Corporate Presentation

Transcription

1 Corporate Presentation January 2019

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 New mechanism of action for targeted T cell therapy: programming T cells in vivo Potential to revolutionize IO and expand its applications beyond checkpoints and CAR-T cells: Monotherapy activity with clinical demonstrations of tumor shrinkages and long duration of responses in both solid and liquid tumors Unique safety profile could be first oncology drug shrinking tumors in the absence of systemic effect Lead IO monotherapy in Ovarian cancer with potential to move into registration trial in 2019 for accelerated approval Not personalized off-the-shelf drug product - fully synthetic & easy to manufacture 3

4 IMV Opportunity First targeted T cell therapy (DPX-Survivac) in 8 Phase 2 trials in 6 indications both as monotherapy and combination with Keytruda 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) Collaboration with Merck including 7 phase 2 trials in 6 indications Focus on fast path to market in ovarian and DLBCL and repeating clinical demonstrations in other indications 50 employees NASDAQ and TSX listed (240M$ mkt cap), well funded beyond key 2019 clinical milestones 2019 expected to 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 (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

6 IMV solution: DPX first-in-class No Release technology DPX is fundamentally different from vaccination and associated technologies - Does not rely on inflammation at the site of injection to generate an immune response - No release MOA forces an active uptake and delivery into the lymph nodes by immune cells of any active ingredient - uptake sustained over a very long period of time (months versus hours/days) Quick or slow release Short lived and limited T cell activation (typical of vaccination) DPX NO release Strong T cell activation maintained over time Aqueous, oil-in-water, depot formulations High inflammation & release at the injection site Lipid nanoparticles (10nm reverse micelles) suspended in oil No inflammation & no release at the injection site Lymph Nodes T cells Tumor T cells Lymph Nodes T cells are attracted back to injection site 6

7 IMV solution: DPX first-in-class No Release technology New MOA enables lymph node delivery of minimal MHC-1 peptides for T-cell activation in a drug-like manner Clinical demonstration best-in-class T cell activation and monotherapy activity in solid and liquid tumors Monotherapy Tumor shrinkages 7

8 Lead Clinical Asset: DPX-Survivac IMV s first targeted T cell therapy is based on Survivin (DPX-Survivac) 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 MOA of DPX to generate 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 8

9 Dual Clinical Strategy Pursuing both monotherapy and combination with Keytruda Phase 1 - ovarian DPX-Survivac Monotherapy Phase 2 - ovarian DPX-Survivac Monotherapy Phase 2 multiple tumors DPX-Survivac + Checkpoint Inhibitors 9

10 Pipeline Indication Candidate N Phase Progress Sponsor Collaborators 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 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 10

11 First in human monotherapy Ovarian maintenance setting 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 Signs of monotherapy activity - PR -46% tumor reduction lasting longer than previous round of chemotherapy - Treatment free intervals of 23+ and 28+ months PR 46% 11

12 First in human combination with IDO Recurrent ovarian Heavily pre-treated patient population with active disease Combination with IDO inhibitor (epacadostat) to evaluate potential added benefits of epacadostat dose escalation 100 and 300 mg BID Multicenter study in USA and Canada - Primary objectives: safety, cell mediated immunity, changes in immune cell infiltration of tumour - Secondary objectives: ORR, DCR, DoR using RECIST v1.1, time to progression ASCO and ESMO IO subjects evaluable for primary and secondary endpoints (epacadostat 100 mg dose n=10 - epacadostat 300 mg dose n=22) Parameter Statistic All Subjects 100mg (N=14) 300mg (N=39) n (%) n (%) n (%) Age (years) 63 (10) 65 (11) 62 (10) Min, Max 35, 87 35, 79 36, 87 White 47 (88.7) 14 (100) 33 (84.6) Race n (%) Black or African American 3 (5.7) 0 (0.0) 3 (7.7) Other 3 (5.7) 0 (0.0) 3 (7.7) ECOG 0 29 (54.7) 11 (78.6) 18 (46.2) 1 24 (42.3) 3 (21.4) 21 (53.8) Epithelial Ovarian 39 (73.6) 8 (57.1) 31 (79.5) Cancer type Fallopian Tube 6 (11.3) 3 (21.4) 3 (7.7) Peritoneal 8 (15.1) 3 (21.4) 5 (12.8) Stage at diagnosis 3b 14 (26.4) 0 (0.0) 14 (35.9) 3c 30 (56.6) 10 (71.4) 20 (51.3) 4 9 (17.0) 4 (28.6) 5 (12.8) Number of Previous 2 19 (35.8) 7 (50.0) 12 (30.1) Treatments 3 34 (64.2) 7 (50.0) 27 (69.1) Sensitivity to Most Sensitive 19 (35.8) 6 (42.8) 13 (33.3) Recent Platinum Resistant/ Refractory 34 (64.2) 8 (57.1) 26 (66.7) unknown 9 (17.0) 3 (21.4) 6 (15.4) Progressive disease 5 (9.4) 0 (0.0) 5 (12.8) Best response to Most Stable disease 11 (20.1) 2 (14.3) 9 (23.1) Recent Platinum Partial response 13 (24.5) 3 (21.4) 10 (25.6) Complete response 15 (28.3) 6 (42.9) 9 (23.1) Evaluable D56 scan/biopsy complete 32 (60.4) 10 (71.4) 22 (56.4) 12

13 Key findings Efficacy Baseline tumour burden < 5 cm Baseline tumour burden > 5 cm Parameter All (N=12) N (%) 100mg (N=5) 300mg (N=7) All (N=20) N (%) 100mg (N=5) 300mg (N=15) PR 4 (33.3) 3 (60.0) 1 (14.3) 1 (5.0) 0 (0) 1 (6.7) SD 6 (50.0) 2 (40.0) 4 (57.1) 12 (60.0) 2 (40.0) 10 (66.7) DCR 10 (83.3) 5 (100) 5 (71.4) 13 (65.0) 2 (40.0) 11 (73.3) (a) 100 mg, < 5cm BTB (c) 300 mg, < 5 cm BTB * (b) 100 mg, > 5 cm BTB PR SD (regression) SD (growth) PD (d) 300 mg, > 5 cm BTB * * DPX-Survivac is active in recurrent Ovarian cancer - Majority of patients generated and maintained high levels of survivin specific T cells - Survivin specific T cells infiltrate tumors - 100% of durable clinical responses correlated with T cell infiltration - Clinical responses where dependant on the balance between baseline tumor burden and T cells - High response rate in subpopulation with nonbulky disease (BTB < 5 cm) - Long duration of clinical benefits (PFS) surpassing previous chemotherapy treatment and reaching more than 2 years - Phase 2 continues as monotherapy 13

14 T cell infiltration into tumors correlates with clinical responses 100% of durable clinical responses correlated with T cell infiltration into tumors (by RNAseq and mihc) (PR,-37%) (PR,-31%) (PR,-43%) Survivin-specific T cells observed in subjects with available samples and correlated with tumor regression (IHC and TCRβ sequencing) Survivin-specific dextramer CD8 antibody (PD,+88%) (PD,+31%) (PD,+16%) Irrelevant dextramer Isotype control Group 1 <5 cm BTB, [ , PR -31%] Group 2 <5 cm BTB, [ , PR -43%] Screening Samples Day 56 Samples Best overall response PD SD (-) HLA type HLA-A2 HLA-A2, A3 Tumour CD8 + T cells Increase No change D56 vs D0 Frequency (N) of D0 0% (0) 0% (0) survivin-specific clones in tumour D56 0% (0) 2.1% (18) 14

15 Progression Free Survival (PFS) Prolong tumor control observed in 3 out 4 PR in the subpopulation: - lasted beyond treatment duration (1 year) - long duration (between 15 and 25 months and still ongoing) - Longer PFS than previous chemotherapy treatment Previous Chemotherapy treatment Best response and PFS P1b study Best response and PFS Improvement over previous treatment 601 PR 4.6 months (Topotecan) PR - 22 months months 606 CR 15.8 months (Platinum) PR - 25 months ongoing months ongoing 614 SD - 10 months (Platinum) PR - 16 months ongoing + 6 months ongoing 611 CR 33 months (Platinum) PR 5 months (non-target lesion PI decision) none 15

16 Epacadostat and checkpoint inhibitors in recurrent ovarian 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. 16

17 Ovarian Cancer Market 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

18 Baseline Tumor Burden (BTB) Balance between tumor and T cells determine outcome There is a threshold beyond which the maximal T cell response that can be generated in a given patient is overcome by the size and growth of tumor burden Part of routine evaluation for cancer patients - doesn t require development of a companion diagnostic Need to target windows of treatment where balance between T cells and tumor burden is optimal Stage of disease related most patient should have a window of treatment in their course of disease Applicable to other indications Increasingly recognized as a prognostic factor of response to checkpoint inhibitors (Huang, Nature, May 2017 Joseph, Clin Cancer Res, Oct 2018) 18

19 First registration as monotherapy in subpopulation Meeting with FDA in December to engage discussion on a potential accelerated path to registration and breakthrough designation - First registration as monotherapy in ovarian cancer subpopulation - High response rate - Long duration of responses - Clinical marker predictive of response - Very favorable safety profile - No systemic toxicity 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 19

20 First combination with Keytruda in DLBCL 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 20

21 Partnering Strategy Keep all rights on lead clinical asset (DPX-Survivac) until clinical value inflexion point (monotherapy and combination) Collaboration with Merck (7 phase 2 trials ongoing in 6 indications) - Merck paying for Ovarian and IMV for DLBCL and basket trial and supplying Keytruda - No option or first right of refusal on DPX-Survivac 21

22 Multiple Key Clinical Milestones Milestones Initiation of Basket trial in 5 solid tumor indications First preliminary Phase 2 clinical results in DLBCL with Merck Keytruda Phase 1b/2 clinical results in Ovarian with Incyte Meeting with FDA on potential accelerated registration trial in Ovarian Projected dates September 2018 September 2018 December 2018 December 2018 Phase 2 monotherapy preliminary results in Ovarian Q Phase 2 clinical results with Merck in DLBCL and Ovarian Q Preliminary clinical results Basket trial Q2-Q Potential registration trial in Ovarian and/or DLBCL for FDA accelerated/breakthrough designation Q2-Q Top line clinical results for Basket trial Q3-Q Meeting with FDA on potential accelerated registration trial from Basket trial Q

23 Corporate Structure Stock Information (in US$) NASDAQ: IMV TSX: IMV Share Price (1 year range): $4.40-$7.21 Market cap as at Jan. 4th, 2019: ~$240M 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 Echelon (CAN) National Bank Financial (CAN) Mackie Research (CAN) Dawson James (US) Raymond James (US) 23

24 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) Dr. Markus Warmuth, MD, Director, Independent, entrepreneur in residence - Third Rock Ventures, ex-ceo of H3 Biomedicine, ex-novartis Shermaine Tilley, Director, Independent, Managing Partner CTI Life Sciences Fund James Hall, Director, Independent, CPA, CA Albert Scardino, Director, Independent, Technology and media investor Frederic Ors, CEO, Chief Executive Officer & Director IMV, Non-independent 24

25 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 25

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