On August 5, 2024 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, reported financial results and business highlights for the second quarter ended June 30, 2024 (Press release, Delcath Systems, AUG 5, 2024, View Source [SID1234645337]).

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Recent Business Highlights

Recognized second quarter 2024 revenues of $6.6 million from sales of HEPZATO KIT (melphalan/Hepatic Delivery System) and $1.2 million in CHEMOSAT sales;

Activated three HEPZATO KIT treating centers in the US during the second quarter with an additional center in July for a total of eight active treating centers. Two additional centers have completed the necessary steps and have scheduled their first treatments in August. An additional four centers are ready to conduct their first commercial treatment and are currently in the process of scheduling patients for treatment;
Received New Technology Add-on Payment status (NTAP) on August 1, 2024 for HEPZATO from the Centers for Medicare & Medicaid Services (CMS) which provides hospitals additional payments to cover the costs associated with the treatment for cases in the inpatient setting. While HEPZATO KIT is used primarily in the outpatient setting, there are instances where it is used in the inpatient setting;
Published key results from the pivotal Phase 3 FOCUS study of HEPZATO KIT in patients with unresectable metastatic Uveal Melanoma in the journal Annals of Surgical Oncology;
Announced the acceptance of the FOCUS study efficacy analysis as a poster presentation at the upcoming ESMO (Free ESMO Whitepaper) conference to be held September 2024;
Reported that independent investigators at the Leiden University have enrolled 70 of the total 76 patients planned in the Phase 2 part of the CHOPIN trial which is evaluating the effect of sequencing Immunotherapy with CHEMOSAT liver directed therapy;
Executed an amendment with Synerx Pharma, LLC and Mylan Teoranta for Delcath’s supply of melphalan hydrochloride which extends the term of the original agreement to December 31, 2028;
Appointed Dr. Bridget Martell to the Company’s Board of Directors effective May 23, 2024;
Submitted the final principal payment due to Avenue Venture Opportunities Fund, L.P. (Avenue) on August 1, 2024 for the Loan and Security Agreement entered into in August 2021; and
Ended the quarter with cash and investments of $19.9 million
"We are excited about the continued adoption of the HEPZATO KIT and the positive feedback from physicians," said Gerard Michel, Delcath’s Chief Executive Officer. "We are optimistic that HEPZATO KIT will become a key part of the therapeutic approach for metastatic uveal melanoma patients."

Second Quarter 2024 Results

Total revenue for the quarter ended June 30, 2024 was $7.8 million compared to $0.5 million for the same period in the prior year. Revenues include sales of $6.6 million of HEPZATO in the U.S. and $1.2 million of CHEMOSAT in Europe.

Research and development expenses for the quarter ended June 30, 2024, were $3.4 million compared to $3.6 million for the same period in the prior year. The change in research and development expenses is primarily due to lower costs associated with NDA submission incurred in previous periods offset by an increase in medical affairs and regulatory costs associated with an approved product.

Selling, general and administrative expenses for the quarter ended June 30, 2024, were $6.8 million compared to $4.8 million for the same period in the prior year. The increase primarily relates to commercial launch activities including marketing-related expenses and additional personnel in the commercial team.

Cash, cash equivalents and investment totaled $19.9 million as of June 30, 2024.

Conference Call Information

To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date:

Monday, August 5, 2024

Time:

4:30 PM Eastern Time

Participant Numbers

Toll Free:

1-877-407-3982

International:

1-201-493-6780

Webcast:

View Source;tp_key=87da4fb106

A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website: View Source

On August 5, 2024 Tubulis reported that Fierce Biotech has named the company as one of 2024’s "Fierce 15" biotechnology companies (Press release, Tubulis, AUG 5, 2024, View Source [SID1234645356]). The annual special report features the most innovative and promising biotechnology companies in the industry.

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"Being selected for this prestigious industry award is an important recognition of our leadership position in the ADC space as well as the potential of our unique approach to ADC development. It also is a great reward for all the hard work our team has been putting into driving innovation and realizing our mission of improving the outcomes for cancer patients. I specifically would like to thank every team member and our Board for their contributions," said Dominik Schumacher, CEO at Tubulis. "2024 is a pivotal year for us and we are committed to further building on this momentum to push the boundaries of ADCs and unlock their full therapeutic potential."

Tubulis was established with the goal of maximizing the overall performance of ADCs by addressing the main bottlenecks in the field through innovation in all aspects of ADC development. The company has created a unique suite of technologies that combine a diverse range of targeting molecules, innovative payloads, and proprietary conjugation technologies to deliver revolutionary ADCs with superior biophysical properties and durable anti-tumor effects. Based on differentiated preclinical results recently presented at AACR (Free AACR Whitepaper) and backed by an upsized €128 million Series B2 financing in March, the company is now translating the durable efficacy of its lead candidates, TUB-030 and TUB-040, into the clinic. In June, the first patient was dosed with TUB-040 in a Phase I/IIa study (NAPISTAR 1-01, NCT06303505) to investigate its safety, pharmacokinetics and efficacy in patients with platinum-resistant high-grade ovarian cancer (PROC) and relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC), who have exhausted other available treatment options. Shortly afterwards, the candidate was granted Fast Track designation by the U.S. Food and Drug Administration ("FDA") for the treatment of patients with PROC.

"For the past 22 years, we have evaluated hundreds of companies for inclusion in the ‘Fierce 15’ special report. Our selection process considers various factors, including technological robustness, strategic partnerships, venture support and market positioning," said Ayla Ellison, Editor-in-Chief, Fierce Life Sciences and Healthcare. "This report highlights innovation and creativity amid intense competition."

On August 5, 2024 Radiopharm Theranostics (ASX:RAD) reported it has secured yet another milestone with a payment of AU$3.0 million (US$2.0 million) from Nasdaq-listed Lantheus Holdings Inc (Nasdaq:LNTH). This payment comes under their recent preclinical assets transfer and development agreement, announced on 20 June 2024.

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Under this agreement, Lantheus, a US-based player in the radiopharmaceutical sector, has committed to an initial equity investment of AU$7.5 million (US$4.99 million) in Radiopharm at 5 cents per share, representing a 47% premium over the share price at that time. Additionally, Lantheus has the option to invest a further AU$7.5 million (US$5.0 million) within the next six months under the same terms.

The agreement also includes a separate transfer and development component in which Radiopharm has assigned and sublicensed two of its preclinical assets to Lantheus. These include a TROP2 targeting nanobody and an LRRC15 targeting monoclonal antibody. These assets are valued at AU$3.0 million (US$2.0 million).

Riccardo Canevari, CEO & MD of Radiopharm Theranostics, expressed enthusiasm about the partnership, stating, "I am delighted with the confidence demonstrated by Lantheus in settling the transfer and development agreement and making this payment ahead of the shareholder meeting later this month. We are well advanced in our strategic planning with Lantheus, and the collaboration between our two companies augurs well for the future."

Lantheus’ investment funds will be allocated to general working capital, drug manufacturing, and clinical trials for Radiopharm Theranostics.

In June, Radiopharm announced the completion of an AU$70 million placement, featuring a strategic investment from Lantheus. Additionally, as per its recent update, RAD aims to achieve a secondary listing on NASDAQ by 2024 end.

(Press release, Radiopharm Theranostics, AUG 5, 2024, View Source [SID1234661592])

On August 5, 2024 Genmab A/S (Nasdaq: GMAB) reported that it will assume sole responsibility for the continued development and potential commercialization of acasunlimab (Press release, Genmab, AUG 5, 2024, View Source [SID1234645338]). BioNTech SE (BioNTech) has opted not to participate in the further development of the acasunlimab program under the parties’ existing collaboration agreement. The program will be subject to payment of certain milestones and a tiered single-digit royalty on net sales by Genmab to BioNTech. Genmab plans to initiate the Phase 3 study in the second half of this year. While the emerging clinical profile of acasunlimab is encouraging, BioNTech informed the company that it has taken this decision for reasons relating to its portfolio strategy. The companies’ long-standing collaboration in antibody science remains in place, and both parties will continue with the existing programs under development under their existing agreements, which were expanded in 2022.

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"Genmab’s partnership with BioNTech is a highly successful one. Together, we have demonstrated acasunlimab’s potential to impact patients with metastatic non-small cell lung cancer, as evidenced by the promising initial results presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Genmab is exceptionally well-positioned to maximize the potential of acasunlimab, and we are confident about the prospect of taking acasunlimab into late-stage development as our second wholly owned Genmab asset in addition to Rina-S. We look forward to our continued partnership with BioNTech on other pipeline programs."

The decision by BioNTech to not participate in the further development of the acasunlimab program is not expected to impact Genmab’s 2024 financial guidance.

About Acasunlimab (GEN1046)
Acasunlimab (GEN1046) is an investigational PD-L1x4-1BB bispecific antibody fusing Genmab’s proprietary DuoBody technology platform and BioNTech’s proprietary immunomodulatory antibodies. Acasunlimab is designed to elicit an antitumor response via conditional activation of 4-1BB on T cells and natural killer (NK) cells, which is strictly dependent on simultaneous binding of the PD-L1 arm.
The candidate is currently being investigated in three clinical trials: (1) a Phase 1/2 safety and PK trial in patients with multiple solid tumors, (2) a Phase 1 dose escalation trial in patients with advanced solid tumors in Japan, and (3) a randomized Phase 2 safety and efficacy trial with acasunlimab as a monotherapy and in combination with pembrolizumab in patients with non-small cell lung cancer (NSCLC) who have failed previous standard of care treatments with immune checkpoint inhibitors. Please visit www.clinicaltrials.gov for more information.

On August 5, 2024 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported the completion of its acquisition of select assets of Invitae (OTC:NVTAQ), a leading medical genetics company (Press release, Invitae, AUG 5, 2024, View Source [SID1234645339]). Together, Labcorp and Invitae will support patients, clinicians and pharmaceutical partners across the continuum of care, including therapy development, patient diagnosis and personalized care.

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"Labcorp and Invitae are on a shared mission to harness the power of genetic insights to transform medicine, deliver personalized care and improve health outcomes," said Mark Schroeder, Executive Vice President and President of Diagnostics Laboratories and Chief Operations Officer of Labcorp. "By adding Invitae’s cutting edge science and industry-leading experience, we will extend our leadership in genetic testing solutions with the most comprehensive offerings in areas such as oncology and select rare diseases. We are excited to welcome Invitae’s talented team to Labcorp and look forward to bringing genetic testing solutions to patients and physicians to improve health and improve lives."

The acquisition expands Labcorp’s specialty testing capabilities and the company’s ability to utilize genetic data to improve clinical trials and treatment regimens in oncology and select rare diseases. By integrating Invitae’s genetic testing technology with Labcorp’s specialty testing capabilities, the company will offer a more complete set of insights for each patient – from testing to diagnosis to treatment.

For more information visit Labcorp.com/invitae.

Invitae is advised by Kirkland & Ellis LLP as legal counsel, Moelis & Company LLC as investment banker and FTI Consulting, Inc. as financial and communications advisor. Citi is serving as Labcorp’s financial advisor and Hogan Lovells and Kilpatrick Townsend are serving as Labcorp’s legal counsel.