On May 12, 2023 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, reported business highlights and certain preliminary financial results for the first quarter ended March 31, 2023 (Press release, Delcath Systems, MAY 12, 2023, View Source [SID1234631592]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Recent Business Highlights
During and since the first quarter, Delcath:
Received an acknowledgement of Class 2 NDA resubmission from the U.S. Food and Drug Administration (FDA) for Hepzato Kit (melphalan hydrochloride for Injection/Hepatic Delivery System) with a Prescription Drug User Fee Act (PDUFA) goal date of August 14, 2023,
Completed a private placement of up to $85 million in gross proceeds, including the closing of initial upfront funding of $25 million. The financing was led by Vivo Capital with participation from Logos Capital, BVF Partners LP, Stonepine Capital Management LLC, and Serrado Capital LLC as well as existing investors including Rosalind Advisors,
Amended an existing loan agreement with Avenue Venture Opportunities Fund, L.P. to provide an interest only period spanning March 31, 2023, to September 30, 2023 thereby deferring $4.3 million in principal payments,
Appointed John R. Sylvester as Chairman of the Board, and
Announced that updated results from the CHOPIN phase 1B trial were published in the Journal Cardiovascular and Interventional Radiology. The article reported seven patients with advanced uveal melanoma treated with CHEMOSAT and ipilimumab plus nivolumab showed a median PFS of 29.1 months at a median follow-up of 29.1 months.
"With a critical financing behind us, the Company is focused on preparing to commercialize Hepzato if approved," said Gerard Michel, Chief Executive Officer of Delcath. Mr. Michel added, "Importantly, as we approach the August 14 PDUFA date, we continue to expand the list of institutions that have indicated their interest in becoming a treating center upon approval."
Preliminary First Quarter 2023 Financial Results
Delcath is in the process of completing its customary quarter-end close and review procedures, including certain valuation work associated with the issuance of warrants and preferred stock in Delcath’s previously announced private placement that closed on March 29, 2023, as of and for the quarter ended March 31, 2023, and the final results for this period could materially differ from the preliminary expected results disclosed in this press release. Delcath’s full first quarter 2023 financial results will be reflected in a Quarterly Report on Form 10-Q, which pursuant to Rule 12b-25, is expected to be filed no later than May 22, 2023. The financial performance measures presented in this press release for the first quarter of 2023 are forward-looking statements, preliminary estimates and unaudited, based on management’s initial review of the information presented, and are thus inherently uncertain and subject to change as Delcath completes its end-of-period reporting process and related activities for the first quarter of 2023. During the course of the review of Delcath’s condensed consolidated financial statements and related notes as of and for the quarter ended March 31, 2023, Delcath’s independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary estimates presented herein. Additional information and disclosures would be required for a more complete understanding of Delcath’s financial position and results of operations as of and for the quarter ended March 31, 2023. Accordingly, undue reliance should not be placed on this preliminary information.
Financial Highlights.
Revenue is expected to be approximately $0.6 million in revenue for the three months ended March 31, 2023, compared to $0.4 million for the three months ended March 31, 2022. The estimated increase in product revenue was due to the transition to direct sales in Europe which occurred in March 2022 as well as an approximately 37% increase in unit volume.
For the three months ended March 31, 2023, research and development expenses is expected to be relatively flat at approximately $4.5 million for both periods compared to the three months ended March 31, 2022.
As of March 31, 2023, the Company had cash, cash equivalents and restricted cash totaling $24.3 million, as compared to cash, cash equivalents and restricted cash totaling $11.8 million as of March 31, 2022. The increase in cash of $12.5 million was due to the proceeds from the private placement which closed on March 29, 2023, offset by the use of $4.3 million of cash in our operating activities and $6.3 million of principal payments toward the Company’s existing loan with Avenue.
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.
Event Date: Friday May 12, 2023
Time: 8:30 AM Eastern Time
Participant Numbers: Toll Free: 1-833-630-1960
International: 1-412-317-1841
Webcast: View Source
CONFERENCE REPLAY
US Toll Free: 1-877-344-7529
Canada Toll Free: 855-669-9658
Replay Access Code: 2940240
End Date: May 19, 2023