On September 8, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported clinical updates and financial results for H1 2026.

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Advances in Clinical Programs

Pancreatic Cancer
Phase 2a study evaluating Namodenoson in patients with advanced pancreatic ductal adenocarcinoma achieved its primary safety endpoint and demonstrated durable overall survival outcomes. The open-label Phase IIa study enrolled 20 patients with advanced pancreatic ductal adenocarcinoma who had progressed following standard therapies. Fourteen patients received Namodenoson as third-line treatment, five as second-line treatment, and one as fourth-line treatment. Namodenoson was well tolerated. Overall survival findings identify a subset of heavily pretreated pancreatic cancer patients achieving prolonged survival despite receiving Namodenoson as third-line therapy. A Phase IIb study protocol which combines chemotherapy and Namodenoson is under development. An abstract highlighting the positive results has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026.

Hepatocellular Carcinoma (HCC)
Blinded overall survival observed across the entire patient population in the Company’s ongoing pivotal Phase III study of Namodenoson in advanced hepatocellular carcinoma (HCC) appears longer than originally anticipated based on the assumptions underlying the study design.

In view of the longer-than-anticipated survival observed in the study population, Can-Fite is evaluating an earlier timing for the study’s planned interim analysis.

Clinical Progress in Psoriasis
The Company completed enrolment of the first 247 patients in its pivotal Phase 3 study evaluating Piclidenoson for the treatment of moderate-to-severe plaque psoriasis. The study has now reached the pre-specified interim analysis stage under a protocol agreed with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The interim analysis will evaluate efficacy and safety data from the enrolled patients. Results are expected during Q1 2027.

Strengthening of Intellectual Property Portfolio
Can-Fite continued to expand its global intellectual property estate with multiple patent allowances across key territories, including Israel, Canada, Brazil, Australia and Japan, covering novel therapeutic uses of Namodenoson and Piclidenoson. These additions further strengthen the Company’s long-term commercial positioning and pipeline value.

Motti Farbstein Can-Fite’s CEO&CFO stated: "The first half of 2026 was marked by meaningful progress across our clinical programs. We are particularly encouraged by the longer-than-anticipated overall survival observed to date in our ongoing pivotal Phase III liver cancer study, while recognizing that the study remains blinded. In parallel, the durable survival outcomes observed in heavily pretreated pancreatic cancer patients and the advancement of our pivotal psoriasis study to its interim analysis stage further strengthen our clinical pipeline. We remain focused on disciplined execution of these late-stage programs and on advancing Namodenoson and Piclidenoson toward important clinical and regulatory milestones."

Financial Results

Revenues

Revenues for the six months ended June 30, 2026 were $0.20 million compared to $0.20 million for the six months ended June 30, 2025. Revenues for the six months ended June 30, 2026 and for the six months ended June 30, 2026 comprise of a portion of advance payments received under our existing out-licensing agreements with Cipher, CKD Gebro and Ewopharma.

Research and development expenses

Research and development expenses for the six months ended June 30, 2026 were $3.45 million, an increase of $0.42 million, or 13.86%, compared to $3.03 million for the six months ended June 30, 2025. Research and development expenses for the first half of 2026 comprised primarily of expenses associated with the ongoing of the Phase 3 study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for MASH. The increase is primarily due to acceleration in expenses associated with both the Namodenoson and Piclidenoson programs.

General and administrative expenses

General and administrative expenses for the six months ended June 30, 2026 were $1.42 million, a decrease of $0.65 million, or 31.40%, compared to $2.07 million for the six months ended June 30, 2025. The decrease is primarily due to lower investors relations expenses. We expect that general and administrative expenses will remain at the same level through 2026.

Financial income, net

Financial income, net for the six months ended June 30, 2026 was $0.08 million compared to $0.02 million for the six months ended June 30, 2025. The increase in financial income, net was mainly due to higher interest income from bank deposits.

Net loss for the six months period ended June 30, 2026 was $4.60 million compared with a net loss of $4.87 million for the six months period ended June 30, 2025 . The decrease in net loss for the six months period ended June 30, 2026 was primarily attributable to a decrease in general and administrative expenses which was offset by an increase in research and development expenses .

As of June 30, 2026, Can-Fite had cash and cash equivalents and short term deposits of $7.03 million as compared to $8.53 million at December 31, 2025. The decrease in cash during the six months period ended June 30, 2026 is mainly due to the Company’s operating loss which was offset by proceeds from issuance of shares and warrants. During September 2026, the Company received aggregate gross proceeds of approximately $4.0 million from warrant exercises and a warrant inducement.

The Company’s consolidated financial results for the six months period ended June 30, 2026 are presented in accordance with US GAAP Reporting Standards.

CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except for share and per share data)
June 30, December 31,
2026 2025
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 2,985 $ 5,528
Short term deposits 4,052 3,011
Prepaid expenses and other current assets 960 900
Short-term investment 6 1
Total current assets 8,003 9,440
NON-CURRENT ASSETS:
Operating lease right of use assets 47 69
Property, plant and equipment, net 5 5
Total non-current assets 52 74
Total assets $ 8,055 $ 9,514

CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except for share and per share data)
June 30, December 31,
2026 2025
Unaudited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables $ 681 $ 1,161
Current maturity of operating lease liability 48 56
Deferred revenues 405 405
Other accounts payable 1,091 1,109
Total current liabilities 2,225 2,731
NON-CURRENT LIABILITIES:
Long – term operating lease liability 1 15
Deferred revenues 974 1,176
Total long-term liabilities 975 1,191
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of no-par value – Authorized: 30,000,000 and 14,000,000 shares at June 30, 2026 and December 31, 2025, respectively; Issued and outstanding: 4,285,093 and 2,618,425 shares as of June 30, 2026 and December 31, 2025, respectively - -
Additional paid-in capital 184,518 180,654
Accumulated other comprehensive income 1,127 1,127
Accumulated deficit (180,790 ) (176,189 )
Total shareholders’ equity 4,855 5,592
Total liabilities and shareholders’ equity $ 8,055 $ 9,514

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except for share and per share data)
Six months ended
June 30,
2026 2025
Unaudited
Revenues $ 202 $ 202
Research and development expenses (3,456 ) (3,034 )
General and administrative expenses (1,426 ) (2,066 )
Operating loss (4,680 ) (4,898 )
Financial income, net 79 22
Operating loss (4,601 ) (4,876 )
Basic and diluted net loss per share (1.24 ) (4.29 )
Weighted average number of ordinary shares used in computing basic and diluted net loss per share 3,711,018 1,137,303

(Press release, Can-Fite BioPharma, SEP 8, 2026, View Source [SID1234670619])

On September 8, 2026 BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), an AI company using three complementary capabilities to turn complex biomedical data into actionable insights, reported its participation in the following upcoming investor conferences.

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iAccess Alpha Virtual Best Ideas Fall Investment Conference, being held September 15 & 16, 2026. BullFrog AI’s CEO Vin Singh will deliver a presentation at 2:00 PM ET on September 15th, available at this link. This will be followed by one-on-one meetings with institutional investors on September 16th.

Water Tower Research Insights Conference, being held virtually September 22 & 23, 2026. James Kisner, Managing Director at Water Tower Research, will lead a fireside chat with BullFrog AI’s CEO Vin Singh at 1:00 PM ET on September 23rd. Investors and interested parties can access the fireside chat event by registering here.

A live webcast of these presentations can be accessed via the Investors section of BullFrog AI’s website at View Source A replay of both webcasts will be archived under the Company’s News & Events page following the events.

For more information about the iAccess Alpha Virtual Best Ideas Fall Investment Conference 2026, or to register and schedule a one-on-one meeting with Bullfrog AI, please visit the conference website at: View Source

For more information about the Water Tower Research Insights Conference and to access registration, please visit: View Source;tp_key=bfed48f4a8.

On September 8, 2026 Bristol Myers Squibb (NYSE: BMY) reported positive Phase 2 results from the registrational QUINTESSENTIAL trial (NCT06297226) of arlocabtagene autoleucel (arlo-cel; BMS-986393) in adult patients with quadruple-class exposed relapsed and refractory multiple myeloma (RRMM). Arlo-cel is a potential first-in-class autologous G protein-coupled receptor class C group 5 member D (GPRC5D)-directed CAR T cell therapy. As a CAR T cell therapy designed to be administered as a single infusion,* arlo-cel potentially represents a differentiated approach for patients with heavily pretreated relapsed and refractory multiple myeloma.

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Results show the study met its primary endpoint with arlo-cel demonstrating a statistically significant and clinically meaningful overall response rate (ORR) in patients with quadruple-class exposed RRMM who had received four or more prior lines of therapy. Quadruple-class exposed consists of those who had been treated with an immunomodulatory inhibitor (IMiD), a proteasome inhibitor (PI), an anti-CD38 therapy and a BCMA-targeted therapy.

The study also met the key secondary endpoint of complete response rate (CRR) in patients with RRMM who had been quadruple-class exposed after four or more prior lines of therapy, and the key secondary endpoints of ORR and CRR after three or more prior lines of therapy. The safety profile of arlo-cel was consistent with that of other CAR T cell therapies and other GPRC5D-targeting therapies in multiple myeloma.

"As combination treatment regimens are now frequently used in earlier lines of therapy, an increasing number of people with multiple myeloma are quadruple-class exposed and resistant to currently available therapies earlier in the treatment journey, creating a critical need for new therapeutic approaches," said Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb. "These topline results support arlo-cel’s potential benefit for patients while showing a safety profile consistent with expectations. They underscore our continued innovation in multiple myeloma and highlight the value of targeting alternative proteins, like GPRC5D, with the power of cell therapy to transform outcomes, laying the foundation for arlo-cel to become an important treatment option for this emerging group of patients who have been exposed to prior BCMA-targeted therapies."

Bristol Myers Squibb thanks the patients and investigators who are participating in the QUINTESSENTIAL clinical trial. Results from QUINTESSENTIAL will be presented at an upcoming medical meeting.

* The treatment process includes collection of T cells from the patient’s blood followed by bridging therapy, CAR T cell manufacturing, lymphodepleting chemotherapy and then arlo-cel administration and side-effect monitoring.

About QUINTESSENTIAL
QUINTESSENTIAL (NCT06297226) is a Phase 2, open-label, multicenter, single-arm study evaluating the efficacy and safety of arlocabtagene autoleucel (arlo-cel; BMS986393) in patients with quadruple-class exposed relapsed and refractory multiple myeloma (RRMM). Quadruple-class exposed consists of those who have been treated with an immunomodulatory inhibitor (IMiD), a proteasome inhibitor (PI), an anti-CD38 therapy and a BCMA-targeted therapy. The trial included patients who had received prior treatment with CAR T cell therapies.

The primary endpoint of the study is overall response rate (ORR), defined as best overall response (BOR) of partial response (PR) or better in quadruple-class exposed patients who had received four or more prior lines of therapy. Key secondary endpoints include complete response rate (CRR) in patients with RRMM who had been quadruple-class exposed after four or more prior lines of therapy, and ORR and CRR in quadruple-class exposed patients who had received three or more prior lines of therapy.

About Arlocabtagene Autoleucel
Arlocabtagene autoleucel (arlo-cel; BMS-986393) is a potential first-in-class autologous G protein-coupled receptor class C group 5 member D (GPRC5D)-directed chimeric antigen receptor (CAR) T cell therapy. GPRC5D is a receptor expressed on plasma cells in multiple myeloma, with limited expression on healthy cells, and is a validated therapeutic target in multiple myeloma. Its expression is independent of BCMA expression and is maintained even after prior BCMA-directed therapy. Arlo-cel is designed to recognize and bind to GPRC5D in order to target and eliminate GPRC5D-expressing myeloma cells.

(Press release, Bristol-Myers Squibb, SEP 8, 2026, View Source;-/default.aspx [SID1234670617])

On September 8, 2026 Astrazeneca reported positive high-level results from a planned interim analysis of the DeLLphi-305 Phase III trial showed Imfinzi (durvalumab) plus Amgen’s Imdelltra (tarlatamab) demonstrated a statistically significant and highly clinically meaningful improvement in overall survival (OS) versus Imfinzi alone as a 1st-line maintenance treatment. The trial included patients with extensive-stage small cell lung cancer (ES-SCLC) who had not progressed following standard induction treatment with Imfinzi in combination with platinum chemotherapy (investigator’s choice of carboplatin or cisplatin) and etoposide.

Imfinzi plus tarlatamab also demonstrated a statistically significant and clinically meaningful improvement in the secondary endpoints of progression-free survival (PFS) and objective response rate.

In 2026, an estimated 195,000 people globally will be treated for ES-SCLC, a highly aggressive, fast-growing form of lung cancer characterised by rapid tumour progression and metastatic spread to organs such as the brain and liver.1,2 Immune checkpoint inhibitors such as Imfinzi have led to significant improvements in OS in ES-SCLC, establishing a 1st-line standard of care. However, many patients still experience disease progression due to the aggressive nature of the disease and median OS with the current standard of care is approximately one year.3

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "These results show that Imfinzi-based induction therapy followed by maintenance treatment with Imfinzi plus tarlatamab demonstrates an unprecedented improvement in overall survival for patients with this highly aggressive form of lung cancer. Imfinzi continues to reshape how lung cancer is treated, establishing new standards of care across multiple settings, and these new findings further underscore its role as the backbone immunotherapy of choice for small cell lung cancer."

Jacob Sands, MD, Associate Chief of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, said: "Given the aggressive nature of small cell lung cancer, many patients quickly relapse on current therapy and never reach second-line treatment. These patients do not have time to wait, making substantial progress in the first-line setting critically important. In my career treating people with extensive-stage small cell lung cancer, these are among the most compelling survival results I have seen, indicating the potential to reshape the natural history of small cell lung cancer. DeLLphi-305 represents an unprecedented milestone and suggests we may be entering a new era where meaningfully longer survival is possible for more patients."

Overall, the safety and tolerability profile of Imfinzi plus tarlatamab was consistent with the known safety profiles of the individual treatments, with no new safety signals identified. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

Imfinzi is approved in the US, EU, Japan, China and many other countries around the world as the standard-of-care treatment for ES-SCLC and limited-stage SCLC (LS-SCLC) based on the CASPIAN and ADRIATIC Phase III trials, respectively.

Notes

Small cell lung cancer
Lung cancer is the leading cause of cancer death globally, accounting for almost one in five (19%) cancer deaths.4,5 Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and SCLC, with about 15% classified as SCLC.6 About two-thirds of SCLC patients are diagnosed with ES-SCLC, in which the cancer has spread widely through the lung or to other parts of the body.3 While survival rates have improved in recent years following the introduction of immune checkpoint inhibitors, prognosis is still poor, with only 18.1% of LS-SCLC patients and 3.6% of ES-SCLC patients alive five years after diagnosis.2

DeLLphi-305
The DeLLphi-305 trial is sponsored by Amgen, with partial funding and Imfinzi provided by AstraZeneca. It is a global Phase III, randomised, open-label clinical trial evaluating the efficacy and safety of Imfinzi in combination with tarlatamab compared to Imfinzi alone as 1st-line maintenance treatment for patients with ES-SCLC who have not progressed following induction treatment with Imfinzi in combination with platinum chemotherapy and etoposide.

Tarlatamab is a first-in-class targeted immunotherapy that binds to both DLL3 on tumour cells and CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells. DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells.

In the trial, 563 patients who completed Imfinzi-based induction treatment were randomised 1:1 to receive either Imfinzi in combination with tarlatamab or Imfinzi alone until progression or unacceptable toxicity. Following tarlatamab infusion on Cycle 1 Day 1 and Cycle 1 Day 8, patients were monitored in a healthcare setting for 1 to 2 hours (6 to 8 hours in certain regions including Europe). The trial included patients with both treated and untreated asymptomatic brain metastases at baseline.

The primary endpoint is OS for Imfinzi plus tarlatamab versus Imfinzi alone. PFS is a key secondary endpoint.

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

In addition to its indications in SCLC, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III 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) and chemotherapy for the treatment of metastatic NSCLC.

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 and the EU. Additionally, in April 2026, Imfinzi in combination with Imjudo, lenvatinib and transarterial chemoembolisation (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS versus TACE alone for patients with unresectable HCC eligible for embolisation in the EMERALD-3 Phase III trial.

Perioperative Imfinzi in combination with neoadjuvant chemotherapy is approved for cisplatin-eligible muscle-invasive bladder cancer (MIBC). Imfinzi in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy is approved in the US and other countries for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer. In May 2026, positive high-level results from the VOLGA Phase III trial showed that perioperative treatment with Imfinzi in combination with neoadjuvant enfortumab vedotin (EV) demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and OS in patients with MIBC who were ineligible for or had declined cisplatin-based chemotherapy. In addition, perioperative Imfinzi plus Imjudo in combination with neoadjuvant EV demonstrated a statistically significant and clinically meaningful improvement in EFS and a favourable trend for OS; however, the OS data were not statistically significant at this planned interim analysis and will be formally reassessed at a subsequent analysis. 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.

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

Since the first approval in May 2017, more than 470,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers.

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(Press release, AstraZeneca, SEP 8, 2026, View Source [SID1234670616])

On September 8, 2026 Alpha-9 Oncology, a clinical-stage radiotherapeutic company developing targeted cancer treatments, reported the dosing of the first 225Ac patient in its Phase 1 study evaluating 225Ac–A9-0642 and 177Lu-A9-0631, Alpha-9’s alpha and beta-emitting radiotherapeutic programs targeting gastrin-releasing peptide receptor (GRPR). GRPR is a solid tumor target with broad clinical potential in breast and other solid tumors.

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"Dosing the first patient in our Phase 1 GRPR trial represents a significant milestone in Alpha-9’s journey as we seek to deliver the next wave of radiotherapeutic breakthroughs," said Paul Blanchfield, Chief Executive Officer of Alpha-9. "We believe our holistically optimized, distinct GRPR compounds have the potential to provide meaningful benefit to those living with cancer. Running both 225Ac and 177Lu programs in parallel allows us to efficiently generate data and validate our modular optimization platform."

GRPR is an ideal radiotherapeutic target given its high expression across breast cancer and other solid tumors with high unmet need, and favorable expression profile in healthy organs. Imaging studies have shown the ability to effectively target GRPR-expressing tumors.

The Phase 1 study is designed to assess the safety, tolerability, dosimetry, and recommended dose for expansion of 225Ac-A9-0642 and 177Lu-A9-0631 in patients with GRPR-positive advanced or metastatic tumors. Alpha-9 will utilize its proprietary GRPR imaging compound, 68Ga-A9-6217, for patient selection. Data is expected in late 2027.

"Diagnostic imaging data generated with 68Ga-A9-6217 demonstrated excellent tumor targeting and limited healthy organ uptake," said Dr. Robert S. Meehan, Chief Medical Officer of Alpha-9. "Additionally, early results from access under compassionate use showed that 177Lu-A9-0631 was well tolerated in individuals with GRPR-positive tumors and we look forward to generating additional data for both our alpha- and beta-emitting compounds."

(Press release, Alpha9 Oncology, SEP 8, 2026, View Source [SID1234670615])