Investor Presentation
(Nasdaq ; TSX: IMV)
August 14, 2020
Forward-looking Statements
- This presentation contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made.
- Such forward-looking statements include, but are not limited to, statements regarding the Company's intention to develop a DPX-based vaccine candidate against COVID-19, the Company's belief that the DPX-based platform creates the opportunity for accelerated development and rapid, large-scale production of a COVID-19 vaccine, the Company's belief in the potential efficacy of its DPX-based vaccine against COVID-19, the Company's belief in the benefits of the third-party research and studies in related coronavirus and SARS studies and third-party sequencing data and their applicability to the Company's DPX platform and a DPX platform related vaccine and the Company's anticipated results from its DPX cancer and infectious disease studies. no responsibility to update forward-looking statements in this presentation except as required by law. These forward-looking statements involve known and unknown risks. Such statements should not be regarded as a representation that any of the plans will be achieved.
- Actual results may differ materially from those set forth in this presentation due to risks and uncertainties affecting the Company and its products. The Company assumes no responsibility to update forward-looking statements in this presentation except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to the Company's ability to develop a DPX-based vaccine candidate against the COVID-19 through the successful and timely completion of clinical trials and studies, the receipt of all regulatory approvals by the Company to commence and then continue clinical studies, and, if successful, the commercialization of its proposed vaccine candidate related to COVID-19, the Company's ability to raise sufficient capital to fund such clinical trials and studies and the production of any COVID-19 vaccine, the ultimate applicability of any third-party research and studies in related coronavirus and SARS studies and sequencing, the Company's ability to enter into agreements with the proposed lead investigators to assist in the clinical development on its vaccine candidate related to COVID-19, the Company's ability to collaborate with governmental authorities with respect to such clinical development, the coverage and applicability of the Company's intellectual property rights to any vaccine candidate related to COVID-19, the ability of the Company to manufacture any vaccine candidate related to COVID-19 rapidly and at scale and other risks detailed from time to time in the Company's ongoing filings and in its annual information form filed with the Canadian regulatory authorities on SEDAR as www.sedar.comand with the United States Securities and Exchange Commission on EDGAR at www.sec.gov/edgar.
- Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Company's continuous disclosure documents which are available on SEDAR and on EDGAR.
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© 2020 IMV Inc. All rights reserved.
Investment Opportunity
First-in-class drug delivery platform DPX ™
Unique mechanism of action targeting the immune system and enabling precision immunotherapy
Clinically-demonstrated activity in both solid and hematologic cancers as well as infectious diseases
Excellent safety profile across all clinical studies phase 1 & 2 studies (N=350)
Clinical portfolio focused on unmet medical needs
Lead program with novel cancer target applicable to most tumor types and with great market potential
Positive results from first phase 2 studies in hard-to-treat cancers provide opportunity and de-risk fast path to market Growth opportunities by expanding DPX™ technology applications to other targets and indications (including COVID-19)
Strong corporate position
Upcoming phase 2 updates in oncology
Clinical phase 1 for DPX COVID-19 expected to start this summer, fully funded through Canadian governmental agencies Experienced leadership and recognized partners (Merck, Wistar)
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© 2020 IMV Inc. All rights reserved.
First-in-class drug delivery platform DPX™
Novel Delivery Platform with "NO-RELEASE" mechanism of action (DPX™)
No-release of at site of injection forcing active uptake of pharmaceutical ingredients by immune cells over greatly extended period of times (months)
Lipid nanoparticle technology
• Fully synthetic & easy to manufacture
• Lyophilized & reconstituted in lipids for injection
• Simple administration & extended shelf life
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© 2020 IMV Inc. All rights reserved.
Next-generation Precision Immunotherapy
MHC peptides as information molecules to precisely control immune responses
- DPX extended delivery into immune cells enables highly targeted T and B cell therapies against cancer cells or pathogens
- Opens way to a next generation of precision immunotherapy with potential for increased safety, efficacy and ease of care
Targeted immune response with
Improved duration and
Typical immune-response limited in time and potency
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© 2020 IMV Inc. All rights reserved.
Clinically Demonstrated Cancer Target
- IMV's lead clinical asset DPX-Survivac is a cancer T cell therapy targeting survivin MHC peptides presented by cancer cells
- Survivin is one of the most recognized and clinically demonstrated cancer specific target
- Apoptotic checkpoint controlling cell death, overexpressed in most cancers1 and with a critical role in tumor resistance to chemotherapy and cell-death
- Considered undruggable as a passenger protein without enzymatic activity
- DPX-Survivacis administered sub-cutaneous every 2 months with intermittent low-dose oral cyclophosphamide (CPA), as an immune- modulator to increase survivin-specific T cells2 without inducing significant cytotoxicity. Several studies have demonstrated beneficial effects for T cell therapies, including reduction of T regulatory cell numbers and increase in effector T cells.3
Cancers | 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 |
Expression level of survivin in cancer cells, by cancer type
1.Garg et al. Cancer Cell Int., 2016 2 Weir et al, AACR, 2016,
3 Hugues et al, Immunology. 2018.
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© 2020 IMV Inc. All rights reserved.
Clinical Pipeline
Top Line update in H2 2020
Top line update in H2 2020
Updated results to be presented in H2 2020
Clinical phase 1 to be initiated during summer 2020
/CPA: oral intermittent low-dose cyclophosphamide (CPA) as an immune modulator
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© 2020 IMV Inc. All rights reserved.
Recurrent Ovarian Cancer
- Fifth most common cause of cancer mortality in women
- 239,000 cases and 152,000 deaths worldwide each year
- Almost all patients relapse and eventually become resistant to platinum-based therapy (70% of patients relapse within 3 years)
- Standard of care for recurrent ovarian cancer
- Single-agentchemotherapy (doxorubicin, paclitaxel, or topotecan)
- 12% objective response rate (ORR)
- 3 to 4.4 months Progression Free Survival (PFS)
- High unmet medical need
- Platinum resistant and non eligible to chemo, elderly population
- No immunotherapy approved
K Moore et al., ESMO 2019; Pujade-Lauraine et al., SGO 2019; Gaillard et al., ESMO 2018; SmartAnalyst report 2019
Garon et al., Lancet 2014; Rittmeyer A, et al. Lancet. 2017; Borghaei H, et al. N Engl J Med. 2015; SmartAnalyst report 2019
© 2020 IMV Inc. All rights reserved.
High unmet medical need
12% ORR
3 to 4.4 months PFS
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Phase 2 - Ovarian Cancer - Monotherapy*
Confirmation of Clinical Activity (Treatment Arm 2, n=19)
26% ORR - PR on target lesions (5/19) (tumor regression > 30%)
37% Clinical benefits - PR or Stable Disease > 6 months (7/19) 79% Disease Control Rate (15/19)
53% Tumor regressions (10/19)
Best Response by Target Lesion (n=19) | Duration on Treatment (n=19) |
PR and SD ˃ 6 months
PR & SD ˃ 6 months (7)
Subjects ongoing (4)
Partial Response
* DPX-Survivac with intermitent low-dose cyclophosphamide
© 2020 IMV Inc. All rights reserved.
- 21% (4/19) patients still on study
- No patient with clinical benefits was discontinued for progression on target lesions
- 3 stable diseases (SDs) with significant tumor regressions: -27%,-25%,-10% removed from study for other reasons than progression on target lesions
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Duration of Clinical Benefits
# (best | Last Therapy | Time to Progression | + months gained | ||
vs previous | |||||
response) | Time to Progression | DeCidE1 Study | |||
treatment | |||||
1 | 1 | (PR) | Platinum | 37 months | + 22 months |
16 months | |||||
Arm | |||||
2 | (PR) | Platinum | > 30 months | > + 20 months | |
10 months | |||||
Treatment | |||||
4 (PR) | Progressed on | 5 months | + 3 months | ||
Topotecan | |||||
3 | (PR) | Progressed on | 21 months | + 17 months | |
treatment: 5 months | |||||
Platinum | |||||
treatment: 2 months | |||||
5 | (PR) | Platinum | 5 months | ||
33 months | |||||
1 | (PR) | Carboplatin/Paclitaxel | > 12 months | >TBD | |
37 months | |||||
2 | (SD | PARPi | |||
Progressed on | > 11 months (ongoing) | > + 3 months | |||
2 | -12%) | ||||
treatment: 6 months | |||||
Arm | |||||
3 | (SD | Carboplatin/PLD | |||
Progressed on | > 11 months (ongoing) | > + 6 months | |||
+9%) | |||||
Treatment | treatment: 5 months | ||||
4 | (PR) | Bevacizumab | > 10 months (ongoing) | > + 1 month | |
9 months | |||||
Carboplatin | |||||
6 | (PR) | Progressed on | > 9 months (ongoing) | > + 8 months | |
treatment: 1 months | |||||
5 | (PR) | Carboplatin/Paclitaxel | 6 months | ||
13 months | (unconfirmed new lesion) | ||||
PARPi | 5 months | ||||
7 | (PR) | Progressed on | (died of unrelated | ||
treatment: 33 months | condition) |
© 2020 IMV Inc. All rights reserved.
- Median duration not reached
- 71% (5/7) of patients with duration
- 7 months (as of May 2, 2020)
- 67% (8/12) of patients responding to treatment have experienced longer benefits than on their previous treatment with chemotherapy +/- PARPi and bevacizumab
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Relapse Refractory DLBCL
- Diffuse Large B Cell Lymphoma (DLBCL) is the most common and aggressive form of Lymphoma
- 27,000 new cases/year in the US ~ 30% of patients do not respond to treatment or experience a relapse
- Patients who fail salvage regimens: median overall survival 4.4 months
- CAR T-cell therapies
- 40-50%complete response (CR) rates with 29-37% being durable
- High rates of severe cytokine release syndrome (13-22%) and severe neurotoxicity (12-28%) - Early onset and severity of toxicities requires intensive inpatient management
- Chemotherapy + Antibodies combinations: 40% CR rate
- Unmet medical need remains
- CAR-Tmanufacturing, treatment and toxicity limit broad application
- Patients for which CAR-T is not an option and before CAR-T
- DPX-Survivac:differentiated MOA and efficacy/safety profile
- Combinations possible (no added toxicity, survivin target - unique MOA)
- Off-the-shelfmfg, no requirement for hospitalization, lymphodepletion or extensive safety monitoring
© 2020 IMV Inc. All rights reserved.
High unmet medical need for non-eligible to CAR-T/chemo elderly population
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Phase 2 r/r DLBCL - Combination with Keytruda
Investigator-sponsored, (n=up to 25), with 22 patients enrolled so far
- Primary endpoint met with 64% response rate (7/11 evaluable patients) PR and CR
- Top line data is expected to be presented at a conference later in 2020
Single agent activity in DLBCL Trials as published in 2019* | 2020: Investigational therapies in r/r DLBCL* |
DPX-Survivac/CPA
plus Keytruda
64% ORR
Green color bars denote agents (CAR-T therapies - Yescarta, Kymriah) that are approved by the FDA; Polatuzumab approved in combination with bendamustine and rituximab
© 2020 IMV Inc. All rights reserved.
Orange color bars denote agents that have been or will be submitted for FDA approval in 2020
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Favorable Comparison With CAR T Cells
IMV's T cell therapy has higher ORR in head-to-head comparison with cyclophosphamide (cy) only
IMV T cell therapy | CAR-T cell | ||||
T cell therapy | Survivin targeted T cells + pembrolizumab | CD-19 CAR T Cells | |||
Chemotherapy | • Intermittent oral low-dose Cy (50mg BID 1 | • High dose lymphodepletion before CAR-T | |||
week on/1 week off) | infusion: Cyclophosphamide (Cy) | ||||
(intravenous 1g/day/3 days) and Fludaribine | |||||
(intravenous 60mg/day/3 days) | |||||
• Bridging chemo allowed before | |||||
lymphodepletion and CAR-T treatment | |||||
Efficacy | • Not tested with Fludarabine | • ORR 50-80% CR 40-60% with high-dose Cy | |||
• ORR 56% - CR 33% with low-dose Cy | and Fludarabine | ||||
(Data presented at ASH, Dec. 2019) | • ORR 30% - CR 10% with Cy only | ||||
Safety | No related SAEs, most common reactions are | Serious adverse reactions (CRS and | |||
grade 1&2 injection site related | Neurotoxicity) | ||||
Ease of care | Off-the-shelf treatment every 8-9 weeks and no | Personalized product, manufacturing time, cell | |||
hospitalization | transplant, hospitalization, high-cost | ||||
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© 2020 IMV Inc. All rights reserved. | |||||
Phase 2 - Combination with Keytruda
Solid Tumor Basket Trial
- Phase 2 study in patients with select advanced & recurrent solid tumors (target n=184) and treated with DPX-Survivac /CPA in combination with pembrolizumab
- As of August 3, 2020, a total of 100 patients were enrolled in recurrent ovarian cancer, hepatocellular, non-small cell lung cancer, bladder cancer and MSI-H cancers
- 1st study scan on 23 patients shows tumor reduction in subjects with ovarian, non-small cell lung and bladder cancer, with partial responses observed in 2 subjects (data presented at ESMO in September 2019)
- Treatments are well tolerated with no immune-related adverse events or grade 3-4 events reported (data presented at ESMO in September 2019)
- T cell infiltration observed in subjects with tumor reduction
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© 2020 IMV Inc. All rights reserved.
Leveraging Our DPX Platform Against COVID-19
IMV's vaccine technology is unique and highly differentiated
- Precision immunology: synthetic peptides to generate targeted immune responses
- Focus and increase the potency of the immune response against epitopes with capacity to neutralize viral infections
- Eliminate non-functional component of the immune response (non- neutralizing epitopes)
- Potential for improved safety and efficacy and best-in-class in most at-risk populations (elderly, immuno-compromised and subjects with comorbidities)
Clinically proven and de-risked: clinical demonstration with another respiratory virus (RSV) provides blueprint for COVID-19
DPX vaccines are fully synthetic and lyophilized products
- Speed to cGMP production and clinic
- Easily scaled commercial production with billion doses capacity
- Stable product with long shelf-life facilitating stockpiling and distribution
© 2020 IMV Inc. All rights reserved.
Different approaches to develop a vaccine against COVID-19
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COVID-19 Program Overview
IMV
* Initiation of phase 2 clinical trial contingent on successful outcome of phase 1 clinical trial
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© 2020 IMV Inc. All rights reserved.
© 2018 IMV Inc. All rights reserved.
DPX-RSV as a Blueprint for DPX-COVID-19
Target Mechanism Of Action (MOA)
Antibodies binding to SH on the infected cell surface. stimulates phagocytosis by alveolar macrophages, limiting viral infection in the lung (deep-lung infection and hospitalization)
23 amino acid B cell epitope
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© 2020 IMV Inc. All rights reserved.
DPX-RSV as a Blueprint for DPX-COVID-19
DPX-RSV formulation and preclinical development
Clinical Results (n=40 older adults)
23 a.a. B cell epitope (
Lyophilized vaccine
content
10 to 25 µg peptide + Lipid nanoparticles
)
Diluent for
reconstitution
Mineral oil (ISA51 VG)
High antibody titers generated in 100% of subjects and can be maintained for more than one year
Anti RSV SH antibody titers
Antibodies bind target protein and are functional
50 µl intramuscular administration
Validation immunogenicity and functionality in preclinical (mouse and cotton rats) studies
© 2020 IMV Inc. All rights reserved.
Ab binding to target | Ab-dependent phagocytosis | ||||
7 | * * * | * | |||
P L A C E B O | |||||
i s | 6 | Placebo | * * * | * * | A L O H S h e |
RSV(A) Alum | |||||
s | |||||
t o | 5 | DPX-RSV(A) | I M V S h e | ||
c y | 4 | ||||
o | |||||
p h a g | 3 | ||||
% | P B S | ||||
2 | |||||
1 | |||||
d a y 0 | d a y 8 4 | d a y 4 2 1 |
Langley et al, J Infect Dis 2018
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DPX-COVID-19 Vaccine Design
Mechanism of Action (MOA)
Coronavirus-neutralizing antibodies primarily target the trimeric spike
(S) on the coronavirus surface that mediate entry into host cells.
S1 subunit, mediates attachment to the host cell and the S2 domain mediates fusion and entry
MOA based on a combination of neutralizing epitope targeting non- overlapping functional areas acting synergistically to increase protective efficacy and avoid risk of immune escape
MOA1 (receptor binding domain)
Human receptor Blocking attachment to human cells
MOA2 (S1/S2 Cleavage)
Spike ProteinBlocking S1/S2 conformational change
SARS COV-2 Virus
MOA3 (Fusion peptide) Blocking entry into human cells
Epitope Mapping
Hundreds peptide epitopes identified
23 targets
selected for
animal studies
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© 2020 IMV Inc. All rights reserved.
Rapid Progress since March 18, 2020
- Predicted and identified several hundred epitopes of SARS-COv-2 based on virus sequences and immunoinformatics of which 23 were selected for validation in preclinical studies based on their biological relevance to the virus and potential to generate neutralizing antibodies against SARS-CoV-2
- All 23 peptide epitopes formulated with the DPX platform were evaluated in preclinical animal models. Majority of peptides generated high targeted antibody responses after the 1st and 2nd dose, without an adjuvant
- DPX-COVID-19is an optimal combination of four complementary peptides with high immunogenicity and ability to bind non-overlapping areas on the virus spike and impact its infective function
- Located outside of the 614 mutation which according to recent research has been demonstrated to increase the virus' ability to infect cells in vitro and suggested to potentially reduce vaccine-induced immunity
- Areas on the virus spike identified as potentially responsible for vaccine-enhanced disease have been excluded from our target selection to minimize safety risk
- Confirmatory preclinical studies have demonstrated the capacity of DPX-COVID-19 to induce strong immunogenicity including the binding on target to the spike protein and viral neutralization
- Agreement from Health Canada on Phase 1 clinical study design protocol including older patients of > 56 years
- Completed cGMP formulation and manufacturing process development for clinical trials
- Fully funded with nearly CDN 5 M$ obtained from various Canadian governmental agencies
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© 2020 IMV Inc. All rights reserved.
DPX-COVID-19 Phase 1 Trial Design agreed with Health Canada
- Randomized controlled study, assessing the safety and immunogenicity of DPX-COVID-19
- 84 healthy adults across two age cohorts:
- (1) adults between 18-55 years old inclusive
- (2) 56 years old and above
- Two dose levels of DPX-COVID-19 will be tested (25μg or 50μg)
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© 2020 IMV Inc. All rights reserved.
DPX-COVID-19 Upcoming Milestones
Summer 2020
- Publication of pre-clinical studies in a peer-reviewed scientific journal
- Initiation of phase 1 clinical study
Fall 2020
- Preliminary results of phase 1 clinical study
- Initiation of phase 2 clinical study assuming positive phase 1 results
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© 2020 IMV Inc. All rights reserved.
COVID-19 : Our track record in infectious diseases
- Our platform has the ability to generate strong B and T cell immune responses in older adults including immunocompromised patients
- We have been working with partners for years to develop a clinical asset pipeline outside of oncology
Disease | Target | Results | Partners | Reference(s) |
RSV | SHe | N=40; well tolerated; robust antigen | VIB | Langley et al, 2019, JID |
B cell epitope | specific immune responses at both | CCfV | ||
dose levels in all subjects | ||||
Anthrax | rPA | Induced protective immune | NIAID | Weir et al, npj vaccines, |
responses to challenge in both | 2019 | |||
rabbits and NHPs (N= 6-8) | ||||
Malaria | CSP, RCR | RCR complex; murine studies | Leidos | Healer et al, ASTMH |
complex, | downslected DPX as the most | abstract 2019 | ||
VLPs | potent of three candidate | |||
formulations | ||||
Ebola | Rabies vector | DPX formulation 100% protective in | NIAID | unpublished |
with GP | NHP challenge study (N=4) | |||
Influenza | rHA/inact | Demonstrated cross strain | CCfV/ | unpublished |
virus/VLP | protection in mouse challenge | Medicago | ||
studies (inactived virus) | ||||
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© 2020 IMV Inc. All rights reserved.
Key Upcoming Clinical Milestones
Milestones | Key dates | |
Initiation of Phase 1 clinical trial with DPX-COVID-19 | Summer 2020 | |
Interim data from Phase 1 clinical trial with DPX COVID-19 | Fall 2020 | |
Top line Phase 2 clinical results update in the DLBCL combination trial | H2 2020 | |
Updated Phase 2 clinical results for basket trial | H2 2020 | |
Top line Phase 2 clinical results from the ovarian monotherapy trial | H2 2020 | |
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© 2020 IMV Inc. All rights reserved. | ||
Experienced Leadership
MANAGEMENT | NON-EXECUTIVE DIRECTORS | ||
Frederic Ors, MSc, MBA | Andrew Sheldon, BSc | ||
Chief Executive Officer | Chairman of the Board | ||
Medicago, Univ. Paris 7 | Former President & CEO at Medicago | ||
Pierre Labbé, CPA | Julia P. Gregory, BA, MBA | ||
Chief Financial Officer | Director of the Board, CEO at Isometry Advisors | ||
Medicago, Leddartech | Former CEO and Board Member at ContraFect, | ||
FivePrime Therapeutics, | |||
Joanne Schindler, DVM, MD | |||
Chief Medical Officer | Markus Warmuth, MD | ||
H3, Constellation, SynDevRx, ImmunoGen, Novartis | Director of the Board, Venture Partner at Versant | ||
Ventures and CEO at Monte Rosa Therapeutics, | |||
Marianne Stanford, PhD | Former CEO of H3 Biomedicine | ||
Vice-President, Research & Development | |||
Jennerex Biotherapeutics, Beatrice Hunter Cancer | Wayne Pisano, BSc, MBA | ||
Research | Director of the Board, former President & CEO at | ||
Sanofi Pasteur | |||
Stephan Fiset, MSc, MBA | |||
Vice-President, Research & Development | Shermaine Tilley, PhD, MBA | ||
Medicago, GlaxoSmithKline, CHUL | Director of the Board, Managing Partner at CTI | ||
Life Sciences Fund, Former Senior Vice- | |||
Annie Tanguay, BSc | President at Drug Royalty Corporation | ||
Senior Vice President, Quality and Regulatory | |||
Abbott Laboratories, Telesta | James Hall, CPA, CA | ||
Director of the Board, President of James Hall | |||
Tariq Massad, PhD, PMP | Advisors, Former Vice-President at Callidus | ||
Vice President, Process Dev and Manufacturing | Capital Corporation. | ||
Sanofi Pasteur, Apotex, Therapure | |||
Michael P. Bailey, MBA | |||
Marie-Eve Charrois, MA | CEO and Director of Aveo Oncology. | ||
Vice President, Regulatory Affairs | Formerly at ImClone Systems (now Eli Lilly), | ||
GSK, Medicago | Genentech, Synta Pharmaceuticals, and | ||
Smithkline Beecham. | |||
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© 2020 IMV Inc. All rights reserved. | |||
Stock Information (August 11, 2020)
Ticker: IMV (Nasdaq & TSX)
Market cap: ~ $US 263M / ~ $CAD 352M
Outstanding shares (May 14, 2020)
Basic : 66.5M
Fully diluted : 71.5M
52 Week Trading Range - Nasdaq: $US 1.35 - $US 6.82
52 Week Trading Range - TSX: $CAD 1.98 - $CAD 9.25 Average daily volume (US & Canada) ~2.93M shares
(as at 07/15/2020, last 30 trading days, includes alternative exchanges in Canada)
Board and Management Ownership (fully diluted basis) : ~ 3.5%
© 2020 IMV Inc. All rights reserved.
Analyst Coverage (9)
USA
B. Riley FBR
BTIG
HC Wainwright
Raymond James
Wells Fargo
Canada
Echelon Partners
Industrial Alliance Securities
Mackie Research
National Bank of Canada
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Nasdaq & TSX: IMV
© 2020 IMV Inc. All rights reserved.
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IMV Inc. published this content on 14 August 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 14 August 2020 14:22:06 UTC