Scorpius Holdings Inc. · OTC:SCPX
Scorpius — Heat Biologics — Technical Presentation (November 2019)
27 slides from Scorpius's technical presentation, Nov 5, 2019
Slide 1: Cohort B New Data Release
Heat Biologics Heat Biologics NASDAQ; HTBX a P<. COHORT B NEW DATA RELEASE vine 5, aS
Slide 2: Forward Looking Statements
rr “Heat Biologics Forward Looking Statements This presentation includes statements that are, or may be deemed, “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, these forward-looking statements can be identified by th
Slide 3: Executive Summary
Or osusiy capes Executive Summary * HS-110, an “off the shelf” cell-based immunotherapy product that has the potential to improve PD(L)-1 based therapy - Broad market potential in multiple oncology indications - Fully allogeneic product with low COGs * Ongoing Phase 2 program demonstrates signals of
Slide 4: HS-110 Mechanism of Action
rrr ——————————— Heat Biologics HS-110 Mechanism of Action Pre-clinically, HS-110 generates an adaptive immune response cy 2 signals Delivered to antigen presenting cells (APCs): Y Antigen cross presentation to MHC class | via CD91 Y Up regulation of co-stimulatory signals via TLR2/4 6. Wor-UeDs" Tel
Slide 5: HS-110 + Opdivo Combination Therapy
HS-110 + Opdivo Combination Therapy Potential to improve clinical responses and survival, without additional toxicity nting Cell jh Antigen-Prese| @ J peer Hs-110 a. SY > (A0100 celttine) 5, Tumor Source: BMS images
Slide 6: Synergistic Combination of HS-110 and PD-1 Inhibitor
Diameter (m m?) Synergistic Combination of HS-110 and PD-1 Inhibitor in preclinical mouse tumor growth B16F10 model 4005 4 Vehicle (PBS) & mis110 3004 -¥ anti-PD1 @ mHS110+anti-PD1 2004 100+ Treatment Initiation 20 * Pre-clinical data showed the synergistic anti-tumor- growth activity of mouse HS-11
Slide 7: HS110-102 Trial Design
Heat Biologics HS110-102 Trial Design A Phase 1b/2 study of HS-110 in combination with multiple treatment regimens for patients with non-small cell lung cancer (HS110-102 trial, aka the “DURGA” Trial ) Patient Treatment . Treatment Arm Cohort Setting 2r¢ Line or Greater HS-110 + We 100 Nivolumab 1%
Slide 8: HS110-102 Trial Schema
Heat Biologics HS110-102 Trial Schema A Phase 1b/2 study of HS-110 in combination with multiple treatment regimens for patients with non-small cell lung cancer (HS110-102 trial, aka the “DURGA” Trial ) HS110 (weekly) Survival Nivolumab (every 2 weeks) _ Follow Up A A (every 3 x x xX X (every 8 weeks
Slide 9: Cohort B: Patient Characteristics
Heat Biologics Cohort B: Patient Characteristics Unresectable or metastatic NSCLC patients, heavily pretreated (63% with > 2 lines of prior therapy) July 2019 data cut ITT (N= 56) July 2019 data cut ITT (N= 56) Median age (range) 68 (50-84) | | Baseline Negative (<1%) 22 (39%) anette cena 30 (54%) P
Slide 10: Cohort B: Estimated Progression Free Survival (PFS)
rent Boge Cohort B: CPI progressors treated by HS-110 + Nivolumab at >2L Estimated Progression Free Survival (PFS) i * ITT Censored Median PFS 95% Cl (months) & 56 7 3.2 (1.9, 4.0) = 100 iy * Estimated with 17 patients (30%) censored. — Progression assessed per RECIST 1.1 3S (754 2 Median PFS of niv
Slide 11: Cohort B: Estimated Median Overall Survival (OS)
Cohort B: CPI progressors treated by HS-110 + Nivolumab at >2L Estimated Median Overall Survival (OS) ITT Censored Median OS*, 95% Cl (mos) 56 39 11.8 (6.6, Not Reached) _, 1007 * Estimated with 70% of patients still alive & ow 754 2 g D SOAs rece eee cece cece cece neces eesnesseeseeeesesorretsretr
Slide 12: Cohort B: Objective Response Rate (ORR)
Heat Biologics scohor eee Objective Response Rate (ORR) HS-110 + Nivolumab at >2L Tumor shrinkage observed in 38% (N = 21) ITT population (N=56) 2 400 of 56 ITT patients iRECISTt RECIST1.1+ oO & 7 ORR 14% (8) 13% (7) 5 50 PR 14% (8) 13% (7) 5 2 sD 46% (26) 46% (26) 3 5 0 Not 7% (4) 7% (4) a Evaluabl
Slide 13: Cohort B: PFS by Injection Site Reaction (ISR)
Heat Biologics Cohort B: bes by Injection Site Reaction (ISR) HS-110 + Nivolumab at >2L ISR Median PFS, 95% Cl (mos) 37 (1.9, 5.8) _ 18 (1.0, 3.7) .40 (95%CI: 0.20— 0.78) p= 0.0068 Progression Free Survival (%) 0s Re Cn renner ree 254 a ISR = Yes L — ISR=No ie} T T T T 0 3 6 9 12 Months Number 39 22
Slide 14: Cohort B: OS by Injection Site Reaction (ISR)
Heat Biologics Cohort B: Os by Injection Site Reaction (ISR) HS-110 + Nivolumab at >2L ISR Median OS, 95% Cl (mos) Yes 12.0 (9.4, Not Reached) pn 100+ No 5.0 (3.0, Not Reached) & HR: 0.16 (95%Cl: 0.05 — 0.45) ws 754 p= 0.0005 2 = an lO Cee Sete eee eee eee eee eee ere erres @ —- ISR=Yes 2 254 — ISR=
Slide 15: Cohort B: % Change in Tumor Burden from Baseline
Cohort B: CPI progressors treated by HS-110 + Nivolumab at >2L 100 % Change in Tumor Burden* from Baseline Best Target Lesion by ISR lm ISR = Yes *RECIST 1.1 July 2019 data cut 15
Slide 16: Cohort B: PFS by Baseline PD-L1 Status
$$ Heat Biologics Cohort B: CPI progressors treated by HS-110 + Nivolumab at >2L PFS by Baseline PD-L1 Status iS PD-L1 Median PFS, 95% Cl (mos) = 100+ Positive 2.5 (1.7, 4.0) = Negative 3.6 (1.9, 12.0) fa 5 754 179) co) 2 uw 504 c 2 B 254 a i —— Negative PD-L1 £ 9 —— Positive PD-L1 oa T T T T 0 3 6
Slide 17: Cohort B: OS by Baseline PD-L1 Status
seer er ocr _ anal re v OSby Baseline PD-L1 Status HS-110 + Nivolumab at >2L PD-L1 Median OS, 95% Cl (mos) 100- Positive 9.5 (6.2, Not Reached) = Negative 12.0 (6.4, Not Reached) s w 754 — 5 QO 504 S co) > 254 —— Negative PD-L1 i) —— Positive PD-L1 0 T T T T 0 3 6 9 12 Months Number 22 22 11 7 3 atr
Slide 18: Cohort B: Best Target Lesion by Baseline PD-L1 Status
Or osusiy capes Cohort B: CPI progressors treated by HS-110 + Nivolumab at >2L Best Target Lesion by Baseline PD-L1 Status 100 ME Negative PD-L1 ME Positive PD-L1 75 lll PD-L1 Not Evaluable 50 25 % Change in Tumor Burden* from Baseline ° Negative PD-L1 is defined as <1% *RECIST 1.1 July 2019 data cu
Slide 19: Cohort B: Duration of Clinical Benefit
ee Cohort B: . a Cymer Cee Duration of Clinical Benefit HS-110 + Nivolumab at >2L 56) ‘Swimmer plot showing time until disease progression and current survival status, with a median follow up time of 11.8 months | * 39 patients (70%) are still alive * 17 patients (30%) have not progressed * Median P
Slide 20: Cohort B: Comparison with Current Literature
Heat Biologics ,Cohor tB: sy Comparison with Current Literature HS-110 + Nivolumab at >2L A comparison with published literature in NSCLC patients after PD-(L)1 progression 4 Treatment Options HS-110 + Nivolumab at > 3rd line after CPI failure iter Gel fallUre ail cane mane ipo aericnne eae N 56 27
Slide 21: Cohort B: Key Data Summary
Heat Biologics Cohort B: CPI progressors treated by Key D ata S U m ma ry HS-110 + Nivolumab at >2L * Response rate by RECIST 1.1 - Objective response rate (ORR) was 13% - Disease control rate (DCR) was 59% * Median overall survival (OS) was estimated at 11.8 months with 70% of patients still alive
Slide 22: Favorable Safety Profile to Date
a Favorable Safety Profile to Date * Over 1,000 doses administered to 150+ patients Immune Reaction* < Grade 3 toxicity * Only one patient ended treatment due to an HS-110 related non-serious adverse reaction * - No treatment-related serious adverse reactions Injection Reactions Week 1 Week 2 * No i
Slide 23: Appendix
Heat Biologics NASDAQ; HTBX a P<. APPENDIX
Slide 24: Cohort B: PFS by Baseline CD8+ TIL
Cohort B: PFS by Baseline CD8+ TIL HS-110 + Nivolumab at >2L z= 400 CD8+ TIL Median PFS, 95% Cl (mos) = Low 33 (17, 5.8) Pas High 2.3 (1.7, 4.0) a 4 a 75 oO 2 mw 504: = 2 Q 254 o ——————— — LowTIL 8 [gpg High TIL oO 0 T T T T 0 3 6 9 12 Months Number 14 9 3 2 1 atrisk 18 9 4 3 2 Low TIL is defined as
Slide 25: Cohort B: OS by Baseline CD8+ TIL
Cohort B: CPI progressors treated by HS-110 + Nivolumab at >2L OS by Baseline CD8+ TIL CD8+ TIL Median OS, 95% Cl (mos) 100-4 Low NR (6.2, Not Reached) rOC High 12.0 (6.6, Not Reached) iS we 754 2 2 B 504- g oO — LowTIL Li > 254 ow [e) —— High TIL 0 T T T T 0 3 6 9 12 Months Number 14 14 "1 a 3 atri
Slide 26: Cohort B: Best Target Lesion by Baseline CD8+ TIL Status
Cohort B: CPI progressors treated by HS-110 + Nivolumab at >2L Best Target Lesion by Baseline CD8+ TIL Status MM High TIL 100 @ lowTit 75 i TIL Unevaluable 50 25 % Change in Tumor Burden* from Baseline Oo Low TIL is defined as CD8+ tumor infiltrating lymphocytes (TIL) < 10% *RECIST 1.1 July 2019 dat
Slide 27: Cohort B: Safety Summary
Heat Biologics Cohort B: CPI progressors treated by S afety S U mm a ry HS-110 + Nivolumab at >2L Most commonly reported treatment-emergent events (regardless of attribution) occurring in the safety population Adverse Events (AEs) _ITT (N=56) Any Adverse Event 54 (96%) Any event 2 Grade 3 13 (23%) F
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