Reported adverse events are shown in Table 3. Table 3 . Phase I (CL-PTL-101): Ewing's sarcoma patients who received Vigil, definitely or probably related adverse events Preferred Term CTC Grade Relationship to Study Drug Number of Subjects Number of Events Bruising 1 Definitely Related 1 1 Erythema @ Injection Site 1 Definitely Related 1 1 Fatigue 1 Probably Related 1 4 Induration / Fibrosis Injection Site Reaction- Induration 1 Definitely Related 2 2 Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide IND 014205 CL-PTL-130 Version: 03 Page 30 of 74 Confidential and proprietary information of Gradalis, Inc. Effective: 05-DEC-2018 It is the user’s responsibility to verify adequate training before executing a document. Do not make unauthorized copies. Preferred Term CTC Grade Relationship to Study Drug Number of Subjects Number of Events Injection Site Reaction – Induration 1 Definitely Related 1 2 Injection Site Reaction - Erythema 1 Definitely Related 11 31 Injection Site Reaction - Induration 1 Definitely Related 12 55 Injection Site Reaction - Pain 1 Definitely Related 3 3 Injection Site Reaction - Pruritus 1 Definitely Related 1 3 Injection Site Reaction - Swelling 1 Definitely Related 2 3 Injection Site Reaction - Tenderness 1 Definitely Related 1 1 Joint -function 1 Probably Related 1 2 Pain – Back 1 Probably Related 1 1 No Grade 3 or 4 related adverse events were observed to Vigil. There were 11 serious adverse events (SAEs) reported involving 7 participants. None of the SAEs were related to Vigil. 2.3 Efficacy Evidence of Vigil in Ewing’s sarcoma A survival advantage was seen in the Vigil treated patients compared to control. Figure 9 shows the results of the Kaplan-Meier analysis of the survival data. Comparison of overall survival from time of procurement (for Vigil manufacture) between the two concurrent groups revealed a 17+ month improvement in survival in the Vigil treated patients. From time of treatment the Vigil treated patients achieved a median survival of 689 days. Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide IND 014205 CL-PTL-130 Version: 03 Page 31 of 74 Confidential and proprietary information of Gradalis, Inc. Effective: 05-DEC-2018 It is the user’s responsibility to verify adequate training before executing a document. Do not make unauthorized copies. Group N Median (mo.) p-value Matched Control 14 6.8 0.056 Vigil 16 24.0 Figure 9 . Survival from surgical procurement of advanced Ewing’s patients in study CL- PTL-101 successfully harvested for Vigil construction. Comparing those who received Vigil (ORR 12.5% (1NED, 1PR)) vs. those who did not receive Vigil censored alive as of dates provided on 10/19/15. The actual 1 -year survival of patients who received Vigil (11/15) was 73% vs. those who did not receive Vigil of 23% (3/13). One Vigil and one control patient remained alive but had not yet achieved actual 1-year survival time point. These results were recently published by Ghisoli et al (Ghisoli, Barve et al. 2016). Retrospective comparison of patient groups to two prognostic risk factor scores (the Wheler score for phase I patients (Wheler, Tsimberidou et al. 2012) and the Ewing’s sarcoma prognostic scores (ESPS) (Cotterill, Ahrens et al. 2000, Bacci, Longhi et al. 2006, Rodriguez -Galindo, Liu et al. 2007, Ladenstein, Pötschger et al. 2009, Jain and Kapoor 2010, Gaspar, Le Teuff et al. 2011, 2016)) suggest similar risk profiles of Vigil and control patients (Table 4) thereby supporting evidence of efficacy related to Vigil . Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide IND 014205 CL-PTL-130 Version: 03 Page 32 of 74 Confidential and proprietary information of Gradalis, Inc. Effective: 05-DEC-2018 It is the user’s responsibility to verify adequate training before executing a document.