Slide 1: Clinical Detail March 2022
Clinical Detail March 2022 Exhibit 99.2
Slide 2: Study AP-013 pivotal trial in OAK
Study AP-013 pivotal trial in OAK Study AP-013 is designed to confirm efficacy observed in first pivotal study AP-003-A to support an Ampion BLA Study AP-013 designed to evaluate independent endpoints in pain and function, which means the study had more patients than required to power pain alone FDA
Slide 3: AP-013 COVID-19 impact on population for efficacy evaluation
Jun Dec Jan Mar May Jul Sep Nov Jan Mar May Jul Sep Nov Jan AP-013 COVID-19 impact on population for efficacy evaluation Date (%) Missing at Week 12 Nov 2019 4% Dec 2019 8% Jan 2020 69% Feb 2020 100% Mar 2020 100% Source: CDC.gov Study pause COVID First Patient Request FDA Meeting 0 1K 2K 3K 4K 2019
Slide 4: Efficacy analysis populations
AP-013 efficacy analysis populations ITT (n=1,043) ITT impacted by high level of imputation due to COVID-19 mITT are subjects Are free from COVID-19 impact, based on randomization date with source documentation With the target condition at time of randomization Powered appropriately Pain is powered
Slide 5: Data demonstrates meaningful improvement with Ampion
AP-013 data demonstrates meaningful improvement with Ampion Significant reduction in pain compared to saline in patients with severe OAK (p<0.05) Per-Protocol (PP) population supports efficacy conclusions Pain relief does not come at the cost of function ITT p-values: p=0.32 for pain and p=0.30 for
Slide 6: mITT shows meaningful effect of Ampion in severe OAK
AP-013 mITT shows meaningful effect of Ampion in severe OAK Pain Function Overall p=0.042 Improvement in Pain from Baseline Study Week Improvement in Function from Baseline Study Week Overall p=0.111 * Week 12 p= 0.017 * Week 12 p= 0.020 * * mITT p-values
Slide 7: PP demonstrates significant Ampion effect in severe OAK
AP-013 PP demonstrates significant Ampion effect in severe OAK Pain Function Study Week Study Week Improvement in Pain from Baseline Improvement in Function from Baseline Overall p=0.020 * * * Week 6 p= 0.012 | Week 12 p= 0.006 * Week 6 p= 0.024 | Week 10 p= 0.033 | Week 12 p= 0.005 Per-protocol p-v
Slide 8: Safety supports intra-articular injection use of Ampion
AP-013 safety supports intra-articular injection use of Ampion Adverse Event Type Saline (%) Ampion (%) Any Adverse Event 34% 36% Serious Adverse Event 2% 3% Related Adverse Event 5% 4% Related Serious Adverse Event 0% 0% Saline Ampion MILD MODERATE SEVERE MILD MODERATE SEVERE Overall 22% 10% 2% 20%
Slide 9: Conclusions
Conclusions We believe AP-013 data confirms pivotal trial AP-003-A Significant reduction in pain with Ampion treatment Pain does not come at the cost of function Supported by safety