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Delcath Systems Inc. (Nasdaq: DCTH) is a prominent interventional oncology company focusing on the treatment of primary and metastatic liver cancers. The company's flagship product, the HEPZATO KIT™ (comprising Hepzato (melphalan) for Injection and the Hepatic Delivery System), offers a revolutionary approach to liver-directed chemotherapy. This system enables high-dose chemotherapy delivery directly to the liver, minimizing systemic exposure and associated side effects.
HEPZATO KIT is FDA-approved in the United States for treating adult patients with metastatic uveal melanoma (mUM) presenting unresectable hepatic metastases, especially when the metastases affect less than 50% of the liver and there is no extrahepatic disease, or extrahepatic disease limited to specific regions like bone or lymph nodes that can be managed surgically or through radiation. The product's approval followed the pivotal Phase 3 FOCUS study, which demonstrated a significant improvement in overall response rates and progression-free survival compared to historical data.
In Europe and the United Kingdom, Delcath markets the product under the trade name CHEMOSAT® Hepatic Delivery System for Melphalan. This device-only configuration has been utilized in over 250 treatments across 20 leading European cancer centers, establishing itself as a reliable option for liver cancer therapy.
Delcath continues to make strides in enhancing treatment accessibility. Recently, the company launched a Healthcare Setting Locator on their website to help patients, caregivers, and healthcare providers find facilities offering HEPZATO KIT treatment. The company also secured a permanent J-code for HEPZATO, streamlining the reimbursement process and facilitating broader patient access.
Recent business highlights include the first commercial use of HEPZATO KIT at Moffitt Cancer Center and the successful closing of a $7 million private placement to support ongoing commercial endeavors. Delcath has also published significant data from the FOCUS study in the Annals of Surgical Oncology, reinforcing the clinical efficacy of their treatment.
As Delcath Systems Inc. forges ahead, they remain committed to expanding the clinical adoption of their innovative therapies in major markets, thus providing critical treatment options to liver cancer patients worldwide.
Delcath Systems (NASDAQ: DCTH) received FDA clearance for its IND application to begin a Phase 2 clinical trial of HEPZATO™ in liver-dominant metastatic colorectal cancer (mCRC). The trial will evaluate HEPZATO combined with standard care versus standard care alone in approximately 90 patients across 20+ US and European sites. Patient enrollment is expected to start in H2 2025, with hepatic progression-free survival results by end-2027 and overall survival data in 2028. The target market includes 6,000-10,000 US patients annually receiving third-line treatment for liver-dominant mCRC.
Delcath Systems (NASDAQ: DCTH) reported strong Q3 2024 results with total revenue of $11.2 million, up 44% from previous quarter. This includes $10.0 million from HEPZATO KIT™ and $1.2 million from CHEMOSAT®. The company activated four new HEPZATO treatment centers in Q3 and one in October, reaching twelve active centers total. Cash position stood at $14.0 million with quarterly burn of $3.6 million. Post-quarter, Delcath cleared all debt obligations and received approximately $25 million from warrant exercises. R&D expenses decreased to $3.9 million from $4.7 million year-over-year, while SG&A expenses increased to $7.0 million from $6.2 million due to commercial launch activities.
Delcath Systems (Nasdaq: DCTH), a company specializing in interventional oncology for liver cancer treatments, has announced its participation in two upcoming investor conferences. The company will participate in the Stephens Biotechnology Virtual Fireside Chats on November 13, 2024, at 9:30 am Eastern Time, which will be held virtually. Additionally, Delcath will attend the 15th Annual Craig-Hallum Alpha Select Conference on November 19, 2024, in New York, NY, where they will conduct one-on-one meetings.
Delcath Systems (Nasdaq: DCTH), an interventional oncology company specializing in liver cancer treatments, has announced it will host a conference call on November 8, 2024, at 8:30 AM Eastern Time to discuss its third quarter 2024 financial results. The call will be accessible via toll-free and international dial-in numbers, with a webcast option available. A replay will be archived on the company's website after the event.
Delcath Systems (Nasdaq: DCTH) announced preliminary Q3 2024 revenue of $11.2 million, including $10.0 million in U.S. revenue from HEPZATO KIT commercialization. This $10 million U.S. revenue milestone triggers the exercise of Tranche B warrants from a previous PIPE, allowing holders to purchase common stock at $6.00 per share for up to $25 million. CEO Gerard Michel highlighted the strong demand for HEPZATO KIT in uveal melanoma patients with liver metastases. The additional $25 million financing will support the ongoing commercial launch and investment in new clinical trials for expanded indications planned for 2025. Delcath will provide final Q3 financial results and a detailed business update on November 8, 2024.
Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on liver cancer treatment, has announced the granting of equity awards to three new employees. These awards, approved by the Company's Compensation Committee, were granted as a material inducement to employment for individuals who joined in August 2024.
The grants include options to purchase a total of 46,000 shares of Delcath's common stock, subject to the terms of the Company's 2023 Inducement Plan. The options were granted on August 30, 2024, with an exercise price of $11.00 per share, matching the closing price of Delcath's stock on that date.
The vesting schedule for these 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 subsequent 24 months. The options have a ten-year term, and vesting is contingent upon continued employment with Delcath. These awards were granted in accordance with Nasdaq Listing Rule 5635(c)(4).
Delcath Systems (Nasdaq: DCTH) presented new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT™ at the ESMO Congress. The trial evaluated the efficacy and safety of HEPZATO KIT™ in patients with metastatic uveal melanoma (mUM). Key findings include:
1. No significant differences in overall survival (OS), objective response rate (ORR), or progression-free survival (PFS) between patients with and without extrahepatic lesions or based on prior therapy.
2. Consistent ORR and PFS regardless of liver tumor burden, but worse OS with more extensive liver involvement.
3. Objective tumor responses observed throughout the entire treatment period.
4. Consistent rates of serious adverse events (SAEs) and Grade 3/4 adverse events (AEs), indicating no cumulative toxicity.
These results support the favorable benefit-risk profile of HEPZATO KIT™ for mUM patients with treatment options.
Delcath Systems (Nasdaq: DCTH), a company specializing in interventional oncology for liver cancer treatment, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for Wednesday, September 11, 2024, at 11:00 a.m. Eastern Time. Delcath's management team will engage in a fireside chat during the conference, which will take place at the Lotte New York Palace Hotel in New York City.
This participation provides an opportunity for Delcath Systems to showcase its focus on treating primary and metastatic liver cancers to potential investors and industry professionals. The H.C. Wainwright conference is a significant platform for companies in the healthcare and life sciences sectors to present their latest developments and strategies.
Delcath Systems, Inc. (Nasdaq: DCTH) announced positive results from an independent study on liver-directed therapy for uveal melanoma patients. The study, published in Therapeutic Advances in Medical Oncology, showed that first-line liver-directed therapies, including Delcath's CHEMOSAT® Hepatic Delivery System, significantly improved melanoma-specific survival (MSS) in patients with liver metastases from uveal melanoma.
Key findings include:
- Patients receiving first-line liver-directed therapy (N=89) had a median MSS of 28 months, compared to 10 months for those receiving first-line systemic therapy (N=45)
- Patients diagnosed between 2016-2021 and treated with first-line liver-directed therapy, including CHEMOSAT, had a median MSS of 30 months, compared to 20 months for those diagnosed between 2005-2015
Delcath Systems, Inc. (Nasdaq: DCTH) announced positive outcomes from an independent study on hepatic perfusion for uveal melanoma patients. The study, conducted by researchers at Moffitt Cancer Center, compared Delcath's HEPZATO KIT™ to immunotherapy and other liver-directed therapies. Key findings include:
1. Overall Survival (OS): Median OS of 22.4 months for first-line therapy and 18.4 months for second-line therapy with HEPZATO KIT.
2. Hepatic Progression-Free Survival (hPFS): First-line HEPZATO KIT showed 17.6 months median hPFS, outperforming immunotherapy (8.8 months) and other therapies (9.2 months).
3. Progression-Free Survival (PFS): First-line HEPZATO KIT demonstrated 15.4 months median PFS, surpassing immunotherapy and other therapies.
The study suggests HEPZATO KIT provides better disease control and improved progression-free survival for patients with hepatic metastases from uveal melanoma.
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