Dawson James Conference

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Transcription:

Dawson James Conference October 2018

Forward-looking Statements Except for historical information, this presentation contains forward-looking statements, which reflect IMV s current expectations regarding future events. These forward-looking statements involve known and unknown risks and uncertainties that could cause IMV s actual results to differ materially from those statements. Those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form. The forward-looking statements in this presentation are also based on a number of assumptions which may prove to be incorrect. Forward-looking statements contained in this presentation represent views only as of the date of this presentation and are presented for the purpose of assisting potential investors in understanding IMV s business, and may not be appropriate for other purposes. IMV does not undertake to update forward-looking statements, whether written or oral, that may be made from time to time by or on its behalf, except as required under applicable securities legislation. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar. 2

IMV Opportunity We have discovered a new mechanism of action& technology to program T cells in vivo Potential to revolutionize IO and expand its applications beyond checkpoints and CAR Ts Checkpoints Reactivate T cells Program T cells in vivo Off-the-shelf T cell targeted therapy drug product is fully synthetic & easy to manufacture Monotherapy activity with clinical demonstrations of tumor shrinkages in both solid and liquid tumors (Ovarian cancer & DLBCL) CAR-T technologies Engineer T cells in vitro Combined with a very favorable safety profile Could be first oncology drug shrinking tumors in the absence of systemic effect Scanning electron micrograph of a human T lymphocyte (also called a T cell) from the immune system of a healthy donor. Credit: NIAID 3

IMV Opportunity New class of immunotherapy based on in vivo programming of immune cells First application and lead clinical asset in 8 Phase 2 trials in 6 indications with multiple readouts upcoming Delivered some of the best IO clinical data in 2018 with clinical demonstrations of tumor regressions in difficult to treat solid and liquid tumors (ovarian cancer and DLBCL) Merck and Incyte collaborations IMV kept all rights Focus on fast path to market in ovarian and DLBCL and repeating clinical demonstration in other indications 50 employees based in Canada - Recent listing on NASDAQ (250M market cap) well funded beyond key clinical milestones in 2019 Next 6 months will be pivotal for IMV 4

DPX Technology: Programming immune cells in vivo Active Ingredients Lipid Nanoparticle Lipid nanoparticle delivery platform with new No release mechanism of action (DPX) Forcing an active uptake and in vivo delivery of active ingredients into immune cells and lymph nodes MOA can be leveraged to program and generate new types of T cell therapeutic capabilities bypassing conventional immune responses and their inherent limitations Multiple manufacturing advantages; fully synthetic; hydrophilic and hydrophobic compounds, wide-range of applications (peptides, small-molecules, RNA/DNA, antibodies ), long term stability & low cost of goods > 200 patents and patents filed to cover technology and multiple applications 5

DPX Technology: A new way to beat cancer Checkpoints/CAR Ts have shown that killing cancer requires a flow of T cells that are maintained over a very long period of time (Treatment with Keytruda is 2 years) Our immune system is not built to naturally produce the intensity and duration of T cell flow it is a quick response/memory system It has to be forced (checkpoints) or re-engineered (CAR Ts) At IMV we are developing another way By bypassing the immune system own limitations we can directly generate a new type of artificial T cell flow in the blood It can be targeted to kill cancer and sustained over long period of time with repeated injections every 2-3 months We believe this new class of IO has the potential to expand immunotherapy market beyond checkpoints and CAR Ts 6

Lead Clinical Asset: DPX-Survivac First clinical application in Immuno Oncology with Survivin T cell therapy Survivin - Controls key cancer processes: apoptosis, cell division and metastasis - Associated with chemo resistance and cancer progression - Broad application: present in majority of cancers, overexpressed in more than 20 indications DPX-Survivac leverages the MOA of DPX generating a constant flow of T cells in the blood that are targeted against Survivin expressed on cancer cells - Five minimal MHC class I peptides to activate naïve T cells against Survivin - Initially developed by Merck KGaA and out-licensed exclusively to IMV Cancer Survivin % Ovarian 90 Breast 90 Melanoma 90 Lung 53 Colorectal 54 Gastric 94 Kidney 23-82 Glioblastoma 80 ALL 70 CML 70 MDS 90 DLBCL 60 7

Pipeline Indication Product Phase Partners Ovarian DPX-Survivac + mcpa + epacadostat Phase 1b Ovarian DPX-Survivac + mcpa DPX-Survivac + mcpa + epacadostat Phase 2 Ovarian DPX-Survivac + mcpa + pembrolizumab Phase 2 DLBCL DPX-Survivac + mcpa + pembrolizumab Phase 2 Lung (NSCLC) DPX-Survivac + mcpa + pembrolizumab Phase 2 Bladder DPX-Survivac + mcpa + pembrolizumab Phase 2 MSI-H DPX-Survivac + mcpa + pembrolizumab Phase 2 Liver (HCC) DPX-Survivac + mcpa + pembrolizumab Phase 2 Ovarian DPX-Survivac + mcpa + pembrolizumab DPX-Survivac + pembrolizumab Phase 2 8

Clinical focus on fast path to market Mechanism of action leading to tumor regressions Translate into clinical benefits Create opportunity for fast path to market Survival PFS & OS Tumor Regressions (Objective Response) T cell infiltration Specific T cells infiltrating the Tumor T cell activation Specific T cells maintained in the Blood (1 year and more) Late stage disease with unmet medical need (eg ovarian) Early clinical proof of activity Identify high responders De risk registration trial Adapted from Chen and Mellman, 2013 Immunity 39(1):1 9

First Phase 1b/2 in late stage recurrent ovarian cancer Parameter Group 1 (N=14) Group 2 (N=12*) Age: Mean (Range) 65 (35-79) 57 (36-72) ECOG: 0 11 (79%) 6 (50%) 1 3 (21%) 6 (50%) HLA Match 14 (100%) 12 (100%) Cancer Type: EOC 8 (57%) 9 (75%) FT 3 (21%) 1 (8%) P 3 (21%) 2 (17%) Stage at Diagnosis: 3c 10 (71%) 8 (67%) 4 4 (29%) 2 (17%) 1 st Line Platinum Sensitivity: S 11 (79%) 10 (83%) R 3 (21%) 2 (17%) Last Line Platinum Sensitivity: S 6 (43%) 1 (8%) R 8 (57%) 11 (92%) Prior Lines: Mean (Range) 3.1 (1-7) 4.5 (1-7) Group 1: DPX-Survivac, mcpa, < 100 mg BID epacadostat All tested subjects expressed survivin Group 2: DPX-Survivac, mcpa, 300 mg BID epacadostat *Enrollment to Group 2 is ongoing Platinum Resistant (R) = 3-6m after first line, 0-6m after last line EOC (epithelial ovarian), FT (fallopian tube), P (peritoneal) One subject diagnosed as 1c and one as 3a ASCO 2018, Oliver Dorigo MD, PhD 10

Tumor shrinkages Best Response Target Lesion Response PR 3 + 1 = 4 SD 4 + 4 = 8 PD 3 + 1 = 4 Subjects considered evaluable if they complete the D56 biopsy and scan ASCO 2018, Oliver Dorigo MD, PhD After ending treatment subjects enter an extended follow-up for PFS and OS 11

Checkpoints have low activity in recurrent Ovarian cancer Epacadostat has no activity in recurrent ovarian cancer Checkpoint inhibitors have shown 8-10% response rate IMV believe DPX Survivac monotherapy will deliver superior results to checkpoints in its first clinical trial 12

Phase 2 with Merck in DLBCL Phase 2 combination DPX-Survivac + mcpa + anti-pd-1 in Patients with Recurrent Diffuse Large B-Cell Lymphoma (DLBCL) - Primary endpoint is to objective response rate (ORR). Secondary objectives include measuring tumor regression, and documenting the toxicity profile and durations of response. - 25 subjects Preliminary results on first four patients at first on-treatment CT scan (70-91 days): - Three tumor regressions of 66% (PR), 48% and 5% - Fourth participant had early disease progression less than two months following treatment initiation and was discontinued from the study - Acceptable safety profile, with no serious adverse events reported to date 13

Recurrent Ovarian Cancer Opportunity Significant unmet medical need - 3% of all new cancers in women and causes more deaths than any other cancer of the female reproductive system - 70% of women have advanced disease at time of first diagnosis - up to 80% will eventually experience recurrence after 1 st line - 12 to 18 months average duration of survival after recurrence - Fewer than one in ten patients survive beyond 5 years Potential market opportunity - Novel treatments projected to reach $7B by 2026 - IO opportunity: $2.6B by 2026 Source: Adapted from Nature Reviews Drug Discovery July 2017 14 2018 All rights reserved.

Collaborations with Merck and Incyte IMV has successfully kept all rights on lead clinical asset (DPX-Survivac) Collaborations with Merck and Incyte - Clinical costs: 50/50 share with Incyte, Merck paying for OC and IMV for DLBCL and basket trial - In addition, Incyte and Merck are paying for their products (epacadostat and pembrolizumab) - Cash and product contribution from Merck > $50M - No option or first right of refusal on DPX-Survivac 15

Clinical Milestones Milestones Projected dates Phase 1b/2 clinical results with Incyte in Ovarian at ASCO June 2018 Initiation of Phase 2 arm with and without epacadostat with Incyte August 2018 Initiation of Basket trial in 5 solid tumor indications September 2018 First preliminary Phase 2 clinical results with Merck Keytruda in DLBCL September 2018 Top line Phase 1b/2 clinical results 300mg dose with Incyte in Ovarian End 2018 Phase 2 monotherapy preliminary results in Ovarian Q1 2019 Meeting with FDA on potential accelerated registration trial in Ovarian and/or DLBCL Q1 2019 Top line Phase 2 clinical results with Merck in DLBCL Q1 2019 Top line Phase 2 clinical results with Merck in Ovarian cancer Q1 2019 Preliminary clinical results Basket trial Q1-Q2 2019 FDA accelerated/breakthrough designation registration trial in Ovarian and/or DLBCL Q1-Q2 2019 Top line clinical results for Basket trial Q3-Q4 2019 Potential FDA accelerated/breakthrough designation from Basket trial Q4 2019 19

Corporate Structure Stock Information (in US$) NASDAQ: IMV TSX: IMV Share Price (1 year range): $3.15-$7.20 Market cap as at Oct 20, 2018: 251M$ Capital Structure Common Shares outstanding: 44.9M Warrants: 0.3M Options and DSUs: 1.8M Fully diluted: 47.0M Shareholders Board and management: 8.5% Institutional investors: 30.5% (Ruffer, CTI Life Science, Fidelity, etc.) Retail: 61% Analysts Coverage Dawson James (US) National Bank Financial (CAN) Echelon (CAN) Mackie Research (CAN) 20