Keymed Biosciences, Inc. · HKEX:2162
Keymed Biosciences — FY2021 Earnings Presentation
42 slides from Keymed Biosciences's earnings presentation, March 2022
Slide 1: Keymed Bio 2021 Annual Results Presentation
Keymed Bio 2021 Annual Results Presentation MAR 2022
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 Bio 2021 Highlights
Keymed Bio 2021 Highlights Efficient Pipeline Advancement Synergistic BD Cooperation ⚫ 9 pipeline products at clinical stage • Collaborate with CSPC, to develop and commercialize CM310 & CM326 for • Core Pipeline the treatment of moderate and severe asthma, COPD and other respiratory • CM310 (IL-4Rα
Slide 4: 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 underserved and challenging di
Slide 5: Diversified Pipeline Targeting Innovative Biological Therapies in the Autoimmune and Oncology Therapeutic Areas
Diversified Pipeline Targeting Innovative Biological Therapies in the Autoimmune and Oncology Therapeutic Areas Abbreviations: 1H = first half; 2H = second half; AD = atopic dermatitis; ADC = antibody drug conjugate; CRS = chronic rhinos inusitis; CRSwNP = chronic rhinosinusitis with nasal polyposis
Slide 6: Promote Drug R&D and Clinical Trials with Efficiency
Promote Drug R&D and Clinical Trials with Efficiency Autoimmune Oncology Promote the pivotal study and the commercialization of CM310 at a fastest pace CMG901（CLDN18.2 ADC） CMG901: Evaluating CMG901 in the dose-escalation Phase I trial in solid tumors (3mg dose group by 2022.3) CM310（IL-4Rα） Expect
Slide 7: Synergistic BD Cooperation
Synergistic BD Cooperation 2021 Emerging Collaborations • 2021.3 Collaborate with CSPC, to develop and commercialize CM310 for the treatment of moderate and severe asthma, COPD and other respiratory diseases in Chinese Mainland, Asthma is in phase II stage • 2021.9 Co-develop CM369（CCR8）:with InnoCa
Slide 8: Top-notch Management Team, Outstanding Industry Reputation
Top-notch Management Team, Outstanding Industry Reputation Bo Chen, Ph.D. Changyu Wang, Ph.D. Chairman Executive Director, Executive Director, Senior Vice President Chief Executive Officer Preclinical Evaluation and Translational Medicine Gang Xu, Ph.D. Qian Jia, Ph.D. Yanrong Zhang Joy Yan, M.D., P
Slide 9: Proven Manufacturing Capability in Compliance with cGMP Standards
Proven Manufacturing Capability in Compliance with cGMP Standards We have consistently and successfully manufactured antibodies in-house for preclinical and clinical studies New Commercial-scale Manufacturing Facility Commercial production base – Phase I construction • We are building a new manufact
Slide 10: 320+ Employees: Recruit Talents to Meet the Growing Demand
Recruit Talents to Meet the Growing Demand for the Development We have built a stable core team and continuously recruit talents to match the Company's growing demand for R&D, clinical trial, manufacture, operation and commercialization By the end of 2021 320+Employees ~40 ~60 100+ 120+ Administrati
Slide 11: 2021 Financial Highlights
2021 Financial Highlights Research and Development Costs Cash, Fixed time deposit and short-term finance （RMB mm) （RMB mm） 400 358 4000 350 18 3,524 16 300 33 3000 250 125 200 150 127 2000 16 100 34 166 50 48 1000 24 354 0 2020.12.31 2021.12.31 0 2020.12.31 2021.12.31 Employee Compensation External
Slide 12: Recognitions from the Capital Market
Recognitions from the Capital Market Keymed Bio has won ample recognitions and supports from the top-tier investment institutions since the establishment in 2016 • 2021.3 Complete Round C Financing, raised a total of 130 million USD • 2021.7 IPO at HKEX, raising a total of HK $3.57 billion • 2022.3
Slide 13: Business Highlights
CHAPTER 2 Business Highlights
Slide 14: 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 15: Integrated biotechnology company that has consistently developed innovative antibody therapies
1 Integrated biotechnology company that has consistently developed innovative 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 16: IL-4Rα-Targeted Medication Market Overview
2 IL-4Rα-Targeted Medication Market Overview IL-4Rα Antibodies as More Effective Biologic Drugs Biologics Treatment IL-4Rα ✓ IL-4Rα antibodies are More Effective for the treatment of Antibody asthma Allergic Diseases (Asthma) Less Effective in reducing exacerbation risk IL-5 IL-5Rα IgE and improving
Slide 17: 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 more
Slide 18: 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 19: 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 20: CM310 - Promising Clinical Efficacy in Clinical Trials Over Dupilumab
2 CM310 - Promising 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 21: CM310 - Encouraging Clinical Efficacy in Phase IIb Clinical Trials, Potential BIC
2 CM310 - Encouraging Clinical Efficacy in Phase IIb Clinical Trials, Potential BIC Primary Endpoint: The proportions of subjects with EASI-75 in high and low dose groups were significantly superior to that in the placebo group Proportion of subjects with EASI-75 100% P<0.0001 P<0.0001 80% 73.1% 70.
Slide 22: CM310 – AD Phase III Clinical Study Design
2 CM310 – AD Phase III Clinical Study Design A Randomized, Double-blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of CM310 Recombinant Human Monoclonal Antibody Injection in Subjects with Moderate-to-Severe Atopic Dermatitis Screening 4W Treatment 52W（W1-W52) F
Slide 23: CM310 – Phase II in Patients with CRSwNP Meets Co-Primary Endpoints
2 CM310 – Phase II in Patients with CRSwNP Meets Co-Primary Endpoints Change from baseline in nasal polyp score at Week 16 (Based on MMRM model) CM310 Placebo 0.0 LS Mean change from baseline -0.5 -0.19 -1.0 -1.5 -2.0 -2.5 -2.32 -3.0 p<0.0001 Change from baseline in nasal congestion score at Week 16
Slide 24: 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 The efficacy of many existing biologic drugs is correlated with Observed from 60% of moderate-to-severe asthma patients elevated eosinoph
Slide 25: 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 26: CM326 - Good Safety Data Obtained in a Phase I Single-dose Study
2 CM326 - Good Safety Data Obtained in a Phase I Single-dose Study of Healthy People The total incidence of TEAEs in the CM326 groups and the placebo group was similar; no TEAEs ≥3, SAE, SUSAR, and deaths were reported, and no subjects withdrew from the study due to drug-related TEAEs CM326 CM326 Pl
Slide 27: CM338 - A Humanized, Highly Potent 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 28: CM338 - Much Higher Binding Affinity Across Species 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 KD=7.15nM KD=12.8nM KD=65.3nM Narsoplimab Analog Source: Company Data
Slide 29: CM338 - More Effective in Inhibiting the Activation of 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 30: CMG901 - World’s First Claudin 18.2 ADC to Have Received 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 31: 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 32: CMG901 - Highly Potent ADCC and CDC Effects and Cytotoxic Payload
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 33: 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 34: CM313 – Highly Potent anti-CD38 Monoclonal Antibody
2 CM313 – Highly Potent anti-CD38 Monoclonal Antibody Promising Drug for RRMM The role of CD38： • CD38 is a type II glycoprotein receptor involved in regulating lymphocyte migration, activation and proliferation, and B-cell differentiation. In hematological tumors, CD38 is mainly expressed on myelom
Slide 35: 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 36: Fully-integrated In-house Capabilities for Efficient, Cost Effective 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 for bispecif
Slide 37: Financial Data
4 & 6 1 KeyMed Biosciences CHAPTER 3 Financial Data
Slide 38: Adjusted Loss for 2021
Adjusted Loss for 2021 （RMB’000） 2021 2020 Note1：Main sources of revenue in 2021: Revenue 110,269 - ①CM310 Asthma and COPD indication licensing revenue: RMB70 Cost of sales (17,200） - million； GROSS PROIT (Note1) 93,069 - ②CM355 licensing revenue: RMB40 million； Other income and gains 52,667 41,190
Slide 39: Summary of the Balance Sheet as at 31 December 2021
Summary of the Balance Sheet as at 31 December 2021 (RMB’000) 2021 2020 （RMB’000） 2021 2020 NON-CURRENT ASSETS CURRENT LIABILITIES Property, plant and 139,419 100,992 Trade payables、Other 98,186 22,816 equipment payables and accruals （Note2） Right-of-use assets 38,111 23,823 Amounts due to related 5
Slide 40: Development Strategy
CHAPTER 4 Development Strategy
Slide 41: 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 42: Thanks for Watching
THANKS FOR WATCHING NAR 2022