Lutetium (177Lu) zadavotide guraxetan

Wednesday saw a slew of biotechs report data for their respective clinical programmes. Some of the most notable readouts came from Marea Therapeutics and MAR001, its monoclonal antibody (mAb) against ANGPTL4; Lantheus' 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) that's partnered with Eli Lilly; and Theriva Biologics, which shared data for its oncolytic adenovirus VCN-01 (zabilugene almadenorepvec) in pancreatic cancer. Triglyceride levels loweredAt the European Atherosclerosis Society (EAS) congress this week, Marea shared results from a Phase IIa study evaluating MAR001 in patients with hypertriglyceridaemia.The trial randomised 55 participants to receive placebo or one of three dose levels of the mAb every two weeks: 150 mg, 400 mg, or 450 mg. At 12 weeks, the 19 patients in the high-dose cohort saw a 52.5% placebo-adjusted mean reduction in remnant cholesterol and a 52.7% placebo-adjusted mean reduction in triglycerides. Of those with significantly elevated triglyceride levels at baseline (≥200 mg/dL), MAR001 led to a 66% placebo-adjusted mean reduction in remnant cholesterol and a 64% placebo-adjusted mean reduction in triglycerides.In regards to safety, the mAb was well-tolerated with no serious adverse events (AEs) or AEs that led to discontinuation from MAR001. Marea expects to launch a Phase IIb study this quarter. No further investments in RLTLantheus said that the final survival results of the Phase III SPLASH study, evaluating PNT2002 in patients with metastatic castration-resistant prostate cancer following progression on an androgen receptor pathway inhibitor (ARPI), were "confounded by patient crossover within the study." As such, the company will not submit a regulatory application for the RLT to the FDA, nor does it plan to "further invest in this asset."After reaching 100% of prespecified overall survival (OS) events, the results of SPLASH were comparable to earlier readouts, Lantheus said. However, when the drugmaker reported data from SPLASH at the European Society of Medical Oncology (ESMO) congress in September, it had claimed that PNT2002 met its primary endpoint, achieving a median radiographic progression-free survival (PFS) of 9.5 months versus 6 months for those in the ARPI control arm. Lantheus said it is now working with Lilly to review the full dataset. The former in-licensed exclusive worldwide rights for PNT2002, outside of certain Asian territories, from POINT Biopharma in December 2022; Lilly acquired POINT for $1.4 billion at the end of 2023.Theriva planning PhIIITheriva revealed topline data from the Phase IIb VIRAGE study, which is comparing VCN-01 plus standard-of-care (SOC) chemotherapy gemcitabine/nab-paclitaxel against chemotherapy alone in patients with first-line metastatic pancreatic ductal adenocarcinoma (PDAC). At the time of the analysis, 48 patients had received VCN-01 — a tumour selective stroma-degrading oncolytic adenovirus — and at least one dose of SOC chemotherapy, and 48 patients in the gemcitabine/nab-paclitaxel comparator group had received treatment.Patients who received the experimental treatment saw a median OS of 10.8 months compared with 8.6 months for chemotherapy alone (hazard ratio = 0.57); a median PFS of 7 months versus 4.6 months (hazard ratio = 0.55); and a median duration of response of 11.2 months versus 5.4 months (hazard ratio = 0.22), respectively. The most common AEs seen in patients who received VCN-01 were pyrexia, flu-like illness, vomiting, nausea and elevated transaminases, but the symptoms were transient and reversible. The results, Theriva said, will help inform the design of a planned Phase III confirmatory trial.

Worldwide revenue of $372.8 million in the first quarter 2025 GAAP fully diluted earnings per share of $1.02 , compared to $1.87 in the first quarter of 2024; adjusted fully diluted earnings per share of $1.53 , compared to $1.69 in the first quarter of 2024 Free cash flow totaled $98.8 million for the first quarter 2025 Closed acquisition of Evergreen Theragnostics early in the second quarter; expect to close on acquisition of Life Molecular Imaging in the coming weeks; and yesterday announced planned divestiture of SPECT business Recently announced positive data for two MK-6240 pivotal studies; plan to file NDA in the third quarter of 2025 Provided updated interim corporate guidance for full year 2025 revenue and adjusted fully diluted earnings per share BEDFORD, Mass. , May 07, 2025 (GLOBE NEWSWIRE) -- 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, today reported financial results for its first quarter ended March 31, 2025 . "We are laying the foundation for the next chapter of Lantheus’ business with the acquisition of Evergreen Theragnostics and planned acquisition of Life Molecular Imaging, both of which add growth drivers that complement our business and diversify our revenues. These transactions also add exciting new pipeline programs in both late- and early-stage development and key capabilities that enable Lantheus to progress novel programs from bench to clinic," said Brian Markison , Chief Executive Officer at Lantheus . "With robust cash flow and a disciplined capital allocation strategy, we are advancing our position as the leading radiopharmaceutical-focused company. We remain dedicated to being the partner of choice for nuclear medicine departments and free-standing imaging centers, delivering sustainable growth, creating long-term value for our shareholders, and bringing innovative products to patients in need." Summary Financial Results First Quarter 2025 Sales of PYLARIFY were $257.7 million , a decrease of 0.5%. Sales of DEFINITY were $79.2 million , an increase of 3.5%. Operating income decreased 4.3% to $102.1 million . Adjusted operating income (non-GAAP) decreased 7.1% to $144.3 million . Fully diluted earnings per share decreased to $1.02 , compared to $1.87 in the prior year period. Adjusted fully diluted earnings per share (non-GAAP) decreased 9.5% to $1.53 , compared to $1.69 in the prior year period. Net cash provided by operating activities and free cash flow were $107.6 million and $98.8 million , respectively. Balance Sheet At March 31, 2025 , the Company's cash and cash equivalents grew to $938.5 million , compared to $912.8 million at December 31, 2024 , after prepaying a $50.0 million deposit related to our Evergreen Theragnostics, Inc. (Evergreen) acquisition, which closed early in the second quarter of 2025. The Company currently has access to up to $750 .0 million from a revolving line of credit. Recent Business Highlights Business Development Updates In January, the Company announced an agreement to acquire Life Molecular Imaging Ltd. (Life Molecular), which is now expected to close in the second quarter of 2025, subject to customary closing conditions. The acquisition will provide Lantheus with Neuraceq®, a globally approved beta-amyloid targeted radiodiagnostic for Alzheimer’s disease, along with a strong commercial footprint and infrastructure. The deal is complementary to Lantheus’ portfolio of late-stage neurology radiodiagnostics and builds on the acquisition of worldwide rights to LNTH-2401 (68Ga-DOTA-RM2) and LNTH-2402 (177Lu-DOTA-RM2) announced last year. Also in January, the Company announced an agreement to acquire Evergreen, a clinical-stage radiopharmaceutical company based in New Jersey . On April 1 , we announced the completion of the acquisition. Through the transaction, Lantheus has acquired OCTEVY™, a registrational-stage PET imaging agent targeting neuroendocrine tumors, which complements Lantheus’ therapeutic candidate PNT2003, as well as acquiring a portfolio of clinical and pre-clinical theranostic pairs. The acquisition also advances Lantheus’ capabilities with the addition of Evergreen’s radioligand therapy manufacturing infrastructure, including a revenue-generating CDMO business. On May 6, 2025 , the Company announced the agreement to sell the Company’s SPECT business to Illuminated Holdings, Inc. , the parent company of SHINE Technologies, LLC (SHINE). Under the terms of the agreement, SHINE will acquire Lantheus’ SPECT business, including its diagnostic agents (TechneLite, NEUROLITE, Xenon Xe-133 Gas , and Cardiolite), the portion of the North Billerica, MA campus that manufactures Lantheus’ SPECT products and the SPECT-related Canadian operations. The transaction allows Lantheus to focus on growing its commercial portfolio of innovative PET radiodiagnostics and microbubbles, while advancing its pipeline of radiopharmaceuticals. The transaction is expected to close by the end of the year, subject to customary closing conditions. Radiopharmaceutical Pipeline Updates Lantheus recently announced that MK-6240, its next-generation tau imaging agent, met its primary endpoints in two pivotal clinical studies assessing the investigational asset’s sensitivity and specificity. The Company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2025. LNTH-2503, a potentially best- and first-in-class lutetium-177 theranostic pair targeting the cholecystokinin receptor (CCK2R) brought in by the Evergreen acquisition, has been authorized to proceed with a therapeutic Phase 1 study in patients with small cell lung cancer by the European Medicines Agency (EMA). The Company expects to initiate the Phase 1 therapeutic study in the United States later this year and continue its ongoing Phase 2 gallium-68 imaging study. The Phase 3 SPLASH study of PNT2002 recently reached 100% of prespecified overall survival events. The results were comparable to the previously reported 46% and 75% readouts and remain confounded by patient crossover within the study. The Company is working closely with partner, Eli Lilly and Company, to review the full dataset, however the Company does not plan to pursue an NDA or further invest in this asset. Full Year 2025 Interim Corporate Financial Guidance On a forward-looking basis, the Company does not provide GAAP income per common share guidance or a reconciliation of GAAP income per common share to adjusted fully diluted EPS because the Company is unable to predict with reasonable certainty business development and acquisition related expenses, purchase accounting fair value adjustments, and any one-time, non-recurring charges. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP. As a result, it is the Company’s view that a quantitative reconciliation of adjusted fully diluted EPS on a forward-looking basis is not available without unreasonable effort. Conference Call and Webcast As previously announced, the Company will host a conference call and webcast on Wednesday, May 7, 2025 , at 8:00 a.m. ET . To access the conference call or webcast, participants should register online at https://investor.lantheus.com/news-events/calendar-of-events. A replay will be available approximately two hours after completion of the webcast and will be archived on the same web page for at least 30 days. The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com. 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. About Lantheus Holdings, Inc. 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. Headquartered in Massachusetts with offices in New Jersey , Canada and Sweden , Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. For more information, visit www.lantheus.com.  Internet Posting of Information The Company routinely posts information that may be important to investors in the “Investors” section of its website at www.lantheus.com. The Company encourages investors and potential investors to consult its website regularly for important information about the Company.  Non-GAAP Financial Measures The Company uses non-GAAP financial measures, such as adjusted net income and its line components; adjusted net income per share - fully diluted; adjusted operating income and its line components, and free cash flow. The Company’s management believes that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the Company’s operations, period over period. However, these measures may exclude items that may be highly variable, difficult to predict and of a size that could have a substantial impact on the Company’s reported results of operations for a particular period. Management uses these and other non-GAAP measures internally for evaluation of the performance of the business, including the evaluation of results relative to employee performance compensation targets. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP. Safe Harbor for Forward-Looking and Cautionary Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “advance,” “believe,” “continue,” “could,” “driving,” “expect,” “guidance,” “maintain,” “may,” “on track,” “plan,” “potential,” “predict,” “progress,” “should,” “target,” “will,” “would” and other similar terms. Such forward-looking statements include our guidance for the fiscal year 2025 and our plans to expand our portfolio of late-stage assets and high potential early-stage candidates, our acquisition of Evergreen, our potential acquisition of Life Molecular and our plans to divest our SPECT business to SHINE, and are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include: (i) continued market expansion and penetration for our established commercial products, particularly PYLARIFY and DEFINITY, in a competitive environment and our ability to clinically and commercially differentiate our products; (ii) our ability to have third parties manufacture our products and our ability to manufacture DEFINITY in our in-house manufacturing facility, in amounts and at the times needed; (iii) the availability of raw materials, key components, and equipment, either used in the production of our products and product candidates, or in the use by healthcare professionals of our products and product candidates, including, but not limited to positron emission tomography (“PET”) scanners for PYLARIFY, MK-6240 and NAV-4694; (iv) our ability to satisfy our obligations under our existing clinical development partnerships using MK-6240 or NAV-4694 as a research tool and under the license agreements through which we have rights to MK-6240 and NAV-4694, and to further develop and commercialize MK-6240 and NAV-4694 as approved products, including the timing for any potential regulatory submissions for these investigational assets; (v) our ability to successfully integrate acquisitions, including of Life Molecular, subject to completion of our acquisition thereof, and Evergreen, including the potential for unforeseen expenses related to integration activities, the accuracy of our financial models, the potential for unforeseen liabilities within those businesses, the ability to integrate disparate information technology systems, retain key talent and create a merged corporate culture that successfully realizes the full potential of the combined organization; (vi) our ability to complete the transaction with SHINE on the proposed terms or on the anticipated timeline, or at all, including risks and uncertainties related to securing the necessary regulatory approvals and satisfaction of other closing conditions to consummate the transaction, unforeseen expenses related to the divestiture, and failure to realize the expected benefits of the transaction; (vii) our ability to obtain FDA approval for LNTH-2501, our investigational kit for the preparation of Gallium-68 DOTATOC, which may be used in conjunction with a PET scan to stage and localize gastroenteropancreatic neuroendocrine tumors in adults and children, and approval for PNT2003, and to be successful in the patent litigation associated with PNT2003; (viii) the cost, efforts and timing for clinical development, regulatory approval, adequate coding, coverage and payment and successful commercialization of our product candidates and new clinical applications and territories for our products, in each case, that we or our strategic partners may undertake; (ix) our ability to identify opportunities to collaborate with strategic partners and to acquire or in-license additional diagnostic and therapeutic product opportunities in oncology, neurology and other strategic areas and continue to grow and advance our pipeline of products; and (x) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q). - Tables Follow - Contacts: Mark Kinarney Vice President, Investor Relations978-671-8842ir@lantheus.com Melissa Downs Executive Director, External Communications 646-975-2533media@lantheus.com Source: Lantheus Holdings, Inc.