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Nerviano Medical Sciences Announces Presentation of Two Trial-in-Progress Posters for Itareparib at ESMO TAT 2026

On March 16, 2026 Nerviano Medical Sciences S.r.l. ("NMS"), a global oncology-focused biopharmaceutical company, reported the presentation of two Trial-in-Progress posters featuring Itareparib (NMS-03305293) at the ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies (TAT) Congress 2026, taking place March 16–18, 2026 in Paris, France.

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The presentations highlight ongoing clinical studies of Itareparib, NMS’s non-trapping, PARP1-specificinhibitor, the only third-generation inhibitor in clinical development. Itareparib is highly brain- and tumor-penetrant, providing an advantage for widely metastatic disease. Itareparib is being studied in combination with established DNA-damaging therapies in two areas of high unmet medical need: recurrent non-BRCA-mutated ovarian cancer and relapsed extensivestage small cell lung cancer (ES-SCLC), including patients with brain metastases.

The posters are:

Poster 57TiP – Phase 1a/1b Study of NMS-03305293 (Itareparib), a Brain-Penetrant, Non-Trapping PARP1- Selective Inhibitor, in Combination with Topotecan in Recurrent HR-Proficient / Refractory Ovarian Cancer.
Poster 58TiP – Poster 58TiP – PARPA-293-004: Phase 1b Study of NMS-03305293 (Itareparib), a Brain-Penetrant, Non-Trapping PARP1-Selective Inhibitor, in Combination with Temozolomide in Relapsed Extensive-Stage Small Cell Lung Cancer (ES-SCLC).
Both studies are open and actively recruiting:

Non-BRCA-mutated ovarian cancer study: NCT06930755
ES-SCLC study: NCT06931626
"These studies reflect our strategy of advancing Itareparib in combination settings where conventional PARP1 approaches have historically been constrained," said Lisa Mahnke, MD PhD, Group CMO. "We believe the differentiated profile of Itareparib has the potential to broaden the use of PARP1 biology beyond traditional BRCA-mutated settings and into larger patient populations through rational combinations with DNA-damaging therapies."

Ovarian cancer and ES-SCLC remain aggressive malignancies with significant unmet need, particularly in relapsed or refractory settings where patients often face limited treatment options and poor outcomes. Through these studies, NMS is evaluating Itareparib for its potential to enhance the activity of widely used chemotherapeutic backbones while maintaining a combination-enabling tolerability profile.

Itareparib is currently being developed across multiple tumor settings, with near-term clinical readouts expected from its ongoing combination programs.

About Itareparib
Itareparib is a novel PARP1 inhibitor, designed to be used in combination, and distinguished by a non-trapping mechanism of action as shown preclinically with high potency, PARP1 selectivity and brain penetrance. Clinically (Geurts et al ENA 2023), the profile improves on poor bone marrow features of trapping PARP1 inhibitors (Yap et al AACR (Free AACR Whitepaper) 2024) and thus removes traditional barriers to combining a DNA damage repair inhibitor with a DNA damaging agent in non-BRCA-mutated tumors.

(Press release, Nerviano Medical Sciences, MAR 16, 2026, View Source [SID1234663570])

Nerviano Medical Sciences S.r.l. Announces Discontinuation of the Clinical Trial to Evaluate NMS-153 in combination with checkpoint inhibitor/cancer immunotherapy due to Lack of Efficacy in Immune Treatment Experienced Patients.

On March 16, 2026 Nerviano Medical Sciences S.r.l. (NMS), a global oncology-focused biopharmaceutical company reported that it is discontinuing its Phase 2 clinical study1 of the investigational Monopolar Spindle 1 (MPS1) inhibitor NMS-153 for the treatment of immune-experienced hepatocellular cancer patients in combination with atezolizumab (Tecentriq).

The trial confirmed favorable safety profile, but no favorable overall benefit-risk profile. The novel anti-cancer mechanism targeting the mitotic checkpoint showed prior monotherapy activity, likely involving innate immunity, but in this more immune-experienced population the effects seem to be less strong," noted Lisa Mahnke, MD, PhD, Chief Medical Officer of NMS. "The mitotic checkpoint kinase mechanism of NMS-153 is unique, and NMS remains committed to developing novel therapeutics that can address unmet medical needs in cancer," stated Hugues Dolgos, PharmD, CEO of NMS.

With the closure of this Phase 2 trial, NMS has decided to discontinue further development of the NMS-153 program.

Phase II Combination Study of NMS-01940153E and Atezolizumab with or without a prior priming with low dose decitabine for the Treatment of Adult Patients with Unresectable Hepatocellular Carcinoma (HCC) Previously Treated with Immune Checkpoint Inhibitors" (EUCT Number: 2024-516737-12-00)
About NMS-153

NMS-153 is a potent, highly selective small-molecule inhibitor of MPS1 (TTK) with a dual anti-cancer mechanism, inducing mitotic catastrophe and apoptosis while potentially activating anti-tumor immunity via the cGAS/STING pathway. It shows prolonged target engagement and broad in vivo activity as a single agent and in combination therapies. In January 2024, the FDA granted Orphan Drug designation for the treatment of hepatocellular carcinoma (HCC).

About NMS

NMS is a global, integrated biopharmaceutical company focused on the discovery and development of innovative oncology therapies. With affiliates in Nerviano/Corsico (Italy), Boston (USA), and Shanghai (China). NMS leverages deep expertise in drug discovery and translational medicine to advance a pipeline of novel candidates from bench to bedside.

(Press release, Nerviano Medical Sciences, MAR 16, 2026, View Source [SID1234663569])

Kyntra Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

On March 16, 2026 Kyntra Bio (Nasdaq: KYNB) reported financial results for the fourth quarter and full year 2025 and provided an update on the company’s recent developments.

"The encouraging results from the investigator-sponsored combination trial of FG-3246 with enzalutamide provide us with valuable insights and reinforce key design elements in our Phase 2 monotherapy study," said Thane Wettig, Chief Executive Officer of Kyntra Bio. "Our Phase 2 monotherapy trial of FG-3246 is progressing as planned, with interim results expected in the second half of 2026. Additionally, we have submitted the Phase 3 trial protocol for roxadustat for the treatment of anemia in patients with LR-MDS and expect feedback from the FDA shortly, with the intention to start a Phase 3 trial in the second half of 2026. With our successful transformation in 2025, we are well-positioned to execute our strategic plan in 2026 and anticipate an exciting year ahead."

Key Highlights of Fourth Quarter 2025, Recent Developments, and Upcoming Milestones

FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent)

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Phase 2 monotherapy trial of FG-3246, a potential first-in-class ADC targeting CD46, in mCRPC is actively enrolling and remains on track for interim analysis in the second half of 2026
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Topline results from the investigator-sponsored Phase 1b/2 study, conducted by UCSF, of FG-3246 in combination with enzalutamide in patients with mCRPC were presented at ASCO (Free ASCO Whitepaper) GU 2026
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FG-3246 and enzalutamide combination therapy, in biomarker unselected patients with androgen receptor pathway inhibitor (ARPI)-treated, taxane-naïve mCRPC, led to a median radiographic progression free survival (rPFS) of 7.0 months in the overall study cohort, with median rPFS of 10.1 months observed in patients who progressed on only one prior ARPI
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Higher tumor uptake of FG-3180 was numerically associated with PSA50 response (nominal p=0.053), highlighting its potential as a biomarker for patient selection
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Combination therapy had a similar safety and exposure profile to the previous FG-3246 Phase 1 monotherapy trial
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Results further validate key FG-3246 Phase 2 monotherapy design elements, most importantly the inclusion of patients who have progressed on only one prior ARPI and integration of baseline FG-3180 PET for all enrolled patients
Roxadustat

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Granted Orphan Drug Designation from the FDA for the treatment of MDS.
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Submitted the pivotal Phase 3 clinical trial protocol for roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden to the U.S. Food and Drug Administration.
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Company is currently exploring the opportunity to develop roxadustat internally or with a strategic partner, with the goal of starting the Phase 3 trial in the second half of 2026.

Financial

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Total revenue from continuing operations for the fourth quarter of 2025 was $1.3 million, as compared to $3.1 million for the fourth quarter of 2024.
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Total revenue from continuing operations for the full year 2025 was $6.4 million, as compared to $29.6 million for the full year 2024.
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Net loss from continuing operations for the fourth quarter of 2025 was $14.6 million, or $3.61 net loss per basic and diluted share, compared to a net loss of $8.7 million, or $2.15 net loss per basic and diluted share, one year ago.
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Net loss from continuing operations for the full year 2025 was $58.2 million, or $14.40 net loss per basic and diluted share, compared to a net loss of $153.1 million, or $38.26 net loss per basic and diluted share, for the full year 2024.
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As of December 31, 2025, Kyntra Bio reported $109.4 million in cash, cash equivalents, investments, and accounts receivable.
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The Company expects its cash, cash equivalents, investments, and accounts receivable to be sufficient to fund operating plans into 2028.

Conference Call and Webcast Presentation

Kyntra Bio management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on Kyntra Bio’s website.

About FG-3246 and FG-3180

FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by Kyntra Bio for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3180 is a companion diagnostic PET imaging agent, using the same CD46-targeting antibody together with an 89Zr tracker. To date, FG-3180 demonstrated specific uptake in CD46 positive tumors and is currently being evaluated as a biomarker for its potential to inform patient selection.

About Roxadustat

Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin.

Roxadustat is approved in Europe, Japan, China, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Kyntra Bio has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and Kyntra Bio are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

(Press release, Kyntra Bio, MAR 16, 2026, View Source [SID1234663568])

Greenwich LifeSciences Announces Use of Commercially Manufactured GP2 in FLAMINGO-01

On March 16, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the following update on the use of commercially manufactured GP2 in FLAMINGO-01.

All US Sites Treating Patients with Commercially Manufactured GP2

The Company previously announced that the first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In 2024, the first of three commercial lots filling GP2 into vials for commercial sale or for clinical use was manufactured in a commercial facility. In addition, drug stability programs were initiated for all four lots. Data on these commercial lots was recently submitted to the FDA, and after review, the first commercial lot of GP2 vials was approved for use in FLAMINGO-01 in the US.

Within weeks following the FDA review, all approximately 40 US sites were supplied with commercially manufactured GP2 vials and these sites began treating patients with these vials immediately. We were able to efficiently distribute the GP2 vials and communicate with the US pharmacists working with our warehouse partners and through our clinical team, which we internalized in Q4 2025.

CEO Snehal Patel commented, "We have started to submit the same manufacturing information to European, UK, and Canadian regulators so that commercially manufactured GP2 can be approved for use by all approximately 160 sites participating in FLAMINGO-01. We are also planning to manufacture additional vials of GP2, seeking a capacity of 500,000 to 1 million vials of GP2 per year, and to make larger lots of GP2 active ingredient to build inventory for a potential commercial launch."

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, MAR 16, 2026, View Source [SID1234663567])

CytomX Therapeutics Announces 2025 Financial Results and Provides Business Update

On March 16, 2026 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported 2025 financial results and provided a business update.

"Today’s encouraging Varseta-M Phase 1 update underscores the program’s intentional design and broad potential in CRC as well as other EpCAM-expressing indications. CytomX’s top priority in 2026 is to align with the FDA on a registrational path for Varseta-M in late-line CRC. We also plan to accelerate Varseta-M combination studies to benefit CRC patients in earlier lines of treatment," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX.

"Our continued and exciting progress with Varseta-M reinforces our leadership in the field of masking and CytomX’s ability to unlock true innovation. Our highly focused portfolio strategy is also illustrated by our second clinical program, CX-801. This masked version of Interferon-alpha-2b is being developed initially in advanced melanoma and, we believe, has the potential to become a new centerpiece of combination immunotherapy across multiple cancers. The CX-801 translational and biomarker data presented to date have been very encouraging, and we expect to share initial proof of concept data for the combination with KEYTRUDA later this year."

Pipeline Program Updates:

Varsetatug masetecan (EpCAM PROBODY Topo-1 ADC, CX-2051)

Announced positive data update from Phase 1 dose expansion study of Varseta-M in patients with advanced colorectal cancer (CRC).
The Company aims to align with the FDA in 2026 on a potential registrational study design for Varseta-M monotherapy in advanced CRC.
Additional Phase 1 follow-up data are also expected to be presented at major medical meeting(s) in 2026.
A Phase 1 Varseta-M combination study with bevacizumab in CRC has been initiated and a Phase 1b/2 study in combination with bevacizumab and chemotherapy is expected to start by the end of 2026.
Initiation of Phase 1 expansion cohort(s) in additional indications is planned for 2H 2026.

CX-801 (PROBODY Interferon alpha-2b)

The CX-801 Phase 1 study is progressing with a focus in advanced melanoma. The CX-801 monotherapy dose escalation portion of the study has reached the fourth dose level.
CX-801 monotherapy has been well tolerated at dose levels exceeding the approved dose of unmasked IFNα2b.1
In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA (pembrolizumab) was initiated. Dose escalation of CX-801 in combination with KEYTRUDA is currently enrolling the 2nd dose level.
Biomarker data from the CX‑801 monotherapy study in advanced melanoma were presented at the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, reinforcing CX‑801’s mechanism of action and supporting the ongoing combination trial with KEYTRUDA.
Initial clinical data for CX-801 in combination with KEYTRUDA in advanced melanoma is projected by the end of 2026.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

Corporate and Financial:

Financial:
CytomX ended 2025 with $137.1 million of cash, cash equivalents and investments with expected cash runway to the second quarter of 2027.
Research Pipeline and Collaborations:
CytomX has research collaborations with Bristol Myers Squibb, Amgen, Regeneron, and Moderna. Multiple drug discovery programs continue across our research collaborations with a focus on bispecific immunotherapies, including T-cell engagers.
In March 2026, Astellas chose to not advance the remaining preclinical research programs under the alliance resulting in a termination of the collaboration effective in the second quarter of 2026.

Full Year 2025 Financial Results:

Cash, cash equivalents and investments totaled $137.1 million as of December 31, 2025, compared to $100.6 million as of December 31, 2024.

Total revenue was $76.2 million for the year ended December 31, 2025, compared to $138.1 million in 2024. The decrease in revenue was driven primarily by the completion of our performance obligations in our collaboration with Bristol Myers Squibb in April 2025 as well as a lower estimated percentage of performance obligation completion for 2025 compared to 2024 in the Moderna, Astellas, and Regeneron collaborations.

In 2025, CytomX remained focused on controlling costs and efficiently progressing its pipeline programs. Total operating expense for 2025 was $98.6 million compared to $113.1 million for 2024, a decrease of $14.5 million.

Research and development expenses decreased by $14.7 million during the year ended December 31, 2025, to $68.7 million compared to $83.4 million for 2024. Research and development expenses decreased primarily due to lower general research and development expenses as a result of our January 2025 restructuring and reduced expenses for CX-904, partially offset by increased manufacturing and clinical spend on Varseta-M.

General and administrative expenses increased by $0.1 million during the year ended December 31, 2025, to $29.8 million, compared to $29.7 million for 2024. The general and administrative expenses for 2025 included $1.1 million of one-time restructuring expenses partially offset by reduced personnel related expenses and legal and consulting related expenses.

(Press release, CytomX Therapeutics, MAR 16, 2026, View Source [SID1234663566])