Slide 1: KP415.E01 Efficacy Trial Results
K Pharm KP415.E01 Efficacy Trial Results
Slide 2: Cautionary Note Regarding Presentation Information
Cautionary Note Regarding Presentation Information This presentation contains forward-looking statements, including statements about our plans to develop and commercialize our product candidates, our planned clinical trials for our prodrug product candidates, the timing of and our ability to obtain
Slide 3: KP415.E01 Efficacy Trial Results Call Participants
KP415.E01 Efficacy Trial Results Call Participants + Travis Mickle, Ph.D. - President & Chief Executive Officer + R. LaDuane Clifton, CPA - Chief Financial Officer, Secretary & Treasurer + Gordon K. “Rusty” Johnson — Chief Business Officer * Dan Cohen, M.A.L.S.-— EVP, Government & Public Relations
Slide 4: KP415 Product Overview
KP415 Product Overview + Prodrug of d-methylphenidate (MPH) with extended release properties, co- formulated with immediate release d-methylphenidate + Potential KP415 features and benefits o Early onset of action o Potential longer total duration than current MPH therapies o Active metabolism may o
Slide 5: KP415.E01 Efficacy Trial Results
KP415.E01 Efficacy Trial Results + Met primary endpoint of the trial: mean difference in SKAMP-C score change from baseline across all post-dose time points (p<0.001) * Trial results, based on a prespecified analysis of SKAMP-C scores using the Visit 5 pre-dose value as baseline, supporta 1 hour pos
Slide 6: KP415.E01 Primary Endpoint Result
KP415.E01 Primary Endpoint Result + KP415.E01 met the primary endpoint of mean difference in change from baseline (pre-dose Visit 5) across all post-dose time points for the SKAMP- C score (p<0.001) Changein SKAMP-C from Pre-dose Vi Difference in 95% Confidence eS Items) LS mean (SE) Interval Statis
Slide 7: KP415.E01 Efficacy Trial Overview
KP415.E01 Efficacy Trial Overview + Double-blind, placebo-controlled, randomized, parallel, analog classroom trial * Children 6 to 12 years with ADHD (150 completers) + 5U.S. trial sites, 2-3 cohorts each; 5-18 subjects per cohort/per site + 3-week open-label KP415 dose optimization period ending wi
Slide 8: KP415.E01 Efficacy Trial: Design Schematic
KP415.E01 Efficacy Trial : Design Schematic Dose Treatment Optimization Screening , Follow-Up 1 week <7weeks {| 1week 1 week Days -49to-1 | Days 1-7 Days 8-14 | Days 15-21 Days 22-28 | Days 29 to 33 rrreris 64 Day 0 Day 7 Day 14 Day 24 Day 28 Day 3122 1 week <5 days Visit 2 Visit 3 Visit 6 Visit 7 O
Slide 9: Selection of Visit as Pre-Dose Baseline
Selection of Visit 5 as Pre-Dose Baseline + The Visit 5 pre-dose SKAMP-C scores were pre-specified in the Statistical Analysis Plan (SAP) as the baseline + Visit 5 was selected due to concerns related to a potential carryover effect related to the steady-state pharmacokinetic profile of KP415 + No K
Slide 10: SKAMP-C Change on Visit Using Visit Pre-Dose Baseline
SKAMP-C Change on Visit 6 Using Visit 5 Pre-Dose Baseline SKAMP-C Change from Baseline + SE Time (hours) —e-KP415 -*—Placebo As per pre-specified SAP. LS means shown. Statistical model includes predose Visit 5 as covariate. | See
Slide 11: Selection of Visit as Pre-Dose Baseline
Selection of Visit 6 as Pre-Dose Baseline + Using the Visit 6 pre-dose SKAMP-C scores as the baseline corrects for any pre-dose differences between the Active and Placebo groups on the efficacy assessment day + Using Visit 6 (full classroom day) pre-dose SKAMP-C scores as the baseline has been accep
Slide 12: SKAMP-C Change on Visit Using Visit Pre-Dose Baseline
SKAMP-C Change on Visit 6 Using Visit 6 Pre-Dose Baseline SKAMP-C Change from Baseline + SE Time (hours) —e-KP415 -#-Placebo LS means shown. Statistical model also includes predose Visit 6 as covariate. WR }§}©= = ee
Slide 13: Differences in SKAMP-C Change Between KP415 and Placebo
Differences in SKAMP-C Change Between KP415 and Placebo on Visit 6 Using Visit 5 vs. Visit 6 Pre-Dose Values as Baseline Baseline = predose (prespecified)" (post hoc)" Difference in Difference in LS mean (SE) LS mean (SE) Time KP415— Placebo p-Value KP415— Placebo _p-Value Predose 2.37 (1.18) 0.044
Slide 14: PERMP-A Change on Visit Using Visit Pre-Dose Baseline
PERMP-A Change on Visit 6 Using Visit 5 Pre-Dose Baseline 60 PERMP-A Change from Baseline + SE 0 Ps - + 2 2 4 * 6 7 @ 9 10 11 12 Time (hours) —e-KP415 -#-Placebo LS means shown. Statistical model includes predose Visit 5 as covariate. No meaningful difference between use of Visit 5 or Visit 6 baseli
Slide 15: PERMP-C Change on Visit Using Visit Pre-Dose Baseline
PERMP-C Change on Visit 6 Using Visit 5 Pre-Dose Baseline PERMP-C Change from Baseline + SE Time (hours) —e-KP415 -#-Placebo LS means shown. Statistical model includes predose Visit 5 as covariate. No meaningful difference between use of Visit 5 or Visit 6 baselines. Wye .}=—ti<‘“COSOSOS UU
Slide 16: Summary and Next Steps
Summary and Next Steps + KP415.E01 efficacy trial met its primary endpoint «Trial results for onset and duration were confounded by pre-dose SKAMP-C baseline differences between Visit 5 and Visit 6 for patients randomized into the placebo arm of the trial + Trial data using Visit 6 as the pre-dose b
Slide 17: Pharm
K Pharm For additional information please contact: riohnson@kempharm.com