On November 19, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF) and Hanmi Pharmaceutical Co. Ltd. ("Hanmi") reported that Aptose, Hanmi and HS North America Ltd., a wholly owned subsidiary of Hanmi ("Hanmi Purchaser" and together with Hanmi, the "Hanmi Purchasers"), have entered into a definitive arrangement agreement (the "Arrangement Agreement") pursuant to which Hanmi Purchaser will acquire all of the issued and outstanding common shares of Aptose ("Common Shares") that are not currently owned or controlled by the Hanmi Purchasers or their respective affiliates.

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Hanmi has participated in multiple financings of Aptose and owns 19.93% of all outstanding Common Shares. During the past 18 months, Hanmi has singularly supported Aptose and the continued development of tuspetinib (TUS) through debt facilities to Aptose totaling more than US$30 million. Under the terms of the Arrangement Agreement, upon the completion of the transactions contemplated under the Arrangement Agreement, Aptose shareholders, other than the Hanmi Purchasers and their respective affiliates that hold any Common Shares, will receive C$2.41 in cash per Common Share, which represents a premium of 28% over Aptose’s 30-day VWAP of C$1.88 on the Toronto Stock Exchange (TSX).

"We are very pleased to have reached an agreement on a transaction with Hanmi," stated William G. Rice, Ph.D., Chairman, President, and Chief Executive Officer of Aptose. "This transaction not only offers a premium value for our minority shareholders but also enables Aptose to continue the development of TUS combined with standard treatment venetoclax plus azacitidine (VEN+AZA) for acute myeloid leukemia (AML) in the TUSCANY Phase 1/2 clinical study. The TUS+VEN+AZA triplet therapy has shown promising response rates and safety in a diverse population of patients newly diagnosed with AML. We are extremely grateful for Hanmi’s ongoing support as we work toward our long-term goal of improving patient outcomes in AML."

"We are very pleased to have reached this agreement with Aptose," said Jae-Hyun Park of Hanmi. "With a growing body of positive data, it is important to support the uninterrupted and expanded development of tuspetinib in the TUSCANY clinical study. This step also marks Hanmi’s first beachhead and direct entry into North America, establishing a strategic foothold for future partnerships and clinical expansion in the region."

Transaction Details

Under the terms of Arrangement Agreement, Aptose will continue from a corporation incorporated under the Canada Business Corporations Act to a corporation continued under the Business Corporations Act (Alberta) (the "Continuance") and, following the completion of the Continuance, Hanmi Purchaser will acquire all of the issued and outstanding Common Shares that are not currently owned or controlled by the Hanmi Purchasers or their respective affiliates by way of a plan of arrangement under the Business Corporations Act (Alberta) (the "Arrangement" and, together with the Continuance, the "Transaction").

Upon the completion of the Transaction, subject to applicable tax withholdings:

each Common Share (other than any Common Share owned or controlled by the Hanmi Purchasers or their respective affiliates or for which dissent rights have been validly exercised) will be transferred to Hanmi Purchaser in exchange for an amount in cash equal to C$2.41 per Common Share;
each Aptose option will cease to represent an option or other right to acquire any Common Share and will be deemed surrendered and exchanged for an amount in cash equal to C$2.41 per Common Share, multiplied by the number of Common Shares subject to the Aptose option, less the aggregate exercise price in respect of such Aptose option;
each Aptose restricted share unit will cease to represent a share unit of Aptose and will be deemed surrendered and exchanged for an amount in cash equal to C$2.41 per Common Share, multiplied by the number of Common Shares subject to the Aptose restricted share unit;
each Aptose warrant held by Armistice Capital Master Fund Ltd. (the "Armistice Warrants") will cease to represent a warrant exercisable for Common Shares and will be deemed surrendered and exchanged for an amount in cash equal to an amount calculated using the "Black Scholes" valuation model in accordance with the terms of the applicable Armistice Warrant; and
each Aptose warrant (other than the Armistice Warrants) will cease to represent a warrant exercisable for Common Shares and will be deemed surrendered and exchanged for an amount in cash equal to C$2.41 per Common Share, multiplied by the number of Common Shares subject to the Aptose warrant, less the aggregate exercise price in respect of such Aptose warrant.
The Arrangement Agreement contains customary non-solicitation provisions prohibiting Aptose from soliciting competing acquisition proposals, as well as "right to match" provisions in favour of Hanmi Purchaser. The Arrangement Agreement provides for a C$300,000 expense fee payable to Hanmi Purchaser if the Arrangement Agreement is terminated in certain circumstances, including in the context of a change in recommendation by the board of directors of Aptose (the "Board") or by the special committee consisting of independent members of the Board formed in connection with the Arrangement (the "Special Committee").

The completion of the Transaction is subject to satisfaction of customary closing conditions, including court approval and approval of Aptose shareholders as further set out below. After completion of the Transaction, Aptose expects to no longer be subject to the reporting requirements of applicable Canadian securities legislation and the Common Shares will be delisted from all stock exchanges where Common Shares are currently listed, including the TSX.

Completion of the Transaction will be subject to the approval of (i) at least two-thirds (66 2/3%) of the votes cast by Aptose shareholders present in person or represented by proxy at a special meeting of Aptose shareholders to be held no later than January 16, 2026 to approve the Transaction (the "Special Meeting"), voting as a single class, and (ii) the majority of the holders of Common Shares present in person or represented by proxy at the Special Meeting, excluding the votes of the Hanmi Purchasers and their respective affiliates, and any other shareholders whose votes are required to be excluded for the purposes of "minority approval" under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101") in the context of a "business combination" (the "Minority Shareholders"). Further details regarding the applicable voting requirements will be contained in a management information circular to be filed and mailed to Aptose shareholders in connection with the Special Meeting to approve the Transaction.

Concurrent with the execution of the Arrangement Agreement, Hanmi Purchaser entered into voting support agreements with each of the directors and officers of Aptose pursuant to which, subject to the terms of the voting support agreements, each Aptose director or officer has agreed to, among other things, vote or cause to be voted all of the Common Shares owned, controlled or directed, directly or indirectly, by them in favour of the Transaction at the Special Meeting.

Further details of the Transaction are set out in the Arrangement Agreement, which will be made available on Aptose’s SEDAR+ profile at www.sedarplus.ca.

Opinion and Formal Valuation

Locust Walk Securities, LLC ("Locust Walk") was retained by the Special Committee to provide financial advice and prepare a formal valuation of the Common Shares, as required under MI 61-101. Locust Walk delivered a valuation that, as of November 18, 2025, and based on Locust Walk’s analysis and subject to the assumptions, limitations and qualifications to be set forth in the formal valuation that will be included in the management information circular that will be sent to Aptose shareholders in connection with the Special Meeting (the "Formal Valuation"), using multiple analyses, including DCF modeling, the fair market value of the Common Shares is in the range of C$1.00 to C$5.23 per Common Share. Locust Walk has also delivered an oral opinion (the "Fairness Opinion") to the Special Committee that, as of November 18, 2025, and subject to the assumptions, limitations and qualifications to be set forth in Locust Walk’s written fairness opinion that will be included in the management information circular, the consideration to be received by the holders of Common Shares (other than the Hanmi Purchasers and their respective affiliates) pursuant to the Arrangement Agreement is fair, from a financial point of view, to such holders of Common Shares. The management information circular will also include factors considered by the Special Committee and the Board and other relevant information.

Unanimous Approval of Aptose Special Committee and Board of Directors

The Special Committee, after consultation with and receiving advice from its financial adviser and outside legal counsel, has unanimously recommended that the Board approve the Arrangement and that Aptose shareholders vote in favour of the Arrangement.

The Board, acting on the unanimous recommendation in favour of the Arrangement by the Special Committee and after receiving advice from its financial adviser and outside legal counsel in evaluating the Arrangement, has unanimously determined that the Arrangement is fair to Aptose shareholders (other than the Hanmi Purchasers and their respective affiliates) and that the Arrangement is in the best interests of Aptose, and resolved to unanimously recommend that Aptose shareholders vote in favour of the Arrangement.

Advisors

Locust Walk is acting as financial advisor and independent valuator to the Special Committee and the Company. McCarthy Tétrault LLP is acting as independent legal advisor to the Special Committee and the Company. Stikeman Elliott LLP is acting as independent legal advisor to Hanmi Purchaser.

About Tuspetinib

Aptose’s lead compound tuspetinib is a convenient once daily oral agent that potently targets SYK, mutated and wild type forms of FLT3, mutated KIT, JAK1/2, and RSK2 kinases, while avoiding many typical toxicity concerns observed with other agents. The ongoing TUSCANY triplet Phase 1/2 study is designed to test various doses and schedules of TUS in combination with standard dosing of azacitidine and venetoclax in newly diagnosed patients with AML who are ineligible to receive induction chemotherapy. Aptose has reported data from the first three dose cohorts that have demonstrated safety, CRs and minimal residual disease (MRD) negativity across patients with diverse mutations. The early data showed that 9 out of 10 patients responded to the TUS triplet therapy, with 100% complete remission (CR/CRh) achieved in the 80mg and 120mg cohorts. Notably, patients with difficult-to-treat mutations in TP53, RAS and FLT3 genes also achieved a 100% CR/CRh rate.

(Press release, Aptose Biosciences, NOV 19, 2025, View Source [SID1234660075])

On November 19, 2025 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest" or "the Company"), a clinical-stage biotechnology company with a pipeline of targeted and immune-mediated therapeutics to fight cancer, reported that it has entered into definitive agreements to acquire certain dual-targeting chimeric antigen receptor (CAR)-T programs from Factor Bioscience Inc. and its affiliates (collectively, "Factor") in an all-stock transaction (the "Proposed Transaction"). The Proposed Transaction is expected to close in early 2026, subject to necessary stockholder approvals and satisfaction of closing conditions (the "Closing").

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The Proposed Transaction will expand and further diversify Tempest’s existing clinical-stage pipeline, with the acquisition of the first clinical-stage CD19/BCMA parallel structured dual-CAR T specifically designed to target patients with extramedullary disease (EMD), which we are referring to as TPST-2003. In addition, the Company expects that existing cash at Closing and an investment commitment from Factor will support the Company’s planned operations to mid 2027, including through potential key development and data milestones in 2026 and 2027.

Key Takeaways:

Subject to stockholder approval and satisfaction of closing conditions, the Proposed Transaction will both further diversify Tempest’s pipeline and extend the Company’s runway to mid 2027, potentially through value-creating milestones
Tempest plans to pursue business development discussions or an additional financing to advance the pivotal development of amezalpat (TPST-1120) in first-line liver cancer ("HCC")
TPST-2003: dual CD19/BCMA CAR-T program
Phase 1 complete in patients with relapsed multiple myeloma ("rrMM"), with data expected in 2026 and a biologics license application ("BLA") in China planned for 2027
Phase 1 currently enrolling patients with POEMs syndrome, with data expected in 2027 and a BLA in China planned for 2028
Tempest will have global rights to TPST-2003 outside of China, India, Turkey and Russia, and plans to pursue a potential registrational study in rrMM in the U.S. starting in 2027
Data from Chinese pivotal study expected to validate probability of success for Tempest program, and rights will include the right to reference data generated in support of the planned China BLA
Tempest expects a Phase 2 study of TPST-1495 in familial adenomatous polyposis ("FAP") to enroll the first patient in 2026 and to be funded by the National Cancer Institute and operationalized by the Cancer Prevention Clinical Trials Network
Plan to continue the development of additional new preclinical and research-stage pipeline programs:
TPST-2206: dual-targeting CD70/CD70 CAR-T for renal cell carcinoma
TPST-3003: allogeneic dual-targeting CD19/BCMA
TPST-3206: allogeneic dual-targeting CD70/CD70
Tempest will issue 8,268,495 shares of its common stock, par value $0.001 per share ("Common Stock"), to an affiliate of Factor, equal to 65% of the outstanding shares of Common Stock, inclusive of newly issued shares, as of November 19, 2025.
Existing Tempest stockholders will be entitled to receive one (1) common stock warrant for every share of Common Stock held and outstanding at a date immediately prior to the Closing (the "Warrants"). The Warrants will be immediately exercisable with an initial exercise price equal to $18.48 and will expire five years from the issuance date.
Existing cash at Closing and an investment commitment from Factor is expected to provide a runway to mid 2027 and potentially through key data milestones.
Upon Closing, Matt Angel, Ph.D. will become president and chief executive officer ("CEO") of Tempest and current Tempest president and CEO Stephen Brady will become Chairman of the Company’s board of directors.
"The Proposed Transaction will result in an even more diversified portfolio that we believe provides stockholders with new opportunity for value creation and patients with new potential therapies," said Stephen Brady, president and chief executive officer of Tempest. "With the new funding support, Tempest has increased its opportunity to realize potential value creating milestones in the midst of this prolonged challenging market."

Dr. Angel added, "I echo Steve’s sentiments and share in the vision to bring innovative therapies to patients with cancer. I believe there is significant potential to be realized in combining these programs and look forward to working with the Tempest team to bring these programs forward for the benefit of patients."

Matt Angel, Ph.D.

Dr. Matt Angel is an experienced biotechnology executive with expertise in leading lean cell therapy companies. Dr. Angel led Brooklyn Immunotherapeutics (Nasdaq: BTX) as CEO from 2022-2023, successfully restructuring the company and extending the company’s runway in a challenging market environment. Dr. Angel has led Factor Bioscience Inc. as co-founder and CEO since 2011 and is co-founder of cell therapy companies Novellus Therapeutics (founded 2014; sold 2021) and Exacis Biotherapeutics (founded 2020; sold 2023). Dr. Angel has deep expertise in cell therapy development and intellectual property protection and licensing. Dr. Angel is also experienced in assembling and managing multidisciplinary teams. A pioneer in cell engineering technology, Dr. Angel is a prolific inventor with more than 150 patents covering mRNA, nucleic acid delivery, gene editing, and cell reprogramming technologies. Dr. Angel received his Ph.D. from the Massachusetts Institute of Technology, where he published seminal discoveries in the then-nascent field of mRNA.

Approvals and Timing

The board of directors of Tempest has unanimously approved the Proposed Transaction and intends to recommend that Tempest stockholders vote to adopt the asset purchase agreement and the related issuance of Common Stock with respect to the Proposed Transaction at a meeting of stockholders.

The Proposed Transaction is conditioned upon approval of the holders of a majority of the outstanding shares of Common Stock of Tempest entitled to vote to adopt the asset purchase agreement with respect to the Proposed Transaction.

Completion of the transaction is expected in early 2026, subject to the approval of Tempest stockholders and the satisfaction of other customary closing conditions.

Advisors

MTS Health Partners, L.P. is serving as financial advisor to Tempest, and Cooley LLP is serving as legal advisor. In addition, MTS Securities, LLC (an affiliate of MTS Health Partners, L.P.) provided an opinion to the board of directors of Tempest regarding the fairness of the purchase price to be paid by Tempest to Factor in connection with the Proposed Transaction, subject to the qualifications and limitations set forth therein.

(Press release, Tempest Therapeutics, NOV 19, 2025, View Source [SID1234660094])

On November 19, 2025 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported it has executed a 4-month extension of its collaboration with The Scripps Research Institute ("Scripps Research") and the lab of Dr. Alexey Stepanov, Institute Investigator at Scripps Research effective November 1, 2025, to advance the development of the Company’s research and development program evaluating the combination of systemic DNase I and CAR T-cell therapies.

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Xenetic’s systemic DNase I candidate, XBIO-015, is currently in preclinical development in combination with CAR-T cell therapy for both hematologic and solid tumors. Studies conducted by Dr. Stepanov and his lab at Scripps Research using lymphoma, metastatic melanoma and leukemia models have shown that co-administration of DNase I with CAR-T cells significantly reduces tumor burden, decreases metastatic lesions, and markedly extends survival compared to CAR-T cell monotherapy. Importantly, systemic DNase I-mediated degrading of neutrophil extracellular traps (NETs) enhances CAR-T cell efficacy, increasing the infiltration of both CAR-T cells and endogenous T cells into tumors and by mitigating the immunosuppressive tumor microenvironment (TME).

"Dr. Stepanov and the Scripps Research team continue to be valued partners, and we are pleased to once again extend our collaboration with them to further explore the full potential of our DNase-based oncology platform. The data generated to date continues to be encouraging and warrants further evaluations. The expertise and dedication of the Scripps Research team to this program further validates our belief in DNase I to improve therapeutic responses in patients undergoing CAR-T cell therapy and we look forward to continued collaboration and innovation together," commented James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic.

Xenetic continues to advance its DNase-based technology towards Phase 1 clinical development for the treatment of pancreatic carcinoma and other locally advanced or metastatic solid tumors. Preclinical proof-of-concept studies combining DNase I with chemotherapy, immunotherapies, and CAR-T therapy in hematological and solid tumor and metastatic cancer models have been completed. Building on proof-of-concept success, the program has now advanced to mechanism-of-action and translational studies in preparation for a Phase 1 clinical trial.

(Press release, Xenetic Biosciences, NOV 19, 2025, https://ir.xeneticbio.com/news/detail/173/xenetic-biosciences-inc-extends-research-and-development-collaboration-with-institute-investigator-at-scripps-research-to-advance-dnase-platform [SID1234660095])

On November 19, 2025 Amgen (NASDAQ: AMGN) reported that the U.S. Food and Drug Administration (FDA) has granted full approval to IMDELLTRA (tarlatamab-dlle) for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The decision to convert IMDELLTRA’s prior accelerated approval to a full approval is based on data from the global Phase 3 DeLLphi-304 study. Additionally, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) were recently updated to include tarlatamab as the only Category 1 preferred treatment option for adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.1*

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The global Phase 3 DeLLphi-304 study met its primary endpoint, demonstrating that IMDELLTRA reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to standard of care (SOC) chemotherapy as a treatment for patients with ES-SCLC who progressed on or after one line of platinum-based chemotherapy (median OS: 13.6 vs. 8.3 months; hazard ratio (HR), 0.60; 95% confidence interval (CI): 0.47, 0.77; P < 0.001).2

"The FDA’s decision reinforces IMDELLTRA as a recognized standard of care for people living with extensive stage small cell lung cancer whose disease progressed on or after frontline therapy," said Jay Bradner, M.D., executive vice president, Research and Development, at Amgen. "We are committed to delivering transformative medicines for patients facing challenging cancers, and we are currently focused on rapidly developing IMDELLTRA in earlier stages of disease and earlier lines of therapy for small cell lung cancer patients."

"For far too long, people living with small cell lung cancer had few options once their first treatment stopped working," said Laurie Fenton Ambrose, co-founder, president, and CEO, GO2 for Lung Cancer. "Today’s full approval is an important step forward, reinforcing long-awaited progress for patients facing this devastating disease."

The safety profile for IMDELLTRA in DeLLphi-304 was consistent with its known profile, with fewer Grade 3 or greater adverse events in the IMDELLTRA arm than in the chemotherapy arm (54% vs 80%). The most common Grade 3 or greater treatment-related adverse events (TRAEs) were neutropenia (4%) and lymphopenia (4%) with IMDELLTRA and anemia (28%) and neutropenia (22%) with SOC chemotherapy. Cytokine release syndrome (CRS) with IMDELLTRA primarily occurred after the first two doses and was primarily low grade (42% Grade 1; 13% Grade 2; 1% Grade 3). No Grade 4 or Grade 5 CRS events were reported.2

"Due to its distinctive biology and aggressive nature, small cell lung cancer has long been particularly challenging to treat, with limited progress compared to many other cancers. After years of research efforts, DeLLphi-304 was the first global Phase 3 trial to demonstrate a significant survival benefit over chemotherapy in its setting, leading to NCCN Guidelines Category 1 status for tarlatamab and further demonstrating the validity of this treatment approach in small cell lung cancer," said Charles M. Rudin, M.D., Ph.D., deputy director, Memorial Sloan Kettering Cancer Center, and principal investigator.* "Importantly, data from DeLLphi-304 reflected in today’s approval also equip physicians with a greater understanding of managing treatment with bispecific T-cell engager therapy."

Amgen’s robust IMDELLTRA development program includes the DeLLphi clinical trials, which evaluate IMDELLTRA as a monotherapy and as part of combination regimens, including in both earlier stages of SCLC and earlier lines of treatment.

About the Phase 3 DeLLphi-304 Study
DeLLphi-304 is a global Phase 3, randomized, controlled, open-label clinical trial evaluating the efficacy and safety of IMDELLTRA as a treatment for patients living with SCLC who progressed on or after a single line of platinum-based chemotherapy.3 Five hundred and nine patients were randomized to receive either IMDELLTRA or local SOC chemotherapy (topotecan in all countries except Japan; lurbinectedin in the U.S., Canada, Australia, Singapore, Korea; and amrubicin in Japan).3,4 The primary outcome measure of the trial is OS.3 Key secondary outcome measures include progression-free survival (PFS) and patient-reported outcomes (PROs) including disease-related symptoms, physical function, and quality of life.3 Results from DeLLphi-304 were reviewed as a late-breaking presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine.2,5

About Tarlatamab Clinical Trials
Tarlatamab is being investigated in multiple studies including DeLLphi-303, a Phase 1b study investigating tarlatamab in combination with SOC therapies in first-line ES-SCLC; DeLLphi-304, a randomized Phase 3 study comparing tarlatamab monotherapy with SOC chemotherapy in second-line treatment of SCLC; DeLLphi-305, a randomized Phase 3 study comparing tarlatamab in combination with durvalumab vs. durvalumab alone as first-line maintenance treatment in ES-SCLC; DeLLphi-306, a randomized placebo-controlled Phase 3 study of tarlatamab following concurrent chemoradiotherapy in limited-stage SCLC; DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab in second-line or later ES-SCLC; DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens with tarlatamab in second-line ES-SCLC; DeLLphi-310, a Phase 1b study of tarlatamab in combination with YL201 with or without anti-programmed death ligand 1 (PD-L1) in patients with ES-SCLC; DeLLphi-311, a Phase 1b study of IMDELLTRA in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), in patients with ES-SCLC; and DeLLphi-312, a Phase 3 study evaluating tarlatamab as an induction and maintenance therapy in first-line treatment of ES-SCLC in combination with carboplatin, etoposide and durvalumab.6

For more information, please visit www.tarlatamabclinicaltrials.com.

About Small Cell Lung Cancer (SCLC)
SCLC is one of the most aggressive and devastating forms of solid tumor cancers. In the United States, the five-year relative survival rate for SCLC is 5-10% across all stages combined.7 Each year, SCLC accounts for approximately 13-15% of the more than 2.4 million cases of lung cancer diagnosed worldwide, including around 227,000 cases in the United States.8-10 Despite initial high response rates to first-line platinum-based chemotherapy, most patients quickly relapse within months and require subsequent treatment options.9

About IMDELLTRA (tarlatamab-dlle)
IMDELLTRA is a first-in-class targeted immunotherapy engineered by Amgen researchers to bind to both DLL3 on tumor cells and CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell.11,12 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, making it an exciting target.13,14

INDICATION
IMDELLTRA (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate treatment with IMDELLTRA using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity.
Neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity.
WARNINGS AND PRECAUTIONS

Cytokine Release Syndrome (CRS): IMDELLTRA can cause CRS including life-threatening or fatal reactions. In the pooled safety population, CRS occurred in 57% (268/473) of patients who received IMDELLTRA, including 39% Grade 1, 15% Grade 2, 1.7% Grade 3 and 0.2% Grade 4. Recurrent CRS occurred in 24% of IMDELLTRA-treated patients including 20% Grade 1 and 3.4% Grade 2; one patient experienced recurrent Grade 3.

Among the 268 patients who experienced CRS, 73% had CRS after the first dose, 60% had CRS after the second dose, and 15% had CRS following the third or later dose. Following the Cycle 1 Day 1, Day 8, Day 15 infusions, 24%, 8%, and 1% of patients experienced Grade ≥ 2 CRS, respectively. From Cycle 2 onwards, 1.5% of patients experienced Grade ≥ 2 CRS. Of the patients who experienced CRS, 31% received steroids and 10% required tocilizumab. The median time to onset of all grade CRS from most recent dose of IMDELLTRA was 16 hours (range: start of infusion to 15 days). The median time to onset of Grade ≥ 2 CRS from most recent dose of IMDELLTRA was 15 hours (range: start of infusion to 15 days).

Clinical signs and symptoms of CRS included pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea, and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC).

Administer IMDELLTRA following the recommended step-up dosing and administer concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA infusions as described in Table 3 of the Prescribing Information (PI) to reduce the risk of CRS. Administer IMDELLTRA in an appropriate healthcare facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRA.

Closely monitor patients for signs and symptoms of CRS during treatment with IMDELLTRA. At the first sign of CRS, immediately discontinue IMDELLTRA infusion, evaluate the patient for hospitalization and institute supportive care based on severity. Withhold or permanently discontinue IMDELLTRA based on severity. Counsel patients and caregivers to seek medical attention should signs or symptoms of CRS occur.

Neurologic Toxicity, Including ICANS: IMDELLTRA can cause life-threatening or fatal neurologic toxicity, including ICANS. In the pooled safety population, neurologic toxicity occurred in 65% of patients who received IMDELLTRA, with Grade 3 or higher events in 7% of patients including fatal events in 0.2%. The most frequent neurologic toxicities were dysgeusia (34%), headache (17%), peripheral neuropathy (9%), dizziness (9%), and insomnia (8%). The incidence of signs and symptoms consistent with ICANS was 10% in IMDELLTRA-treated patients including events with the preferred terms: ICANS (4.7%), muscular weakness (3.2%), cognitive disorder (0.6%), aphasia (0.6%), depressed level of consciousness (0.4%), seizures (0.4%), encephalopathy (0.4%), and leukoencephalopathy (0.2%). There was one fatal reaction of ICANS. Recurrent ICANS occurred in 1.5% of patients. Of the patients who experienced ICANS, most experienced the event following Cycle 1 Day 1 (2.5%) and Cycle 1 Day 8 (3.6%). Following Day 1, Day 8, and Day 15 infusions, 1.3%, 1.3% and 0.4% of patients experienced Grade ≥ 2 ICANS, respectively. ICANS can occur several weeks following administration of IMDELLTRA. The median time to onset of ICANS from the first dose of IMDELLTRA was 16 days (range: 1 to 862 days). The median time to resolution of ICANS was 4 days (range: 1 to 40 days).

The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia.

Patients receiving IMDELLTRA are at risk of neurologic adverse reactions and ICANS resulting in depressed level of consciousness. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until neurologic symptoms resolve.

Closely monitor patients for signs and symptoms of neurologic toxicity and ICANS during treatment with IMDELLTRA. At the first sign of ICANS, immediately discontinue the infusion, evaluate the patient and provide supportive therapy based on severity. Withhold IMDELLTRA or permanently discontinue based on severity.

Cytopenias: IMDELLTRA can cause cytopenias including neutropenia, thrombocytopenia, and anemia. In the pooled safety population, based on laboratory data, decreased neutrophils occurred in 16% of patients, including 9% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased neutrophil count was 41 days (range: 2 to 306 days). Decreased platelets occurred in 30% including 2.2% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased platelets was 67 days (range: 3 to 420 days). Decreased hemoglobin occurred in 56% of patients, including 4.7% Grade 3 or 4. Febrile neutropenia was reported as an adverse event in 1.5% of patients treated with IMDELLTRA.

Monitor patients for signs and symptoms of cytopenias. Perform complete blood counts prior to treatment with all doses of IMDELLTRA, up through Cycle 5 Day 15 and then prior to administration on Day 1 of each cycle starting with Cycle 6. Based on the severity of cytopenias, temporarily withhold, or permanently discontinue IMDELLTRA.

Infections: IMDELLTRA can cause serious infections, including life-threatening and fatal infections.

In the pooled safety population, infections, including opportunistic infections, occurred in 43% of patients who received IMDELLTRA, including 14% Grade 3 or 4. The most frequent infections were pneumonia (11%), urinary tract infection (9%), COVID-19 (6%), upper respiratory tract infection (4.7%), respiratory tract infection (4%), candida infection (2.1%), oral candidiasis (2.1%), and nasopharyngitis (2.1%).

Monitor patients for signs and symptoms of infection prior to and during treatment with IMDELLTRA and treat as clinically indicated. Withhold or permanently discontinue IMDELLTRA based on severity.

Hepatotoxicity: IMDELLTRA can cause hepatotoxicity. In the pooled safety population, based on laboratory data, elevated ALT occurred in 39% of patients who received IMDELLTRA, including 2.5% with Grade 3 or 4 ALT. Elevated AST occurred in 43% of patients, including 3.2% Grade 3 or 4. Elevated bilirubin also occurred in 16% of patients, including 1.3% Grade 3 or 4. Liver enzyme elevation can occur with or without concurrent CRS.

Monitor liver enzymes and bilirubin prior to treatment with IMDELLTRA, and as clinically indicated. Withhold IMDELLTRA or permanently discontinue based on severity.

Hypersensitivity: IMDELLTRA can cause severe hypersensitivity reactions. Clinical signs and symptoms of hypersensitivity may include, but are not limited to, rash and bronchospasm. Monitor patients for signs and symptoms of hypersensitivity during treatment with IMDELLTRA and manage as clinically indicated. Withhold or consider permanent discontinuation of IMDELLTRA based on severity.

Embryo-Fetal Toxicity: Based on its mechanism of action, IMDELLTRA may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRA and for 2 months after the last dose.
ADVERSE REACTIONS

The pooled safety population reflects exposure to intravenous IMDELLTRA, as a single agent, at the recommended dosage of IMDELLTRA 1 mg on Cycle 1 Day 1 followed by 10 mg on Days 8 and 15, and then every 2 weeks until disease progression or intolerable toxicity in 473 patients with small cell lung cancer enrolled in three clinical trials: DeLLphi-300, DeLLphi-301 and DeLLphi-304. Among 473 patients who received IMDELLTRA, 40% were exposed for 6 months or longer and 19% were exposed for greater than one year.
The most common (≥ 20%) adverse reactions were CRS (57%), fatigue (48%), decreased appetite (38%), dysgeusia (34%), pyrexia (33%), constipation (31%), musculoskeletal pain (31%), and nausea (25%).
The most common (≥ 5%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (43%), decreased sodium (12%), decreased total neutrophils (9%), and increased uric acid (6%).
DOSAGE AND ADMINISTRATION: Important Dosing Information

Administer IMDELLTRA as an intravenous infusion over 1 hour.
Administer IMDELLTRA according to the step-up dose and schedule in the IMDELLTRA PI (Table 1) to reduce the incidence and severity of CRS.
Evaluate complete blood count, liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary if clinically indicated.
For Cycle 1, administer recommended concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA infusions to reduce the risk of CRS reactions as described in the PI (Table 3).
IMDELLTRA should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including ICANS.
Due to the risk of CRS and neurologic toxicity, including ICANS, monitor patients from the start of the IMDELLTRA infusion for 22 to 24 hours following Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.
Recommend that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with IMDELLTRA following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver.
Inform both the patient and the caregiver on the signs and symptoms of CRS and ICANS prior to discharge.
Ensure patients are well hydrated prior to administration of IMDELLTRA.
Please see IMDELLTRA full Prescribing Information, including BOXED WARNINGS.

(Press release, Amgen, NOV 19, 2025, View Source [SID1234660080])

On November 19, 2025 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in immuno-oncology, reported it will host its End-of-Year 2025 Stakeholder Webcast on Wednesday, December 3, 2025 at 4:00 p.m. ET. The session will feature leading experts in gastrointestinal oncology and patient advocates discussing progress with the BOT/BAL program, emerging clinical insights, and the evolving treatment landscape for colorectal cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The session will be moderated by Garo Armen, PhD, Founder, Chairman, and CEO, and will conclude with a live Q&A. Questions can be submitted in advance to [email protected]

Featured Topics and Speakers

Role of Immuno-Oncology in Colorectal Cancer
Christopher Lieu, MD, FASCO, Professor of Medicine; Sohrab Amini, MD, FACS Endowed Chair in Pancreatic Cancer Research; Associate Director for clinical Research, University of Colorado Cancer Center
Dr. Christopher Lieu will discuss the evolving role of immuno-oncology in colorectal cancer, and how expectations for MSS disease are shifting with emerging mechanisms and combination approaches. He will also highlight select clinical insights from his practice, including a notable case that illustrates the potential for deep and durable responses.
Global Phase 3 BATTMAN Study (CO.33) Update
Jonathan Loree, MD; Medical Oncologist, BC Cancer; Associate Professor, University of British Columbia; Senior Investigator, Canadian Cancer Trials Group (CCTG); Co-Chair, NCI Colon Cancer Task Force
Dr. Jonathan Loree will provide an update on the global Phase 3 BATTMAN study, including site engagement, operational readiness, and early feedback from investigators supporting strong trial momentum heading into 2026.
A Caregiver & Physician Perspective: Early-Onset CRC and Paving a New Path Forward
Benny Johnson, DO; Senior Medical Director, Agenus; Former Assistant Professor, GI Medical Oncology MD Anderson Cancer Center
Dr. Johnson will share his family’s experience navigating early-onset colorectal cancer from diagnosis through treatment decision-making, including the choice to participate in a clinical trial evaluating BOT/BAL. Their conversation will highlight the lived realities behind clinical innovation and the importance of expanding patient-centered options for the growing early-onset population, from the perspective of a family impacted by CRC.
Stakeholder Briefing Details:

Registration Link: View Source
Live webcast link will be provided once registration is completed.

Have a Question? Submit them in advance to [email protected]

This session is the third in Agenus’ 2025 Stakeholder Briefing Webcast Series, following the October event highlighting new pan-tumor data from ESMO (Free ESMO Whitepaper) 2025 and perspectives on the French AAC program. Webcasts will resume in 2026, continuing the dialogue on BOT/BAL’s progress and corporate milestones.

(Press release, Agenus, NOV 19, 2025, View Source [SID1234660096])