Financial Data and Key Metrics Changes - The company ended 2025 with cash and cash equivalents of $13.2 million, down from $23.3 million at the end of 2024 [8] - Net loss for the full year 2025 was $21.8 million or $8.35 per share, compared to a net loss of $44.6 million or $36.52 per share in 2024 [10] - Research and development expenses decreased to approximately $11.5 million in Q4 2025 from $26.6 million in 2024, primarily due to the conclusion of patient enrollment in the CLOVER-WaM clinical study [9] Business Line Data and Key Metrics Changes - The company advanced its lead asset, Iopofosine I 131, and initiated a phase 1b study of CLR 125 in triple-negative breast cancer [4][6] - CLR 125 is designed for precise tumor targeting, with early interim data expected in mid-2026 [7] - The company raised approximately $15.2 million throughout 2025 to support ongoing advancements in its pipeline [7] Market Data and Key Metrics Changes - The European market for the second-line setting is estimated to be over 12,000 patients, slightly higher than the U.S. market [53] - The conditional marketing authorization in Europe is expected to target a third-line or later post-BTKI patient population, with plans to shift to a second-line setting upon the confirmatory study [54] Company Strategy and Development Direction - The company aims to submit a conditional marketing authorization application for Iopofosine I 131 in Europe in Q3 2026, with potential approval and commercialization as early as 2027 [4][5] - The focus remains on advancing the regulatory position in both Europe and the U.S. while engaging in partnering conversations to support global program development [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the CLOVER-WaM data set and the unmet medical need for Iopofosine I 131, anticipating a milestone-rich 2026 [11][18] - The company is optimistic about the potential of Iopofosine across multiple oncology indications, supported by promising data from various studies [15][14] Other Important Information - The company expanded its global intellectual property estate with new patents issued across multiple regions, enhancing protection for its assets [7] - The company has strengthened its supply partnerships for isotopes, which are crucial for future clinical development [16] Q&A Session Summary Question: Can the same submission package for EMA be used for FDA? - Management confirmed that while the formats differ, much of the data is similar and can be applied to both submissions [22][23] Question: What is the timeline for submitting to the FDA post-initiation of the confirmatory study? - The company plans to submit the NDA to the FDA about one to two months after initiating the study, expecting a response within 7 to 9 months [27][26] Question: What is the expected progression-free survival (PFS) compared to standard care? - Management indicated that the primary endpoint for the confirmatory study is PFS, with secondary endpoints including major response rates [37][39] Question: What is the interest level among physicians and patients for participation in the trial? - There is high interest from physicians and patients, with many believing the drug fills a significant need in the market [40][41] Question: What are the plans for distribution in Europe? - The company plans to partner with other parties for commercialization in Europe, leveraging a logistical chain that allows for easier distribution of the product [52][53]

Financial Data and Key Metrics Changes - The company ended 2025 with cash and cash equivalents of $13.2 million, down from $23.3 million at the end of 2024 [8] - Net loss for the full year 2025 was $21.8 million or $8.35 per share, compared to a net loss of $44.6 million or $36.52 per share in 2024 [10] - Research and development expenses decreased to approximately $11.5 million in Q4 2025 from $26.6 million in 2024, primarily due to the conclusion of patient enrollment in the CLOVER-WaM clinical study [9] Business Line Data and Key Metrics Changes - The company advanced its lead asset, Iopofosine I 131, and initiated a Phase 1b study of CLR 125 in Triple-Negative Breast Cancer [4][6] - CLR 125 is designed for precise tumor targeting, with early interim data expected in mid-2026 [7] - CLR 225, another asset, is ready to initiate a Phase 1 trial pending funding [16] Market Data and Key Metrics Changes - The European market for the second line setting is estimated to be over 12,000 patients, slightly higher than the U.S. market [53] - The company plans to submit a conditional marketing authorization application for Iopofosine in Europe in Q3 2026, targeting potential approval as early as 2027 [4][5] Company Strategy and Development Direction - The company aims to submit a conditional marketing authorization application for Iopofosine I 131 in Europe and pursue an NDA under the Accelerated Approval pathway in the U.S. [4][11] - The focus is on expanding the clinical development pipeline of radiopharmaceuticals and strengthening regulatory positions in both Europe and the U.S. [4][11] - The company is engaged in partnering conversations to support global program development [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory and clinical progress made in 2025, positioning the company for a milestone-rich 2026 [11][18] - The strength of the CLOVER-WaM data set and the unmet medical need for Iopofosine were highlighted as key factors for future success [5][14] - Management anticipates multiple value-creating milestones in the coming months and remains committed to delivering transformative therapies [18] Other Important Information - The company raised approximately $15.2 million in 2025, extending its cash runway [7] - Significant expansion of the global intellectual property estate was achieved with new patents issued across various regions [7] Q&A Session Summary Question: Can the same submission package for EMA be used for FDA? - Management confirmed that while the formats differ, much of the data is similar and can be applied to both submissions [22][23] Question: What is the expected timeline for FDA submission post Phase III trial initiation? - Management indicated that they expect to submit the NDA within 1-2 months after initiating the confirmatory study, with a response from the FDA expected within 7-9 months [27][28] Question: What is the current environment for enrollment in the trial? - Management noted high interest from physicians and patients, emphasizing the significant need for the drug in the marketplace [40][41] Question: What are the plans for distribution in Europe? - The company plans to partner with various parties for commercialization in Europe, with a unique competitive advantage due to the longer shelf life of their product [52][53]

Financial Data and Key Metrics Changes - The company ended 2025 with cash and cash equivalents of $13.2 million, down from $23.3 million as of December 31, 2024 [7] - Net loss for the full year 2025 was $21.8 million or $8.35 per basic and diluted share, compared to a net loss of $44.6 million or $36.52 per basic share and $41.89 per diluted share in 2024 [9] - Research and development expenses for Q4 2025 were approximately $11.5 million, a decrease from approximately $26.6 million for the year ended December 31, 2024 [8] Business Line Data and Key Metrics Changes - The company advanced its lead asset, Iopofosine I 131, and is on track to submit a conditional marketing authorization application in Q3 2026 [4] - CLR 125, a new asset for triple-negative breast cancer, has initiated a phase 1b study, with early interim data expected in mid-2026 [5][6] - The company raised approximately $15.2 million throughout the year, extending its cash runway for ongoing pipeline advancements [7] Market Data and Key Metrics Changes - The European market for the second line setting is estimated to be over 12,000 patients, slightly higher than the U.S. market, which is just below 12,000 patients [54] - The conditional marketing authorization in Europe is expected to target a third line or later post-BTKI patient population, with plans to shift to a second line setting upon completion of the confirmatory study [54][55] Company Strategy and Development Direction - The company is focused on advancing its regulatory position in both Europe and the U.S. for Iopofosine I 131, with a clear strategy for market approval [4][10] - Strengthening supply chain infrastructure and expanding the global intellectual property estate are key components of the company's strategy [6][7] - The company aims to deliver transformative therapies to patients with difficult-to-treat cancers, supported by robust science and regulatory engagement [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory paths for Iopofosine I 131, highlighting the strength of the clinical data and the unmet medical need [5][10] - The company anticipates a milestone-rich 2026, with multiple value-creating milestones expected throughout the year [17] - Management noted high interest from physicians and patients in participating in upcoming trials, indicating a strong market demand for their therapies [41][42] Other Important Information - The company has made significant progress in its clinical development pipeline, including the initiation of new studies and strengthening partnerships for isotope supply [6][16] - The company has expanded its global patent estate, providing long-term protection for its key assets [6] Q&A Session Summary Question: Can the same submission package for EMA be used for FDA? - Management confirmed that while the formats differ, much of the data is similar and can be applied to both submissions [22][23] Question: What is the expected timeline for FDA submission post-initiation of the confirmatory study? - Management indicated that they expect to submit the NDA to the FDA about one to two months after initiating the study, with a response expected within 7 to 9 months [25][27] Question: What is the expected progression-free survival (PFS) compared to standard care? - Management provided insights into historical data, indicating that the median PFS for standard therapies is around 8 months, and they expect Iopofosine to perform better based on their data [29][40] Question: What are the plans for distribution in Europe? - The company plans to partner with various parties for commercialization in Europe, with a unique competitive advantage due to the longer shelf life of their product [53][54]

Core Insights - Cellectar Biosciences is advancing its lead product, iopofosine I-131, towards a Conditional Marketing Authorization (CMA) submission to the European Medicines Agency (EMA) in Q3 2026, targeting potential commercialization in 2027 for Waldenström Macroglobulinemia treatment [1][4] - The company has initiated a Phase 1b dose-finding study for CLR 125 in Triple Negative Breast Cancer (TNBC), with early data expected by mid-2026 [1][4] - Cellectar's financial results for 2025 show a significant reduction in net loss compared to 2024, indicating improved operational efficiency [5][9] Corporate Developments - The CMA submission for iopofosine I-131 will be supported by data from the CLOVER WaM study, which includes 12-month follow-up data on all patients and updated response rates [4] - The company received Breakthrough Therapy Designation from the FDA for iopofosine I-131 in relapsed/refractory WM, expanding its market potential [4] - CLR 125 has shown good tolerability in vivo with no signs of end-organ toxicity and has demonstrated tumor reduction in preclinical studies [4][10] Financial Performance - As of December 31, 2025, Cellectar reported cash and cash equivalents of $13.2 million, down from $23.3 million in 2024, which is expected to fund operations into Q3 2026 [9] - Research and Development (R&D) expenses decreased to approximately $11.5 million in 2025 from $26.1 million in 2024, primarily due to reduced activity in the CLOVER WaM clinical study [9] - General and Administrative (G&A) expenses also decreased to approximately $11.5 million in 2025 from $25.6 million in 2024, reflecting reduced pre-commercialization efforts [9] Product Pipeline - The product pipeline includes iopofosine I-131, which is being evaluated for multiple cancer indications, including relapsed or refractory multiple myeloma and CNS lymphoma [8] - CLR 125 is currently in a Phase 1b study for TNBC, with the primary endpoint to determine a recommended Phase 2 dose and evaluate safety and initial response [4][10] - Cellectar is also developing CLR 225, targeting solid tumors with significant unmet needs, such as pancreatic cancer [11]

Core Insights - Cellectar Biosciences, Inc. has expanded its global intellectual property estate, securing new patents across Europe, Asia-Pacific, the Middle East, and the Americas, which strengthens its protection around iopofosine I 131 and its broader portfolio [1][2] Group 1: Intellectual Property Expansion - The newly issued patents cover critical therapeutic and platform strategies, reinforcing the uniqueness of the company's technology [2] - The expansion of the IP estate is seen as essential for the company's long-term commercial strategy and supports its commitment to providing new therapeutic options for patients with limited treatment choices [2] Group 2: Product Pipeline - The company's product pipeline includes iopofosine I 131, designed for targeted delivery of iodine-131, and CLR 125, an iodine-125 Auger-emitting program for treating triple negative breast cancer [4] - iopofosine I 131 has been studied in Phase 2b trials for multiple myeloma and CNS lymphoma, and is eligible for a Pediatric Review Voucher from the FDA upon approval [5] Group 3: Regulatory Designations - iopofosine I 131 has received multiple designations from the FDA, including Breakthrough Therapy, six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations for various cancer indications [5]

Cellectar Biosciences FY Conference Summary Company Overview - **Company Name**: Cellectar Biosciences - **Stock Symbol**: CLRB (NASDAQ) - **Focus**: Oncology, platform technology, and radiopharmaceuticals, specifically phospholipid ether (PLE) delivery systems for targeting cancer cells while sparing healthy tissue [2][3] Core Points and Arguments Clinical Data and Breakthrough Designation - **Lead Product**: CLR 131 (iodine-131), targeting Waldenstrom's macroglobulinemia - **Phase 2b Study Results**: - Major response rate achieved: 58.2% (target was 20%) - Overall response rate: 84% - Disease control rate: nearly 99% [3][4][16] - **Regulatory Designations**: - Received FDA breakthrough designation - Received EMA's PRIME designation, allowing for conditional marketing authorization submission [4] Upcoming Studies and Market Potential - **Triple-Negative Breast Cancer Study**: Initiated in Q1 2026, with significant market potential due to lack of available treatments [5][11] - **CLR 225 for Pancreatic Cancer**: Phase 1 ready, with plans to initiate post-partnership [5][11] - **Market Dynamics**: - U.S. market for second-line treatment in Waldenstrom's macroglobulinemia has approximately 11,500 patients, with 1,000 patients not seeking treatment due to lack of options [18][19] - High unmet medical need, with 60% of treatments being off-label [19] Financial and Approval Insights - **NDA Application**: Finalizing application with expected submission in early Q3 2026 [4][12] - **Cost of Studies**: CLR 225 study estimated at $42 million, with approximately $15 million to approval [12] - **Approval Rates**: - FDA approval rate for breakthrough designation drugs: 79% - EMA approval rate for CMA eligibility: 80% [12] Mechanism of Action and Delivery System - **PLE Delivery System**: Allows for targeted delivery of therapeutic payloads to cancer cells, enhancing efficacy and reducing adverse events [2][13] - **CNS Penetration**: Demonstrated ability to cross the blood-brain barrier, effective in treating malignant brain tumors [13][14] Pipeline and Future Opportunities - **Diverse Pipeline**: Includes various isotopes (alpha, beta, Auger) for different tumor types, with ongoing evaluations for optimal isotope selection [14][24] - **Upcoming Data**: Expecting dosimetry and initial response data for triple-negative breast cancer in the first half of 2026 [10][25] Additional Important Information - **Patient Demographics**: The most refractory patient population studied in clinical trials for Waldenstrom's macroglobulinemia, with high rates of treatment resistance [15][16] - **Adverse Events**: Clean profile with manageable cytopenias and negligible off-target effects [17][24] - **Commercial Strategy**: Minimal marketing investment required due to concentrated patient population in specific states [19][20] Conclusion Cellectar Biosciences is positioned for significant growth with its innovative radiopharmaceuticals targeting various cancers, backed by promising clinical data and strategic regulatory designations. The company is actively preparing for upcoming studies and market entries, particularly in the U.S. and EU, with a focus on maximizing shareholder value through effective partnerships and commercialization strategies [26][27]

Cellectar Biosciences Conference Call Summary Company Overview - **Company**: Cellectar Biosciences - **Stock Symbol**: CLRB (NASDAQ) - **Focus**: Oncology, platform technology, and radiopharmaceuticals, specifically phospholipid radioconjugates (PRCs) [2][3] Key Points and Arguments Product Development and Clinical Trials - **Lead Product**: CLR 131 (iodine-131) for Waldenstrom's macroglobulinemia - Achieved a major response rate of 58.2% in a highly relapsed, refractory patient population, exceeding the FDA's primary endpoint of 20% [3] - Overall response rate of 84% and disease control rate of nearly 99% [3] - **Regulatory Designations**: - Received FDA breakthrough designation and EMA's PRIME designation [4] - Anticipated submission for conditional marketing authorization to EMA in early Q3 2026 [4] - Preparing for U.S. FDA accelerated application [4] Future Studies and Market Opportunities - **Upcoming Studies**: - Initiated study for CLR 125 in triple-negative breast cancer in Q1 2026 [5] - CLR 225 for pancreatic cancer is phase 1 ready [5] - **Market Potential**: - Significant unmet medical need in relapsed, refractory patient populations, particularly in triple-negative breast cancer [5][20] - Approximately 11,500 patients in the U.S. for second-line treatment, with 1,000 patients not seeking treatment due to lack of options [20] - 60% of treatments are off-label, indicating high unmet medical need [20] Financial and Operational Insights - **Financial Position**: - As of September 30, the company had $12.6 million, with an additional $5.2 million added in October, totaling just under $18 million [26] - 4 million-plus shares of common stock outstanding, fully diluted at 7.5 million [26] - **Study Costs**: - Estimated study cost for CLR 225 is $42 million, with approximately $15 million needed to reach approval [12] Mechanism of Action and Technology - **Delivery Technology**: - Utilizes phospholipid ether (PLE) delivery moiety to target cancer cells while sparing healthy tissue, enhancing therapeutic window [2][13] - Demonstrated CNS penetration and ability to treat various malignant brain tumors [13] Clinical Data and Efficacy - **Efficacy in Challenging Populations**: - CLR 131 showed a disease control rate of 98% in a highly refractory patient population [17] - Average duration of response (DOR) and progression-free survival (PFS) reported at 11.4 months [17] - Minimal adverse events, with all patients recovering from cytopenias [18] Competitive Landscape - **Market Dynamics**: - The EU market is approximately 30% larger than the U.S. in terms of patient population [21] - Only one class of approved agents (BTK inhibitors) currently available, indicating a significant opportunity for Cellectar's products [21] Additional Important Information - **Pipeline Expansion**: - Ongoing discussions for partnerships to maximize the potential of WM and iopofosine in both the EU and U.S. [6] - **Upcoming Data Releases**: - Expecting imaging data and initial response data for CLR 125 in the first half of the year [9][10] This summary encapsulates the critical insights from the Cellectar Biosciences conference call, highlighting the company's focus on innovative oncology treatments, regulatory progress, and market opportunities.

Core Insights - Cellectar Biosciences plans to submit for conditional marketing approval for iopofosine I 131 in Europe by Q3 2026, following guidance from the EMA [1][5] - The company aims to present final results from the Phase 2 CLOVER WaM clinical study of iopofosine I 131 and initiate a Phase 1b study for CLR 125 targeting triple-negative breast cancer in early 2026 [1][6] Clinical Development - Cellectar received positive feedback from the EMA's SAWP supporting a Conditional Marketing Authorization filing for iopofosine I 131 based on the CLOVER WaM study [5] - The FDA granted Breakthrough Designation for iopofosine I 131 in relapsed/refractory Waldenstrom's Macroglobulinemia [5] - A Phase 1b clinical study for CLR 125 has been initiated, targeting triple-negative breast cancer [5] Regulatory Milestones - The company plans to submit a CMA application to the EMA for iopofosine I 131 in WM in Q3 2026, with potential approval in early 2027 [6] - Preparations for a New Drug Application (NDA) for U.S. accelerated approval of iopofosine I 131 are underway [6] - The company is actively enrolling patients for the Phase 1b study of CLR 125, with interim data expected in mid-2026 [6] Financial Strategy - Cellectar raised approximately $15.2 million through financings and warrant exercises to support pipeline development and regulatory milestones [5] - The company is focused on disciplined capital management and exploring non-dilutive funding opportunities [7] - The anticipated conditional marketing approval in 2027 from the EMA could impact around thirty countries, potentially expanding the patient population significantly compared to the U.S. [7]

Financial Data and Key Metrics Changes - The company ended Q3 2025 with cash and cash equivalents of $12.6 million, down from $23.3 million as of December 31, 2024 [11] - Net loss for Q3 2025 was $4.4 million or $1.41 per share, compared to a net loss of $14.7 million or $11.18 per basic share in Q3 2024 [14] Business Line Data and Key Metrics Changes - Research and development expenses decreased to approximately $2.5 million in Q3 2025 from approximately $5.5 million in Q3 2024, attributed to lower costs related to the CLOVER-WaM study and completed manufacturing efforts [12][13] - General and administrative expenses also decreased to $2.3 million in Q3 2025 from $7.8 million in Q3 2024, primarily due to reduced pre-commercialization efforts and lower personnel costs [13] Market Data and Key Metrics Changes - The company received confirmation from the EMA regarding eligibility to file for conditional marketing approval in the EU based on the CLOVER-WaM study, which could lead to market access as early as 2027 [6][10] - The FDA requested 12-month follow-up data on all patients from the CLOVER-WaM study, which is now available, allowing the company to plan for an NDA submission under the accelerated approval pathway [7] Company Strategy and Development Direction - The company is focused on advancing its lead asset, iopofosine I 131, as a first-in-class radioconjugate therapy for Waldenstrom's macroglobulinemia, with a clear regulatory strategy in both Europe and the U.S. [4][5] - Active discussions are ongoing with potential partners to secure non-dilutive capital and commercial expertise for iopofosine I 131, aiming to expedite patient access [8][10] - The company is also advancing its next-generation radiopharmaceutical pipeline, including CLR 125 and CLR 225, targeting solid tumors with significant unmet needs [9][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory strategy and the potential for iopofosine I 131 to receive approval, highlighting the high probability of success based on historical data for similar filings [6][38] - The company anticipates several near-term milestones that could position it for rapid growth, including the initiation of clinical trials and regulatory submissions [10][22] Other Important Information - The company raised approximately $12.7 million in recent financings to strengthen its balance sheet and support clinical trials [10] - The company has received multiple designations from the FDA and EMA, including Breakthrough Therapy Designation and Orphan Drug Designation, enhancing its regulatory position [15][16] Q&A Session Summary Question: Can you help us understand the specific data considered by the EMA for the conditional marketing authorization? - Management provided insights into the comprehensive data package submitted to the EMA, emphasizing the focus on post-BTKi patient populations and the high response rates observed in the CLOVER-WaM study [25][30] Question: What are the estimated costs and resources needed to initiate the Phase III trial in the U.S.? - Management estimated the total cost of the study at approximately $40 million, with about $10 million needed to initiate the trial and $15 million for full patient enrollment [33][36] Question: How have partnering discussions evolved since the EU regulatory update? - Management indicated that interest in partnering has increased following the positive regulatory developments, with ongoing discussions with various parties focused on both U.S. and European markets [50][53] Question: What is the current status of the CLOVER-WaM follow-up data and PFS? - Management confirmed that the most recent PFS data from the CLOVER-WaM study was robust, with a follow-up of 12 months now available, although no new data would be announced until after regulatory submissions [68][74]

Financial Data and Key Metrics Changes - The company ended Q3 2025 with cash and cash equivalents of $12.6 million, down from $23.3 million as of December 31, 2024 [12] - Net loss for Q3 2025 was $4.4 million or $1.41 per share, compared to a net loss of $14.7 million or $11.18 per basic share in Q3 2024 [15] Business Line Data and Key Metrics Changes - Research and development expenses decreased to approximately $2.5 million in Q3 2025 from approximately $5.5 million in Q3 2024, attributed to lower costs related to the Clover-WM study [13] - General and administrative expenses also decreased to $2.3 million in Q3 2025 from $7.8 million in Q3 2024, primarily due to reduced pre-commercialization efforts and lower personnel costs [14] Market Data and Key Metrics Changes - The company received confirmation from the EMA that it is eligible to file for conditional marketing approval in the EU based on the Clover-WM study, which could bring iopofosine I 131 to patients as early as 2027 [6][10] - The FDA has requested 12-month follow-up data on all patients from the Clover-WM study, which is now available, allowing the company to plan for an NDA submission under the accelerated approval pathway [7] Company Strategy and Development Direction - The company is focusing on advancing its lead asset, iopofosine I 131, as a first-in-class radioconjugate therapy for Waldenstrom's macroglobulinemia, with a clear regulatory strategy in both the EU and the U.S. [4][6] - Active discussions are ongoing with potential partners to secure non-dilutive capital and commercial expertise for iopofosine I 131 [8] - The company is also advancing its next-generation radiopharmaceutical pipeline, including CLR 125 and CLR 225, targeting solid tumors with significant unmet needs [9][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory strategy for iopofosine I 131, highlighting the high probability of success for conditional marketing authorization in Europe and accelerated approval in the U.S. [6][16] - The company is energized by the opportunities ahead and remains committed to delivering innovative therapies to patients with cancers [10][24] Other Important Information - The company raised approximately $12.7 million in recent financings to strengthen its balance sheet and support clinical trials [10] - The company has received multiple designations from the FDA and EMA, including Breakthrough Therapy Designation and Orphan Drug Designation, enhancing the value of its lead asset [17] Q&A Session Summary Question: Can you help us understand the specific data considered by the EMA for the recommendation? - The company provided a comprehensive data package to the EMA, focusing on the post-BTKi patient population, which is seen as having the greatest unmet need [26][30] Question: How much resources are needed to initiate the trial in the U.S.? - The total cost of the study is approximately $40 million, with about $10 million needed to initiate the trial [34][38] Question: Can you comment on the pricing potential for iopofosine in Europe and the U.S.? - The company anticipates a premium pricing opportunity, with potential for higher prices in Europe due to significant unmet medical needs [41][46] Question: Are there any gating items on CLR 225 to begin the trial? - Financing is the gating issue for initiating the CLR 225 trial, with all preparations in place to start once capital is secured [57][58] Question: Where are you in the Clover-WM follow-up regarding PFS? - The company has not updated PFS data since January last year, which was reported at 11.4 months with 8 months of follow-up [70][74]