- August 9, 2023
- Posted by: legaleseblogger
- Category: Related News
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**Delcath Systems, Inc. Reports Business Highlights and Financial Results for Q2 2023**
New York, Aug. 9, 2023 /PRNewswire/ — Delcath Systems, Inc. (Nasdaq: DCTH) (“Delcath” or the “Company”), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced its business highlights and financial results for the second quarter ended June 30, 2023. The Company continues to make significant progress in its mission to provide effective treatments for liver cancers.
**Business Highlights**
During the second quarter and beyond, Delcath achieved several key milestones:
1. Communication with FDA: Delcath has maintained consistent communication with the United States Food and Drug Administration (FDA) regarding the review of the HEPZATO KITÔäó New Drug Application (NDA) resubmission. The expected PDUFA date for the NDA is August 14, 2023.
2. Stockholder Approval: Delcath received stockholder approval for the potential issuance of over 19.99% of the Company’s outstanding common stock. This issuance is contingent upon the conversion of preferred stock issued through a private placement that closed on March 29, 2023. The private placement generated $25 million upon closing with the potential for up to an additional $35 million upon the exercise of warrants and achievement of specific revenue milestones.
3. Key Hires: Delcath has expanded its team by hiring experienced professionals in critical roles. Dr. Vojislav Vukovic, MD, PhD has joined as Chief Medical Officer, Sandra Pennell as Senior Vice President of Finance, and Zac MacLean as Director of Sales and Strategy. These additions will enhance Delcath’s ability to navigate the commercialization process effectively.
4. Continued Patient Treatment: Delcath has continued to treat patients at three Expanded Access Program sites. This ongoing treatment demonstrates the Company’s commitment to improving patient outcomes and advancing the field of interventional oncology.
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**Second Quarter 2023 Results**
Financial Highlights:
– Total revenue for the three months ended June 30, 2023, was approximately $0.5 million, compared to $0.8 million for the same period in the prior year. This slight decrease in product revenue is primarily attributed to potential commercial patients in the Netherlands being treated in the CHOPIN trial and reduced demand in Germany, possibly due to tebentefusp usage.
– Research and development expenses for the quarter were $3.6 million, a decrease from $5.6 million in the prior year quarter. The decrease is mainly due to the completion of clinical trial activities. The prior year quarter included expenses related to the preparation of the pre-NDA meeting with the FDA.
– Selling, general, and administrative expenses for the quarter increased to $4.8 million, compared to $4.5 million in the prior year quarter. This increase is primarily related to activities aimed at preparing for a potential commercial launch of HEPZATO KIT upon approval.
**About Delcath Systems, Inc.**
Delcath Systems, Inc. is an interventional oncology company that focuses on the treatment of primary and metastatic liver cancers. The Company’s proprietary products, HEPZATO KIT and CHEMOSAT Hepatic Delivery System, are designed to deliver high-dose chemotherapy to the liver while minimizing systemic exposure and associated side effects.
HEPZATO KIT is considered a combination drug and device product in the United States and is regulated as a drug by the FDA. It consists of the chemotherapeutic drug melphalan and Delcath’s proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the liver during melphalan infusion, resulting in loco-regional delivery of a high melphalan dose with minimal hepatotoxicity.
In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan. It has been used in major medical centers to treat various liver cancers.
**Safe Harbor / Forward-Looking Statements**
Delcath Systems, Inc. cautions that the statements included in this news release may contain forward-looking statements. These statements are subject to certain risks and uncertainties, which could cause actual results to differ materially from those described. Factors that may cause such differences include the potential approval and commercialization of HEPZATO KIT, the availability of necessary financing, clinical adoption and resulting sales of the CHEMOSAT system, regulatory actions, manufacturing delays, and the Company’s ability to obtain resources for research and development activities.
Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
[email protected]
**DELCATH SYSTEMS, INC.**
**Condensed Consolidated Balance Sheets** (Unaudited)
(in thousands, except share and per share data)
|                       |June 30,2023   |December 31,2022|
|———————–|—————|—————-|
|**Assets**             |               |                |
|Current assets         |14,540         |7,671           |
|Restricted cash        |50             |4,151           |
|Accounts receivable, net|127            |366             |
|Inventory              |2,480          |1,998           |
|Prepaid expenses and other current assets|2,275|1,969|
|Total current assets   |19,472         |16,155          |
|Property, plant and equipment, net|1,403|1,422|
|Right-of-use assets    |175            |285             |
|Total assets           |21,050         |17,862          |
**Liabilities and Stockholders’ Equity**
|                       |June 30,2023   |December 31,2022|
|———————–|—————|—————-|
|**Liabilities**        |               |                |
|Current liabilities    |               |                |
|Accounts payable       |966            |2,018           |
|Accrued expenses       |5,546          |4,685           |
|Lease liabilities, current|92           |186             |
|Loan payable, current  |4,510          |7,846           |
|Total current liabilities|11,114        |14,735          |
|Warrant liability┬á┬á┬á┬á┬á┬á|3,780┬á┬á┬á┬á┬á┬á┬á┬á┬á┬á|ÔÇö┬á┬á┬á┬á┬á┬á┬á┬á┬á┬á┬á┬á┬á┬á┬á|
|Other liabilities, non-current|1,146      |1,144           |
|Loan payable, non-current|411           |3,070           |
|Convertible notes payable, non-current|4,841|4,772|
|Total liabilities      |21,292         |23,721          |
|Commitments and contingencies|          |                |
|**Stockholders’ Equity (Deficit)**|┬á┬á┬á┬á┬á┬á|┬á┬á┬á┬á┬á┬á┬á┬á┬á┬á┬á┬á┬á┬á┬á┬á|
|Preferred stock, $0.01 par value; 10,000,000 shares authorized; 20,981 and 11,357 shares issued and outstanding at June┬á30, 2023 and December┬á31, 2022, respectively|ÔÇö|ÔÇö|
|Common stock, $0.01 par value; 80,000,000 shares authorized; 15,250,469 shares and 10,046,571 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively|153|100|
|Additional paid-in capital|473,355             |451,
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