Delcath Systems Reports First Quarter 2022 Results and Provides Business Update
10 Mai 2022 - 1:30PM
Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology
company focused on the treatment of primary and metastatic cancers
of the liver, today reported business highlights and financial
results for the first quarter ended March 31, 2022.
Recent Business Highlights
During and since the first quarter, Delcath:
- Held a pre-NDA
meeting with FDA and announced plans to file an NDA in the third
quarter of 2022,
- Announced the
acceptance of a poster presentation updating results from the FOCUS
Phase 3 Trial at the upcoming American Society of Clinical Oncology
(ASCO) 2022 Annual Meeting,
- Resumed direct
responsibility for sales, marketing, and distribution activities
for the CHEMOSAT® Hepatic Delivery System in all
of Europe,
- Achieved medical
device regulation (MDR) certification for CHEMOSAT in Europe,
which is now regulated as a Class lll device,
- Announced that
investigators from the University Hospital Southampton published in
Melanoma Research results of a single center study on Delcath's
CHEMOSAT Hepatic Delivery System in 81 metastatic uveal melanoma
patients with liver dominant disease receiving 250 treatments
showing hepatic disease control rate of 88.9%, hepatic response
rate of 66.7% and overall response rate of 60.5%, and
-
Appointed David Hoffman as General Counsel and Chief
Compliance Officer and Anthony Dias as Vice President of
Finance.
“During and since the first quarter, we held a pre-NDA meeting
with FDA and, while we wait for the final meeting minutes from FDA,
we do not believe any additional pre-clinical or clinical studies
will be required in order to file the NDA. We expect to file the
NDA in the third quarter of 2022,” said Gerard Michel, CEO of
Delcath. “Additionally, the body of published research on the
efficacy of our CHEMOSAT system in the European commercial setting
continued to grow, we resumed direct sales of CHEMOSAT in Europe,
and we strengthened our leadership team. These accomplishments move
us much closer to achieving our strategic priorities — filing
of the HEPZATO NDA, preparing for the subsequent US launch when
approved, and expanding the clinical development of HEPZATO and
CHEMOSAT into additional indications of high unmet medical
need.”
First Quarter 2022 Results
Income Statement Highlights.
Total revenue for the three months ended March 31, 2022 and
2021, was approximately $0.3 million, from primarily sales of
CHEMOSAT in Europe. Research and development expenses for the
quarter were $4.2 million compared to $3.7 million in the prior
year quarter. Selling, general and administrative expenses for the
quarter were approximately $3.6 million compared to $3.3 million in
the prior year quarter. Total operating expenses for the quarter
were $7.9 million compared with $7.0 million in the prior year
quarter.
The Company recorded a net loss for the three months ended March
31, 2022, of $8.2 million, compared to a net loss of $6.7 million
for the same period in 2021.
Balance Sheet Highlights
On March 31, 2022, the Company had cash, cash equivalents and
restricted cash totaling $20.5 million, as compared to cash, cash
equivalents and restricted cash totaling $27.0 million on December
31, 2021. During the three months ended March 31, 2022, and March
31, 2021, we used $6.4 million and $4.6 million, respectively, of
cash in our operating activities.
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes
before the beginning of the call.
Event Date: Tuesday, May 10, 2022Time: 8:30 AM Eastern
TimeParticipant Numbers: Toll Free: 877-545-0523; Participant
Access Code: 633971International: 973-528-0016 Participant Access
Code: 633971Webcast:
https://www.webcaster4.com/Webcast/Page/2475/45401
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 percutaneous hepatic perfusion (PHP)
system is designed to administer high-dose chemotherapy to the
liver while controlling systemic exposure and associated side
effects. In the United States, the PHP system is being developed
under the tradename HEPZATO KIT (melphalan hydrochloride for
injection/hepatic delivery system), or HEPZATO, for the treatment
of patients with unresectable hepatic-dominant metastatic ocular
melanoma (mOM), also known as metastatic uveal melanoma (mUM) and
is considered a combination drug and device product regulated by
the United States Food and Drug Administration (FDA).
In Europe, the PHP system is now regulated as a Class lll
medical device and is approved for sale under the trade name
CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where
it has been used at major medical centers to treat a wide range of
cancers of the liver.
Safe Harbor / Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a
safe harbor for forward-looking statements made by the Company or
on its behalf. This news release contains forward-looking
statements, which are subject to certain risks and uncertainties
that can cause actual results to differ materially from those
described. Factors that may cause such differences include, but are
not limited to, uncertainties relating to: the timing and results
of the Company’s clinical trials, including without limitation the
mOM and ICC clinical trial programs, as well as the receipt of
additional data and the performance of additional analyses with
respect to the mOM clinical trial, our determination whether to
continue the ICC clinical trial program or to focus on other
alternative indications, and timely monitoring and treatment of
patients in the global Phase 3 mOM clinical trial and the impact of
the COVID-19 pandemic on the completion of our clinical trials; the
impact of the presentations at major medical conferences and future
clinical results consistent with the data presented; approval of
Individual Funding Requests for reimbursement of the CHEMOSAT
procedure; the impact, if any, of ZE reimbursement on potential
CHEMOSAT product use and sales in Germany; clinical adoption, use
and resulting sales, if any, for the CHEMOSAT system to deliver and
filter melphalan in Europe including the key markets of Germany and
the UK; 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; our ability to obtain
reimbursement for the CHEMOSAT system in various markets; 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; the Company’s ability to
successfully enter into strategic partnership and distribution
arrangements in foreign markets and the timing and revenue, if any,
of the same; uncertainties relating to the timing and results of
research and development projects; and uncertainties regarding the
Company’s ability to obtain financial and other resources for any
research, development, clinical trials and commercialization
activities. These factors, and others, are discussed from time to
time in our filings with the Securities and Exchange Commission.
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.
Contact:
Delcath Investor
RelationsEmail: investorrelations@delcath.com
Hayden IRJames
Carbonara(646)-755-7412james@haydenir.com
|
|
|
|
|
|
|
|
|
|
|
|
DELCATH
SYSTEMS, INC. |
Condensed
Consolidated Balance Sheets |
(Unaudited, in
thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2022 |
|
|
|
2021 |
|
Assets |
|
|
|
Current
assets |
|
|
|
Cash and cash equivalents |
$ |
16,340 |
|
|
$ |
22,802 |
|
Restricted cash |
|
4,151 |
|
|
|
4,151 |
|
Accounts receivable, net |
|
178 |
|
|
|
44 |
|
Inventories |
|
2,011 |
|
|
|
1,412 |
|
Prepaid expenses and other current assets |
|
2,704 |
|
|
|
2,743 |
|
Total current assets |
|
25,384 |
|
|
|
31,152 |
|
Property, plant and equipment, net |
|
1,406 |
|
|
|
1,348 |
|
Right-of-use assets |
|
527 |
|
|
|
624 |
|
Total assets |
$ |
27,317 |
|
|
$ |
33,124 |
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
Current
liabilities |
|
|
|
Accounts payable |
$ |
1,243 |
|
|
$ |
638 |
|
Accrued expenses |
|
4,495 |
|
|
|
4,109 |
|
Deferred revenue, current |
|
— |
|
|
|
170 |
|
Lease liabilities, current |
|
404 |
|
|
|
416 |
|
Loan payable, current |
|
2,520 |
|
|
|
621 |
|
Total current liabilities |
|
8,662 |
|
|
|
5,954 |
|
Lease liabilities, non-current |
|
122 |
|
|
|
207 |
|
Loan payable, non-current |
|
8,633 |
|
|
|
10,372 |
|
Convertible notes payable, non-current |
|
4,675 |
|
|
|
4,639 |
|
Total liabilities |
|
22,092 |
|
|
|
21,172 |
|
|
|
|
|
Commitments
and contingencies (Note 13) |
|
— |
|
|
|
— |
|
|
|
|
|
Stockholders' equity |
|
|
|
Preferred stock, $.01 par value; 10,000,000 shares authorized;
11,357 shares issued and outstanding at March 31, 2022 and December
31, 2021 |
|
— |
|
|
|
— |
|
Common stock, $.01 par value; 40,000,000 shares authorized;
7,906,728 shares issued and outstanding at March 31, 2022 and
December 31, 2021 |
|
79 |
|
|
|
79 |
|
Additional paid-in capital |
|
434,305 |
|
|
|
432,831 |
|
Accumulated deficit |
|
(429,179 |
) |
|
|
(420,976 |
) |
Accumulated other comprehensive income |
|
20 |
|
|
|
18 |
|
Total stockholders' equity |
|
5,225 |
|
|
|
11,952 |
|
Total liabilities and stockholders' equity |
$ |
27,317 |
|
|
$ |
33,124 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DELCATH
SYSTEMS, INC. |
Condensed
Consolidated Statements of Operations and Comprehensive
Loss |
(Unaudited) |
(in thousands,
except share and per share data) |
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
2022 |
|
|
|
2021 |
|
Product
revenue |
$ |
207 |
|
|
$ |
261 |
|
Other
revenue |
|
171 |
|
|
|
127 |
|
Cost of
goods sold |
|
(33 |
) |
|
|
(112 |
) |
Gross profit |
|
345 |
|
|
|
276 |
|
|
|
|
|
Operating
expenses: |
|
|
|
Research and development expenses |
|
4,240 |
|
|
|
3,707 |
|
Selling, general and administrative expenses |
|
3,648 |
|
|
|
3,296 |
|
Total operating expenses |
|
7,888 |
|
|
|
7,003 |
|
Operating loss |
|
(7,543 |
) |
|
|
(6,727 |
) |
|
|
|
|
Interest
expense, net |
|
(645 |
) |
|
|
(41 |
) |
Other income
(expense), net |
|
(15 |
) |
|
|
21 |
|
Net loss |
|
(8,203 |
) |
|
|
(6,747 |
) |
|
|
|
|
Other comprehensive income: |
|
|
|
Foreign currency translation adjustments |
|
2 |
|
|
|
94 |
|
Total other comprehensive loss |
$ |
(8,201 |
) |
|
$ |
(6,653 |
) |
|
|
|
|
Common share
data: |
|
|
|
Basic and diluted loss per common share |
$ |
(1.00 |
) |
|
$ |
(1.04 |
) |
|
|
|
|
Weighted average number of basic and diluted shares
outstanding |
|
8,190,483 |
|
|
|
6,496,922 |
|
|
|
|
|
Delcath Systems (NASDAQ:DCTH)
Historical Stock Chart
Von Jun 2024 bis Jul 2024
Delcath Systems (NASDAQ:DCTH)
Historical Stock Chart
Von Jul 2023 bis Jul 2024