Alzheimer’s Treatment Needs a New Approach – Xanamem™ Bill Ketelbey – September 2018 Singapore
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Actinogen Medical (ASX:ACW) In May 2018, Actinogen raised • Xanamem, Actinogen’s lead compound, in S T O C K M E T R I C S * $16.5m via an institutional development for the treatment of Alzheimer's A S X C O D E A C W placement and SPP that saw disease (AD) and cortisol-associated cognitive Market Capitalisation $63.1m leading US biotech investor, BVF impairment Enterprise Value $53.1m Partners LP take a 19.9% holding 52-week High/Low $0.039-$0.066 and leading Australia-based • Xanamem, a novel differentiated mechanism Top 20 Shareholdings 61% institutional investors Australian of action: prevents the production of excess Ethical and Platinum Asset brain cortisol Management join the register. T O P 1 0 H O L D E R S Rank Name % • Persistently raised cortisol in the brain is 1 HSBC Custody Nominees 24.34% associated with the development and 2 National Nominees Ltd 4.49% progression of AD 3 Edinburgh Technology Fund Limited 4.43% 4 JK Nominees Pty Ltd 3.68% • First-in-class, brain penetrant, orally active, 5 Citicorp Nominees 2.12% inhibitor of 11βHSD1 enzyme, reducing 6 CS Fourth Nominees 2.04% conversion of cortisone to cortisol 7 Warambi Sari 2.01% 8 BNP Paribas Nominees Pty Ltd 1.93% • Experienced board and management; expert 9 Mr Martin Rogers 1.84% clinical and scientific advisory boards 10 Sunset Capital Management Pty Ltd 1.84% 3 Xanamem™ - novel approach to Alzheimer’s dementia
Commercially experienced, globally recognised Board of Directors Xanamem Clinical Advisory Board Dr. Geoff Brooke Dr. Bill Ketelbey Dr. Jason Loveridge Dr. George Morstyn Prof. Craig Ritchie Prof. Colin Masters Prof. Jeffrey Cummings Chairman CEO & MD Non-Executive Director Non-Executive Director Chair 4 Xanamem™ - novel approach to Alzheimer’s dementia
A foundation of cutting edge research and translation Scientific Advisory Board Prof Brian Walker Prof Scott Webster Prof Jonathan Seckl Pro-Vice-Chancellor Professor of Medicines Discovery Vice Principal Research Strategy and University of Edinburgh University of Edinburgh Resources University of Newcastle Combining deep understanding of endocrinology, 11 β HSD1 and drug discovery • • Conducted seminal research linking cortisol with cognitive decline • Actively engaged in the progress and development of Xanamem Xanamem™ - novel approach to Alzheimer’s dementia 5
Human pilot studies (2004) - Cortisol inhibition improves cognition Inhibiting cortisol production in the brain with carbenoxolone improves cognitive function in healthy elderly men & type 2 diabetics VERBAL FLUENCY – Study 1* VERBAL MEMORY – Study 2** P=0.006 P=0.005 Mean SD Mean SD 40.6 12.4 55.2 8 Placebo Placebo Treatment 44.2 10.6 Treatment 58.8 5.2 0 10 20 30 40 50 60 70 0 10 20 30 40 50 60 70 * Study 1 = 10 healthy subjects Age 55-75 (Mean Age = 65.5 ± 5.5) receiving 100mg carbenoxolone **Study 2 = 12 type 2 diabetics (m=9; f=3) Age 52-70 (Mean Age = 60 ± 4.9) receiving 100mg 3 times daily compared to placebo for 4 weeks, in a double-blind randomised crossover study. carbenoxolone 3 times daily compared to placebo for 6 weeks, in a double-blind randomised crossover study. Significant improvement in verbal fluency and verbal memory after only 4 and 6 weeks treatment 11β -Hydroxysteroid dehydrogenase inhibition improves cognition function in healthy elderly men and type 2 diabetics Sandeep et al., 2004 PNAS (vol. 101, no. 17) 6734-6739 6 Xanamem™ - novel approach to Alzheimer’s dementia
Robust animal data with new candidate Symptomatic and disease modifying effects in mouse models – AUD $25 million invested pre-licensing by ACW COGNITION: treatment 28 days AMYLOID CLEARANCE: treatment 28 days P=0.004 P=0.01 43 ± 21 38 Control Control ± 3 Treatment Treatment 172 ± 28 22 Treatment ± 5 Treatment p=0.01 p=0.004 0 50 100 150 200 250 0 10 20 30 40 50 Latency to enter dark compartment (seconds) Number of Plaques / brain area (total) Mean ± SEM Mean ± SEM Significant improvement in cognition after only 28 days treatment, continuing out to 41 weeks UE2316 in Tg2576 rodent model of Alzheimer’s disease . Sooy, et al., 2015. Endocrinology 156 (12) 4592-4603 7 Xanamem™ - novel approach to Alzheimer’s dementia
Xanamem 8 Xanamem™ - novel approach to Alzheimer’s dementia
Mechanism of action Inhibition of 11 β HSD1, reducing brain cortisol production 9 Xanamem™ for Alzheimer’s disease CONFIDENTIAL
Xanamem • Actinogen’s lead compound • A novel, first in class, potent, orally bioavailable, brain-penetrant, 11βHSD1 inhibitor 1 • Differentiated mechanism of action: blocking cortisol production in the brain • Symptomatic and disease modifying effects in vivo 1 • Well-tolerated – dosed >100 patients/subjects: acceptable clinical safety, toxicity and PK/PD profile 1 • Effective human brain concentrations demonstrated 1 • XanADu – phase II clinical study underway, dosing subjects with mild AD dementia in USA, UK, AU • Fully funded following completion of ~A$5.3 million capital raise in Nov 2017. • Planning ongoing for additional studies and clinical indications • A range of additional studies adequately funded following completion of ~$16.5 million capital raising in May-July 2018 • Composition of matter IP coverage ≥ 2031, patents granted in all major markets 1. Webster et al ., 2017, British J Pharmacol 174:396-408 10 Xanamem™ - novel approach to Alzheimer’s dementia
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