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].

Core Insights - Ascentage Pharma presented results from five preclinical studies at the 2025 AACR Annual Meeting, showcasing its innovative drug pipeline targeting hematological malignancies [1][3][19] Group 1: Drug Candidates and Their Mechanisms - The five drug candidates presented include olverembatinib (HQP1351), lisaftoclax (APG-2575), APG-2449, APG-5918, and AS03157, each targeting different pathways in cancer treatment [2][19] - Olverembatinib combined with lisaftoclax showed strong synergistic effects in overcoming venetoclax resistance in acute myeloid leukemia (AML) models, indicating potential for new therapeutic strategies [4][7] - APG-5918, an EED inhibitor, demonstrated potent antitumor activity and synergized with enzalutamide in preclinical prostate cancer models, suggesting a promising combination therapy [10][16] - APG-2449, a FAK inhibitor, enhanced the antitumor activity of chemotherapy in small-cell lung cancer (SCLC) models, supporting its further clinical development [13][17] - AS03157, an IAP antagonist, showed high affinity for cIAP1 and XIAP, with potent antiproliferative activities in cancer cell lines, indicating its potential as a therapeutic candidate [25] Group 2: Clinical Development and Regulatory Status - Olverembatinib is already approved in China and included in the National Reimbursement Drug List, while a New Drug Application for lisaftoclax has been accepted for Priority Review by the China CDE [21][22] - Ascentage Pharma has received 16 Orphan Drug Designations from the US FDA and 1 from the EMA for its investigational drug candidates, highlighting its commitment to addressing unmet medical needs [22][19] Group 3: Company Overview and Strategic Goals - Ascentage Pharma is focused on discovering and developing therapies for hematological malignancies, with a robust pipeline of innovative drug candidates [19][20] - The company aims to strengthen its R&D capabilities and accelerate clinical development programs to meet global clinical needs [23]

Company Overview - HUTCHMED (China) Limited is an innovative, commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [12]. Recent Developments - HUTCHMED announced new and updated data from studies of its compounds, including savolitinib, fruquintinib, and surufatinib, which will be presented at the American Association of Cancer Research (AACR) Annual Meeting 2025 [1]. - The company is actively involved in multiple clinical trials, including the SACHI and SAFFRON trials, assessing the combination of savolitinib with TAGRISSO® (osimertinib) for treating patients with advanced non-small cell lung cancer (NSCLC) [10][11]. Product Information - Savolitinib is a selective MET tyrosine kinase inhibitor developed by HUTCHMED and AstraZeneca, approved in China for treating adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alterations [7][6]. - Fruquintinib is being studied in various treatment regimens for metastatic colorectal cancer (mCRC), with ongoing trials evaluating its efficacy in combination with other therapies [2][3]. Market Context - Lung cancer is the leading cause of cancer death globally, with NSCLC accounting for approximately 80% of cases. A significant portion of NSCLC patients in Asia have epidermal growth factor receptor (EGFR) mutations, which are targetable by therapies like savolitinib [4][5]. - The prevalence of MET aberrations in NSCLC patients who progress after EGFR TKI treatment is notable, with studies indicating that 15-50% of these patients may present with such mutations [8][9]. Clinical Trial Highlights - The SACHI trial met its primary endpoint of progression-free survival (PFS) during its interim analysis, leading to the acceptance of a New Drug Application (NDA) in China [10]. - The SAFFRON trial is ongoing, assessing the combination of savolitinib and TAGRISSO® against platinum-based chemotherapy in a specific patient population [11]. Future Prospects - HUTCHMED is focused on expanding the clinical development of its compounds, with promising data from ongoing trials expected to support potential regulatory filings in the US and other global markets [9][11].

Core Insights - Merus N.V. announced the acceptance of an abstract for the presentation of interim clinical data on petosemtamab in combination with pembrolizumab for the treatment of PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) at the 2025 ASCO Annual Meeting [1][2] - The presentation will include data from a phase 2 trial involving 45 patients, showcasing early clinical efficacy and safety data [2][3] - The company believes petosemtamab has the potential to be a first and best-in-class treatment for r/m HNSCC, demonstrating substantial clinical activity superior to historical controls across multiple efficacy endpoints [3] Company Overview - Merus N.V. is focused on developing innovative full-length multispecific antibodies and antibody drug conjugates, referred to as Biclonics, Triclonics, and ADClonics [1][10] - Petosemtamab (MCLA-158) is a Biclonics low-fucose human full-length IgG1 antibody targeting EGFR and LGR5, designed to exhibit multiple mechanisms of action [6] - The company is conducting a phase 3 trial (LiGeR-HN1) to evaluate the safety and efficacy of petosemtamab in combination with pembrolizumab compared to pembrolizumab alone in r/m HNSCC patients [9] Industry Context - HNSCC is the sixth most common cancer globally, with over 930,000 new cases and more than 465,000 deaths reported in 2020 [8] - The incidence of HNSCC is expected to rise by 30%, surpassing 1 million new cases annually by 2030, indicating a growing need for effective treatment options [8]

Core Insights - Moleculin Biotech, Inc. announced that an abstract regarding its next-generation anthracycline, Annamycin, has been selected for poster presentation at the AACR Annual Meeting 2025 [1][2] Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat cancers and viruses [3] - The lead program, Annamycin, is designed to avoid multidrug resistance and eliminate cardiotoxicity associated with current anthracyclines, targeting relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases [3] Clinical Trials - The company is initiating the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory AML [4] - Following a successful Phase 1B/2 study, the company believes it has de-risked the development pathway towards potential approval for Annamycin [4] Additional Developments - Moleculin is also developing WP1066, an immune/transcription modulator targeting brain tumors and other cancers, and a portfolio of antimetabolites including WP1122 for treating pathogenic viruses and certain cancer indications [5]