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IMUGENE LIMITED — AGM Information 2014
Nov 24, 2014
65124_rns_2014-11-24_24571e23-867b-4631-b219-93bd02f3036e.pdf
AGM Information
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25th November 2014
ASX: IMU
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An Immuno-oncology Company Developing HER-2+ Gastric and Breast Cancer Therapies
Annual General Meeting Radisson Blu Plaza Hotel, Sydney
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Disclaimer
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This presentation is confidential and has been provided to the recipient for information purposes only, and no representation or warranty, express or implied, is made as to the completeness or accuracy of the information contained herein. This presentation does not constitute an offer to purchase securities in Imugene Limited (the “Company”) or an offer to sell, or a solicitation of an offer to buy any securities in the Company. This presentation neither constitutes nor includes a prospectus to offer securities. Further, this presentation does not constitute an offer by the Company to enter into any transaction with any person or a solicitation of an offer to enter into any transaction with the Company in any manner. This presentation is being made only to qualified institutional buyers and institutions that are accredited investors, as those terms are defined under the U.S. federal securities laws and regulations, pursuant to Section 105(c) of the Jump Start Our Business Startups Act of 2012, for the sole purpose of determining whether such persons might have an interest in a contemplated securities offering. This presentation may not contain all the details and information necessary for you to make a decision or evaluation. Neither this presentation nor any of its contents may be used for any other purpose without the prior written consent of the Company. This presentation is not being distributed through mass communication media or addressed to the general public, or to any person other than the immediate audience that is receiving this presentation in person on the date hereof. This presentation must not be distributed, published, reproduced or disclosed (in whole or in part) by recipients to any other person. By attendance at the presentation each recipient agrees to keep the presentation confidential, not to disclose any information included in the presentation in any manner whatsoever and not to disclose the fact of the presentation or any of the terms, conditions, or other facts with respect thereto. No recipient is permitted to utilize this presentation to make an offer, or to solicit any offer, to enter into any transaction whatsoever with or on behalf of the Company.
Certain statements contained in this presentation, including, without limitation, statements containing the words “believes,” “plans,” “expects,” “anticipates,” and words of similar import, constitute “forward-looking statements.” Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the following: the risk that our clinical trials will be delayed and not completed on a timely basis; the risk that the results from the clinical trials are not as favorable as we anticipate; the risk that our clinical trials will be more costly than anticipated; and the risk that applicable regulatory authorities may ask for additional data, information or studies to be completed or provided prior to their approval of our products. Given these uncertainties, undue reliance should not be placed on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the results of any revisions to any of the forward-looking statements contained herein to reflect future events or developments except as required by law.
This presentation may not contain all the details and information necessary for you to make a decision or evaluation. Neither this presentation nor any of its contents may be used for any other purpose without the prior written consent of the Company.
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Imugene is an immuno-oncology company developing B- cell based immunotherapies, known as HER-Vaxx, for HER-2 positive gastric and breast cancer, in the highest profile area of oncology today – immunotherapy.
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What is Immuno-oncolo ? gy
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Immuno-oncology is an emerging therapeutic approach being studied for its potential in the 1 fight against cancer
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Immuno-oncology focuses on understanding how cancer evades the immune system
Immuno-oncology is different from other approaches for treating cancer because it uses 3 the natural capability of the patient's own immune system to fight the cancer
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Imugene’s technology is being developed to stimulate a patient’s immune system to produce its own antibodies to a known and validated target for cancer – the HER-2 receptor
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Immuno-oncology: Gathering Momentum
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Source: Oppenheimer & Co., FactSet and company websites Notes:
1. Immuno-oncology index includes Advaxis, Argenus, Argos, Celldex, Cellectis, Five Prime, Heat Biologics, Innate Pharma, Idera, Inovio, Macrogenics, NewLink and Northwest Bio. Excludes Imune Design, Kite Pharma as theyhave traded for less than 90 days
2. Oncology index excludes Immune Design, Kite Pharma, and Loxo Oncology as they have traded for less than 90 days
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Wh Invest? y
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Compelling science from one of Europe's leading cancer institutes
Pronounced undervaluation anomaly compared with other immuno-oncology companies or ASX listed biotechnology companies at similar development stages
The right, experienced, successful team on board to aggressively drive HER-Vaxx development
Approximately $10 million invested to date
Numerous milestone announcements and valuation inflection points over next 12 months for investors
Long-life patents up to 2030, granted in all major jurisdictions
Potential to improve on Roche's $6.9bn drug, Herceptin
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Leadershi – Ex erience and Track Record p p
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Charles Walker CEO
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Paul Hopper Executive Chairman
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Former CEO and CFO of ASX-listed Alchemia, a late stage oncology biotech company
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20+ years in the life science industry, including a decade in specialist corporate finance in London
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Executed ~50 capital markets transactions as principal and advisor
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Extensive international and ASX biotech capital markets experience particularly in cancer vaccines
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Head of Life Sciences Desk and Australia Desk at Los Angeles-based investment bank, Cappello Capital Corp
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Currently Vice President Oncology R&D at GlaxoSmithKline
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Previously Clinical Lead on Ipilumimab at Bristol-Myers Squibb
Dr Axel Hoos Non-Executive Director
- Co-Director of the think-tank Cancer Immunotherapy Consortium; Imugene is his only Board seat world wide
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- Extensive and successful experience in investment research and financial services management. Active and substantial investor in the biotechnology sector with a particular focus on oncology opportunities. Has built significant positions in several ASX listed companies including Imugene
Otto Buttula Non-Executive Director
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Former CTO Consegna, CEO Adistem Ltd, CEO Mimotopes P/L, COO EQiTX Ltd (ZingoTX & VacTX)
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VP Chemistry Chiron (now Novartis), Research Fellow CRC Vaccine Technology
Dr Nick Ede Head of Manufacturing & Operations
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HER-Vaxx
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HER-Vaxx is a cancer immunotherapy designed to stimulate a patient’s own immune system to attack the cancer
HER-Vaxx stimulates a patient’s B cells to produce antibodies that target only those cancer cells with HER-2 on their surface
About 20% of patients with gastric cancer have the HER-2 molecule – known as being “HER-2 positive (+)”
A Phase I study has shown:
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Generation of anti HER-2 antibodies by patients
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Patient antibodies showed potent anti-tumour activity
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Patients generated immune responses
A Phase Ib/II clinical study is planned in patients with HER-2 overexpression with gastric cancer
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HER-2/neu
P4
P6
P7
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Wh Is HER-2 A Prime Tar et? y g
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HER-2
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Higher chance of cancer spreading
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Greater probability of cancer recurrence (local and systemic)
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Roche’s Herceptin is an antibody targeting HER-2 for breast cancer and HER-2 positive gastric cancer in some countries
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Herceptin sales of $6.9bn pa
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Roche’s newly launched Perjeta also targets HER-2
Cancer cell over expressing HER-2
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Normal cell
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HER-2 Tar et g
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HER-2 receptor
P4
Imugene’s
Binding site of
HER–Vaxx:
x3 peptides
joined P6
Binding site of
together
P7
Cancer cell
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HER-Vaxx Manufacture Process
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PEPTIDE
VIROSOME ASSEMBLED
HER-Vaxx
P6 P4 P7 x3 peptides from HER-2 linked together to stimulate production of the right antibodies
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‘FLU ANTIGENS
Peptide and antigen incorporated into virosome to carry peptides and antigens Influenza antigens to stimulate immune stystem
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“ Peptide vaccines have the benefit of being easy to construct and manufacture on a large scale, they’re inexpensive, and very importantly they are off-the-shelf therapy ,” Elizabeth Mittendorf, associate professor of surgical oncology, MD Anderson Cancer Center
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Clinical Status: Phase I Com leted p
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||||
|---|---|---|
|OBSERVATIONS|
|CLINICAL|
|ENDPOINTS|
|1|n=10|
|All metastatic breast cancer|
|2|
|patients|
|1|Safety and|
|•|
|Patients developed anti-HER-2 antibodies|
|HER-2 +/++|Tolerability|
|3|
|•|
|Antibodies induced displayed potent anti-|
|tumour activity|
|Endocrine dependent disease|
|4|
|•|
|Showed immune response|2|Immunogenicity:|
|antibodies/humoral|
|5|Life expectancy > 4 months|
|and cellular|
|responses|
|Conducted at University of|
|6|
|Vienna|
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Phase I trial in patients with breast cancer published:
Wiedermann et al., Breast Cancer Res Treat (2010) 119 :673 - 683
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Positive Phase I Trial Results
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Humoral • Produced Her-2 specific antibodies 1 Disease • Stable disease in 50% of patients • 1 patient in remission, indicating a 3 beneficial effect of the immune responses induced by vaccination, even in a non-target population
• • 2
Cellular
Cellular immune responses (PBMCs): IL-2, IFNγ, TNFα indicated induction of TH-1 biased immune γ, TNFα indicated induction of TH-1 biased immune , TNFα indicated induction of TH-1 biased immune α indicated induction of TH-1 biased immune indicated induction of TH-1 biased immune responses
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IL-2,
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IFNγ, TNFα indicated induction of TH-1 biased immune γ, TNFα indicated induction of TH-1 biased immune , TNFα indicated induction of TH-1 biased immune α indicated induction of TH-1 biased immune indicated induction of TH-1 biased immune responses
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• Sufficient induction of memory T & B cells after vaccination (comparable to healthy controls)
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• Significant reduction of reg T cells after vaccination (indicating a good vaccine responsiveness as well as beneficial anti-tumour effect)
Safety / Toxicity • No side-effects • Negligible toxicity 4
- “We believe this data is encouraging given the trial was conducted in a non target population” - RM Research
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Clinical Trials
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Combined Phase Ib / II clinical trial planned to confirm safety, evaluate optimal dosing and to show efficacy
Phase Ib Lead in to Phase II Trial
Phase II Trial
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Open label
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~68 patients from Australia and Europe
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18 patients, x3 groups of 6 patients
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Endpoints:
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Efficacy, safety and immune response
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� Blinded, placebo controlled
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Dose of HER-Vaxx to use in Phase II part of study
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Safety: any HER-Vaxx toxicity
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Immunogenicity (anti-HER2/neu antibody titers)
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Test booster schedule (q 4 weeks or 8 weeks)
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Primary endpoints: • Overall survival
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• Progression-free survival
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Secondary endpoint; • Immune response
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Robust Phase II Clinical Desi n: Bi Pharma Focused g g
Double blind, randomised, placebo-controlled study
Small open label lead-in phase (n=18), to determine dosing
1:1 randomisation Arm1: n=34; Arm 2: n=34
Relapsed metastatic gastric cancer patients over expressing HER-2/neu
Phase II N>=68
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34 patients with 34 patients with HER-Vaxx + Chemo Chemo alone
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Gastric Cancer
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Gastric cancer is the second leading cause of cancer mortality and the fourth most common cancer in the world
Approximately 934,000 new cases diagnosed and an anticipated 700,000 deaths annually accounting for 10.4% of cancer deaths worldwide
In European Union (EU27) there were estimated to be around 83,000 new cases of stomach cancer diagnosed, with 55,896 deaths.
Incidence
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In the US, an estimated 21,300 new cases and 10,540 deaths in 2012
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In Australia, there are approximately 1,900 new cases each year
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China has the largest patient population with 42% worldwide cases
Median overall survival in advanced gastric cancer is under 12 months
Sources:
Int J Cancer. 2012 Feb 15;130(4):745-53 Expert Rev Gastroenterol Hepatol, 2012
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Intellectual Property
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| Claim | Expiry Date |
|---|---|
| “Vaccine against diseaes that are associated with the HER-2/Neu oncogene” |
27 Feb 2022 |
| “HER-2/Neu Multi-peptide vaccine” |
11 Apr 2027 |
| “Multi-epitope vaccines for HER-2/Neu associated cancers |
18 Aug 2030 |
| “Lyophilisation of virosomes” | 21 Dec 2025 |
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Newsflow and Milestones
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Commercialize 16
License for Phase III trial 15
Report Phase II results 2H 2017/1H 2018 14 Report Phase I trial results 2H 2015 to 1H 2016 13
Recruit and run Phase II double-blind randomized placebo controlled Phase II trial 2H 2015
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Recruit and run lead in Phase Ib trial 2H 2015 11
Announce Preclinical immunologic results 1H 2015
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Announce Preclinical toxicology results 1H 2015 9 Appoint Principal Investigator 1H 2015 8 US FDA IND granted 1H 2015
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Appoint CRO to run clinical trial 1H 2015 Finalize trial protocol 2H2014
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Appoint manufacturer of HER-Vaxx vaccine
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Appoint manufacturer of peptide antigen Appoint USFDA regulatory consultant
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Complete acquisition of Biolife
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3
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Pronounced Valuation Anomal – Below US Peers y
| Company | Market Cap (USDm) | Development Phase |
|---|---|---|
| Agios Pharmaceuticals,Inc. | $3,400 | Phase I |
| Karyopharm Therapeutics,Inc. | $1,310 | Phase I |
| Dicerna Pharmaceuticals,Inc. | $178 | Phase I |
| Immune Design Corp. | $536 | Phase I |
| Heat Biologics,Inc. | $28 | Phase I |
| Imugene Ltd. | $12 | Phase I |
| Loxo Oncology,Inc. | $185 | Phase I |
| Epizyme,Inc. | $768 | Phase I/II |
| Kite Pharma,Inc. | $1,640 | Phase I/II |
| Idera Pharmaceuticals,Inc. | $218 | Phase I/II |
| Ignyta,Inc. | $127 | Phase I/II |
| Inovio Pharmaceuticals,Inc. | $570 | Phase I/Iia |
| Five Prime Therapeutics,Inc. | $332 | Phase Ib |
| OncoMed Pharmaceuticals,Inc. | $633 | Phase Ib/II |
| Acceleron Pharma,Inc. | $1,040 | Phase II |
| Innate Pharma S.A. | $381 | Phase II |
| MacroGenics,Inc. | $658 | Phase II |
| ArrayBioPharma,Inc. | $467 | Phase II |
| TG Therapeutics,Inc. | $639 | Phase II |
| ZIOPHARM Oncology,Inc. | $373 | Phase II |
| Bionomics Ltd. | $222 | Phase II |
| Verastem,Inc. | $228 | Phase II |
| BIND Therapeutics,Inc. | $137 | Phase II |
| MEI Pharma,Inc. | $145 | Phase II |
| Fate Therapeutics,Inc. | $80 | Phase II |
| TetraLogic Pharmaceuticals Corporation | $107 | Phase II |
| Cerulean Pharma Inc. | $105 | Phase II |
| Endocyte,Inc. | $263 | Phase IIb |
| Stemline Therapeutics,Inc. | $185 | Phase IIb |
Source: Oppenheimer & Co.; Google Finance As of midday AEST 21 November 2014
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Pronounced Valuation Anomaly – Below ASX Peers
| Company | Market Cap (A$m) | Development Phase |
|---|---|---|
| Cellmid | $20 | Pre-clinical |
| Phylogica | $19 | Pre-clinical |
| Antisense Therapeutics | $15 | Phase I |
| Benitec Biopharma | $84 | Phase I |
| Circadian Technologies | $13 | Phase I |
| Patrys | $13 | Phase I |
| Imugene | $12 | Phase I/II |
| Oncosil Medical | $36 | Phase II |
| Viralytics | $55 | Phase II |
| Innate Immuno Therapeutics | $27 | Phase II |
| Bionomics | $222 | Phase II |
| Neuren Pharmaceuticals | $183 | Phase II |
Source: Google Finance As of 12.00pm AEST, 21 November 2014
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Recent Immuno-oncolo Licensin Deals gy g
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| Date | Licensor | Licensee | Technology/ Product | Dev Status | Amount (USD) | Amount (USD) |
|---|---|---|---|---|---|---|
| Upfront | Total | |||||
| 28-Oct-14 | F-Star | BMS | FS-102 targeting HER-2 | Phase I ready | ~$50m | $475m |
| 20-Oct-14 | NewLink Genetics |
Genentech | NLG919 | Phase I | $150m | $1,150m |
| 16-Oct-14 | Aduro Biotech | Janssen | Several candidates | Discovery | $30m | $847m |
| 19-Aug-14 | Emergent Biosolutions |
Morphosys | ES414 | Preclinical | $20m | $183m |
| 18-Jun-14 | Cellectis | Pfizer | CAR-T therapy program | Preclinical | $80m | $299m |
| 27-May-14 | CytomX | BMS | Probody platform | Discovery | $50m | $348m |
| 17-Mar-14 | Five Prime Therapeutics |
BMS | Immuno-oncology therapies |
Discovery | $20m | $351m |
Source: Oppenheimer & Co., Company news, internet
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Financial Information
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Market capitalisation FY 2014 loss: Sample Idea 1 Sample Idea 1 (2 Nov 2014): $2.1m $12.0m Cash and Share Price equivalents 30 Sample Idea 1(20 Nov 2014): 1.1 Sample Idea 1 cents Sept 2014: $0.88m Shares on issue: Net assets Sample Idea 11,156,562,516 Sample Idea 1(June 30 2014): $6.7m
Where applicable, currency in A$
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Investment Summary
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The subject of numerous peer reviewed published journals
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Medical University of Vienna, one of Europe’s leading cancer institutes
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� Technology developed over 10 years
Unlike many immunotherapies, HER-Vaxx is directed against a validated target, HER-2
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HER-Vaxx addresses the targets of Herceptin and Perjeta combined
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Herceptin and Perjeta have proven synergy
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Herceptin sales of $6.9bn in 2013
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IP portfolio 100% owned with 2030 horizon
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Leading clinical and scientific experts; experienced and well incentivised management. Board has significant shareholdings, aligning it with shareholders
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HER-Vaxx FDA Phase II trial designed to be robust and big pharma orientated, to support potential future partnership
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Focused 24 month program to deliver results/value inflection
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Attractively priced and heavily discounted to ASX and international peers
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Contact:
Charles Walker Chief Executive Officer [email protected] + 61 450 44 6990
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