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Delcath Systems Announces Preliminary Third Quarter 2025 Financial Results

On October 18, 2025 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported preliminary revenue and financial results for the quarter ended September 30, 2025, and updated 2025 full-year revenue guidance.

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Preliminary Third Quarter Financial Results (unaudited)

Total CHEMOSAT and HEPZATO KIT revenue of approximately $20.5 million
HEPZATO KIT revenue of $19.2 million
CHEMOSAT revenue of $1.3 million
Gross margins expected to be 87%
Net income of $0.8 million

Positive adjusted EBITDA of $5.3 million
Positive operating cashflow of approximately $4.8 million

As of September 30, 2025, the Company had approximately $88.9 million of cash, cash equivalents and short-term investments and no debt.

2025 Full Year Financial Guidance

Total CHEMOSAT and HEPZATO KIT revenue of $83 million to $85 million, reflecting an approximate 150% increase in treatment volume over 2024
Quarterly gross margins between 85% to 87%
Positive adjusted EBITDA and operating cashflow in each quarter of 2025
"Although our third quarter revenue was modestly lower than the second quarter, this decline was primarily due to the NDRA discounts and unexpected summer seasonality which impacted the scheduling of new patient starts," said Gerard Michel, Chief Executive Officer of Delcath Systems. "We are confident that we will achieve strong growth in 2026 and beyond. This expectation is based on our ongoing expansion of active treatment centers and the positive influence of the CHOPIN trial results, which have demonstrated impressive efficacy and offer practical advantages for initiating patients on systemic therapy, while preparing for PHP therapy."

Conference Call Information

Delcath Systems, Inc. will host a conference call and webcast on October 20, 2025, at 8:45 a.m. Eastern Time to discuss the Phase 2 CHOPIN Trial results and provide a brief overview of the financial results announced in this release. Joining Delcath management on the call with pre-recorded remarks will be Dr. Vincent T. Ma, Assistant Professor and Medical Oncologist at the University of Wisconsin Department of Medicine, a current user of HEPZATO KIT for the treatment of metastatic uveal melanoma patients, an expert in treating cutaneous melanoma, and a co-author on the seminal Nature Medicine paper exploring liver immune tolerance mechanisms in cancer.

To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Monday, October 20
Time: 8:45 AM Eastern Time

Participant Numbers:
Toll Free: 1-877-407-3982
International: 1-201-493-6780
Webcast: View Source;tp_key=6f3953dd75

A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website View Source

(Press release, Delcath Systems, OCT 18, 2025, View Source [SID1234656767])

Delcath Systems Announces Investigator-Initiated CHOPIN Clinical Trial Meets Primary Endpoint

On October 18, 2025 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported the results of the CHOPIN randomized Phase 2 clinical trial (CHOPIN Trial) presented by Principal Investigator and Lead Author Professor Ellen Kapiteijn, MD, from Leiden University Medical Center’s Department of Medical Oncology at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress.

CHOPIN Trial Design

The investigator-initiated, prospective, randomized Phase 2 CHOPIN Trial was designed to compare the safety, tolerability, and efficacy of Delcath’s CHEMOSAT Hepatic Delivery System (HDS) with melphalan for percutaneous hepatic perfusion (PHP) when used alone versus when combined with the systemic immune checkpoint inhibitors (ICI) ipilimumab and nivolumab. Patients with metastatic uveal melanoma (mUM) were randomized 1:1 to receive PHP alone or in combination with ipilimumab and nivolumab. CHEMOSAT is the device component of the U.S. Food and Drug Administration (FDA) approved combination drug and device product HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System). HEPZATO KIT is approved for the liver-directed treatment of adult patients with uveal melanoma with unresectable hepatic metastases with less than 50% liver involvement and is administered every six to eight weeks for up to six melphalan/HDS treatments.

Ipilimumab and nivolumab are approved by the FDA and European Union for the treatment of unresectable metastatic melanoma, typically administered intravenously every three weeks for four doses, followed by maintenance nivolumab monotherapy every two to four weeks until disease progression.

The CHOPIN Trial randomized 76 patients 1:1 to receive PHP alone at weeks one and seven (PHP group) or four cycles of ipilimumab (1 mg/kg) and nivolumab (3 mg/kg) every three weeks over approximately nine weeks with two PHP treatments at weeks one and seven (combination group). The CHOPIN Trial design did not include additional PHP treatments beyond two treatments or nivolumab maintenance monotherapy. Once the nine-week treatment period was completed patients were monitored until progression. Key eligibility criteria included unresectable hepatic metastases with 50% or less unresectable disease and limited extrahepatic disease. The primary endpoint was one-year progression-free survival; secondary endpoints included safety, best overall response rate, overall survival, and hepatic progression-free survival.

CHOPIN Trial Results

Key Results from the CHOPIN Phase 2 Trial:

Progression-Free Survival (95% CI):
One Year % (95% CI)
Combination group: 54.7% (36.8 – 69.5)
PHP group: 15.8% (5.8 – 30.1)
Median months (95% CI)
Combination group: 12.8 (9.2 – 15.4)
PHP group: 8.3 (6.0 – 9.6)
Hazard Ratio 0.34 (0.19 – 0.60)
P<0.001
Overall Survival – (95% CI):
One Year % (95% CI)
Combination group: 82.8% (65.6 – 91.9)
PHP group: 82.2% (64.5 – 91.6)
Two Year % (95% CI)
Combination group: 49.6% (29.3 – 67.0)
PHP group: 22.1% (7.9 – 40.6)
Median: months (95% CI)
Combination group: 23.1 (20.2 – 38.5)
PHP group: 19.6 (15.2 – 21.8)
Hazard Ratio: 0.39 (0.20 – 0.77)
P = 0.006
Best Overall Response Rate (95% CI):
Combination group: 76.3 (59.4 – 88.0)
PHP group: 39.5 (24.5 – 56.5)
P < 0.001
Grade 3 or higher treatment-related adverse events were more frequent in the combination group (81.6% vs. 40.5%, P<0.001), but most were manageable with standard care. Overall, the combination treatment was well tolerated, with types, rates and frequencies of adverse events consistent with individual use of PHP and checkpoint inhibitors. No new safety signals were identified.

The abstract is available at ESMO (Free ESMO Whitepaper) Congress 2025 – Mini Oral Session LBA59.

"The CHOPIN trial clearly demonstrates that adding ipilimumab and nivolumab to PHP is both effective and tolerable. The efficacy results are impressive, especially when considering the treatment regime included only two PHP treatments and did not include nivolumab maintenance. Since many oncologists start systemic therapy first, this approach provides valuable lead time for patient assessment and scheduling PHP, helping to overcome logistical barriers and support broader adoption and near- to medium-term uptake," said Gerard Michel, Chief Executive Officer of Delcath Systems.

A number of large, randomized clinical trials shows that patients with liver metastases typically have poorer outcomes than those with metastases elsewhere when treated with ICIs across multiple tumor types, including melanoma, non-small-cell lung cancer (NSCLC), urothelial carcinoma, and renal cell carcinoma1, 2. This diminished efficacy of ICIs has been attributed to the well-documented immunosuppressive nature of the liver microenvironment, with underlying mechanisms increasingly understood through preclinical and clinical research3.

"In addition to the potential immediate benefit to patients with metastatic uveal melanoma, the possible synergy of PHP and ICI therapy seen in the successful Phase 2 CHOPIN trial may be transferable to other cancers with liver-dominant disease, and Delcath looks forward to investigating that potential," said Dr. Vojislav Vukovic, Chief Medical Officer of Delcath Systems.

Conference Call Information

Delcath Systems, Inc. will host a conference call and webcast on October 20, 2025, at 8:45 a.m. Eastern Time to discuss the Phase 2 CHOPIN Trial results and provide a brief overview of the financial results and guidance announced in this release. Joining Delcath management on the call with pre-recorded remarks will be Dr. Vincent T. Ma, Assistant Professor and Medical Oncologist at the University of Wisconsin Department of Medicine, a current user of HEPZATO KIT for the treatment of metastatic uveal melanoma patients, an expert in treating cutaneous melanoma, and a co-author on the seminal Nature Medicine paper exploring liver immune tolerance mechanisms in cancer.

To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Monday, October 20
Time: 8:45 AM Eastern Time

Participant Numbers:
Toll Free: 1-877-407-3982
International: 1-201-493-6780
Webcast: View Source;tp_key=6f3953dd75

A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website View Source

(Press release, Delcath Systems, OCT 18, 2025, View Source [SID1234656766])

Results from EORTC trial define new standard of care for aggressive brain tumours

On October 18, 2025 EORTC reported that final results from CATNON trial show that the addition of 12 cycles of chemotherapy to radiotherapy can improve overall survival in a group of patients with a particular type of the rare brain tumour anaplastic glioma. The data will be presented today [Saturday] at the 20th Meeting of the European Association of Neuro-Oncology (EANO) by the study’s principal investigator, Dr Martin van den Bent, from the Erasmus MC Cancer Centre, Rotterdam, The Netherlands.

The results show that, after a median follow up of nearly 11 years, the addition of 12 cycles of the chemotherapy agent temozolomide (TMZ) to radiotherapy in patients with an anaplastic astrocytoma improved overall survival in the subset of patients with a tumour that had a mutation in the IDH gene (IDHmt). The median overall survival in IDHmt patients who received TMZ after RT was around 12 years.

There was no observable benefit when TMZ chemotherapy was given during radiotherapy, nor in patients in which the tumour did not show an IDH mutation. Several biological markers were associated with outcome in patients with an IDH mutated glioma but, importantly, benefit from the treatment was still observed regardless of those markers.

The study was carried out by researchers from ten countries worldwide, and randomised 751 adult patients with newly diagnosed anaplastic glioma to radiotherapy alone, radiotherapy with concurrent TMZ, radiotherapy with TMZ given after treatment (adjuvant therapy), and radiotherapy with both concurrent and adjuvant TMZ. The patients were enrolled in the trial between 2007 and 2015.

The researchers found that adjuvant (post-radiation) TMZ significantly extended survival. The study confirms the importance of distinguishing between patients with tumours with an IDH mutation and those without. In patients whose tumours had the IDH mutation, the median survival increased to 12.5 years compared with six years in the control group who were initially treated with radiotherapy only. There was no benefit to patients who had concurrent TMZ if they also received an adjuvant treatment, regardless of the IDH status of the tumour.

Methylation profiling, a technique that allows the precise detection of specific regions of DNA, helped predict patient prognosis but did not affect their response to TMZ. This suggests that the chemotherapy benefits most risk groups, the researchers say. The use of methylation profiling to identify DNA modifications showed that more aggressive tumours had significantly worse outcomes, but all patients with IDH-mutant tumours benefited from the standard treatment.

This combined treatment should become the standard of care for patients with anaplastic astrocytoma with an IDH mutation, according to the researchers. This was underlined by the EANO Scientific Committee with its award of the Best Oral Presentation for Clinical Research. Dr van den Bent said: "These results emphasise the importance of long-term follow-up. Thanks to the commitment of patients and the collaboration with partners worldwide, we have been able to identify the optimal treatment strategy that can extend life significantly in this patient population."

EORTC CEO Dr Denis Lacombe said: "Given the rarity of these tumours and the fact that the role of IDH in glioma was only discovered recently, it is a significant achievement to have delivered these results in a short time period, and further underlines the important role of academic clinical research in helping rare disease patients."

Presentation number: OS05.2.A Final clinical and molecular analysis of the EORTC randomized phase III intergroup CATNON trial on concurrent and adjuvant temozolomide in anaplastic glioma without 1p/19q codeletion.

(Press release, EORTC, OCT 18, 2025, View Source [SID1234656764])

Genentech’s Phase III evERA Data Showed Giredestrant Significantly Improved Progression-Free Survival in People With ER-Positive Advanced Breast Cancer

On October 18, 2025 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported positive results from the Phase III evERA Breast Cancer study. Data showed giredestrant in combination with everolimus significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 44% and 62% in the intention-to-treat (ITT) and ESR1-mutated populations, respectively, compared with standard-of-care endocrine therapy plus everolimus. The evERA study is evaluating the investigational giredestrant combination in people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer previously treated with cyclin-dependent kinase (CDK) 4/6 inhibitor and endocrine therapy. This is the first positive head-to-head Phase III trial investigating a selective estrogen receptor degrader-containing regimen versus a standard-of-care combination. The results are being presented in an oral session at the European Society for Medical Oncology Congress 2025. Data will be shared with health authorities, with the aim of bringing this potential treatment option to people as soon as possible.

"A particularly high unmet need remains for people who become resistant to endocrine therapies and CDK inhibitors. These study results support the potential for the giredestrant combination to become a new standard-of-care for all patients in this setting," said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development.

"Resistance to standard-of-care therapies is common in the post-CDK inhibitor setting, and the results from evERA validate using a combination to address this challenge," said Erica L. Mayer, M.D., Medical Oncologist at Dana-Farber Cancer Institute. "The clinically meaningful benefit observed with the giredestrant and everolimus all-oral combination is impressive and speaks to its potential to improve outcomes for patients in need of new treatment options."

The giredestrant combination demonstrated a statistically significant and clinically meaningful improvement in PFS compared with standard-of-care endocrine therapy plus everolimus. In the ITT population, the median PFS was 8.77 months compared with 5.49 months in the giredestrant and comparator arm, respectively (stratified hazard ratio [HR]=0.56; 95% CI: 0.44-0.71, p-value= <0.0001). In the ESR1-mutated population, the median PFS was 9.99 months compared with 5.45 months in the giredestrant and comparator arm, respectively (HR=0.38; 95% CI: 0.27-0.54, p-value= <0.0001). The PFS benefit was consistent across pre-specified subgroups in both populations. Overall survival (OS) data were immature at the time of analysis, but a clear positive trend has been observed in the ITT (HR=0.69, 95% CI: 0.47-1.00, p-value=0.0473) and ESR1-mutated populations (HR=0.62, 95% CI: 0.38-1.02, p-value=0.0566). Follow-up for OS will continue to next analysis. Giredestrant in combination with everolimus also demonstrated improvements in key secondary endpoints (objective response rate and duration of response) compared with the comparator arm across both patient populations.

Adverse events for the giredestrant-based combination were manageable and consistent with the known safety profiles of the individual medicines. No new safety signals were observed, including no photopsia.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases. Resistance to endocrine therapies, particularly in the post-CDK inhibitor setting, increases the risk of disease progression and is associated with poor outcomes. All-oral combination therapies, such as giredestrant plus everolimus, could address this by targeting two different signaling pathways while helping to minimize the impact of treatment on people’s lives without the need for injections.

Our extensive giredestrant clinical development program spans multiple treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.

About the evERA Breast Cancer study

evERA Breast Cancer [NCT05306340] is a Phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of giredestrant in combination with everolimus versus standard-of-care endocrine therapy in combination with everolimus in people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor and endocrine therapy, either in the adjuvant or locally advanced/metastatic setting.

The co-primary endpoints are investigator-assessed progression-free survival in the intention-to-treat and ESR1-mutated populations, defined as the time from randomization to the time when the disease progresses or a patient dies from any cause. The trial has been enriched for ESR1-mutated patients above the natural prevalence to assess the efficacy in this population. In the post-CDK inhibitor setting, up to 40% of people with ER-positive disease have ESR1 mutations. Key secondary endpoints include overall survival, objective response rate, duration of response, clinical benefit rate and safety.

About estrogen receptor (ER)-positive breast cancer

Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year. Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases. A defining feature of ER-positive breast cancer is that its tumor cells have receptors that attach to estrogen, which can contribute to tumor growth.

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity. Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy. There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.

About giredestrant

Giredestrant is an investigational oral, next-generation selective estrogen receptor degrader (SERD) and full antagonist.

Giredestrant is designed to block estrogen from binding to the estrogen receptor (ER), triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.

Giredestrant has an extensive clinical development program and is being investigated in five company-sponsored Phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in ER-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)
Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)
Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)
Giredestrant plus investigator’s choice of a cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)
Giredestrant plus dual HER2 blockade versus dual HER2 blockade in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)

(Press release, Genentech, OCT 18, 2025, View Source [SID1234656757])

Salubris Biotherapeutics Announces Dose Escalation Data for JK06, a 5T4-Targeted Antibody Drug Conjugate, at the European Society for Medical Oncology 2025 Congress

On October 18, 2025 Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, reported data from the dose escalation portion of the Phase 1/2 study of JK06, a 5T4-targeted antibody drug conjugate (ADC), in patients with unresectable locally advanced or metastatic cancer, including non-small cell lung cancer (NSCLC) and breast cancer, which is being presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

Data presented at ESMO (Free ESMO Whitepaper) include 34 patients enrolled in Europe with advanced relapsed/refractory solid tumors who were treated with JK06, once every three weeks, across five dose levels (1.5-8.0 mg/kg) in dose escalation. Among the 34 patients, 29 were response-evaluable, all having failed standard of care therapy, and among whom 83% had received three or more prior lines of treatment and 59% had received four or more prior lines of therapy at the time of enrollment.

Key efficacy findings among the 29 response-evaluable patients include:

6 patients attained confirmed partial responses (PRs) (21%).
Among 13 NSCLC patients, 5 attained confirmed PRs (ORR 38%), with the longest duration of response lasting 30 weeks.
Among 7 response-evaluable breast cancer patients, 1 attained a confirmed PR with a duration of response lasting 18 weeks.
PRs were observed at 3.0 mg/kg (1 NSCLC), 4.5 mg/kg (3 NSCLC and 1 breast cancer), and 6.0 mg/kg (1 NSCLC).
Treatment with JK06 has been generally well-tolerated with predominantly low grade (Grades 1 and 2), manageable toxicities, such as fatigue, alopecia, decreased appetite, dry eye and diarrhea. Among treatment-related adverse events (TRAEs) occurring in at least 5% of patients, only the following ≥ Grade 3 events were observed:

At dose levels 1.5-3.0 mg/kg (n=12 patients), 1 patient with Grade 3 peripheral neuropathy.
At dose level 4.5 mg/kg (n=15 patients), 1 patient with Grade 3 keratitis.
At dose levels 6.0-8.0 mg/kg (n=7 patients), 1 patient with Grade 3 fatigue, 1 patient with Grade 3 ALT increase, and 1 patient with Grade 5 pneumonitis.
Pharmacokinetic analysis demonstrated free monomethyl auristatin E (MMAE) levels that were favorable at dose levels up to 4.5 mg/kg.
"We are encouraged by the promising preliminary data demonstrating the combination of safety and efficacy of JK06 among heavily pre-treated metastatic solid tumors, including in NSCLC and breast cancer, supporting our belief that JK06 has the potential to be a first-in-class, differentiated therapy for patients with 5T4-expressing cancers," said Sam Murphy, Chief Executive Officer of Salubris Biotherapeutics. "We look forward to advancing the study into dose expansion in tumor-specific cohorts for NSCLC and breast cancer, while continuing to explore activity in other solid tumors known to overexpress 5T4, as we aim to improve outcomes for these patients with advanced, aggressive disease and limited therapeutic options."

The Phase 1/2 open-label, dose-escalation and expansion study (NCT06667960) to assess the safety, pharmacokinetics, and preliminary efficacy of JK06 is ongoing, and the cohort expansion phase, which is currently enrolling, will determine the recommended Phase 2 dose for further development.

Details of the ESMO (Free ESMO Whitepaper) presentation are as follows:

Title: A Phase 1/2 Study of JK06, a 5T4-Targeted Antibody Drug Conjugate (ADC), in Patients with Unresectable Locally Advanced or Metastatic Cancer
Presenter: Nuria Kotecki, M.D. at Institut Jules Bordet, Anderlecht, Belgium
Abstract #: 961P
Session: Developmental Therapeutics
Date/Time: Sunday, October 19, 2025 | 12:00 – 1:00 PM CEST

About JK06

JK06 is a first-in-class quadrivalent, biparatopic ADC that selectively targets 5T4 with a monomethyl auristatin E (MMAE) payload. 5T4 is an oncofetal protein that is overexpressed in a wide range of solid tumors, including NSCLC, breast, renal and genitourinary cancers, and is associated with more aggressive tumor progression and reduced survival. JK06 has demonstrated picomolar affinity for 5T4 and rapid internalization due to the biparatopic design. Together with stable, site-specific payload conjugation, JK06 has further demonstrated robust efficacy and a clean safety profile in non-clinical studies.

(Press release, Salubris Biotherapeutics, OCT 18, 2025, View Source [SID1234656756])