Context Therapeutics Inc. · NASDAQ:CNTX
Context Therapeutics — IPO Roadshow (October 2021)
45 slides from Context Therapeutics's IPO roadshow presentation, Oct 18, 2021
Slide 1: Advancing Medicines For Female Cancers
Filed Pursuant to Rule 433 of the Securities Act of 1933 Issuer Free Writing Prospectus dated October 15, 2021 Relating to the Preliminary Prospectus dated October 15, 2021 Registration Statement File No. 333-256572 context therapeutics Advancing Medicines For Female Cancers Context Therapeutics Inc
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) (1) Proposed Aggregate Offering $25,000,000 Price Range $5.00 per share Shares Offered 5,000,000 Pre-IPO Common Shares Outstanding 5,209,792 (2) as converted Advancing clinical development of ONA-XR, our lead PR
Slide 5: Executive Summary
Executive Summary Executive Summary Our Focus → Women’s oncology → Onapristone extended release (ONA-XR) Lead Asset: → ONA-XR is a full progesterone receptor (PR) antagonist ONA-XR → PR oncogenic signaling associated with breast, ovarian, and endometrial cancer → ONA-XR in multiple clinical trials:
Slide 6: Progesterone Receptors Antagonism: Ready for Prime Time
Executive Summary Progesterone Receptors Antagonism: Ready for Prime Time There is heightened interest in Development of PRAs ONA-XR is designed to PR antagonists (PRAs) for hindered by PK issues, address prior treating hormone-dependent poor selectivity, and mixed limitations of PRAs cancers due to
Slide 7: Market Opportunity for Lead Program (ONA-XR)
Executive Summary Market Opportunity for Lead Program (ONA-XR) • We target large, underserved markets • Within the G7 countries, over 355,000 patients are living with metastatic breast, ovarian, or endometrial cancer • Based upon published data, up to 70% of these patients are potentially eligible f
Slide 8: Recent Drug Launches
Executive Summary Recent Drug Launches • Since 2012, there have been 5 major drug approvals, as shown below, for hormone-dependent breast cancer • We believe that ONA-XR will be additive or synergistic with these recently approved drugs, leading to a billion- dollar plus peak sales potential $14.4 B
Slide 9: Focus on Execution
Executive Summary Focus on Execution Management • We believe that clinical development of ONA-XR is primarily a function of exacting clinical execution Evan Dick, PhD Martin Lehr Tarek Sahmoud, MD, PhD SVP R&D CEO and Director Chief Medical Officer • Context has an experienced • SVP, Aclaris Therape
Slide 10: ONA-XR
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 is Being Developed to Enhance SOC Efficacy
ONA-XR ONA-XR is Being Developed to Enhance SOC Efficacy in Hormone-dependent Breast Cancer • The current standard of care (SOC) for primary, hormone-dependent breast cancer (ER+,PR+,HER2-) is antiestrogen therapy st 1 • The current 1 line SOC treatment for metastatic breast cancer is antiestrogen t
Slide 12: Progesterone Receptor (PR) Signaling is Oncogenic
ONA-XR Progesterone Receptor (PR) Signaling is Oncogenic Hormone-Dependent Growth Factor-Mediated PR Signaling PR Signaling 1 • Cancer initiation Oncogenic 2 PR signaling • Metastatic spread Estrogen Progesterone Growth Factors (FGF, EGF) is associated • Resistance to current with: 2,3 therapies PI3
Slide 13: Stereochemical Basis of Onapristone's Full PR Antagonism
ONA-XR Stereochemical Basis of Onapristone’s Full PR Antagonism → Onapristone is the only full PR antagonist (PRA) from among all clinically evaluated PRAs • Full PR antagonism means it exhibits no PR agonist activity → Onapristone’s full PRA activity is attributed, in part, to a unique spatial orie
Slide 14: Patient-Derived Xenograft Data
ONA-XR Patient-Derived Xenograft Data Addition of onapristone to standard of care drugs enhanced tumor regression PDX Xenograft PR+, PIK3CA mutant Placebo Ona Fulv Fulv Fulv Pal Ful Pal Ona Ona Pal Ona Triplet treatment: fulvestrant, onapristone, palbociclib → Onapristone, in triplet with standard o
Slide 15: Promising Evidence of Clinical Efficacy as a First-Line Rx
ONA-XR Promising Evidence of Clinical Efficacy as a First-Line Rx in Breast Cancer Onapristone Immediate Release (ONA-IR) as First Line Therapy → Onapristone in an immediate release formulation 68% (ONA-IR) had a meaningful impact on treatment of 66% 66% hormone-dependent breast cancer 64% → In 1999
Slide 16: ONA-XR Was Designed to Improve Therapeutic Window of ONA-IR
ONA-XR ONA-XR Was Designed to Improve Therapeutic Window of ONA-IR ONA-XR versus ONA-IR: plasma onapristone 1 concentrations at Day 1 and at steady-state → PK dataset enabled a direct comparison between C and steady-state trough concentrations (C ) max min-ss ONA-IR 100 mg QD, Day 1 ONA-IR 100mg QD
Slide 17: ONA-XR Evaluation in Breast Cancer Trials
ONA-XR ONA-XR Evaluation in Breast Cancer Trials Treatment Estimated Standard of Care Line Context Trial Trial Status Patients (US)* (SOC) Medical Need Enrollment Adjuvant Completed; Window of Enhance antiestrogen potency; (after primary >>250,000 Antiestrogen 1 Opportunity decrease progression to T
Slide 18: ONA-XR Evaluation in Gynecologic Trials
ONA-XR ONA-XR Evaluation in Gynecologic Trials Estimated Standard of Care Cancer Context Trial Trial Status Patients (US)* (SOC) Medical Need Combination with Limited treatment Recurrent Anastrozole in PR+ Enrolling Patients 25,000 Lenvima + Keytruda options after Endometrial 1 patients recurrence M
Slide 19: Granulosa Cell Tumor of Ovary: A White Space Opportunity
Granulosa Cell Tumor of Ovary Granulosa Cell Tumor (GCT) of Ovary: A White Space Opportunity • GCT of Ovary are Rare Tumors 3 – Estimated 5,000 patients with recurrent disease in US 1,2 – Almost 100% are progesterone receptor (PR) positive • Current Treatment Options are Limited 3 – Primary treatmen
Slide 20: ONA-XR in Late Line Granulosa Cell Tumors of the Ovary
Granulosa Cell Tumor of Ovary ONA-XR in Late Line Granulosa Cell Tumors of the Ovary Durability of Prior Therapies %, Median prior therapy (Range) 15 Overall 4 (1-17) Durability of Prior Therapy 14 Letrozole + ketoconazole (5 mos) Chemotherapy 1.5 (1-8) 13 Lupron + Cyclophosphamide (2 mos) Antiestro
Slide 21: ONA-XR Summary
ONA-XR Summary ONA-XR • ONA-XR is the only full progesterone receptor (PR) antagonist in clinical development • Clinical activity established with ONA-IR, new data emerging with ONA-XR • ONA-XR has superior safety profile to ONA-IR • IP protection through at least 2034 Market • Hormone-dependent can
Slide 22: Claudin 6 Program
context t h e r a p e u t i c s Claudin 6 Program 22 Nasdaq: CNTXcontext t h e r a p e u t i c s Claudin 6 Program 22 Nasdaq: CNTX
Slide 23: CLDN6 x CD3 Bispecific Antibody
Claudin 6 CLDN6 x CD3 Bispecific Antibody The bispecific antibody simultaneously binds to a CLDN6- • A “pure” cancer target expressing tumor cell and a cytotoxic T-cell. This brings the ̶ Claudin-6 (CLDN6) is an oncofetal protein expressed in several tumor types, T-cell into close proximity to the t
Slide 24: CLDN6 x CD3 Bispecific Retains Selectivity of Parental mAb
Claudin 6 CLDN6 x CD3 Bispecific Retains Selectivity of Parental mAb CLDN6 Binding CLDN9 Binding 4 5 3×10 3×10 IM-271-1HHP Antibody (IgG) Clinical Benchmark (IgG) Context Antibody (IgG) BioNTech Antibody (IgG) IM-271-1HHP (IgG) IMC-20-4 (bispecific) Context (bispecific) Context Antibody (IgG) IMC-20
Slide 25: Context Bispecifics Activate T Cells Against CLDN6+ Cells
Claudin 6 Context Bispecifics Activate T Cells Against CLDN6+ Cells T Cell Activation T Cell Dependent Cytotoxicity • Context bispecifics activate T-cells as determined by T-cell expression of CD25 • Context bispecifics drive T-cell dependent cytotoxicity • Background activation (PBMCs alone) is not
Slide 26: Competitive Landscape/Advantage
Claudin 6 Competitive Landscape/Advantage • Context anti-CLDN6 binding is at least 10x more selective vs. CLDN9 than competitive anti-CLDN6 mAbs and bispecifics • CLDN6:CLDN9 binding selectivity is a critical safety factor for CLDN6-targeted bispecific antibodies Context Xencor BioNTech BNT211 Progr
Slide 27: Claudin 6 Summary
Claudin 6 Summary Claudin-6 is a tumor-specific protein in adults Integrating Claudin-6 binding with the CD3 T-cell engager couples immunotherapy to tumor specific targeting st nd Opportunity to be 1 /2 in market based on current competition Entering IND-enabling studies in 2022 27 Nasdaq: CNTXClaud
Slide 28: Corporate
context t h e r a p e u t i c s Corporate 28 Nasdaq: CNTXcontext t h e r a p e u t i c s Corporate 28 Nasdaq: CNTX
Slide 29: Pipeline
Executive Summary Pipeline FDA Cancer Clinical Indication Research Phase 1 Phase 2 Phase 3 Upcoming Milestones Fast Track 1 ONA-XR (PR antagonist) 1L ER+,PR+,HER2- • First patient Q3 2021 Phase 1b/2 Trial high ctDNA • Phase 1b data 1H 2022 Breast Cancer • First patient Q3 2021 2L/3L ER+,PR+,HER2- Ph
Slide 30: Anticipated Use of Proceeds
Corporate (1) Anticipated Use of Proceeds: $21.0 million Capital Activity Description (2) Allocation ONA-XR development, including our three ongoing Clinical Development ~$9.5 million Phase 2 trials and our ongoing Phase 1b/2 trial Preclinical Development CLDN6xCD3 bsAb development ~5.5 million Gene
Slide 31: Upcoming Milestones
Upcoming Milestones Q3 2021 Q4 2021 1H 2022 2H 2022 ONA-XR Breast – 1L (ctDNA enriched) Phase 1b trial update Breast – 2L/3L (post-CDK4/6) Phase 2 trial update Breast – Window of Opportunity data presentation Breast – PDX mechanism of action data Granulosa Cell – monotherapy Phase 2 trial update Gra
Slide 32: Cap Table and Valuation
Corporate Cap Table Valuation Valuation drivers are: Capitalization 5,209,792 (1) Common Stock ONA-XR Multiple Phase 2 trial readouts (2) Options 436,437 Claudin 6 Precision medicine meets immunotherapy Fully Diluted Common 5,646,229 Business Development Opportunistic pipeline expansion Experienced
Slide 33: 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 34: Advancing Medicines for Female Cancers
Advancing Medicines context for Female Cancers th er ap eu tic s context 34 © CONTEXT THERAPEUTICS 2021 Nasdaq: CNTXAdvancing Medicines context for Female Cancers th er ap eu tic s context 34 © CONTEXT THERAPEUTICS 2021 Nasdaq: CNTX
Slide 35: Appendix
context t h e r a p e u t i c s Appendix 35 Nasdaq: CNTXcontext t h e r a p e u t i c s Appendix 35 Nasdaq: CNTX
Slide 36: 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 37: Epidemiologic Evidence: Progesterone Increases Breast Cancer Risk
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 38: 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 39: 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 40: 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 41: 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 42: 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 43: 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 44: 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 45: Corporate 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 designed and optimized a novel onapristone CD3 bispecific antibody manufactu