Delcath Systems, Inc. (Nasdaq:
DCTH), an
interventional oncology company focused on the treatment of rare
primary and metastatic cancers of the liver, today reported
business highlights and financial results for the third quarter
ended September 30, 2021.
Recent Business Highlights
During and since the third quarter Delcath:
- Entered a debt
facility with Avenue Venture Opportunities Fund, L.P. providing up
to $20 million with an initial $15 million funded at closing,
- Submitted to and
received approval from the FDA for an expanded access protocol for
the use of HEPZATO™ Kit (melphalan hydrochloride for
injection/hepatic delivery system) in the treatment of patients
with liver dominant metastatic ocular melanoma,
- Updated guidance
of the Class 2 resubmission of the NDA to mid-year from the end of
the first quarter,
- Hired 3 senior
executives in clinical operations, regulatory and medical affairs
to support the resubmission of the NDA and further clinical
development of HEPZATO, and
- Announced it will
host a comprehensive Investor Update event on Thursday,
December 2nd, from 10:00am ET – 1:00pm ET covering
FOCUS trial results as well as development plans for the use of
HEPZATO in the treatment of patients with intrahepatic
cholangiocarcinoma and colorectal cancer.
In addition, during the third quarter independent
investigators:
- Presented three
abstracts on the use of Chemosat® Hepatic Delivery System with
Melphalan in the treatment of metastatic ocular melanoma (mOM) at
the 2021 Cardiovascular and Interventional Radiological Society of
Europe conference (CIRSE) including,
- Safety and
toxicity of combining hepatic percutaneous perfusion with
ipilimumab plus nivolumab in advanced uveal melanoma: phase 1b of
the CHOPIN Trial1
- Long-term results
of percutaneous hepatic perfusion with melphalan in patients with
unresectable liver metastases from uveal melanoma: a multicenter
retrospective study2
- Safety and
efficacy of chemosaturation with percutaneous hepatic perfusion of
melphalan for metastatic uveal melanoma: an 8-year retrospective
study of 250 interventions in 81 patients3
- Published Repeated
percutaneous hepatic perfusion with melphalan can maintain
long-term response in patients with liver cancers4 in the journal
Cardiovascular and Interventional Radiology.
“It’s very exciting to see the initial results of the CHOPIN
Trial. These early results in the first trial to combine
percutaneous hepatic perfusion with combination immunotherapy show
promise with no dose limiting toxicities observed to date. The
significant disease control and repeatability of the procedure with
limited cumulative toxicity observed in these recent publications
is consistent with what we have seen documented from other
institutions,” said Dr. Johnny John, SVP Clinical Operations and
Medical Affairs.
“During the quarter we strengthened our balance sheet and added
senior personnel to the Delcath team,” said Gerard Michel, CEO of
Delcath. “With the additional capital and senior leadership,
Delcath has the required resources to accomplish its strategic
priorities – the filing of the HEPZATO NDA in mid-2022, preparing
for the subsequent US launch when approved, and expanding the
development of HEPZATO into additional areas of high unmet
need.”
Financial Results:
Income Statement Highlights.
Product revenue for the three months ended September 30, 2021
was approximately $522 thousand, compared to $466 thousand for the
prior year period from our sales of CHEMOSAT procedures in Europe.
Selling, general and administrative expenses were approximately
$4.0 million compared to $2.0 million in the prior year quarter.
Research and development expenses for the quarter were $3.0 million
compared to $3.3 million in the prior year quarter. Total operating
expenses for the quarter were $7.0 million compared with $5.3
million in the prior year quarter. Expenses for the quarter
included approximately $2.5 million of stock option expense
compared to no stock option expense in the prior year quarter.
The Company recorded a net loss for the three months ended
September 30, 2021, of $7.1 million, compared to a net loss of $5.0
million for the same period in 2020.
Balance Sheet Highlights.
On September 30, 2021, we had cash, cash equivalents and
restricted cash totaling $29 million, as compared to cash, cash
equivalents and restricted cash totaling $11.1 million at September
30, 2020. During the three months ended September 30, 2021 and
September 30, 2020, we used $16.2 million and $17.8 million,
respectively, of cash in our operating activities.
On August 6, 2021 we closed a $20 million venture debt financing
transaction with Avenue Venture Opportunities Fund, L.P. ("Avenue
Venture Fund"), at which time an initial $15 million tranche of the
loan was funded, including $4 million funded into a restricted
account to be released upon achievement of certain milestones. The
Company may request an additional $5 million tranche of the loan
between October 1, 2022 and December 31, 2022, the funding of which
will be at Avenue Venture Fund’s discretion.
Also, on August 6, 2021, we amended two existing convertible
notes through an extension of the term of the notes until 2024 and
lowered the conversion factor in consideration for the notes
becoming subordinate to the Avenue Venture Fund debt.
Additional details concerning the Avenue Venture Fund facility
and modification of the existing convertible notes are contained in
the Company's Current Report on Form 8-K filed with the Securities
and Exchange Commission on August 11, 2021.
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes
before the beginning of the call.
Date: November 9, 2021Time: 8:30 AM Eastern TimeToll Free:
888-506-0062; Entry Code: 676028International: 973-528-0011; Entry
Code: 676028
The call will also be available over the Internet and accessible
at:
https://www.webcaster4.com/Webcast/Page/2475/43392
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, 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 regulated as a Class IIb 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.
- Tong T, Burgmans M,
van der Kooij M, Speetjens F, van Erkel A, Van der Meer R, van
Rijswijk C, van den Bosch S, Jonker M, Roozen I, Lutjeboer J,
Rijksen F, van Persijn van Meerten E, Martini C, Zoethout R, Tijl
F, Blank C, Kapiteijn E. Safety and Toxicity of Combining Hepatic
Percutaneous Perfusion with Ipilimumab plus Nivolumab in advanced
Uveal Melanoma: phase 1b of the CHOPIN Trial. In: Cardiovascular
and Interventional Radiological Society of Europe (CIRSE) Summit
2021 Abstract Book; 25-27 September 2021; Online. FP-96:s95.
- Samim M, Tong T,
Kapiteijn E, Meijer TS, Speetjens F, Brüning R, Schroeder H,
El-Sanosy S, Maschke H, Wacker F, Vogel A, Dewald C, Goeman J,
Burgmans M. Long-term results of percutaneous hepatic perfusion
with melphalan in patients with unresectable liver metastases from
uveal melanoma: a multicenter retrospective study. In:
Cardiovascular and Interventional Radiological Society of Europe
(CIRSE) Summit 2021 Abstract Book; 25-27 September 2021; Online.
FP-97:s96.
- Gibson T,
Vigneswaran G, Patel S, Gupta S, Karydis I, Wheater M, Stedman B,
Modi S. Safety and efficacy of chemosaturation with percutaneous
hepatic perfusion of melphalan for metastatic uveal melanoma: an
8-year retrospective study of 250 interventions in 81 patients. In:
Cardiovascular and Interventional Radiological Society of Europe
(CIRSE) Summit 2021 Abstract Book; 25-27 September 2021; Online.
FP-132:s106-s107.
- Veelken R, Maiwald B, Strocka S, Petersen TO, Moche M, Ebel S,
Denecke T, Rehak M, Struck MF, Forstmeyer D, Rademacher S, Seehofer
D, Berg T, van Bömmel F. Repeated percutaneous hepatic perfusion
with melphalan can maintain long-term response in patients with
liver cancers. Cardiovasc Intervent Radiol. 2021 Oct 29. doi:
10.1007/s00270-021-02983-2. Epub ahead of print.
Contact:
Delcath Investor Relations
Email: investorrelations@delcath.com
Hayden IR
James
Carbonara(646)-755-7412james@haydenir.com
DELCATH SYSTEMS,
INC.Condensed Consolidated Balance
Sheets(Unaudited)(in thousands, except
share and per share data)
|
September 30, |
|
|
December 31, |
|
|
2021 |
|
|
2020 |
|
Assets |
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
24,865 |
|
|
$ |
28,575 |
|
Restricted cash |
|
4,151 |
|
|
|
181 |
|
Accounts receivable, net |
|
69 |
|
|
|
57 |
|
Inventories |
|
1,238 |
|
|
|
855 |
|
Prepaid expenses and other current assets |
|
1,995 |
|
|
|
2,670 |
|
Total current assets |
|
32,318 |
|
|
|
32,338 |
|
Property, plant and equipment, net |
|
1,380 |
|
|
|
1,351 |
|
Right-of-use assets |
|
727 |
|
|
|
946 |
|
Total assets |
$ |
34,425 |
|
|
$ |
34,635 |
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
Accounts payable |
$ |
1,187 |
|
|
$ |
1,774 |
|
Accrued expenses |
|
3,269 |
|
|
|
4,859 |
|
Deferred revenue, current |
|
496 |
|
|
|
525 |
|
Lease liabilities, current |
|
409 |
|
|
|
495 |
|
Loan payable, current |
|
— |
|
|
|
382 |
|
Convertible notes payable, current |
|
— |
|
|
|
2,000 |
|
Total current liabilities |
|
5,361 |
|
|
|
10,035 |
|
Deferred revenue, non-current |
|
1,584 |
|
|
|
2,072 |
|
Lease liabilities, non-current |
|
318 |
|
|
|
450 |
|
Loan payable, non-current |
|
10,834 |
|
|
|
— |
|
Convertible notes payable, non-current |
|
4,602 |
|
|
|
— |
|
Total liabilities |
|
22,699 |
|
|
|
12,557 |
|
|
|
|
|
|
|
|
|
Commitments and contingencies
(Note 11) |
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
|
Preferred stock, $.01 par value; 10,000,000 shares authorized;
11,707 and 20,631 shares issued and outstanding at September
30, 2021, and December 31, 2020, respectively |
|
— |
|
|
|
— |
|
Common stock, $.01 par value; 40,000,000 shares authorized;
7,356,289 and 5,996,101 shares issued and outstanding at
September 30, 2021, and December 31, 2020, respectively |
|
74 |
|
|
|
60 |
|
Additional paid-in capital |
|
427,301 |
|
|
|
417,449 |
|
Accumulated deficit |
|
(415,629 |
) |
|
|
(395,327 |
) |
Accumulated other comprehensive loss |
|
(20 |
) |
|
|
(104 |
) |
Total stockholders' equity |
|
11,726 |
|
|
|
22,078 |
|
Total liabilities and stockholders' equity |
$ |
34,425 |
|
|
$ |
34,635 |
|
DELCATH SYSTEMS,
INC.Condensed Consolidated Statements of
Operations and Comprehensive
Loss(Unaudited)(in thousands, except
share and per share data)
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Product revenue |
$ |
395 |
|
|
$ |
340 |
|
|
$ |
1,054 |
|
|
$ |
778 |
|
Other revenue |
|
127 |
|
|
|
126 |
|
|
|
393 |
|
|
|
361 |
|
Cost of goods sold |
|
(227 |
) |
|
|
(188 |
) |
|
|
(541 |
) |
|
|
(434 |
) |
Gross profit |
|
295 |
|
|
|
278 |
|
|
|
906 |
|
|
|
705 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
2,955 |
|
|
|
3,260 |
|
|
|
10,159 |
|
|
|
8,457 |
|
Selling, general and administrative expenses |
|
4,036 |
|
|
|
1,998 |
|
|
|
10,621 |
|
|
|
6,571 |
|
Total operating expenses |
|
6,991 |
|
|
|
5,258 |
|
|
|
20,780 |
|
|
|
15,028 |
|
Operating loss |
|
(6,696 |
) |
|
|
(4,980 |
) |
|
|
(19,874 |
) |
|
|
(14,323 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of the
warrant liability, net |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2,832 |
) |
Interest expense, net |
|
(420 |
) |
|
|
(44 |
) |
|
|
(501 |
) |
|
|
(132 |
) |
Other income (loss) |
|
(9 |
) |
|
|
33 |
|
|
|
73 |
|
|
|
160 |
|
Net loss |
|
(7,125 |
) |
|
|
(4,991 |
) |
|
|
(20,302 |
) |
|
|
(17,127 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deemed dividend for triggering of warrant down round feature |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(55 |
) |
Net loss attributable to common stockholders |
$ |
(7,125 |
) |
|
$ |
(4,991 |
) |
|
$ |
(20,302 |
) |
|
$ |
(17,182 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(7,125 |
) |
|
$ |
(4,991 |
) |
|
$ |
(20,302 |
) |
|
$ |
(17,127 |
) |
Other comprehensive (loss) income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments |
|
51 |
|
|
|
(103 |
) |
|
|
84 |
|
|
|
(39 |
) |
Total other comprehensive loss |
$ |
(7,074 |
) |
|
$ |
(5,094 |
) |
|
$ |
(20,218 |
) |
|
$ |
(17,166 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common share data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per common share |
$ |
(0.94 |
) |
|
$ |
(1.16 |
) |
|
$ |
(2.93 |
) |
|
$ |
(7.75 |
) |
Diluted loss per common share |
$ |
(0.94 |
) |
|
$ |
(1.16 |
) |
|
$ |
(2.93 |
) |
|
$ |
(7.75 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of basic shares outstanding |
|
7,587,643 |
|
|
|
4,288,593 |
|
|
|
6,923,541 |
|
|
|
2,217,611 |
|
Weighted average number of diluted shares outstanding |
|
7,587,643 |
|
|
|
4,288,593 |
|
|
|
6,923,541 |
|
|
|
2,217,611 |
|
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