Financial Data and Key Metrics Changes - For Q2 2025, the company received total orders of over $3 million and recorded revenue of $2.2 million, with $1.6 million from recurring revenue and $650,000 from one-time capital equipment sales [6][7] - Gross margin in Q2 2025 was 73%, up from 64% in Q2 2024 [6] - Total operating expenses in Q2 2025 were $15.4 million, compared to $9.3 million in Q2 2024 [6] - The net loss for Q2 2025 was $15.7 million, or $0.52 per share, compared to a net loss of $6.9 million, or $0.28 per share, in Q2 2024 [7] Business Line Data and Key Metrics Changes - The company is transitioning from a placement model to a capital model, which is expected to lead to a backend-loaded revenue operation [8][9] - The sales pipeline includes close to 500 prospects, with over 100 leads engaged and 80 qualified leads in the verification, negotiation, and contracting stages [10][11] Market Data and Key Metrics Changes - The U.S. sales team has been streamlined to focus on organizational sales to corporatized hospitals, emphasizing the importance of intangible attributes like grit and perseverance in sales success [12][13] - The company aims to increase the number of active sites in the U.S., with a target of at least 75 by the end of the year [61] Company Strategy and Development Direction - The CAPTAIN trial has been fully recruited, which is expected to drive adoption of the TULSA procedure and influence treatment guidelines [15][16] - The pilot release of the new TULSA AI volume reduction software is anticipated to enhance efficiency in BPH procedures, moving TULSA from a niche to a mainstream treatment option [19][20] - The company is optimistic about the integration of TULSA with new interventional MR technologies, which could enhance its market position [63] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 70% to 75% revenue growth in 2025 compared to 2024, despite short-term revenue shortfalls due to delays in capital sales [8][22] - Positive feedback from physicians regarding the CAPTAIN trial completion is expected to enhance adoption and pipeline growth [36][37] - The company anticipates that as more data is published, it will lead to new guidelines requiring that TULSA be presented as a treatment option alongside traditional methods [23] Other Important Information - The company has approximately $35.2 million in cash as of June 30, 2025 [7] - The initial clinical outcomes from the CAPTAIN trial are expected to be presented at major medical meetings in December [19][94] Q&A Session Summary Question: Can you provide insights on the sales contribution from recurring and capital perspectives? - Management indicated that the revenue mix is expected to shift from recurring to capital revenue as the installed base grows, with a long-term goal of 70% recurring and 30% capital revenue [29][30] Question: What feedback are you receiving from physicians regarding the CAPTAIN trial? - High positive feedback has been received, particularly regarding the completion of the trial, which is seen as a significant achievement in the field [36][37] Question: How does the proposed reimbursement rule for BPH treatments affect TULSA? - The company maintained favorable reimbursement levels compared to other BPH procedures, which positions TULSA advantageously in the market [44][45] Question: What is the current number of active TULSA placements in the U.S.? - There are about 60 active sites, with plans to install three more, aiming for at least 75 by year-end [61] Question: How is the soft launch of the volume reduction module for BPH going? - Initial feedback has been excellent, with procedure times averaging closer to 60 minutes, which is a significant improvement [90][91]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content includes insights across sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Insights - CEO.CA is a leading investor social network focused on junior resource and venture stocks, providing exclusive updates to CEOs of junior mining explorers [1][6] - The platform has gained popularity since its founding in 2012, attracting millions of global investors to discuss stocks, commodities, and emerging companies [2][6] - The "Inside the Boardroom" series offers insights from industry leaders, enhancing understanding of their vision and strategies [3][4] Company Highlights - Dr. John Yu, CEO of Kairos Pharma, discussed the company's prostate cancer trial, which reported zero grade 3 or 4 toxicities, a significant improvement compared to over 50% with standard treatments [4] - The upcoming efficacy data in September and plans for expansion into lung cancer and other tumor types were also highlighted [4][8] - CEO.CA serves as a platform for showcasing companies and connecting with investors, emphasizing its role in the investment community [5][6]

Core Insights - The European Commission has granted marketing authorization for darolutamide, an oral androgen receptor inhibitor, in combination with androgen deprivation therapy for the treatment of metastatic hormone-sensitive prostate cancer [2][8] - The approval is based on the positive results from the Phase III ARANOTE trial, which demonstrated a 46% reduction in the risk of radiological progression or death compared to placebo [2][7] Company Overview - Darolutamide, marketed as Nubeqa®, is developed jointly by Orion and Bayer and is already approved in over 85 countries for various indications related to prostate cancer [3][8] - Orion Corporation is a Nordic pharmaceutical company with a focus on oncology and pain management, employing approximately 3,700 professionals and generating net sales of EUR 1,542 million in 2024 [15][17] Industry Context - Prostate cancer is the second most common cancer among men globally, with an estimated 1.5 million new cases diagnosed in 2022 and projected to rise to 2.9 million by 2040 [4] - The ARANOTE trial involved 669 patients and aimed to assess the efficacy and safety of darolutamide plus ADT, with the primary endpoint being radiological progression-free survival [5][6]

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]

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]