ORION CORPORATION PRESS RELEASE 21 JULY 2025 at 10:30 EEST Darolutamide receives EU approval in third indication for patients with advanced prostate cancer European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC).Approval is based on positive results from the pivotal Phase III ARANOTE trial.This broadened indication allows doctors to use darolutamide plus ADT, with or without chemothera ...

Core Insights - Novartis anticipates Kisqali to become a blockbuster drug, shifting focus from Entresto [1] - Kisqali sales increased by 64% globally in Q2, with 100% growth in the U.S. [1] - The company reported a 56% increase in Kisqali sales in Q1 [2] Industry Trends - Global breast cancer diagnoses and deaths are expected to rise significantly by 2050, with 1 in 20 women projected to be diagnosed [2] - This could lead to 3.2 million new cases and 1.1 million deaths annually by 2050, compared to 2.3 million new cases and 670,000 deaths in 2022 [3] Company Pipeline - Novartis has a strong pipeline with other potential blockbusters like Pluvicto for prostate cancer and Scemblix for chronic myeloid leukemia [3] - The company is focused on driving performance for Kisqali, Pluvicto, and Scemblix, indicating a strategy to replace reliance on older therapies [3]

Company Overview - ESSA Pharma is focused on developing novel therapies for prostate and other androgen-driven cancers[7] - The company's lead candidate, EPI-7386, is a first-in-class oral, small molecule androgen receptor N-terminal domain inhibitor ("Aniten")[9, 28] - As of March 31, 2023, ESSA had $157 million in cash and short-term deposits, providing a runway through 2025[9, 69] EPI-7386 Monotherapy Development - Phase 1a study showed EPI-7386 was safe and well-tolerated, with tumor volume decreases observed in some patients[38] - ctDNA declines were observed in patients with AR mutations, amplifications, and truncations, suggesting activity against these tumors[38] - Phase 1b expansion study is underway to verify the recommended Phase 2 dose and gain further insight into EPI-7386's biological activity[40, 41] EPI-7386 Combination Therapy Development - ESSA is collaborating with multiple companies to evaluate EPI-7386 in combination with second-generation antiandrogens like enzalutamide, apalutamide, and darolutamide[49] - Initial data from the Phase 1/2 EPI-7386 + enzalutamide combination study showed rapid, deep, and durable PSA reductions[58] - In the combination study, 5 out of 6 patients achieved a PSA90, and 4 out of 6 patients achieved a PSA90 in 90 days and ultimately achieved a PSA < 02 ng/mL[58] Market and Opportunity - Prostate cancer is the 2nd most common cause of male cancer deaths, with an estimated 268,000 new cases and 34,500 deaths in 2022 in America[19] - Global sales of leading antiandrogens generated over $86 billion in 2021[19]

NASDAQ: LNTH Lantheus Investor Presentation Building on our Foundation to Power the Future of Radiopharmaceuticals May 2025 © 2025 Lantheus. All rights reserved. Safe Harbor Statements Cautionary Statement Regarding Forward-Looking Statements This document 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 Ac ...

Investor Event © 2024 PROCEPT BioRobotics Corporation. All Rights Reserved. Safe Harbor Statement This presentation and accompanying oral presentation contain "forw ard-looking statements" w ithin the meaning of the Private Securities Litigation Reform Act of 1995, including the ex pected financial results of PROCEPT BioRobotics Corporation (the "Company"). W ords such as "anticipates," "believes," "ex pects," "intends," "projects," "anticipates," and "f uture" or similar ex pressions are intended to identi ...

A Portfolio Company Corporate Presentation February 2025 1 This Presentation is not an Offer or a Representation. This Presentation does not constitute an offer, or a solicitation of an offer, to buy orsell any securities, investment or otherspecific product, or a solicitation of any vote or approval, norshall there be any sale ofsecurities, investment or otherspecific product in any jurisdiction in which such offer,solicitation orsale would be unlawful priorto registration or qualification underthe securit ...

Commercial Portfolio Performance - PYLARIFY achieved blockbuster status in 2024 with over $1 billion in sales[154], and Q1 2025 net sales reached $257.7 million[13] - DEFINITY remains the 1 utilized ultrasound enhancing agent, with Q1 2025 net sales of $79.2 million, a 3.5% year-over-year growth[24] Market Opportunities - The U S PSMA PET imaging market has a potential of over $3.5 billion by 2030, driven by expansion of radiotherapeutics and increasing clinical utility in BCR population[19, 20] - The U S ultrasound enhancing agent total addressable market is over $600 million[35] Pipeline Development - Lantheus is advancing an innovative pipeline of radiopharmaceuticals, including diagnostic and therapeutic candidates for prostate cancer, neuroendocrine tumors, and Alzheimer's disease[38, 40] - LNTH-2402, a GRPR-targeted radiotherapeutic, is expected to have an IND filing in Q4 2025, with Phase 1 initiation planned for 2026[109] Financial Highlights - As of March 31, 2025, Lantheus had $938.5 million in cash on hand and $98.8 million in free cash flow in Q1 2025[10] - The updated interim corporate financial guidance for the full year 2025 projects revenue between $1.550 billion and $1.585 billion, and adjusted fully diluted EPS between $6.60 and $6.70[142] Strategic Transactions - The acquisition of Evergreen Theragnostics closed in April 2025, strengthening radiodiagnostic and therapeutic capabilities[10, 165] - The acquisition of Life Molecular Imaging is expected to close by 2Q 2025, expanding the commercial portfolio and pipeline in Alzheimer's disease[10, 144]

Company Overview - Medicus Pharma Ltd. is a biotechnology company focused on developing novel therapeutics, particularly in the field of oncology [6][7] - The company's lead asset, SkinJect Inc., is developing a treatment for non-melanoma skin cancer using a patented dissolvable doxorubicin-containing microneedle array (D-MNA) [2][6] Clinical Trials - Medicus is conducting a Phase 2 clinical study (SKNJCT-003) across nine clinical sites in the United States, which began randomizing patients in August 2024 [3] - An interim analysis in March 2025 showed over 60% clinical clearance after more than 50% of the targeted 60 patients were randomized [3] - The investigational review board increased the number of participants in SKNJCT-003 to 90 subjects and expanded clinical trial sites to Europe [3] - A separate clinical study (SKNJCT-004) is underway in the UAE, aiming to randomize 36 patients across four sites [4] Acquisition Plans - In April 2025, Medicus entered into a binding letter of intent to acquire Antev Ltd., a UK-based biotech company developing Teverelix for advanced prostate cancer patients [5][8] - The acquisition is subject to due diligence, negotiation of definitive agreements, and regulatory approvals [8] Upcoming Events - Dr. Raza Bokhari, Executive Chairman and CEO of Medicus, will present corporate updates at the 2025 Bio International Convention on June 17, 2025 [1][2]

Core Insights - The U.S. FDA has approved darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic castration-sensitive prostate cancer (mCSPC), marking the third indication for this drug [2][9] - The approval is based on the Phase III ARANOTE trial, which demonstrated a 46% reduction in the risk of radiological progression or death compared to placebo plus ADT [2][10] - Darolutamide is already approved in over 85 markets globally for various indications related to prostate cancer, including mHSPC and non-metastatic castration-resistant prostate cancer (nmCRPC) [5][6] Company Overview - Darolutamide, marketed as Nubeqa®, achieved blockbuster status with annual sales of EUR 1.52 billion reported by Bayer for the full year of 2024 [6] - The drug is developed jointly by Orion and Bayer, indicating a strong collaboration in the oncology sector [6][11] - Orion Corporation has a robust clinical development program for darolutamide, exploring its efficacy across various stages of prostate cancer [13] Industry Context - Prostate cancer is the second most common cancer in men, with an estimated 1.5 million diagnoses and approximately 397,000 deaths worldwide in 2022 [4] - The incidence of prostate cancer is projected to rise to 2.9 million by 2040, highlighting the growing need for effective treatment options [4] - The ARANOTE trial involved 669 patients and assessed the efficacy and safety of darolutamide plus ADT, reinforcing the drug's established safety profile [7][8]

Core Insights - The Phase 3 AMPLITUDE study demonstrates the efficacy of AKEEGA® (niraparib and abiraterone acetate) in delaying cancer progression and symptom worsening in patients with metastatic castration-sensitive prostate cancer (mCSPC) with BRCA alterations, showing a nearly 50% reduction in disease progression compared to standard care [1][2][3] Group 1: Study Results - The AMPLITUDE study involved 696 patients and met its primary endpoint of radiographic progression-free survival (rPFS), with patients having BRCA alterations showing a median rPFS not reached compared to 26 months for placebo [2][3] - The combination treatment reduced the risk of symptomatic progression by 56% in BRCA-altered patients and 50% in those with any homologous recombination repair (HRR) alterations [2][3] - An early trend toward improved overall survival (OS) was observed, with a 25% reduction in risk of death for BRCA patients and 21% for HRR patients [2][3] Group 2: Patient Demographics and Treatment Implications - Approximately 25% of mCSPC patients have HRR alterations, with about half being BRCA, who typically experience faster disease progression and poorer outcomes [2][3] - The study supports the combination of a PARP inhibitor with an androgen receptor pathway inhibitor as a new treatment option for HRR-altered mCSPC patients [2][3] Group 3: Company Background and Future Directions - Johnson & Johnson has nearly 20 years of experience in prostate cancer treatment, having treated over 750,000 patients globally [3] - The AMPLITUDE study positions Johnson & Johnson as the first to demonstrate clinical improvement with a PARP-based combination in mCSPC, indicating a significant advancement in treatment options for this patient population [3][4]