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ANAGENICS LIMITED — AGM Information 2014
Oct 9, 2014
64383_rns_2014-10-09_5834b254-b96c-4378-9f84-7bc4021944ac.pdf
AGM Information
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ASX ANNOUNCEMENT
AGM PRESENTATION BY CEO
SYDNEY, Friday, 10 October 2014: Cellmid Limited (ASX: CDY) – Attached is the presentation to be given by Maria Halasz, the Chief Executive Officer, at Cellmid’s Annual General Meeting to be held today at 11:00am at Cliftons, Level 13, 60 Margaret Street, Sydney, 2000.
End
Contact: Maria Halasz, CEO T +612 9221 6830
Cellmid Limited (ASX: CDY)
Cellmid is an Australian biotechnology company developing innovative novel therapies and diagnostic tests for inflammatory diseases and cancer. Cellmid holds the largest and most comprehensive portfolio of intellectual property related to midkine and midkine antagonists globally. The Company’s most advanced development programs involve using its antimidkine antibodies for the treatment of cancer and inflammatory diseases. In addition, Cellmid is commercialising midkine as a biomarker for cancer diagnosis. Elevated midkine concentration in the blood and other body fluids is strongly indicative of cancer. For further information please see www.cellmid.com.au.
CELLMID LIMITED ACN 111 304 119 ASX I CDY Suite 1802, Level 18, 15 Castlereagh Street Street, Sydney NSW 2000 AUSTRALIA TELEPHONE +61 2 9221 6830 FACSIMILE +61 2 9221 8535 WEB www.cellmid.com.au
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CELLMID LIMITED CEO PRESENTATION ANNUAL GENERAL MEETING
10 October 2014 Maria Halasz CEO
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This presentation contains forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown risks that may cause the actual results, performance or achievements of Cellmid to be materially different from the statements in this presentation.
Actual results could differ materially depending on factors such as the availability of resources, the results of clinical studies, the timing and effects of regulatory actions, the strength of competition and the effectiveness of the Company's patent protection.
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Cellmid Limited (CDY:ASX)
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KEY STATISTICS
• Share price 3 cents
•
Market cap $21
• Shares on issue 736M
• Options 290M
• Cash (30 June 2014) $2.5M
• Top 20: 35%
•
6 month turnover 675M shares ($23.6M)
• Base cash burn $300K/m (before revenue)
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12 MONTHS SHARE PRICE PERFORMANCE
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BOARD
•
Dr David King (Chairman)
•
Maria Halasz (CEO and MD)
•
Graeme Kaufman (NED)
•
Martin Rogers (NED)
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MANAGEMENT
• Maria Halasz (CEO and MD)
• Darren Jones (Head of Product Development)
• Koichiro Koike (General Manager, Japan)
• Emma Chen (General Manager, Australia)
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Cellmid Limited
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Midkine oncology
antibody program
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Midkine cancer
diagnostics
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Novel target with strong validation
from 690+ publications
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Quest LungDx for differentiating
indeterminate lung nodules
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Comprehensive intellectual property
with 50 patents in cancer
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Fujikura Kasei for Japanese latex
diagnostics and supply
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Companion biomarker patented,
validated with assay
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Diagnostic collaborations in liver,
colorectal cancer and glioma
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Advangen: Consumer
health
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Novel anti-aging hair care products
(FGF5 inhibitors)
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$2.8 million
revenue in
2014
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Highly basic 13kD (121aa) protein with 2 functional domains C domain Flexible hinge N domain
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Midkine
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Growth factor prominent in embryogenesis, but barely detectable in healthy adults
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In adults, midkine expression occurs in two settings:
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Malignancy
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• Inflammation
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90% amino acid identity between mammalian species
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Allows strong validation in animal models
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Midkine is an important cancer target
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Midkine
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| Blood a a a a a a a a a a a a a a a a a a a a Tissue a a a a a a a a a a a a a a a a a a a a a a a Urine a a a a a a a a a a Breast Prostate Ovarian Cervical Uterine Lung (NSC) Lung (SC) Lung (brain mets) Neuroblastoma Glioblastoma Medulloblastoma Primative neurectodermal Meninginoma Neurofribromatosis type I Gastric GI stromal Bladder Colorectal Duodenal Oral SCC Osophageal SCC Hepatocellular Bile Duct Pancreatic Thyroid Osteosarcoma Renal CLL |
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Midkine
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Human prognostic studies confirm clinical relevance
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100
80
MK negative (n=33)
60
40
20 MK positive (n=74)
MK-positive IHC
Gastric adenocarcinoma
0
0 20 40 60 80
Months
Zhao et al Mol Med Report 2012
% survival
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Midkine antibody slows tumour growth and metastasis
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Midkine antibody inhibits primary tumour growth and slows metastasis in osteosarcoma
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Intra-muscular xenograft (143B cell line)
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IP injection 24h post xenograft, then every 5 days to 42 days (dose 4mg/kg)
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Tumor growth Lung metastases
Anti-MK mAb
n =5
Time (weeks) n =5
Sueyoshi et al Can Lett 2011
Tumor growth
(calf circumference, mm)
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Midkine in the literature
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Midkine is one of the most extensively validated disease targets 2014: British Journal of Pharmacology Midkine Special Edition 2012: Springer book
2010-14: 3 Midkine Symposia, well attended by global research leaders from 15 countries
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3 [rd] midkine symposium highlights
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Significant new findings on midkine biology, manufacture and clinical utility reported
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Serum-stable, drug-like MK manufacture achieved at large scale for clinical use by one of the company’s commercial partners A major milestone for Cellmid’s MK therapeutic protein programs
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Cellmid’s anti-MK antibodies shown to overcome drug-resistance in the deadly brain cancer glioma in pre-clinical efficacy studies conducted by the company’s collaborators at Complutense University, Spain Clinical relevance
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Cellmid’s anti-MK antibody shown to enhance bone fracture healing in vivo in animal studies conducted by the company’s collaborators at the University of Ulm, Germany Utility
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Precise mechanism of action by which MK promotes inflammatory cell infiltration into tissues was presented by an academic delegate from Ludwig-Maximillians University, Germany Insight into how anti-MK therapeutics might disrupt this process
Continues to add enormous value to Cellmid’s therapeutic and diagnostics programs through collaborations and partnerships
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3 [rd] MK Symposium, Kyoto Japan 2014
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MK diagnostics: Cxbladder
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Launched in USA in March 2013
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Monitoring bladder cancer patients for re-occurrence
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$800K revenue for Cellmid in 2014, $1 million to date
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Reimbursement secured for more than 150 million Americans so far
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Cellmid will receive single digit royalty from sales
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First royalty is expected in late 2014
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Developed by licensee Pacific Edge Biotechnology ($300 million market cap)
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• Pacific Edge maintains target of $100 million in sales in year 5 from launch
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MK diagnostics: LungDx
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Diagnosing lung cancer in indeterminate pulmonary nodules identified by CT-scans
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Currently being developed by Quest Diagnostics
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$250K received by Cellmid to date
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Clinical validation in progress including PLCO study funded by NIH
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• Cellmid will receive single digit royalty from sales
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Update is expected in March 2015 on progress
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MK diagnostics: Fujikura Kasei
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Latex assay platform using Cellmid antibodies
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$600K revenue received by Cellmid to date
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Multiple cancer indications, Japan only
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Clinical validation in progress in ESCC
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Cellmid will sell antibodies for the test in addition to receiving double digit royalties from product sales
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Material supply and license agreement to be signed in 2015
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Midkine: 2014 highlights
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18 Jul 2013 Fujikura exercises option to license Cellmid's diagnostics 29 Jul 2013 Cellmid collaborates on early diagnosis of colorectal cancer 01 Aug 2013 Cellmid receives Pacific Edge milestone shares 03 Oct 2013 Midkine antibodies effective in cancer - clinical direction for its MK antibodies determined 08 Oct 2013 Key patent for midkine antibodies to prevent and treat cancer, inflammatory and autoimmune diseases granted in EU 18 Oct 2013 Key patent for treating autoimmune disorders using midkine antibodies granted in Japan 18 Dec 2013 Results of completed CK3000 diagnostic study – healthy MK levels determined 10 Feb 2014 Patent for surgical adhesion using MK-specific RNA/DNA antisense molecules allowed in the USA 06 Mar 2014 BJP publishes special issue of midkine 15 Apr 2014 Cellmid signs Mk Tribody collaboration agreement with Biotecnol 30 Apr 2014 Significant new findings presented at 3rd midkine symposium in Kyoto 07 May 2014 Cellmid selects lead antibody (CAB102) for clinical trials 19 Jun 2014 Manufacturing partner appointed for CAB102 antibody 20 Jun 2014 Celera/Quest diagnostic license update
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Advangen: anti-aging hair products
inhibiting FGF5
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Novel mechanism to prevent hair aging: thinning,
shedding and volume loss
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21% increase in hair growth rate*
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35% reduction in hair loss*
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Significant increase in growing follicles*
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• 74% found the treatment beneficial for hair growth*
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*Double blinded placebo controlled clinical study
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Market for anti-aging hair products
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Addressing hair thinning, volume loss, hair quality concerns
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38% of women over 35 have excessive hair thinning*
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Hair care market topped $80 billion in 2013**
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Anti-aging hair care is the fastest growing segment in the cosmetics, shampoos and hair lotions segments**
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92% of growth from emerging markets Brazil, China and India**
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49% of total hair care market is in emerging markets**
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*Independent market research
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**Euromonitor international
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Advangen: 2014 highlights
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September 2013 December 2013 January 2014 February 2014 March 2014
April 2014 June 2014
Signed major Japanese distribution agreement with Natural Garden Filed provisional patent application for new FGF5 inhibitors Signed Chinese distribution agreement with Huana Likang Completed new formulation with patented ingredient (évolis plus) Commenced discussions with potential distributors and licensees for évolis plus in USA and Europe Commercial launch into salons commenced in Australia Completed topical safety study of évolis plus
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Financial performance
2012 - 2014
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Revenue history 2012 - 2014
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Total revenue
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$3,000,000
$2,500,000
Total revenue increased from
$2,000,000
$171,000 to $2.8 million
$1,500,000
between 2012 and 2014
$1,000,000 (up 1500%)
$500,000
$-
2012 2013 2014
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Revenue analysis 2014
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| 2012 2013 2014 |
||
|---|---|---|
| Sales revenue Licensing income Other |
$ 29,106 $ 541,649 $ 1,150,931 $ - $ 49,233 $ 1,438,707 $122,941$170,406$206,310 |
|
| **Total ** | $ 152,047$ 761,288$ 2,795,948 |
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R&D spending between 2012 - 2014
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R&D spending
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$2,500,000
$2,000,000
$1,500,000
$1,000,000
$500,000
$-
2012 2013 2014
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R&D spending increased from
$1.6 million to $2.1 million as
antibody program getting
closer to the clinic
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Assets between 2012 - 2014
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Current assets
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$5,000,000
$4,500,000
$4,000,000
$3,500,000
$3,000,000
$2,500,000
$2,000,000
$1,500,000
$1,000,000
$500,000
$-
2012 2013 2014
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Net tangible asset backing per share in
cents
0.52
0.51
0.50
0.49
0.48
0.47
0.46
2012 2013 2014
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•
Current assets increased by 84% between 2012 and 2014
•
Net tangible asset backing continued to increase strongly
during the period even with issuing new equity
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Loss between 2012 - 2014
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Loss after income tax
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Loss per share in cents
$2,500,000
0.50
$2,000,000
0.40
$1,500,000
0.30
$1,000,000 0.20
$500,000 0.10
$- 0.00
2012 2013 2014 2012 2013 2014
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Financial performance 2012 - 2014
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| 2012 2013 2014 % change 2012-2014 |
|
|---|---|
| Total revenue | $ 171,273 $ 761,288 $ 2,795,948 up 1532% $ 1,972,483 $ 1,541,307 $ 1,480,836 down 25% $ 1,636,711 $ 1,746,369 $ 2,100,000 up 28% $ 2,441,636 $ 3,778,936 $ 4,499,891 up 84% 0.46 0.27 0.21 down 54% 0.48 0.48 0.51 up 6% 6% 25% 59% |
| Loss after income tax | |
| R&D spending | |
| Current assets | |
| Loss per share | |
| Net tangible asset backing per share | |
| Revenue/Expenditure ratio |
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Outlook for 2015 and beyond
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Planned phase 1/2a clinical study
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1Q2015: Complete single dose toxicity studies
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• 2Q2015: Complete dose escalation studies
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• 2Q2015: pre-IND meeting • 2Q2015: Commence open label study in multiple solid tumours
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• 4Q2015: Expected completion of phase 1/2a
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Late or end stage patients with prior chemotherapy
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12 patients in 4 groups of 3 each
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Log 3 dose escalating (4 doses, 1 per week)
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The above is subject to a number of internal and external factors including the availability of funding and resources, the outcome of studies and
the timing and effects of regulatory actions.
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Therapeutic pipeline
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| Platform | Disease Program R&D Pre-Clinical Phase 1 Phase 2 Phase 3 On Market Anticipated Milestones Year |
|---|---|
| Anti-Midkine Antibodies |
Solid tumours CAB102 Phase I clinical testing 2015 |
| Kidney injury, inflammatory diseases CAB101 Collaboration 2015 |
|
| Midkine Tribodies | Oncology indications MK Tribody Lead generation 2015 |
| Midkine Protein | Myocardial Ischemia CMK103 IND-enabling studies 2015 |
| Alopecia STAY-MK IND-enabling studies 2015 |
- All dates are indicative only and are subject to risks associated with funding, as well as technical and business uncertainties
| Platform Licensee Disease/Target Program Utility Proof of Concept Clinical Validation Regulatory Approval On Market MK mRNA Multiplex (Urine) Pacific Edge Biotechnology Bladder Cancer Cxbladder Detection, monitoring recurrence MK Protein Multiplex (Blood) Quest Diagnostics Lung Cancer LungDx Early detection MK Protein (Blood) Fujikura Kasei Multiple Cancers Cancer Screen Pan-cancer screening MK Protein (Blood) Midkine MK ELISA Companion Dx Diagnostic pipeline |
|
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Milestone timetable
1Q 2Q 3Q 4Q 1Q 2Q 3Q
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4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 2014 2015 2015 2015 2015 2016 2016 2016 Cancer IND enabling studies Therapeutic Pre-IND meeting Phase 1/2a Cancer Fujikura license Diagnostics Cxbladder royalty LungDx (Quest) Consumer New product range health USA, EU distribution Key milestones
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The above is subject to a number of internal and external factors including the availability of resources, the results of studies, the timing and
effects of regulatory actions, the strength of competition and the effectiveness of the Company's patent protection.
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Summary
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Oncology program ready for phase 1/2a
clinical studies commencing in mid-2015
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Consumer health division is growing rapidly
and close to monetization
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High value oncology platform underpinned by revenue
producing assets
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Thank you
www.cellmid.com.au
@mariahalasz
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