Delcath Sys Stock Price, News & Analysis

Delcath Systems (Nasdaq: DCTH) announced promising results from an independent study on its CHEMOSAT® Hepatic Delivery System for liver tumors. The study, conducted at the University Hospital of Leipzig, Germany, evaluated 33 patients with various cancers, including uveal melanoma and cholangiocarcinoma. Key findings include:

- A 91% disease control rate
- 18.2% of patients achieved complete response in the liver
- Median hepatic progression-free survival of 52 weeks across all patients
- 69 weeks median hPFS in uveal melanoma patients
- 38 weeks median hPFS in cholangiocarcinoma patients

The study highlights the efficacy and safety of repeated CHEMOSAT treatments, showing potential as an essential tool for managing primary and secondary liver tumors.

Delcath Systems (Nasdaq: DCTH) announced a poster presentation at the 2024 ESMO Congress in Barcelona, Spain. The presentation, scheduled for September 14, 2024, will showcase data from the FOCUS Phase 3 study, focusing on the efficacy of the Melphalan/Hepatic Delivery System (Melphalan/HDS) in patients with unresectable metastatic uveal melanoma (mUM).

The poster, titled 'Subgroup Analysis of FOCUS Phase 3 Trial Efficacy Results,' will highlight the treatment's effectiveness across six patient subgroups. This presentation represents an important opportunity for Delcath to share its research findings with the international oncology community at one of the field's most prestigious conferences.

Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company, has announced the granting of an equity award as a material inducement to employment. The grant, approved by the Company's Compensation Committee, includes the right to purchase 23,000 shares of Delcath's common stock. The options were granted on July 31, 2024, with an exercise price of $8.62, matching the closing price of Delcath's common stock on that date.

The vesting schedule for the options is as follows: one-third will vest on the first anniversary of the grant date, with the remaining two-thirds vesting in equal monthly installments over the following 24 months. The options have a ten-year term and are subject to the employee's continued employment with Delcath. This award was granted in accordance with Nasdaq Listing Rule 5635(c)(4) and the terms of the Company's 2023 Inducement Plan.

Delcath Systems (Nasdaq: DCTH) reported Q2 2024 results, with total revenue of $7.8 million, including $6.6 million from HEPZATO KIT™ sales in the US and $1.2 million from CHEMOSAT sales in Europe. The company activated three new HEPZATO KIT treating centers in Q2, bringing the total to eight active centers. Delcath received New Technology Add-on Payment status for HEPZATO from CMS, published key results from the Phase 3 FOCUS study, and announced the acceptance of the FOCUS study efficacy analysis for presentation at the upcoming ESMO conference. The company ended the quarter with $19.9 million in cash and investments.

R&D expenses were $3.4 million, down from $3.6 million in Q2 2023, while SG&A expenses increased to $6.8 million from $4.8 million, primarily due to commercial launch activities. CEO Gerard Michel expressed optimism about HEPZATO KIT's adoption and its potential as a key therapeutic approach for metastatic uveal melanoma patients.

Delcath Systems (Nasdaq: DCTH) has announced that the Centers for Medicare & Medicaid Services (CMS) has granted New Technology Add-on Payment (NTAP) status for its HEPZATO KIT™. This approval, effective from October 1, 2024, will support the adoption of this innovative liver-directed therapy under the CMS Inpatient Prospective Payment System.

The NTAP designation will help cover costs associated with HEPZATO KIT for eligible Medicare inpatients, ensuring broader access to this treatment. The HEPZATO KIT is a combination product that delivers high-dose chemotherapy directly to the liver while minimizing systemic exposure, indicated for treating adult patients with unresectable hepatic-dominant metastatic uveal melanoma.

Delcath Systems (Nasdaq: DCTH), an interventional oncology company focusing on liver cancer treatments, has announced its participation in two upcoming investor conferences. The company will attend the BTIG Virtual Biotechnology Conference on August 6, 2024, which will be held virtually. Additionally, Delcath will present at Canaccord Genuity's 44th Annual Growth Conference on August 14, 2024, at 9:30 am Eastern Time in Boston, MA.

These conferences provide Delcath Systems with opportunities to showcase its advancements in liver cancer treatment and engage with investors. The company's participation in both virtual and in-person events demonstrates its commitment to maintaining strong investor relations and promoting its innovative oncology solutions.

Delcath Systems (Nasdaq: DCTH), an interventional oncology company specializing in liver cancer treatments, has announced its upcoming second quarter 2024 earnings call. The call is scheduled for August 5, 2024, at 4:30 PM Eastern Time. Investors and interested parties can participate by dialing the provided toll-free or international numbers. A webcast of the call will also be available, with a replay accessible on the company's website shortly after the event concludes.

This earnings call will provide insights into Delcath's financial performance and operational updates for the quarter ended June 30, 2024. As a company focused on innovative liver cancer treatments, the call may offer valuable information on Delcath's progress in the oncology field and its market position.

Delcath Systems (Nasdaq: DCTH) reported its Q1 2024 financial results and business highlights on May 14, 2024. The company recognized $3.1 million in total revenue, a significant increase from $0.6 million in Q1 2023, driven by sales of HEPZATO KIT and CHEMOSAT. Delcath updated its U.S. center activation guidance to 20 by end of 2024, activated six new centers, and has five more preparing for activation. The company raised $7.0 million in a private placement and has cash reserves totaling $27.2 million.

Delcath appointed Martha S. Rook, Ph.D., as COO and received a permanent J-code and pass-through payment status for HEPZATO KIT from CMS effective April 1, 2024. Research and development expenses decreased to $3.7 million, while selling, general, and administrative expenses rose to $8.8 million, mainly due to commercial launch activities. The company also published pivotal Phase 3 FOCUS study results on HEPZATO KIT for treating unresectable metastatic Uveal Melanoma in the Annals of Surgical Oncology.

Delcath Systems, Inc. (Nasdaq: DCTH) will host a conference call on May 14, 2024, to discuss first quarter results. The company focuses on interventional oncology for liver cancers.