Slides
Page 1
BRINGING HOPE TO PEOPLE LIVING WITH NEURODEGENERATIVE DISEASES Corporate Presentation, July 2025 www.alphacognition.com
Page 2
FORWARD-LOOKING STATEMENTS This presentation has been prepared by Alpha Cognition Inc. (“ACI” or the “Company”). This presentation includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this presentation may be a forward-looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements include statements regarding the Company’s business strategy, future plans, market size, potential growth opportunities, capital requirements, clinical development activities, the timing and results of clinical trials, regulatory submissions, potential regulatory approval and commercialization of the technology. Although the Company believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements as a result of known and unknown risks, uncertainties, assumptions and other factors. These risks include those associated with clinical studies and manufacturing; risks around development and commercialization of the Company’s products; the need for additional financing to maintain operations; risks posed by the economic and political environments in which the Company operates and intends to operate; market instability due to the COVID-19 pandemic; the potential for losses arising from the expansion of operations into new markets; increased competition; assumptions regarding market trends and the expected demand and desires for the Company’s products and proposed products; reliance on industry manufacturers, suppliers and key personnel; the failure to adequately protect intellectual property; a failure to adequately manage future growth; adverse market conditions; and failure to satisfy ongoing regulatory requirements or obtain regulatory approvals. These forward-looking statements speak only as of the date of this presentation and, other than as required by applicable securities laws, the Company undertakes no obligation to revise or update any forward-looking statements, even if new information becomes available in the future. This presentation includes industry and market data that we obtained from periodic industry publications, third-party studies and surveys, filings of public companies in our industry, patient and disease advocacy educational sites and internal company surveys. These sources include government and industry sources. Industry publications and surveys generally state that the information contained therein has been obtained from sources believed to be reliable and reasonable. Although we believe the industry and market data to be reliable as of the date of this presentation, this information could prove to be inaccurate. Industry and market data could be wrong because of the method by which sources obtained their data and because information cannot always be verified with complete certainty due to the limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other limitations and uncertainties. In addition, we do not know all of the assumptions regarding general economic conditions or growth that were used in preparing the forecasts from the sources relied upon or cited herein. The projections, assumptions and estimates of the future performance of the markets in which we operate and our future performance are necessarily subject to uncertainty and risk due to a variety of factors. These and other factors could cause results to differ materially from those expressed in the estimates made by third parties and by us. All currencies denoted are in united states dollars unless otherwise indicated www.alphacognition.com 2
Page 3
3 ALPHA COGNITION’S ORAL THERAPY ZUNVEYL HAS RECEIVED FDA APPROVAL TO TREAT ALZHEIMER'S DISEASE The Second Oral Therapy Approved This Decade, ZUNVEYL’s Dual MOA Was Designed to Eliminate Drug Absorption in the Gastrointestinal (GI) Tract, Potentially Addressing Certain Tolerability Issues with Leading ALZHEIMER’S DISEASE (AD) Medications, Combined with a Long-Term Efficacy Profile Indication: ZUNVEYL (benzgalantamine) is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults.
Page 4
4 COMMERCIAL & R&D BIOPHARMACEUTICAL COMPANY FOCUSED ON NEURODEGENERATIVE DISEASES ZUNVEYL® – Differentiated Treatment Potential for ALZHEIMER’S DISEASE Pipeline to expand treatments for ALZHEIMER’S DISEASE Experienced Leadership Team - History Of Multi-Billion Drug Launches • Large US 11M annual prescription (Rx) market characterized by high drug dissatisfaction and discontinuation1 • Oral therapy uniquely designed to reduce side effects, address cognition, and improve long term patient outcomes • Long Term Care (LTC) represents approximately 36%2 of annual prescriptions ($2B)3 with future expansion to Neurology (27% of annual prescription, $1.5B)4 • ZUNVEYL approved for treatment of mild-to-moderate ALZHEIMER’S DISEASE (AD) July 26, 2024 • ALPHA-1062 sublingual tablet to treat AD patients with dysphagia/aphagia in pre-clinical development • ALPHA-1062 combination product to treat AD patients with moderate-to-severe disease in pre-clinical development • Patent protection granted through 2044 • Commercial Leadership team involved with over 55 product launches with other companies • Extensive commercial experience in Long Term Care (LTC) • Multiple billion dollar drug launches (CELEBREX , CRESTOR , ADVAIR , CYMBALTA , NEXIUM , SEROQUEL ) by leadership team 1. Symphony METYS Retail 2019:Includes donepezil, galantamine, rivastigmine and Namzaric 2. Symphony METYS Retail 2019; Average WAC prices from Access Pointe Managed Markets Market Research 3. Estimated based on US$11 million annual prescriptions x LTC percentage of prescriptions (36%) x average WAC price of $500 4. Estimated based on US$11 million annual prescriptions x Neurology percentage of prescriptions (27%) x average WAC price of $500 5. Prescription Drug User Free Act
Page 5
5 ALZHEIMER’S DISEASE HAS SIGNIFICANT TREATMENT CHALLENGES AND HIGH DRUG DISCONTINUATION ALZHEIMER’S DISEASE (AD) is a type of dementia that causes a slow decline in memory, thinking and reasoning. AD therapy represents a significant US market with high dissatisfaction, primarily due to adverse events and limited efficacy over time. AD Impacts 7.2M people in the U.S.1 At age 80, ~75% of people with AD live in a nursing home compared with only 4% of the general population1 72% of MD’s are dissatisfied with treatments mainly due to medication side effects 4 55% of patients discontinue current medications therapy at 12 months 3 Significant Market Unmet Medical Need 1.Alzheimer’s Association 2025 Facts and Figures 2. Neurosci, 2023 Pless, et al https://doi.org/10.3389/fnins.2023.1263771 3. Data on File Symphony METYS Retail 2019 4. Data on File Market Research, Affinity Group July 2021 In addition to cognition issues, up to 97% of individuals with AD will experience at least one behavior or psychological symptom during the course of the disease.2
Page 6
6 ZUNVEYL: UNIQUELY DESIGNED PRODRUG OF GALANTAMINE Potential treatment designed to optimize efficacious dose, minimize treatment- limiting side-effects & improve long- term outcomes. The formation of the benzoyl ester eliminates AChE inhibition; the gluconate salt increases solubility ZUNVEYL is absorbed in the small intestine as an inactive compound with minimal or no side effects ZUNVEYL is subject to 1 st pass effect, cleaving the benzoyl ester, resulting in the release of galantamine (active moiety) Galantamine, the metabolite, may circulate with greater bioavailability (ability to be absorbed and used by the body)
Page 7
7 GALANTAMINE (ZUNVEYL’S ACTIVE MOIETY) ENHANCES ACETYLCHOLINE LEVELS & MODULATES NICOTINIC RECEPTOR SENSITIVITY Decreased acetylcholine levels and loss of nicotinic acetylcholine receptors (nAChR) negatively impacts learning, memory, and function Current therapeutics1 increase acetylcholine levels by inhibiting acetylcholinesterase (AChE) Modulation of nAChR (a7/a4b2)2: • Stimulates the cholinergic pathway • Modulates inflammation • Buffers the effects of amyloid • Enhances release of other transmitters: • Glu, DA, GABA, 5HT - resulting in enhanced: Memory acquisition and retrieval Stabilization of behaviour Inhibition of cell death and neuroprotectionAttention & activity Galantamine raises the concentration of Ach in the synaptic cleft by inhibiting AChE Galantamine modulates nAChRs, making them more sensitive to ACh Raised ACh & enhanced response of nAChRs to ACh lead to improved post-synaptic response 1. Excluding Memantine for moderate-to-severe Alzheimer’s disease 2. Lilienfeld, S. (2002) CNS Drug Reviews, 8(2), 159-176
Page 8
8 PIVOTAL TRIAL RESULTS PROVIDED DATA ENABLING NDA FILING Bioequivalence Studies vs. Immediate Release Bioequivalence Study vs. Extended Release ALPHA-1062 Delayed Release 5mg (n=36) Gal HBr Immediate Release 4mg (n=36) % to Reference Drug 80-125% Enabled NDA Filing ALPHA-1062 Delayed Release 5mg (n=20) Gal HBr Immediate Release 8mg (n=20) % to Reference Drug 80-125% Enabled NDA Filing PK Parameter AUC0-inf (μg × h/mL) Fasted State Cmax (ng/mL) Fasted State AUC0-inf (μg × h/mL) Fed State Cmax (ng/mL) Fed State 306.8 30.7 286.7 27.6 30.2 329.9 40.5 321.5 95% 76% 87% 91% PK Parameter AUC0-24 (μg × h/mL) Steady State Cmax (ng/mL) Steady State 527.5 41.7 492.1 32.8 107% 127% Data suggests ALPHA-1062 AUC was bioequivalent to galantamine hydrobromide IR and ER Cmax for ALPHA-1062 is bracketed between IR & ER providing data for NDA filing (scientific bridge) Minimal adverse events reported in these trials Enabled NDA filing based on 505(b)(2) requirements
Page 9
9 STUDIES HAVE REPORTED IMPROVED GASTROINTESTINAL SIDE EFFECT PROFILE* % of Subjects Reporting Gl Episode ALPHA-1062 5-15mg Single and Multi-Dose Trials (n=150)1 RAZADYNE 8 mg/day Single Dose (n=120)2 RAZADYNE Pooled AE Data (Doses ranging 8 to 32 mg/day) (n=2,932)3 Median duration of nausea was 5-7 days per episode *Data from separate product monographs; comparative clinical significance has not been proven 40 35 30 25 20 15 10 5 0 2 1 8 20.0 9 37.8 1. Alpha Cognition: Data on File 2. ISSO; Completed Phase 1 trials in healthy adults; J&J Reminyl NDA package submission 3. RAZADYNE Full Prescribing Information accessed: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RAZADYNE+ER-pi.pdf Nausea, Vomiting Diarrhea
Page 10
10 ZUNVEYL’s differentiated profile will make a meaningful difference in the lives of those affected by Alzheimer’s disease GALANTAMINE RIVASTIGMINE DONEPEZIL There is a significant need for better treatment options Current treatment options can have significant gastrointestinal and insomnia side effects. Physicians report feeling dissatisfied and/or apathetic about their symptomatic treatment options.3 Caregivers also express dissatisfaction with the currently approved treatments options.3 Purposefully Designed Prodrug Technology No impact on Sleep Long Term Outcome1 Proven Medication Dual Acting Mechanism of Action No significant difference vs placebo across a broad range of sleep-related outcomes No incidence of insomnia in ZUNVEYL label Significant risk reduction in risk of developing severe dementia Significant and sustained improvement in cognitive and functional performance Potentiates acetylcholine transmission and modulates nAChR (a7/a4b2)2 ARICEPT is a registered trademark of Eisai Co., Ltd. RAZADYNE is a registered trademark of Johnson & Johnson EXELON is a registered trademark of Novartis Pharmaceuticals Corp 1. Xu et al. Neurology 96 (17) e2221 (2021) 2. Feldman et al. International Journal of Geriatric Psychiatry 2009; 24: 479–488 3. Data on File, Infinity Group, HCP and Caregiver Market Research, July 2021 *Rivastigmine is also available as a transdermal patch Designed to minimize absorption in the stomach to avoid stimulation of the GI nervous system Protects from Peripheral and Central Cholinergic Side Effects
Page 11
11 ZUNVEYL WAS DESIGNED TO ELIMINATE DRUG ABSORPTION IN THE GI TRACT AND HAS ZERO INCIDENCE OF INSOMNIA 0% incidence of insomnia in ZUNVEYL label …Accumulating evidence shows that sleep disturbance contributes to cognitive decline.1 Galantamine may be the first choice of cholinesterase inhibitor in mild to moderate dementia patients in terms of improving sleep quality.2 1. Lim, Gerstner, Holtzman “Neurodegenerative Dis Management. 2014; 4(5):351-362 doi:10.2217/nmt.14.30 2. Acta Neurol Belg (2015) 115:563–568 DOI 10.1007/s13760-015-0453-900 • Enteric coat designed to pass through the stomach inertly, limiting absorption in the stomach • Prodrug design allows ZUNVEYL to remain inactive until after first pass metabolism in the liver, which then converts to active galantamine
Page 12
12 GALANTAMINE (ZUNVEYL’S ACTIVE MOIETY) REDUCES RISK OF DISEASE PROGRESSION & HAS THE STRONGEST EFFECT ON COGNITION Galantamine affects multiple brain receptors to exert effect Galantamine has demonstrated anti-inflammation effects1 Galantamine has been associated with:1,2 Improved Memory and Attention Significantly lower risk of death (P-value <0.001) Strongest AChEI effect on cognitive decline Demonstrates significant reduction in risk of developing severe dementia (P-value 0.05) compared to donepezil (P-value 0.13) and rivastigmine (P-value 0.24) Use of Galantamine reduces nursing home admission by 31% per year of treatment3 1. 2. Lilienfeld, S. (2002) CNS Drug Reviews, 8(2), 159-176 3. Xu et al. Neurology 96 (17) e2221 (2021) 3. Feldman et al. International Journal of Geriatric Psychiatry 2009; 24: 479–488
Page 13
13 MANY SUCCESSFUL DRUG LAUNCHES FOR ALZHEIMER’S TREATMENT INDICATE NEED FOR NEW AND IMPROVED TREATMENTS Peak Sales (in B)1 $1.8 $1.25 $0.270 $0.650 $0.250 $2.6 Namenda Namenda XR Namzaric Aricept Exelon Razadyne $700.00 $600.00 $500.00 $400.00 $300.00 $200.00 $100.00 $- Oral Patch Large US 11M annual prescription market characterized by high drug dissatisfaction and discontinuation Multiple successful launches into the AD space Significant brand sales despite generic competition Exelon Patch (above graph) achieved $650M in peak sales in fully generic market on promise of lower gastrointestinal adverse events 1. Source – IQVIA National Sales Perspectives – 1993 through 2020. Exelon Follow-On (Oral to GI-Bypassing Patch)
Page 14
15 ACHEI’S MARKET LARGE BUT DISSATISFIED CREATING OPPORTUNITY FOR IMPROVED TREATMENT OPTION, SPECIFICALLY IN LONG TERM CARE (LTC) Large, but dissatisfied market creates significant market opportunity Initial go-to-market commercial footprint to focus on highest volume, most favourable market access conditions • LTC accounts for 36% of total market Rx’s2 • LTC provides estimated, potential initial commercial opportunity ($2B potential)3 with future expansion to Neurology ($1.5B potential)4 • Branded medications used more commonly in LTC market • 65-70% of LTC lives have access to ZUNVEYL with zero co-pay Neuro/Psych Other Primary Care Physicians Initial Go-to-Market Commercial Footprint 27% 9% 28% LTC 36% 11M AChEI RX’s dispensed each year1 High discontinuation rates due to side-effects Prescriptions by Specialty1 1. Symphony METYS Retail 2019:Includes donepezil, galantamine, rivastigmine and Namzaric 2. Symphony METYS Retail 2019; Average WAC prices from Access Pointe Managed Markets Market Research 3. Estimated based on US$11 million annual prescriptions x LTC percentage of prescriptions (36%) x average WAC price of $500 4. Estimated based on US$11 million annual prescriptions x Neurology percentage of prescriptions (27%) x average WAC price of $500
Page 15
LTC represent ~13% of the AD population but delivers 36% of the market 16 ALZHEIMER’S DEMENTIA AFFECTS 70% LONG TERM CARE (LTC) RESIDENTS & 88% LTC DOCTORS LIKELY TO PRESCRIBE Large, Underserved LTC Market Significant Dissatisfaction with Current Treatments Leads to ZUNVEYL Opportunity In Nursing Homes, Alzheimer’s Dementia: Affects 58% residents1 Is the leading reason for placement1 Is the leading cause of death1 Current treatment options cause burden for staff and risks for residents due to GI side effects and insomnia2 55% patients discontinue their AD medication due to side effects2 Market research indicates ~88% of LTC HCPs Likely to prescribe ZUNVEYL2 Americans living with mild-to-moderate AD3 Americans living in nursing homes4 1. Alzheimer’s Association Facts and Figures - 2025 2. Data on File - LTC Market Research, October 2021 3. https://www.nia.nih.gov/news/half-alzheimers-disease-cases-may-be-mild 4. https://oig.hhs.gov/reports-and-publications/featured-topics/nursing-homes/ 5. Rosewood Nursing Key Facts about American Seniors 2025 5.4M 1.2M 15K Nursing homes in United States5
Page 16
Experienced, account-based sales team with demonstrated success in LTC $749 WAC price per month with limited payor barriers with 70% of residents Commercial team may develop strategic partnerships with Physicians and Consultant Pharmacists 17 COMMERCIALIZATION STRATEGY WILL LEVERAGE LTC EXPERIENCE & FOCUSED SALES EFFORT AT LAUNCH 36 Person Commercial Team Covers >80% of the LTC Segment 726 – 9K 11K – 23K 24K – 35K 40K – 99K Target largest geographies with highest concentration of LTC lives
Page 17
18 ZUNVEYL ALZHEIMER'S DEMENTIA OPPORTUNITY Large but Dissatisfied Market ZUNVEYL Potential Near-term Milestones Additional Development Programs• LTC represents largest AD prescription volume • >50% discontinue treatment at 12 months • 88% LTC HCPs potentially willing to prescribe • ZUNVEYL sublingual tablet formulation and pharmacokinetic work • ALPHA-1062 pre-clinical stage program in mTBI • ZUNVEYL first full quarter sales reported – Q3 • ZUNVEYL sublingual tablet formulation – Q4 • Growing market with high unmet need • Differentiated product profile • Experienced commercial team with extensive LTC experience
Page 18
19 ALPHA COGNITION CLINICAL PIPELINE Cognitive Impairment with Mild Traumatic Brain Injury Acute Pancreatitis Preclinical Phase 1 Phase 2 Phase 3 /Pivotal Approved Next Advancement Oral: Mild-to-Moderate Alzheimer’s Disease (AD) Sublingual Formulation: Mild-to-Moderate Alzheimer’s Disease (AD) Alzheimer’s Dementia Other Conditions Moderate-to-Severe Alzheimer’s Combination with Memantine (AD) Complete Formulation and pharmacokinetic studies Type C Meeting with FDA Pre-IND Meeting with FDA Complete Retrospective analysis for LTC Market
Page 19
20 POTENTIAL CATALYSTS AND UPCOMING EVENTS ZUNVEYL pricing determination (Q1) ZUNVEYL commercial launch (Q1) DOD Sponsored Pre-clinical Bomb-blast results, final (Q2) ZUNVEYL submission for approval in Singapore and Hong Kong (Q3) Sublingual formulation completion (Q4) 2025 2026 Sublingual pharmacokinetic study completion (1H) ZUNVEYL approval in Singapore (2H) ZUNVEYL approval in Hong Kong (2H) Sublingual IND submission for AD (2H)
Page 20
20 LEADERSHIP HAS IMPRESSIVE TRACK RECORD FOR SUCCESSFUL NEW DRUG DEVELOPMENT AND COMMERCIALIZATION Michael McFadden, Chief Executive Officer • 30+ years in drug discovery & commercialization (16+years in Neuroscience) • Former COO at MPower Health and Urovant Sciences (acquired by Sumitovant Biopharma for $584M) • Former SVP Sales & Marketing at Avanir Pharmaceuticals (acquired by Otsuka for $3.5B) LaurenD’Angelo,MBA Chief Operating Officer 20 Lauren D’Angelo, Chief Operating Officer • 25+ years in pharmaceuticals marketing, sales, and operations • Led 20+ launch plans and successfully launched 15 products across 9 therapeutic areas • Former VP of Marketing and Commercial Strategy at Urovant Sciences (acquired by Sumitovant Biopharma for $584M) Dennis Kay, Chief Scientific Officer • 30+ years of experience in developing & characterizing animal models of neurological diseases • Co-founded Neurodyn Life Sciences in August 2006; served as Chief Scientific Officer since inception • Grant recipient of the Michael J. Fox Foundation and funded by multiple agencies for research and product development Henry Du, VP Finance & Accounting, Interim CFO • 20+ years of experience in finance and accounting leadership roles • Former Sr. VP of Accounting and Administration at Amplify Surgical; Former VP of Finance at HUYABIO International • Multiple pharmaceutical and life science commercial company experience in leadership positions
Page 21
22 Share Capitalization NASDAQ: ACOG Issued & Outstanding 150,855,536 7,916,380 6,641,057 69,441,236 20,399,367 10,770,133 244,483,443 56.7% 2.9% 2.5% 26.1% 7.7% 4.05% 100.0% 6,034,221 316,655 265,642 2,933,555 1,019,968 430,805 12,224,172 % of total Proforma Outstanding 1 *Additional stock options may be granted to new employees through the end of the year. July 1, 2025 Issued and Outstanding % of Total Common Shares 16,023,119 71.7% Class B Preferred Series A Shares 316,655 1.4% Performance Shares 265,642 1.2% Non-Trading Warrants 3,632,631 16.3% Stock Options* 2,101,697 9.4% Total all shares 22,339,744 100.0%
Page 22
Investor Relations IR@alphacognition.com www.alphacognition.com Copyright 2024 Alpha Cognition | Legal