Context Therapeutics Inc. · NASDAQ:CNTX
Context Therapeutics — IPO Roadshow (July 2021)
42 slides from Context Therapeutics's IPO roadshow presentation, Jul 2, 2021
Slide 1: Advancing Medicines for Female Cancers
Filed pursuant to Rule 433 of the Securities Act of 1933 Issuer Free Writing Prospectus dated July 1, 2021 Relating to the Preliminary Prospectus dated July 1, 2021 Registration Statement File No. 333-256572 context therapeutics Advancing Medicines For Female Cancers Context Therapeutics Inc.Filed p
Slide 2: Forward Looking Statement
Forward Looking Statement Except for statements of historical fact, any information contained in These forward-looking statements are subject to a number of risks, this presentation may be a forward-looking statement that reflects uncertainties and assumptions, including those described under the th
Slide 3: Free Writing Prospectus
Free Writing Prospectus This Presentation is not an offer to sell, and is not seeking an This presentation shall not constitute an offer to sell or the offer to buy, any securities of Context Therapeutics Inc. (the solicitation of an offer to buy these securities, nor shall there be Company , or we,
Slide 4: Offering Summary
Offering Summary Issuer Context Therapeutics Inc. Listing CNTX (NASDAQ Capital Markets) Proposed Aggregate Offering $19,500,000 Price Range $12.00-$14.00 per share Shares Offered 1,500,000 Pre-IPO Common Shares Outstanding 6,824,569 as converted Advancing clinical development of ONA-XR, our lead PR
Slide 5: Executive Summary
Executive Summary • Clinical-stage women’s oncology company headquartered in Philadelphia, PA • Lead program is in Phase 2 development for female hormone-dependent cancers • Up to 70% of breast, ovarian, and endometrial cancers are hormone-dependent • Management and advisors have been associated wit
Slide 6: Executive Summary: Lead Product ONA-XR Targets Female Hormone-Dependent Cancers
Executive Summary Lead Product ONA-XR Targets Female Hormone-Dependent Cancers Prevalence of Metastatic Female Hormone-Dependent Cancers in EU5, Japan, and US 250,000 35,000 200,000 150,000 104,000 100,000 12,000 11,000 50,000 89,000 30,000 28,000 28,000 25,000 - Breast Cancer Ovarian Cancer Endomet
Slide 7: Executive Summary: Management and Board of Directors
Executive Summary Management Board of Directors Richard Berman, JD, MBA Jennifer Evans Stacey, Esq Evan Dick, PhD Martin Lehr Tarek Sahmoud, MD, PhD Independent Director Chairman and Independent Director SVP R&D CEO and Director Chief Medical Officer • SVP, Aclaris Therapeutics • GC, Wistar Institut
Slide 8: How We Will Advance Medicines for Female Cancers
Executive Summary How We Will Advance Medicines for Female Cancers Search and Development Model Has Precedence Our Pipeline Preclinical Mid Stage Phase 2 CLDN6xCD3 ONA-XR In-licensing or Acquiring Acquisition from Bispecific Additional Drug Candidates to Build a Arno Therapeutics Research Fully Inte
Slide 9: Executive Summary: Pipeline
Executive Summary Pipeline FDA Cancer Clinical Indication Research Phase 1 Phase 2 Phase 3 Upcoming Milestones Fast Track 1 ONA-XR (PR antagonist) • First patient Mid 2021 1L ER+,PR+,HER2- Phase 1b/2 Trial high ctDNA • Proof of concept data 2022 Breast Cancer 2L/3L ER+,PR+,HER2- • First patient Mid
Slide 10: ONA-XR: Progesterone Receptor Antagonist
context t h e r a p e u t i c s ONA-XR Progesterone Receptor Antagonist 10 Nasdaq: CNTXcontext t h e r a p e u t i c s ONA-XR Progesterone Receptor Antagonist 10 Nasdaq: CNTX
Slide 11: ONA-XR: Oral PR Antagonist for ER+,PR+,HER2- Breast Cancer
ONA-XR ONA-XR: Oral PR Antagonist for ER+,PR+,HER2- Breast Cancer • Up to 70% of breast cancer patients have hormone-dependent disease referred to as ER+,PR+,HER2- • For these patients, estrogen deprivation (via anti-estrogen) therapy is the core treatment modality • Anti-estrogen resistance leads t
Slide 12: Vast Market Opportunity for ONA-XR in Hormone-Driven Breast Cancer
ONA-XR Vast Market Opportunity for ONA-XR in Hormone-Driven Breast Cancer $14.4 Billion $1.4 Billion $0.8 Billion CDK4/6 Inhibitors PI3K Inhibitors mTOR Inhibitors Highest projected or historical annual peak sales for currently marketed products in breast cancer; includes 12 Nasdaq: CNTX historical
Slide 13: ONA-XR Works by Blocking PR Activation of Cancer Signaling Pathways
ONA-XR ONA-XR Works by Blocking PR Activation of Cancer Signaling Pathways Hormone-Dependent Hormone-Independent Activation Activation Estrogen Progesterone Growth Factors How Onapristone Works (FGF, EGF) • Onapristone prevents progesterone receptor (PR) PI3K Ras ER dimerization and nuclear PR trans
Slide 14: ONA-XR is a Full PR Antagonist
Rationale for ONA-XR ONA-XR is a Full PR Antagonist Full Antagonist MIFEPRISTONE ULIPRISTAL ACETATE ORIC-101 ONA-XR TM TM (Korlym ) (Esmya ) (Oric Pharmaceuticals) PR Classification Full Antagonist Partial Antagonist Partial Antagonist Partial Antagonist Configuration 3-Dimensional Flat Flat Flat C-
Slide 15: Clinical Activity Supported by Prior Studies with Immediate Release Formulation
ONA-XR Clinical Activity Supported by Prior Studies with Immediate Release (IR) Formulation Antiprogestin Clinical Indication Response Positives Limitations 2 Onapristone 56% ORR 1L (first line) Immediate Release 67% CBR Breast Cancer Signs of transient liver 1 (ONA-IR) Monotherapy activity enzyme e
Slide 16: Our Strategy to Improve Clinical Outcomes from ONA-IR Studies
ONA-XR Our Strategy to Improve Clinical Outcomes from ONA-IR Studies Extended-Release Incorporate New Utilize PR Biomarker Formulation (ONA-XR) Diagnostic Technologies for patient selection to improve safety to predict response for use in future trials 16 Nasdaq: CNTXONA-XR Our Strategy to Improve C
Slide 17: Clinical Development Plan in Breast Cancer
ONA-XR Clinical Development Plan in Breast Cancer Estimated Treatment Market Size Standard of Care Line (US)* (SOC) Unmet Need Context Trial Trial Status Enrollment Enhance Antiestrogen Adjuvant Completed; Window of (after Primary >>250,000 Antiestrogen potency; decrease 1 Opportunity Data Anticipat
Slide 18: Additional Clinical Opportunity in Gynecologic Cancers
ONA-XR Additional Clinical Opportunity in Gynecologic Cancers Estimated Market Size Standard of Care Cancer (US)* (SOC) Unmet Need Context Trial Trial Status Combination with Recurrent Lenvima + Limited treatment 25,000 Anastrozole in Study Open Endometrial Keytruda options after recurrence 1 PR+ pa
Slide 19: ONA-XR Summary
ONA-XR Summary ONA-XR • ONA-XR is an oral, full progesterone receptor (PR) antagonist • PR is a validated clinical target in breast cancer, emerging target in gynecologic cancers • IP protection through 2034, assuming no additional patent filings Large Market Opportunity • Hormone driven cancer (bre
Slide 20: Claudin 6 Program
context t h e r a p e u t i c s Claudin 6 Program 20 Nasdaq: CNTXcontext t h e r a p e u t i c s Claudin 6 Program 20 Nasdaq: CNTX
Slide 21: CLDN6 x CD3 Bispecific Antibody Designed to Recruit Cytotoxic T-cells
Claudin 6 CLDN6 x CD3 Bispecific Antibody Designed to Recruit Cytotoxic T-cells to Claudin 6-expressing Tumors • Unique Drug Target Tumor cell T cell Lysis Claudin 6 (CLDN6) is an oncofetal membrane protein target expressed in multiple hormone-dependent cancers and absent from healthy adult tissues
Slide 22: Claudin 6 Competitive Landscape
Claudin 6 Competitive Landscape Competition differentiated by stage, drug format, and Claudin 6 selectivity Context BioNTech Abbvie BNT211 Program Confidential SC-004 BNT142 CLDN6xCD3 CLDN6 CAR-T, CLDN6/9 Antibody Format Bispecific CLDN6xCD3 (bi(sFc)) ADC Phase 1, Stage Preclinical Phase 2 Phase 1 i
Slide 23: Claudin 6 Summary
Claudin 6 Summary Precision Medicines Meets Immunotherapy Claudin 6 is Enriched in Multiple Cancers st nd Opportunity to be 1 /2 in Market Based on Current Competition Entering IND Enabling Studies in 2022 23 Nasdaq: CNTXClaudin 6 Summary Precision Medicines Meets Immunotherapy Claudin 6 is Enriched
Slide 24: Corporate
context t h e r a p e u t i c s Corporate 24 Nasdaq: CNTXcontext t h e r a p e u t i c s Corporate 24 Nasdaq: CNTX
Slide 25: Anticipated Use of Proceeds: $19,500,000
Corporate 1 Anticipated Use of Proceeds: $19,500,000 Capital Activity Description 2 Allocation Clinical Development Complete ONA-XR Phase 2 trials $11,000,000 Preclinical Development CLDN6xCD3 bsAb development $3,500,000 General Corporate and Corporate expenses $5,000,000 Working Capital 1 Anticipat
Slide 26: Comparables
Corporate Comparables Female Cancers Search and Development $1,223M $2,083M IPO 2020 Public $614M $227M Acquired IPO 2020 $649M $606M IPO 2020 Public $2,197M $1,121M IPO 2020 IPO 2021 The above listed valuations are based on the closing price of the applicable Company’s common stock on Bloomberg as
Slide 27: Cap Table and Valuation
Corporate Cap Table Valuation Valuation drivers are blended values from the Capitalization (06/25/2021) 5,558,476 following: Common Stock ONA-XR Options 1,266,093 Multiple Phase 2 trial readouts Claudin 6 Fully Diluted Common 6,824,569 Precision medicine meets immunotherapy Search and Development Op
Slide 28: Partnerships
Corporate Partnerships Worldwide Exclusive License to CMC Partnership and Out-licensing of Rights CDLN6 Antibody in Bispecific Format to ONA-XR in Greater China • Integral Molecular to design and optimize CLDN6 x • Tyligand to design and optimize a novel onapristone CD3 bispecific antibody manufactu
Slide 29: Investment Highlights
Corporate Investment Highlights Large Unmet Need Female Cancers High Value Targets Progesterone Receptor and Claudin 6 Lead Product Candidate ONA-XR Being Evaluated in Multiple Phase 2 Trials Strong Team Deep Domain Experience, Track Record of Success Near-Term Milestones Multiple Data Readouts in 2
Slide 30: Advancing Medicines for Female Cancers
Advancing Medicines context for Female Cancers t h e r a p e u t i c s context Nasdaq: CNTX 30 © CONTEXT THERAPEUTICS 2021Advancing Medicines context for Female Cancers t h e r a p e u t i c s context Nasdaq: CNTX 30 © CONTEXT THERAPEUTICS 2021
Slide 31: Appendix
context t h e r a p e u t i c s Appendix 31 Nasdaq: CNTXcontext t h e r a p e u t i c s Appendix 31 Nasdaq: CNTX
Slide 32: Abbreviations
Appendix Abbreviations AR Androgen Receptor ctDNA Circulating tumor DNA ER Estrogen receptor ESR1 Estrogen receptor 1 gene Ful Fulvestrant GR Glucocorticoid Receptor MAPK Mitogen activated protein kinase mBCa Metastatic breast cancer ONA-IR Onapristone immediate release ONA-XR Onapristone extended r
Slide 33: Role of Progesterone in Cancer: Epidemiologic Evidence
Role of Progesterone in Cancer Epidemiologic Evidence: Progesterone Increases Breast Cancer Risk Progesterone promotes oncogenic progression and maintenance of stem cells, creating a reservoir of pre-malignant cells to seed metastasis. Initial evidence for this tumorigenic role is derived from longi
Slide 34: Role of Progesterone in Cancer: Target Validation In Vivo Models
Role of Progesterone in Cancer Target Validation: In Vivo Models 80% 450 14 75% 400 12 350 10 MPA 300 8 Control 250 6 200 4 150 100 2 50 0 Number of Mice With Tumors Proliferative Index of Tumors 0 (n=20 per arm) (Mean BrdU as %) 0 10 20 30 Days WT PR KO Progesterone Receptor Knockout (PR KO) Inhibi
Slide 35: ONA-XR Active in Hard-to-Treat ESR1 Mutations
Rationale for ONA-XR ONA-XR Active in Hard-to-Treat ESR1 Mutations 1,2 • 20-35% of ER+,PR+,HER2- metastatic breast tumors are ESR1 mutated (hyperactive estrogen receptor) 1,2 • Estrogen receptor mutations are associated with resistance to anti-estrogen + CDK4/6i therapy 3 • ESR1 mutations stimulate
Slide 36: Onapristone Clinical Experience
Rationale for ONA-XR Onapristone Clinical Experience Prior Treatments Antiprogestin Stage Patients (n) Clinical Indication Biomarker Data Reference Median (Range) 56% ORR, 17.5-month DoR Onapristone IR Robertson Breast Cancer Phase 2 19 Hormone naïve 67% CBR Locally Advanced or Metastatic (100mg QD)
Slide 37: Safety: ONA-XR Has Improved Tolerability Over ONA-IR
Rationale for ONA-XR Safety: ONA-XR Has Improved Tolerability Over ONA-IR ONA-XR Significantly Reduced Rate ONA-XR Has Lower Cmax and Equivalent (1) (1) of Liver Enzyme Elevations Cmin Compared to ONA-IR Jayaram 2017, Patient plasma exposures exceed cellular IC targets Study Robertson 1999 90 Cottu
Slide 38: ONA-XR: Summary of Cumulative Serious Adverse Events
ONA-XR ONA-XR: Summary of Cumulative Serious Adverse Events* Overall 10mg BID 20mg BID 30mg BID 40mg BID 50mg BID 100mg QD (N=128) (N=16) (N=18) (N=15) (N=14) (N=47) (N=6) System Organ Class Preferred Term n (%) n (%) n (%) n (%) n (%) n (%)* n (%) Any Serious TEAE 34 (27) 7 (44) 7 (39) 6 (40) 3 (21
Slide 39: First Line Metastatic Breast Cancer Phase 1b/2 Adaptive Trial
Breast Cancer 1 First Line Metastatic Breast Cancer Phase 1b/2 Adaptive Trial utilizing ctDNA for Selection of Patients Who Are at High Risk of Early Relapse First Line (1L) Dose Escalation and Expansion Standard of Care Patient Enrichment via ctDNA ® Ibrance ONA-XR + (palbociclib) ® Ibrance (palboc
Slide 40: Second / Third Line Metastatic Breast Cancer Phase 2 Trial
Breast Cancer 1 Second / Third Line Metastatic Breast Cancer Phase 2 Trial Evaluating Complete Hormone Blockade in Women Who Progressed on Prior Therapy in the Metastatic Setting Endpoints: • Primary: ORR Stage 1 Stage 2 • Secondary: ctDNA, PFS, safety ONA-XR ONA-XR 2L / 3L + + ER+,PR+,HER2- Fulvest
Slide 41: Breast Cancer Pharmacodynamic Studies
Breast Cancer Pharmacodynamic Studies Study Target Deliverables • Target engagement 1 Radiolabeled Progesterone • Confirmation of recommended 18 ( F-FFNP PET) Uptake in Tumors phase 2 dose (RP2D) • Drug distribution 2 Window of Opportunity • On-target drug effects in primary breast cancer Studies Se
Slide 42: Onapristone Intellectual Property
Corporate Onapristone Intellectual Property • Will be considered a New Chemical Entity (NCE) • Eligible for regulatory exclusivity in all territories worldwide, outside of China* • ANDA challenge would have to provide bioequivalence to ONA-XR • Issued patents in the US and Japan around extended-rele