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IMMUTEP LIMITED — AGM Information 2020
Oct 26, 2020
65122_rns_2020-10-26_321a908f-b3de-4ff2-b6c2-617ff6069926.pdf
AGM Information
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2020 AGM Presentation Marc Voigt, CEO
The global leader in developing LAG-3 therapeutics
Notice: Forward Looking Statements
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The purpose of the presentation is to provide an update of the business of Immutep Limited ACN 009 237 889 (ASX:IMM; NASDAQ:IMMP). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly, these slides and the information they contain should be read in conjunction with past and future announcements made by Immutep and should not be relied upon as an independent source of information. Please refer to the Company's website and/or the Company’s filings to the ASX and SEC for further information.
The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified. No representation or warranty is made as to the accuracy, completeness or reliability of the information. Any forward-looking statements in this presentation have been prepared based on a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside Immutep’s control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks. Because actual results could differ materially to assumptions made and Immutep’s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward-looking statements contained in this presentation with caution.
This presentation should not be relied on as a recommendation or forecast by Immutep. Nothing in this presentation should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.
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General Overview
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Corporate Snapshot
Continued global leadership in LAG3 therapeutics with four product candidates in immuno-oncology and autoimmune diseases
Compelling clinical data reported from multiple clinical trials supporting potential of lead product candidate efti as a combination therapy
Strengthened partnerships & collaborations with pharma industry leaders
| Ticker symbols | IMM (ASX) IMMP (NASDAQ) |
|---|---|
| Securities on | |
| issue(1) | 492.9 million |
| (as at 20 October 2020) |
ordinary shares |
| Market Cap(2) | A$120.7 million |
| (as at 20 Oct 2020) | (US$85.0 million) |
(1) Currently ~25% of the ordinary shares are represented by ADSs listed on NASDAQ where 1 ADS represents 10 ordinary shares. Please refer to latest Appendix 2A released on ASX for a detailed summary of all securities on issue.
(2) Market capitalisation based on ASX share price. NB: US equivalent of market capitalisation is calculated using FX rate of 0.7043 as at 20 October, 2020.
Encouraging efficacy results for efti throughout FY20
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Building Breast
AIPAC
efti’s Cancer
intrinsic
value
TACTI-
002
INSIGHT-
004
TACTI-
mel Melanoma
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-
6-month landmark showed improvement compared to placebo group
-
48.3% Overall Response Rate compared to 38.4% in placebo group
-
• Favourable results in different predefined patient subgroups
-
3 patients with Complete Responses (complete disappearance of all lesions)
-
5 Partial Responses in patients with negative (< 1%) or moderate PD-L1 expression
Lung Cancer & Head and Neck
-
11.8 months Median Progression Free Survival (PFS) in 1st line NSCLC
-
4.3 months median PFS in 2[nd] line HNSCC, with 47% progression free at 6-month landmark
Solid Cancers
-
41.7% of patients showed a Partial Response
-
Early anti-tumour activity signals in difficult to treat cancers
-
Deep durable responses
-
50% of patients decrease of ≥ 75% in the target lesions
-
38% of patients treated for ≥ 12 months
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Other Highlights
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Post FY20
-
Limited impacts to trial recruitment from COVID-19:
-
AIPAC and INSIGHT-004 enrolment complete
-
TACTI-002 >80% enrolment complete
Encouraging TACTI-002 data presented at ESMO
-
IMP761 stable CHO cell line developed with sufficient yields and the manufacturing steps advanced
-
Continued progress with partners and collaborators: Novartis, GSK, Merck & Co (MSD), Merck (Germany) and Pfizer, plus EOC Pharma and CYTLIMIC
ARC grant funding for LAG-3 research partnership with Monash University renewed for a further 3 years
- COVID-19 response prioritised employees and patients - collaboration with clinical sites and regulators
A further 3 patents added to the portfolio, which contains 12 patent families
- Intellectual property position strengthened with 4 new patents in FY20
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Partner & Collaboration Highlights
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Novartis
IMP701 (LAG525) - Phase II
- 5 clinical trials advancing in multiple cancer indications - more than 1,000 patients
GlaxoSmithKline (GSK)
CYTLIMIC
-
Phase I studies of peptide vaccine, CYT001 in advanced or metastatic solid cancer
-
Positive results from YNP01 trial - 70% of patients showed an immune response
-
Interim results from YCP02 study - tumour cell death and infiltration of T cells into tumour regions in 6/9 patients
IMP731 (GSK2831781) - Phase I
-
Ulcerative colitis - 1st patient dosed prompted £4M (AU$7.4M) milestone payment
-
Also completed a Phase I study in 36 healthy Japanese and Caucasian volunteers
EOC Pharma
IMP321 - Phase I in breast cancer
- Patient recruitment completed for EOC202A1101
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•
•
•
•
•
Key Financials
Licensing revenue increased significantly mainly due to a GSK milestone payment of £4M (A$7.49M)
Research material sales decreased due to a single bigger purchase by a customer in FY19
A$1.44M cash rebate & A$1.16M grant income from Federal Government R&D tax incentive program, plus A$6.16M (€3.74M) from French rebate scheme
As expected, R&D and IP expenses increased due to the increased clinical trial activity
Strengthened cash balance with continued investor support through A$10M placement and fully underwritten Entitlement Offer (July/August 2019), plus A$12M Placement (April 2020)
Loss after tax for FY20 was significantly lower compared to FY19 mainly due to the significant increase in the licencing income
•
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| FY20 | FY19 | ||
|---|---|---|---|
| Revenue and other income | A$16.5M | $7.5M | |
| G&A Expenses | A$6.3M | $6.4M | |
| R&D and IP expenses | A$20.4M | $16.6M | |
| Net loss | A$13.5M | $18.3M | |
| Net operating cash outflow | A$10.8M | $15.3M | |
| Cash and cash equivalents at the end of the year |
A$26.3M | $16.6M | |
| Cash in bank (30 September 2020) |
A$22.7M |
7
Immutep Pipeline Update
LAG-3 Therapeutic Landscape Overview
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Autoimmune Oncology |
Company | Program | Preclinical | Phase I | Phase II | Phase III | Total Trials | Patients | |
|---|---|---|---|---|---|---|---|---|---|
| 2 2 |
424 6 |
455 | |||||||
| st | |||||||||
| goni | Eftilagimo | d Alpha Eftilagimod Alpha |
3 4 |
||||||
| A | |||||||||
| BMS | Relatlimab | 8 | 25 | 2 | 35 | 9,982 | |||
| N | ovartis |
LAG525 (IMP701) LAG525 lilib |
1 1 |
4 4 |
~~1,122~~ 5 |
1,069 | |||
| M B. R Te M Xe Antagonist Agonist Depleting AB |
(eramma) | ||||||||
| I. B.I. |
BI754111 BI754111 |
4 4 |
1 1 |
699 5 |
849 | ||||
| ~~erck & Co Inc~~ Macrogenics |
~~MK4280~~ MGD013 |
~~2~~ 2 |
~~1~~ 2 |
910 4 |
854 | ||||
| ~~. ,~~ Merck & Co. Inc. |
MK4280 | 2 |
1 | 3 | 940 | ||||
| egeneron(1) Incyte |
REGN3767 INCAGN02385 |
1 1 |
1 | 546 2 |
92 | ||||
| saro(2) Regeneron(1) |
TSR-033 REGN3767 |
1 1 |
1 | 260 2 |
769 | ||||
Symphogen A/S |
SYM022 | ~~1~~ 2 |
~~255~~ 2 |
132 | |||||
| ~~acrogenics~~ Tesaro(2) |
~~MGD013~~ TSR-033 |
2 |
2 | 75 | |||||
| ncor H-L Roche |
XmAb-22841 RG6139 |
1 1 |
230 1 |
320 | |||||
| Innovent | IBI110 | 1 | 1 | 268 | |||||
| Xencor | XmAb-22841 | 1 | 1 | 242 | |||||
| F-Star | FS-118 | 1 | 1 | 43 | |||||
| IMP761 | 347 -- |
-- | |||||||
| (3) | GSK2831781 (IMP731) |
1 2 |
1 1 |
3 | 346 |
Notes:
Sources: Company websites, clinical trials.gov, and sec.gov, as of October 2020. The green bars above represent programs conducted by Immutep &/or its partners.
9
Tesaro was acquired by and is now part of GSK (https://www.gsk.com/en-gb/media/press-releases/gsk-completes-acquisition-of-tesaro-anoncology-focused-biopharmaceutical-company/ )
1) As of January 7, 2019 Regeneron is in full control of program and continuing development (https://www.sec.gov/Archives/edgar/data/872589/000110465919000977/a19-1325_18k.htm)
2)
Immutep’s Market Opportunity
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Estimated Market Opportunity by 2025
250
200
Oncology [1]
Exposure to
$176.50 billion
three very large Autoimmune [2]
150
and growing $149.40 billion
pharmaceutical
markets
100 Infectious
Disease [3]
$86.20 billion
50
0
0 2 4 6 8 10
CAGR %
Market Value US$ billion
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1) https://www.prnewswire.com/news-releases/oncologycancer-drugs-market-to-reach-176-50-bn-globally-by-2025-at-7-6-cagr-alliedmarket-research-300937810.html
2) https://www.prnewswire.com/news-releases/the-global-autoimmune-disease-therapeutics-market-size-is-expected-to-reach-149-4-billion-by-2025--rising-at-a-mar-ket-growth-of-4-34-cagr-during-the-forecast-period-300902336.html and www.kbvresearch.com/autoimmune-disease-therapeutics-market/
3) Grand View Research: Infectious Disease Therapeutics Market Worth $86.2 Billion By 2025, published 2017. Infectious Disease Therapeutics Market Analysis By Dis-ease Type (HIV infection, Influenza, Malaria, Tuberculosis, Hepatitis,
Immutep Controlled Immunotherapy Pipeline*
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| Oncology Autoimmune |
Program | Preclinical | Phase I | Phase II | Late Stage(5) | Commercial Rights |
Market Size(6) (by) |
|
|---|---|---|---|---|---|---|---|---|
| Eftilagimod Alpha (efti or IMP321) APC activating soluble LAG-3 protein |
Metastatic Breast Cancer AIPAC |
(Chemo – IO) | Global Rights | US$12.7 billion (2024) |
||||
| Non-Small-Cell Lung Ca TACTI-002 |
rcinoma (IO – IO)(1) | US$33.9 billion (2026) |
||||||
| Head and Neck Squamo TACTI-002 |
us Cell Carcinoma (IO – IO | )(1) | US$2.8 billion (2026) |
|||||
| Solid Tumors (IO – IO)(2 INSIGHT-004 |
), (3) | ~~§~~ | ||||||
| Melanoma (IO – IO) TACTI-mel |
US$7.8 billion (2026) |
|||||||
| Solid Tumors (In situ Im INSIGHT |
munization)(2) | |||||||
| Solid Tumors (Cancer Va YNP01 and YCP02 |
ccine)(4) | |||||||
| Metastatic Breast Cancer | (Chemo – IO) | § | Chinese Rights | |||||
| IMP761 (Agonist AB) |
§ | Global Rights | US$149.4 billion (2025) |
|||||
| Notes | ||||||||
| * |
- Information in pipeline chart current as at October 2020
(1) In combination with KEYTRUDA® (pembrolizumab) in non-small cell lung carcinoma (“NSCLC”) or head and neck carcinoma (“HNSCC”) (2) INSIGHT Investigator Initiated Trial (“IIT”) is controlled by lead investigator and therefore Immutep has no control over this clinical trial (3) In combination with BAVENCIO® (avelumab)
- Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials
(5)
Estimation of Datamonitor Healthcare, Informa Pharma Intelligence for US, JP, EU (5) and KBV Research
(6)
(Breast cancer: HR+/HER2- Forecast, January 2017; Non-small cell lung cancer (NSCLC) Forecast, August 2018; Head and neck cancer
Efti: Potential Pipeline in a Product
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Potential for use in various combination settings
Efti is the ideal candidate to combine with available cancer treatments
First-in-Class MHCII agonist
Good safety profile
Encouraging efficacy data Low cost of goods
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Other Eftilagimod Alpha Partnerships
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-
EOC, an Eddingpharm spin-off holding the Chinese rights for efti, Phase I study in MBC ongoing
-
Milestone and royalty bearing partnership
-
Spin off from NEC, Japan: aims to develop cancer drugs discovered by artificial intelligence → mainly cancer vaccines
-
Clinical Trial Collaboration (up to US$5 million for IMM); Phase I completed
-
Strategic supply partnership for the manufacture of efti
-
Through WuXi, Immutep was the first company to use a Chinese manufactured biologic in a European clinical trial
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Broad potential in targeting auto-reactive memory T cells with IMP761
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THE PRESENT: FIGHTING THE SYMPTOMS : Treating general inflammation corticoids, methotrexate, anti-TNF- α , -IL-6, -IL-17, -IL-23 mAbs
THE FUTURE: FIGHTING THE CAUSE : Treating the disease process silencing the few autoimmune memory T cells accumulating at the disease site with IMP761
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Potential game-changer in autoimmune disease Publication in Journal of Immunology in early 2020
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Immutep Out-Licensed Immunotherapy Pipeline*
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Commercial Program Preclinical Phase I Phase II Late Stage[(1)] Updates Rights/Partners Solid Tumors + Blood Cancer (IO-IO Combo) Triple Negative Breast Cancer (Chemo-IO Combo) Novartis currently has five Global Rights clinical trials ongoing for LAG525 Melanoma (IO-IO-Small Molecule Combo) LAG525 in multiple cancer (Antagonist AB) ~~§~~ indications for over 1,000 patients Solid Tumors (IO-IO Combo) Triple Negative Breast Cancer (Chemo-IO-Small Molecule Combo) Ulcerative Colitis GSK’s ongoing Phase II clinical study is evaluating Global Rights GSK‘781 GSK’781 in 242 ulcerative Healthy Japanese and Caucasian Subjects[(2)] (Depleting AB) § colitis patients with clinical Proof-of-Concept expected H1 2021. Psoriasis[(3)]
Notes
- Information in pipeline chart current as at October 2020 (1) Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials (2) Reflects completed Phase I study in healthy volunteers
EAT COVID trial
• Window of opportunity to boost the immune response prior to deterioration requiring intensive care unit (ICU) admission and mechanical ventilation
-
Goal is to:
-
prevent T cell exhaustion and profound lymphopenia
-
eradicate the COVID-19 virus
-
avoid any extensive organ tissue damage
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Notes:
Source: https://covid19.who.int/
EAT COVID trial
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EAT COVID is an investigator-initiated trial evaluating efti in hospitalised COVID-19 patients
Aims to “push the gas” on a patient’s immune response to prevent severe COVID-19 symptoms requiring intensive care and leading to respiratory failure and death.
-
Fully funded by University Hospital Pilsen, Czech Republic
-
Efti supplied under a Material Transfer Agreement
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Phase II
Placebo controlled, double blinded and 1:1 randomised study
Up to 110 Adult patients hospitalised with COVID-19
Next : Recruitment for open label safety run-in of 6 patients, then first cohort of 26 randomised patients Initial interim results expected from early 2021
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15 day Primary endpoint is patient’s clinical status at day 15 (WHO recommended)
Single site Czech Republic
Efti is currently the only APC activator of its kind being evaluated against COVID-19 in a randomised Phase II trial
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Outlook
2020 & 2021 News Flow*
2020
-
AIPAC - interim Overall Survival data to be presented at San Antonio Breast Cancer Symposium 2020: Dec 2020
-
TACTI-002 - more data from NSCLC 1st line: throughout 2020
-
TACTI-002 - more data from HNSCC 2nd line: throughout 2020
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2021
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Final data from TACTI-002 Parts A and C
-
Final data from INSIGHT-004
-
Ongoing regulatory engagement
-
Updates from IMP761
-
Progress from partnered programs
-
TACTI-002 - initial data from NSCLC 2nd line: 2020
-
INSIGHT-004 - data from combination with avelumab: throughout 2020
-
Regulatory progress
-
Progress from partnered programs
Notes:
*The actual timing of future data readouts may differ from expected timing shown above. These dates are provided on a calendar year basis.
Summary
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Global leadership position in LAG-3 with four related product candidates in immuno-oncology and autoimmune diseases
10 active clinical trials (including partnered products) with further significant data read-outs throughout 2020 and 2021
Compelling clinical data from efti & strong rationale to combine with multiple FDA approved treatments
Established commercial partnerships with Merck (MSD), Pfizer / Merck KGaA, Novartis and GSK
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