Praxis Precision Medicines, Inc. · NASDAQ:PRAX
Praxis Precision Medicines — Q3 2021 Earnings Presentation
17 slides from Praxis Precision Medicines's earnings presentation, Nov 3, 2021
Slide 1: 3Q 2021 Corporate Update
PAGE 1 3 Q 2 0 2 1 CORPORATE UPDATE N o v e m b e r 2 0 2 1
Slide 2: Forward-looking statements
PAGE 2 Forward-looking statements This presentation may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations, and financial conditions, including but not limited to express or implied statements regarding
Slide 3: Leveraging genetics to efficiently translate insights into therapies repeatedly
PAGE 3 Leveraging genetics to efficiently translate insights into therapies repeatedly 0401 02 03 Targets identified through genetics Efficient, rigorous clinical development paths to PoC Patient-guided development strategies Translational tools to inform development 01 02 03 04
Slide 4: Broad portfolio of highly differentiated programs across multiple CNS disorders
PAGE 4 Broad portfolio of highly differentiated programs across multiple CNS disorders REGISTRATIONAL ENABLINGDISCOVERY PRECLINICAL PHASE 1 PHASE 2 Figures represent est. worldwide prevalence PROGRAMMECHANISM OF ACTION PRAX-944 PRAX-114PSYCHIATRY Nav1.2 downregulation SCN2A PRAX-562 PRAX-222* KCNT1
Slide 5: Six placebo-controlled trials across three clinical programs by end of 2021
PAGE 5 Six placebo-controlled trials across three clinical programs by end of 2021 END OF 2021 PRAX-114 ARIA Study for Monotherapy MDD Phase 2/3 ongoing Topline results expected 1H22 PRAX-114 Acapella Study for MDD Phase 2 ongoing Topline results expected 1H22 PRAX-114 Study for PTSD Phase 2 expecte
Slide 6: Substantial potential for value creation across the portfolio
PAGE 6 Substantial potential for value creation across the portfolio MULTIPLE POTENTIAL VALUE-CREATING MILESTONES EXPECTED WITHIN THE NEXT 12+ MONTHS * Plans for upcoming PRAX-114 Phase 2b study in women with menopausal and mood symptoms to be disclosed by end of 2021 INDICATIONPROGRAM PRAX-114 PRAX
Slide 7: PRAX-114 GABAA Receptor PAM key upcoming milestones
PAGE 7 GABAA Receptor PAM PRAX-114 PSYCHIATRY & MOVEMENT DISORDERS Depression Post-traumatic Stress Disorder Essential Tremor 1H 2022 Ph 2/3 Monotherapy MDD Aria Study Topline 1H 2022 Ph 2 MDD Dose-Ranging Acapella Study Topline 2H 2022 Ph 2 PTSD Topline 2H 2022 Ph 2 ET Topline KEY UPCOMING MILESTON
Slide 8: PRAX-114 monotherapy MDD Phase 2/3 Aria Study
PAGE 8 PRAX-114 monotherapy MDD Phase 2/3 Aria Study topline data expected 1H 2022 Ph 2/3 1:1 RANDOMIZED PLACEBO CONTROLLED IN MONOTHERAPY MDD 1 2 3 4 5 6 -114 40 mg tablet PLACEBO WEEK KEY SECONDARY ENDPOINT HAM-D17 at Day 29 PRIMARY ENDPOINT HAM-D17 at Day 15 ~200 participants First of two registr
Slide 9: PRAX-114 MDD Phase 2 Acapella Study
PAGE 9 PRAX-114 MDD Phase 2 Acapella Study topline data expected 1H 2022 Ph 2 RANDOMIZED PLACEBO CONTROLLED PRIMARILY IN ADJUNCTIVE MDD 1 2 3 4 5 6 -114 60 mg tablet PLACEBO WEEK KEY SECONDARY ENDPOINT HAM-D17 at Day 29 PRIMARY ENDPOINT HAM-D17 at Day 15 ~125 participants Dose-ranging study to evalu
Slide 10: PRAX-114 PTSD Phase 2 study
PAGE 10 PRAX-114 PTSD Phase 2 study expected to initiate in 4Q21 Ph 2 1:1 RANDOMIZED PLACEBO CONTROLLED IN PTSD 1 2 3 4 5 6 -114 40 mg tablet WEEK PRIMARY ENDPOINT CAPS-5 Total Score at Day 29 ~80 participants To evaluate safety, tolerability and efficacy of PRAX-114 for treatment of adults with PTS
Slide 11: PRAX-114 ET Phase 2 study
PAGE 11 PRAX-114 ET Phase 2 study expected to initiate in 4Q21 STUDY DESIGN Randomized, double-blind, placebo- controlled, cross-over study ~15 participants To evaluate safety, tolerability, PK and efficacy of daytime dosing of PRAX- 114 for treatment of adults with ET Participants will receive a si
Slide 12: PRAX-944 T-Type calcium channel inhibitor key upcoming milestones
PAGE 12 T-Type calcium channel inhibitor PRAX-944 MOVEMENT DISORDERS Essential Tremor Parkinson’s Disease Q4 2021 Ph2a ET High Dose Cohort Preliminary OL 1H 2022 Initiate Ph2 PD Trial 2H 2022 Ph2b Essential1 Study Topline KEY UPCOMING MILESTONES
Slide 13: PRAX-944 Phase 2a high dose cohort
PAGE 13 To evaluate safety, tolerability and efficacy of PRAX-944 in patients treated up to 120 mg per day 4Q21 Preliminary open-label safety, tolerability and efficacy results 1H22 Complete open-label and placebo- controlled randomized withdrawal results PART B: Open-Label Titration & Randomized Wi
Slide 14: PRAX-944 ET Phase 2b Essential1 Study
PAGE 14 Dose-ranging study to evaluate safety, tolerability and efficacy of PRAX-944 for treatment of adults with ET KEY INCLUSION CRITERIA Ages 18 or older Diagnosis of ET for at least 3 years TETRAS UL score ≥10 TOPLINE DATA EXPECTED 2H22Randomized, double-blind, placebo-controlled study in ~112 p
Slide 15: PRAX-562 Persistent Sodium Channel Blocker key upcoming milestones
PAGE 15 Persistent Sodium Channel Blocker PRAX-562 RARE DISEASES Adult Cephalgias Pediatric Epilepsies (DEEs) KEY UPCOMING MILESTONES Q4 2021 Initiate Ph 2 Adult Cephalgias Trial 1H 2022 Topline Ph 1 ASSR Biomarker 1H 2022 Initiate Ph 2 DEE Trial
Slide 16: PRAX-562 well tolerated in Phase 1 healthy volunteer study
PAGE 16 PRAX-562 well tolerated in Phase 1 healthy volunteer study No clinically significant safety findings All TEAEs mild to moderate in severity No drug- related SAEs or severe AEs Percentage of treatment emergent adverse events (TEAEs) reported in ≥5% of PRAX-562 participants* 0% 5% 10% 15% 20%
Slide 17: PRAX-562 development strategy in rare cephalgias and pediatric epilepsies
PAGE 17 PRAX-562 development strategy in rare cephalgias and pediatric epilepsies OBJECTIVE Identify PoC and safety in SUNCT/SUNA & Trigeminal Neuralgia while continuing efforts to expand to rare pediatric epilepsies PHASE 1 HEALTHY VOLUNTEERS SAD/MAD, ASSR Biomarker, Food Effect PHASE 2 SUNCT/SUNA
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