Slide 1: Bringing Change for Female Cancers
Corporate Presentation August 2022 BRINGING CHANGE FOR FEMALE CANCERS
Slide 2: Forward Looking Statement
Forward Looking Statement Except for statements of historical fact, any information contained in this presentation may be a forward-looking statement that reflects the Company’s current views about future events and are subject to risks, uncertainties, assumptions and changes in circumstances that m
Slide 3: Company Highlights
Company Highlights Context Therapeutics Inc. - August 20223 Executive Summary Focus on Women’s Oncology → Unmet clinical need in breast, ovarian, and endometrial cancers Financial Strength → Expected cash runway into Q4 2023 ONA-XR oral PR antagonist → Progesterone receptor (PR) oncogenic signaling
Slide 4: Pipeline Executive Summary
Pipeline Executive Summary (1) Tyligand Biosciences Ltd licensed rights to ONA-XR in China, HK, Macau Cancer Clinical Indication Research Phase 1 Phase 2 Phase 3 Upcoming Milestones FDA Fast Track ONA-XR (PR antagonist)1 Breast Cancer 1L ER+,PR+,HER2- ctDNAhigh • Phase 1b data Mid 2023 2L/3L ER+,PR+
Slide 5: Progress Since IPO and Follow-on; Use of Proceeds
Progress Since IPO and Follow-on Use of Proceeds • ONA-XR ̶ Q3 2022: clinical trial collaboration with Menarini Group to evaluate elacestrant, an oral Selective Estrogen Receptor Degrader (SERD), plus ONA-XR ̶ Q2 2022: three presentations at AACR highlighting potential of ONA-XR beyond anti-estrogen
Slide 6: ONA-XR Progesterone Receptor Antagonist
ONA-XR Progesterone Receptor Antagonist 6 Context Therapeutics Inc. - August 2022
Slide 7: Onapristone Extended Release (ONA-XR)
Onapristone Extended Release (ONA-XR) Context Therapeutics Inc. - August 20227 ONA-XR Mechanism of Action → Onapristone is a progesterone receptor (PR) antagonist that suppresses PR oncogenic signaling → PR oncogenic signaling is associated with breast, ovarian, and endometrial cancer → Onapristone
Slide 8: Clinical Development Strategy
Clinical Development Strategy Blocking cancer growth by combining antiestrogen and antiprogestin therapies Context Therapeutics Inc. - August 20228 ONA-XR Cell Survival Stemness Immune Evasion Proliferation Estrogen Progesterone Cancer Driver Stimulus Cancer Growth and MetastasisOutcome Antiestrogen
Slide 9: ONA-XR Evaluation in Breast Cancer Clinical Trials
ONA-XR Evaluation in Breast Cancer Clinical Trials 9 Context Therapeutics Inc. - August 2022 Breast Cancer Treatment Line Context Trial Design Clinical Collaborator Treatment Trial Status PR+ Patients (US)1 Medical Need Adjuvant (after primary disease treatment) Window of Opportunity ONA-XR Complete
Slide 10: ONA-XR Evaluation in Gynecologic Clinical Trials
ONA-XR Evaluation in Gynecologic Clinical Trials 10 Context Therapeutics Inc. - August 2022 Cancer Context Trial Clinical Collaborator Trial Status PR+ Patients (US)1 Standard of Care (SOC) Medical Need Recurrent Endometrial Combination with Anastrozole in PR+ patients Enrolling Patients ~25k Lenvim
Slide 11: Elacestrant + ONA-XR Combination Clinical Trial
Elacestrant + ONA-XR Combination Clinical Trial Clinical Trial Collaboration with Menarini Group 11 Context Therapeutics Inc. - August 2022
Slide 12: Rationale for Clinical Trial Collaboration
Rationale for Clinical Trial Collaboration • Elacestrant is the first oral SERD to show positive Ph 3 top line results1 • Submitted NDA in June 2022 • Potential to enhance elacestrant clinical activity in metastatic breast cancer • Establish clinical proof of concept for ONA-XR combination therapy w
Slide 13: Elacestrant: Potential to be 1st FDA Approved Oral SERD
Elacestrant: Potential to be 1st FDA Approved Oral SERD Strong efficacy/safety data across clinical trials Menarini Clinical Trial Collaboration Context Therapeutics Inc. - August 202213 (1) Patel et al., Breast Cancer Research, 2019 (2) Jager et al., Breast Cancer Research, 2020 (3) Bardia, SABCS,
Slide 14: Elacestrant + ONA-XR: Potential to Improve Breast Cancer Treatment
Elacestrant + ONA-XR: Potential to Improve the Treatment of Breast Cancer • Elacestrant is first oral SERD to show positive top line results in a Phase 3 clinical trial1,2 • If approved, elacestrant has the potential to become the antiestrogen standard of care • When used in combination, ONA-XR may
Slide 15: Phase 1b/2 (ELONA Trial) Design
Phase 1b/2 (ELONA Trial) – Designed to Evaluate Combination Efficacy and Tolerability • Indication: ER+,PR+,HER2- advanced or metastatic breast cancer • Study: Phase 1b (n=12-28) / Phase 2 (n=45) • Primary Endpoint: overall response rate (ORR) • Secondary Endpoint: progression free survival (PFS), c
Slide 16: Claudin Program
Claudin 6 Program 16 Context Therapeutics Inc. - August 2022
Slide 17: Claudin 6 is an Exciting, Emerging Oncology Target
Claudin 6 (CLDN6) is an Exciting, Emerging Oncology Target Context Therapeutics Inc. - August 202217 CLDN6 x CD3 Bispecific Program Claudins are major components of tight junctions that maintain cell polarity and intercellular adhesion. CLDN6 is a tumor-specific protein in adults that is present in
Slide 18: Claudin 18.2 versus Claudin 6
Claudin 18.2 versus Claudin 6 A more advanced Claudin-targeting approach, Claudin 18.2, provides a relevant comparison for Claudin 6 Claudin 18.2 Claudin 6 Most advanced program Phase 3 Phase 1 Competition (clinical) 20+ programs 4 programs Targeting approaches ADC, bispecific, CAR-T, mAb ADC, bispe
Slide 19: CLDN6xCD3 Bispecific Antibody Program
CLDN6xCD3 Bispecific Antibody Program Context Therapeutics Inc. - August 202219 CLDN6 x CD3 Bispecific Program Well characterized anti-CD3gd partner arms Highly specific CLDN6 MAbs generated by Integral Molecular Highly diverse molecular propert ies: SizeAffinity Funct ionSpecif icity 54 Bispecif ic
Slide 20: Our Antibodies Display High Selectivity for CLDN6
Our Antibodies Display High Selectivity for CLDN6 CLDN6 x CD3 Bispecific Program Context Therapeutics Inc. - August 202220 Benchmark = IMAB027 Rucker et al., Development of CLDN6 bispecific antibodies for treatment of ovarian cancer, AACR 2022 IM171 -10 -9 -8 -7 -6 0 50,000 100,000 150,000 Log [MAb]
Slide 21: CLDN6xCD3 Bispecific Antibody Library
CLDN6xCD3 Bispecific Antibody Library CLDN6 x CD3 Bispecific Program Bispecific antibodies retain high CLDN6 specificity Clinical Benchmark Bispecific Formats Log [Bispecific] (M) CLDN9 Reactivity % C y to to x ic it y -4 -3 -2 -1 0 1 2 0 50 100 Candidate Panel 1 - OV90 IMC-16-10 IMC-16-3 IMC-16-15
Slide 22: Corporate
Corporate 22 Context Therapeutics Inc. - August 2022
Slide 23: Experienced Team
Context Therapeutics Inc. - August 202223 Corporate Experienced Team • Experienced team with deep oncology experience • Our CMO led the clinical development of multiple blockbuster drugs for female cancers, including Kisqali, Arimidex, and Afinitor • Our management team is supported by a Board with
Slide 24: Recent and Upcoming Milestones
Recent and Upcoming Milestones ONA-XR Q4 2021 1H 2022 2H 2022 2023 Breast – Window of Opportunity data presentation Breast – AACR preclinical update Breast – Oral SERD clinical trial collaboration Endometrial – Phase 2 trial update Granulosa Cell – Combination Phase 2 trial update Breast – 2L/3L (po
Slide 25: Corporate Investment Highlights
Corporate Investment Highlights Female Cancers Large Unmet Need Progesterone Receptor and Claudin 6 High Value Targets Multiple Data Readouts in 2022 Near-Term Milestones Deep Domain Experience, Track Record of Success Strong Team Expected Cash Runway into Q4 2023 Financial Strength Context Therapeu
Slide 26: Bringing Change for Female Cancers
BRINGING CHANGE FOR FEMALE CANCERS © CONTEXT THERAPEUTICS 2022