Annovis Bio, Inc. · NYSE:ANVS
Annovis Bio — AAIC Panel 2021
20 slides from Annovis Bio's conference presentation, Jul 29, 2021
Slide 1: AAIC Panel July 28, 2021
AAIC Panel July 28, 2021 Symbol: ANVS (NYSE American)
Slide 2: Neurotoxic proteins impair axonal transport and cause a toxic cascade
NEUROTOXIC PROTEINS IMPAIR AXONAL TRANSPORT AND CAUSE A TOXIC CASCADE Posiphen IMPROVES AXONAL TRANSPORT AND IMPEDES THE TOXIC CASCADE IMPAIRED AXONAL TRANSPORT SLOWER SYNAPTIC TRANSMISSION INFLAMMATION DEATH OF NERVE CELLS LOSS OF COGNITIVE AND MOTOR FUNCTION IMPROVED AXONAL TRANSPORT INCREASED SYN
Slide 3: Two Phase 2 clinical trials
3 TWO PHASE 2 CLINICAL TRIALS AD Trial PD Trial Therapeutic Area Early to Moderate AD Early to Moderate PD Patients 14 14 + 40 Phase 2 Sites 12 Country United States Design Double - Blind, Placebo - Controlled, Biomarker Study Endpoints Reversal of Toxic Cascade Exploratory Efficacy
Slide 4: Timeline of Phase 2 clinical trial in AD and PD
TIMELINE OF PHASE 2 CLINICAL TRIAL IN AD AND PD Start Up AD/PD Study August 2020 June/July 2021 September 2021 4 AD & PD Markers AD & PD Efficacy Whole Study May 2021 Efficacy and biomarker d ata as of July 2021. Additional markers in CSF and plasma are still being measured A meeting with the FDA to
Slide 5: Reversal of toxic cascade: efficacy
REVERSAL OF TOXIC CASCADE EXPECTED OUTCOME ACTUAL OUTCOME AD PD Neurotoxic proteins Axonal transport Axonal damage Inflammation Synaptic Markers Control proteins 0 Efficacy: WAIS coding Efficacy: Motor function Efficacy: Cognition REVERSAL OF TOXIC CASCADE: EFFICACY Data from first 14 AD and 14 PD p
Slide 6: Baseline demographics
ALZHEIMER PARKINSON Patients Enrolled Placebo (N=6) Posiphen 80mg (N=10) Total (N=16) Placebo (N=5) Posiphen 80mg (N=10) Total (N=15) Age (years) 68.0 ( 6.87) 72.8 ( 6.34) 71.0 ( 6.75) 75.4 ( 3.13) 65.0 ( 9.31) 68.5 ( 9.18) Male 3 ( 50.0%) 2 ( 20.0%) 5 ( 31.3%) 3 ( 60.0%) 8 ( 80.0%) 11 ( 73.3%) Fema
Slide 7: Efficacy in AD patients – ADAS-Cog11
EFFICACY IN AD PATIENTS – ADAS - Cog11 D ata from 14 AD patients 7 Left: From baseline to 25 days in the Posiphen - treated group, ADAS - Cog11 improved by 4.4 points, a statistically significant improvement of 30% (p < 0.05). Right: Posiphen - treated group compared to placebo group at baseline and
Slide 8: Efficacy in AD patients – ADAS-Cogs
EFFICACY IN AD PATIENTS – ADAS - Cogs11 Data from 14 AD patients 0.5 0.6 0.7 0.8 0.9 1 1.1 ADAS-COG3 ADAS-COG6 ADAS-COG11 ADAS-COG14 ADAS COGs %Placebo %Posiphen Posiphen - treated group showed trends of improvement in all four ADAS - Cog tests performed compared to placebo group. 8
Slide 9: Efficacy in PD patients – MDS-UPDRS test
EFFICACY IN PD PATIENTS – MDS - UPDRS TEST Data from 14 PD patients -30% -25% -20% -15% -10% -5% 0% 5% 10% 15% Part1 Part2 Part3 Part4 Total UPDRS Placebo Posiphen Posiphen - treated group showed trends of improvement in all four parts of UPDRS test compared to placebo group. 9
Slide 10: Efficacy in AD and PD patients – WAIS coding test
EFFICACY IN AD AND PD PATIENTS – WAIS CODING TEST D ata from 14 AD and 14 PD patients This is the first double - blind, placebo - controlled study that shows cognitive improvements in AD patients as measured by ADAS - Cog and functional improvements in PD patients as measured by the Unified Parkinso
Slide 11: Efficacy in AD and PD patients - MMSE
EFFICACY IN AD AND PD PATIENTS - MMSE 11 While there is a positive trend in AD, the changes in MMSE are not statistically significant. MMSE AD PD Placebo Posiphen Placebo Posiphen MMSE Baseline 24.5 25.4 27.6 29.1 25 Days later 25.7 26.2 28.0 29.1 Improvement in MMSE 1.2 0.8 0.4 0.0
Slide 12: Efficacy in AD patients – CDR – Sum of Boxes
EFFICACY IN AD PATIENTS – CDR – SUM OF BOXES 12 In AD patients there are positive trends in orientation, judgement and problem solving, home and hobbies as well as total CDR score, but the data is not statistically significant. CDR Placebo Posiphen Improvement in total score - 1.17 - 0.96
Slide 13: Safety summary
SAFETY SUMMARY 13 AD Patients PD Patients Placebo (N=6) Posiphen 80mg (N=10) Total (N=16) Placebo (N=5) Posiphen 80mg (N=10) Total (N=15) Subjects with any AEs 3 (50.0%) 5 (50.0%) 8 (50.0%) 3 (60.0%) 3 (30.0%) 6 (40.0%) Number of AEs 4 7 11 5 3 8 Serious AEs 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.
Slide 14: Reversal of toxic cascade: markers
REVERSAL OF TOXIC CASCADE EXPECTED OUTCOME ACTUAL OUTCOME AD PD Neurotoxic proteins Axonal transport Axonal damage Inflammation Synaptic Markers Control proteins 0 Efficacy: WAIS coding Efficacy: Motor function Efficacy: Cognition REVERSAL OF TOXIC CASCADE: MARKERS D ata from first 14 AD and 14 PD p
Slide 15: Step one of toxic cascade: neurotoxic proteins are lowered
STEP ONE OF TOXIC CASCADE NEUROTOXIC PROTEIN S ARE LOWERED Data from first 14 AD and PD patients - 14.00% - 12.00% - 10.00% - 8.00% - 6.00% - 4.00% - 2.00% 0.00% 2.00% 4.00% Ab40 Ab42 sAPPa sAPPb P - Tau T - Tau % difference Posiphen vs Placebo_AD T - Tau -14.00% -12.00% -10.00% -8.00% -6.00% -4.00%
Slide 16: Aβ42/Aβ40 ratio in AD and PD patients
A β 42/A β 40 RATIO IN AD AND PD PATIENTS Data from first 14 AD and PD patients 16 AD Patients PD Patients Placebo Posiphen Placebo Posiphen Baseline 0.064 0.059 0.083 0.097 25 Days 0.064 0.062 0.083 0.097 p - Value 0.0113 The A β 42/A β 40 is < 0.072 in AD. Our ratios in fact show that AD patients
Slide 17: Step two of toxic cascade: neurofilament light is lowered
STEP TWO OF TOXIC CASCADE NEUROFILAMENT LIGHT IS LOWERED IN AD AND PD PATIENTS Data from first 14 AD and PD patients 17 -14% -12% -10% -8% -6% -4% -2% 0% AD PD % Difference Posiphen vs. Placebo Neurofilament light represents the health of the axon and neuron. In both Posiphen - treated patient popul
Slide 18: Step three of toxic cascade: inflammation is lower in PD patients
STEP THREE OF TOXIC CASCADE INFLAMMATION IS LOWER IN PD PATIENTS Data from first 14 PD patients 18 The trial measured four inflammatory markers that are prevalent in the brains of AD and of PD patients. Each of the inflammatory markers showed statistically significant reduction after 25 days of trea
Slide 19: Work in progress & summary
19 WORK IN PROGRESS & SUMMARY • We have finished treating the additional 40 PD patients and are expecting to complete all the biomarkers of the toxic cascade in the next two months. • The reversal of the toxic cascade confirms and cements the data seen to date. • Showing efficacy in AD and in PD pat
Slide 20: Thank you
THANK YOU Symbol: ANVS (NYSE American)