Dawson James Conference - Seeking Alpha

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© 2018 IMV Inc. All rights reserved. Dawson James Conference October 2018

Transcript of Dawson James Conference - Seeking Alpha

© 2018 IMV Inc. All rights reserved.

DawsonJames

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 © 2018 IMV Inc. All rights reserved.

IMV Opportunity

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Program T cells in vivo

CAR-T technologies

Engineer T cells in vitro

• 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

• 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)

• Combined with a very favorable safety profile –Could be first oncology drug shrinking tumors in the absence of systemic effect

Checkpoints

Reactivate T cells

© 2018 IMV Inc. All rights reserved.

Scanning electron micrograph of a human T lymphocyte (also called a T cell) from the immune system of a healthy donor. Credit: NIAID

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 © 2018 IMV Inc. All rights reserved.

• 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

DPX Technology: Programming immune cells in vivo

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Active Ingredients Lipid Nanoparticle

© 2018 IMV Inc. All rights reserved.

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)

© 2018 IMV Inc. All rights reserved.6

• 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

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 than20 indications

• DPX-Survivac leverages the MOA of DPX generating a constant flow of T cells inthe 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

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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

© 2018 IMV Inc. All rights reserved.

Pipeline

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Indication Product Phase Partners

Ovarian DPX-Survivac + mCPA + epacadostat

OvarianDPX-Survivac + mCPA

DPX-Survivac + mCPA + epacadostat

Ovarian DPX-Survivac + mCPA + pembrolizumab

DLBCL DPX-Survivac + mCPA + pembrolizumab

Lung (NSCLC) DPX-Survivac + mCPA + pembrolizumab

Bladder DPX-Survivac + mCPA + pembrolizumab

MSI-H DPX-Survivac + mCPA + pembrolizumab

Liver (HCC) DPX-Survivac + mCPA + pembrolizumab

OvarianDPX-Survivac + mCPA + pembrolizumab

DPX-Survivac + pembrolizumab

Phase 1b

Phase 2

Phase 2

Phase 2

Phase 2

Phase 2

Phase 2

Phase 2

© 2018 IMV Inc. All rights reserved.

Phase 2

Clinical focus on fast path to market

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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

Mechanism of action leading to tumor regressions Translate into clinical benefits

Create opportunity for fast path to market

© 2018 IMV Inc. All rights reserved.

First Phase 1b/2 in late stage recurrent ovarian cancer

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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%)

1st 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)

EOC (epithelial ovarian), FT (fallopian tube), P (peritoneal)

Platinum Resistant (R) = 3-6m after first line, 0-6m after last line

• 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

†One subject diagnosed as 1c and one as 3a

ASCO 2018, Oliver Dorigo MD, PhD

© 2018 IMV Inc. All rights reserved.

Tumor shrinkages

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After ending treatment subjects enter an extended follow-up for PFS and OS

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

© 2018 IMV Inc. All rights reserved.

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

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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

© 2018 IMV Inc. All rights reserved. 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 1st 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 2026Source: Adapted from Nature Reviews | Drug

Discovery – July 2017

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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 © 2018 IMV Inc. All rights reserved.

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

© 2018 IMV Inc. All rights reserved. 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$

© 2018 IMV Inc. All rights reserved.

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)

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