DCTH

Appointment Announcement: Beta Bionics, Inc. has appointed Gerard Michel as an independent board member, effective March 26, 2025. Michel is the CEO of Delcath Systems and brings over 30 years of experience in the pharmaceutical and medical technology industries.

Company Overview: Beta Bionics focuses on developing innovative diabetes management solutions, including the iLet Bionic Pancreas, which autonomously delivers insulin to improve treatment outcomes for people with diabetes.

Equity Awards Granted: Delcath Systems, Inc. has granted equity awards to six new employees, allowing them to purchase 264,000 shares of common stock at an exercise price of $14.17, with a vesting schedule over three years contingent on continued employment.

Company Overview: Delcath is focused on interventional oncology for liver cancers, offering products like HEPZATO KIT™ and CHEMOSAT® that deliver high-dose chemotherapy directly to the liver while minimizing systemic exposure and side effects.

Market Capitalization Drop: The market capitalization required for companies to join the Russell 2000 Index has decreased by 12% to $129M due to a decline in stock performance, with the index falling 9.4% recently compared to a smaller drop in the Russell 1000 index.

Impact on New Additions: Poor performance of small-cap stocks, particularly those in the Russell Microcap index, has contributed to the lower market-cap cutoff for new additions to the Russell 2000, which is set for reconstitution on June 27, 2025.

Financial Performance: Delcath Systems reported a total revenue of $15.1 million for Q4 2024 and $37.2 million for the full year, primarily driven by HEPZATO KIT sales, while also achieving a gross margin of 86% in Q4 despite a net loss of $3.4 million for the quarter.

Business Developments: The company activated additional treatment centers and received FDA clearance for a Phase 2 clinical trial of HEPZATO in liver-dominant metastatic colorectal cancer, indicating progress in expanding its treatment options and market presence.

Major Earnings Reports: Key earnings reports expected before the market opens on Thursday include Canadian Natural Resources, JD.com, Kroger, Macy's, and TORM.

Additional Earnings Releases: Other companies set to release earnings include ACDC, BJ, BURL, CBRL, DCTH, and several others listed in the article.

Conference Call Announcement: Delcath Systems Inc. will hold a conference call on March 6, 2025, at 8:30 AM ET to discuss their Q4 24 earnings results.

Access Information: The call can be accessed via a live webcast or by dialing specific phone numbers for US and international listeners.

Update on HEPZATO KIT: Delcath Systems announced that the NCCN Clinical Practice Guidelines now include HEPZATO KIT as a Category 2A treatment option for patients with hepatic-dominant uveal melanoma, expanding its use beyond just those with liver-confined metastases.

Significance of the Update: This revision acknowledges the critical role of liver metastases in metastatic uveal melanoma, potentially benefiting over 90% of patients who develop liver-related complications from the disease.

Stock Performance: Delcath Systems Inc. (DCTH) shares reached a 52-week high of $16.97, marking over a 100% increase in less than six months, with the stock closing at $16.25 after a slight decline.

Product Overview: The company’s HEPZATO KIT, approved by the FDA for treating liver cancer, has shown steady revenue growth, with sales increasing from $2 million in Q1 2024 to a projected $13.7 million in Q4 2024.

Impact of Federal Funding on Biotech: The Trump administration's recent freeze and subsequent lifting of the freeze on federal funding has created uncertainty in the biotech sector, which heavily relies on federally funded research for clinical trials and lab operations.

Market Insights and Predictions: Analyst Mara Goldstein discusses potential impacts of regulatory changes under Trump's second term, highlighting specific biotech companies as top picks while noting the uncertain influence of Robert F. Kennedy Jr.'s confirmation as Secretary of Health and Human Services.

Delcath Systems Conference Attendance: Delcath Systems, Inc. will participate in the BTIG Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on February 11-12, 2025, in Snowbird, Utah.

HEPZATO KIT and CHEMOSAT Overview: Delcath's HEPZATO KIT and CHEMOSAT are specialized systems for delivering high-dose chemotherapy to the liver, approved for treating metastatic uveal melanoma and regulated as a drug-device combination in the U.S. and as a medical device in Europe.

Retail and Institutional Ownership: Delcath Systems has significant retail investor ownership at 58%, while institutional investors hold 35%, indicating that key decisions may be influenced by a large group of smaller shareholders.

Insider and Private Equity Influence: Insiders own about $12 million worth of shares, and private equity firms with 5.3% ownership can impact corporate strategy, but the presence of warning signs suggests caution for potential investors.

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Stock Performance: Delcath Systems' shares rose 8.9% in premarket trading after announcing preliminary revenue figures for Q4 and the full year that exceeded analysts' expectations.

Revenue Projections: The company anticipates Q4 revenues of $15.1 million and full-year revenues of $37.2 million, both surpassing forecasts and indicating strong growth prospects.

Equity Award Announcement: Delcath Systems, Inc. granted an equity award of 30,000 shares to a new employee as part of their 2023 Inducement Plan, with options vesting over three years and an exercise price set at $12.04.

Company Overview: Delcath specializes in interventional oncology for liver cancers, offering products like HEPZATO KIT™ and CHEMOSAT®, which deliver high-dose chemotherapy directly to the liver while minimizing systemic exposure and side effects.

Funding Announcement: Delcath Systems, Inc. announced the exercise of 1.7 million Series E and E1 warrants, resulting in $16.3 million in funding, which will support their commercialization efforts and clinical development plans for HEPZATO, a treatment for uveal melanoma patients.

Product Overview: The HEPZATO KIT is an FDA-approved combination drug and device designed for high-dose chemotherapy delivery to the liver, while minimizing systemic exposure and side effects, specifically targeting metastatic uveal melanoma with unresectable hepatic metastases.

Zoomcar Holdings Performance: Zoomcar Holdings, Inc. saw a significant 142% increase in its shares to $3.46 during pre-market trading, attributed to a 43% year-on-year growth in bookings for November 2024, driven by heightened demand from the wedding season.

Market Movements: Several stocks experienced notable fluctuations in pre-market trading, with SciSparc Ltd. gaining 161% and Hour Loop, Inc. dropping 30.5%, reflecting a volatile market environment following previous gains.

Expansion of Healthcare Equity Research: Clear Street has launched a new Healthcare Equity Research franchise focused on the biotechnology sector, enhancing its existing research offerings to better serve institutional clients and asset managers.

Expert Team and Coverage Areas: The new franchise is led by experienced analysts Dr. Kaveri Pohlman and Dr. Bill Maughan, who will cover various therapeutic areas including oncology and autoimmune diseases, highlighting under-represented companies in the biotechnology space.

FDA Approval for Clinical Trial: Delcath Systems, Inc. has received FDA authorization to begin patient enrollment for a Phase 2 clinical trial evaluating HEPZATO™ in combination with standard treatments for liver-dominant metastatic colorectal cancer (mCRC), with approximately 90 patients expected to participate.

Market Potential and Treatment Goals: The company aims to address the annual market of 6,000 to 10,000 patients in the U.S. with liver-dominant mCRC by providing a novel treatment option, expanding the use of HEPZATO beyond its current application for metastatic uveal melanoma.

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Financial Performance: Delcath Systems Inc reported $11.2 million in Q3 2024 revenue, with significant growth from the U.S. market and plans to activate 20 treatment centers by early 2025, while maintaining a strong financial position with no debt.

Future Outlook: The company anticipates a slowdown in treatment rates during the holiday season, increased R&D expenses for 2025, and is navigating its first holiday season post-launch with potential shifts in patient treatment schedules.