Summary of EDAP Conference Call Company Overview - **Company**: EDAP - **Industry**: MedTech, specifically focused on prostate cancer treatment through Focal therapy Key Points Capital Environment - The capital demand and spending environment for hospitals is under pressure, leading to strategic investments in clinically necessary equipment like Focal One, which addresses prostate cancer, the most diagnosed cancer in men [4][5] - EDAP reported a **167% growth** in capital sales for Focal One last quarter, indicating strong momentum in the capital equipment space [5] Market Dynamics - The U.S. market is characterized by a strategic approach to capital investments, while the international (OUS) market varies by region, with notable sales increases in Western Europe [6][7] - Focal therapy is emerging as the fastest-growing treatment category for prostate cancer, with hospitals increasingly recognizing its clinical value [6][7] Sales Process and Customer Engagement - The sales process is heavily influenced by clinical efficacy and economic arguments, with hospitals showing a preference for outpatient procedures that are economically viable [9][10] - EDAP is present in nearly **50 academic centers** in the U.S., including top institutions like Memorial Sloan Kettering and Mayo Clinic, with some hospitals acquiring multiple Focal One systems [10] Clinical Evidence and Adoption - The HIFI Study, involving **3,200 patients**, supports the efficacy of Focal therapy, showing oncologic control and better patient outcomes compared to radical treatments [17][21] - EDAP is in the early adopter phase of the market adoption lifecycle, with ongoing efforts to educate hospitals on the value of Focal therapy [18][19] Financial Performance - EDAP expects HIFU revenue to grow by **26-34%**, while non-core business is projected to decline by **25-30%** [46] - Gross margins for HIFU are trending in the high forties, with an increase from **39% to 42%** in Q3 2024, indicating a positive financial trajectory [47] Product Development and Future Outlook - The launch of Focal One Eye, a new platform, is expected to enhance performance and gross margins, with an average selling price of around **$650,000** in the U.S. [49] - EDAP is actively pursuing additional indications for HIFU technology, including studies for benign prostatic hyperplasia (BPH) and women's health applications [34][42][28] Strategic Focus - The company is transitioning away from non-core businesses to concentrate on HIFU, which is seen as the growth engine for the future [46][51] - EDAP is working with strategic suppliers to improve cost structures and optimize margins, aiming for mid-single-digit improvements in gross margins [54] Additional Insights - The company is leveraging its legacy in urology to expand its market presence and capitalize on the growing demand for targeted robotic HIFU therapy [22][23] - The potential for HIFU technology extends beyond prostate cancer, with applications being explored in various medical fields, indicating a broad growth opportunity [25][28]

Summary of ORIC Pharmaceuticals Conference Call Company Overview - **Company Name**: ORIC Pharmaceuticals - **Ticker**: NasdaqGS:ORIC - **Focus**: Development of small molecule drugs in oncology, specifically targeting solid tumors like prostate cancer and lung cancer [2][3] Key Points and Arguments Lead Programs - ORIC is currently focused on two lead programs in prostate cancer and lung cancer, both in dose optimization and expected to start pivotal phase three studies in 2026 [2][3] ORIC-944 Program - Recent data showed encouraging results for the ORIC-944 program, particularly in combination with apalutamide and daralutamide, with impressive PSA response rates [3][4] - ORIC-944 has a 20-hour half-life compared to Pfizer's memoremedistat, which has a five-hour half-life, suggesting a potential safety advantage [3][19] - The ability to clear ctDNA was observed in 59% of patients, which correlates strongly with long-term outcomes like PFS and OS [5][9] Safety Profile - The safety profile of ORIC-944 appears favorable, with only one grade 3 adverse event reported in 20 patients, compared to multiple grade 3 events in Pfizer's studies [13][15] - A clean safety profile is crucial for future development, especially in earlier lines of treatment for prostate cancer [14][15] Market Opportunity - The metastatic CRPC market is estimated at approximately 50,000 patients, with a total addressable market (TAM) of about $3.5 billion in the US for each of the post-AR inhibitors and post-abiraterone populations [29][30] - Historical data suggests that even with an undifferentiated profile, a second-to-market drug can capture about 35% of the market [30] Future Development Plans - ORIC plans to submit dose optimization data to regulators in early 2026 to align on pivotal study design [25][26] - The first phase three study is expected to start in the first half of 2026, with primary readout anticipated in the second half of 2027 [27][28] Pipeline Asset ORIC-114 - ORIC-114 is focused on non-small cell lung cancer, with updates expected at ESMO Asia in December, including data from multiple cohorts [35] - The drug is designed to be CNS-penetrant, which may lead to longer PFS outcomes for patients with brain metastases [36][37] Financial Position - As of the third quarter, ORIC had $413 million in cash and investments, providing a runway into the second half of 2028, covering pivotal studies for both ORIC-944 and ORIC-114 [42] Additional Important Information - ORIC maintains strong relationships with Bayer and Johnson & Johnson, which are crucial for future collaborations [31][32] - The company is exploring the potential of PRC2 inhibitors in other oncology indications beyond prostate cancer, including breast cancer and lung cancer [33][34]

Core Insights - ORIC Pharmaceuticals announced additional efficacy and safety data from the Phase 1b trial of ORIC-944 in combination with androgen receptor inhibitors for metastatic castration-resistant prostate cancer (mCRPC) [1][2] Efficacy Data - The trial demonstrated a 55% PSA50 response rate and a 20% PSA90 response rate among patients [6] - Rapid and deep circulating tumor DNA (ctDNA) reductions were observed in 76% of patients, with 59% achieving ctDNA clearance, indicating potential long-term treatment benefits [1][7] - PSA responses and ctDNA reductions were consistent across all ORIC-944 dose levels and in combination with both apalutamide and darolutamide [4][5] Safety Profile - The combination of ORIC-944 with apalutamide or darolutamide showed a safety profile compatible with long-term dosing, with most adverse events being Grade 1 or 2 [8] - As of the cutoff date, only one patient experienced a Grade 3 treatment-related adverse event, with no Grade 4 or 5 adverse events reported [8] Next Steps - ORIC has selected provisional recommended Phase 2 doses for ORIC-944 to be tested in combination with darolutamide and apalutamide, with ongoing enrollment in the dose optimization portion of the trial [9] - Preliminary dose optimization data is expected to be announced in Q1 2026, ahead of initiating the first global Phase 3 registrational trial in mCRPC in the first half of 2026 [2][9] Company Overview - ORIC Pharmaceuticals is focused on developing treatments that address mechanisms of therapeutic resistance in cancer, with ORIC-944 being an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) [11]

Medical Innovation - A doctor is advocating for a more precise, humane, and effective alternative treatment for prostate cancer [1] - The alternative aims to improve the binary choice faced by men with prostate cancer: living with the cancer versus living with the consequences of removing it [1]

Core Insights - EDAP TMS SA's Focal One Robotic HIFU treatment was highlighted during Prostate Cancer Awareness Month, reaching millions through national television exposure [1][2] - The treatment offers a non-invasive option for prostate cancer patients, allowing them to maintain their quality of life while effectively targeting cancer [3] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices using ultrasound technology [4] - The Focal One system is positioned as a leading prostate focal therapy, with potential applications beyond prostate cancer [4] Patient Experience - A patient named Peter D. shared his positive experience with Focal One Robotic HIFU, emphasizing minimal disruption to his daily life and a quick return to normal activities [2] - Dr. Eric Giesler, Peter's urologist, noted the importance of non-invasive treatment options in improving patient outcomes and quality of life [3] Awareness Campaign - The national exposure from the television segment is part of a broader campaign to raise awareness about prostate cancer treatment options among patients, caregivers, and healthcare professionals [3]

Summary of Oric Pharmaceuticals Conference Call Company Overview - **Company**: Oric Pharmaceuticals (ORIC) - **Industry**: Biotechnology, specifically oncology - **Focus**: Development of small molecule drugs targeting solid tumors, particularly prostate cancer and lung cancer [4][5] Key Pipeline Developments - **ORIC-944**: A PRC2 inhibitor in combination with AR inhibitors (apalutamide and darolutamide) for prostate cancer, currently in dose optimization and preparing for Phase 3 studies [5][6][7] - **ORIC-114**: A brain-penetrant small molecule targeting lung cancer, focusing on patient populations with EGFR exon 20, atypical mutations, and HER2 exon 20, also in dose optimization [5][6][7] Financial Position - The company has strengthened its balance sheet through capital raising, providing a cash runway until 2028, which covers the primary data readouts for both programs [7][8] Market Opportunity - The prostate cancer market is significant, with existing AR inhibitors (enzalutamide, apalutamide, darolutamide) showing strong efficacy but limited options for patients who progress on these therapies [11][12][13] - ORIC-944 aims to resensitize patients to AR inhibitors, potentially improving progression-free survival (PFS) outcomes [13][14] Competitive Landscape - Current AR inhibitors have similar efficacy profiles, but ORIC-944's better tolerability and dosing regimen (once daily with a 20-hour half-life) may provide a competitive edge [20][21][23] - The company aims to differentiate itself through improved drug properties and potentially better patient outcomes [25][26] Clinical Data Insights - Early clinical data showed ORIC-944 achieving higher rates of confirmed PSA50 (47%) and PSA90 (24%) compared to Pfizer's data (34% and 12%, respectively) [37][38] - The drug's toxicity profile appears favorable, with lower incidence and severity of expected toxicities compared to competitors [39][40] Future Plans - The company plans to initiate the first Phase 3 study in the first half of next year, selecting one AR inhibitor (either apalutamide or darolutamide) for the trial [49][50] - Upcoming updates will provide clarity on dosing regimens and additional clinical data, including ctDNA metrics [46][48] ORIC-114 Development - ORIC-114 (enozertinib) targets EGFR exon 20, atypical mutations, and HER2 exon 20, with a focus on CNS activity and a clean safety profile [57][64] - The company has made strategic decisions to prioritize first-line settings over second-line due to market size and cost considerations [69] Regulatory Considerations - The company is observing regulatory feedback from the FDA regarding competitive products in the space, particularly concerning atypical mutations [74][75] Conclusion Oric Pharmaceuticals is positioned to make significant advancements in oncology with its innovative drug candidates, particularly ORIC-944 and ORIC-114, while maintaining a strong financial position and strategic focus on market opportunities. The upcoming clinical data and Phase 3 study initiation will be critical in determining the company's trajectory in the competitive oncology landscape.

Summary of Radiopharm Theranostics (RADX) Update / Briefing Company and Industry Overview - **Company**: Radiopharm Theranostics (RADX) - **Industry**: Prostate cancer treatment and radiopharmaceuticals Key Points and Arguments 1. **Prostate Cancer Treatment Landscape**: - Significant advancements in prostate cancer treatments, particularly with radiotherapy options like radium-223 combined with enzalutamide and targeted therapies such as PSMA radiotherapeutics like Pluvicto [3][4] - Pluvicto has shown efficacy in prostate cancer patients both before and after chemotherapy, as evidenced by the PSMA-4 and VISION trials [3] 2. **Unmet Medical Needs**: - Despite advancements, there remains a substantial medical need for new therapies, especially targeted radiotherapy, as all patients receiving PSMA-targeting treatments will eventually relapse [4] 3. **Introduction of Betabart**: - Betabart, a monoclonal antibody targeting B7-H3, is being developed as a new treatment option. It has a modified half-life to reduce side effects while maintaining strong target affinity [4][5] - The upcoming study will enroll patients with various tumors, including those with prostate cancer who have previously received Pluvicto [5] 4. **KLK3 Targeting**: - KLK3 (PSA) is identified as a promising new target for prostate cancer therapy, with a focus on its specific expression in prostate tissues compared to PSMA, which is expressed in multiple organs [7][8] - The KLK3-targeted study is set to begin in Australia early next year [8] 5. **Preclinical Data**: - Preclinical studies show that KLK2 and KLK3 are highly specific to prostate tissues, with KLK3 exhibiting higher expression levels than KLK2 [9][19] - The therapeutic efficacy of KLK2-targeted therapies has been demonstrated in advanced mouse models, showing significant tumor reduction [13][14] 6. **Mechanism of Action**: - The therapeutic approach exploits the upregulation of androgen receptors (AR) in response to DNA damage, which increases the expression of KLK2 and KLK3, enhancing the targeting efficacy over time [16][29] 7. **Comparison with Other Therapies**: - KLK3-targeted therapies are positioned as a more advanced approach compared to KLK2, with a higher expression level and a more extensive research background [20][29] - The antibody developed for KLK3 is designed to avoid targeting PSA in circulation, focusing instead on the free form of PSA in tissues [28] 8. **Clinical Development Plans**: - RAD402 (KLK3 targeting molecule) is expected to enter clinical studies in Australia before the end of the year, alongside RV-01 (B7-H3 targeting molecule) in the U.S. [48] Additional Important Content - **Market Potential**: - The arrival of radiopharmaceuticals has significantly changed the metastatic prostate cancer treatment landscape, with improved patient survival rates [45] - There is a recognition that existing treatments like Pluvicto are not perfect, indicating a need for further scientific advancements [46] - **Future Directions**: - The company is exploring new targets and approaches to enhance treatment efficacy and patient outcomes in metastatic prostate cancer [46][47] - **Community Engagement**: - The webinars have attracted significant interest, indicating a strong community engagement and support for ongoing research and development in prostate cancer therapies [45]

Summary of Radiopharm Theranostics (RADX) Update / Briefing August 26, 2025 Company and Industry Overview - **Company**: Radiopharm Theranostics (RADX) - **Industry**: Oncology, specifically focusing on prostate cancer treatment and radiopharmaceutical therapies Key Points and Arguments 1. **Prostate Cancer Treatment Landscape**: The treatment of prostate cancer has evolved significantly, moving from traditional methods like surgery and chemotherapy to incorporating genetics, molecular imaging, and targeted therapies, including immunotherapy and radiopharmaceuticals [11][12][30] 2. **B7-H3 as a Target**: B7-H3 is highlighted as a promising new target for prostate cancer treatment, being highly expressed in various tumors, including 93% of castrate-resistant prostate cancer cases. This makes it a viable alternative to PSMA-targeted therapies, especially in cases where PSMA expression is low [39][41][43] 3. **Need for New Therapies**: There is a critical need for more effective therapies for metastatic castration-resistant prostate cancer, as current treatments often provide limited survival benefits [18][30] 4. **NCCN Guidelines**: The National Comprehensive Cancer Network (NCCN) guidelines are discussed, emphasizing the importance of treatment sequencing and the variety of options available based on prior therapies [19][20] 5. **Theranostics Concept**: The concept of theranostics is introduced, where ligands are designed to bind to specific cancer cell targets, allowing for both diagnosis and treatment using radiopharmaceuticals [24][25] 6. **Clinical Trials and FDA Approvals**: The presentation mentions several clinical trials demonstrating survival benefits from new therapies, including the FDA approval of Plavicto (lutetium-177) for prostate cancer treatment [27][28][51] 7. **BetaBART Development**: The development of BetaBART, a humanized monoclonal antibody targeting the four Ig isoform of B7-H3, is presented as a novel approach in radioimmunotherapy, with plans for a Phase 1 trial in 2025 [51][66] 8. **Competitive Landscape**: The competitive landscape for B7-H3 targeting is discussed, noting that while there are other modalities like ADCs and CAR T-cell therapies, the unique properties of BetaBART provide a competitive advantage [75][78][87] 9. **Immunological Memory**: Evidence of secondary immune memory from prior treatments suggests that BetaBART may not only target tumors but also enhance the immune response against them [64][66] 10. **Market Potential**: The potential market for B7-H3 targeting therapies is significant, with opportunities extending beyond prostate cancer to other solid tumors [46][51] Other Important but Overlooked Content 1. **Challenges with Current Therapies**: The limitations of existing therapies, including the need for better options post-Plavicto treatment, are emphasized, highlighting the urgency for innovation in this space [30][102] 2. **Mechanism of Action**: The mechanism of action for BetaBART is discussed, focusing on its ability to selectively target the four Ig isoform of B7-H3 while minimizing off-target effects and toxicity [49][66] 3. **Future Directions**: The discussion includes the need for randomized control groups in future trials to better assess the efficacy of new treatments [31] This summary encapsulates the critical insights from the briefing, focusing on the advancements in prostate cancer treatment, the significance of B7-H3 as a target, and the innovative approaches being developed by Radiopharm Theranostics.

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $79.2 million, representing a growth of 48% compared to Q2 2024 [21] - U.S. revenue for Q2 was $69.6 million, reflecting a growth of 46% year-over-year [21] - Gross margin for Q2 2025 was 65.4%, an increase of 640 basis points year-over-year [25] - Net loss for Q2 2025 was $19.6 million, compared to a net loss of $25.6 million in Q2 2024 [26] - Adjusted EBITDA loss was $8 million, an improvement from a loss of $18 million in the prior year [26] Business Line Data and Key Metrics Changes - U.S. handpiece and consumable revenue for Q2 2025 was $43.1 million, a growth of 58% compared to Q2 2024 [21] - Approximately 12,750 handpieces were sold in Q2 2025, representing a year-over-year unit growth of 59% [22] - U.S. system revenue was $22.1 million, with 48 new HydroS robotic systems sold [23] - International revenue reached $9.6 million, marking a growth of 69% compared to the prior year [24] Market Data and Key Metrics Changes - The company expects to exit 2025 with an estimated installed base of 715 systems, with only 20% procedural share in the hospital market, indicating significant room for expansion [4] - The 2026 proposed Medicare physician fee schedule includes a category one code for Ag population therapy, which is expected to enhance adoption and reimbursement consistency [14][15] Company Strategy and Development Direction - The company aims to become a global leader in urology, focusing on evidence-based innovation and expanding Hydro's adoption in greenfield accounts [10][34] - A leadership transition is underway, with Larry Wood set to become the new CEO, emphasizing a commitment to innovation and growth [10][36] - The company is eliminating the role of Chief Commercial Officer to strengthen commercial execution, creating two new leadership positions [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to achieve long-term profitability despite current tariff challenges, estimating a potential gross margin headwind of $1 million to $2 million in 2025 [31][92] - The company remains optimistic about the stability of the capital environment, with no indications of hospitals slowing or pausing capital spending [91] - Management highlighted the importance of clinical outcomes in driving adoption and utilization of their systems, despite recent reductions in physician fee schedules [60] Other Important Information - The company is actively pursuing operational strategies to mitigate tariff exposure, with a focus on maintaining gross margins and profitability [16][31] - Enrollment in the WATERFORT trial is progressing well, with expectations for full enrollment by 2026 [17] Q&A Session Summary Question: Guidance confidence and system placements - Management confirmed slight increases in guidance, with confidence stemming from strong sales force execution and visibility into the sales funnel [41][46] Question: Disruption from leadership changes - Management reassured that the experienced sales team will maintain focus and execution despite leadership transitions [48][49] Question: CCO role split rationale - The decision to split the CCO role aims to enhance commercial execution and support long-term growth objectives [52] Question: Utilization growth in accounts - Management noted that longer tenure in accounts correlates with increased utilization of aquablation procedures, with examples of it becoming the standard of care [55] Question: Impact of physician fee schedule reductions - Management emphasized that clinical outcomes will drive continued adoption, despite reductions in resective procedure payments [60] Question: System placements and future expectations - Management indicated that replacement sales are expected to pick up in 2026, aligning with the useful life of the systems [62] Question: International market strength - The UK remains the primary driver of international revenue growth, with emerging progress in Japan and Korea [68] Question: Hydros rollout and customer reception - Early feedback on the Hydros system has been positive, with expectations for utilization metrics to improve as accounts ramp up [75]

Financial Performance & Guidance - PROCEPT BioRobotics reported Q1 2024 global revenue of $445 million, an 83% year-over-year increase [22] - International revenue in Q1 2024 reached $43 million, a 65% year-over-year increase [22] - The U S installed base grew to 354 systems, an 84% year-over-year increase [22] - U S handpiece sales reached 6800, a 100% year-over-year increase [22] - The company projects total revenue for 2024 to be approximately $2135 million, representing a 57% year-over-year growth [26] - The company anticipates a gross margin of approximately 58% to 59% for 2024 [26] - Adjusted EBITDA loss is projected to be approximately $70 million for 2024 [26] - As of March 31, 2024, the company had a total cash and cash equivalents balance of $226 million and a debt balance of $52 million [27] Commercial Strategy & Market Expansion - The company aims to convert all resective BPH hospital-based procedures to Aquablation Therapy [39] - The company reports that over 95% of U S covered lives are now under signed majority IDN contracts [43] - Aquablation Therapy cases at Georgia Urology have increased 95x since 2019 [67] Prostate Cancer Research & Development - Approximately 1/3 of men with BPH also have prostate cancer, representing 300000 diagnoses per year [89] - Initial Aquablation impressions for prostate cancer show promise, with real-time imaging and surgeon confidence [113, 114] - Early results from a study (n=5) show 0% incontinence and 0% erectile dysfunction, as well as 0% actionable disease and 0% residual tumor on MRI [138, 148]