On February 26, 2026 ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported completion of enrollment in its Phase 2 clinical trial evaluating ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors.

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 QUILT 2.005 trial (NCT02138734), which completed enrollment ahead of schedule, includes 366 patients randomized to receive either BCG alone, the current standard-of-care for NMIBC CIS, or ANKTIVA in combination with BCG. An interim analysis requested by the U.S. Food and Drug Administration (FDA) demonstrated that treatment with ANKTIVA plus BCG resulted in a statistically significant improvement in the duration of complete response compared with BCG alone, with no significant safety concerns reported.

The interim analysis demonstrated that at six months, 85% of patients receiving ANKTIVA plus BCG maintained a complete response, compared with 57% of patients treated with BCG alone. At nine months, 84% of subjects in the ANKTIVA plus BCG arm maintained a complete response, compared with 52% of patients in the BCG-alone arm. Despite the limited sample size of the interim analysis, the difference in duration of complete response at nine months reached statistical significance (p=0.0455).1

"The interim results from this randomized study are encouraging and suggest that ANKTIVA plus BCG may improve the durability of response in patients with BCG-naïve NMIBC," said Dr. Christopher Pieczonka, Corporate Director of Clinical Research at U.S. Urology Partners and Global Principal Investigator of the trial. "Given the historical limitations of BCG alone, continued evaluation of this combination has the potential to inform future treatment strategies and potentially change the current standard-of-care recommendations for NMIBC. Importantly, no new or worsening safety signals have been observed to date, which is encouraging when considered alongside prior studies evaluating BCG in combination with checkpoint inhibitors in this disease setting."

Additional study results are expected to be available in the fourth quarter of 2026. Based on these data, ImmunityBio anticipates submitting a biologics license application (BLA) to the FDA by Q4 2026.

"We are encouraged by these interim results and await the final unblinding of the completed trial," said Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "If approved, ANKTIVA plus BCG could offer a new treatment option earlier in the disease course for patients with NMIBC CIS, building on the therapy’s existing approval in the BCG-unresponsive setting."

In parallel, ImmunityBio continues to address the ongoing shortage of TICE BCG through its Expanded Access Program (EAP) for recombinant BCG (NCT06810141), which is progressing and supporting patient access. The Company has requested consultation with the FDA regarding the potential approval of recombinant BCG as an alternative supply source in anticipation of continued clinical need, including for patients with BCG-naïve disease.

About ANKTIVA (nogapendekin alfa inbakicept-pmln)

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, FEB 26, 2026, View Source [SID1234663077])

On February 26, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported participation at the following investor conferences:

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!

TD Cowen 46th Annual Health Care Conference – Dave Lennon, PhD, President and CEO, will participate in a hybrid presentation and fireside chat on Tuesday, March 3 at 10:30 AM ET

Leerink 2026 Global Healthcare Conference – executives will participate in investor meetings on Monday, March 9

Citizens Life Sciences Conference – Dave Lennon, PhD, President and CEO, will give a corporate presentation on Tuesday, March 10 at 12:30 PM ET
A live webcast of the TD Cowen and Citizens presentations can be accessed by visiting the Whitehawk Therapeutics IR website and will be available for replay for approximately 30 days following the event.

(Press release, Whitehawk Therapeutics, FEB 26, 2026, View Source [SID1234663093])

On February 26, 2026 Amphista Therapeutics ("the Company" or "Amphista"), a leader in the discovery and development of next generation non-cereblon/VHL targeted protein degradation (TPD) medicines, reported new data at the Keystone Symposia on Proximity Based Biology and Therapeutics: Targeted Protein Degradation and Beyond in Banff, AB, Canada, 23-26 February.

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!

In an oral presentation titled "Expanding Targeted Glue Applications for Clinical Use by Recruiting Novel E3 Ligases", Louise Modis, Chief Scientific Officer at Amphista outlined the translation of Amphista’s Targeted Glue technology from discovery to clinical development. It showcased how the Company’s target-first approach and proprietary chemistry is delivering differentiated and advanced molecular glue degraders beyond traditional cereblon/VHL-based approaches.

The presentation built on insights shared at the TPD & Induced Proximity Summit in October 2025, demonstrated how Amphista is leading the rational discovery and development of molecular glue degraders functioning via novel E3 ligases, including DCAF16, FBXO22 and DCAF11 into clinically viable oral therapeutics.

Louise provided new data from Amphista’s Targeted Glue pipeline, which exemplifies the exquisite selectivity, deep and sustained target degradation, and exceptional degradation kinetics that can be achieved in vivo with this innovative approach. Amphista’s progress is underpinned by its proprietary Eclipsys platform technology which combines high-resolution CryoEM of ternary complexes, geometric deep learning, advanced folding algorithms and cheminformatics to rationalize and enhance molecular glue degrader development. The therapeutic potential of Amphista’s chemistry is further expanded by its compatibility with degrader-antibody conjugate (DAC) approaches.

Louise Modis, Chief Scientific Officer of Amphista Therapeutics, said: "We have made significant progress in advancing our Targeted Glue technology toward clinical application. This presentation at Keystone demonstrates how Amphista’s mechanistically differentiated approach of recruiting the most structurally efficient E3 ligase – including DCAF16, FBXO22 and now DCAF11 – translates into exceptional molecular properties, tissue distribution and degradation of the target. We have now demonstrated that we can successfully and reproducibly harness multiple novel E3 ligases beyond cereblon/VHL with advanced drug-like degraders. We’re excited to share data on AMX-883, our first clinical candidate, alongside innovations in degrader-antibody-conjugates and CNS-penetrant degraders that further expands the therapeutic opportunity for our Targeted Glue technology."

Presentation details:

Title: Expanding Targeted Glue Applications for Clinical Use by Recruiting Novel E3 Ligases
Date and Time: Wednesday 25 February 2026, 8:00–11:00 AM MST (UTC-7)
Presenter: Louise Modis, Chief Scientific Officer, Amphista Therapeutics

(Press release, Amphista Therapeutics, FEB 26, 2026, View Source [SID1234663059])

On February 26, 2026 Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, reported business updates and financial results for the fourth quarter and year ended December 31, 2025.

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!

"2025 was a time of accomplishment and resiliency for Intellia as we presented encouraging longer term Phase 1/2 clinical data for both lonvo-z and nex-z, rapidly enrolled patients in our three Phase 3 trials, commenced activities to prepare for a potential lonvo-z launch in HAE and responded to the clinical holds on our nex-z Phase 3 trials late in the year," said Intellia President and Chief Executive Officer John Leonard, M.D. "We expect the year ahead to be a pivotal one, highlighted by our topline Phase 3 data and planned BLA submission for lonvo-z, which has the potential to transform the HAE treatment paradigm by freeing most patients from both their attacks and chronic therapy. Additionally, we are focused on resuming our forward momentum with nex-z by completing patient enrollment in MAGNITUDE-2 and resolving the clinical hold on MAGNITUDE."

Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE)

Lonvo-z is a wholly owned, investigational in vivo CRISPR-based therapeutic candidate designed to inactivate the KLKB1 gene in the liver, drive consistent, deep and potentially lifelong reduction in kallikrein levels, and dramatically reduce or eliminate HAE attacks via a one-time treatment.

In the fourth quarter at the American College of Allergy, Asthma & Immunology (ACAAI) 2025 Annual Scientific Meeting, Intellia presented positive clinical data from a pooled analysis of all patients who received a 50 milligram (mg) dose of lonvo-z in the company’s ongoing Phase 1/2 clinical trial in patients with HAE. Observations from the analysis included durable reductions in plasma kallikrein in all patients at month 24, a high percentage of patients achieving prolonged attack-free status (for at least seven months and up to 32 months for patients with the longest follow-up) and a well-tolerated safety profile for lonvo-z.
Intellia sponsored a blinded market research study in late 2025 with 104 U.S. HAE patients and 151 U.S. HAE treating physicians. After reviewing a blinded target product profile aligned with lonvo-z’s Phase 1/2 clinical data, 99% of patients said they would be at least somewhat likely – and 64% said they would be extremely or very likely – to take lonvo-z if prescribed. Additionally, 92% of healthcare providers indicated they would prescribe a product with this profile, estimating they would prescribe it to 54% of the approximately 4,000 patients with HAE under their care.
This weekend, the company will present four posters at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting taking place February 27 – March 2 in Philadelphia, Pennsylvania (poster numbers 003, 005, 061 and 716). The presentations include three-year follow-up data from patients receiving a one-time 50 mg dose of lonvo-z and new survey findings assessing the chronic treatment burden and unmet needs among patients living with HAE.
Dosing in the global HAELO Phase 3 clinical trial was initiated in January 2025 and was completed in September 2025, with 80 patients enrolled. Intellia expects to report HAELO topline data by mid-2026 and, if the data are supportive, submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the second half of 2026.
To prepare for a planned launch in the first half of 2027, the company has expanded its field medical team, strengthened engagement with treating physicians and patient advocacy groups, initiated its payer engagements and advanced its launch strategy. In 2026, the company intends to build its field sales and reimbursement teams, finalize its distribution models, identify U.S. treatment centers and advance its pricing and access planning strategy.
Nexiguran Ziclumeran (Nex-z) for Transthyretin (ATTR) Amyloidosis

Nex-z is an investigational in vivo CRISPR-based therapeutic candidate designed to inactivate the TTR gene in the liver, thereby preventing the production of transthyretin (TTR) protein. Nex-z offers the possibility of halting and reversing disease by driving a deep, consistent and potentially lifelong reduction in TTR protein after a one-time treatment. Intellia leads the development and commercialization of nex-z in collaboration with Regeneron Pharmaceuticals, Inc.

In the fourth quarter at the American Heart Association (AHA) Scientific Sessions, Intellia presented positive follow-up data from the ongoing Phase 1 clinical trial of nex-z in patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM). Observations from these longer-term data included consistent and durable reductions in serum TTR through up to three years of follow up, stability or improvement in multiple markers of cardiomyopathy for most patients and encouraging mortality data.
As previously reported, on October 29, 2025, the FDA placed a clinical hold on the Investigational New Drug (IND) applications for the MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials for patients with ATTR-CM and hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN), respectively.
On January 27, 2026, the company announced the FDA lifted the clinical hold on the IND for MAGNITUDE-2. The company is in the process of resuming MAGNITUDE-2 enrollment.
Intellia’s engagement with FDA is ongoing regarding the clinical hold on the IND for the MAGNITUDE Phase 3 clinical trial of nex-z for patients with ATTR-CM. The company plans to provide an update once alignment has been achieved on the path forward for this program.
Fourth Quarter and Full-Year 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $605.1 million as of December 31, 2025, compared to $861.7 million as of December 31, 2024. The company’s cash, cash equivalents and marketable securities as of December 31, 2025 are expected to fund operations into the second half of 2027 and through lonvo-z’s anticipated U.S. commercial launch for HAE.

Collaboration Revenue: Collaboration revenue was $23.0 million for the fourth quarter of 2025, compared to $12.9 million for the fourth quarter of 2024. The increase was primarily driven by the recognition of $9.0 million in revenue related to the termination of the license and collaboration agreement with SparingVision SAS and an increase in cost reimbursements related to the company’s collaboration with Regeneron.
R&D Expenses: Research and development (R&D) expenses were $88.7 million for the fourth quarter of 2025, compared to $116.9 million for the fourth quarter of 2024. The $28.2 million decrease was primarily driven by employee-related expenses, stock-based compensation, research materials and contracted services, partially offset by an increase in facility-related expenses as well as clinical trial expenses related to nex-z. Stock-based compensation expense included in R&D expenses was $10.5 million for the fourth quarter of 2025.
G&A Expenses: General and administrative (G&A) expenses were $33.1 million for the fourth quarter of 2025, compared to $32.4 million for the fourth quarter of 2024. Stock-based compensation expense included in G&A expenses was $6.2 million for the fourth quarter of 2025.
Net Loss: Net loss was $95.8 million for the fourth quarter of 2025, compared to $128.9 million for the fourth quarter of 2024.

Conference Call Information
The company will host a conference call and webcast today at 8:00 a.m. ET to discuss recent updates and the company’s fourth quarter and full-year 2025 financial results. To join the webcast, please visit the Events and Presentations page of the Investors & Media section on Intellia’s website at intelliatx.com. To join by phone, U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726 approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call. A replay of the webcast will be available for approximately 90 days.

(Press release, Intellia, FEB 26, 2026, View Source [SID1234663078])

On February 26, 2026 ImmVira Group reported preliminary positive results from its clinical trial evaluating MVR-T3011, an oncolytic virus, in BCG-naïve high-risk papillary Ta/T1 NMIBC patients for its leading oncolytic virus product, MVR-T3011, via intravesical administration. The data were presented in a poster at the ASCO (Free ASCO Whitepaper) GU 2026 Conference in San Francisco, California.

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!

In the study involving 18 BCG-naïve high-risk papillary Ta/T1 NMIBC patients treated with intravesical MVR-T3011 at two dose levels: 2×109 PFU (3 patients) and 1×1010 PFU (15 patients), preliminary data as of December 31, 2025, demonstrated encouraging efficacy and durability. Among the 14 evaluable patients, the 12-month recurrence-free-survival (RFS) rate was 100% (3/3) at the 2×109 PFU dose level. At the 1×1010 PFU dose level, the 3-month RFS rate was 100% (11/11). The 6-month and 9-month RFS rates were 75% (3/4) and 66.7% (2/3), respectively, but these data are preliminary, given the small patient numbers reaching those timepoints.

Consistent with BCG-unresponsive clinical data, MVR-T3011 maintained a favorable safety profile in this study with most treatment-emergent adverse events (TEAEs) being at Grades 1 or 2. No treatment-related adverse events (TRAEs) were observed.

Bladder cancer ranks as the ninth most prevalent cancer worldwide[1], with approximately 75% of cases classified as NMIBC. While Bacillus Calmette-Guerin (BCG) remains the current SOC for high-risk NMIBC, global shortages have limited its availability. As a result, oncolytic immunotherapy, which offers enhanced immune activation and potential durability, is emerging as a promising alternative.

"We are highly encouraged by the preliminary efficacy and safety data from the study," said Dr. Grace Zhou, Chairwoman and CEO of ImmVira. "MVR-T3011 shows its potential to serve as a reliable and widely accessible alternative to BCG, ultimately benefiting patients worldwide."

(Press release, Immvira, FEB 26, 2026, View Source [SID1234663094])