Corporate Presentation

Transcription

1 Corporate Presentation November 27 th, 2018

2 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 and on EDGAR at 2

3 IMV Opportunity We have discovered a new mechanism of action and technology to program T cells in vivo Potential to revolutionize IO and expand its applications beyond checkpoints and CAR Ts Monotherapy activity with clinical demonstrations of tumor shrinkages in both solid and liquid tumors (Ovarian cancer & DLBCL) Checkpoints Reactivate T cells Program T cells in vivo Long duration of responses Clinical biomarker Combined with a very favorable safety profile Could be first oncology drug shrinking tumors in the absence of systemic effect CAR-T technologies Engineer T cells in vitro Off-the-shelf drug product - fully synthetic & easy to manufacture 3

4 IMV Opportunity New class of IO based on in vivo programming of immune cells monotherapy 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 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 (260 M$US market cap) well funded beyond key clinical milestones in 2019 Next 6 months will be pivotal for IMV 4

5 DPX Technology: Programming immune cells in vivo Active Ingredients Lipid Nanoparticle Lipid nanoparticle delivery platform with new No release mechanism of action (MOA) 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

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 Glioblastoma 80 ALL 70 CML 70 MDS 90 DLBCL 60 6

7 Clinical focus on fast path to market Mechanism of action leading to tumor regressions Translate into objective responses & 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 Late-stage High responder population Accelerated approval/breakthrough designation As monotherapy & combinations T cell activation Specific T cells maintained in the Blood (1 year and more) Adapted from Chen and Mellman, 2013 Immunity 39(1):1 7

8 Pipeline Indication Treatment N Phase Progress Monotherapy Ovarian (Maintenance) DPX-Survivac monotherapy 56 Phases 1& 1b Completed Ovarian subpopulation (Treatment) DPX-Survivac monotherapy 33 Phase 2 Ongoing Combinations Ovarian Combination with epacadostat 53 Phases 1b Enrollment completed Ovarian Combination with Keytruda 42 Phase 2 Ongoing DLBCL Combination with Keytruda 25 Phase 2 Ongoing Lung (NSCLC) Combination with Keytruda 43 Phase 2 Ongoing Bladder Combination with Keytruda 35 Phase 2 Ongoing MSI-H Combination with Keytruda 41 Phase 2 Ongoing Liver (HCC) Combination with Keytruda 55 Phase 2 Ongoing Ovarian subpopulation Combination with Keytruda 58 Phase 2 Ongoing 8

9 First in human Maintenance setting Phase 1/1b Phase 1/1b Ovarian cancer maintenance setting post surgery and chemotherapy (n=56) Survivin Specific CD8+ T Cells Proof of concept study to demonstrate new MOA and select best dosing regimen 87% of patients generated Survivin specific T cells maintained during a year of treatment with repeated injection every 2-3 months PR 46% Signs of monotherapy activity - PR -46% tumor reduction lasting longer than previous round of chemotherapy - Treatment free intervals of 23+ and 28+ months 9

10 First Phase 1b/2 in late stage recurrent ovarian cancer (ROC) Late stage recurrent ovarian cancer patient population ASCO 2018 Subjects considered evaluable if they complete the D56 biopsy and scan ASCO 2018, Oliver Dorigo MD, PhD 10

11 Subpopulation of high responders MOA analysis - Majority of patients developed targeted survivin specific T cells in the blood only those where we find evidence of significant T cell infiltration in the tumors have clinical responses Study of factors potentially influencing T cell infiltration led to identification of a subpopulation of high responders Easily accessible clinical marker with a link to the mechanism of action of DPX-Survivac All responses so far are in subpopulation - 100% of patients treated with 100mg responded - 5/5 tumor regressions, 100% DCR, 60% ORR (3 PR, 2 SD) - 2/3 PR have been remarkably long lasting reaching 1.5 and 2 years and still ongoing 11

12 Epacadostat and other checkpoint inhibitors in ROC Epacadostat Kristeleit et Al,Gynecologic Oncology 2017 No activity ASCO 2018 ORR 8% - longest duration of response reported in 376 patients 18.6 months Pfizer/Merck KGaA, Nov. 19, 2018: Avelumab Misses Primary Endpoints in Phase III Ovarian Cancer Trial ORR 3.7% 556 patients with platinum-resistant or -refractory ovarian cancer - up to 3 lines of systemic therapy Avelumab alone or in combination with pegylated liposomal doxorubicin (PLD), a type of chemotherapy, compared with PLD did not meet the prespecified primary endpoints of overall survival (OS) or progression-free survival (PFS) The ORR was 13.3% (95% CI, 8.8%-19.0%) for avelumab combined with PLD, 3.7% (95% CI, 1.5%-7.5%) for single-agent avelumab, and 4.2% (95% CI, 1.8%-8.1%) for PLD alone. 12

13 First registration as monotherapy in ROC subpopulation Meeting planned with FDA in December to engage discussion on a potential accelerated path to registration and breakthrough designation - First registration as monotherapy in ROC subpopulation - High response rate - Long duration of responses - Clinical marker predictive of response - Very favorable safety profile - No systemic toxicity Will continue to explore combinations with Keytruda and other checkpoints but will also evaluate earlier lines of treatments as monotherapy and/or in combination with standard of care such a chemotherapy and other types of treatments 13

14 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 IO opportunity: $2.6B by 2026 Source: Adapted from Nature Reviews Drug Discovery July

15 Phase 2 in DLBCL with Keytruda Phase 2 combination in Patients with Recurrent Diffuse Large B-Cell Lymphoma (DLBCL) - Primary endpoint is 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 15

16 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 Q Meeting with FDA on potential accelerated registration trial in Ovarian and/or DLBCL Q Top line Phase 2 clinical results with Merck in DLBCL Q Top line Phase 2 clinical results with Merck in Ovarian cancer Q Preliminary clinical results Basket trial Q1-Q FDA accelerated/breakthrough designation registration trial in Ovarian and/or DLBCL Q1-Q Top line clinical results for Basket trial Q3-Q Potential FDA accelerated/breakthrough designation from Basket trial Q

17 Summary DPX-Survivac is more than a combination drug for checkpoints - DPX-Survivac is the first targeted T cell therapy to shrink solid tumors - Duration of responses and favorable safety profile - Clinical biomarker predictive of response identified in our first efficacy trial Monotherapy represents a very significant market opportunity and value creation path for IMV - Since checkpoint inhibitors approvals no other IO drug has shown significant monotherapy activity - DPX-Survivac has the potential to create a new-class of IO and become the first new IO drug to be approved after checkpoints - Monotherapy activity is a strong differentiation in a space over crowded with combinations trials - Independence from checkpoint inhibitors will provide more market opportunities for IMV ROC opportunity - Market opportunity for immunotherapy in ROC is $2.6B - Significant unmet medical need no checkpoint inhibitor approved - Late stage patients with a hard-to-treat cancer represent a very high bar for immunotherapy a first approval in recurrent ovarian cancer would have the potential to open the way to multiple other indications known to be easier for Immunotherapy 17

18 Board Of Directors Andy Sheldon, Chairman of the board, Independent, ex CEO Medicago/Mitsubishi Pharma Wayne Pisano, Director, Independent, ex CEO Sanofi Pasteur, Vaxinnate Julia Gregory, Director, Independent, ex CEO ContraFect (NASDAQ: CFRX) and FivePrime Therapeutics (NASDAQ: FXRX) Markus Warmuth, Director, Independent, EIR Third Rock Ventures, ex-ceo H3 Biomedicine, ex-novartis Oncology Shermaine Tilley, Director, Independent, Managing Partner CTI Life Sciences Fund James Hall, Director, Independent, CPA, CA, VP Callidus, SVP Investment GrowthWorks Albert Scardino, Director, Independent, Technology and media investor Frederic Ors, CEO, Chief Executive Officer & Director IMV, Non-independent 18

19 Management Team Frederic Ors, MSc/MA Chief Executive Officer 20 years experience Pierre Labbé, CPA Chief Financial Officer 30 years experience Joe Sullivan, MBA Senior Vice-President Business Development 35 years experience Gabriela Rosu, MD Chief Medical Officer 25 years of experience Stephan Fiset, MSc/MBA Vice-President Clinical Research 20 years experience Tariq Massad, MSc Vice-President of Manufacturing 25 years experience Marianne Stanford, PhD Vice-President of Research 17 years experience Annie Tanguay, BSc Senior Director of Quality Assurance 27 years experience 19

20 Corporate Structure Stock Information (in US$) NASDAQ: IMV TSX: IMV Share Price (1 year range): $3.47-$7.20 Market cap as at Nov. 23th, 2018: 260M$ Capital Structure Common shares outstanding: 45M Warrants: 0.3M Options and DSUs: 1.7M 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) Raymond James (US) National Bank Financial (CAN) Echelon (CAN) Mackie Research (CAN) 20

21 IMV Inc. 130 Eileen Stubbs Avenue, Suite 19 Dartmouth, Nova Scotia B3B 2C4 Canada Tel: Fax: