NEW YORK, Nov. 14, 2017 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (OTCQB:DCTHD), an interventional oncology
Company focused on the treatment of primary and metastatic liver cancers, announces financial results for the three and nine months
ended September 30, 2017.
Highlights from the third quarter of 2017 and recent weeks include:
- Revenue for the third quarter of 2017 increased 75% to $0.7 million from $0.4 million in the prior-year quarter;
- Revenue for the first nine months of 2017 increased 53% to $2.0 million from $1.3 million in the prior-year period;
- Medical University of Hannover achieved its 100th CHEMOSAT treatment milestone; over 450 commercial CHEMOSAT
procedures have been performed in Europe;
- Positive results from a single institution study of CHEMOSAT filtration efficiency were presented at 2017 CIRSE annual
meeting in September; and
- Reverse stock split effected at ratio of 1:350 on November 6, 2017.
Management Commentary
“During our third quarter, we focused on resolving the cash constraints and other restrictions related to our
authorized shares limit, which necessitated the reverse stock split we effected on November 6, 2017. The authorized share
limit prevented the Company from accessing the restricted cash otherwise available under our 2016 convertible notes. With the
ability to issues shares now restored, we are able to access the balance of the restricted cash and begin exploring opportunities
for new equity financing necessary to execute on our Clinical Development Program (CDP) and European commercialization,” said
Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath.
“Despite the cash constraints, revenues for the third quarter of 2017 increased 75% over the prior year quarter,
continuing the steady growth in our core European markets. This growth was supported by the establishment of ZE
diagnostic-related (DRG) reimbursement for CHEMOSAT in Germany last year, which we are leveraging to obtain market access and
reimbursement in other regions such as the United Kingdom and the Netherlands. In the Netherlands, Dutch Health Authorities have
included CHEMOSAT treatment in their published guidelines for ocular melanoma liver metastases, an important step toward eventual
reimbursement coverage of CHEMOSAT in the Dutch market. During the quarter, Medical University of Hannover performed their
100th treatment since beginning CHEMOSAT procedures in 2014, the second of our Europe centers to have achieved this
milestone. Since launching CHEMOSAT in Europe, over 450 commercial CHEMOSAT procedures have been performed.
“In our Clinical Development Program (CDP), our primary focus continues to be on our FOCUS Phase 3 clinical
trial of Melphalan/HDS in hepatic dominant ocular melanoma (the FOCUS trial). Enrollment in this trial has been proceeding more
slowly than anticipated, and cash constraints during the quarter limited our ability to take steps to accelerate enrollment. With
the reverse split effected we are exploring steps to accelerate enrollment, and will seek to add new trial sites in both the U.S.
and Europe once new equity financing is secured. We still expect to conduct an interim safety analysis by the end of this
year.
“For our pivotal trial in intrahepatic cholangiocarcinoma (ICC), we continue to work with potential trial sites
with a view to initiating enrollment when financial resources permit. Our ICC pivotal trial is based on the prior work done
in our Phase 2 trial program in hepatocellular carcinoma (HCC) and ICC, which had the objective of identifying an efficacy signal
worthy of further clinical investigation. This objective was met by the retrospective data collection performed by European
investigators last year, which informed our development path for ICC. With the Phase 2 trial program goals now met, we have closed
enrollment in the Phase 2 trials to devote available resources to the FOCUS Trial and the ICC pivotal trial.
“Though the recent months have been financially difficult, we remain committed to advancing the clinical
programs for our innovative Melphalan/HDS as well as to our commercialization efforts for CHEMOSAT in Europe. We are
continuously working to advance our ability to operate so we can advance these important programs to increase value to our
shareholders,” concluded Dr. Simpson.
Three Month Financial Results
Revenue for the third quarter of 2017 was $0.7 million, an increase of 75% from $0.4 million for the third
quarter of 2016. Selling, general and administrative expenses increased modestly to $2.9 million in the 2017 third quarter
from $2.4 million in the prior-year third quarter. Research and development expenses for the third quarter of 2017 declined
slightly to $2.3 million from $2.7 million in the prior-year quarter. Total operating expenses for the current quarter
were $5.1 million compared with $5.0 million in the prior-year quarter.
The Company reported a net loss for the 2017 third quarter of $12.6 million, or $9.36 per share based on 1.4
million weighted average common shares outstanding on a split adjusted basis. This compares with a net loss in the prior-year
period of $1.0 million, or $230.99 per share based on 4,349 weighted average common shares outstanding on a split adjusted
basis. This increase in net loss is primarily due to an $8.7 million change in the fair value of the warrant liability and a
$3.0 million loss related to two transactions to settle convertible note debt, both non-cash items.
Nine Month Financial Results
Revenue for the first nine months of 2017 was $2.0 million, an increase of 53% from $1.3 million for the first
nine months of 2016. Selling, general and administrative expenses in the first nine months 2017 were approximately $7.8
million compared with $7.0 million in the prior-year period. Research and development expenses for the first nine months of
2017 increased to $7.1 million from $6.0 million in the first nine months of 2016. Total operating expenses for the
first nine months of 2017 were approximately $15.0 million compared with $13.0 million in the prior-year quarter.
The Company recorded a net loss of $25.8 million for the first nine months of 2017, or $34.99 per share based on
754,421 weighted average common shares outstanding on a split adjusted basis. This compares with a net loss for the first
nine months of 2016 of $9.5 million, or $2,232.30 per share based on 4,249 weighted average common shares outstanding on a split
adjusted basis. The increase in net loss is due to an approximately $13.7 million increase in interest expense primarily
related to the amortization of debt discounts and a $3.0 million loss related to two transactions to settle convertible note debt,
offset by a $9.6 million gain on the extinguishment of the June 2016 Series C Warrants, both non-cash items. Additionally, there
was a $1.9 million increase in operating expenses and a $7.9 million change in the fair value of the warrant liability, a non-cash
item, offset by a $0.5 million increase in gross profit.
Balance Sheet Highlights
As of September 30, 2017, Delcath had cash and cash equivalents of $2.5 million, compared with $4.4 million as
of December 31, 2016. In addition, the Company had $8.3 million in restricted cash primarily related to the Convertible Notes
issued in June 2016. During the nine months ended September 30, 2017, the Company used $11.7 million of cash to fund operating
activities. Management believes that its capital resources are adequate to fund operating activities through January 2018.
About Delcath Systems
Delcath Systems, Inc. is an interventional oncology Company focused on the treatment of primary and
metastatic liver cancers. Our investigational product – Melphalan Hydrochloride for Injection for use with the Delcath Hepatic
Delivery System (Melphalan/HDS) – is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure
and associated side effects. We have commenced a global Phase 3 FOCUS clinical trial for Patients with Hepatic Dominant Ocular
Melanoma (OM) and plan to initiate a Registration trial for intrahepatic cholangiocarcinoma (ICC) in the fall of 2017.
Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S. In Europe,
our system has been commercially available since 2012 under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan
(CHEMOSAT), where it has been used at major medical centers to treat a wide range of cancers of the liver.
Forward Looking Statements
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 OM and ICC clinical trial programs, timely enrollment and treatment of patients in the
global Phase 3 OM clinical trial, IRB or ethics committee clearance of the Phase 3 OM and ICC Registration trial
protocols from participating sites and the timing of site activation and subject enrollment in each trial, 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
Melphalan HDS/CHEMOSAT system and the potential of the Melphalan HDS/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 Melphalan HDS/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 other 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 Relations
Email: investorrelations@delcath.com
-Tables to Follow-
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Delcath Systems, Inc. |
Condensed Consolidated Statements of Operations
and Comprehensive Loss
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(Unaudited)
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(in thousands, except share data) |
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Three months ended
September 30, |
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Nine months ended
September 30, |
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2017 |
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2016 |
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2017 |
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2016 |
Product revenue |
|
$ |
684 |
|
|
$ |
435 |
|
|
$ |
2,011 |
|
|
$ |
1,316 |
|
Cost of goods sold |
|
|
172 |
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|
|
112 |
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|
527 |
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|
|
373 |
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Gross profit |
|
|
512 |
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|
|
323 |
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|
1,484 |
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|
943 |
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Operating expenses: |
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Selling, general and administrative expenses |
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2,860 |
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|
|
2,361 |
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|
|
7,807 |
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|
|
7,025 |
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Research and development costs |
|
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2,279 |
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|
|
2,686 |
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|
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7,119 |
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|
|
5,975 |
|
Total operating expenses |
|
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5,139 |
|
|
|
5,047 |
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|
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14,926 |
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|
13,000 |
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Operating loss |
|
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(4,627 |
) |
|
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(4,724 |
) |
|
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(13,442 |
) |
|
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(12,057 |
) |
Change in fair value of the warrant liability, net |
|
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27 |
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|
|
8,680 |
|
|
|
1,227 |
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|
|
9,171 |
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Gain on warrant extinguishment |
|
|
- |
|
|
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- |
|
|
|
9,613 |
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|
|
- |
|
Loss on debt settlement |
|
|
(2,952 |
) |
|
|
- |
|
|
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(2,952 |
) |
|
|
- |
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Interest income (expense) |
|
|
(5,042 |
) |
|
|
(4,963 |
) |
|
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(20,324 |
) |
|
|
(6,584 |
) |
Other income (expense) |
|
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(2 |
) |
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3 |
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5 |
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(15 |
) |
Net loss |
|
$ |
(12,596 |
) |
|
$ |
(1,004 |
) |
|
$ |
(25,873 |
) |
|
$ |
(9,485 |
) |
Other comprehensive loss: |
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Foreign currency translation adjustments |
|
$ |
(15 |
) |
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$ |
(2 |
) |
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$ |
7 |
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$ |
(12 |
) |
Comprehensive Loss |
|
$ |
(12,611 |
) |
|
$ |
(1,006 |
) |
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$ |
(25,866 |
) |
|
$ |
(9,497 |
) |
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Common share data: |
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Basic and diluted loss per share* |
|
$ |
(9.36 |
) |
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$ |
(230.99 |
) |
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$ |
(34.99 |
) |
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$ |
(2,232.30 |
) |
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Weighted average number of basic and diluted common
shares outstanding* |
|
|
1,401,413 |
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|
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4,349 |
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754,421 |
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|
4,249 |
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|
*reflects a one-for-sixteen (1:16) reverse stock split effected on July 21, 2016
and a one-for-three hundred and fifty (1:350) reverse stock split effected on November 6, 2017 |
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DELCATH SYSTEMS, INC. |
Consolidated Balance Sheets |
as of September 30, 2017 and December 31, 2016 |
(in thousands, except share and per share data) |
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September
30, |
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December
31, |
|
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2017 |
|
2016 |
|
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(Unaudited) |
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Assets |
|
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Current assets |
|
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Cash and cash equivalents |
|
$ |
2,495 |
|
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$ |
4,409 |
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Restricted cash |
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|
8,362 |
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|
27,287 |
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Accounts receivables, net |
|
|
298 |
|
|
|
403 |
|
Inventories |
|
|
1,164 |
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|
660 |
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Prepaid expenses and other current assets |
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|
385 |
|
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|
698 |
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Deferred financing costs |
|
|
529 |
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|
|
699 |
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Total current assets |
|
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13,233 |
|
|
|
34,156 |
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Property, plant and equipment, net |
|
|
1,253 |
|
|
|
1,083 |
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Total assets |
|
$ |
14,486 |
|
|
$ |
35,239 |
|
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Liabilities and Stockholders' Deficit |
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Current liabilities |
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Accounts payable |
|
$ |
1,891 |
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$ |
594 |
|
Accrued expenses |
|
|
3,755 |
|
|
|
3,407 |
|
Series C preferred shares |
|
|
494 |
|
|
|
- |
|
Convertible notes payable, net of debt discount |
|
|
9,736 |
|
|
|
13,343 |
|
Warrant liability |
|
|
16 |
|
|
|
18,751 |
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Total current liabilities |
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|
15,892 |
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|
|
36,095 |
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Deferred revenue |
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|
- |
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|
30 |
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Other non-current liabilities |
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|
444 |
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|
|
604 |
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Total liabilities |
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16,336 |
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|
36,729 |
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Commitments and contingencies (Note 12) |
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Stockholders' deficit |
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Preferred stock, $.01 par value; 10,000,000 shares authorized; no
shares
issued and outstanding at September 30, 2017 and December 31, 2016,
respectively |
|
|
- |
|
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|
- |
|
Common stock, $.01 par value; 500,000,000 shares authorized;
1,426,153 and
11,805 shares issued and 1,425,862 and 11,750 shares outstanding
at September 30, 2017 and December 31, 2016, respectively* |
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14 |
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- |
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Additional paid-in capital |
|
|
303,808 |
|
|
|
277,790 |
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Accumulated deficit |
|
|
(305,587 |
) |
|
|
(279,188 |
) |
Treasury stock, at cost; 1 share at September 30, 2017 and December
31, 2016,
respectively* |
|
|
(51 |
) |
|
|
(51 |
) |
Accumulated other comprehensive loss |
|
|
(34 |
) |
|
|
(41 |
) |
Total stockholders' deficit |
|
|
(1,850 |
) |
|
|
(1,490 |
) |
Total liabilities and stockholders' deficit |
|
$ |
14,486 |
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|
$ |
35,239 |
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|
*reflects a one-for-sixteen (1:16) reverse stock split effected on July
21, 2016 and a one-for-three hundred and fifty (1:350) reverse stock split effected on November 6, 2017 |
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