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): October 17, 2019

DELCATH SYSTEMS, INC.

(Exact Name of Registrant as Specified in Its Charter)

1633 Broadway, Suite 22C, New York, New York 10019

(Address of principal executive offices) (Zip Code)

(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:

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

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.  ☐

On October 18, 2019, Delcath Systems, Inc (the “Company”) and holders of a majority of the Company’s Series E and Series E-1 Convertible Preferred Stock entered into a second amendment (the “Second Amendment”) to those certain registration rights agreements, dated as of July 11, 2019 (effective as of July 15, 2019) and August 15, 2019, in each case as amended on September 30, 2019, between the Company and the holders signatory thereto. The Second Amendment eliminates the deadline to file a pre-effective registration statement amendment within 10 days of the Company’s receipt of comments from the Securities and Exchange Commission (the “SEC”).

The foregoing description of certain terms contained in the Second Amendment does not purport to be complete and is qualified in its entirety by reference to: (i) the copy of the Second Amendment filed as Exhibit 10.1 to this Current Report on Form 8-K, (ii) the copy of the form of Registration Rights Agreement between the Company and each other party signatory thereto filed as Exhibit 4.2 to the Current Report on Form 8-K filed with the SEC on July 11, 2019, (iii) the copy of the form of Registration Rights Agreement between the Company and each other party signatory thereto filed as Exhibit 4.2 to the Current Report on Form 8-K filed with the SEC on August 16, 2019 and (iv) the copy of the Amendment to the Registration Rights Agreements, dated as of September 30, 2019, filed as Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on October 1, 2019.

On October 17, 2019, the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment to the Company’s Amended and Restated Certificate of Incorporation (the “Charter Amendment”) to effect a reverse stock split of the issued and outstanding shares of the Company’s common stock, $0.01 par value per share, at a ratio of 1-for-100 to be effective as of October 22, 2019 at 8:30 a.m., New York City time (the “Reverse Stock Split”). The Charter Amendment did not change the par value or any other terms of the common stock.

On October 22, 2019, the Company filed with the Secretary of State of the State of Delaware a Certificate of Correction (the “Certificate of Correction”) to the Charter Amendment, rescinding the Charter Amendment, citing an inaccuracy in Article Third of the Charter Amendment, which states an effective time for the Reverse Stock Split of 8:30 a.m. New York City time on October 22, 2019. Such effective time was based upon the Company’s prior receipt, on October 17, 2019, of confirmation by the Financial Industry Regulatory Authority, Inc. (“FINRA”) that it had completed its review of the Reverse Stock Split, including the effective time, whereupon the Company undertook to effect the Reverse Stock Split by filing the Charter Amendment. On the evening of October 21, 2019, subsequent to the Company’s filing of the Charter Amendment and issuance of a press release on October 18, 2019 announcing the confirmation by FINRA, FINRA notified the Company’s counsel that it was rescinding its prior confirmation. The Certificate of Correction further provides that the Company is currently awaiting FINRA confirmation. When such confirmation is obtained, the Company intends to file a Certificate of Amendment effectuating the Reverse Stock Split.

As previously disclosed in the Company’s Current Report on Form 8-K filed on September 19, 2019, the Reverse Stock Split was approved by the stockholders of the Company at the annual meeting of stockholders held on September 17, 2019, with the ratio of the reverse stock split to be fixed at a ratio ranging from 1-for-50 to 1-for-1,200, as determined by the Company’s Board of Directors. In accordance with the stockholder authorization, the Company’s Board of Directors approved the Charter Amendment providing for a 1-for-100 ratio to be effective as soon as reasonably practicable.

The foregoing descriptions of the Charter Amendment and the Certificate of Correction do not purport to be complete and are qualified in their entirety by reference to the full text of the Charter Amendment and the Certificate of Correction, which are filed as Exhibit 3.1 and Exhibit 3.2 to this Current Report on Form 8-K.

On October 18, 2019, upon receipt of FINRA’s confirmation of the completion of its review of the Company’s Reverse Stock Split, the Company issued a press release announcing, among other things, that the Reverse Stock Split approved by the Company’s stockholders and Board of Directors would be effected prior to the initiation of trading on October 22, 2019, consistent with FINRA’s forthcoming announcement on the FINRA Daily List on October 21, 2019. This press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this Item 8.01 by reference.

On October 22, 2019, the Company issued a press release announcing that the Reverse Stock Split to be effective on October 22, 2019 previously announced on FINRA’s Daily List on October 21, 2019 will be postponed per a subsequent notification received from FINRA after market close on October 21, 2019 that FINRA had decided to continue its review. This press release is attached as Exhibit 99.2 to this Current Report on Form 8-K and incorporated into this Item 8.01 by reference.

(d) Exhibits

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.

Exhibit 3.1

I, JEFFREY W. BULLOCK, SECRETARY OF STATE OF THE STATE OF DELAWARE, DO HEREBY CERTIFY THE ATTACHED IS A TRUE AND CORRECT COPY OF THE CERTIFICATE OF AMENDMENT OF “DELCATH SYSTEMS, INC.”, FILED IN THIS OFFICE ON THE SEVENTEENTH DAY OF OCTOBER, A.D. 2019, AT 4:36 O`CLOCK P.M.

AND I DO HEREBY FURTHER CERTIFY THAT THE EFFECTIVE DATE OF THE AFORESAID CERTIFICATE OF AMENDMENT IS THE TWENTY-SECOND DAY OF OCTOBER, A.D. 2019 AT 8:30 O’CLOCK A.M.

A FILED COPY OF THIS CERTIFICATE HAS BEEN FORWARDED TO THE NEW CASTLE COUNTY RECORDER OF DEEDS.

Amendment to the Amended and Restated Certificate of Incorporation

Pursuant to Section 242 of the General

Corporation Law of the State of Delaware

DELCATH SYSTEMS, INC., a Delaware corporation (hereinafter called the “Corporation”), does hereby certify as follows:

FIRST: Upon the filing and effectiveness (the “Effective Time”) pursuant to the General Corporation Law of the State of Delaware (the “DGCL”) of this Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Corporation, the Corporation’s Amended and Restated Certificate of Incorporation shall be amended by adding the following paragraph at the end of Article FOURTH:

“Each one hundred (100) shares of the Corporation’s Common Stock, par value $0.01 per share (“Common Stock”), issued and outstanding or held by the Corporation in treasury stock immediately prior to the Effective Time shall automatically be combined into one (1) validly issued, fully paid and non-assessable share of Common Stock without any further action by the Corporation or the holder thereof, subject to the treatment of fractional interests as described below. Notwithstanding the immediately preceding sentence, no fractional shares will be issued in connection with the reverse stock split. Stockholders of record who otherwise would be entitled to receive fractional shares, will be entitled to rounding up of their fractional share to the nearest whole share. No stockholders will receive cash in lieu of fractional shares. Each certificate that immediately prior to the Effective Time represented shares of Common Stock (“Old Certificates”) shall thereafter represent that number of shares of Common Stock into which the shares of Common Stock represented by the Old Certificate shall have been combined, subject to the adjustment for fractional shares as described above.”

SECOND: The foregoing amendment was duly adopted in accordance with Section 242 of the General Corporation Law of the State of Delaware.

THIRD: This Certificate of Amendment shall become effective as of October 22, 2019 at 8:30 a.m., New York City time.

IN WITNESS WHEREOF, DELCATH SYSTEMS, INC., has caused this certificate to be duly executed in its corporate name on October 17, 2019.

Exhibit 3.2

I, JEFFREY W. BULLOCK, SECRETARY OF STATE OF THE STATE OF DELAWARE, DO HEREBY CERTIFY THE ATTACHED IS A TRUE AND CORRECT COPY OF THE CERTIFICATE OF CORRECTION OF “DELCATH SYSTEMS, INC.”, FILED IN THIS OFFICE ON THE TWENTY-SECOND DAY OF OCTOBER, A.D. 2019, AT 3:21 O’CLOCK P.M.

A FILED COPY OF THIS CERTIFICATE HAS BEEN FORWARDED TO THE NEW CASTLE COUNTY RECORDER OF DEEDS.

				/s/ Jeffrey W. Bullock
				Jeffrey W. Bullock, Secretary of State
2168713   8100				Authentication: 203847069
SR# 20197671399				Date: 10-23-19
You may verify this certificate online at corp.delaware.gov/authver.shtml

Page 1

CERTIFICATE OF CORRECTION

TO

AMENDMENT TO THE AMENDED AND RESTATED CERTIFICATE OF

INCORPORATION

OF

DELCATH SYSTEMS, INC.

(Under Section 103 of the General Corporation Law of Delaware)

DELCATH SYSTEMS, INC., a corporation organized and existing under the laws of the State of Delaware (the “Corporation”), hereby certifies as follows:

FIRST: The name of the Corporation is Delcath Systems, Inc.

SECOND: An Amendment to the Amended and Restated Certificate of Incorporation (the “Amendment”) of the Corporation was filed with the Secretary of the State of Delaware on October 17, 2019 and said Amendment requires correction as permitted by Section 103 of the General Corporation Law of the State of Delaware.

THIRD: The inaccuracy in said Amendment is set forth in Article Third, which states an effective time of 8:30 a.m. New York City time on October 22, 2019. Such effective time was based upon the Corporation’s prior receipt of confirmation by the Financial Industry Regulatory Authority, Inc. (“FINRA”) that it had completed its review of the reverse stock split set forth in the Amendment, including the effective time. On the evening of October 21, 2019, FINRA rescinded its prior confirmation. The Amendment is hereby rescinded. The Corporation is currently waiting for FINRA to issue another confirmation. When such confirmation is obtained, the Corporation intends to file a revised amendment.

IN WITNESS WHEREOF, the undersigned has duly executed this Certificate of Correction as of October 22, 2019.

Exhibit 10.1

SECOND AMENDMENT TO REGISTRATION RIGHTS AGREEMENTS

This Second Amendment (this “Second Amendment”), dated as of October 18, 2019, is made to those certain Registration Rights Agreements (the “Registration Rights Agreements”), dated as of July 11, 2019 (effective as of July 15, 2019), and August 15, 2019, and as amended on September 30, 2019, between Delcath Systems, Inc. (the “Company”) and the purchasers signatories thereto. Capitalized terms used but not defined herein shall have the meanings ascribed to them in the Registration Rights Agreements.

WHEREAS, pursuant to Section 2(d)(iii) of the Registration Rights Agreements, the Company will incur certain penalties if “prior to the effective date of a Registration Statement, the Company fails to file a pre-effective amendment and otherwise respond in writing to comments made by the Commission in respect of such Registration Statement within ten (10) Trading Days after the receipt of comments by or notice from the Commission that such amendment is required in order for such Registration Statement to be declared effective;” and

WHEREAS, on August 21, 2019, the Company filed the Initial Registration Statement with the Commission; and

WHEREAS, on September 25, 2019, in response to a comment letter received by the Commission, the Company filed an amendment to the Initial Registration Statement with the Commission; and

WHEREAS, on October 7, 2019, the Company received an oral comment from the Commission requiring that the Company file a second amendment to the Initial Registration Statement by October 18, 2019, pursuant to Section 2(d)(iii) of the Registration Rights Agreements in order to avoid incurring penalties; and

WHEREAS, prior to the filing of a second amendment to the Initial Registration Statement and the Effective Date of the Registration Statement, the Company intends to effect a reverse stock split on the OTC QB, the timing of which transaction is subject to ongoing FINRA review; and

WHEREAS, pursuant to Section 6(f) of the Registration Rights Agreements, the Registration Rights Agreements may be amended by the written consent of the Company and Holders of at least a majority in interest of the Registrable Securities; and

WHEREAS, the Company and Holders of at least a majority in interest of the Registrable Securities desire to eliminate the requirement set forth in Section 2(d)(iii).

NOW, THEREFORE, in consideration of the premises set forth above, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree to eliminate the requirement set forth in Section 2(d)(iii).

This Second Amendment to the Registration Rights Agreements set forth herein shall take effect upon receipt of fully executed copies of this Second Amendment by Holders representing a majority in interest of the then outstanding Registrable Securities.

Except as expressly set forth above, all of the terms and conditions of the Registration Rights Agreements shall continue in full force and effect after the execution of this agreement and shall not be in any way changed, modified or superseded by the terms set forth herein.

This Second Amendment may be executed in two or more counterparts and by facsimile or “.pdf” signature or otherwise, and each of such counterparts shall be deemed an original and all of such counterparts together shall constitute one and the same agreement.

[signature pages follows]

2

This Amendment is effective as of the date hereof.

[Holder signature pages follow]

3

[Signature Page to DCTH Second Amendment]

4

[Signature Page to DCTH Second Amendment]

5

[Signature Page to DCTH Amendment]

6

Exhibit 99.1

Delcath Systems Announces Ratio for Reverse Stock Split

October 18, 2019

NEW YORK, Oct. 18, 2019 (GLOBE NEWSWIRE) — Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announces that the Company’s Board of Directors has authorized a reverse stock split of the Company’s common stock at a ratio of 1-for-100. The Company’s Board of Directors was authorized to effect the reverse stock split by shareholder approval of its Proxy Solicitation filed with the Securities Exchange Commission on August 19, 2019. The proposal to effect a reverse stock split was approved by shareholders on September 17, 2019. The reverse stock split will be effected prior to the initiation of trading on October 22, 2019.

Beginning with the October 22, 2019 trading date, Delcath’s shares will be designated by the symbol DCTHD for 20 trading days, and thereafter will revert to the symbol DCTH. The new CUSIP number for the common stock following the reverse stock split will be 24661P 807.

The reverse stock split will reduce the number of shares of common stock issued and outstanding or reserved for issuance from approximately 1.4 billion to approximately 14 million.

American Stock Transfer & Trust Company is acting as the exchange agent and transfer agent for the reverse stock split. Stockholders holding their shares in book-entry form or in brokerage accounts need not take any action in connection with the reverse stock split. Beneficial holders are encouraged to contact their bank, broker or custodian with any procedural questions.

About Delcath System, Inc.

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 been enrolling a global Registration clinical trial for Patients with Hepatic Dominant Ocular Melanoma (OM) called The FOCUS Trial and have initiated a global Phase 3 clinical trial for intrahepatic cholangiocarcinoma (ICC) called The ALIGN Trial. Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S. In Europe, our system is marketed under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT) and has been used at major medical centers to treat a wide range of cancers of the liver. Since January 2019 CHEMOSAT is marketed under an exclusive licensing agreement with medac, a privately held multi-national pharmaceutical company headquartered in Germany and specializing in the treatment and diagnosis of oncological, urological and autoimmune diseases.

Safe Harbor / 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, and timely enrollment and treatment of patients in the global Phase 3 OM and ICC clinical trials; 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

Hayden IR

James Carbonara

(646)-755-7412

james@haydenir.com

Brett Maas

(646) 536-7331

brett@haydenir.com

Source: Delcath Systems, Inc.

Exhibit 99.2

Delcath Systems Announces Postponement of Reverse Stock Split

October 22, 2019

NEW YORK, Oct. 22, 2019 (GLOBE NEWSWIRE) — Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announces that the Reverse Stock Split reported on October 21, 2019 will be postponed per a subsequent notification received from FINRA after-market that they have decided to continue their review.

About Delcath System, Inc.

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 been enrolling a global Registration clinical trial for Patients with Hepatic Dominant Ocular Melanoma (OM) called The FOCUS Trial and have initiated a global Phase 3 clinical trial for intrahepatic cholangiocarcinoma (ICC) called The ALIGN Trial. Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S. In Europe, our system is marketed under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT) and has been used at major medical centers to treat a wide range of cancers of the liver. Since January 2019 CHEMOSAT is marketed under an exclusive licensing agreement with medac, a privately held multi-national pharmaceutical company headquartered in Germany and specializing in the treatment and diagnosis of oncological, urological and autoimmune diseases.

Safe Harbor / 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, and timely enrollment and treatment of patients in the global Phase 3 OM and ICC clinical trials; 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

Hayden IR

James Carbonara

(646)-755-7412 james@haydenir.com

Brett Maas

(646) 536-7331 brett@haydenir.com

Source: Delcath Systems, Inc.