UNITED STATES
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FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition. |
On January 13, 2025, Delcath Systems, Inc. (“Delcath”) issued a press release announcing preliminary financial results for the quarter ended and full year ended December 31, 2024 (the “Press Release”). A copy of the Press Release is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto and is incorporated herein by reference.
The information contained in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section nor shall it be incorporated by reference into any other filing by Delcath with the U.S. Securities and Exchange Commission whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing.
| Item 7.01 | Regulation FD Disclosure. |
On January 13, 2025, Delcath made available an updated corporate presentation that may be used in connection with presentations at conferences and investor meetings, which can be found on the Company’s website (the “Corporate Presentation”). The Corporate Presentation is furnished as Exhibit 99.2 and incorporated by reference in this Item 7.01.
The information contained in this Item 7.01, including Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section nor shall it be incorporated by reference into any other filing by Delcath with the U.S. Securities and Exchange Commission whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing.
| Item 8.01 | Other Events. |
On January 13, 2025, Delcath disclosed in the Corporate Presentation that as of December 31, 2024, (i) it had a total of 14 active sites utilizing HEPZATO KIT and (ii) there were approximately 36.2 million shares of its common stock issued and outstanding.
On January 13, 2025, Delcath also announced the following preliminary unaudited fourth quarter and full year 2024 financial and operational results:
| • | Total fourth quarter and full year revenue expected to be approximately $15.1 million and $37.2 million, respectively |
| • | HEPZATO KIT™ fourth quarter and full year revenue expected to be approximately $13.7 million and $32.3 million, respectively |
| • | CHEMOSAT® fourth quarter and full year revenue expected to be approximately $1.4 million and $4.9 million, respectively |
| • | Gross margins expected to be in the 80%-85% range |
| • | $53.2 million of cash, cash equivalents and short term investments and no debt as of December 31, 2024 |
Delcath has not yet completed its financial close process for the fourth quarter and full year 2024 and, as a result, actual results may vary from the estimated preliminary results set forth in this Current Report on Form 8-K due to a number of factors, including audit adjustments and other developments that may arise between now and the time the financial results for the fourth quarter and fiscal year ended December 31, 2024, are finalized. The estimated preliminary financial results have not been audited or reviewed by the Delcath’s independent registered public accounting firm. These estimates should not be viewed as a substitute for Delcath’s full interim or annual audited financial statements.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit |
Description | |
| 99.1 | Press Release, dated January 13, 2025. | |
| 99.2 | Corporate Presentation, dated January 13, 2025. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| DELCATH SYSTEMS, INC. | ||||||
| Date: January 13, 2025 | By: | /s/ Gerard Michel | ||||
| Name: | Gerard Michel | |||||
| Title: | Chief Executive Officer | |||||
Exhibit 99.1
Delcath Systems Announces Preliminary Fourth Quarter and Full Year 2024 Financial Results
Fourth Quarter Revenue Approximately $15.1 Million and
Full Year Total Revenue Approximately $37.2 Million
QUEENSBURY, NY – January 13, 2025, Delcath Systems, Inc. (Nasdaq: DCTH) (“Delcath” or the “Company”), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced preliminary financial results for the fourth quarter and year-ended December 31, 2024.
Preliminary Fourth Quarter and Full-Year 2024 Financial Results (unaudited)
| • | Total fourth quarter and full year revenue expected to be approximately $15.1 million and $37.2 million, respectively |
| • | HEPZATO KIT™ fourth quarter and full year revenue expected to be approximately $13.7 million and $32.3 million, respectively |
| • | CHEMOSAT® fourth quarter and full year revenue expected to be approximately $1.4 million and $4.9 million, respectively |
| • | Gross margins expected to be in the 80%-85% range |
| • | As of December 31, 2024, the Company had approximately $53.2 million of cash, cash equivalents and short-term investments and no debt |
Final financial results for the fourth quarter and full year 2024 and a detailed business update will be provided during Delcath’s annual financial results release and investor call scheduled for March 6, 2025.
About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT
Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company’s proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.
In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath’s proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT.
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In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver.
Preliminary and Unaudited Nature of Reported Results
The Company has not yet completed its financial close process for the fourth quarter and full year 2024 and, as a result, actual results may vary from the estimated preliminary results set forth in this press release due to a number of factors, including audit adjustments and other developments that may arise between now and the time the financial results for the fourth quarter and fiscal year ended December 31, 2024, are finalized. The estimated preliminary financial results have not been audited or reviewed by the Company’s independent registered public accounting firm. These estimates should not be viewed as a substitute for the Company’s full interim or annual audited financial statements.
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 press release contains forward-looking statements, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to: changes to the estimated preliminary results set forth in this press release as a result of audit adjustments and other developments that may arise between now and the time the financial results for the fourth quarter and fiscal year ended December 31, 2024, are finalized; the Company’s commercialization plans and its ability to successfully commercialize the HEPZATO KIT; the Company’s successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company’s successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company’s ability to obtain reimbursement for the HEPZATO KIT; and the Company’s ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the Company, please see the Company’s filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, 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.
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Investor Relations Contact:
ICR Healthcare
investorrelations@delcath.com
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Exhibit 99.2 Corporate Presentation NASDAQ: DCTH January 2025
Forward-Looking Statement The Private Securities Litigation Reform Act of 1995 provides a safe harbor for ability to successfully enter into any necessary purchase and sale agreements with users of forward-looking statements made by the Company or on its behalf. This the HEPZATO KIT; the timing and results of the Company’s clinical trials; our determination presentation contains forward-looking statements, which are subject to certain risks whether to continue a clinical trial program or to focus on other alternative indications; the and uncertainties that can cause actual results to differ materially from those impact of the COVID-19 pandemic or other pandemics on the completion of our clinical described. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” trials; the impact of the presentations at major medical conferences and future clinical “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” results consistent with the data presented; uncertainties relating to the timing and results of “would” and similar expressions are intended to identify forward-looking research and development projects; and uncertainties regarding the Company’s ability to statements, although not all forward-looking statements contain these identifying obtain financial and other resources for any research, development, clinical trials and words. commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. Factors that may cause such differences include, but are not limited to, You should not place undue reliance on these forward-looking statements, which speak uncertainties relating to: changes to the estimated preliminary results set forth only as of the date they are made. We undertake no obligation to publicly update or revise herein as a result of audit adjustments and other developments that may arise these forward-looking statements to reflect events or circumstances after the date they are between now the time the financial results for the fourth quarter and fiscal year made. ended December 31, 2024, are finalized; the Company’s ability to The Company has not yet completed its financial close process for the fourth quarter and successfully commercialize the HEPZATO KIT; the Company's successful full year 2024 and, as a result, actual results may vary from the estimated preliminary results management of the HEPZATO KIT supply chain, including securing adequate set forth in this presentation due to a number of factors, including audit adjustments and supply of critical components necessary to manufacture and assemble the other developments that may arise between now and the time the financial results for the HEPZATO KIT; successful FDA inspections of the facilities of Delcath and third-party fourth quarter and fiscal year ended December 31, 2024, are finalized. The estimated suppliers/manufacturers; the Company's successful implementation and preliminary financial results have not been audited or reviewed by the Company's management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the independent registered public accounting firm. These estimates should not be viewed as a potential of the HEPZATO KIT as a treatment for patients with primary and substitute for the Company's full interim or annual audited financial statements. metastatic disease in the liver; our ability to obtain reimbursement for commercialized product; the Company’s 2
Delcath Corporate Summary HEPZATO/CHEMOSAT Commercial Opportunity Strong Financial Position • 1Q 2024 HEPZATO (drug/device) US • Ultra orphan pricing with J-Code • Cash and investments as of launch for mUM*, CHEMOSAT 12/31/2024 = $53.2M • Focused call points (device only) in EU • At $11.2M of Revenue, Q3 2024 • US mUM TAM ~$600M • Included in NCCN Guidelines Operating Cash Burn of $3.6M • First and only FDA approved whole- • Expected Q2 2025 receipt of ~$17M liver directed therapy from warrant exercise ($10 strike • Preliminary Q4 Results; Expected to price) be $15.1M of Revenue and Gross • No outstanding debt obligations Margins 80%-85% Experienced Significant upside Anticipated 2025 Catalysts Management Team beyond mUM • Further site activation and revenue build • Expertise in commercializing • HDS platform technology with utility • Cash flow positive high value, specialty products across a broad set of cancer types • CHOPIN data readout • TheraSphere (BSX) veterans • Strong efficacy signals in multiple • Initiate CRC and BCC trials other tumor types • Unique interventional oncology * metastatic Uveal Melanoma (mUM) asset 3
HIGH UNMET NEED: Liver-Dominant Cancers 4
Liver-Dominant Cancers: High Incidence with High Unmet Medical Need US Incidence of Liver-Dominant Cancers Up to (partial set shown) of patients with liver metastases are not amenable to surgical resection % 50,000 80 1 largely due to extensive tumor burden Delcath Opportunity 40,000 • Limited Overall Survival - Unresectable Liver Cancer 30,000 • Liver: Common Site of Metastases 20,000 o Often the life-limiting organ • Limited Effective Systemic Treatments 10,000 o Systemic Therapies: low efficacy o Immuno-oncology agents become less effective in 0 the presence of metastases mUM* ICC mBC mNET mPC mCRC HCC *Metastatic Uveal Melanoma (mUM) First Approved Indication 1 Reddy S, et al. Isolated hepatic perfusion for patients with liver metastases, Ther Adv Med Oncol. 2014 Jul; 6(4): 180-194. 5
Diffuse Disease and Whole Liver Treatment Liver metastases in mUM and other Cancers are Often Multi-focal • Solitary liver lesions are often treated with surgery or ablation. • Radiographically, metastatic disease can initially present only as focal lesions. • Micrometastases are difficult to detect – recurrence is common • Traditional liver-directed therapy mechanism of action is not optimal if a whole liver treatment is needed. • Whole organ therapy delivers medication to a specific organ Actual mUM patient sent for a liver resection based upon radiographic diagnosis* then filters out the medication to minimize systemic exposure. * Data on File . 6
Major Liver-Directed Therapies MAJORITY OF TREATMENT 3 SIRT (Y90) Trans Arterial Chemo 2 Embolization (TACE) • Beads obstruct blood flow to tumor and elute chemo • Radioactive beads delivered into a portion of the liver • 50-60k treatments and rising per year in US • 10-15k treatments and rising per year in US Limitations Tumors recur and Diffuse disease cannot be Many tumors not Neither approved for the retreatment options limited treated with a tumor-by- imageable and micro- treatment of mUM and due to damage to tumor modality (TACE) and metastases are common, lacking substantial high vasculature (TACE) and bilobar treatment is neither TACE or Y90 can quality data set to hepatotoxicity (Y90) hepatotoxic (Y90) treat the entire liver support usage 2 Xu L, T, Funchain P, F, Bena J, F, Li M, Tarhini A, Berber E, Singh A, D: Uveal Melanoma Metastatic to the Liver: Treatment Trends and Outcomes. Ocul Oncol Pathol 2019;5:323-332. doi: 10.1159/000495113. 3 Lane AM, Kim IK, Gragoudas ES. Survival Rates in Patients After Treatment for Metastasis From Uveal Melanoma. JAMA Ophthalmol. 2018 Sep 1;136(9):981- 986. 7
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Percutaneous Hepatic Perfusion (PHP) Effective, Safe & Repeatable Liver-focused Disease Control 1. Isolation Hepatic venous flow is isolated, enabling >6X greater local concentration of chemo Isolation Filtration 2. Saturation Melphalan (chemo) treats micro and macro lesions simultaneously regardless of location in the liver Saturation 3. Filtration Proprietary filters remove greater than 4 85% of chemo from the body 4 Heppt, M, et al. Combined immune checkpoint blockade for metastatic uveal melanoma: a retrospective, multi-center study. J Immunotherap Cancer. 2019 Nov 13;7(1):299. 9
Indication Statement HEPZATO KIT (melphalan) for Injection/Hepatic Delivery System HEPZATO KIT is indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. • Indicated Patient Population Includes: o No HLA genotype restrictions o Treatment naïve and previously treated patients 10
Metastatic Uveal Melanoma (mUM) 11
Patient Journey MILESTONE MILESTONE Initial Screening Surveillance Decision Metastases Detected • Ophthalmologist/ • Surgical Oncologist Ocular Oncologist Screening frequency Surgical Resection Initial diagnosis & treatment Treatment Decision Surveillance dependent on risk level • Enucleation • Radiation • Higher risk patients (50%) • Photodynamic therapy are screened at a high • Interventional frequency • Medical Oncologist Most patients Radiologist Surveillance at receive both • Lower risk patients (50%) Liver-directed therapy Academic Center o Ophthalmology systemic and liver- are screened at a lower o Optometrists directed therapies frequency o Eye Specialist • Medical Oncologist • Medical Oncologist Gene expression Surveillance at Systemic Therapy profiling may occur Nonacademic Center ~800 patients ~2,000 patients ~1,000 patients eligible • Ophthalmologist • Ocular Oncologist Pre-Metastatic | 3-5 years Post-Metastatic 2 2 ~2,000 per Year (US) ~1,000 per Year (US) 2 Xu L, T, Funchain P, F, Bena J, F, Li M, Tarhini A, Berber E, Singh A, D: Uveal Melanoma Metastatic to the Liver: Treatment Trends and Outcomes. Ocul Oncol Pathol 2019;5:323-332. doi: 10.1159/000495113. 12
mUM: Beachhead Market Opportunity • Liver involved in >90% of cases of metastatic disease 2,3 (1,000 mUM patients) • In 50% of mUM patients, the liver is the only site of 5,6 metastasis 6 • Most patients with mUM die from liver failure o 1-year OS rate of patients with metastatic disease in the liver is 13% ~50% 2,7 o Median survival ranging from 4 to 15 months metastasize 1,2 to the liver 3 Lane AM, Kim IK, Gragoudas ES. Survival Rates in Patients After Treatment for Metastasis From Uveal Melanoma. JAMA Ophthalmol. 2018 Sep 1;136(9):981- 986. 5 Krantz BA, et al. Uveal Melanoma: Epidemiology, Etiology, and Treatment of Primary Disease. Clin Ophthalmol. 2017;11:279-289. 6 Eschelman DJ et al. Transhepatic Therapies for Metastatic Uveal Melanoma. Semin Intervent Radiol. 2013;30(1):39-48. 7 Carvajal RD, et al. Metastatic Disease from Uveal Melanoma: Treatment Options and Future Prospects. Br J Ophthalmol. 2017;101(1):38-44. 13
Competitive Landscape • 55% of patients have no approved systemic treatment option • Most patients treated with multiple lines of therapy Primary Systemic Competitors Primary LDT Competitors • Kimmtrak (tebentafusp) for HLA + (~45% of patients) • TACE (limited efficacy data, not suited for diffuse disease) • IPI/NIVO (in combination) for HLA – • SIRT (limited to two treatments, not suitable for multi-lobar disease) Competitive Positioning Competitive Positioning st st • Ideally all patients will receive a Liver Directed Therapy • 1 line for all that believe in LDT 1 line st nd (LDT) as either 1 or 2 line • Whole liver treatment vs. targeted treatment is necessary • Currently, a growing minority of Oncologists/MDs • PHP leaves options for additional LD therapies, Y90 and TACE st believe LDT as a 1 line is critical do not • For others we stress that patients die of liver failure – treat the liver before its too late (have a specific plan nd for LDT as 2 line) 14
Demonstrated Demand for FDA Approved Treatment in mUM KIMMTRAK KIMMTRAK U.S. Quarterly Sales • Reported $57.3 million in Q3 2024 US sales ($230M annualized (USD) revenue) 70,000,000 60,000,000 • Only 45% of mUM patients (~400) are eligible for treatment due 50,000,000 to HLA restriction 40,000,000 30,000,000 HEPZATO KIT: FDA Approved August 14, 2023 to 20,000,000 Treat Patients with Liver-Dominant mUM 10,000,000 • Approximately 800 patients potentially eligible for treatment 0 Q1 Y1 Q2 Y1 Q3 Y1 Q4 Y1 Q1 Y2 Q2 Y2 Q3 Y2 Q4 Y2 Q1Y3 Q2Y3 Q3Y3 • HEPZATO has no HLA genotype restrictions KIMMTRAK • Patients often receive both systemic and liver-directed treatment Mean HEPZATO treatment vs. mean treatment duration of KIMMTRAK (per pivotal trials) DRUG DOSE COST* MEAN TREATMENTS #** TOTAL COST KIMMTRAK $20,480 41 weeks $839,680 HEPZATO $187,500 4.1 kits $768,750 *Dose Cost ASP calculated using CMS payment allowance limit ** Mean from published phase 3 trials 15
HEPZATO KIT: Commercialization 16
Delivering an Innovative Treatment with a Well-Trained Team Treatment with HEPZATO KIT involves training and a team approach. The team members below complete a preceptorship and proctorship as well as a risk evaluation and mitigation strategy (REMS) training. Interventional radiologist leads and performs the vascular interventional procedure Perfusionist establishes, monitors, and controls the extracorporeal pump and veno-venous bypass circuit Anesthesiologist manages sedation, analgesia, and respiratory and cardiovascular support All REMS materials are available at www.HEPZATOKITREMS.com or by calling the REMS Coordinating Center at 1-833-632-0457. 17
Referring Centers HEPZATO Medical Medical Specialized, Targeted Treating Center Oncologist Oncologist Sales Teams Trained Treating Team Three Complementary Representatives: Perfusionist Interventional Radiologist Clinical Specialists Anesthesiologist Liver-Directed Therapy Representatives Medical Medical Oncologist Medical Ocular Oncologist Oncologist Oncologist Oncology Managers Medical Medical Oncologist Oncologist Medical Oncologist 18
Current and Pending Commercial Centers As of 01/09/2025 First commercial use of HEPZATO KIT January 12, 2024 at Moffitt 22 sites are accepting referrals Healthcare Setting Locator HEPZATOKIT.COM 14 sites active as of December 31, 2024 Cleveland Clinic Main Campus - Cleveland, OH * Regional One Health - Memphis, TN Duke Cancer Center - Durham, NC Stanford Health Care - Stanford, CA 20+ additional sites in active HonorHealth Scottsdale Shea - Scottsdale, AZ Thomas Jefferson University Hospital - conversations Philadelphia, PA Massachusetts General Hospital - Boston, MA UC San Diego Health - San Diego, CA Mayo Clinic - Jacksonville, FL 30 active center target for end of 2025 UCLA Health - Santa Monica, CA MD Anderson Cancer Center - Houston, TX * UNC Health Medical Center - Chapel Hill, NC Moffitt Cancer Center - Tampa, FL University of Alabama - Birmingham, AL * Northwestern University – Chicago, IL* University of Miami Hospital - Miami, FL * Ohio State University - Columbus, OH University of Utah Hospital - Salt Lake City, UT Piedmont Atlanta - Atlanta, GA * University of Kansas Cancer Center – Kansas, KS * Providence Saint John's Health Center - Santa Monica, CA * University of Wisconsin Hospital – Madison, WI *Sites accepting referrals; not yet REMS certified 19
HEPZATO KIT: Reimbursement & Pricing 20
Reimbursement Medicare Patients Private Payer Patients • Follow Medicare guidelines • J-Code assigned and active April 1, 2024 o For rare disease o Patients to be treated as outpatients • Majority of patients expected to be outpatient • Medical Prior-Authorization of patients likely required o Drug directly covered by Medicare as pass through o Delcath has engaged a hub service to assist with benefit verification and navigation • Centers of Excellence (Prospective Payment System (PPS) exempt and NCI designated Cancer Centers) have the leverage to negotiate favorable rates and reimbursement terms o ~50% of target sites are PPS exempt or NCI Cancer Centers 21
PHP is Already Part of Current NCCN Guidelines for mUM Regional Isolation Perfusion Methods include isolated hepatic infusion (IHP), percutaneous hepatic perfusion (PHP), HAI, and embolization techniques. PHP is a simpler, less invasive alternative to IHP that can be repeated. It uses a double-balloon catheter inserted into the inferior vena cava to isolate hepatic venous blood that is then filtered extracorporeally. TREATMENT OF METASTATIC DISEASE NCCN Guidelines Version 1.2024 Melanoma: Uveal Clinical Trial (preferred) OR Consider on or more of the following: WORKUP nn • Liver-directed therapies ii Imaging to Residual or Isolated liver • Regional isolation perfusion of the liver assess response 99 • Biopsy if clinically appropriate metastases progressive disease oo • Melphalan percutaneous hepatic perfusion or progression ii • Imaging for baseline staging and n • Embolization (chemotherapy, radiation, immunotherapy) Distant to evaluate specific signs and • Ablative procedures (thermal ablation, chryotherapy) Metastatic symptoms • Consider resection and/or RT (photon beam or SRS for Disease * II • HLA-A 02:01 testing n limited or symptomatic disease of the liver) Clinical trial, if available II • Consider liver function tests • Systemic therapies No evidence or Observation (LFTs), including lactate Non-isolated • Best supportive/palliative care of disease mm dehydrogenase (LDH) (Follow-up, UM-4) liver metastases mm • Consider alkaline phosphatase Clinical Trial (preferred) OR ii Imaging to Residual or Consider on or more of the following: assess response progressive disease SOURCE: National Comprehensive II • Systemic therapies or progression ® Cancer Network • Best supportive/palliative care 22
Components of Hospital Reimbursement Assuming Outpatient Pass Through Status with J-Code HEALTHCARE FACILITY FEE “PHYSICIAN” PAYMENT DRUG • MDs primarily on salary but physician payments • The existing CPT codes should capture all • ASP+6% (CMS) and associated RVUs are still relevant steps of the procedure • The existing CPT codes should capture all steps • Likely similar for commercial • Believe the existing codes will provide of the procedure payers payment competitive with other • Believe the existing codes will provide interventional procedures payment competitive with other interventional procedures CPT Code mapping complete No meaningful impact on treatment decisions 23
NEXT STEPS: Future Indications 24
Clinical Rationale for Broad Development Effort Melphalan has demonstrated clinical activity in multiple tumor types Promising ORR, DCR and PFS signals seen across multiple tumor types with CHEMOSAT in Europe and in earlier studies with IHP In many solid tumor patients, liver metastases are often life limiting HEPZATO is currently the only liver-directed treatment that can repeatedly treat the whole liver Potential for significant improvement in survival Converting unresectable liver metastases into resectable metastases and adjuvant usage to prevent recurrence Potential for sequential usage with Immune- Oncology (I/O) agents Liver metastases reduce I/O therapy efficacy due to the tumor microenvironment inducing immune tolerance, HEPZATO may reduce this effect 25
Strong Correlation of IHP and PHP Efficacy in mUM Patients IHP activity in CRC and NET 15 IHP / Melphalan in mCRC Meta-analysis o f 8 mUM clinical studies N=154 ORR 50% 16 Endpoint IHP (%) PHP (%) Van Iersel mPFS 7.4 months mOS 24.8 months mOS 17.1 17.3 N=120 ORR 61% 17 Alexander mOS 17.4 months mPFS 7.2 9.6 2-year survival 34% hPFS 10 9.5 IHP in mNET Complications 39.1 23.8 ORR 50% DOR 15 months 18 Grover mhPFS 7 months Mortality 5.5 1.8 mOS 48 months IHP, or Intrahepatic Perfusion, is an invasive surgical technique for delivering high doses of chemotherapy to the liver; procedure related mortality and morbidity prevented common usage. PHP is a minimally invasive, safer procedure which accomplishes the same goals as IHP and can be performed up to 6 times. 15 Bethlehem MS et al. Meta-Analysis of Isolated Hepatic Perfusion and Percutaneous Hepatic Perfusion as a Treatment for Uveal Melanoma Liver Metastases. Cancers (Basel). 2021 Sep 21;13(18):4726. 16 Van Iersel LB, Gelderblom H, Vahrmeijer AL, et al. Isolated hepatic melphalan perfusion of colorectal liver metastases: outcome and prognostic factors in 154 patients. Ann Oncol. 2008;19:1127–34Grover A et al. Isolated Hepatic Perfusion with 200 mg Melphalan for Advanced Noncolorectal Liver Metastases. Surgery. (2005). 136. 1176-82. 17 Alexander HR Jr, Bartlett DL, Libutti SK, et al. Analysis of factors associated with outcome in patients undergoing isolated hepatic perfusion for unresectable liver metastases from colorectal center. Ann Surg Oncol. 2009;16:1852–9 18 Grover AC, Libutti SK, Pingpank JF, Helsabeck C, Beresnev T, Alexander HR. Isolated hepatic perfusion for the treatment of patients with advanced liver metastases from pancreatic and gastrointestinal neuroendocrine neoplasms. Surgery. 2004;136(6):1176-1182. doi:https://doi.org/10.1016/j.surg.2004.06.044 26
Rationale for Combining HEPZATO with IO Therapy Liver Metastases Suppress IO Therapy Efficacy 27
Encouraging Signal of Efficacy for PHP and I/O Drug Combination From Phase 1b Part of the Chopin Trial % Change of Target Lesions from Baseline by Response Category 19 • N=7 in Phase 1b portion of the trial • RP2D: IPI 1mg/kg and NIVO 3mg/kg. Well tolerated, no DLTs or deaths. • 1CR, 6 PR and 1 PD (85.7% ORR, 100% DCR) – meta-analysis of prior IO trials has shown ORR<<10% • As of 11/15/22 the median follow-up was 29.1 months, the median PFS was 29.1 months, and the median duration of response was 27.1 months. • 3 of 4 patients who subsequently experienced PD continued with treatment in the form of repeated Melphalan Chemosat treatments • Ongoing randomized Phase 2 (control is Chemosat) has recruited and enrolled all 76 patients, Primary endpoint is 1 Yr PFS and results expected in Fall of 2025 Ipilimumab + melphalan liver Ipilimumab + Ipilimumab + melphalan liver Ipilimumab + Inclusion nivolumab* chemo-saturation nivolumab* nivolumab* chemo-saturation nivolumab* *c1: 1+1mg/kg, c2: 1+3mg/kg 19 Tong TML et al. Combining Melphalan Percutaneous Hepatic Perfusion with Ipilimumab Plus Nivolumab in Advanced Uveal Melanoma: First Safety and Efficacy Data from the Phase Ib Part of the Chopin Trial. Cardiovasc Intervent Radiol. 2023 Mar;46(3):350-359. 28
Planned Market Expansion U.S. TAM Potential Significant Upside >$1B per year U.S. Incidence of Liver-Dominant Cancers 50,000 40,000 Approved Phase 2* Initiation planned in 2025 30,000 Potential future opportunity 20,000 10,000 0 mUM ICC mBC mNET mPC mCRC HCC rd *mBC and mCRC planned trials will address 3 line liver-dominant metastatic patients 29
DELCATH: Financials 30
Financial Metrics (unaudited) Total revenues: quarterly progression ($ in millions) $16.0 Highlights – Preliminary Q4 and YE 2024 (unaudited) $1.4 $14.0 $12.0 • Fourth Quarter Revenue to be Approximately $15.1 $1.2 $10.0 Million $8.0 • Full Year Total Revenue to be Approximately $37.2 39% $1.2 $13.7 Million $6.0 $10.0 40% $4.0 • Revenue growth driven primarily by HEPZATO site 150% $6.6 activation $1.1 $2.0 $2.0 $0.0 • Gross Margins expected to be 80-85% Q1 2024 Q2 2024 Q3 2024 Preliminary Q4 • Expected Cash and Investments of $53.2M 2024 HEPZATO CHEMOSAT • No outstanding debt obligations ($ in millions) Q1 2024 Q2 2024 Q3 2024 Preliminary Q4 2024 Revenue HEPZATO $2.0 $6.6 $10.0 $13.7 CHEMOSAT $1.1 $1.2 $1.2 $1.4 Operating Cash Burn ($9.6) ($4.5) ($3.6) TBD 31
Capital Structure and Share Information DCTH (NASDAQ) Capitalization a. As of December 31, 2024; includes 33.0M of Common plus; 1.8M Preferred E, E-1 a 36.2M and F Series & 1.4M Pre-funded Warrants Shares Outstanding as converted. b. 1.8M warrants at a $10 exercise price b 1.8M Warrants Outstanding (expiring May 2025). c. Used NASDAQ closing price information 5.8M Stock Options Outstanding starting on January 1, 2024 to December 31, 2024. 43.8M d. 30-day average calculated between Fully Diluted Shares November 20, 2024 to December 31, 2024. c $3.72 - $12.67 52 Week Low - High d 342k 30d Average Daily Volume 32
Multi-Disciplinary, Experienced Leadership Team David Hoffman Gerard Michel Martha S. Rook, PhD GENERAL COUNSEL, CORP SECRETARY & CHIEF EXECUTIVE OFFICER CHIEF OPERATING OFFICER CHIEF COMPLIANCE OFFICER • 30+ yrs. pharma/medtech • 25+ yrs. molecular bio., process dev., manufacturing, supply chain and experience quality experience • 20+ yrs. advising biotech • C-suite roles at Vericel Corp, companies with a focus on the • Senior roles at insitro, Sigilon Biodel, & NPS commercialization of therapies Therapeutics, and MilliporeSigma • M.S. Microbiology, B.S. Biology & • Previously Associate General • Ph.D. Biochemistry from MIT, B.S. in Geology from the Univ. of Counsel and Chief Compliance chemistry from Texas A&M Rochester School of Medicine Officer at Vericel Corporation • Postdoctoral studies at Harvard • M.B.A. Simon School of Business & Medical School Leadership Kevin Muir Sandra Pennell Vojislav Vukovic, MD PhD GENERAL MANAGER, INTERVENTIONAL ONCOLOGY SVP, FINANCE CHIEF MEDICAL OFFICER • 20+ yrs. medtech/bioTx sales & • 20+ years' biotech financial marketing experience • Oncology dev. exec, global clinical oversight experience expertise • Senior leadership roles at BTG, • Manages global financial affairs, ClearFlow, Aragon Surgical, Kensey • Former CMO at Aileron, Taiho, Synta U.S. GAAP compliance Nash Corporation, and Kyphon • MD, Univ. of Sarajevo | MSc, PhD, • Led finance at Invivyd • Field Artillery officer, U.S. Army Univ. of Toronto • VP at Vericel Corp • B.S. in Management Systems • Published, AACR, ASCO, ASH, ESMO Engineering, U.S. Military Academy member • MSc, Accountancy, Univ. of Illinois at West Point John R. Sylvester, Chairman Elizabeth Czerepak, Director Dr. Gil Aharon, Ph.D., Director Board of Directors Bridget Martell, MA, MD, Director Steven Salamon, Director Gerard Michel, CEO 33
U.S. Registration Trial for the Treatment of Patients with mUM 34
FOCUS TRIAL 9 Summary of Efficacy Results Endpoints HEPZATO KIT (N=91) ORR, n 33 (36.3%) DOR, Median in months 14.0 DCR, n 67 (73.6%) PFS, Median in months 9.0 OS, Median in months 20.53 • Full analysis with final data cut pending publication • HEPZATO Tx every 6-8 weeks up to a maximum of 6 cycles • Prescribing Information includes ORR, DOR and response categories • Trial powered to show an ORR advantage over a meta-analysis of Best Alternative Care o Checkpoint inhibitors, chemotherapy, other liver-directed therapy • Lower bound of FOCUS ORR (26.4%) is significantly higher than the upper bound of the meta-analysis (8.3%) 9 DOI: 10.1200/JCO.2022.40.16_suppl.9510 Journal of Clinical Oncology 40, no. 16_suppl (June 01, 2022) 9510-9510. 35
FOCUS TRIAL * Published mUM Prospective and Retrospective Studies Median OS Median PFS Clinical Study/Publication Study Type Treatment N 1 year OS (months) (months) AL FOCUS Single-Arm HEPZATO 91 20.53 80% 9.03 systemic and liver- 10 Khoja et al 2019 Meta-Analysis 912 10.2 NA 3.3 directed therapies systemic and liver- 11 Rantala et al 2019 Meta-Analysis 2,494 12.84 NA NA directed therapies 12 TN Piulats et al 2021 Single-Arm ipi plus nivo 52 12.7 NA 3.0 ipi plus (pembro or 13 AL Heppt et al 2019 Single-Arm 64 16.1 NA 3.0 nivo) TN tebentafusp 252 21.7 73% 3.3 14 Nathan et al 2021 Randomized TN control 126 16 59% 2.9 TN = Treatment Naïve, AL = Any Line Ipi = ipilimUMab, nivo = nivolumab, pembro = pemUMab *Studies from 2019 or later with >50 patients 10 Khoja L, et al. Meta-analysis in metastatic uveal melanoma to determine progression free and overall survival benchmarks: an international rare cancers initiative (IRCI) ocular melanoma study. Ann Oncol 2019 Aug 1, 30(8): 1370-1380. 11 Ranjala, E, et al. Overall survival after treatment for metastatic uveal melanoma: a systematic review and meta-analysis. Melanoma Res. 2019 Dec; 29(6): 561–568 12 Piulats, J, et al. Nivolumab Plus Ipilimumab for Treatment-Naïve Metastatic Uveal Melanoma: An Open-Label, Multicenter, Phase II Trial by the Spanish Multidisciplinary Melanoma Group (GEM-1402). Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 586-598. 13 Heppt, M, et al. Combined immune checkpoint blockade for metastatic uveal melanoma: a retrospective, multi-center study. J Immunotherapy Cancer. 2019 Nov 13;7(1):299. 14 Nathan, P, et al. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med 2021; 385:1196-1206 36
FOCUS TRIAL Adverse Reactions Related to Study Treatment Occurring in ≥10% of Patients (N=95) Adverse Events ALL GRADES (%) GRADES 3 OR 4 (%) Thrombocytopenia* 64 55 Leukopenia* 44 34 Anemia* 61 33 Neutropenia* 35 29 International normalized ratio increased 29 8 Activated partial thromboplastin time prolonged 26 8 Aspartate aminotransferase increased 27 3 Hypocalcemia 12 3 Blood bilirubin increased 11 3 Alanine aminotransferase increased 31 2 Blood alkaline phosphatase increased 25 2 Troponin I increased 12 2 Abdominal pain upper 18 1 Dyspnea 11 1 Nausea 47 0 Fatigue 43 0 Vomiting 27 0 Contusion 16 0 Adverse reactions are described further in the HEPZATO KIT PI. Asthenia 13 0 Back pain 13 0 Decreased appetite 13 0 • Most hematological side effects Abdominal pain 12 0 result from melphalan Lethargy 12 0 Groin pain 11 0 • Side effect profile similar to Headache 11 0 standard melphalan use Anemia includes anemia, febrile bone marrow aplasia, hemoglobin decreased, normochromic normocytic anemia, red blood cell count decreased. Leukopenia includes leukopenia, lymphocyte count decreased, lymphopenia, and white blood cell count decreased. Neutropenia includes neutropenia and neutrophil count decreased. Thrombocytopenia includes thrombocytopenia and platelet count decrease. 37
Thank You 38
References 1. Reddy S, et al. Isolated hepatic perfusion for patients with liver metastases, Ther Adv Med Oncol. 2014 Jul; 6(4): 180-194. 2. Xu L, T, Funchain P, F, Bena J, F, Li M, Tarhini A, Berber E, Singh A, D: Uveal Melanoma Metastatic to the Liver: Treatment Trends and Outcomes. Ocul Oncol Pathol 2019;5:323-332. doi: 10.1159/000495113. 3. Lane AM, Kim IK, Gragoudas ES. Survival Rates in Patients After Treatment for Metastasis From Uveal Melanoma. JAMA Ophthalmol. 2018 Sep 1;136(9):981- 986. 4. Heppt, M, et al. Combined immune checkpoint blockade for metastatic uveal melanoma: a retrospective, multi-center study. J Immunotherap Cancer. 2019 Nov 13;7(1):299. 5. Krantz BA, et al. Uveal Melanoma: Epidemiology, Etiology, and Treatment of Primary Disease. Clin Ophthalmol. 2017;11:279-289 6. Eschelman DJ et al. Transhepatic Therapies for Metastatic Uveal Melanoma. Semin Intervent Radiol. 2013;30(1):39-48. 7. Carvajal RD, et al. Metastatic Disease from Uveal Melanoma: Treatment Options and Future Prospects. Br J Ophthalmol. 2017;101(1):38-44. 8. Olofsson BR, et al. Isolated Hepatic Perfusion With Melphalan for Patients With Isolated Uveal Melanoma Liver Metastases: A Multicenter, Randomized, Open-Label, Phase III Trial (the SCANDIUM Trial). J Clin Oncol. 2023 Jun 1;41(16):3042-3050. 9. DOI: 10.1200/JCO.2022.40.16_suppl.9510 Journal of Clinical Oncology 40, no. 16_suppl (June 01, 2022) 9510-9510. 10. Khoja L, et al. Meta-analysis in metastatic uveal melanoma to determine progression free and overall survival benchmarks: an international rare cancers initiative (IRCI) ocular melanoma study. Ann Oncol 2019 Aug 1, 30(8): 1370-1380. 11. Ranjala, E, et al. Overall survival after treatment for metastatic uveal melanoma: a systematic review and meta-analysis. Melanoma Res. 2019 Dec; 29(6): 561–568 12. Piulats, J, et al. Nivolumab Plus Ipilimumab for Treatment-Naïve Metastatic Uveal Melanoma: An Open-Label, Multicenter, Phase II Trial by the Spanish Multidisciplinary Melanoma Group (GEM-1402). Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 586-598. 13. Heppt, M, et al. Combined immune checkpoint blockade for metastatic uveal melanoma: a retrospective, multi-center study. J Immunotherapy Cancer. 2019 Nov 13;7(1):299. 14. Nathan, P, et al. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med 2021; 385:1196-1206 15. Bethlehem MS et al. Meta-Analysis of Isolated Hepatic Perfusion and Percutaneous Hepatic Perfusion as a Treatment for Uveal Melanoma Liver Metastases. Cancers (Basel). 2021 Sep 21;13(18):4726. 16. Van Iersel LB, Gelderblom H, Vahrmeijer AL, et al. Isolated hepatic melphalan perfusion of colorectal liver metastases: outcome and prognostic factors in 154 patients. Ann Oncol. 2008;19:1127–34Grover A et al. Isolated Hepatic Perfusion with 200 mg Melphalan for Advanced Noncolorectal Liver Metastases. Surgery. (2005). 136. 1176-82. 17. Alexander HR Jr, Bartlett DL, Libutti SK, et al. Analysis of factors associated with outcome in patients undergoing isolated hepatic perfusion for unresectable liver metastases from colorectal center. Ann Surg Oncol. 2009;16:1852–9. 18. Grover AC, Libutti SK, Pingpank JF, Helsabeck C, Beresnev T, Alexander HR. Isolated hepatic perfusion for the treatment of patients with advanced liver metastases from pancreatic and gastrointestinal neuroendocrine neoplasms. Surgery. 2004;136(6):1176-1182. doi:https://doi.org/10.1016/j.surg.2004.06.044 19. Tong TML et al. Combining Melphalan Percutaneous Hepatic Perfusion with Ipilimumab Plus Nivolumab in Advanced Uveal Melanoma: First Safety and Efficacy Data from the Phase Ib Part of the Chopin Trial. Cardiovasc Intervent Radiol. 2023 Mar;46(3):350-359. 39