Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $23 million, including net product revenues of $17.4 million, consistent with Q1 2024 and an increase from $16.4 million in Q4 2024 [5][17] - Net loss for Q1 2025 was $38.6 million, an improvement from a net loss of $46.6 million in Q1 2024, attributed to higher license revenues and lower expenses [18] - Cash and cash equivalents as of March 31, 2025, were $194.7 million, down from $250.9 million at December 31, 2024, primarily due to net loss from operations [18] Business Line Data and Key Metrics Changes - The company reported $5.6 million in milestone and royalty payments included in total revenue for the quarter [6] - The LOTUS-seven study showed an overall response rate of 95.5% and a complete response rate of 90.9% in 22 efficacy evaluable patients [14] Market Data and Key Metrics Changes - The company is focusing on maintaining its position as a treatment option for third-line plus DLBCL patients, with promising data from the LOTUS-seven study [5][10] - The competitive landscape is highlighted by the potential of ZYNLATA plus glufitamab to be a best-in-class combination in a highly competitive market [6][11] Company Strategy and Development Direction - The company aims to expand the use of ZYNLATA into earlier lines of therapy in DLBCL and indolent lymphomas, believing in the potential for significant revenue growth [10][22] - The strategy includes pursuing regulatory discussions and compendia strategies based on the data from ongoing trials [8][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming catalysts and the company's cash runway expected to fund operations into the second half of 2026 [10][21] - The management is optimistic about the promising data from ongoing trials and the potential to change treatment paradigms for patients with aggressive lymphoma [15][22] Other Important Information - The LOTUS-five trial is on track to reach the pre-specified number of progression-free survival events by the end of 2025, with top-line data expected thereafter [8][20] - The company is engaged in discussions for potential research collaborations to advance its programs [9][20] Q&A Session Summary Question: Follow-up time for patients and CR conversion times - Management indicated that follow-up assessments are ongoing, with high complete response rates being a strong biomarker for durability [27][28] Question: Competitive strategy and regulatory engagement - The company plans to engage with regulatory authorities once sufficient data from approximately 100 patients is available [30] Question: Expected patient numbers at upcoming conferences - Management confirmed that more patients than the 22 already discussed will be presented at the EHA and ICML conferences, but exact numbers cannot be disclosed [34] Question: Timing for LOTUS-five data readout - The company expects to reach the pre-specified number of PFS events this year, with data readout potentially at the end of this year or early next year [42] Question: Discontinuation of the ADCT-602 program - The discontinuation of the ADCT-602 program has minimal capital implications, allowing focus on advancing other research programs [50][51]

Core Insights - Aprea Therapeutics is making significant clinical progress with its lead candidates, ATRN-119 and APR-1051, showing early evidence of anti-tumor activity and advancing towards recommended Phase 2 doses [2][4] Clinical Trials - ATRN-119 has shown tumor shrinkage in three patients (7%, 14%, and 21%) in the ongoing ABOYA-119 clinical trial, indicating its potential effectiveness against DDR-deficient cancers [2][9] - The ACESOT-1051 trial for APR-1051 is progressing, with patients currently dosed at 100 mg once daily, and preliminary efficacy data expected in the second half of 2025 [3][5] Financial Position - As of March 31, 2025, Aprea reported cash and cash equivalents of $19.3 million, down from $22.8 million at the end of 2024, which is projected to cover operating expenses into early Q2 2026 [10][15] - The company reported an operating loss of $4.1 million for Q1 2025, compared to a loss of $3.1 million in Q1 2024, with R&D expenses increasing to $2.5 million due to the initiation of new clinical trials [10][17] Business Strategy - Aprea is focused on developing therapies that exploit cancer cell vulnerabilities while minimizing damage to healthy cells, targeting cancers with specific mutations [11][9] - The company has entered into a Material Transfer Agreement with MD Anderson Cancer Center to support preclinical research on APR-1051 for treating head and neck cancers [10]

Core Viewpoint - Tempest Therapeutics, Inc. reported promising developments in its clinical-stage oncology programs, particularly highlighting the amezalpat program's potential as a cancer therapy and ongoing efforts to maximize stockholder value through strategic alternatives [2][5]. Recent Highlights - The amezalpat program demonstrated its ability to reduce immunosuppression and activate the immune system against tumors, supported by positive randomized Phase 2 data [2]. - Tempest received Orphan Drug designation from the FDA for TPST-1495 for familial adenomatous polyposis (FAP) and for amezalpat for hepatocellular carcinoma (HCC) [5][6]. - The company is preparing for a Phase 2 trial of TPST-1495, expected to begin in 2025, emphasizing innovative cancer prevention strategies [6]. Financial Results - For the first quarter of 2025, Tempest reported a net loss of $10.9 million, or $3.16 per share, compared to a net loss of $7.9 million, or $4.62 per share, in the same period of 2024 [6][15]. - Research and development expenses increased to $7.6 million from $4.3 million year-over-year, primarily due to costs associated with preparing for a pivotal Phase 3 trial of amezalpat [6][7]. - The company ended the quarter with $21.5 million in cash and cash equivalents, down from $30.3 million at the end of 2024, mainly due to cash used in operating activities [6][12]. Corporate Developments - The company announced plans to explore a full range of strategic alternatives to advance its clinical-stage programs and maximize stockholder value [6]. - A reduction in force was completed on April 30, 2025, as part of its strategic initiatives [6].

Financial Performance & Guidance - Q1 2025 XPOVIO净产品收入为2110万美元，受到非典型过期产品退货的影响，减少了约500万美元[86, 87] - 公司预计2025年总收入为140-155百万美元[112] - 公司预计2025年美国XPOVIO净产品收入为115-130百万美元[112] - 公司预计2025年研发和SG&A支出为240-255百万美元，其中包括约2000万美元的非现金股票补偿[112] Myelofibrosis Program - Myelofibrosis的美国峰值年收入机会高达约10亿美元[7, 19] - 在JAKi初治的骨髓纤维化患者中，Selinexor联合Ruxolitinib治疗的SVR35达到79%[28] - 75%的美国医生表示有意采用联合疗法治疗骨髓纤维化[21, 99] Clinical Trials & Pipeline - SENTRY试验的顶线数据预计在2025年末/2026年初公布[7, 59] - XPORT-MF-035试验中，Selinexor单药治疗使脾脏体积缩小率增加了一倍以上，SVR25为67%，SVR35为33%[35, 36] - 完成了评估SPd治疗既往接受过治疗的多发性骨髓瘤患者的3期全球研究（XPORT-MM-031/EMN291）的患者招募，预计在2026年上半年获得顶线数据[78, 79, 81] Commercial Strategy - Selinexor已在超过45个国家获得批准[7, 90] - 现有销售团队已覆盖约80%的社区骨髓纤维化客户[21]

Core Insights - Allarity Therapeutics continues to show clinical benefits of stenoparib in heavily pre-treated ovarian cancer, with two patients on treatment for over 19 months [1][5] - The company has initiated a share repurchase program and ended Q1 2025 with approximately $27 million in cash and restricted cash, indicating financial stability [1][10] Clinical and Drug Development Progress - Enrollment is set to begin in self-funded ovarian cancer trials and a Veterans Administration-funded trial for small cell lung cancer [2] - A new Phase 2 protocol for platinum-resistant advanced ovarian cancer patients has been implemented to optimize dosing and patient selection [5][10] - A new Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer has been launched, fully funded by the U.S. Veterans Administration [5][10] - Updated Phase 2 clinical data presented at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting shows durable clinical benefits in heavily pre-treated ovarian cancer patients [5] Financial Strengthening and Corporate Development - The company fully utilized its At-the-Market (ATM) offering program initiated in March 2024, concluding the current ATM program [5] - A $5 million share repurchase program has been authorized, with approximately 2 million shares repurchased to date [5] - Cash, cash equivalents, and restricted cash totaled approximately $27.7 million as of March 31, 2025, compared to $20.9 million at the end of 2024 [10] - Research and Development (R&D) expenses for Q1 2025 were $1.4 million, down from $2.2 million in Q1 2024 [10] - General and Administrative (G&A) expenses for Q1 2025 were $1.6 million, down from $2.1 million in Q1 2024 [10] - The net loss for Q1 2025 was $2.7 million, compared to $3.8 million for the same period in 2024 [10]

COMBINING TO CURE ® Arcus is at the forefront of designing combination therapies, with best-in-class potential, in the relentless pursuit of cures for cancer. May 6, 2025 CORPORATE PRESENTATION Notice of Trademark: The Arcus name and logo are the property of Arcus. All other trademarks used herein are the property of their respective owners and are used for reference purposes only. Such use should not be construed as an endorsement of Arcus. Forward-Looking Statements/Safe Harbor Forward Looking Statements ...

Core Insights - Sensei Biotherapeutics reported favorable clinical data for its lead product candidate, solnerstotug, in patients with PD-(L)1-resistant cancers, indicating a potential breakthrough in treatment options for this challenging patient population [2][3] - The company has completed enrollment for its dose expansion cohort and expects to present full data by the end of 2025 [1][6] - Sensei's cash position is strong, with a runway expected to last into the second quarter of 2026 [5] Clinical Development - Solnerstotug is designed to target the immune checkpoint VISTA, which is associated with poor survival rates in various cancers [3] - The ongoing Phase 1/2 clinical trial is evaluating solnerstotug both as a monotherapy and in combination with Regeneron's PD-1 inhibitor, Libtayo [4] - Preliminary data from the trial shows response rates nearly three times higher than historical expectations for PD-(L)1-resistant patients [2][6] Financial Performance - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling $34.3 million, down from $41.3 million at the end of 2024 [5] - Research and Development (R&D) expenses decreased to $3.7 million in Q1 2025 from $4.9 million in Q1 2024, primarily due to lower personnel and facility costs [7] - General and Administrative (G&A) expenses also saw a decrease, totaling $3.5 million in Q1 2025 compared to $3.8 million in Q1 2024 [8] Operational Highlights - The company has completed enrollment of 63 patients in the dose expansion stage, including 10 patients with microsatellite stable colorectal cancer (MSS CRC) and 53 patients with PD-(L)1-resistant "hot" tumors [6] - Sensei participated in various conferences to discuss its clinical progress and strategic direction, enhancing its visibility in the oncology sector [6]

Financial Data and Key Metrics Changes - Total revenues for Q1 2020 were $235 million, including ADCETRIS net sales of $164 million (up 22% year-over-year) and PADCEV net sales of $34 million [22][6][5] - Royalty revenues increased to $20 million from $16 million in Q1 2019, while collaboration revenues decreased to $16 million from $45 million due to a prior milestone payment [23][24] - R&D expenses were $195 million, reflecting higher investment across the pipeline, while SG&A expenses were $122 million, driven by commercialization efforts [24][25] Business Line Data and Key Metrics Changes - ADCETRIS net sales were $164 million, maintaining guidance for full-year sales between $675 million and $700 million [6][7] - PADCEV achieved net sales of $34 million in its first full quarter, with strong uptake noted particularly in community settings [10][20] - TUKYSA was launched with positive reception, and the company is investing in a broad development program across HER2 positive cancers [12][21] Market Data and Key Metrics Changes - ADCETRIS sales growth was driven by frontline indications in Hodgkin lymphoma and T-cell lymphoma [17] - PADCEV's initial sales performance indicates strong physician and patient reception, with ongoing efforts to evaluate its use in earlier lines of bladder cancer [10][20] - TUKYSA's launch is supported by a dedicated sales force and marketing materials ready on the approval day, indicating strong market entry [21] Company Strategy and Development Direction - The company aims to establish ADCETRIS as the standard of care in frontline Hodgkin lymphoma and PTCL while advancing clinical trials [40] - Continued focus on the PADCEV launch and broad development program, including trials in first-line metastatic and muscle-invasive bladder cancer [40] - TUKYSA's development program includes ongoing regulatory efforts and trials in various HER2 positive cancers [36][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining guidance despite potential impacts from COVID-19, emphasizing the importance of ongoing cancer treatments [28][81] - The company is closely monitoring the impact of COVID-19 on operations and has implemented measures to ensure continuity [28] - Management remains optimistic about the future, citing strong demand for their products and ongoing clinical trials [28][40] Other Important Information - The company is involved in an arbitration process with Daiichi Sankyo regarding technology ownership, which is expected to be more efficient than court proceedings [15][100] - The company has a robust early-stage clinical pipeline, including several ADCs and immunotherapy agents [14] Q&A Session Summary Question: What has been the key drivers for the rapid uptake of PADCEV? - Management noted strong initial sales of $34 million and emphasized the drug's importance for a disease with limited treatment options [42][43] Question: What impact has COVID-19 had on ADCETRIS use? - Management acknowledged potential impacts but maintained that ADCETRIS remains a critical treatment for patients [48][50] Question: What are the plans for TUKYSA regarding co-pay barriers? - The company has established programs to assist eligible patients with co-pay costs to minimize barriers to access [56][59] Question: Can you elaborate on the discussions with the FDA regarding accelerated approval for PADCEV? - Management confirmed strong interactions with the FDA and ongoing enrollment in trials aimed at supporting accelerated approval [62][65] Question: How is the company handling Nectin-4 expression in studies? - The company is measuring Nectin-4 expression in trials and is prepared to adapt if it becomes a relevant biomarker for patient selection [90][93]

Core Viewpoint - Annamycin is a next-generation anthracycline that shows potential for synergistic effects with various FDA-approved anticancer therapies, indicating opportunities for expanded clinical applications in treating both hematological malignancies and solid tumors [1][2][4] Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat cancers and viral infections, with Annamycin as its lead program [6][7] - The company is advancing its pipeline through pivotal clinical trials, including the MIRACLE trial for relapsed or refractory acute myeloid leukemia (AML) [8] Research Findings - Recent studies presented at the AACR Annual Meeting 2025 demonstrate that Annamycin can work effectively in combination with various FDA-approved drugs, both in vitro and in vivo [1][4] - The research aims to identify new clinical applications for Annamycin, particularly in combination therapies for treatment-resistant cancers [4][5] Clinical Trials - The company is initiating the MIRACLE trial, which evaluates Annamycin in combination with cytarabine for AML treatment, following a successful Phase 1B/2 study [8] - Annamycin has shown high activity against drug-resistant cell lines in previous experiments, suggesting its potential effectiveness in challenging cancer cases [3][4] Future Development - The company is exploring additional indications for Annamycin, including pancreatic cancer and soft tissue sarcomas, as part of its strategy to expand the drug's market potential [2][4]

Core Viewpoint - Tempest Therapeutics presented new data at the 2025 AACR Annual Meeting supporting the immune-mediated anti-cancer activity of amezalpat, reinforcing its potential as a novel cancer treatment [1][2]. Group 1: Amezalpat's Mechanism and Efficacy - Amezalpat reduces tumor-promoting immunosuppression by M2 macrophages and T regulatory cells, leading to immune activation [2]. - The drug is an inhibitor of PPAR-alpha, which regulates fatty acid oxidation, a pathway utilized by immunosuppressive cells associated with poor cancer prognosis [2]. - Clinical data indicate that amezalpat shows superiority in overall survival when combined with atezolizumab and bevacizumab in advanced HCC patients compared to standard care [3]. Group 2: Company Overview - Tempest Therapeutics is a clinical-stage biotechnology company focused on developing small molecule therapeutics with tumor-targeted and immune-mediated mechanisms [4]. - The company is headquartered in Brisbane, California, and is advancing a diverse portfolio of product candidates aimed at treating various tumors [4].