Crinetics Pharmaceuticals, Inc. · NASDAQ:CRNX
Crinetics Pharmaceuticals — FY2020 Earnings Presentation
12 slides from Crinetics Pharmaceuticals's earnings presentation, Mar 30, 2021
Slide 1: 2021 Clinical Strategy and 2020 Financial Results
2021 CLINICAL STRATEGY AND 2020 FINANCIAL RESULTS March 30, 2021
Slide 2: Safe Harbor Statement
SAFE HARBOR STATEMENT This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation are forward-looking statements, including statements regarding: the potential to initiate Phase 3 trials of paltusotine in acromegaly,
Slide 3: Key 2020 and Early 2021 Accomplishments
Key 2020 and Early 2021 Accomplishments Positive paltusotine acromegaly Phase 2 data and completed FDA 1 meeting to inform design of upcoming Phase 3 program Initiated Phase 1 study of CRN04894, an investigational ACTH antagonist 2 being developed for Cushing’s disease and congenital adrenal hyperpl
Slide 4: Phase 3 Program: Designed to Support Potential for Broad First-Line Medical Therapy
Phase 3 Program: Designed to Support Potential for Broad First-Line Medical Therapy Two double-blind, placebo-controlled studies planned to support broad labeling in the U.S. and Europe for use in all acromegaly patients who require pharmacotherapy PATHFNDR-1: Switching from SOC Evaluate safety and
Slide 5: PATHFNDR-1: Enabling Switching from SOC
PATHFNDR-1: Enabling Switching from SOC Placebo (n = 26) Endpoints Key Eligibility Criteria R Total Treatment Period: 9 months Patients controlled on Paltusotine (n= 26) Primary: octreotide or lanreotide • Percent responders vs. placebo depot monotherapy • Start on 40 mg QD or placebo • IGF-1 assess
Slide 6: PATHFNDR-2: Enabling Use in Untreated Patients
PATHFNDR-2: Enabling Use in Untreated Patients Placebo (n = 37) Endpoints Key Eligibility Criteria R Total Treatment Period: 12 weeks Medication naïve Paltusotine (n= 37) Primary: (or untreated ≥4 mo.) • Percent responders vs. placebo • Starting dose: 20 mg QD or placebo OR • Weeks 1-2: Initial forc
Slide 7: Anticipated Paltusotine Milestones
Anticipated Paltusotine Milestones Initiate PATHFNDR-1: switching from SOC 1 (anticipated in 2Q 2021) Initiate PATHFNDR-2: use in untreated patients 2 (anticipated in 2H 2021) Initiation of Phase 2 NETs trial in carcinoid syndrome 3 (end of 2021) Report topline data from PATHFNDR-1 & 2 trials 4 (exp
Slide 8: Endocrinology Development Strategy: Focus on Hormone Levels from Preclinical to Approval
Endocrinology Development Strategy: Focus on Hormone Levels from Preclinical to Approval Phase 2/3 Preclinical POC Disease Efficacy ∆Hormones, ∆Hormones, PK, Safety PROs, PK, Safety Phase 1 Healthy Phase 2/3 Trials Volunteers (Patients) Phase 1 Healthy Volunteer POC ∆Hormones, PK, Safety CONFIDENTIA
Slide 9: CRN04894 Phase 1 Clinical POC Cushing's Disease and CAH – Adrenal Suppression
CRN04894 Phase 1 Clinical POC Cushing’s Disease and CAH – Adrenal Suppression Healthy volunteers: SAD data expected 1H 2021; MAD data expected 2H 2021 Objectives ACTH Stimulation Test Baseline (day -1) Treated (SAD day 1; MAD day 10) • Safety and tolerability ACTH ‘4894 (po) ACTH • Pharmacokinetics
Slide 10: CRN04777 Phase 1 Clinical POC Congenital Hyperinsulinism – Insulin Suppression
CRN04777 Phase 1 Clinical POC Congenital Hyperinsulinism – Insulin Suppression Healthy volunteers: SAD data expected mid-2021; MAD data expected 2H 2021 Objectives 1. IV Glucose Tolerance Test (IVGTT) Baseline (day -1) Treated (SAD day 1) • Safety and tolerability IV glucose ‘4777 (po) IV glucose •
Slide 11: Financials
Financials Funded into 2023 based on current projections Cash Position and Outstanding Shares Cash, cash equivalents and investments $170.9 million as of Dec. 31, 2020 Common shares outstanding 33,028,876 as of Feb. 28, 2021 Fourth Quarter and Full Year 2020 Financials 4Q 2020 Full Year 2020 Total O
Slide 12: 2021 Goal: Three Programs with Clinical POC
2021 Goal: Three Programs with Clinical POC Poised for steady cadence of milestones in 2021 Q1 Q2 Q3 Q4 Initiate PATHFNDR-1 Initiate PATHFNDR-2 Paltusotine SST2 Agonist for Acromegaly & NETs Initiate Phase 2 NETs Trial in Carcinoid Syndrome CRN04894 ACTH Antagonist for Initiate Phase 1 Phase 1 SAD D
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