Scorpius Holdings Inc. · OTC:SCPX
Scorpius — Heat Biologics — Investor Presentation (May 2019)
28 slides from Scorpius's investor presentation, May 7, 2019
Slide 1: Heat Biologics Corporate Presentation May 2019
Heat Biologics NASDAQ: HTBX CORPORATE PRESENTATION May 2019
Slide 2: Forward Looking Statements
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 the use of fo
Slide 3: Snapshot of Heat Biologics
Snapshot of Heat Biologics (Nasdaq: HTBX) HS - 110, an “off the shelf” cell - based immunotherapy product that has the potential to improve PD(L) - 1 based therapy ◦ Planning for registrational trial ◦ Ongoing Phase 2 program demonstrates signals of efficacy in two treatment settings ◦ Broad market
Slide 4: Product Pipeline
Product Pipeline Product MOA (Modality) Indication Preclinical Phase 1 Phase 2 Phase 3 HS - 110 gp96 (Cell Therapy) NSCLC HS - 130 gp96 + OX40L (Cell Therapy) Multiple Solid Tumor PTX - 35 TNFRSF25 (mAb) Multiple Solid Tumor 4
Slide 5: Overview
HS - 110 Overview • HS - 110 is a Phase 2 cell - based immunotherapy administered in combination with PD - (L)1 therapies to improve clinical outcomes for NSCLC patients ◦ Allogeneic cells with engineered gp96 to present 70+ different cancer testis antigens ◦ Selectively activate CD8+ “killer” T cel
Slide 6: Top Cancers Worldwide by Incidence
Top 7 Cancers W orldwide by Incidence 6 Data Source: Globocan 2018. Graph production by E stimated Number of New Cases in 2018 Worldwide Cancer Cases Number Percentage Lung 2 093 876 11.6% Breast 2 088 849 11.6% Colorectum 1 849 518 10.2% Prostate 1 276 106 7.1% Stomach 1 033 701 5.7% Liver 841 080
Slide 7: PD(L)-1 Therapy is Approved for Multiple Cancers
PD(L) - 1 Therapy is Approved for Multiple Cancers 7 Data Source: Globocan 2018. Graph production by Cancer Cases Number Percentage Lung 2 093 876 11.6% Breast 2 088 849 11.6% Colorectum 1 849 518 10.2% Prostate 1 276 106 7.1% Stomach 1 033 701 5.7% Liver 841 080 4.7% Esophagus 572 034 3.2% Other ca
Slide 8: Combination of Therapy and PD(L)-1
Combination of HS - 110 and PD(L) - 1 therapy • HS - 110 is designed to overcome mechanisms of immune evasion, thereby having the potential to enable effective treatment with PD(L) - 1 ◦ Target to be effective in patients that generally do not benefit from PD(L) - 1 therapy Cold Tumor HS - 110 + PD(
Slide 9: Clinical Support for Combination with Nivolumab MOA
Clinical Support for HS - 110 + Nivolumab MOA CD8+ TIL Infiltration Associated with Clinical Response Combination treatment drives “killer” CD8+ T - cells deep into tumors Baseline (Cold) Week 10 (Hot) Patient 1 Partial Response at Week 18 High CD8+ TIL ( > 10%) Patient 2 Partial Response at Week 9
Slide 10: Clinical Data: Phase 1b/2 Study in NSCLC
HS - 110 Clinical Data A Phase 1b/2 Study of HS - 110 in Combination with Multiple Treatment Regimens in Patients with NSCLC Exploratory Endpoints • Baseline CD8+ TILs (Low defined as ≤ 10% stromal CD8+ TILs) • PD - L1 expression (Negative defined as < 1% on tumor cells) • Peripheral blood tumor mut
Slide 11: Cohort A: PD-(L)1 naïve patients
Cohort A: PD - (L)1 naïve patients CPI naïve pts treated by HS - 110 + Nivolumab at > 2L HS - 110 + Nivolumab ITT (N = 42) Per Protocol (N = 36) ORR 21.4% 22.2% DCR 50% 53% PFS 2.6 months 4.6 months Median OS Not Reached 60% of pts still alive with median follow - up time of 14.4 months Not Reached
Slide 12: Improved Survival in Cold Tumor Patients
0 6 12 18 24 30 36 42 0 25 50 75 100 Months S u r v i v a l ( % ) CD8+ TIL (10%), n = 12 CD8+ TIL (>10%), n = 8 CD8+ TIL NE, n = 22 0 6 12 18 24 30 36 42 25 50 75 Overall Survival (%) 100 Months Low CD8+ TIL ( < 10%), N = 12 High CD8+ TIL (>10%), N = 8 Baseline CD8+ TIL NE ‡, N = 22 *Gibney et al.
Slide 13: Cohort B: PD(L)-1 progressors
Cohort B: PD(L) - 1 progressors Advanced NSCLC CPI Progressors Treated by HS - 110 + Nivolumab at > 2L 13 HS - 110 + Nivolumab ITT (N = 20) ORR 15.0%* * Investigator - assessed ORR = 20% DCR 55% PFS 2.7 months Median OS Not Reached Median follow - up time = 43 days From Heat Phase 2 Trial Interim Re
Slide 14: Addition May Restore Responsiveness in PD(L)-1 Progressors
14 Addition of HS - 110 May Restore Responsiveness in PD(L) - 1 Progressors -100 -75 -50 -25 0 25 50 75 100 C h a n g e f r o m B a s e l i n e ( % ) 4 2 6 2 3 1 1 4 2 2 1 2 4 2 4 4 2 1 Best Target Lesion Response # of Prior Lines of Therapy Labeled on Each Bar 25 50 100 75 0 - 25 - 50 - 75 Change f
Slide 15: Safety Profile to Date
Safety Profile to Date 1,000+ Doses - No Serious Adverse Reactions Favorable Safety Profile To Date ▪ Over 1,000 doses administered to 120+ patients ▪ No increase in immune - related adverse events ( irAE ) ▪ No systemic use of steroids required to treat reactions ▪ No suspected unexpected serious a
Slide 16: Product Pipeline
Product Pipeline Product MOA (Modality) Indication Preclinical Phase 1 Phase 2 Phase 3 HS - 110 gp96 (Cell Therapy) NSCLC HS - 130 gp96 + OX40L (Cell Therapy) Multiple Solid Tumor PTX - 35 TNFRSF25 (mAb) Multiple Solid Tumor 16
Slide 17: HS-130 Overview
HS - 130 Overview HS - 130 is a “off - the - shelf” cell - based immunotherapy product ◦ Leverage HS - 110 clinical experience and manufacturing know - how ◦ Addition of OX40L to extend and expand T cell memory ◦ IND filing expected in 2019 Mechanism of Action offers broad market potential Heat Biol
Slide 18: Product Pipeline
Product Pipeline Product MOA (Modality) Indication Preclinical Phase 1 Phase 2 Phase 3 HS - 110 gp96 (Cell Therapy) NSCLC HS - 130 gp96 + OX40L (Cell Therapy) Multiple Solid Tumor PTX - 35 TNFRSF25 (mAb) Multiple Solid Tumor 18
Slide 19: PTX-35 Overview
PTX - 35 Overview Potential first - in - class T cell co - stimulator targeting TNFRSF25, with preferential specificity to generate “memory” CD8+ T cells ◦ IND filing expected in 2019 Broad market potential ◦ Efficacy demonstrated in multiple preclinical in vivo colon, lung and breast cancer models
Slide 20: 2019 Corporate Milestones
2019 Corporate Milestones Q1 Q2 Q3 Q4 Phase 2 interim data readout Complete Phase 2 enrollment Phase 2 interim data readout HS - 110 File IND Initial data readout PTX - 35 File IND Initial data readout HS - 130 20
Slide 21: Heat Biologics' Value Proposition
Heat Biologics’ Value Proposition 21 Unique platform based on harnessing natural innate immunity with transformative capacity of “Turning Cold Tumors Hot” and restoring responsiveness to patients failing CPI therapy HS - 110, an “off the shelf” cell - based immunotherapy product that has the potenti
Slide 22: Appendix
Heat Biologics NASDAQ: HTBX APPENDIX
Slide 23: Top Cancers in China by Incidence
Top 10 Cancers in China by Incidence Lung cancer 733.3 Gastric cancer 679.1 Esophageal cancer 477.9 Liver cancer 466.1 Colorectal cancer 376.3 Pancreas cancer 90.1 Lymphoma 88.2 Bladder cancer 80.5 Leukemia 75.3 Prostate cancer 60.3 Others 1164.5 Lung cancer Gastric cancer Esophageal cancer Liver ca
Slide 24: PD(L)-1 Therapy is Approved for Multiple Cancers
PD(L) - 1 Therapy is Approved for Multiple Cancers Lung cancer 733.3 Gastric cancer 679.1 Esophageal cancer 477.9 Liver cancer 466.1 Colorectal cancer 376.3 Pancreas cancer 90.1 Lymphoma 88.2 Bladder cancer 80.5 Leukemia 75.3 Prostate cancer 60.3 Others 1164.5 Lung cancer Gastric cancer Esophageal c
Slide 25: TNFRSF25 as a Novel I/O Combination Target
TNFRSF25 as a Novel I/O Combination Target • TNFRSF25 is one of the most recently discovered T cell costimulator , and is a rapidly emerging target • Pelican is the only company developing TNFRSF25 agonist antibodies for I/O Mahoney K. et al . Nat Rev Drug Discov . 2015 “Although TNFRSF25 is chromos
Slide 26: TNFRSF25: Why So Complicated?
TNFRSF25: Why So Complicated? TNFRSF25’s evolutionary origin Potentially a mechanism that preserves needed tissue and friendly bacteria during an immune response Example: gut invasion occurs in the context of friendly microbiome bacteria. How does the body protect what is needed while weeding out in
Slide 27: TNFRSF25 Causes No Intra-tumoral T-reg Proliferation in a Lung-tumor Model
TNFRSF25 Causes No Intra - tumoral T - reg Proliferation in a Lung - tumor Model George Fromm et al 2014 Heat Biologics Internal Data 27
Slide 28: Development of Agonist Antibody: PTX-35
Development of Agonist Antibody: PTX - 35 • The lead mAb , PTX - 35, was affinity - matured and selected based on functional activation of TNFRSF25 across species • The functional cross - reactivity of PTX - 35 was further validated by demonstrating that PTX - 35 binds a unique epitope conserved in