On January 16, 2026 Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ("Tiziana"), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, reported the closing of its previously announced Company best efforts registered direct offering ("Offering") of 7,040,000 ordinary shares at an offering price of $1.25 per ordinary share conducted without an underwriter or placement agent to members of senior management and existing shareholders. The gross proceeds to Tiziana from the Offering, before deducting estimated Offering expenses payable by Tiziana, were $8.8 million. For every ordinary share subscribed, participants will receive one warrant entitling the holder to subscribe for one new ordinary share at a price of $1.50 at any time up to and including July 16, 2026 (when the warrants expire) resulting in additional gross proceeds of up to approximately $10.56 million.

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The Offering was led by Tiziana’s Chief Executive Officer, Ivor Elrifi, who purchased 2,400,000 ordinary shares, bringing his total holding to 2,757,848 ordinary shares. Executive Chairman and Founder of Tiziana, Mr. Gabriele Cerrone purchased 1,600,000 ordinary shares in the Offering through Panetta Partners Ltd, an entity in which he has a beneficial interest, bringing his total holdings to 44,974,830 ordinary shares.

The proceeds from this offering enable the company to complete its Phase 2 na-SPMS and MSA clinical trials, and achieve top line data readouts in both trials.

The securities described above are being offered and sold pursuant to a shelf registration statement on Form F-3 (File No. 333-286064), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on March 24, 2025, and declared effective on March 27, 2025. The Offering is being made only by means of a prospectus supplement and the accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that the Company may file with the SEC. The final prospectus supplement related to the Offering has been filed with the SEC and is available on the SEC website.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

About Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biologic candidate that has been shown to stimulate T regulatory cells when dosed intranasally. Currently, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.

(Press release, Tiziana Life Sciences, JAN 16, 2026, View Source [SID1234662071])

On January 16, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported updated efficacy and safety results from the ongoing QUILT-106 clinical study (NCT06334991) evaluating an off-the-shelf allogeneic CD19 chimeric antigen receptor natural killer cell therapy (CAR-NK). This CD19 t-haNK (CAR-NK) is a targeted high-affinity natural killer (NK) cell therapy engineered to express a CD19-specifc chimeric antigen receptor (CAR) used in combination with rituximab (anti-CD20) for patients with Waldenström Non-Hodgkins lymphoma, a rare B-cell malignancy.

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Updated follow-up demonstrates sustained complete responses with durations now extending to 15 months and ongoing, with 100% disease control observed to date. Patients who failed standards of care received a total of eight doses of cell therapy in the outpatient setting without lymphodepletion which requires chemotherapy. The tumors were targeted with both CD19 and CD20 immunotherapies by infusing CD19 CAR NK cells with rituximab, two doses per cycle every 21 days for a total of four cycles (eight doses of NK-CAR and six doses of rituximab) and no further therapy thereafter. Response to therapy was evaluated after two cycles.

To date four patients with Waldenstrom Non-Hodgkin Lymphoma have been enrolled and all remain in clinical disease control. Two patients are evaluable for long-term follow-up and continue to demonstrate durable complete remission at 7 and 15 months and ongoing, respectively, despite receiving no additional treatment after the initial eight doses of immunotherapy.

Both the rapid onset of complete remission (after only two cycles) and the durability of complete response following treatment cessation underscores the potential for long-term immune-mediated disease control without continuous therapy.

"This updated follow-up reinforces the central thesis that restoring and activating the immune system can deliver durable control of disease without chemotherapy or lymphodepletion," said Patrick Soon‑Shiong, MD, Founder, Executive Chairman, and Global Chief Medical and Scientific Officer of ImmunityBio. "Seeing complete responses persist beyond a year after treatment has stopped, in patients who had exhausted available options, represents a meaningful advance for patients with this rare disease of Waldenström lymphoma and validates CAR-NK as a potential next-generation immunotherapy platform."

In two patients evaluable for long-term follow up who presented with extensive disease at baseline, one with multiple lymphomatous bone lesions and one with approximately 95% bone marrow infiltration by tumor cells, complete responses were observed after only four doses of CAR-NK + rituximab.

The patient with significant bone marrow involvement had complete bone morphological remission. In this patient in which 95% of the bone marrow was overtaken and replaced by tumor cells, the CR after four doses has been maintained now for 15 months and is ongoing as of this date with no further treatment after a total of eight doses.

These findings represent the first chemotherapy-free and lymphodepletion-free immunotherapy regimen combining off-the-shelf allogeneic CD19 CAR-NK cells with rituximab to demonstrate 100% disease control in Waldenström Non-Hodgkins lymphoma, administered entirely in the outpatient setting. This approach eliminates the need for cytotoxic conditioning for lymphodepletion or inpatient hospitalization, addressing key limitations associated with conventional CAR-T therapies.

"These data highlight a favorable safety and efficacy profile that is particularly important for patients with indolent yet incurable lymphomas," said Lennie Sender, M.D., Chief Medical Officer, Liquid Tumors and Cell Therapy at ImmunityBio. "To date, all patients have been treated as outpatients with no serious adverse events, demonstrating the feasibility of delivering potent cellular immunotherapy without the morbidity traditionally associated with cell-based treatments."

Waldenström Non-Hodgkins lymphoma remains an area of significant unmet medical need, particularly for patients who relapse or become refractory to available targeted and antibody-based therapies. The updated results from QUILT-106 support off-the-shelf CD19 CAR-NK as a next-generation cell therapy for liquid tumors, combining durable efficacy with an outpatient-based treatment.

Enrollment and follow-up in QUILT-106 are ongoing, and additional clinical updates will be provided as more patients become evaluable and response durability continues to mature.

QUILT-106 was designed to examine CD19 CAR NK as a single experiential therapy combined with rituximab. A followup study is being designed to test the further combination of the NK-CAR with ANKTIVA (nogapendekin alfa inbakicept; N-803), a superagonist IL-15, and rituximab to build on the success of the QUILT-106 in indolent lymphoma including Waldenström’s Macroglobulinemia.

ImmunityBio’s CD19 CAR-NK Therapy

CD19 CAR-NK is a targeted high-affinity natural killer cell therapy – an off-the-shelf, allogeneic NK cell line engineered to express a CD19-specific chimeric antigen receptor (CAR) and a high-affinity CD16 (FcγRIIIa 158V) receptor. This design enables dual anti-tumor mechanisms: direct CAR-mediated cytotoxicity and augmented antibody-dependent cellular cytotoxicity when paired with anti-CD20 monoclonal antibody rituximab. Combining CD19 CAR-NK cells with rituximab could thereby target CD19⁺/CD20⁺ lymphoma cells to enhance tumor cell killing.

About ANKTIVA (nogapendekin alfa inbakicept)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the Company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

(Press release, ImmunityBio, JAN 16, 2026, View Source [SID1234662070])

On January 16, 2026 ImmunityBio, Inc. (NASDAQ: IBRX) reported an update on the status of enrollment in its randomized registrational trial in BCG-naïve non-muscle-invasive bladder cancer (NMIBC), QUILT-2.005. Enrollment has exceeded internal expectations and is now over 85% complete, with full enrollment of the planned study population anticipated by Q2 2026. Based on the current enrollment trajectory, ImmunityBio anticipates submitting a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) by year end 2026.

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In 2023, to determine the contribution of effect of ANKTIVA (nogapendekin alfa inbakicept), the FDA requested that an interim analysis of this randomized controlled trial be performed to assess complete response rate and duration of complete response in subjects treated with ANKTIVA plus BCG compared with BCG alone. These data were submitted to the Agency and publicly presented at the American Urological Association (AUA) Annual Meeting in 2024.

The interim analysis demonstrated that ANKTIVA significantly prolonged the duration of complete response when combined with BCG compared to BCG alone in the BCG-naïve NMIBC setting. At six months, 85% of patients receiving ANKTIVA plus BCG maintained a complete response, compared with 57% of patients receiving BCG alone. At nine months, 84% of subjects in the experimental arm maintained a complete response, while subjects receiving BCG alone demonstrated a complete response rate of 52%. Despite the limited sample size of this interim analysis, the difference in duration of complete response at nine months reached statistical significance (p=0.0455).1.

"We look forward to the final accrual of this important registrational randomized trial in patients with BCG-naïve non-muscle-invasive bladder cancer, which represents a substantial proportion of newly diagnosed bladder cancer cases," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman, and Global Chief Medical and Scientific Officer of ImmunityBio. "The interim analysis is encouraging and consistent with findings in the approved BCG-unresponsive setting, where the duration of complete response has exceeded 47 months."

Recognizing the ongoing shortage of TICE BCG, ImmunityBio’s Expanded Access Program of recombinant BCG continues to progress and support patient access. The Company has requested consultation with the FDA to address the use of recombinant BCG as an alternative supply source in anticipation of continued clinical need, including patients with BCG-naïve disease.

About ANKTIVA (nogapendekin alfa inbakicept)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the Company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, JAN 16, 2026, View Source [SID1234662069])

On January 16, 2026 Genmab A/S (Nasdaq: GMAB) reported topline results from the Phase 3 EPCORE DLBCL-1 trial evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, which demonstrated an improvement in progression-free survival (PFS) (HR: 0.74 [95% CI 0.60 to 0.92])* in patients treated with epcoritamab monotherapy. Additionally, improvements were observed in the complete response rate, duration of response, and time to next treatment among patients treated with epcoritamab monotherapy. EPCORE DLBCL-1 is the first Phase 3 study to demonstrate an improvement in PFS in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who were treated with a CD3xCD20 T-cell engaging bispecific monotherapy. The study demonstrated an overall survival (OS) of HR: 0.96 [95% CI 0.77 to 1.20], which did not reach statistical significance.

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The global study enrolled 483 patients with R/R DLBCL with at least one prior line of therapy (73% had received two or more prior lines) who were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The study evaluated the safety and efficacy of epcoritamab monotherapy compared to investigator’s choice of either rituximab plus gemcitabine and oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR).

The adverse events observed in this study appear consistent with the known safety profile of epcoritamab. Further analysis of the results is ongoing, including the potential impact of various factors, such as the COVID-19 pandemic and increasing availability of novel anti-lymphoma therapies. The full trial results will be submitted for presentation at a future medical meeting. Genmab and AbbVie will engage with global regulatory authorities to discuss next steps.

Data is anticipated in 2026 from two Phase 3 trials evaluating fixed duration epcoritamab in patients with DLBCL, including EPCORE DLBCL-2, a front-line study evaluating epcoritamab in combination with standard-of-care rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP), and EPCORE DLBCL-4, evaluating epcoritamab in combination with lenalidomide versus chemo-immunotherapy in patients with relapsed or refractory DLBCL.

"The EPCORE DLBCL-1 trial is the first Phase 3 study evaluating a bispecific antibody monotherapy to demonstrate improvements in progression-free survival in patients with relapsed or refractory DLBCL," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "The results from this global trial contribute to the growing body of evidence supporting epcoritamab and build upon the robust foundation established by epcoritamab, which has been used to treat thousands of patients in need of additional therapeutic options. Together with our partner, AbbVie, we remain deeply committed to advancing the development of epcoritamab as a potential core therapy across a broad range of B-cell malignancies."

Epcoritamab (approved under the brand name EPKINLY in countries including the U.S. and Japan, and as TEPKINLY in the European Union) has received regulatory approval in certain lymphoma indications in more than 65 countries. Genmab and AbbVie remain committed to advancing the potential of epcoritamab, with ongoing clinical programs evaluating the therapy as a monotherapy and in combination regimens across treatment lines and a broad range of hematologic malignancies.

About Diffuse Large B-Cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases.i,ii In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year.iii DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.iv,v DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.iv,vi

About the EPCORE DLBCL-1 Trial
EPCORE DLBCL-1 (NCT04628494) is a global Phase 3 open label, multi-center, randomized trial to evaluate the efficacy of epcoritamab (GEN3013, DuoBody-CD3xCD20) compared to investigator’s choice of chemotherapy, either rituximab plus gemcitabine plus and oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR), in patients with relapsed or refractory DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The trial started on January 13, 2021, and is ongoing.

More information on this trial can be found at View Source

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.vii

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Where approved, epcoritamab is a readily accessible therapy. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes three ongoing Phase 3, open-label, randomized trials, among them a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

(Press release, Genmab, JAN 16, 2026, View Source [SID1234662068])

On January 16, 2026 EORTC, together with the European Medicines Agency (EMA), and in collaboration with key stakeholders reported to have published a multistakeholder roadmap outlining strategic actions to advance treatment optimisation research in oncology. The recommendations were developed within the Cancer Medicines Forum (CMF)1 and are presented in a new article titled "Accelerating cancer treatment optimisation: a multistakeholder roadmap from the Cancer Medicines Forum" published in the Journal of Cancer Policy.

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Treatment optimisation research focuses on determining how anticancer therapies can be used most effectively in clinical practice, addressing questions related to dose, duration, schedule, sequence, and combinations. While current regulatory trials support marketing authorisation, many of these questions remain unanswered at approval, creating challenges for clinicians, patients, and healthcare systems.

The roadmap is based on a multidisciplinary workshop held in April 2024 within the CMF, which brought together multiple international stakeholders, including regulators, health technology assessment bodies, clinicians, patient representatives, academic researchers, industry, public health organisations. The discussions align with ongoing EORTC initiatives to support treatment optimisation, including a recent event held in the European Parliament focused on the challenges and opportunities in this area. Participants identified key barriers, including limited incentives, funding constraints, regulatory hurdles, and challenges in implementing optimisation findings, and proposed coordinated solutions.

"Recognising treatment optimisation as a public health priority is essential to ensuring that cancer therapies are used as effectively and sustainably as possible," said Dr Denis Lacombe, EORTC CEO. "Strengthening collaboration and creating the right conditions for pragmatic clinical trials will be key to making this happen."

The roadmap also emphasises the importance of aligning evidence requirements across regulators and HTA bodies to ensure that optimisation results can inform regulatory approvals, clinical practice and reimbursement decisions.

EORTC remains committed to supporting independent, practice-informing research and to strengthening evidence generation throughout the lifecycle of cancer medicines.

(Press release, EORTC, JAN 16, 2026, View Source [SID1234662067])