Lantheus Holdings, Inc.

KNOXVILLE, Tenn.--( BUSINESS WIRE )--On January 16, 2025, Neuraly Inc. (Neuraly), a wholly owned subsidiary of D&D Pharmatech Inc., and Enigma Biomedical USA, Inc. (Enigma) announced the signing of a research license and commercialization option agreement for PMI04, a PET (Positron Emission Tomography) imaging biomarker of neuroinflammation developed by Neuraly. Under the agreement, Enigma acquires an exclusive research license for PMI04, as well as the option to negotiate commercialization rights based on the research results. PMI04 is a PET imaging biomarker that selectively binds to CSF-1R (Colony Stimulating Factor 1 Receptor) expressed in activated microglia. It enables visualization of the pathological activity of microglia, the fundamental contributors to neuroinflammatory responses, aiding in the diagnosis of various neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis. Enigma plans to focus its development efforts on utilizing PMI04 for the assessment of neurodegenerative diseases. Currently, PET imaging targeting TSPO (Translocator Protein) is used in neuro research, but exhibits limited specificity, leading to challenging interpretation and quantitative assessment. In contrast, CSF-1R specifically binds to activated microglia, directly correlating with microglial proliferation and survival. This makes PMI04 a next-generation PET imaging biomarker capable of quantifying assessment, early detection, and pathological analysis of inflammation-related neurodegenerative diseases, which may ultimately benefit the development of therapeutics. With successful conclusion of the research, a commercialization license agreement will be established between the two companies, granting Enigma exclusive development and commercialization rights for PMI04. Neuraly will receive an upfront payment and milestone payments based on development and commercialization progress, along with sales royalties upon the commercial sales in the future. Seulki Lee, CEO of Neuraly stated "We hope this partnership will represent a significant step forward in providing alternatives for the diagnosis and treatment of neurodegenerative diseases. We will do our utmost to ensure that PMI04 is commercialized swiftly through close collaboration with Enigma." “We are delighted to have been selected as a development partner by Neuraly,” said Rick Hiatt, President and CEO of Enigma. “We will build on demonstrated successes with the best-in-class neuroimaging biomarkers MK-6240 (Cerveau Technologies) and NAV-4694 (Meilleur Technologies). We believe the Neuraly CSF-1R PET imaging biomarker has unique properties and will prove useful in developing current and future therapeutics for neurodegenerative disease. Our commitment is to expand the availability of this novel investigational imaging agent to the broader scientific community.” About Enigma Biomedical USA, Inc. Enigma Biomedical USA ’s vision is to be the premier provider of imaging biomarkers for neurological pathologies, associated information technology, and related tools to accelerate the development, approval, and adoption of effective therapies to treat neurodegenerative diseases. Enigma’s neuroimaging biomarkers provide Pharma and Academic researchers with state-of-the-art tools for enabling Disease-Modifying Therapy development with the highest precision and accuracy. In pursuit of this vision, subsidiaries of Enigma have provided the best-in-class Tau and Amyloid PET imaging biomarkers, MK-6240 and NAV-4694, to our partners to enable their research efforts. Both tracers have recently been acquired by a third party for further development. Enigma also recently announced a partnership with AbbVie to explore their novel 4R Tau PET Imaging Biomarkers. About D&D Pharmatech, Inc. and Neuraly Inc. D&D Pharmatech Inc. (D&D) , listed on the KOSDAQ in Korea, specializes in the development of GLP-1 receptor agonists. The company has established a long-term partnership with the Johns Hopkins University School of Medicine to develop imaging biomarkers related to neurodegenerative diseases. Additionally, D&D is conducting clinical trials for GLP-1 candidates in various indications, including a completion of a Phase 2 trial in the U.S. for the weekly injectable GLP-1 receptor agonist pegsebrenatide (NLY01) in Parkinson’s disease patients in 2023. Neuraly Inc. (Neuraly) , D&D's wholly-owned subsidiary located in Gaithersburg, Maryland, USA, specializes in IND-enabling studies and clinical development for D&D’s programs targeting neurodegenerative, metabolic, and fibrotic diseases. Neuraly has successfully cleared multiple INDs and conducted five clinical trials to date, including four completed studies and an ongoing Phase 2 trial of DD01 for metabolic dysfunction-associated steatohepatitis (MASH).

Radiopharmaceutical maker Lantheus Holdings plans to acquire Life Molecular Imaging for $350 million in a bid to build up its commercial Alzheimer’s diagnostics business. In addition to the $350 million upfront payment, the deal includes up to $400 million in potential earnout and milestone payments. Six months ago, Lantheus made a deal with Life Molecular Imaging to license a diagnostic and therapeutics pair of radiopharmaceuticals, both of which target a protein called gastrin-releasing peptide receptor that’s highly expressed in breast and prostate cancer. Lantheus’ top-selling drug is a radioactive agent used to diagnose prostate cancer called Pylarify. Lantheus is gaining five assets from the buyout, namely a commercial Alzheimer’s diagnostic agent called Neuraceq. It’s an area that Lantheus has been investing in, though previous acquisitions were for experimental agents. In July, Lantheus bought Meilleur Technologies and its experimental beta amyloid PET imaging agent called NAV-4694. In 2023, Lantheus bought Cerveau Technologies for its experimental tau-targeted PET imaging agent known as MK-6240. “This puts us squarely in the Alzheimer’s space a whole lot earlier — at least a year earlier — than we were planning with the launch of [MK-6240], and we’ve got a ready-[to]-go franchise,” CEO Brian Markison said.

Private placement to radiopharmaceutical industry leader Lantheus, for US$5.0 millionPlacement at A$0.060 per share, representing a premium of 150% to the last closing price of A$0.024Lantheus shareholding in Radiopharm increases to 12.16% following the placementThe funds raised will be applied to the development of Radiopharm’s clinical pipeline SYDNEY, Jan. 10, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD; NASDAQ:RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce that it has executed a subscription agreement for a private placement of ordinary shares to Lantheus Holdings Inc. ( “Lantheus”), raising US$5.0 million (A$8.0 million). The placement of 133 million shares was completed at an issue price of A$0.060 per share, representing a 150% premium to the last traded price of RAD shares (A$0.024). Settlement is expected to occur within 7 days. The placement replaces 6-month options that the Company issued in August 2024 (see ASX announcement 20 June 2024). Radiopharm Theranostics CEO Riccardo Canevari said: “We are delighted to have Lantheus increase its shareholding in RAD, now making it the largest shareholder with over 12% of the Company. We have been working closely with Lantheus since the initial investment announced in June 2024, and we are delighted with the collaboration that has been taking place between our two companies. We look forward to continuing this positive momentum going forward.” Lantheus CEO Brian Markison said: “We are pleased to increase our holding in Radiopharm, while continuing to work jointly in Australia on the clinical development of radiopharmaceutical assets.” Massachusetts-based Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. It also has offices in Canada and Sweden and has provided radiopharmaceutical solutions for more than 65 years. The placement of shares in RAD to Lantheus is being completed under Radiopharm’s existing placement capacity under ASX Listing Rules. About Radiopharm Theranostics Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm has been listed on ASX (RAD) since November 2021. The company has a deep pipeline of highly differentiated molecules spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development. The pipeline has been built based on the potential to be first-to-market or best-in-class. The clinical program includes one Phase II and three Phase I trials in a variety of solid tumour cancers including brain, lung, breast and pancreas. Learn more at radiopharmtheranostics.com. Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper. For more information: Riccardo CanevariCEO & Managing DirectorP: +1 862 309 0293E: rc@radiopharmtheranostics.com Matt WrightNWR CommunicationsP: +61 451 896 420E: matt@nwrcommunications.com.au Follow Radiopharm Theranostics: Website – https://radiopharmtheranostics.com/ Twitter – https://twitter.com/TeamRadiopharm Linked In – https://www.linkedin.com/company/radiopharm-theranostics/InvestorHub – https://investorhub.radiopharmtheranostics.com/ Not an offer of securities This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States or any other jurisdiction. Any securities described in this announcement have not been, and will not be, registered under the US Securities Act of 1933 and may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the US Securities Act and applicable US state securities laws.