Delcath Systems Reports Second Quarter 2022 Results and Provides Business Update

New York, August 8, 2022 /PRNewswire/ — Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on treating primary and metastatic cancers of the liver, today announced business highlights and second-quarter results. Reported financial results. June 30, 2022.

Recent business highlights

During the second quarter and beyond, Delcath said:

• We held a pre-NDA meeting with the FDA to resubmit the NDA for the Hepzato Kit and locked the Phase 3 FOCUS trial database.^® In Q3 2022 (Melphalan Hydrochloride for Injection/Hepatic Delivery System),
• Presented a poster updating FOCUS study results at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting,
• Opened two Extended Access Program (NCT05022901) sites,
• Raised $5 million Private placement at market price.

Additionally, during and after the fourth quarter, independent investigators:

• Published Predictive parameters in patients undergoing percutaneous liver perfusion with melphalan for unresectable liver metastases from uveal melanoma: a retrospective pooled analysis. In Cardiovascular and Interventional Radiology,
• Published two abstracts on the use of Chemosat^® Liver Delivery System with Melphalan in the Treatment of Metastatic Uveal Melanoma at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting:
• Safety and Efficacy of Melphalan Percutaneous Liver Perfusion (M-PHP) with Ipilimumab and Nivolumab (IPI+NIVO) in Metastatic Uveal Melanoma: Initial Results from the Phase Ib Portion of the CHOPIN Trial, When
• Temporal change in quality of life after melphalan percutaneous liver perfusion in patients with metastatic uveal melanoma.

“As we prepare to resubmit the NDA for the Hepzato kit by the end of the third quarter, the Europe A growing number of publications endorse both the Chemosat and Hepzato Kits. ” Gerald Michel, CEO of Delcas. Michelle continued, “If FDA confirms receipt of the submission within 30 days of the resubmission and agrees that the resubmission is satisfactorily complete and requires review, the FDA will issue a PDUFA later in the first quarter. We expect to set a date for 2023.”

Q1 2022 Results

Income statement highlights.

Total revenue for the 3 months ended June 30, 2022was approximately $800,000, compared with $0.5 million in the same period last year from CHEMOSAT sales in Europe. This product revenue increase was primarily due to the overall quarter of direct product sales by Delcas compared to revenue sharing agreements with distribution partners. Europe 2021 years.

R&D expenses for the quarter were $5.5 millioncompared to $3.5 million in the previous quarter. The increase in R&D expenses is primarily due to increased activities related to his NDA preparation.Quarterly selling, general and administrative expenses were approximately $4.1 millioncompared to $3.3 million in the previous quarter.Total operating expenses for the quarter are $9.6 millioncompared to $6.8 million in the previous quarter.

The company posted a net loss in the three months ended June 30, 2022of $9.7 millioncompared to the net loss of $6.4 million Same period in 2021.

Balance sheet highlights

upon June 30, 2022the company had a total of cash, cash equivalents, and restricted cash $14.4 millioncompared to the sum of cash, cash equivalents and restricted cash $27 million upon December 31, 2021. Terminated 3 months June 30, 2022When June 30, 2021used $6.1 million When $7.1 millionrespectively, of cash in operations.

upon July 20, 2022Delcath will issue and sell to certain investors 690,954 shares of its common stock (“Common Stock”) and 566,751 pre-funded warrants to purchase its common stock (“Pre-funded Warrants”). We closed a private placement forEach share of common stock was sold at a price per share $3.98 The prefunded warrant is $3.97 Per advance funding warrant.The exercise price of the prefunded warrant is $0.01 It is per share of common stock and is exercisable immediately. Delcath from private placement to approximately $5 million Before deduction of delivery costs paid by Delcath. Delcath intends to use the net proceeds from the private placement for working capital purposes and other general corporate purposes.

Conference call information

To join this event, please dial approximately 5-10 minutes before the call starts.

event date: Monday, August 8, 2022

time: 8:30 AM ET

Participant Number: Toll Free: 1-844-836-8745
International: 1-412-317-6797
Webcast: https://app.webinar.net/leg9qEP2vWK

About Delcath Systems, Inc.

Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancer. The company’s proprietary percutaneous liver perfusion (PHP) system is designed to deliver high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects.of usaThe PHP system, developed under the trade name HEPZATO KIT (Melphalan Hydrochloride for Infusion/Hepatic Delivery System) or HEPZATO, is a metastatic uveal melanoma (mUM) and has been approved by the U.S. Food and Drug Administration (FDA) to It is considered a regulated drug-device combination product.

of EuropeThe PHP system is currently regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System (CHEMOSAT) for melphalan. liver.

Safe Harbor/Forward-Looking Statements

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by or on our behalf. This news release contains forward-looking statements that involve certain risks and uncertainties that could cause actual results to differ materially from those set forth. Factors that could cause such differences include, but are not limited to, uncertainties related to: Study timing and results, receipt of additional data and additional analysis on performance mOM clinical trials, decision to continue ICC clinical trial program or focus on other alternative indications, global Phase 3 mOM clinical trials Timely monitoring and treatment of patients and impact of the COVID-19 pandemic upon completion of clinical trials; impact of presentations at major medical conferences and future clinical outcomes consistent with presented data. Approval of an individual funding request for reimbursement of the CHEMOSAT procedure; impact of his ZE reimbursement on potential use and sales of his CHEMOSAT products in Germany (if any). Clinical adoption, use and consequent sales (if any) of the CHEMOSAT system for supplying and filtering melphalan in Europe, including the key markets of Germany and the United Kingdom. Our ability to successfully commercialize the HEPZATO KIT/CHEMOSAT System and its potential as a treatment for patients with primary and metastatic liver disease. Our ability to receive reimbursement of the CHEMOSAT system in various markets. Approval of current or future HEPZATO KIT/CHEMOSAT systems for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or international markets. Actions by the FDA or a foreign regulatory agency. our ability to successfully enter into strategic partnerships and distribution agreements in foreign markets, as well as their timing and earnings (if any); Uncertainty about the timing and outcome of research and development projects. uncertainties regarding our ability to obtain funding and other resources for our research, development, clinical trials and commercialization activities; These and other factors are discussed from time to time in 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 these forward-looking statements are made.

Delcas Systems Co., Ltd.
Condensed Consolidated Balance Sheet
(unaudited)
(1,000 shares, excluding per share data)
		June 30th		December 31
		2022		2021
assets
current assets
cash and cash equivalents		$10,203		$22,802
restricted cash		4,151		4,151
Accounts receivable, net		438		44
stock		2,040		1,412
Prepaid expenses and other current assets		2,370		2,743
Total current assets		19,202		31,152
Property, plant and equipment, net		1,457		1,348
right-of-use assets		407		624
Total assets		$21,066		$33,124
Liabilities and shareholders’ equity (deficit)
Current Liabilities
accounts payable		$2,067		$638
accrued expenses		5,417		4,109
deferred revenue		—		170
lease liability		294		416
borrowed money, current		4,474		621
Total current liabilities		12,252		5,954
Lease liabilities, non-current		113		207
Outstanding loans, illiquid		6,838		10,372
convertible bonds, illiquid		4,709		4,639
total liabilities		23,912		21,172
Commitments and contingencies		—		—
Shareholders’ equity (deficit)
Preferred Stock, $0.01 par value. 10,000,000 shares approved. 11,357 shares Issued and unpaid as of June 30, 2022 and December 31, 2021		—		—
Common stock, $0.01 par value. 40,000,000 shares have been approved. 7,906,728 shares Issued and unpaid as of June 30, 2022 and December 31, 2021		79		79
capital surplus		435,922		432,831
Cumulative deficit		(438,836)		(420,976)
Accumulated other comprehensive (loss) income		(11)		18
Total shareholders’ equity (deficit)		(2,846)		11,952
Total liabilities and shareholders’ equity (deficit)		$21,066		$33,124

Delcas Systems Co., Ltd.
Condensed Consolidated Income Statement and Comprehensive Loss
(unaudited)
(1,000 shares, excluding per share data)
	For the three months ended June 30,				For the six months ended June 30,
	2022		2021		2022		2021
product revenue	$797		$398		$1,003		$659
Other income	—		138		171		265
Cost of sales	(180)		(202)		(214)		(314)
gross profit	617		334		960		610
Operating expenses:
R&D expenses	5,456		3,497		9,696		7,204
Selling, general and administrative expenses	4,145		3,288		7,791		6,584
Total project cost	9,601		6,785		17,487		13,788
operating loss	(8,984)		(6,451)		(16,527)		(13,178)
Interest expense, net	(665)		(40)		(1,309)		(81)
Other (loss) income	(8)		61		(twenty four)		82
net loss	(9,657)		(6,430)		(17,860)		(13,177)
Other comprehensive income:
Foreign currency translation adjustment	(31)		(61)		(29)		33
Total other comprehensive loss	$ (9,688)		$ (6,491)		$ (17,889)		$ (13,144)
Common stock data:
Basic and diluted loss per common share	$ (1.18)		$ (0.96)		$ (2.18)		$ (2.00)
Weighted average of basic and diluted shares outstanding	8,190,483		6,681,369		8,190,483		6,589,655

Source Delcath Systems, Inc.

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