Recent Business Highlights
During and since the third quarter
- 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.
“During the quarter we strengthened our balance sheet and added senior personnel to the
Financial Results:
Income Statement Highlights.
Product revenue for the three months ended
The Company recorded a net loss for the three months ended
Balance Sheet Highlights.
On
On
Also, on
Additional details concerning the
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.
Date:
Time:
Toll Free: 888-506-0062; Entry Code: 676028
International: 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
In
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
- 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)-755-7412
james@haydenir.com
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands, except share and per share data)
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, |
— | — | |||||
Common stock, |
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 |
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share data)
Three months ended |
Nine months ended |
||||||||||||||
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 |
Source: Delcath Systems, Inc.