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A Neurodegenerative Disease Company

June 2020

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ACI is focused on the development of two new therapeutic products:

• Alpha-1062 for the treatment of mild to moderate Alzheimer’s Disease

• Alpha-602 for the treatment of amyotrophic lateral sclerosis (ALS)

ACI’s team consists of industry experts who each have extensive experience in all aspects of drug development.

For additional information about ACI and its research programs, visit our website: www.alphacognition.com

A privately held biopharmaceutical company headquartered in Vancouver, Canada

Alpha Cognition, Inc (ACI)

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A global CRO focused on CNS clinical research and development

Global Team Approach to Drug Development

A full-service CDMO specializing in Nasal Delivery, Development, and Production

Specializes in the production of unique Active Pharmaceutical Ingredients (APIs)

Tablet/Capsule development, lab testing, and clinical trial supplies

AMRI provides drug discovery, development, and physical chemistry assessment

The Centre for Human Drug Research (CHDR) specializes in innovative early clinical drug research

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New Alzheimer’s Disease (AD) Therapy

As the population continues to age, Alzheimer’s disease is a large and growing market.

Currently approved therapies are symptomatic only, there is no cure.

Current AD Medications

• Have significant GI side effects (nausea, diarrhea, & vomiting)

• Require a 4 to 8 week up-titration period to achieve an efficacious dose

• The adverse event profile for this class of drugs:

• limits the ability to achieve efficacious dosing

• results in a lack of patient compliance

Immediate efficacious dosing has demonstrated better cognitive outcomes.

Current Treatments are Acetylcholine Esterase Inhibitors (AChEI) and have significant adverse

events, impacting compliance/effectiveness

Over 30%of patients drop out of treatment

due to GI side effects

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Alpha-1062 is a nicotinic receptor alpha-7 subunit up-regulator and an acetylcholine esterase inhibitor. Alpha-1062 passes readily into the circulatory system, where carboxylesterase enzymes metabolize it into galantamine.

Alpha-1062 is pharmacologically inert, therefore has significantly reduced side effects common to all other marketed acetylcholine esterase inhibitors.

• Alpha-1062 avoids nausea, vomiting, & diarrhea• There is no up-titration period• Patient compliance increases• Efficacious dosing from onset may reduce overall cost of care

Alpha-1062 has been developed in three delivery modalities designed to further minimize first pass GI adverse event concerns while leveraging the benefits of traditional galantamine therapy.

This product concept encompasses several patent families:

• Composition of Matter – 2033 Expiration Date• Method of Use – 2033 Expiration Date• API Manufacture – 2040 Expirations Date• Nasal Spray Delivery Device – 2040 Expiration Date• Formulation – 2040 Expiration Date• Pending/Issued Applications in US, CA, CN, HK, IN, JP, & EU

Favorable Side Effect Profile / Three Delivery Systems in Development / Strong IP Position

Our Unique Solution for Alzheimer’s Disease:

Alpha-1062

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Alpha-1062 in Three Dosage Modalities

Nasal Spray and Metered Dose DeviceThe nasal spray formulation of Alpha-1062 has been developed as a ready-to-use

liquid formulation. Each metered spray container is charged with an aqueous

solution containing a concentration of 83 mg/ml Alpha-1062. The spray actuation

device is a sophisticated system that remains primed for the entire 30-day period

and maintains the contents free from microbiol contamination. The device sprays a

uniform, reproducible plume into the nose with a particle size which avoids passage

to the back of the throat or into the lungs. The device is recently patented.

Sub-Lingual Tablet This fast-disintegrating dose proportional tablet is formulated to contain 8 mg, 16

mg and 24 mg of the galantamine equivalent of Alpha-1062. The largest tablet in

the series is much smaller than a standard aspirin. When placed below the tongue,

and exposed to local moisture, an adhesive component of the formulation will keep

the granules in place while the tablet dissolves. Residence time in the mouth is less

than a minute and the taste is masked with a strong peppermint additive and

sweetener.

Enteric-Coated Tablet The tablet is formulated to contain 8 mg, 16 mg and 24 mg of the galantamine

equivalent of Alpha-1062. The tablet coating is designed to withstand the low pH of

the stomach and release the drug contents once the pH returns to a more neutral

environment in the mid-small intestine.

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Alpha-1062 Clinical Results

Bi-daily dosing of dose levels up to 22 mg Alpha-1062 for 7 days was well tolerated in healthy elderly adults. Reported Alpha-1062 GI side effects were “less intense” compared to 16 mg oral galantamine. Nasal complaints most frequently reported AE. No indication of cardiovascular toxicity.

A Marked Reduction in GI effects vs Oral Razadyne (Reminyl) per Dose Administered

The measurement of bioavailability, AUC, shows comparable levels of galantamine (Razadyne) and Alpha-1062.

In 58 healthy subjects, the Single Ascending Dose Study (SAD Trial), and in 48 elderly patients, the Multiple Ascending Dose Study (MAD Trial) data show Alpha-1062 doses up to 33 mg were well tolerated and induced a dose-dependent increase in the plasma concentrations of Alpha-1062 and galantamine*.

* Alpha-1062 had a dose-dependent statistically significant positive effect on verbal memory and attention.

0 10 20 30

0

20

40

60

80

100

Galantamine levels after Alpha-1062 treatment

Time (h)

Ga

lan

tam

ine

co

nc

en

trati

on

in p

las

ma

(n

g/m

l)

Alpha-1062 5.5 mg

Alpha-1062 11 mg

Alpha-1062 22 mg

Alpha-1062 44 mg

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FDA & PMDA have agreed that a single pivotal trial scheduled to commence in 2021 could be sufficient to obtain marketing approval

Alpha-1062 Clinical Timeline

De-risked Regulatory Strategy with FDA & PMDA Agreement:

• Confirmation Study will qualify the new patented preservative free nasal pump device and provide dose ranging data for the tablet formulations

• Short-term Pivotal studies will be conducted in 2021, followed by NDA submissions in early 2022

• Upon approval, Alpha-1062 will be a unique and patented new treatment for AD

• The label modification study will allow usage without need for a titration period

The Pre-clinical/SAD/MAD trials demonstrate that Alpha-1062’s nasal dosage meets the requirements set by the FDA. The confirmation study will confirm the alternative dosages and validate our nasal device selection.

2020 2022

2021NDA Filing

Confirmation Study -Nasal/Tablet Delivery

Pivotal Studies

Label Modification Study

2022

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*Source: Zion Market Research

At 8% CAGR, Alzheimer’s Drugs Market to Hit Record value of USD 5.66 billion By 2024*

Alpha-1062 Revenue Estimates

Internal market research and demand forecast models predict Alpha-1062 sales could peak over $900M globally.

Ongoing Physician, Payer, and Caregiver surveys are being conducted in the US and Japan to update and fine tune product attribute values, utilization

estimates, and pricing tiers.

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Alpha-602 (progranulin) is a protein that has a potent ability to protect neurons that are under stress. ACI is developing Alpha-602 for the treatment of amyotrophic lateral sclerosis (ALS), where the protein plays a major role in regulating lysosomal function and microglial responses to disease.

ACI has been granted several patents for the treatment of neurodegenerative diseases using progranulin.

Orphan Drug Designation for the treatment of ALS granted in Q1:2020, offering:

• Tax incentives for conduct of Clinical Trials / Waived user fees (FDA)

• Eligibility for 7 years of market exclusively (independent of patent status)

The drug development, clinical and regulatory plan is being developed with portions of the program supported by anticipated non-dilutive grants.

Alpha-602 is in Early Stage Pre-Clinical Development for ALS

Our Unique Solution for ALS:

Alpha-602

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Summary

Alpha-1062 is a Next-Gen AD Drug/ Defined Development Path/ Low Risk

• Adverse events studies show improved gastrointestinal safety over current drugs

• FDA has accepted an abbreviated regulatory strategy and clinical path

• Data indicates that improved safety may allow higher doses without titration periods

• Phase IV (post-Approval) study planned to demonstrate superior efficacy

• Multiple delivery options: oral tablet, sub-lingual, nasal spray