january 2017 corporate presentation

28
Investor Presentation January 2017 www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF

Upload: oncolyticsinc

Post on 22-Jan-2017

300 views

Category:

Investor Relations


4 download

TRANSCRIPT

Investor Presentation

January 2017

www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF

Forward Looking Statements

This presentation contains certain forward looking statements relating to the company’s

business prospects and the development and commercialization of REOLYSIN®, a therapeutic

reovirus. These statements are based on management’s current expectations and beliefs and

are subject to a number of factors which involve known and unknown risks, delays,

uncertainties and other factors not under the company’s control which may cause actual

results, performance or achievements of the company to be materially different from the

results, performance or other expectations implied by these forward looking statements.

In any forward looking statement in which Oncolytics Biotech® Inc. expresses an expectation or

belief as to future results, such expectations or beliefs are expressed in good faith and are

believed to have a reasonable basis, but there can be no assurance that the statement or

expectation or belief will be achieved. These factors include results of current or pending clinical

trials, risks associated with intellectual property protection, financial projections, actions by the

FDA/HPB/MHRA and those other factors detailed in the company’s filings with SEDAR and the

Securities and Exchange Commission. Oncolytics does not undertake an obligation to update

the forward looking statements, except as required by applicable laws.

2

Investment Highlights

3

� Novel immuno-oncology (I/O) therapy exploiting both adaptive and

innate immunity

� Emerging evidence that REOLYSIN® has meaningful impact on overall

survival (OS)

� Six randomized Ph 2 studies with potential to generate OS data in 2017 � Ovarian, Breast, Prostate, Pancreatic, NSCLC & Colorectal

� Supports potential additional registration pathways

� Near-term focus on chemo-combos for late-stage clinical development

� Potential to establish REOLYSIN® as a backbone I/O agent in

combination with checkpoint inhibitors and IMiD’s

� Extensive patient safety data showing little to no additional toxicity

when used as combination therapy

� Manufacturing at scale with sufficient supplies on hand to support late

stage development and early commercialization

Oncolytics Overview

Defined clinical program and potential registration pathway

Final formulation produced

• 100L scale under cGMP

900+ patients treated systemically

• Strong safety profile

New class of immuno-oncology viral agent

4

What is REOLYSIN®

� First in class systemically administered immuno-oncology viral agent for solid tumors and heme malignancies

� Proprietary isolate of the unmodified reovirus

� Non-pathogenic

5

The Future of REOLYSIN® as an Immuno-

Oncology Viral AgentR

EO

LYSI

C

linic

al D

eve

lop

me

nt

Pla

n

Chemo Combos

Immuno Therapy Combos

Targeted / IMiDCombos

Continuing positive benefit-risk profile

6

Conceptual data

What’s New and Lessons Learned

• Strong OS data trumps Progression Free Survival (PFS)

• Emerging OS results support mechanism of action (MOA)o Pancreatic, Lung & Colorectal

1 Hodi, NEJM 2010, 363:711; 2 Borghaei, NEJM 2015,371:1627; 3 Ferris, NEJM 2016, 375:1856

Emerging paradigm from immune checkpoint inhibition studies1. Chemo impacts the overall response rate (ORR) and PFS because of its rapid

antitumor response, yet OS is not always improved

2. Immunotherapies (e.g., immune checkpoint inhibitors (ICI)), by contrast, may not

improve ORR or PFS but survival rates are consistently better than with

chemotherapy in certain cancers 1-3

Melanoma

treated with ICI

vs. chemo

Ipilimumab

SOC

Hodi et.al., NEJM 2010

Ipilimumab

SOC

Overall SurvivalProgression Free Survival

7

REOLYSIN® &

Mechanism of Action

www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF

REOLYSIN® Mechanism of Action

1. Replication and lysis in permissive cancer cells 1-15, 24

Alerts the immune system resulting in immunological recognition

of cancer cells.

2. Innate immunity 2,16-21, 27

Viral replication resulting in a cascade of chemokines/cytokines causing

NK (natural killer) cells to recognize and attack cancer cells.

3. Adaptive immunity 17-27

Viral replication and resulting cell lysis releasing TAA (tumor associated

antigens – “biological shrapnel”). The fragments of the tumor cell and virus

are epitopes or antigenic determinants that educate T-cells to recognize and

destroy cancer cells.

1 Adair, Sci Transl Med 2012,4:138; 2 Adair, Int J Cancer, 2013, 132:2327; 3 Chakrabarty, Invest New Drugs 2015, 33:761; 4 Gong, Frontiers in Oncology 2014; 4:1; 5 Garant, Oncogene 2016, 35:771; 6

Pan, PLosOne 2013, 8:e54006; 7 Kelly, Oncogene. 2012, 31:3023; 8 Mahalingam BMC Cancer 2015, 15:513; 9 Nuovo Mod Pathol 2012, 25:1333; 10 Roulstone, Clin Cancer Res 2015, 21:1305; 11

Roulstone, Gene Ther 2013, 20:521; 12 Sei, Mol Cancer 2009, 8:47; 13 Strong, EMBO J 1998, 17:3351; 14 Villalona Calero, Cancer 2016, 122:875; 15 Wadler, Eur J Cancer Suppl, 2004, 2:135; 16 El-

Sherbiny, Clin Exp Immunol 2014, 180:98; 17 Gujar., Mol Cancer Ther 2010 9:2924; 18 Gujar, Mol Ther 2011, 19:797; 19 Rajani, Mol Ther 2016, 24:166;20 Steele, Mol Cancer 2011, 10:20; 21 White,

Gene Ther 2008, 15:911; 22 Gujar Br J Cancer 2014, 110:83; 23 Gujar, Mol Ther 2013, 21:338; 24 Gujar, Frontiers in Oncology 2014, 4:1; 25 Shashi, Front Oncol. 2014; 4: 77;. 26 Kim, Viruses 2015, 7,

6506; 27 Noonan, Mol Ther 2016, 24:1150

9

REOLYSIN® Mechanism of Action

10

REOLYSIN® Combination Therapy

Enhances the Mechanism of Action

T-cells are recruited to cancer cells due to thepresence of viral and tumor antigens ( ).However, T-cells can be prevented fromattacking cancer cells due to the presence ofimmune checkpoint ligands ( ).

Enhancement of Cell Lysis: REOLYSIN® + Chemotherapy

REOLYSIN®

alone

REOLYSIN® + Chemotherapy

More cancer cells aresusceptible to REOLYSIN®

when cancer cells are stressedwith chemo and/or radiationtherapy

Enhancement of Innate Immune Response: REOLYSIN® + IMiDs

Enhancement of Adaptive Immune Response: REOLYSIN®

+ immune checkpoint inhibition

REOLYSIN® alone

REOLYSIN® + IMiDs

Inhibiting the function of immune checkpointligands enhances REOLYSIN® induced T-celltargeting. REOLYSIN® also induces PD-1 andPD-L1 expression on T- and tumor-cells,respectively

REOLYSIN® alone

REOLYSIN® + αPD-L1

Activated T-cell

Release of inflammatory cytokines

Increased activation of NK cells

Release of inflammatory

cytokines

Activation of NK cells

Activated T-cell

+ IMiDs

11

Clinical

Development Plan

www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF

Clinical Development Plan: Key Points

1. Critical analysis of maturing data from relevant studies to

streamline our clinical development plan

2. Focus on the registration pathway with REO-chemo

(based on data emerging from NCI and NCIC randomized Phase

2 studies)

3. Establish REOLYSIN® as a backbone I/O agent for combo with

checkpoint inhibitors & IMiD’s / targeted therapy

13

Clinical Development Plan: Pathways

The clinical development plan addresses drug combinations that

can potentially boost each response of the MOA

1. Chemo combos (direct cell lysis):

The basis of the first registration pathway

2. Immuno therapy combos (adaptive immune response):

Approaches with checkpoint inhibitors embodied in the ongoing

REOLYSIN® + pembrolizumab study and possible future collaborations

3. Combo with IMiDs / targeted therapy (innate immune response):

The proposed approach to be used in collaboration with Myeloma UK where

we expect enhancement of innate immunity

14

Path 1: Chemotherapy Combo’s

Metastatic Pancreatic Cancer (1st Line)o Regulatory Status

o Orphan Drug Designation Granted (FDA / EMA)

o Seeking scientific advice - potential for

Fast-Track Designation

o Preparing for End of Phase 2 Meeting

15

Path 1: Chemotherapy Combo’s

16

Metastatic Pancreatic Cancer (1st Line)o Excellent safety and encouraging benefit in 2y-survival in single arm Ph 2 studies:

Randomized Intent To Treat (NCI-8601)

o Carbotax + REO (n=36)

o Carbotax (n=37)

Randomized Excluding Crossover

o Carbotax + REO (n=36)

o Carbotax (n=20)

Single Arm (REO 017)

o REO + Gemcitabine

(n=34)

Reo + gem

2y-OS = 24 %

Path 1: Chemotherapy Combo’s

Metastatic Pancreatic Cancer (1st Line)o REO 017 vs historical controls:

17

Median OS

(months)

1-year survival 1.5-year survival 2-year survival

Burris et al., 1997

Gemcitabine (n=63) 5.65 18% NR NR

5-Fluorauracil (n=63) 4.41 2% NR NR

Conroy et al., 2011

Gemcitabine (n=171) 6.8 (5.5-7.6) NR 6% NR

Folfirinox (n=171) 11.1 (9.0-13.1) NR 19% NR

Von Hoff et al., 2013

Gemcitabine (n=430) 6.7 (6.0-7.2) 22% NR 4% (2%-7%)

Gem + nab paclitaxel (n=431) 8.5 (7.9-9.5) 35% NR 9% (6%-13%)

REO 017

REOLYSIN® + Gemcitabine (n=34) 10.2 46% NR 24%

Path 1: Chemotherapy Combo’s

Pending survival data expected to read out in 2017

Study Phase Tumor Type Enrollment Timeline

NCI-GOG 0186H(REO + paclitaxel)

2Ovarian Epithelial, Fallopian Tube,

Primary Peritoneal Cancern=100 1H 2017

NCI-8601

(REO + paclitaxel +

carboplatin)

2 Metastatic Pancreatic Cancer n=73 1H 2017

NCIC-CTG IND.213

(REO + paclitaxel)2

Advanced or Metastatic Breast Cancer

n=74 1H 2017

NCIC-CTG IND.209

(REO + docetaxel)2

Recurrent or Metastatic Castration Resistant Prostate Cancer

n=85 2H 2017

NCIC-CTG IND.210

(REO + FOLFOX6 + Avastin)2 Recurrent Colorectal Cancer n=109 2H 2017

NCIC-CTG IND.211

(REO + docetaxel or

pemetrexed)

2Previously Treated Advanced or

Metastatic NSCLCn=90 2H 2017

18

Path 2: Immunotherapy Combo’s

REO + Pembrolizumab

(anti-PD-1 antibody) in pancreatic cancero Establish safety profile

o Final analysis in 2017

Future potential collaborations pending

Rajani, Viruses 2015, 7:588; Noonan, Mol Ther 2016;

Rajani, Mol Ther 2016,24:166

19

Path 3: Targeted/IMiD Combo’s

REO + Pomalidomide in multiple myelomao Establish safety profile

o Ongoing collaboration with Myeloma UK

Enhancement of Innate Immune Response: REOLYSIN® + IMiDs

REOLYSIN® alone

REOLYSIN® + IMiDs

Release of inflammatory cytokines

Increased activation of NK cells

Release of inflammatory cytokines

Activation of NK cells

+ IMiDs

20

Safety & Milestones

www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF

REOLYSIN® and Safety

� 1,100+ patients treated, 900+ intravenously

� No maximum tolerated dose (MTD) reached to date

Monotherapy Toxicity Symptoms

Symptoms frequently observed from day 2 of treatment

and usually lasted < 6 hours

Intravenous local

� Toxicities have generally been mild (grade 1 or 2) and included chills, fever,

headache, cough, myalgia, runny nose, sore throat, fatigue, and grade 1 or 2

lymphopenia or neutropenia

� Transient grade 3 and 4 toxicities included lymphopenia or neutropenia

22

Manufacturing

� Final formulation produced at

100L scale under cGMP

� Commercial scale

manufacturing agreement

with SAFC

23

Corporate & Financial

www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF

Patent Portfolio

� More than 440 patents issued

worldwide, including 61 US and

20 Canadian

� Reovirus issue patent claims cover:

• Compositions of matter comprising reovirus

• Pharmaceutical use of reoviruses to treat

neoplasia and cellular proliferative diseases

• Combination therapy with radiation,

chemotherapy and/or immune suppressants

• Methods for manufacturing reovirus and

screening for susceptibility to reovirus

• Pharmaceutical use of reoviruses in

transplantation procedures

� Over 60 pending

applications worldwide

25

Market and Capital Data

ExchangesOTCQX: ONCYF

TSX: ONC

Shares Outstanding (December 31, 2016)

121,258,222

Options

Restricted/performance share units(December 31, 2016)

7,974,227

1,612,829

Fully Diluted (December 31, 2016)

130,845,278

Cash / Cash Equivalents /

Short Term Investments (November 2, 2016)

$17.7 million

Cash runway Into 2018

26

Investment Highlights

27

� Novel I/O therapy exploiting both adaptive and innate immunity

� Emerging evidence that REOLYSIN® has meaningful impact on OS

� Six randomized Ph 2 studies with potential to generate OS data in 2017 � Ovarian, Breast, Prostate, Pancreatic, NSCLC & Colorectal

� Supports potential additional registration pathways

� Near-term focus on chemo-combos for late-stage clinical development

� Potential to establish REOLYSIN® as a backbone I/O agent in

combination with checkpoint inhibitors and IMiD’s

� Extensive patient safety data showing little to no additional toxicity

when used as combination therapy

� Manufacturing at scale with sufficient supplies on hand to support late

stage development and early commercialization

Investor Presentation

www.oncolyticsbiotech.com TSX ONC OTCQX ONCYF