Scorpius Holdings Inc. · OTC:SCPX
Scorpius — Heat Biologics — Investor Presentation (March 2018)
37 slides from Scorpius's investor presentation, Mar 6, 2018
Slide 1: Heat Biologics Corporate Presentation March 2018
Heat Biologics Corporate PresentationMarch 2018
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 forward-
Slide 3: Investment Opportunity: We turn COLD tumors HOT
Potential Best-in-Class Activation of CD-8+ cancer killing T-cells Diverse Technologies Multiple platform technologies Investment Opportunity Combination Therapies Robust pipeline of Combination Therapies Checkpoint Inhibitors Signals in lung cancer with checkpoint inhibitors Safety Profile Favorabl
Slide 4: Our Mission
To activate CD8+ “Killer” T-cells to turn “COLD” tumors “HOT” 4 Our Mission We seek to combine with checkpoint inhibitors and other immunotherapies to dramatically increase their effectiveness
Slide 5: What are Hot and Cold Tumors?
5 Cold Tumors Tumors that have not been subject to robust CD8+ “Killer” T-cell attackBiopsied tumors contain minimal CD8+ T-cells Hot Tumors Tumors that have been subject to robust CD8+ “Killer” T-cell attack Biopsied tumors are loaded with CD8+ T-cells HOT tumors are associated with clinical respon
Slide 6: Immuno-Oncology Combination Therapy
6 Immuno-Oncology Combination Therapy The three legs of an Immuno-Oncology Stool T-cell Activation Co-stimulation Checkpoint Inhibition Heat’s Core Focus
Slide 7: Unlocking the Body's Natural Defenses with a Broad Range of Combination Therapies
Unlocking the Body’s Natural Defenses with a Broad Range of Combination Therapies 7 Combination Therapies T-cell Activation Co-Stimulation Pelican PTX-35Monoclonal AntibodyPelican PTX-15Fusion Protein Checkpoint Inhibitors PD1/PDL1CTLA-4Lag-3TIM-3Plus others Combined with ImPACT® TherapyCell-based D
Slide 8: ImPACT: Immune Pan-antigen Cytotoxic Therapy
8 ImPACT®: Immune Pan-antigen Cytotoxic Therapy ImPACT Cell Cancer-killing T-cell ImPACT cells secrete antigens designed to specifically activate patient’s killer T-cells T-cells circulate to destroy patient’s tumor Cluster of five 0.1 mL intradermal injections Activated cells EXPRESS chaperoned ant
Slide 9: Product Pipeline
9 Product Pipeline Combination Therapies Designed to Activate CD8+ T-cells to Fight Cancer T-cell infiltration seen deep inside tumorsPositive safety profile, to-date Clinical proof of mechanism activating an immune responseActivated T-cell immune response seen at 10 weeks Combination Therapies Indi
Slide 10: Phase 1b/2 Study of HS-110 (DURGA Trial)
A Phase 1b/2 study of Viagenpumatucel-L (HS-110) in Combination with Multiple Treatment Regimens in Patients with Non-Small Cell Lung Cancer (The “DURGA” Trial) Objective Evaluate objective response rate of HS-110 and anti-PD-1 immune checkpoint inhibitor and other agents Patient Population NSCLCAde
Slide 11: Pre-Specified Patient Populations Analyzed
Pre-Specified Patient Populations Analyzed 11 ITT (n=35)The Intent-to-Treat Population includes all patients enrolled into the study PP (n=26)The Per Protocol Population includes patients who have received at least 6 doses of HS-110 and a pre/post treatment tumor assessment 3 patients died before co
Slide 12: ImPACT (HS-110) Safety Profile to Date
12 ImPACT (HS-110) Safety Profile to Date ~1,000 HS-110 Doses – No Serious Adverse Reactions ~1,000 doses administered to ~100 patientsOnly one patient ended treatment due to a non-serious adverse reaction*No systemic use of steroids required to treat reactionsNo serious adverse reactions beyond tho
Slide 13: TIL Infiltration Associated with Clinical Response
Baseline Week 10 TIL Infiltration Associated with Clinical Response 13 Patient 1:Partial Response at Week 18 High CD8+ TIL (>10%) Patient 2:Partial Response at Week 9 High CD8+ TIL (>10%)* Patient 3:Partial Response at Week 18 Low CD8+ TIL (<10%) High CD8+ TIL (>10%) Clinical evidence that HS-110 is
Slide 14: HS-110 Overall Survival
HS-110 Overall Survival 14 ITT survival curve has not yet reached medianm(OS) of nivolumab alone = 12.2 months mOS nivolumab12.2 months* *N Engl J Med 2015; 373: 1627-1639
Slide 15: Target Lesion Response Based on Initial TIL Status
Target Lesion Response Based on Initial TIL Status 15 Change from Baseline (%) TIL Evaluable ITT Population Change from Baseline (%) High TIL Low TIL HS-110 shows effect in low TIL “cold tumor” patients who typically do not respond well to PD-1 inhibitors4 of 9 achieved a partial clinical response
Slide 16: Durable Target Lesion Responses Based on Initial TIL Status
Durable Target Lesion Responses Based on Initial TIL Status 16 Low TIL High TIL Change from Baseline (%) Tumor Type at Baseline Evaluable ITT Population Days from First Dose Durable responses (> 6 months) observed in difficult-to-treat low TIL “cold” patients
Slide 17: Overall Survival Based on TIL Status
Overall Survival Based on TIL Status 17 HS-110 Treated Patients Days Known to Be Alive Low TIL High TIL Tumor Type at Baseline Ϯ Reported Death TIL Evaluable ITT Population
Slide 18: Target Lesion Response Based on Initial PD-L1 Status
Target Lesion Response Based on Initial PD-L1 Status 18 Change from Baseline (%) PD-L1 Evaluable ITT Population Change from Baseline (%) >1% PD-L1 Tumor Type at Baseline <1% PD-L1 Tumor Type at Baseline High PD-L1 Low PD-L1 HS-110 shows effect in low PD-L1 patients who typically do not respond to ch
Slide 19: Durable Target Lesion Responses Based on Initial PD-L1 Status
Durable Target Lesion Responses Based on Initial PD-L1 Status 19 Change from Baseline (%) PD-L1 Evaluable ITT Population Days from First Dose Change from Baseline (%) Days from First Dose >1% PD-L1 Tumor Type at Baseline <1% PD-L1 Tumor Type at Baseline Durable responses observed in difficult-to-tre
Slide 20: ELISPOT Activity and Survival
ELISPOT Activity and Survival 20 High = ELISPOT activity above the median of patients tested Low = ELISPOT activity below the median of patients tested A trend of survival benefit is observed higher ELISPOT activity of immune response 203 337 ELISPOT Evaluable ITT Population
Slide 21: Summary of Phase 2 Interim Data
Summary of Phase 2 Interim Data Tumor shrinkage and disease control demonstrated in a majority of evaluable patientsOverall responses are durable and long lastingWhile survival data is still maturing, the median overall survival has not yet been reachedHS-110 shows durable responses in difficult-to-
Slide 22: Heat Biologics Acquires Pelican Therapeutics
22 Heat Biologics Acquires Pelican Therapeutics Unlocking the Body’s Natural Defenses with a Broad Range of Combination Therapies Heat acquired 80% controlling interest in PelicanPelican to operate as a subsidiary in TexasPre-clinical synergy with Heat’s ImPACT® and checkpoint therapy$15.2M grant aw
Slide 23: Corporate Highlights
23 Corporate Highlights Closing price as of March 2, 2018Reported as of December 31, 2017 Market Cap$10M1 Cash & Equiv.$9.8M2 NasdaqHTBX Shares Outstanding4.2M2 Shares Price$2.381 Grant Funds$15.2M
Slide 24: Turning COLD Tumors HOT
Cold Tumors Hot Tumors Turning COLD Tumors HOT 24
Slide 25: Appendix
Appendix 25
Slide 26: Introducing gp96: The Immune System's Swiss Army Knife
26 Introducing gp96 The Immune System’s “Swiss Army Knife”* *Schild, H. & Rammensee, H. Gp-96 – The Immune System’s Swiss Army Knife. Nature Immunology 2, 100-101 (2000) “Molecular Warning System” Natural biological process to deliver proteins (antigens) & gp96 adjuvant to our immune systemGp96 “cha
Slide 27: ImPACT Platform: Severing the Leash
Genetically modify tumor cells by “severing the leash” that binds the gp96 to the endoplasmic reticulum of the cell and replacing it with a sequence that pumps gp96 out of the cellEnables living cancer cells to “pump-out” their own surface antigens along with their gp96 chaperoneMimics necrotic cell
Slide 28: ImPACT Manufacturing
28 ImPACT® Manufacturing Robust, Multi-antigen T-cell Activation Compare Using Our Proprietary Technology ID Cell Line with Most Antigen OverlapTransfect with Activation Technology Scale-up for Manufacturing by CMO Collect CancerCell Line & Patient Tissue Samples Sample Screen Select Scale Frozen, f
Slide 29: Substantial Antigenic Overlap with Patient Tumors
29 Substantial Antigenic Overlap with Patient Tumors HS-410 selected due to high expression of >30 shared cancer antigens >15 antigens also found in individual patient tumors Source: Heat’s HS-410 Phase 1 trial results CD8+ T-Cells Dendritic Cells This information used to track T-cells antigen speci
Slide 30: ComPACT Platform Technology
30 ComPACT™ Platform Technology gp96-Ig OX40L-Fc The first potential dual-acting immunotherapy designed to deliver T-cell activation andco-stimulation in a single product – combination therapy without additive costs
Slide 31: ComPACT Outperforms OX40 Monoclonal Antibodies in Pre-clinical Models
31 ComPACT™ Outperforms OX40 Monoclonal Antibodies in Pre-clinical Models ComPACT generates ~50% complete tumor rejection compared to ~16% with OX40 agonist antibody combinations Superior primary and memory T-cell response in mouse model Translates into increased overall survival and tumor reduction
Slide 32: PTX-35 Comparative Pre-clinical Anti-tumor Activity
32 PTX-35 Comparative Pre-clinical Anti-tumor Activity Schreiber T. et al. SITC 2014 Activity of agonists TNFRSF25, 4-1BB, OX40 and GITR during nine-day B16-F10 melanoma model TNFRSF25 agonists leads to increased survival compared to other co-stimulatory antibodies 4-1BB and GITR agonists have a mod
Slide 33: Preferential CD8+ T-cell Induction with TNFRSF25
33 Preferential CD8+ T-cell Induction with TNFRSF25 Pre-clinical studies with murine agonist antibody shows preferential CD8+ T-cell Induction; differentiation from other T-cell co-stimulators The frequency of antigen-specific memory CD4+ or memory CD8+ T-cells following treatment of mice with ImPAC
Slide 34: Many companies are pursuing co-stimulators with less specificity for CD8+
Many companies are pursuing co-stimulators with less specificity for CD8+ “memory” activation 34 Emerging Target in T-cell Co-stimulation Only Pelican is targeting TNFRSF25, an emerging target in immuno-oncology Target Agonist to Target Clinical Stage Company Comments 4-1BB PF-05082566 (utomilumab)B
Slide 35: Expression of T-cell Co-stimulators
35 Expression of T-cell Co-stimulators TNFRSF25 is preferentially expressed on CD8+ T-cells compared to other T-cell co-stimulators Genomics Institute of the Novartis Research Foundation Su et al. PNAS 2004:101(16);6062-7 (red = high expression)
Slide 36: Strong supporting pre-clinical data
Strong supporting pre-clinical data 36 Pre-clinical Data Source: Fromm et al. Society for Immunotherapy of Cancer Annual Meeting, 2016 CD8+ T-cell Activation Higher T-cell responses observed in mice treated with ImPACT aloneImPACT® boosted CD+ T-cells to even higher levels when combined with co-stim
Slide 37: Highlights from Pelican Pre-clinical Studies
37 Highlights from Pelican Pre-clinical Studies mAb to TNFRSF25:Drives the development of antigen-specific CD8+ T-cells (mimics TL1A, the specific ligand of TNFRSF25)Equals co-stimulation and expansion of antigen-experienced memory T-cells: CD4+ and CD8+Significantly enhanced effect on memory CD8+ T