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Affimed (AFMD) Earnings Call Presentation
2025-07-03 07:10
AFM24 (EGFR) + atezolizumab in NSCLC - In EGFRwt NSCLC, the Disease Control Rate (DCR) was 76% (25/33 patients), with 48% (16/33) showing tumor shrinkage and an Objective Response Rate (ORR) of 21% (1 CR, 6 PRs)[16] - In EGFRmut NSCLC, the DCR was 71%, with 41% (7/17) showing tumor shrinkage and an ORR of 24% (1 CR, 3 PRs)[16] - Preliminary median Progression-Free Survival (PFS) in EGFRwt NSCLC was 5.6 months, with 36% of patients ongoing[33, 49] - Patients without prior taxane exposure in EGFRwt NSCLC showed a 25% ORR and a preliminary median PFS of 74 months[47, 53] - Post-hoc analysis showed increasing AFM24 exposure resulted in higher ORR, with the highest exposure group (Q4) achieving a 5455% ORR and a 9091% DCR[68] Acimtamig (AFM13) + AlloNK® in r/r HL - In relapsed/refractory Hodgkin Lymphoma (r/r HL), the ORR was 864% (19/22 patients), including a 545% Complete Response (CR) rate[16, 91] - All patients in the LuminICE-203 study were refractory to brentuximab vedotin (BV) and checkpoint inhibitors (CPIs)[80] AFM28 in r/r AML - In the highest dose level (300 mg), a composite complete remission rate (CRcR) of 40% (4/10 patients) was achieved in relapsed/refractory Acute Myeloid Leukemia (r/r AML)[16, 107]
INmune Bio Inc. Announces First Quarter 2025 Results and Provides Business Update
Globenewswire· 2025-05-08 20:10
Core Insights - INmune Bio Inc. reported its financial results for Q1 2025, highlighting a net loss of approximately $9.7 million, an improvement from a loss of $11.0 million in Q1 2024 [6][11][21] - The company is advancing its clinical programs, including the MINDFuL phase 2 trial for Alzheimer's and plans to submit a Biologics License Application (BLA) for CORDStrom targeting Recessive Dystrophic Epidermolysis Bullosa (RDEB) [6][14] Financial Results - For the quarter ended March 31, 2025, the company reported revenue of $50,000, compared to $14,000 in the same period of 2024 [21] - Research and development expenses were approximately $7.6 million, down from $8.7 million in Q1 2024 [6][21] - General and administrative expenses remained stable at approximately $2.3 million [11][21] - As of March 31, 2025, cash and cash equivalents totaled approximately $19.3 million, a decrease from $20.9 million at the end of 2024 [11][18] Clinical Developments - Top-line results from the MINDFuL phase 2 trial in Alzheimer's are expected in the second half of June 2025 [6] - The company plans to file a BLA for CORDStrom in early 2026 [6] - The INKmune Phase II trial has been expanded to include veterans with prostate cancer [6] Product Platforms - The XPro™ platform is a next-generation TNF inhibitor currently in clinical trials, targeting neuroinflammation [8][14] - CORDStrom™ is a cell medicine platform utilizing pooled human umbilical cord-derived mesenchymal stromal cells, aimed at treating complex inflammatory diseases [9][10] - INKmune® is designed to prime a patient's NK cells for cancer treatment, currently in trials for metastatic castration-resistant prostate cancer [12][14]