Scorpius Holdings Inc. · OTC:SCPX
Scorpius — Heat Biologics — Investor Presentation (November 2015)
27 slides from Scorpius's investor presentation, Nov 9, 2015
Slide 1: Heat Biologics – November 6, 2015
NASDAQ:HTBX November 6, 2015
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation includes statements that are, or may be deemed, ‘‘forward-looking statements.’’ In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expec
Slide 3: Investment Opportunity
Investment Opportunity 3 Developing first new immunotherapy in non-muscle invasive bladder cancer (NMIBC) Platform technologies designed to activate CD8+ T cells against multiple tumor antigens Immuno-oncology company developing novel therapies to activate a patient’s immune system against cancer Co
Slide 4: Vision and Strategy
Vision and Strategy Addressing Three Distinct But Synergistic Mechanisms of Action to Optimize Cancer Immunotherapy 4 Activation of CD8+ “killer” T cells Co-stimulation to enhance immune response Overcome tumor defenses through combination therapies T Cell Costimulation Checkpoint Inhibition T Cell
Slide 5: ImPACT mechanism of action
ImPACT 5 Intradermal InjectedImPACT Cells ImPACT cells secrete Gp96-Ig chaperone + tumor antigens (TAA) ImPACT Cells Gp96-Ig+TAA Selectively activate CD8+ T Cells CD8+ T-Cells Dendritic Cells CD8+ T cells circulate & eliminate tumor cells Tumor Cells CD8+ CD8+ CD8+ CD8+ 2 Dual antigen carrier & adju
Slide 6: Drug Development and Manufacturing Highlights
Drug Development and Manufacturing 6 Highlights Ready-to-use / Off-the-shelf productNo tumors extractedScalable manufacturingLower cost of production than autologous cell therapiesEstablished regulatory path Choose cancer of interest Proprietaryscreening assay to identify representativecancer cell l
Slide 7: ComPACT gp96-Ig OX40L-Fc
ComPACT 7 gp96-Ig OX40L-Fc The first potential dual-acting immunotherapy designed to deliver T cell activation and costimulation in a single product
Slide 8: ComPACT Outperforms OX40 Monoclonal Antibodies in Preclinical Models
ComPACT Outperforms OX40 Monoclonal Antibodies in Preclinical Models 8 ComPACT leads to approx. 50 percent complete tumor rejection as compared to approx. 16 percent with OX40 agonist antibody combinationsHeat expects to announce its selection of the first product candidate based on ComPACT in the f
Slide 9: Pipeline
Pipeline 9 Heat Biologics Corporate Model Deck ImPACT Product Combination Indication Preclinical Mfg Phase 1 Phase 2 Phase 3 HS-410(vesigenurtacel-L) monotherapy; BCG NMIBC HS-110(viagenpumatucel-L) Nivolumab and other checkpoint inhibitors NSCLC HS-110 (viagenpumatucel-L) cyclophosphamide NSCLC Com
Slide 10: Pipeline
Pipeline 10 Heat Biologics Corporate Model Deck ImPACT Product Combination Indication Preclinical Mfg Phase 1 Phase 2 Phase 3 HS-410(vesigenurtacel-L) monotherapy; BCG NMIBC HS-110(viagenpumatucel-L) Nivolumab and other checkpoint inhibitors NSCLC HS-110 (viagenpumatucel-L) cyclophosphamide NSCLC Co
Slide 11: Bladder Cancer – NMIBC Opportunity
Bladder Cancer – NMIBC Opportunity 1. American Cancer Society 2012 Statistics; 2. BCG is Bacillus Calmette-Guérin; 3. NCI-PDQ, NCI costs of cancer care Over 500,000 bladder cancer patients in U.S.173,000+ new cases and 15,000 deaths per year in U.S.1No new NMIBC treatments in 25 yearsCurrent standar
Slide 12: HS-410 Phase 1 NMIBC Trial Overview
HS-410 Phase 1 NMIBC Trial Overview Design Open-label, multicenter safety trial; 10 patients enrolledPatients received BCG for 3-6 weeks followed by weekly intradermal injections of HS-410 for 12 weeks and subsequent monthly HS-410 injections for 3 months Results HS-410 had a positive safety profile
Slide 13: Clinical and Immune Response
Clinical and Immune Response Disease Characteristics and Recurrence Status 13 Patient T-Class CIS Grade Disease Status Induction BCG Vaccine Doses Maintenance BCG 3-month Cysto 6-month Cysto Recurrence Status 12-001 T1 No High Newly Diagnosed 5 15 4 No 23-001 T1 Yes High Newly Diagnosed 6 15 3 No 23
Slide 14: Significant Correlation Between TIL Clonality and Clinical Outcome
Significant CorrelationBetween TIL Clonality and Clinical Outcome 14 HS-410 significantly increased TIL clonality in patients who exhibited a positive clinical outcome (disease-free); P-value 0.0126 Data are consistent with HS-410 mechanism of action = Disease-free = Recurrent Disease Source: Heat’s
Slide 15: Post-treatment Induction of CD8+ TIL
Post-treatment Induction of CD8+ TIL 15 Before treatment there are few CD8+ (red) TIL in the disease-free patient (25-007, upper left), whereas TIL are abundant in the recurring patient (25-004, lower left)Following treatment with HS-410, there is robust induction of TIL in the disease-free patient,
Slide 16: HS-410 Phase 2 NMIBC Trial Overview
HS-410 Phase 2 NMIBC Trial Overview 16 Topline data expected 4Q:16 Objective Evaluate safety and tolerability of HS-410 either alone or in combination with BCG Patient Population 100 patients with NMIBC (Ta, T1, CIS) after TURBT Enrollment 16 U.S. sitesCompleted enrollment of 75 randomized patients;
Slide 17: Pipeline
Pipeline 17 Heat Biologics Corporate Model Deck ImPACT Product Combination Indication Preclinical Mfg Phase 1 Phase 2 Phase 3 HS-410(vesigenurtacel-L) monotherapy; BCG NMIBC HS-110(viagenpumatucel-L) Nivolumab and other checkpoint inhibitors NSCLC HS-110 (viagenpumatucel-L) cyclophosphamide NSCLC Co
Slide 18: NSCLC Opportunity
NSCLC Opportunity 18 1. National Cancer Institute 2013 statistics; Graphic source: Teng et al., 2015 Can Res; Gettinger et al., 2015 JCO CD8+ (TIL+) patients may respond to anti-PD-(L)1 CD8- (TIL-) patients may not respond to anti-PD-(L)1 Approx. 50% PD-1 ORR Approx. 10% PD-1 ORR Estimated 45% NSCLC
Slide 19: Scientific Support for HS-110 + Nivolumab Combination
Scientific Support forHS-110 + Nivolumab Combination 19 Cohen, R.B. et al, ASCO 2015 2 Schreiber T.H., et al. Keystone 2014 1 Preclinical studies demonstrate synergy between ImPACT vaccines + anti-PD-1Clinical data demonstrate that HS-110 treated patients upregulate PD-1 on CD8+ T cellsTumor biopsie
Slide 20: HS-110 Phase 1b NSCLC DURGA Trial Overview
HS-110 Phase 1b NSCLC “DURGA” Trial Overview HS-110 weekly intradermally for 18 weeks; nivolumab i.v. every other week until progression One Year Topline Data Expected 4Q:16 Objective Evaluate safety and tolerability of HS-110 + a PD-1 checkpoint inhibitor Patient Population Potential to expand coho
Slide 21: Development Milestones
Development Milestones 21 Phase 2 NMIBC trial enrollment for randomized arms DURGA top-line readout for nivolumab arm (18 pts)Phase 2 combo with cyclophosphamide readout (~65 pts)Registration-directed trial initiation Phase 1 NMIBC readout (10 patients) Phase 2 NMIBC readoutRegistration-directed tri
Slide 22: Summary: Value Proposition
Summary: Value Proposition 22 Commercially Viable Combinable with Checkpoints + Others Pan-antigen cell-basedSpecific tumor killingT cell activatingApplicable to all cancers Positive safety profile to dateEstablished regulatory path Ready-to-useScalable, low cost manufacturingNo tumors extracted Dif
Slide 23: Corporate Overview
Corporate Overview 23 1. As reported for the nine months ended September 30, 2015 Nasdaq HTBX Shares Outstanding 8.41M Market Cap $37.9M Cash & Equiv. $15.0 M1 Consensus Price Target $15.5
Slide 24: Appendix
eat Biologics APPENDIX
Slide 25: HS-410 Injection Site Reactions Kinetics
Third Injection Site First Injection Site Second Injection Site HS-410 Injection Site Reactions Kinetics Follow Delayed-type Hypersensitivity Reaction; Consistent with Mechanism of Action 25 No visible reaction Week 1 Week 2 Week 3 No visible reaction 1 2 3 Week 1 Week 2 Week 3 Week 1 Week 2
Slide 26: High Degree of Overlap with Patient Tumor Antigens
High Degree of Overlapwith Patient Tumor Antigens 26 Recurrent DiseaseDisease-free (-) <5 Reads(+) >5 Normalized Reads(++) >25 Normalized Reads(+++) >100 Normalized Reads C Antigen HS-410 23-002 25-001 25-004 25-005 25-003 25-007 25-008 ACTL8 +++ – – – – – – – ADAM22 +++ +++ +++ ++ +++ +++ +++ +++ A
Slide 27: Thank You
eat Biologics THANK YOU
Heat Biologics — Investor Presentation (November 2015) on 6ix