Table 4 . Prognostic Indicator Studies of Ewing's sarcoma Ewing’s Sarcoma Prognostic Scores (ESPS)° RISK OF LOW SURVIVAL Group High Intermediate Low Grand Total Matched Control 6 8 0 14 Vigil 6 10 0 16 High: 16-21 pts Intermediate: 11-15 pts Low: 0-10 pts °males higher risk of death Phase 1 Prognostic Scores* RISK OF LOW SURVIVAL Group High High - intermediate Intermediate Low- intermediate Low Grand Total Matched Control 0 1 8 5 0 14 Vigil 1 6 3 6 0 16 High: 4 -5 pts High-intermediate: 3 pts Intermediate: 2 pts Low-intermediate: 1 pts Low: 0 pts * Phase 1 Prognostic scores include factors like LDH, number of metastatic sites, albumin, etc. 2.4 Vigil Phase II Trial: Ewing’s sarcoma (CL-PTL-121, Part 1) A Phase llb randomized open label trial (CL-PTL-121) comparing Vigil versus standard of care chemotherapy (gemcitabine/taxol) in metastatic, refractory or recurrent (≥2 prior systemic treatment lines) Ewing’s sarcoma patients was initiated and enrolled the first patient 13 months ago. Part 1 of the trial was open to enrollment at 10 sites (5 in development) across the USA but only 13 patients registered into the study. Eight were randomized to control and received gemcitabine/taxol and 5 received Vigil. No Grade 3 or greater toxicity to Vigil has been observed. Grade 3 or greater toxic events related to chemotherapy were observed in 2 Ewing’s patients (hematologic, compromise, edema/facial blisters) and significant chemotherapy related toxicity of Grade 1 and 2 involving fever, fatigue, erythroderma, pruritus, neuropathy, nausea, vomiting was observed as expected. Early assessment of survival is shown in Figure 10. Kaplan Meier survival of 172 days (5.7 months) was observed in the chemotherapy group while the Vigil (initial treatment) group has not yet reached survival median. Mean survival of the Vi gil group is 271 days (8.9 months). This is consistent with the results observed with Phase I/II results in study CL-PTL-101. Futility analysis also revealed that the current trend of positive survival to Vigil is on track to achieve statistical significant survival advantage to Vigil at a 90% power (46 events). Further assessment of all advanced Ewing’s patients who received Vigil in studies CL-PTL-101 and CL-PTL-121 (21 patients) vs. matched (n=14) and randomized controls Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide IND 014205 CL-PTL-130 Version: 03 Page 33 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. (total n=22) provide additional support of potential benefit to Vigil in third-line Ewing’s sarcoma (Figure 11). A Kaplan Meier survival of 757 (24.9 months) days was observed with Vigil. Group N No. of Deaths Mean OS (mo.) Median OS (mo.) p-value Randomized Control 8 3 5.7 5.7 0.395 Vigil 5 1 8.9 Not reached Figure 10. Overall Survival Since Procurement on Study CL-PTL-121 Preliminary Results. Two cross-over patients censored. Data updated as of 01/19/17. Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide IND 014205 CL-PTL-130 Version: 03 Page 34 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. Figure 11. Study CL -PTL-101 and -121 Combination Data of Ewing’s sarcoma. Overall Survival Since Procurement. Median PFS is 6 months. Expected median PFS is 1.5-2 months (Juergens, Daw et al. 2011; Choy, Butrynski et al. 2014; Yoon, Kwon et al. 2014).