NEW
YORK, May 12, 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 reported business
highlights and certain preliminary financial results for the first
quarter ended March 31, 2023.
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: https://app.webinar.net/EwPL2ydl3ra
CONFERENCE REPLAY
US Toll Free: 1-877-344-7529
Canada Toll Free: 855-669-9658
Replay Access Code: 2940240
End Date: May 19,
2023
About Delcath Systems, Inc.
Delcath Systems, Inc. is an interventional oncology company
focused on the treatment of primary and metastatic liver cancers.
The company's proprietary products, HEPZATO Kit (melphalan
hydrochloride for Injection/Hepatic Delivery System) and
CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous
hepatic perfusion (PHP) are designed to administer high-dose
chemotherapy to the liver while controlling systemic exposure and
associated side effects during a PHP procedure.
In the United States, HEPZATO Kit is considered an
investigational drug/device combination product regulated as a drug
by the United States Food and Drug Administration (FDA).
HEPZATO Kit is comprised of the chemotherapeutic drug melphalan
and Delcath's proprietary Hepatic Delivery System (HDS).
The HDS is used to surgically isolate the liver while
simultaneously filtrating hepatic venous blood during melphalan
infusion and washout. The use of the HDS results in loco-regional
delivery of a relatively high melphalan dose, which can potentially
induce a clinically meaningful tumor response with minimal
hepatotoxicity and reduce systemic exposure. In the US, HEPZATO Kit
was the subject of a February 14, 2023 new drug
application resubmission to FDA for the treatment of patients with
unresectable hepatic-dominant metastatic ocular melanoma (mOM),
also known as metastatic uveal melanoma (mUM). FDA has established
an August 14, 2023 PDUFA date for the resubmission.
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, or CHEMOSAT, where it has been used in the conduct of
percutaneous hepatic perfusion procedures at major medical centers
to treat a wide range of cancers of the liver.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These forward-looking
statements include, without limitation, statements relating to:
Delcath's preliminary estimated financial results for the quarter
ended March 31,2023; the timing of
the filing of Delcath's Form 10-Q for the quarter ended
March 31, 2023; the therapeutic and
commercial potential of Delcath's product candidates, including the
Hepzato Kit and CHEMOSTAT; and other statements that are not
historical fact. These statements are not guarantees of
future performance and are subject to certain risks and
uncertainties that can cause actual results to differ materially
from those described herein. Factors that could cause actual
results to differ include, but are not limited to, uncertainties
relating to: adjustments to
Delcath's preliminary measures of financial
performance resulting from, among other things, the
completion of Delcath's financial close procedures, including
valuation work associated with the issuance of warrants and
preferred stock in the private placement; achievement of
milestones; the likelihood and timing of the potential approval of
HEPZATO by the FDA by the PDUFA date of August 14, 2023; the
Company's ability to commercialize HEPZATO;; the sufficiency of
Delcath's upfront and milestone financing payments to fund
commercialization of HEPZATO in the U.S.; Delcath's ability to
generate revenue from HEPZATO; clinical adoption, use and resulting
sales, if any, for the CHEMOSAT system to deliver and filter
melphalan in; the Company's ability to successfully commercialize
the HEPZATO KIT/CHEMOSAT system and the potential of the HEPZATO
KIT/CHEMOSAT system as a treatment for patients with primary and
metastatic disease in the liver; approval of the current or future
HEPZATO KIT/CHEMOSAT system for delivery and filtration of
melphalan or other chemotherapeutic agents for various indications
in the U.S. and/or in foreign markets; actions by the FDA or
foreign regulatory agencies; uncertainties relating to the timing
and results of research and development projects; uncertainties
regarding the Company's ability to obtain financial and other
resources for any research, development, clinical trials and
commercialization activities. These risks and uncertainties are
described more fully in our Securities and Exchange Commission
("SEC") filings and reports, including our Annual Report on Form
10-K for the year ended December 31,
2022, and other filings and reports made from time to time
with the SEC. You should not place undue reliance on these
forward-looking statements, which speak only as of the date they
are made. We undertake no obligation to publicly update or revise
these forward-looking statements to reflect events or circumstances
after the date they are made.
Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com
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SOURCE Delcath Systems, Inc.