UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 22, 2024

 

DELCATH SYSTEMS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

 

Delaware		001-16133		06-1245881
(State or other jurisdiction of incorporation or organization)		(Commission File Number)		(IRS Employer Identification No.)

566 Queensbury Avenue

Queensbury, New York 12804

(Address of principal executive offices)

(212) 489-2100

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class		Trading symbol(s)		Name of each exchange on which registered
Common Stock, $0.01 par value		DCTH		The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

Item 1.01

Entry into a Material Definitive Agreement.

On April 22, 2024, Delcath Systems, Inc. (“Delcath”) entered into a Fifth Amendment, effective May 1, 2024 (the “Amendment”), to the License, Supply and Contract Manufacturing Agreement with Synerx Pharma, LLC and Mylan Teoranta, dated October 13, 2010 (as subsequently amended, the “Agreement”), for Delcath’s supply of melphalan hydrochloride (the “Product”). The Amendment (i) extends the term of the Agreement to December 31, 2028; (ii) requires Delcath to place purchase orders for the Product at least 210 days before the delivery date; (iii) modifies the price per vial for the Product; and (iv) provides for certain annual price increases for the Product equivalent to the percent increase of the published producer price index for pharmaceutical preparation and manufacturing measured per calendar year.

The foregoing description of the Amendment is not complete and is qualified in its entirety by the full text of the Amendment, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2024.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.

 

				DELCATH SYSTEMS, INC.
Date: April 26, 2024				By:		/s/ Gerard Michel
				Name:		Gerard Michel
				Title:		Chief Executive Officer