TenNor Therapeutics Ltd Zhenkun Ma, PhD Founder & CEO TenNor - - PowerPoint PPT Presentation

TenNor Therapeutics Ltd

Zhenkun Ma, PhD ǀ Founder & CEO

TenNor Overview

• Founded in 2013 as a Cayman corporation, TenNor is a clinical-stage new drug

development company specialized in infectious diseases

• Product portfolio targeting major unmet needs – implant infections, peptic ulcer,

hepatic encephalopathy and bacterial vaginosis

• Lead products with blockbuster market potential - completed Phase I and entering

Phase II clinical trials in the US and China

• Experienced management team with global new drug development expertise and

track records

• Strong financial support from top tier VCs – 6 Dimensions Capital, Northern Light

Venture Capital, etc.

Core Technology

Clearly differentiated from traditional antibiotics

• Multi-targeting – active against drug resistance and low propensity for development of drug resistance
• Unique PK
• Greater synergy than parent drug combination

Synthesis Design Evaluation

Expertise in design of dual- acting molecules

• Mode of action
• Structure-activity

relationships

• Target-inhibitor crystal

structure Novel dual-acting molecular evaluation platform

• Isolated target enzyme assays
• Novel isogenic bacterial mutant

panels

• Specially designed animal models

Patent-protected dual-acting molecule series

• Novel linking site and linker

chemistry

Dual-acting drug conjugates – an unique solution to antibiotic resistance problem

Drug

• H. Pylori Isogenic Strains, MIC (g/ml)

WT R to A R to B R to AB Antibiotic A 0.5 >32 1 >32 Antibiotic B 4 4 64 64 A+B 1 8 1 >8 Conjugate A-B 0.02 0.25 0.04 0.25 Multi-targeting molecules have demonstrated greater synergy than simple drug combinations

Product Portfolio

Drug Discovery Preclinical Dev Clinical Dev Phase I Clinical Dev Phase II Clinical Dev Phase III

TNP-2092 IV Implant and other bacterial biofilm infections TNP-2092 PO (13/5 Grant)* Hepatic encephalopathy (HE) and

• ther GI tract infections

TNP-2198 (13/5 Grant)* Peptic ulcer, bacterial vaginosis and other anaerobic Infections MDR-TB (12/5 Grant)* Multidrug-resistant tuberculosis MDR-GN Multidrug-resistant Gram-negative bacterial infections

* Supported by China major new drugs innovation and development grants

Global IP Protection

▪ Aggressive product lifecycle management strategy – filed 20 additional new patent applications in past 3 years to extend exclusivity to 3036 for key products

U.S. Patent Title Filed Territories Issued 7,666,864 Bicyclic nitroimidazole-substituted phenyl

• xazolidinones

2009.03.25 US, China, JP, AU, NZ, Germany, France, Switzerland, UK, Netherlands, Canada, Russia, India, SA, Brazil 7,884,099 Quinolone Carboxylic Acid-Substituted Rifamycin Derivatives 2008.11.12 US 7,678,791 Nitroheteroaryl-containing Rifamycin derivatives 2007.07.12 US 7,265,107 Rifamycin C-11 oxime cyclo derivatives effective against drug-resistant microbes 2005.03.09 US 7,256,187 Rifamycin C-11 Oxime Derivatives effective against drug-resistant microbes 2005.03.09 US 7,250,413 C-25 carbamate rifamycin derivatives w/ activity against drug-resistant microbes 2005.04.26 US 7,247,634 Rifamycin derivatives effective against drug- resistant microbes 2005.01.12 US, France, UK, Germany, Switzerland, Ireland, Japan 7,238,694 Rif imino derivatives effective against drug- resistant microbes 2005.01.12 US 7,202,246 Spiro-rifamycin derivatives targeting RNA polymerase 2005.06.08 US 7,229,996 Rifamycin derivatives 2005.07.21 US 7,226,931 (R/S) Rifamycin derivatives, their preparation and pharmaceutical compositions 2005.07.21 US, China, Germany, France, UK, Canada, Japan, Hong Kong, Australia, New Zealand

TNP-2092 IV for Implant Infections

Unmet needs

• Joint replacements: 1 million in 2010 increase to 4 million in 2030 (US)
• 2% infection rate; biofilm formation
• Lack of effective therapy: surgical implant removal required
• High cost and patient suffering
• Other biofilm infections – catheter infection, endocarditis, etc.

TNP-2092 profile

• Low potential for development of resistance (multi-targeting)
• Advantage over current therapies in multiple biofilm animal models
• Completed Phase I in the US
• Held FDA formal meeting for clinical development plan
• Plan to apply QIDP and Orphan Drug statues and initiate Phase II in 2018

Market Potential: peak annual sales >$1 billion An intravenous formulation for the treatment of implant and other biofilm infections

TNP-2092 Oral for GI Tract Infections

Unmet needs

• Hepatic encephalopathy (HE): few treatment options
• Irritable bowel syndrome-diarrhea (IBS-D): few treatment options
• Peptic ulcer (H. pylori infection): complicated quadruple therapy; drug resistance

Xifaxan (rifaximin)

• A GI specific antibiotic approved for HE and IBS-D; safety for long-term use
• Current annual sale > $1 billion; $5 billion peak sale projected
• Rapid development of drug resistance

TNP-2092 Profile

• GI specific with <1% systemic exposure
• Lower potential for development of resistance
• Completed Phase 1 – excellent safety/tolerability demonstrated
• Plan to initiate Phase 2 for HE in 2018

▪ Market potential: peak annual sales >$1 billion An oral GI-specific formulation for the treatment of HE and other GI tract infections

TNP-2198 for Anaerobic Infections

Unmet Needs

• Metronidazole a first-line therapy for HP and BV; high level of desistance

−

• H. pylori: 70% resistance rate

−

• G. vaginalis (BV): 40% resistance rate

−

• C. difficile: 25-40% relapse rate

TNP-2198 Profile

• More potent than metronidazole (100-1000 folds) against key pathogens
• Low potential for development of resistance
• High distribution into infection tissues and excellent efficacy in animal models
• Excellent safety/tolerability in GLP toxicology/safety pharmacology studies
• Plan to file IND in 2018

Market Potential: Peak annual sales >$1 billion An oral formulation for the treatment of H. pylori (HP) and bacterial vaginosis (BV)

Experienced Team

China Team (15)

• Zhenkun Ma, PhD (CEO): Abbott, Cumbre and TB Alliance
• Ying Yuan, PhD (VP/Biology): NIH, Pathogenesis and Pfizer
• Xiaomei Wang (VP/Clinical Operation): China CDC
• Xiangyi Xu (Director/Regulatory): Suzhou FDA
• Yu Liu, PhD (Project Management): WuXi AppTec
• Huan Wang, PhD (Project Management): Notre Dame

US/UK Team (10)

• Martin Laurenzi, MD (Clinical Dev): Merck and TB Alliance
• Mark Goldberger, MD (Regulatory): FDA and AbbVie
• Aaron Dane (Statistician): AstraZeneca
• Adam Belley, PhD (Clinical Microbiology): Medicine Co
• Thomas Kovalcik, PhD (CMC): Eurofins
• Paul B. Watkins, MD (Toxicology): U. of North Carolina

临床批件 TenNor Facilities

Meeting Space Office Space Chemistry Lab Microbiology Lab Analytical Lab Drug Stability Lab Sample Storage Document Room

Valuation of Antibiotic Companies

Company Profile (Indication, Class) Lead Product Stage Value (NASDAQ, USD) Arsanis (ASNS) VAP/HAP-MRSA, mAB (Novel) Phase 1 $314M Spero (SPRO) Potentiator, Polymyxin (Known) Phase 1 $206M Nabriva (NBRV) CAP, Pleuromutilin (Known) Phase 2 $193M Summit (SMMT) CDI, Ridinilazole (Novel) Phase 2 $201M Achaogen (AKAO) UTI/IAI, Aminoglycoside (Known) Phase 3 $593M Paratek (PRTK) CAP, Tetracycline (Known) Phase 3 $426M Insmed (INSM) CF/NTM, Amikacin Inhalation (Known) Phase 3 $ 1.74B

(Date: 2018/03/27)

2018-2019 Strategy

Portfolio

• TNP-2092 IV: complete Phase 2 proof-of-concept study, initiate Phase 3 for implant infections
• TNP-2092 PO: complete Phase 2 proof-of-concept study in HE
• TNP-2198: complete Phase 1 for HP and BV

Financial

• Completed Series A in 2013 ($7M)
• Completed Series B in 2016 ($25M)
• Plan for a B+ round to support company until end 2019

Initiate IPO process in NASDAQ or HKEX in 2019-2020

TenNor Therapeutics Limited

Contact: Zhenkun Ma zhenkun.ma@tennorx.com 186-2629-2110 www.tennorx.com