Keymed Biosciences, Inc. · HKEX:2162
Keymed Biosciences — H1 2021 Earnings Presentation
40 slides from Keymed Biosciences's earnings presentation, August 2021
Slide 1: KeyMed Bio 2021 Interim Presentation
KeyMed Bio 2021 Interim Presentation August 2021
Slide 2: Disclaimer
Disclaimer THIS DOCUMENT OR THE INFORMATION CONTAINED HEREIN IS NOT INTENDED TO AND DOES NOT CONSTITUTE ANY OFFER OR INVITATION, SOLICITATION, COMMITMENT OR ADVERTISEMENT OF ANY OFFER FOR SUBSCRIPTION, PURHCASE OR SALE OF ANY SECURITIES, NOR SHALL ANY PART OF THIS DOCUMENT FORM THE BASIS OF OR BE RE
Slide 3: Keymed at a Glance
Keymed at a Glance We are a biotechnology company with multiple clinical-stage assets, each of them being the leading contender within its respective competitive landscape Internally-developed Pipeline Fully-integrated R&D platform Consistently and successfully take on • Innovative antibody discover
Slide 4: Fully-integrated Platform Encompassing All of the Key Functions in Biologic Drug Development
Fully-integrated Platform Encompassing All of the Key Functions in the Biologic Drug Development Autoimmune CM310 (AD) Oncology CM310 (CRSwNP) CM310 (Asthma) CMC313 CMG901 (RRMM, lymphoma and (Solid tumors) other hematological CM350 malignancies) （Solid tumors） CM326 (Asthma) CMG901 (Gastric and GEJ
Slide 5: Top-notch Management Team
Top-notch Management Team Dr. Bo CHEN Dr. Changyu WANG Chairman Executive Director, Executive Director, Senior Vice President Chief Executive Officer Preclinical Evaluation and Translational Medicine Dr. Gang XU Dr. Qian JIA Ms. Yan Mr. Yanrong Executive Director, Senior Vice President ZHANG ZHANG S
Slide 6: Diversified Pipeline Targeting Innovative Biological Therapies in Autoimmune and Oncology
Diversified Pipeline Targeting Innovative Biological Therapies in the Autoimmune and Oncology Therapeutic Areas Status Drug Target Focused Lead Pre- Commercial Candidate (Modality) Indications Identification Clinical IND Ph-I Ph-II Ph-III Partner Rights Moderate-to-severe AD ---Adults China Trial Gl
Slide 7: Proven Manufacturing Capability in Compliance with cGMP Standards
Proven Manufacturing Capability in Compliance with cGMP Standards NMPA/FDA Compliant New Commercial-scale GMP Manufacturing Facility Manufacturing Facility • Commercial production base – Phase I construction (expected • Our Chengdu facility is equipped with three 200 L and completion by 2022)： one 1
Slide 8: Our Key Milestones
Our Key Milestones 2019 2020 2021 Clinical Development • Obtained IND • Obtained IND approval from the NMPA for MIL95/CM312 • Obtained IND approval from the • Initiated the Phase Ib/ IIa clinical trial to evaluate CM310 in patients with moderate-to- approval from NMPA for CM310 severe AD NMPA for CM
Slide 9: Upcoming Milestones
Upcoming Milestones July 2021 - CM310 (IL-4Rα) AD trail-Children & Adolescents：IND application Nov 2020 - CM310 (IL-4Rα) Mar 2021 - CM310 (IL-4Rα) July 2021 - CM355 (CD20 x CD3) AD trial: Phase IIb initiation Asthma, COPD and other NMPA IND application respiratory diseases indications: out-license t
Slide 10: Upcoming Milestones - Core Products
Upcoming Milestones Core Products CM310 CM326 1H 2021：Initiated a Phase IIb trial to evaluate 1H 2021：Initiated a Phase I trial CM310 in moderate-to-severe AD patients. 2H 2021: Expect to complete clinical data collection 1H 2022: Expect to complete clinical data August 2021：CM326 in moderate-to-sev
Slide 11: Upcoming Milestones - Other Products
Upcoming Milestones Other Products CM338 IND application for IgA nephropathy 2H 2021: Expect to initiate a Phase I trail CM355 IND application for B-NHL 2H 2021: Expect to initiate a Phase I trail MIL95/CM312 Initiated a Phase I trail for Lymphoma and solid tumors CM313 Initiated a Phase I trail for
Slide 12: Business Highlights
SECTION 1 Business Highlights
Slide 13: Investment Highlights
Investment Highlights 1 Integrated biotechnology company that has consistently developed innovative antibody therapies, targeting some large underserved medical needs in the autoimmune and oncology therapeutic areas 2 A differentiated autoimmune portfolio led by an IL-4Rα antibody drug targeting a w
Slide 14: Integrated biotechnology company developing innovative antibody therapies
Integrated biotechnology company that has consistently developed innovative 1 antibody therapies, targeting some large underserved medical needs in the autoimmune and oncology therapeutic areas Fully-integrated platform encompassing all of the key functions in the biologic drug development Industry-
Slide 15: A Differentiated Autoimmune Portfolio Led by an IL-4Rα Antibody Drug
2 A Differentiated Autoimmune Portfolio Led by an IL-4Rα Antibody Drug Targeting a Wide Spectrum of Allergic Patients Growth Drivers of Allergic Diseases Treatment Paradigm Evolution Increase in Improvement of Traditional Options Urbanization Hygiene Condition Significant Unmet Clinical Needs Glucoc
Slide 16: IL-4Rα-Targeted Medication Market Overview
2 IL-4Rα-Targeted Medication Market Overview IL-4Rα Antibodies as More Effective Biologic Drugs Sales and IP Rights of Dupixent Million USD 4,030.5 387.8 Regulatory Allergic Diseases (Asthma) District Compound Exclusivity 440.2 • 2027.10 United • 2031.03 2029.03 Biologics Treatment 2,322.8 States wi
Slide 17: Indication Expansion of Dupilumab
2 Indication Expansion of Dupilumab 2017 2018 2019 2020 Clinical Stage 2017.03 2019.03 2020.03 Moderate-to-severe1 Moderate-to-severe Moderate-to-severe Adults Adolescents Children (6~11) 2017.09 2019.08 2020.11 Moderate-to-severe Moderate-to-severe Severe Infants & Children AD Adults Adolescents Ch
Slide 18: CM310 - Most Advanced Domestically-developed IL-4Rα Antibody Candidate in China
2 CM310 - most advanced domestically-developed IL-4Rα antibody candidate in China Significant market potential The first and only marketed IL-4Rα antibody and the only approved biologic targeting IL-4Rα in China • Large market potential: • Launched in 2017, Dupixent has achieved annual sales of US$4
Slide 19: CM310 - Inhibition on IL-4 and IL-13 Activities with High Potency
2 CM310 - Inhibition on IL-4 and IL-13 Activities with High Potency CM310 demonstrated comparable or even higher potency to its competitors in inhibition of T cell stimulation in vitro. CM310 was shown to inhibit the IL-4 or IL-13-induced phosphorylation of the STAT6 more effectively than Dupilumab
Slide 20: CM310 - Favorable Safety and PK/PD Profile
2 CM310 - Favorable Safety and PK/PD Profile CM310 induced decrease in TARC concentration faster than dupilumab (day 8 vs. day 15). At dosing of 300 mg, TARC reduction induced by CM310 is at a greater degree comparing to data of dupilumab in a publicly reported study in healthy volunteers that analy
Slide 21: CM310 - Encouraging Clinical Efficacy Over Dupilumab
2 CM310 - Encouraging Clinical Efficacy in Clinical Trials Over Dupilumab 77.8% patients achieved EASI-75 at day 43 (10.0% of placebo group) Proportion of Patients with EASI-75 Response1 CM310 AD Phase Ib/IIa Trial in China Dupilumab AD Phase III Trial in China 100% 70 57.3%* 75% 77.8% 53 50% 35 ~40
Slide 22: CM326 - Most Advanced Domestically-developed TSLP Antibody Candidate in China
2 CM326 - Most Advanced Domestically-developed TSLP Antibody Candidate in China Potential drug for both eosinophil dependent and independent inflammatory diseases Observed from 60% of moderate-to-severe asthma The efficacy of existing biologic drugs is correlated with patients elevated eosinophil le
Slide 23: CM326 - Higher Potency in Preclinical Studies
2 CM326 - Higher Potency in Preclinical Studies The potency of CM326 to inhibit TSLP-induced cell proliferation was approximately 6-fold higher than that of tezepelumab analog (which internally produced based on public data), although CM326 binds to TSLP with similar affinity to tezepelumab analog T
Slide 24: CM338 - Humanized Antagonist Antibody Against MASP-2
2 CM338 - A Humanized, Highly Potent Antagonist Antibody Against Mannose-binding Lectin-associated Serine Protease-2 (MASP-2) Potentially breakthrough treatment for complement-mediated diseases Role of MASP-2: • MASP-2 is an effector enzyme and key mediator of the lectin pathway, which is one of the
Slide 25: CM338 - Much Higher Binding Affinity Against Narsoplimab Analog
2 CM338 - Much Higher Binding Affinity Across Species Against Narsoplimab Analog Human Cynomolgus monkey Mouse KD=36.4pM KD=45.5pM KD=2.14nM CM338 Source: Company Data KD=7.15nM KD=12.8nM KD=65.3nM Narsoplimab Analog Source: Company Data KEYMED BIOSCIENCES BUSINESS OVERVIEW 26
Slide 26: CM338 - More Effective in Inhibiting the Lectin Pathway
2 CM338 - More Effective in Inhibiting the Activation of the Lectin Pathway In comparison with narsoplimab analog, CM338 is more than 50-fold potent in inhibiting the activation of the lectin pathway Inhibition on formation of C3 convertase (C4b2a) Inhibition on C3b deposition 1.5 1.5 1.0 1.0 OD OD
Slide 27: CMG901 - World's First Claudin 18.2 ADC to Receive IND Approval
3 CMG901 - World’s First Claudin 18.2 ADC to Have Received IND Approval CMG901 is a Claudin 18.2-targeting ADC for the treatment of advanced gastric cancer, pancreatic cancer and other solid tumors. It enables selective cancer killing by attaching a highly potent payload to a Claudin 18.2-specific a
Slide 28: CMG901 - High Affinity and Specificity for Claudin 18.2
3 CMG901 - High Affinity and Specificity for Claudin 18.2 CM311 binds to the target cells with higher binding activity (EC50 = 1.2 nM), compared to zolbetuximab analog (EC50 = 2.2 nM). Most notably, in Claudin 18.2 low-expression cells (3T3-CLDN18.2Dim), CM311 shown much higher binding activity than
Slide 29: CMG901 - Highly Potent ADCC and CDC Effects
3 CMG901 - Highly Potent ADCC and CDC Effects and Highly Active Cytotoxic Payload with Potential By-stander Killing Effects CM311-mediated ADCC is highly efficient against Claudin 18.2-expressing CMG901 is significantly more potent in killing tumor cells with killing rate reaching ~50% vs. 30% with
Slide 30: CMG901 - High Potency in Tumor Growth Inhibition in Vivo
3 CMG901 - High Potency in Tumor Growth Inhibition in Vivo 3 mg/kg of CMG901 led to complete regression of the tumor, while 1 mg/kg of CMG901 resulted in significant tumor growth inhibition of 77%. Notably, CMG901 showed much stronger antitumor effects even at a low dose of 1 mg/kg as compared to 10
Slide 31: T cell Engaging Bispecific Antibodies Developed from Proprietary nTCE Platform
3 T cell Engaging Bispecific Antibodies Developed from Proprietary nTCE Platform Bispecific antibodies Maximal T cell-mediated Minimal cytokine developed from proprietary cell killing effects release syndrome nTCE platform CD20xCD3 bispecific antibody co-developed with InnoCare § Indication: lymphom
Slide 32: Fully-integrated In-house Capabilities for Efficient Development and Manufacturing
4 Fully-integrated In-house Capabilities that Well Position Our Drug Candidates for Efficient, Cost Effective Development and Manufacturing • Innovative antibody discovery platform • Manufacturing facilities are constructed in • Novel T cell engager (nTCE) compliance with cGMP standards in bispecifi
Slide 33: Business Strategies
SECTION 2 Business Strategies
Slide 34: Our Strategies
Our Strategies 3 Strengthen our translational research capabilities to Design and execute accelerate drug discovery and 4 2 Scale up our cost- efficient and cost- development effective manufacturing conscious clinical capacity to provide development plan to affordable innovative advance our drug bio
Slide 35: Financial Updates
4 & is Ti KeyMed Biosciences SECTION 3 Financial Updates
Slide 36: Research and Development Expenses & Administrative Expenses
Research and Development Expenses & Administrative Expenses Research and Development Expenses Administrative Expenses FY2020H1 FY2020H1 RMB million RMB million 10 2 25% 2 29% 40 5% 8 7 1 20% 14% 1 11 14% 100% 28% 100% 3 9 43% 23% Total Pre-clinical study Clinical trial Employee Raw material and Othe
Slide 37: Consolidated Statement of Comprehensive Loss
Consolidated Statement of Comprehensive Loss RMB million 2021 H1 2020 H1 • Other income and gains mainly consist of government grants Other income and gains 21 9 income and foreign exchange gains; R&D expenses -191 -40 Administrative expenses -27 -7 • The share-based payment expenses of RMB96 millio
Slide 38: Consolidated Statement of Financial Position
Consolidated Statement of Financial Position RMB million 30 June 31 December 2021 2020 Non-currents assets Property, plan and equipment 104 101 Right-of-use assets 28 24 Prepayments, other receivables 36 24 and other assets • As at 30 June 2021, cash and Total non-current assets 168 149 cash equival
Slide 39: Consolidated Statement of Financial Position (continued)
Consolidated Statement of Financial Position (continued) RMB million 30 June 2021 31 December 2020 Current liabilities Trade payables 3 4 Other payables and accruals 42 19 Amounts due to related parties - 42 Deferred income 3 3 Contract liabilities 78 8 Lease liabilities 6 4 Total current liabilitie
Slide 40: Consolidated Statement of Financial Position (continued)
Consolidated Statement of Financial Position (continued) RMB million 30 June 2021 31 December 2020 Net liabilities 4,626 1,095 Equity Share capital - - Deficits attributable to owners 4,624 1,095 of the parent Non-controlling interests 2 - Total Deficits 4,626 1,095 KEYMED BIOSCIENCES FINANCIAL OVER