Context Therapeutics Inc. · NASDAQ:CNTX
Context Therapeutics — Investor Presentation (February 2023)
40 slides from Context Therapeutics's investor presentation, Feb 6, 2023
Slide 1: Corporate Presentation: Advancing Medicines for Female Cancers and Other Solid Tumors
February 2023 Corporate Presentation Advancing Medicines for Female Cancers and Other Solid Tumors
Slide 2: Important Notice and Disclaimers
Important Notice and Disclaimers 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
Slide 3: Context Therapeutics Overview
Context Therapeutics Overview Context Therapeutics Inc. - February 20233 Company Overview Our Mission • Advancing medicines for solid tumors, with a primary focus on female cancers CTIM-76 CLDN6 x CD3 bispecific antibody • Claudin 6 (CLDN6) is uniquely expressed in a broad range of solid tumors, inc
Slide 4: Pipeline Highlights
Pipeline Highlights 4 1 Tyligand Biosciences Ltd licensed rights to ONA-XR in China, HK, Macau * Investigator Sponsored Trial Cancer Clinical Indication Preclinical Phase 1 Clinical Phase 2 Clinical Milestones CTIM-76 (CLDN6xCD3 bispecific antibody) CLDN6-positive cancers Candidate selection Q4 2022
Slide 5: 2022 Highlights and Future Milestones
2022 Highlights and Future Milestones Context Therapeutics Inc. - February 20235 Company Overview ONA-XR 2H 2022 1H 2023 2H 2023 1H 2024 Endometrial – OATH trial Phase 2 initial data Endometrial – OATH trial Phase 2 data update Endometrial – OATH trial Phase 2 top line data Breast – ELONA trial Phas
Slide 6: CTIM-76 CLDN6xCD3 bispecific antibody
CTIM-76 CLDN6xCD3 bispecific antibody 6 Contex t Therapeut ics Inc. - February 2023
Slide 7: Emerging Role of Bispecific Antibodies in Treating Solid Tumors
Emerging Role of Bispecific Antibodies in Treating Solid Tumors Harnessing the Immune System to Attack Solid Tumors • A challenge for targeting solid tumors is that many tumor-associated antigens are also expressed on normal tissues, raising concerns about “on-target off-tumor” toxicities • Bispecif
Slide 8: Claudin (CLDN6) is an Ideal Target for Bispecific Antibodies
Claudin 6 (CLDN6) is an Ideal Target for Bispecific Antibodies Opportunity • CLDN6 is a tumor-specific protein that is present at high surface density across many adult and pediatric cancers1 • CLDN6 is expressed at very low levels or absent in normal adult tissue Challenge • CLDN6 antigen is confor
Slide 9: CLDN6 Has the Potential to Reach a Large Patient Population
CLDN6 Has the Potential to Reach a Large Patient Population ~62,500 patients per year in the United States in the Relapse/Refractory Setting CTIM-76 Program Context Therapeutics Inc. - February 20239 Selected Cancer indications Incidence Relapse / Remitting (R/R) Incidence CLDN6 Positive Patient Pop
Slide 10: CLDN6 is Enriched in Cancer Cells vs. Non-Cancer Cells
CLDN6 is Enriched in Cancer Cells vs. Non-Cancer Cells CTIM-76 Program Context Therapeutics Inc. - February 202310 (a) adrenal gland, (b) fallopian tube, (c) kidney, (d) liver, (e) thyroid, (f) prostate, (g) esophagus, (h) stomach, (i) colon, (j) cerebrum, (k) cerebellum, (l) spinal cord, (m) thymus
Slide 11: High CLDN6 Associated with a Worsened Prognosis in Cancer Patients
High CLDN6 Associated with a Worsened Prognosis in Cancer Patients CTIM-76 Program Context Therapeutics Inc. - February 202311 Endometrial Cancer1 Overexpression of CLDN6 is associated with worse overall survival in endometrial cancer patients 1 Kojima, Cancers, 2020 2 Zhang, Front. Cell Dev. Biol.,
Slide 12: CTIM-76: Claudin x CD3 Bispecific Antibody
CTIM-76: Claudin 6 x CD3 Bispecific Antibody Wide therapeutic window • Highly selective CLDN6 binding fragment antibody-binding (Fab) arm • Immunostimulatory CD3 binding single-chain fragment variable (scFv) domain is designed to be functionally monovalent to avoid aberrant T-cell activation, potent
Slide 13: CTIM-76 Exhibits Excellent Selectivity and Specificity
CTIM-76 Exhibits Excellent Selectivity and Specificity CTIM-76 Program Context Therapeutics Inc. - February 202313 • IM301 Mab (CLDN6 Fab arm of CTIM-76) screened for specificity using Integral Molecular Membrane Proteome Array, consisting of ~6,000 human membrane proteins in their native state in u
Slide 14: CTIM-76 Preferentially Targets CLDN6 Over Other Claudin Family Proteins
CTIM-76 Preferentially Targets CLDN6 Over Other Claudin Family Proteins CTIM-76 Program Context Therapeutics Inc. - February 202314 • There is high sequence homology between CLDN6 and CLDN9 in the extracellular loops • CTIM-76 preferentially targets CLDN6, with minimal activity against CLDN9-express
Slide 15: CTIM-76 has the Potential for a Wide Therapeutic Window
CTIM-76 Program Context Therapeutics Inc. - February 202315 CTIM-76 has the Potential for a Wide Therapeutic Window • Data supports potential to dose at levels that promote cancer cell killing but have manageable levels of free cytokine production, thereby potentially reducing the risk of cytokine r
Slide 16: CLDN6 Competitive Landscape
CLDN6 Competitive Landscape1 Programs differentiated based upon treatment modality and selectivity for CLDN6 over CLDN9 CTIM-76 Program Context Therapeutics Inc. - February 202316 Candidate IND Phase 1 Antibody Drug Conjugate (ADC) Bispecific Antibody Cell Therapy CLDN6-CAR-NK CAR-NK + IL7 (not disc
Slide 17: Potential for CTIM-76 to Separate From the Competition
Potential for CTIM-76 to Separate From the Competition Company Program (Development Stage) Description / Details3 Active Programs BioNTech BNT211: CLDN6CAR-T + CARVac (Phase 1) Initial data for BNT211 were presented April 2022 (AACR), with an update in Sept 2022 (ESMO). Received PRIME Designation fo
Slide 18: Role of Bispecific Format in Activity
Role of Bispecific Format in Activity CTIM-76 format demonstrates superior potency compared to a traditional BiTE molecule (e.g., AMG-794) CTIM-76 Program Context Therapeutics Inc. - February 202318 -4 -3 -2 -1 0 -50 0 50 100 Log [bsAb] (nM) % S p e c if ic C y to to x ic it y Negative Control IMC-2
Slide 19: ONA-XR Progesterone Receptor Antagonist for Female Cancers
ONA-XR Progesterone Receptor Antagonist for Female Cancers 19 Contex t Therapeut ics Inc. - February 2023
Slide 20: Unmet Need in Female Cancers
Unmet Need in Female Cancers Prevalence of Metastatic Female Cancers in EU5, Japan, and US ONA-XR Program Context Therapeutics Inc. - February 202320 Source: secondary epidemiologic estimates, 2020 estimates 89,000 28,000 25,000 104,000 30,000 28,000 35,000 12,000 11,000 - 50,000 100,000 150,000 200
Slide 21: Onapristone Extended Release (ONA-XR)
Onapristone Extended Release (ONA-XR) • Progesterone Receptor (PR) oncogenic signaling is associated with female cancers and is a potential resistance mechanism to standard of care treatments including antiestrogens and CDK4/6 inhibitors • Onapristone (ONA) is a progesterone receptor (PR) antagonist
Slide 22: Mechanism of Action
Mechanism of Action Context Therapeutics Inc. - February 202322 ONA-XR Program Cell Survival Stemness Immune Evasion Proliferation Estrogen Progesterone Cancer Driver Stimulus Cancer Growth and MetastasisOutcome Antiestrogens aromatase inhibitors, SERM, SERCA, injectable SERD, oral SERD Antiprogesti
Slide 23: Completed Clinical Trials
Completed Clinical Trials Summary of select clinical trials evaluating onapristone with immediate (IR) or extended release (XR) formulation Onapristone Treatment Stage Patients (n) Clinical Indication Prior Treatments Median (range) Biomarker Data IR (100 mg QD) Ph 2 19 Breast Cancer First line (1L)
Slide 24: Key Ongoing Clinical Trials
Key Ongoing Clinical Trials ONA-XR Program Context Therapeutics Inc. - February 202324 Treatment Clinical Indication Stage Patients (n) Key Inclusion and Exclusion Criteria Ongoing Trial Data Completed Trials / Historical Data2 ONA-XR + Anastrozole1 Endometrial Cancer OATH Trial Ph 2 25 • Must have
Slide 25: ONA-XR Recurrent PR+ Endometrial Cancer
ONA-XR Recurrent PR+ Endometrial Cancer 25 Contex t Therapeut ics Inc. - February 2023
Slide 26: Endometrial Cancer
Endometrial Cancer • Endometrial cancer is the 4th most common cancer in women ̶ Endometrial cancer is on the rise and is linked to obesity1,2 ̶ 12,500 patient deaths per year in the US3 ̶ Market is projected to grow from $1.5bn in 2020 to $5.1bn in 20295 • Hormone signaling is a driver of endometri
Slide 27: Endometrial Cancer Patient Treatment Landscape
Endometrial Cancer Patient Treatment Landscape1 ONA-XR in PR+ Endometrial Cancer Context Therapeutics Inc. - February 202327 Primary Adjuvant 1L Watchful Waiting 2L 3L • Chemotherapy• Chemotherapy • Radiotherapy • Chemotherapy • Lenvima + Keytruda • CPI (MSI-H, dMMR) • Antiestrogen • Clinical trials
Slide 28: ONA-XR + Anastrozole in PR+ Endometrial Cancer
ONA-XR + Anastrozole in PR+ Endometrial Cancer1 • Ongoing Phase 2 Trial ̶ Investigator-initiated, open-label, multi-center trial (the “OATH” trial) evaluating ONA-XR 50 mg BID in combination with the antiestrogen anastrozole 1 mg QD administered orally to treat women with ER+/PR+ advanced or metasta
Slide 29: Preliminary Data vs Historical Trials
Preliminary Data vs Historical Trials1 ONA-XR in PR+ Endometrial Cancer Context Therapeutics Inc. - February 202329 1 Analysis based upon publicly available information and represents a non-head-to-head summary comparison. Data cut off as of September 30, 2022; preliminary raw data ONA-XR + Anastroz
Slide 30: Preliminary Data vs Historical Trials
Preliminary Data vs Historical Trials1 ONA-XR in PR+ Endometrial Cancer Context Therapeutics Inc. - February 202330 1 Analysis based upon publicly available information and represents a non-head-to-head summary comparison. Data cut off as of September 30, 2022; preliminary raw data 0% 10% 20% 30% 40
Slide 31: ONA-XR 2L/3L Metastatic Breast Cancer
ONA-XR 2L/3L Metastatic Breast Cancer 31 Contex t Therapeut ics Inc. - February 2023
Slide 32: Hormone Receptor-positive Breast Cancer
Hormone Receptor-positive Breast Cancer • Breast Cancer is the 2nd most common cancer in women ̶ 2L/3L+ therapy, could represent a $3-5B U.S. segment of $20B endocrine therapy market ̶ Potential to expand ONA-XR into earlier treatment lines • Hormone signaling is a driver of breast cancer ̶ Approxim
Slide 33: ONA-XR has the Potential to be Used Across Many Lines of Treatment
ONA-XR has the Potential to be Used Across Many Lines of Treatment1 ONA-XR in PR+ Breast Cancer Context Therapeutics Inc. - February 202333 1L (First Line) HR+, HER2- Metastatic Breast Cancer 2L 2L 3L • Antiestrogen + CDK4/6 (Ibrance®, Verzenio®, Kisqali®) • Fulvestrant • HER2low (Enhertu®) • mTOR (
Slide 34: Our Development Strategy in 2L/3L HR+,HER2- Metastatic Breast Cancer
Our Development Strategy in 2L/3L HR+,HER2- Metastatic Breast Cancer ONA-XR in PR+ Breast Cancer Context Therapeutics Inc. - February 202334 • Estimated 115,000 treatment eligible patients in United States and EU5 • Unmet need for new therapies that can improve antiestrogen response after CDK4/6 inh
Slide 35: Preliminary Data vs Historical Trials
Preliminary Data vs Historical Trials1 ONA-XR in PR+ Breast Cancer Context Therapeutics Inc. - February 202335 1 Analysis based upon publicly available information and represents a non-head-to-head summary comparison. Data cut off as of September 30, 2022; preliminary raw data ONA-XR + Fulvestrant P
Slide 36: Corporate
Corporate 36 Contex t Therapeut ics Inc. - February 2023
Slide 37: Experienced Leadership Team
Corporate Experienced Leadership 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 strong public company operating
Slide 38: Corporate Investment Highlights
Corporate Investment Highlights (Nasdaq: CNTX) Solid Tumors, Primary Focus on Female Cancers Large Unmet Need Progesterone Receptor and Claudin 6 High-Value Targets Multiple Data Readouts in 2023 Near-Term Milestones Deep Domain Experience, Track Record of Success Strong Team Expected Cash Runway in
Slide 39: Advancing Medicines For Female Cancers and Other Solid Tumors
Advancing Medicines For Female Cancers and Other Solid Tumors © Context Therapeutics 2023
Slide 40: Appendix: Abbreviations
Appendix Abbreviations Context Therapeutics Inc. - February 202340 Clinical Trial Efficacy CBR (CR+PR+ SD ≥6 mos) Clinical benefit rate CR Complete response DCR (CR+PR+ SD) Disease control rate DoR Duration of response mPFS Median PFS ORR (CR+PR) Objective response rate PFS Progression free survival
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