NASDAQ & TSX: IMV BIO Investor Forum 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 T cells are at the forefront of the Immuno Oncology (IO) revolution with checkpoint inhibitors and CAR Ts IMV has discovered a new mechanism of action to program T cells in vivo Checkpoints Reactivate T cells Program T cells in vivo Enabling highly targeted T cell therapy with potential to expand the application of IO beyond checkpoint and CAR T therapies CAR-T technologies Engineer T cells in vitro Clinical demonstration of activity on solid tumor (Ovarian cancer) combined with a very with favorable safety profile 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 Platform defining a new class of immunotherapy based on in vivo programming of immune cells - Potential across multiple markets with T cell and B cell therapies First application and lead clinical development in IO - Targeted T cell therapy against well known cancer antigen Survivin - Phase 1/1b completed in 56 patients - 8 Phase 2 combination trials ongoing in six cancer indications - Collaborations with Incyte and Merck - Some of the best IO results reported in 2018 in both solid (recurrent late stage ovarian cancer - Dec 2017 and June 2018 ASCO) and liquid tumors (Sept 2018) - Next steps: accelerated path to market in recurrent in ovarian cancer and DLBCL and expansion into other indications Partnering strategy for other applications of our platform Listed on Nasdaq and TSX: IMV - 47 employees - $240 US market cap - Well funded with cash until Q4 2019 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 MOA can be leveraged to program and generate new types of T and B 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
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 6
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 7
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 8
Phase 1b/2 with Incyte in 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 9
Percent Change From Baseline in Target Lesions (modified RECIST v 1.1) 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 10
Comparison with Ovarian Cancer IO Results Checkpoints as monotherapy and combinations have shown limited activity so far in recurrent ovarian cancer Ovarian Cancer IO clinical trials Phase (nb patients) DCR (SD, PD and CR) ORR (PR and CR) References Checkpoint Immunotherapy Ipilumab-BMS (CTLA-4) P1 (9) 44% (1 PR + 3 SD) 11% (1 PR) Hodi F. S. et al. 2008 Proc. Natl Acad. Sci. USA 105:3005 Epacadostat-Incyte (IDO1) P2 (20) 0% (1 CA 125 reduction) 0% Kristeleit et al Gynecol Oncol. 2017 Sep;146(3):484-490 Pembrolizumab-Merck (PD-1) P2 (376) 37% (7 CR + 23 PR + 110 SD) 8% (7 CR + 23 PR) Matulonis ASCO 2018 Nivolumab-BMS (PD-1) P2 (18) 44% (2 CR +1 PR + 5 SD) 17% (2 CR +1 PR) Hamanishi J et al. (2014) J Clin Oncol 32: 5511 Avelumab-Merck KgA (PD-L1) P1b (124) 54% (12 PR + 55 SD) 10% (12 PR) Disis ML et al. J Clin Oncol 34, 2016 (suppl; abstr 5533) BMS-936559 (PD-L1) P1 (17) 24% (1 PR + 3 SD) 6% (1 PR) Brahmer JR et al. N Engl J Med. 2012;366(266);2455-2465 Checkpoint + PARP inhibitor Durvalumab-AZ (PD-L1) + Olaparib (PARPi) P1/2 (12) 83% (2 PR + 9 SD) 17% (2 PR) Lee JM et al. J Clin Oncol. 2017 Jul 1;35(19):2193-2202 Pembrolizumab + Niraparib (PARPi)* P2 (60) 67% (3 CR+12 PR+25 SD ) 25% (3 CR+12 PR) Panagiotis Konstantinopoulos at 2018 ASCO Annual Meeting Combination Immunotherapy Epacadostat + Pembrolizumab P2 (37) 35% (10 SD + 3 PR) 8% (3 PR) Lee S. Schwartzberg Post-ASCO Immunotherapy Highlights:June 27, 2017 Epacadostat 100mg + Nivolumab P1/2 (18) 28% (3 SD + 2 PR) 11% (2 PR) Lee S. Schwartzberg Post-ASCO Immunotherapy Highlights:June 27, 2017 Epacadostat 300mg + Nivolumab P1/2 (11) 36% (2 SD + 1 PR + 1 CR) 18% (1 PR + 1 CR) Lee S. Schwartzberg Post-ASCO Immunotherapy Highlights:June 27, 2017 Average 44% 12% DPX-Survivac+ Epacadostat 100mg P1b (10) 70% (3 PR + 4 SD) 30% (3 PR) 11
ASCO 2018: Keytruda 8-10% response rate in recurrent Ovarian 12
T Cell Infiltration in Tumors Correlate with Clinical Responses 03-0606 PR 03-0601 PR 05-0610 SD 05-0609 SD 04-0607 PD 05-0608 PD 04-0605 PD 01-0603 PD ASCO 2018, Oliver Dorigo MD, PhD Image source: KEGG Pathway Database 13
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): - Two tumor regressions of 48% and 66% (PR) - One stable disease with very aggressive form of DLBCL (cutaneous) - 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 In comparison PD-1 checkpoint results have shown modest activity in DLBCL - No results published with Keytruda but several results have been published with Opdivo: - 36% ORR in a small Phase 1 (4 responses/11 patients), 10% ORR in a Phase 2 (9/87 patients) with a more defined population, 20% ORR (2/10 patients) in a Phase 1 combination between Opdivo and Yervoy 14
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 > $50M - No option or first right of refusal on DPX-Survivac 15
Clinical Milestones Milestones Projected dates Phase 1b/2 clinical results with Incyte in Ovarian at ASCO June 2018 Initiation of Phase 2 arm with and without epacadostat with Incyte August 2018 Initiation of Basket trial in 5 solid tumor indications September 2018 First preliminary Phase 2 clinical results with Merck Keytruda in DLBCL September 2018 Top line Phase 1b/2 clinical results 300mg dose with Incyte in Ovarian End 2018 Meeting with FDA on potential accelerated registration trial in Ovarian and/or DLBCL End 2018 Top line Phase 2 clinical results with Merck in DLBCL Q1 2019 Top line Phase 2 clinical results with Merck in Ovarian cancer Q1 2019 Preliminary clinical results Basket trial Q1-Q2 2019 FDA accelerated/breakthrough designation registration trial in Ovarian and/or DLBCL Q1-Q2 2019 Top line clinical results for Basket trial Q3-Q4 2019 Potential FDA accelerated/breakthrough designation from Basket trial Q4 2019 16
Investment Opportunity Platform defining a new class of immunotherapy based on in vivo programming of immune cells First application and lead clinical asset (survivin) in 8 Phase 2 trials in 6 indications with multiple readouts upcoming Delivered some of the best IO clinical data in 2018 with clinical demonstrations of tumor regressions in difficult treat solid and liquid tumors (ovarian cancer and DLBCL) Merck and Incyte collaborations IMV kept all rights Focus on fast path to market in ovarian and DLBCL and repeating clinical demonstration in other indications Recent listing on NASDAQ funded beyond key clinical milestones Next 6 months should be pivotal for IMV 17
Corporate Structure Stock Information (in US$) NASDAQ: IMV TSX: IMV Share Price (1 year range): $2.69-$7.20 Market cap as at Oct. 16, 2018: 240M$ 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) 18
IMV Inc. 130 Eileen Stubbs Avenue, Suite 19 Dartmouth, Nova Scotia B3B 2C4 Canada Tel: 902.492.1819 Fax: 902.492.0888