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Lantheus to Acquire Evergreen Theragnostics for Upfront Payment of $250 Million to Drive Strategic Evolution into Fully Integrated Radiopharmaceutical Leader

On January 28, 2025 Lantheus Holdings, Inc. ("Lantheus" or the "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported a definitive agreement to acquire Evergreen Theragnostics, Inc. ("Evergreen"), in an all-cash transaction consisting of an upfront payment of $250 million and up to an additional $752.5 million in potential milestone payments. Evergreen is a clinical-stage radiopharmaceutical company engaged in Contract Development and Manufacturing (CDMO) services as well as drug discovery and commercialization of proprietary products.

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This transaction is expected to solidify Lantheus’ capabilities as a fully integrated radiopharmaceutical company. The addition of Evergreen’s scalable manufacturing capabilities and infrastructure enhances Lantheus’ ability to meet the complex demands of radiopharmaceutical development and production. The acquisition also expands Lantheus’ oncology diagnostic pipeline by adding both OCTEVY, a registrational-stage PET diagnostic agent for certain neuroendocrine tumors (NETs) that could complement Lantheus’ therapeutic candidate PNT2003, as well as a number of clinical and pre-clinical novel theranostic pairs.

"As Lantheus continues to advance its industry leadership, this transaction, along with the agreement to acquire Life Molecular Imaging, enhances our operations across the radiopharmaceutical value chain," said Brian Markison, CEO of Lantheus. "With Evergreen’s manufacturing and development capabilities, we become fully integrated and will ultimately make a difference in the lives of more patients. We are pleased to welcome Evergreen’s talented team to Lantheus and are confident that their expertise in radiopharmaceutical theranostics and culture focused on developing new solutions for cancer patients will enrich our organization."

"Today marks an exciting new chapter for Evergreen as we look to join the Lantheus team," said James Cook, CEO of Evergreen. "Lantheus’ industry expertise and financial strength will help us bring our innovations to a broad patient population faster and support our mission to improve options for cancer patients through theranostic radiopharmaceuticals. We look forward to benefiting from Lantheus’ experience and resources to further advance our pipeline and continue developing cutting-edge therapies and diagnostics that have the potential to transform patient care. I am very pleased to have our Evergreen team join another industry-leading company with a shared vision."

Compelling Strategic and Financial Rationale

Enhanced Radiopharmaceutical Manufacturing Infrastructure: The acquisition advances Lantheus’ capabilities with the addition of Evergreen’s radioligand therapy (RLT) manufacturing infrastructure, including a revenue-generating CDMO business. Evergreen’s ability to work with a variety of diagnostic and therapeutic isotopes will enhance Lantheus’ ability to address the complexities of radiopharmaceutical development and production. Internalizing this infrastructure will enable Lantheus to develop technical and operational expertise, supply its clinical trials, scale manufacturing for commercial launches, mitigate third party risk, and support long-term growth.
Adds Near-Term Revenue with OCTEVY, which Complements PNT2003 Commercialization: Acquiring OCTEVY, a registrational-stage diagnostic imaging agent, provides Lantheus with additional growth potential while expanding its presence in NETs. Subject to FDA approval, OCTEVY is expected to be indicated for use with positron emission tomography (PET) for localization of somatostatin receptor-positive NETs in adult and pediatric patients. OCTEVY and Lantheus’ PNT2003 could be used as a theranostic pair.
Advanced Early Development Capabilities: Evergreen brings a fully integrated drug discovery and early-stage clinical development platform, promising early-stage oncology assets, and a highly skilled team that can generate novel targets and advance promising radiotherapeutic programs.
Additional Transaction Details
Under the terms of the agreement, Lantheus will pay an upfront amount of $250 million, payable in cash at closing, and up to $752.5 million in development and sales milestones related to OCTEVY and Evergreen’s clinical and pre-clinical pipeline. The transaction has been approved by the Boards of Directors of both companies and is expected to close in the second half of 2025, subject to customary closing conditions, including regulatory clearances.

Company Reaffirms Full Year 2024 Financial Guidance

Guidance Issued November 6, 2024
FY 2024 Revenue $1.51 billion – $1.52 billion
FY 2024 Adjusted Fully Diluted EPS $6.65 – $6.70

Advisors
Solomon Partners Securities, LLC acted as financial advisor to Lantheus in this transaction, while Cooley LLP and Ropes & Gray LLP acted as legal advisors, and Ernst & Young LLP acted as financial and tax advisor.

Centerview Partners LLC acted as financial advisor to Evergreen, while Skadden, Arps, Slate, Meagher & Flom LLP and Lowenstein Sandler LLP acted as legal advisors, and Grant Thornton Advisors LLC acted as tax advisor.

Conference Call and Webcast Details
Lantheus will hold a conference call on Tuesday, January 28, 2025, at 8:30 AM ET. To access the live conference via webcast, please register here. A replay will be available after the conclusion of the call on Lantheus’ investor website at: View Source

The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.

(Press release, Lantheus, JAN 28, 2025, View Source [SID1234662962])

Delcath Systems to Participate at the BTIG Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference

On January 28, 2025 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that management will be attending the BTIG Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference from February 11-12, 2025 at The Cliff Lodge in Snowbird, UT (Press release, Delcath Systems, JAN 28, 2025, View Source [SID1234649922]).

Genialis Advances Biomarker Discovery to Reduce Risk in Cancer Drug Development Targeting DNA Damage Response Pathways

On January 28, 2025 Genialis, the RNA biomarker company, reported an extension of its collaboration with Debiopharm, a Swiss-based global biopharmaceutical company, to develop a predictive biomarker for WEE1-targeted therapy (Press release, Genialis, JAN 28, 2025, View Source [SID1234649918]). This extension builds on a 2024 agreement to define and discover biomarkers within the DNA damage response (DDR) biological space to predict the clinical benefit of one or more drugs in Debiopharm’s pipeline. Debiopharm’s WEE1 asset is currently in Phase 1 clinical research and is being studied in monotherapy and in combination in collaboration with international partners.

"As an industry, we must redefine what it means to develop a biomarker that is highly effective in selecting patients for the right therapies," said Luke Piggott, PhD, Principal Scientist at Debiopharm. "Genialis is leveraging advanced artificial intelligence and RNA-sequencing data to classify patients into responder/non-responder groups based on a comprehensive evaluation of relevant biological mechanisms. This approach has shown great promise in our early work together, and we look forward to further refining this innovative solution to get therapies that are more precisely targeted and effective for patients."

DDR is a promising arena for the development of precision medicines, highlighted by the approvals of various PARP inhibitors indicated for ovarian, breast, pancreatic, and prostate cancers associated with BRCA mutations. Other druggable DDR targets, such as ATR, ATM, and WEE1, show potential in preclinical and early clinical trials, but also face challenges balancing toxicity and efficacy. While BRCA-indicated PARP therapies have received approvals in various clinical settings, most drugs under development lack accurate and informative biomarkers to guide clinical trial and treatment decisions.

One solution addressing the lack of biomarkers in the DDR space is the Genialis Supermodel, an AI-powered foundation model known as a large molecular model, or "LMM." This technology enables rapid configuration of biomarkers across the entire landscape of cancer drug targets, including DDR. Trained on hundreds of thousands of globally diverse RNA-seq samples, the Genialis Supermodel generates biomarkers that stratify response groups, identify mechanisms of response and resistance, and suggest combination therapies.

"A persistent challenge in developing DDR therapies is the lack of truly predictive biomarkers to guide patient selection and optimize clinical outcomes. Most cancers cannot be adequately characterized by individual mutations or proteins, or even a composite of these," said Rafael Rosengarten, Ph.D., CEO of Genialis. "The Genialis Supermodel is the cornerstone of our biomarker programs, driving innovation across a broad range of cancer drug targets. We’re taking the success we’ve had with KRAS-targeted therapies and applying a similar approach to the DDR drug space. I am confident our work with Debiopharm will move the needle for WEE1 and am excited to explore the rest of the target-rich DDR landscape."

Today’s announcement follows the recent dispatch from Tempus AI (NASDAQ: TEM), a leader in AI-driven precision medicine, announcing a multi-year agreement with Genialis to leverage Tempus’ multimodal dataset for the validation of new RNA-based biomarker algorithms across various cancer types.

Genialis will be attending the 8th Annual DDR Inhibitors Summit in Boston, January 28-30, 2025, and presenting an abstract with Debiopharm at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 meeting in April. To schedule a meeting or learn more about Genialis Supermodel, please visit www.genialis.com or email [email protected].

Personalis to Participate at the BTIG Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference

On January 28, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported that its management team will be attending the BTIG Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Tuesday, February 11, 2025, at The Cliff Lodge in Snowbird, UT (Press release, Personalis, JAN 28, 2025, View Source [SID1234649917]).

Lutris Pharma Secures $30 Million Financing to Advance the Development of Biopharmaceutical to Improve Anti-Cancer Drug Effectiveness

On January 28, 2025 Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing cutaneous dose-limiting toxicity, reported that it has secured a $30 million financing to advance the development of LUT014, an innovative topically applied gel aimed at reducing EGFRi-induced rashes, a common adverse side effect of these cancer-fighting therapies (Press release, Lutris Pharma, JAN 28, 2025, View Source [SID1234649916]). The round was led by Columbus Venture Partners and Pontifax Venture Capital, an existing investor, with Peregrine Ventures and aMoon Fund also participating.

While EGFRi therapies are highly effective for the treatment of cancer, they have dose-limiting skin toxicities, leading to substantial discontinuation of patients’ treatment in less than three months due to intolerable acneiform rashes. LUT014, a novel B-Raf inhibitor, is used for patients who develop dose-limiting rashes, potentially allowing them to continue EGFRi treatment with an improved quality of life.

"We are grateful to these investors who recognize the potential of LUT014 to address the significant unmet need caused by the toxicity of EGFRi therapies, which are otherwise effective therapeutic regimens. This financing will enable us to continue the clinical development of LUT014 with the goal of treating the acneiform rash to improve life quality and enabling adherence to EGFRi therapies," stated Noa Shelach, Ph.D., Chief Executive Officer of Lutris Pharma. "The development and ultimate commercialization of LUT014 aligns with our mission to improve anti-cancer therapy effectiveness and to meaningfully impact the quality of life for patients."

In October 2024, Lutris successfully completed enrollment in the international phase 2 trial of LUT014 in patients with metastatic colorectal cancer (mCRC) treated with EGFRi therapy who develop dose-limiting acneiform rash. The company expects to report top-line results from this trial during the first half of 2025 at a major medical meeting.

"Based on the broad use of EGFRi’s to treat cancer and the dermal toxicity that often emerges, many of these patients do not receive the optimal treatment against their cancer, either due to dose reduction or outright discontinuation in response to the intolerable dermal toxicity," stated Antoni Ribas, M.D., Ph.D., Chairman and Founder of Lutris Pharma. "Despite extensive research efforts in the past, no standard of care has emerged to deal with this prevalent issue, leading to a significant unmet medical need. By reversing the inhibitory effect of EGFRi therapy on downstream signaling in the skin cells, we believe that LUT014 has the potential to become an important therapeutic for EGFR inhibitor induced skin toxicity and can have a tremendous impact for patients who currently have no other effective treatment options."

"Acneiform rash is the most common side effect of EGFRi therapies, with up to 90% of patients experiencing an adverse dermatologic event, taking a toll which can be detrimental to their therapy. It is all too common that patients terminate treatment due to these effects, leading to continued disease progression and prolonged treatment. The need to manage this condition is crucial and Lutris is doing just that with the advent of LUT014," said Dr. Yael Gruenbaum-Cohen, DMD, PhD, Partner at aMoon Fund. "As development of LUT014 proceeds, we can foresee a paradigm shift wherein EGFRi treatment will be regularly coupled with LUT014 as a valuable adjunct. This aligns with aMoon’s mission of helping people live longer, healthier lives, and we are proud to support Lutris on their journey towards success."

About EGFR Inhibitor-Induced Rash
EGFR is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin. The EGFR signaling pathway is one of the key pathways that regulate growth, survival, proliferation, and differentiation of cells. B-Raf is a protein encoded by the BRAF gene and is a downstream effector component of EGFR signaling pathway. EGFR has been shown to be over-activated in various human cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic and breast cancers, eliciting downstream phosphorylation and activation of the MAP Kinase pathway.

Drugs called EGFR inhibitors can block the EGFR signal responsible for cell growth. Among the various types of pharmacological therapies for cancer, EGFR inhibitors are increasingly being used both as primary therapy as well as in patients who have failed prior chemotherapy. Although effective as anti-cancer therapy leading to tumor shrinkage, EGFR inhibitors have many adverse reactions associated with their use. The majority of patients treated with EGFR inhibitors will experience adverse dermatological side effects typically manifested as a papulopustular skin rash, also known as acneiform lesions, which can impact quality of life and affect adherence to therapy. Accordingly, LUT014 has the potential to impact not only on quality of life but also on oncologic outcome.

About LUT014
LUT014 is a novel B-Raf inhibitor which is applied topically on the skin. When the B-Raf protein is mutated, as is the case in some human cancers such as melanoma, blocking this pathway leads to apoptosis of the cells and tumor shrinkage. However, when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to reactivate the MAPK pathway and reverse the rash induced by the inhibition of this signaling pathway.