Germ Cell and Embryonal Neoplasms

NEW YORK, March 19, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on March 26, 2024, at 8:30 AM Eastern Time to discuss results for its fourth quarter and year ended December 31, 2023 and provide a business update. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Tuesday, March 26, 2024 Time: 8:30 AM Eastern Time Participant Numbers: Toll Free: 1-833-630-1960 International: 1-412-317-1841 Webcast: Conference Replay 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 surgically isolate the liver 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. 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. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. Contact: Investor Relations Contact: Ben Shamsian Lytham Partners 646-829-9701 [email protected] SOURCE Delcath Systems, Inc.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Metis Therapeutics, a Boston-area company integrating drug discovery and delivery with AI and machine learning, today announced they have entered a license agreement with Voronoi, Inc., a Korean company focused on precision medicine. Under the terms of this license agreement, METiS will receive exclusive license to develop and commercialize Voronoi’s pan-RAF inhibitor program worldwide. In exchange, Voronoi will receive up to $1.7 million in upfront cash and success-based near-term discovery milestones. Voronoi will also be eligible for success-based payment up to $480.5 million in development, regulatory and sales milestones and tiered royalties based on annual net sales. “We view this program as a potential best-in-class asset addressing high unmet clinical needs for Class II and Class III BRAF mutant cancer patients, particularly those with CNS metastasis,” said Chris Lai, Co-Founder and CEO of METiS Therapeutics. “We see it as a compelling proof-of-concept opportunity for our AiTEM platform to improve compound pharmacokinetics and deliver a differentiated profile, including CNS penetration. In addition, we view this as a foundational asset for our oncology portfolio.” BRAF is a protein kinase involved in cancer cell growth and BRAF mutations are the most common mutation found in tumor cells1. While several BRAF v600E inhibitors have been approved, this mutation only represents about 45% of total BRAF mutations, compared to Class II and III mutations which represent 55 percent of total BRAF mutations. This underscores the need for new therapeutic options in this space. “We developed our structurally distinguished type II pan-RAF inhibitor to address unmet medical needs, and this partnership brings us closer to our goal of delivering this candidate to patients,” says Daekwon Kim, CEO of Voronoi. “We are excited to partner with METiS’ seasoned team to continue on development of our pan-RAF inhibitor,” added Daekwon. This news follows METiS’ announcement that the company had joined the Roche Accelerator earlier this year. In December, METiS closed an $86 million Series A financing round. The company recently leased 14,000 square feet of mixed office and laboratory space at 101 Cambridgepark Drive in Cambridge, MA. About METiS METiS is a biotechnology company that aims to drive best-in-class therapies in a wide range of disease areas by integrating drug discovery and delivery with AI, machine learning, and quantum simulation. To learn more, please visit metistx.com. 1 MEK and BRAF inhibitors plus other melanoma targeted therapies. Memorial Sloan Kettering Cancer Center. (n.d.). Retrieved August 29, 2022, from

ATLANTA, March 19, 2024 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, announces that the first patient has been randomized in the DRCR Retina Network’s Protocol AL. The study is titled, “A Randomized Clinical Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss due to Radiation Retinopathy.” The study, chaired by Arun Singh, M.D. (Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio), plans to include 600 participants with primary choroidal melanoma receiving treatment with plaque brachytherapy. It will assess development of macular edema and associated long-term visual acuity effects of consistent and continuous release of corticosteroid or repeated injections of anti-VEGF initiated near the time of radiation therapy compared to observation until macular edema develops in patients at risk for radiation retinopathy. “We are very excited that this study is underway as it has the potential to show ILUVIEN addressing another unmet need affecting the retina,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “We believe ILUVIEN with CONTINUOUS MICRODOSING™ delivery may prevent, delay or reduce the occurrence of the complication of radiation retinopathy and consequent vision loss when used in patients treated with plaque brachytherapy and look forward to the continuing progress of this study.” About Radiation Retinopathy Radiation retinopathy (RR) is a common complication after Iodine-125 plaque brachytherapy for choroidal melanoma. Although the initial radiation insult is immediate, clinical onset of RR is not seen until many months later and RR frequently progresses over time to profound vision loss. The Collaborative Ocular Melanoma Study reported that at three years, 45% of patients have visual acuity 20/200 or worse. A treatment that prevents the development of RR, or dampens its severity, would have important consequences for many of these eyes that may be successfully treated for choroidal melanoma but will likely develop severe RR and loss of vision over time. About the DRCR Retina Network (DRCR.net) The DRCR Retina Network was formed in 2002 and includes clinical sites and physicians throughout the United States and Canada. It is funded by the National Eye Institute (NEI), part of the National Institutes of Health, which is the federal government agency that funds medical research. The DRCR Retina Network is supported in overall operation and leadership by the office of the Network Chairs (Daniel F. Martin, M.D., Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio and Jennifer K. Sun, M.D., M.P.H., Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts) and the Coordinating Center (Executive Director Adam R. Glassman, M.S., Jaeb Center for Health Research, Tampa, FL), and the National Eye Institute (Project Officer, Sangeeta Bhargava, Ph.D.). About ILUVIEN The Company’s primary product is ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to reduce the recurrence of disease, enabling patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Kuwait, Lebanon and the U.A.E. to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. In 17 European countries, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In March 2019, ILUVIEN received approval in the 17 countries under the Mutual Recognition Procedure for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. The 17 European countries include the U.K., Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czechia, the Netherlands, and Luxembourg. The non-infectious posterior uveitis indication for ILUVIEN was launched in Germany and the U.K. in late 2019, Belgium in 2021 and Spain and Italy in 2022. Alimera markets YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18mg for treatment of uveitis in the United States. About Alimera Sciences, Inc. Alimera Sciences is a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer. For more information, please visit . Forward Looking Statements This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera’s expectations with respect to ILUVIEN’s potential to address another unmet need affecting the retina. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, ILUVIEN’s ability to prevent or reduce the occurrence of the complication of radiation retinopathy and consequent vision loss when used in patients treated with plaque brachytherapy, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2023 which is on the Securities and Exchange Commission (SEC) and available on the SEC’s website at All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For press inquiries: Cassy Dump for Alimera Sciences 619-971-1887 cassydoespr@gmail.com For investor inquiries: Scott Gordon for Alimera Sciences scottg@coreir.com