation to update any forward-looking statement to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

Investors Contact:

[email protected] 

Media Contact:

[email protected] 

CALIDI BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value data)
 
  September 30,
2026
    December 31,
2025
 
  (unaudited)        
ASSETS          
Current assets:          
Cash $ 3,947     $ 5,600  
Restricted cash, current   219       100  
Prepaid expenses and other current assets   570       556  
Total current assets   4,736       6,256  
Noncurrent assets:          
Restricted cash, noncurrent   –       119  
Machinery and equipment, net   704       781  
Operating lease right-of-use assets, net   83       1,682  
Other noncurrent assets   –       19  
Total assets $ 5,523     $ 8,857  
           
LIABILITIES AND TOTAL EQUITY          
Current liabilities:          
Accounts payable $ 1,347     $ 595  
Related party accounts payable   –       18  
Accrued expenses and other current liabilities   1,517       1,186  
Related party accrued expenses and other current liabilities   –       530  
Promissory note and accrued interest, current   668       90  
Operating leases, current   53       1,405  
Finance leases, current   141       111  
Total current liabilities   3,726       3,935  
Noncurrent liabilities:          
Operating leases, noncurrent   30       277  
Finance leases, noncurrent   132       171  
Promissory note, noncurrent   –       600  
Warrant liability   4       107  
Related party warrant liability   –       8  
Total liabilities   3,892       5,098  
Total equity   1,631       3,759  
Total liabilities and total equity $ 5,523     $ 8,857  
               

CALIDI BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except par value data)
 
  Three months ended September 30,  
  2026     2025  
Operating expenses:          
Research and development $ 2,703     $ 2,361  
General and administrative   1,642       2,687  
Total operating expenses   4,345       5,048  
Loss from operations   (4,345 )     (5,048 )
Other income (expense), net:          
Interest expense   (29 )     (31 )
Interest expense – related party   (8 )     (10 )
Change in fair value of other liabilities and derivatives   59       (93 )
Change in fair value of other liabilities and derivatives – related party   5       (7 )
Other income, net   681       18  
Total other income (expense), net   708       (123 )
Loss before income taxes   (3,637 )     (5,171 )
Provision for income taxes   (9 )     (10 )
Net loss   (3,646 )     (5,181 )
Net loss attributable to noncontrolling interest   –       (32 )
Net loss attributable to controlling interest   (3,646 )     (5,149 )
Deemed dividend on warrants   –       (5,673 )
Net loss attributable to common stockholders $ (3,646 )   $ (10,822 )
Net loss per share – basic and diluted $ (1.47 )   $ (35.25 )
Weighted average shares outstanding – basic and diluted   2,476       307  



ArrowMark Financial Corp. Announces Monthly Cash Distribution of $0.15 per Share for November 2026

DENVER, Nov. 13, 2026 (GLOBE NEWSWIRE) — ArrowMark Financial Corp. (Nasdaq: BANX) (“ArrowMark Financial” or the “Company”), an SEC registered closed-end management investment company, today announced that its Board of Directors has declared a monthly cash distribution of $0.15 per share for November 2026. The total distribution of $0.15 per share will be payable on November 30, 2026, to shareholders of record on November 23, 2026.

About ArrowMark Financial Corp.

ArrowMark Financial Corp. is an SEC registered non-diversified, closed-end fund listed on the NASDAQ Global Select Market under the symbol “BANX.” Its investment objective is to provide shareholders with current income. The Fund pursues its objective by investing primarily in regulatory capital securities of financial institutions. ArrowMark Financial is managed by ArrowMark Asset Management, LLC. To learn more, visit ir.arrowmarkfinancialcorp.com or contact the Fund’s secondary market service agent at 877-855-3434.

Disclaimer and Risk Factors:

There is no assurance that ArrowMark Financial will achieve its investment objective. ArrowMark Financial is subject to numerous risks, including investment and market risks, management risk, income and interest rate risks, banking industry risks, preferred stock risk, convertible securities risk, debt securities risk, liquidity risk, valuation risk, leverage risk, non-diversification risk, credit and counterparty risks, market at a discount from net asset value risk and market disruption risk. Shares of closed-end investment companies may trade above (a premium) or below (a discount) their net asset value. Shares of ArrowMark Financial may not be appropriate for all investors. Investors should review and consider carefully ArrowMark Financial’s investment objective, risks, charges and expenses. Past performance does not guarantee future results.

The Annual Report, Semi-Annual Report and other regulatory filings of the Fund with the SEC are accessible on the SEC’s website at www.sec.gov and on the Fund’s website at ir.arrowmarkfinancialcorp.com.

Contact:

[email protected] 

Destra Capital Advisors LLC (877) 855-3434
Destra Capital Advisors LLC provides secondary market services for the Fund by agreement.



Liberty Defense Clarifies Previously Announced Credit Facility and Term Loan

WILMINGTON, Mass., Nov. 13, 2026 (GLOBE NEWSWIRE) — Liberty Defense Holdings Ltd. (“Liberty” or the “Company”) (NASDAQ: DETX; TSXV: SCAN), a leading provider of AI-based next-generation detection solutions for concealed weapons and threats, issues this clarifying news release requested by the TSX Venture Exchange (the “TSXV”) regarding a credit facility and term loan entered into by the Company with PFF, LLC (“Parabilis”) previously announced on August 22, 2024.

The Company’s wholly-owned subsidiary Liberty Defense Technologies Inc. (the “Subsidiary”) and Parabilis entered into a Loan and Security Agreement dated August 19, 2024, as amended March 15, 2025, July 15, 2025, August 14, 2025 and September 1, 2025, pursuant to which Parabilis provided the Subsidiary with a US$1.8 million term loan (the “Term Loan”) and a US$2.5 million revolving credit facility (the “Credit Facility”) secured by substantially all of the Subsidiary’s assets, with the obligations of the Subsidiary unconditionally guaranteed by the Company. The Credit Facility and Term Loan were established to provide the Company with additional working capital flexibility.

The Credit Facility bears interest at 14.99% per annum and the Term Loan bears interest at 17.99% per annum payable monthly in arrears. The Term Loan had a term of 104 weeks and was scheduled to mature on August 15, 2026. The Credit Facility originally had a maturity date of August 31, 2025, with an option to extend at Parabilis’ sole discretion. On September 1, 2025, the parties amended the Credit Facility by extending the maturity date to May 31, 2026, with automatic one-year renewals unless Parabilis provides 90-days’ notice and the Company agreeing to pay a 0.083% monthly commitment fee. On August 14, 2025, the Term Loan was amended to provide for additional advances which contemplated total principal advances of approximately US$2.9 million, but only US$650,000 in additional advances were funded, resulting in total funded principal advances of US$2.45 million to the Subsidiary.

The borrowing base for the Credit Facility is determined based on the following percentages: 90% of eligible billed receivables, 65% of eligible unbilled receivables, and 30% of eligible delivery orders. The aggregate of eligible billed and unbilled receivables, along with eligible delivery orders, establishes the Subsidiary’s borrowing capacity under the Credit Facility. When invoicing occurs, payments on the invoices are applied directly to the outstanding principal and interest on the Credit Facility. As of the date of this press release US$Nil is outstanding under the Credit Facility and all principal and accrued interest under the Term Loan have been fully repaid and there is no outstanding balance under the Term Loan.

About Liberty Defense

Liberty Defense (NASDAQ: DETX; TSXV: SCAN) provides multi-technology security solutions for concealed weapons detection in high volume foot traffic areas and locations requiring enhanced security such as airports, stadiums, schools, and more. Liberty’s HEXWAVE product, for which the Company has secured an exclusive license from Massachusetts Institute of Technology (MIT), as well as a technology transfer agreement for patents related to active 3D radar imaging technology, provides discrete, modular, and scalable protection to provide layered, stand-off detection capability of metallic and non-metallic weapons. Liberty has also recently licensed the millimeter wave-based, High-Definition Advanced Imaging Technology (HD-AIT) body scanner and shoe scanner technologies as part of its technology portfolio. Liberty is committed to protecting communities and preserving peace of mind through superior security detection solutions.

For updates and news, please visit the Company website to subscribe to email alerts or follow Liberty Defense on social channels.

FORWARD-LOOKING STATEMENTS
When used in this press release, the words “estimate”, “project”, “belief”, “anticipate”, “intend”, “expect”, “plan”, “predict”, “may” or “should” and the negative of these words or such variations thereon or comparable terminology are intended to identify forward-looking statements and information. Although Liberty believes, in light of the experience of its officers and directors, current conditions and expected future developments and other factors that have been considered appropriate, that the expectations reflected in the forward-looking statements and information in this press release are reasonable, undue reliance should not be placed on them because Liberty can give no assurance that such statements will prove to be correct. Such statements and information reflect the current view of Liberty.

By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. There are a number of important factors that could cause Liberty’s actual results to differ materially from those indicated or implied by forward-looking statements and information, including those appearing in Liberty’s public filings. Such factors include, among others: currency fluctuations; limited business history of Liberty; disruptions or changes in the credit or security markets; results of operation activities and development of projects; project cost overruns or unanticipated costs and expenses; general development, market and industry conditions; and other factors described in Liberty’s public filings. Liberty undertakes no obligation to comment on analyses, expectations or statements made by third parties in respect of its securities or its respective financial or operating results (as applicable).

Liberty cautions that the foregoing list of material factors is not exhaustive. When relying on Liberty’s forward-looking statements and information to make decisions, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Liberty has assumed that the material factors referred to in the previous paragraph will not cause such forward-looking statements and information to differ materially from actual results or events. However, the list of these factors is not exhaustive and is subject to change and there can be no assurance that such assumptions will reflect the actual outcome of such items or factors. The forward-looking information contained in this press release represents the expectations of Liberty as of the date of this press release and, accordingly, are subject to change after such date. Liberty does not undertake to update this information at any particular time except as required in accordance with applicable laws.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.



Investor Relations:

For further information about Liberty Defense, please contact:

Kevin O’Dowd
Investor Relations
617-755-4602
[email protected]

For sales information, please contact:

Ian McNaughton
Senior Director Business Development, Liberty Defense
613-292-3669
[email protected]

Datavault AI Receives Notice of Nasdaq Trading Suspension; Common Stock Eligible to Trade on OTC Markets

Datavault AI Receives Notice of Nasdaq Trading Suspension; Common Stock Eligible to Trade on OTC Markets

PHILADELPHIA–(BUSINESS WIRE)–Datavault AI Inc. (“Datavault” or the “Company”) (OTC: DVLT), today announced that the Company expects its common stock will be eligible to trade on the over-the-counter market (“OTC Markets”) effective with the open of the market on November 17, 2026. The move to OTC Markets follows Nasdaq’s decision to suspend trading in the Company’s common stock effective November 17, 2026, due to the Company’s non-compliance with Nasdaq’s $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) and the “low stock price” rule set forth in Nasdaq Listing Rule 5810(c)(3)(A)(iii), which requires a suspension of Nasdaq trading for an issuer that evidences a closing bid price of less than $0.10 per share for ten consecutive business days.

The Company intends to request a hearing before the Nasdaq Hearings Panel to maintain its Nasdaq listing. At the hearing, the Company will present its plan to evidence compliance with the bid price requirement and to request an extension of time to do so and the reinitiation of trading and continued listing of the Company’s securities on Nasdaq as a result thereof.

About Datavault AI

Datavault AI Inc. verifies, values and tokenizes data and real-world assets for organizations and people. Its exchanges bring those assets to market. Through its media, acoustic and live-event technologies and services, the Company powers how organizations reach and engage customers across business and consumer channels. Its technologies are protected by a portfolio of issued patents, which the Company makes available through licensing. Learn more at www.dvlt.ai.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to, among other things, the Company’s ability to list its common stock on a national exchange and the successful execution of the Company’s business strategy. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Such risks and uncertainties include, among other things, the timing of regulatory processes, the ability to appeal, the actions of third parties, and management of growth and other risks and uncertainties that may be detailed from time to time in the Company’s reports filed with the SEC. There can be no assurance that a broker will continue to make a market in the Company’s common stock or that trading of the common stock will continue on an over-the-counter market or elsewhere. There can be no assurance that a favorable decision from the Panel will be obtained. Should one or more of these risks or uncertainties materialize, or should assumptions underlying forward-looking statements prove incorrect, actual results may differ materially from those described in this press release as intended, planned, anticipated, believed, estimated, or expected. Any forward-looking statement made by us in this press release is based on information currently available to us and speaks only as of the date on which it is made. Except to the extent required by law, we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, a change in events, conditions, circumstances, or assumptions underlying such statements, or otherwise.

Media and investor contacts

Datavault
Edward Barger, VP, Investor Relations
[email protected]

Media Contact: [email protected]

KEYWORDS: United States North America Pennsylvania

INDUSTRY KEYWORDS: Technology Finance Security Fintech Banking Professional Services Networks Internet Data Management Cryptocurrency

MEDIA:

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