CHOPIN Trial Results - The CHOPIN trial demonstrated that adding ipilimumab and nivolumab to PHP is effective and tolerable [9] - The combination group showed a one-year progression-free survival rate of 54.7% (95% CI: 36.8 - 69.5) compared to 15.8% (95% CI: 5.8 - 30.1) in the PHP group [6] - Median progression-free survival was 12.8 months (95% CI: 9.2 - 15.4) in the combination group versus 8.3 months (95% CI: 6.0 - 9.6) in the PHP group [6] - The hazard ratio for progression-free survival was 0.34 (0.19 - 0.60), with P<0.001 [6] - One-year overall survival was 82.8% (95% CI: 65.6 - 91.9) in the combination group and 82.2% (95% CI: 64.5 - 91.6) in the PHP group [6, 7] - Two-year overall survival was 49.6% (95% CI: 29.3 - 67.0) in the combination group and 22.1% (95% CI: 7.9 - 40.6) in the PHP group [7] - Median overall survival was 23.1 months (95% CI: 20.2 - 38.5) in the combination group and 19.6 months (95% CI: 15.2 - 21.8) in the PHP group [7] - The hazard ratio for overall survival was 0.39 (0.20 - 0.77), with P = 0.006 [7] - The best overall response rate in the combination group was 76.3% (59.4 - 88.0) [7] - Grade 3 or higher treatment-related adverse events were more frequent in the combination group (81.6% vs 40.5%, P<0.001) [7] Company Statements - Delcath Systems is focused on the treatment of primary and metastatic liver cancers [2, 14]

Core Insights - CytoDyn Inc. is making significant progress with leronlimab as a treatment for oncology, particularly in addressing unmet needs in solid tumor oncology, supported by both preclinical and clinical evidence [1][3][4] - The company has appointed Robert E. Hoffman as the new Chief Financial Officer to enhance its financial and strategic capabilities [2] - Leronlimab's novel mechanism of action shows promise in increasing PD-L1 expression, potentially allowing for better synergy with immune checkpoint inhibitors [3][24] Clinical Development - Leronlimab has shown prolonged survival in patients with Metastatic Triple-Negative Breast Cancer (mTNBC), with a 5-year survival rate around 15% [4] - A Phase II proof of concept protocol for PD-L1-negative mTNBC patients will be submitted, combining leronlimab with standard chemotherapy and an immune checkpoint inhibitor [4][5] - The company is also advancing leronlimab in metastatic Colorectal Cancer (mCRC), with ongoing enrollment in a Phase II study [6] Scientific Progress - Data presented at the European Society for Medical Oncology (ESMO) meeting indicates that leronlimab induces PD-L1 expression, which could transform treatment approaches for solid tumors [3][24] - In a study, 76% of patients showed increased PD-L1 expression after starting leronlimab, suggesting a shift from a "cold" to a "hot" tumor microenvironment [24] - The company is preparing to submit a comprehensive manuscript detailing the clinical and PD-L1 data from the ESMO presentation [31][32] Regulatory Matters - CytoDyn has successfully resolved investigations by the SEC and DOJ, indicating a positive compliance standing [9] - The company maintains a collaborative relationship with the FDA, focusing on responsible pathways for oncology development [10] Commitment to Shareholders - The company expresses gratitude for shareholder support and emphasizes the importance of maintaining respectful communication with industry partners [11] - CytoDyn is actively pursuing collaborations to maximize the potential of leronlimab [11] Future Directions - The company is exploring the use of leronlimab in glioblastoma, with funding secured for an investigator-initiated study [28] - Ongoing projects include studies on Alzheimer's disease and HIV, with recent approvals and funding arrangements in place [29][30]

XmAb® Fc Domain Technology - Xencor's XmAb® Fc domains augment native immune functions, preserve half-life, stability and production of antibodies[4] - XmAb® Fc domains are 99.5% identical to natural antibodies and can be easily substituted into any antibody[9] - Xencor has over 500 issued and pending patents worldwide related to XmAb® Fc domains[4] Bispecific Antibody Pipeline - Xencor has 6 XmAb bispecific antibodies in Phase 1 clinical studies[4] - XmAb23104 (PD-1 x ICOS) entered Phase 1 in May 2019, and XmAb22841 (CTLA-4 x LAG-3) initiation was anticipated in Q2 2019[4,39] - Novartis has a co-development and ex-U.S license for XmAb14045 (CD123 x CD3)[4] - Amgen's AMG 424 (CD38 x CD3) is in Phase 1 study in myeloma, and AMG 509 (Undisclosed x CD3) is advancing in prostate cancer[4,11,44] IL-15 Cytokine Program - Genentech has a co-development collaboration with Xencor for novel IL-15 cytokines[4] - The collaboration includes $120 million upfront and up to $160 million in XmAb24306 development milestone payments, and up to $180 million for each new IL-15 program[42] - The first IND submission for XmAb24306 is planned for H2 2019[4,42] Clinical Programs and Partnerships - Xencor has 13 XmAb clinical programs ongoing internally or with partners, including tafasitamab/MOR208 (Morphosys) in Phase 3 and Ultomiris™ (Alexion) approved in the U.S for the treatment of adult patients with PNH[4,11] - In a Phase 1 study of XmAb14045 in relapsed/refractory AML, 28% of evaluable patients achieved either complete remission (CR) or CR with incomplete hematologic recovery (CRi) at 2 highest initial doses (1.3 and 2.3 mcg/kg weekly)[29,34] Financial Status - Xencor had $650.5 million in cash at March 31, 2019, providing runway beyond 2024[46]