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Alpha Cognition Inc(ACOG) - 2025 Q2 - Quarterly Report
2025-08-14 20:02
[PART I – FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS](index=4&type=section&id=ITEM%201.%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) This section presents Alpha Cognition Inc.'s unaudited condensed interim consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with detailed notes explaining the company's financial position, performance, and significant accounting policies for the periods ended June 30, 2025, and December 31, 2024 [Condensed Interim Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Interim%20Consolidated%20Balance%20Sheets) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :------------------ | | Cash and cash equivalents | $39,405,210 | $48,546,210 | | Total current assets | $44,648,207 | $50,251,178 | | Total assets | $45,122,942 | $50,736,938 | | Total current liabilities | $3,039,658 | $3,350,752 | | Total liabilities | $13,226,626 | $9,273,893 | | Total stockholders' equity | $31,896,316 | $41,463,045 | [Condensed Interim Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) | Metric (Three Months Ended June 30) | 2025 | 2024 | | :---------------------------------- | :------------ | :------------ | | Product, net revenue | $1,576,411 | $- | | Licensing revenue | $81,276 | $- | | Total revenue | $1,657,687 | $- | | Total costs and expenses | $7,394,688 | $2,421,211 | | Net loss and comprehensive loss | $(10,488,952) | $(2,115,512) | | Net loss per share, basic and diluted | $(0.65) | $(0.35) | | Metric (Six Months Ended June 30) | 2025 | 2024 | | :---------------------------------- | :------------ | :------------ | | Product, net revenue | $1,923,340 | $- | | Licensing revenue | $2,663,001 | $- | | Total revenue | $4,586,341 | $- | | Total costs and expenses | $14,009,774 | $6,832,729 | | Net loss and comprehensive loss | $(12,495,495) | $(7,118,223) | | Net loss per share, basic and diluted | $(0.78) | $(1.21) | [Condensed Interim Consolidated Statements of Stockholders' Equity (Deficiency)](index=6&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficiency)) - For the three months ended June 30, 2025, total stockholders' equity decreased from **$40,811,875 to $31,896,316**, primarily due to a net loss of **$10,488,952**, partially offset by share-based compensation of **$1,547,570** and warrants exercised for **$25,823**[12](index=12&type=chunk) - For the six months ended June 30, 2025, total stockholders' equity decreased from **$41,463,045 to $31,896,316**, driven by a net loss of **$12,495,495**, partially offset by share-based compensation of **$2,902,943** and warrants exercised for **$25,823**[13](index=13&type=chunk) [Condensed Interim Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Cash%20Flows) | Cash Flow Activity (Six Months Ended June 30) | 2025 | 2024 | | :-------------------------------------------- | :-------------- | :-------------- | | Net cash provided by (used in) operating activities | $(8,183,776) | $(3,873,814) | | Net cash (used in) investing activities | $(71,585) | $- | | Net cash provided by (used in) financing activities | $(845,111) | $3,573,424 | | Change in cash and cash equivalents | $(9,100,472) | $(300,390) | | Cash and cash equivalents, end of period | $39,463,610 | $1,194,183 | [NOTE 1 – NATURE OF OPERATIONS](index=10&type=section&id=NOTE%201%20%E2%80%93%20NATURE%20OF%20OPERATIONS) - Alpha Cognition Inc. is a commercial-stage biopharmaceutical company focused on neurodegenerative diseases, with its common shares trading on NASDAQ under 'ACOG' since **November 12, 2024**[17](index=17&type=chunk) - The company received **FDA approval on July 29, 2024**, for ZUNVEYL (formerly ALPHA-1062) to treat mild-to-moderate Alzheimer's disease[18](index=18&type=chunk) [NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES](index=10&type=section&id=NOTE%202%20%E2%80%93%20SIGNIFICANT%20ACCOUNTING%20POLICIES) - Revenue from product sales (Zunveyl tablets) is recognized when control transfers to the distributor, typically upon delivery, with deductions for chargebacks, returns, and distributor fees[24](index=24&type=chunk)[25](index=25&type=chunk) - Licensing revenue is recognized based on a five-step model, identifying distinct performance obligations and allocating transaction price, with variable consideration (like milestones and royalties) recognized when probable or when related sales occur[27](index=27&type=chunk)[28](index=28&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk) - Inventory is valued at the lower of cost or net realizable value, with costs capitalized after regulatory approval (July 2024) when future commercialization is probable[36](index=36&type=chunk)[37](index=37&type=chunk) - Share-based compensation and liability-based awards (bonus rights) are fair valued using the Black-Scholes model, with changes in bonus rights fair value recognized in general and administrative expense[39](index=39&type=chunk)[41](index=41&type=chunk) - Warrant liabilities are measured at fair value using the Black-Scholes option pricing model, with changes recognized in the consolidated statements of operations and comprehensive loss[49](index=49&type=chunk)[50](index=50&type=chunk) - The company adopted ASU 2023-09 (Income Tax Disclosures) effective after **December 15, 2024**, and is evaluating ASU 2024-03 (Expense Disaggregation Disclosures) effective after **December 15, 2026**[61](index=61&type=chunk)[62](index=62&type=chunk) [NOTE 3 – R&D GRANT](index=15&type=section&id=NOTE%203%20%E2%80%93%20R%26D%20GRANT) - The Company was awarded a **$750,000 R&D grant** from the Army Medical Research and Material Command on June 5, 2023, for a pre-clinical study on ALPHA-1062 Intranasal for mild Traumatic Brain Injury (mTBI), with funds restricted for specified research and expiring **September 30, 2028**[63](index=63&type=chunk)[64](index=64&type=chunk) | Metric (Six Months Ended June 30) | 2025 | 2024 | | :-------------------------------- | :-------- | :-------- | | Cash received | $174,675 | $290,825 | | Grant income recognized | $71,095 | $272,340 | | Balance Sheet (As of) | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Restricted cash | $58,400 | $17,872 | | Deferred income (receivable) | $23,936 | $(79,643) | [NOTE 4 – INVENTORY](index=16&type=section&id=NOTE%204%20%E2%80%93%20INVENTORY) | Inventory Type | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Raw materials | $- | $- | | Work in progress | $- | $615,133 | | Finished goods | $875,852 | $- | | Total | $875,852 | $615,133 | - During the six months ended June 30, 2025, the Company recognized **$67,919 in cost of sales**, compared to $nil in 2024[67](index=67&type=chunk) [NOTE 5 – BALANCE SHEET COMPONENTS](index=16&type=section&id=NOTE%205%20%E2%80%93%20BALANCE%20SHEET%20COMPONENTS) | Prepaid Expenses and Other Current Assets | June 30, 2025 | December 31, 2024 | | :---------------------------------------- | :------------ | :---------------- | | Other receivables | $140,272 | $253,426 | | Prepaid insurance and other expenses | $2,292,953 | $795,141 | | Prepaid legal expenses | $61,824 | $23,396 | | Total | $2,495,049 | $1,071,963 | | Accounts Payable and Accrued Liabilities | June 30, 2025 | December 31, 2024 | | :---------------------------------------- | :------------ | :---------------- | | Accounts payable | $752,334 | $872,676 | | Other accrued liabilities | $805,761 | $643,063 | | Accrued payroll and bonuses | $1,249,727 | $923,550 | | Total | $2,807,822 | $2,439,289 | [NOTE 6 – INTANGIBLE ASSETS](index=17&type=section&id=NOTE%206%20%E2%80%93%20INTANGIBLE%20ASSETS) - The Company's intangible assets, primarily licenses, had a net balance of **$402,196** as of June 30, 2025, down from **$412,969** at December 31, 2024[70](index=70&type=chunk) - A new patent granted on January 25, 2025, for 'Coated Tablets for pH-Dependent Release of Benzgalantamine' extended the estimated useful life of the related license from **5 years to 19 years**, effective **January 1, 2025**, resulting in a decrease in amortization expense by approximately **$28,700** for the six months ended June 30, 2025[70](index=70&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk) | Year Ending December 31, | Estimated Annual Amortization Expense | | :----------------------- | :------------------------------------ | | 2025 | $10,774 | | 2026 | $21,546 | | 2027 | $21,546 | | 2028 | $21,546 | | 2029 | $21,546 | | Thereafter | $305,238 | | Total | $402,196 | [NOTE 7 – PROMISSORY NOTE](index=18&type=section&id=NOTE%207%20%E2%80%93%20PROMISSORY%20NOTE) - The **promissory note of $1,400,000** issued to Neurodyn Life Sciences Inc. (NLS) in March 2015 for the ALPHA-1062 Technology was fully repaid on **January 29, 2025**, with the principal balance outstanding reducing from **$911,463** at December 31, 2024, to $nil at June 30, 2025[75](index=75&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk) [NOTE 8 – CONVERTIBLE DEBENTURES AND CONVERSION FEATURE LIABILITY](index=18&type=section&id=NOTE%208%20%E2%80%93%20CONVERTIBLE%20DEBENTURES%20AND%20CONVERSION%20FEATURE%20LIABILITY) - On **November 13, 2024**, convertible debentures issued on **September 24, 2024**, automatically converted into **801,413 Common Shares at $5.75 per share** following a Qualified Offering[78](index=78&type=chunk)[79](index=79&type=chunk)[81](index=81&type=chunk) - In connection with the conversion, the Company issued an additional **215,421 warrants** and repriced existing **430,805 warrants** from **$10.55 to $7.19 per share**[80](index=80&type=chunk)[81](index=81&type=chunk) [NOTE 9 – OTHER LONG-TERM LIABILITIES](index=18&type=section&id=NOTE%209%20%E2%80%93%20OTHER%20LONG-TERM%20LIABILITIES) - The Company's bonus rights liability increased from **$102,783** at December 31, 2024, to **$187,851** at June 30, 2025, with total compensation expense for bonus rights recognized within general and administrative expenses being **$82,598** for the six months ended June 30, 2025 (compared to a recovery of **$(23,371)** in 2024)[85](index=85&type=chunk) - The bonus rights agreements were amended on **April 16, 2024**, extending the vesting date to **April 28, 2027**, and reducing the grant price from **$39.50 to $29.75**[84](index=84&type=chunk) | Valuation Assumptions (Weighted Average) | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :------------ | :---------------- | | Risk-free interest rate | 3.72% | 4.25% | | Expected life (in years) | 1.84 | 2.33 | | Volatility | 140.89% | 166.95% | | Weighted average fair value per bonus right | $4.33 | $3.30 | [NOTE 10 – STOCKHOLDERS' EQUITY](index=19&type=section&id=NOTE%2010%20%E2%80%93%20STOCKHOLDERS'%20EQUITY) - During the six months ended June 30, 2025, the Company issued **3,332 Common Shares** for the exercise of warrants, generating **$25,823 in proceeds**[87](index=87&type=chunk) | Warrants Activity | Number of Warrants | Weighted Average Exercise Price (as converted) | Remaining Contractual Term (Years) | | :---------------- | :----------------- | :--------------------------------------------- | :--------------------------------- | | Balance, Dec 31, 2024 | 3,635,962 | $7.37 | 3.30 | | Exercised | (3,332) | $7.75 | - | | Balance, Jun 30, 2025 | 3,632,630 | $7.40 | 2.80 | - Warrant liabilities increased significantly, with the derivative liability for CAD exercise prices rising from **$503,129 to $792,893 (a $289,764 loss)**, Initial and Additional Debenture Warrants from **$2,646,843 to $4,514,619 (a $1,867,776 loss)**, and Agent Warrants from **$2,670,386 to $4,537,055 (a $1,866,669 loss)** for the six months ended June 30, 2025, primarily due to the fundamental transaction clause linking volatility to Bloomberg's HVT function, causing them to fail the 'fixed-for-fixed' test and be classified as derivative liabilities[91](index=91&type=chunk)[95](index=95&type=chunk)[96](index=96&type=chunk)[98](index=98&type=chunk)[99](index=99&type=chunk) - The 2025 Stock and Incentive Plan was approved on **June 19, 2025**, reserving **2,000,000 Common Shares** for equity-based compensation, with no awards granted as of June 30, 2025[101](index=101&type=chunk) | Share-Based Compensation Expense (Six Months Ended June 30) | 2025 | 2024 | | :---------------------------------------------------------- | :---------- | :-------- | | Research and development | $71,835 | $153,541 | | General and administrative | $2,831,108 | $453,867 | | Total share-based compensation | $2,902,943 | $607,408 | - Common Share options outstanding increased from **888,529** at December 31, 2024, to **2,101,696** at June 30, 2025, with **1,213,097 options** granted during the period[105](index=105&type=chunk) [NOTE 11 – CMS LICENSE AND COLLABORATION AGREEMENT](index=26&type=section&id=NOTE%2011%20%E2%80%93%20CMS%20LICENSE%20AND%20COLLABORATION%20AGREEMENT) - On **January 8, 2025**, the Company entered into an exclusive license agreement with CMS International Development and Management Limited for ZUNVEYL in the Asia-Pacific region (excluding Japan), Australia, and New Zealand[111](index=111&type=chunk) - The Company received a **$3.0 million upfront payment** and is eligible for up to **$11.0 million in development/regulatory milestones** and **$30.0 million in sales milestones**, plus **9% annual royalties on net sales**[112](index=112&type=chunk) - **$3.0 million upfront payment** was allocated to two performance obligations: **$2,525,900** for the intellectual property license (recognized in **Q1 2025**) and **$474,100** for regulatory, technical, and clinical assistance (recognized over time, with **$111,650** recognized as of June 30, 2025)[114](index=114&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk) [NOTE 12 – RELATED PARTY TRANSACTIONS AND BALANCES](index=28&type=section&id=NOTE%2012%20%E2%80%93%20RELATED%20PARTY%20TRANSACTIONS%20AND%20BALANCES) - The CEO's annual base compensation increased to **$625,000** and the COO's to **$500,000** on **February 18, 2025**[121](index=121&type=chunk)[123](index=123&type=chunk) - As of June 30, 2025, **$397,644** was owing to directors and officers, included in accounts payable and accrued liabilities, down from **$799,941** at December 31, 2024[125](index=125&type=chunk) | Key Management Personnel Compensation (Six Months Ended June 30) | 2025 | 2024 | | :--------------------------------------------------------------- | :---------- | :---------- | | Management fees and salaries in research and development | $41,680 | $372,786 | | Management fees and salaries in selling, general and administrative expenses | $1,233,828 | $725,279 | | Share-based compensation in research and development | $34,434 | $264,722 | | Share-based compensation in selling, general and administrative expenses | $1,261,617 | $453,868 | | Total related party transactions | $2,571,559 | $1,816,655 | [NOTE 13 – COMMITMENTS AND CONTINGENCIES](index=29&type=section&id=NOTE%2013%20%E2%80%93%20COMMITMENTS%20AND%20CONTINGENCIES) - Under the Memogain Technology License Agreement for ALPHA-1062, the Company has cumulative payment obligations to Galantos Pharma GmbH of up to **$17,613,000 (EUR 15,000,000)** and royalty payments (**3% of net sales, 10% of sublicensing revenue, 25% of upfront/milestone payments from sub-licensees**)[130](index=130&type=chunk) - As of June 30, 2025, the Company recognized **$797,389 in royalty fees** for ALPHA-1062, with **$755,944** paid[132](index=132&type=chunk) - The Company assumed obligations under a Royalty Agreement with Galantos Consulting, with cumulative payments up to **$3,523,000 (EUR 3,000,000)**, and recognized **$75,994 in royalty fees** as of June 30, 2025, with **$63,601** paid[133](index=133&type=chunk)[134](index=134&type=chunk) - For ALPHA-0602 Technology, the Company has a license agreement with NLS involving a **1.5% royalty on commercial sales (capped at $2,000,000)** and **10% of upfront payments exceeding $2,000,000**, but development of ALPHA-0602 technology was discontinued in **2024**[135](index=135&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk)[140](index=140&type=chunk) [NOTE 14 – NET LOSS PER SHARE](index=31&type=section&id=NOTE%2014%20%E2%80%93%20NET%20LOSS%20PER%20SHARE) | Metric (Three Months Ended June 30) | 2025 | 2024 | | :---------------------------------- | :------------ | :------------ | | Net loss – basic and diluted | $(10,488,952) | $(2,115,512) | | Weighted average shares | 16,020,702 | 6,009,373 | | Net loss per share | $(0.65) | $(0.35) | | Metric (Six Months Ended June 30) | 2025 | 2024 | | :---------------------------------- | :------------ | :------------ | | Net loss – basic and diluted | $(12,495,495) | $(7,118,223) | | Weighted average shares | 16,020,015 | 5,877,006 | | Net loss per share | $(0.78) | $(1.21) | - Potentially dilutive common shares, including 3,632,630 warrants and 2,101,696 common share options as of June 30, 2025, were excluded from diluted net loss per share computation because their effect would have been anti-dilutive[143](index=143&type=chunk) [NOTE 15 – SUBSEQUENT EVENTS](index=31&type=section&id=NOTE%2015%20%E2%80%93%20SUBSEQUENT%20EVENTS) - Subsequent to June 30, 2025, the Company granted **9,600 Common Shares options** to employees with exercise prices of **$11.24 and $9.11 per share**, vesting over three years[144](index=144&type=chunk) - The Company issued **9,090 Common Shares** on **July 23, 2025**, for **$70,448** and **128,578 Common Shares** on **August 6, 2025**, for **$923,190**, both from warrant exercises[144](index=144&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=32&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section provides management's perspective on Alpha Cognition Inc.'s financial condition and results of operations, highlighting the launch of ZUNVEYL, operational challenges, funding strategies, and key financial performance drivers for the periods ended June 30, 2025, and 2024 [Overview](index=32&type=section&id=Overview) - Alpha Cognition Inc. is a commercial-stage biopharmaceutical company focused on neurodegenerative diseases, with ZUNVEYL (for mild-to-moderate Alzheimer's disease) launched on **March 17, 2025**, targeting long-term care facilities[146](index=146&type=chunk)[147](index=147&type=chunk) - ZUNVEYL's Wholesale Acquisition Cost (WAC) is set at **$749 per month**, aiming to balance patient access with innovative healthcare value[147](index=147&type=chunk) - The Company has three additional pre-clinical development programs: ZUNVEYL in combination with memantine, ALPHA-1062 sublingual formulation, and ALPHA-1062 intranasal (ALPHA-1062IN) for mTBI. ALPHA-0602, ALPHA-0702 & ALPHA-0802 (Progranulin and GEMs) are pre-clinical assets that the Company will seek to out-license[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk) - The Company's common shares commenced trading on The Nasdaq Capital Market under 'ACOG' on **November 12, 2024**, following delisting from the CSE[150](index=150&type=chunk) [Operations](index=33&type=section&id=Operations) - As of June 30, 2025, the Company had a deficit of **$88,780,533** (compared to **$76,285,038** at December 31, 2024) and **$39,463,610** in cash and cash equivalents[151](index=151&type=chunk) - Management believes it has sufficient working capital but will need to raise additional capital for planned R&D, ZUNVEYL commercialization, and operating costs, exploring dilutive and non-dilutive strategic sources[151](index=151&type=chunk)[152](index=152&type=chunk) - A **1-for-25 reverse stock split** of common shares was completed on **November 5, 2024**[152](index=152&type=chunk)[153](index=153&type=chunk) [Components of our Results of Operations](index=33&type=section&id=Components%20of%20our%20Results%20of%20Operations) - Research and development expenses include costs for clinical supplies, non-clinical materials, contract manufacturers, employee-related expenses (salaries, benefits, stock-based compensation), travel, and consulting services[154](index=154&type=chunk)[158](index=158&type=chunk) - General and administrative expenses cover personnel costs, professional services (legal, HR, audit, accounting), consulting, pre-commercialization expenses (selling and marketing), and public company compliance costs[155](index=155&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) | Metric (Three Months Ended June 30) | 2025 | 2024 | Dollar Change | Percentage Change | | :---------------------------------- | :------------ | :------------ | :------------ | :---------------- | | Total revenue | $1,657,687 | $- | $1,657,687 | 100% | | Total costs and expenses | $7,394,688 | $2,421,211 | $4,973,477 | 205% | | Net loss and comprehensive loss | $(10,488,952) | $(2,115,512) | $(8,373,440) | 396% | | Net loss per share | $(0.65) | $(0.35) | $(0.30) | 86% | | Metric (Six Months Ended June 30) | 2025 | 2024 | Dollar Change | Percentage Change | | :---------------------------------- | :------------ | :------------ | :------------ | :---------------- | | Total revenue | $4,586,341 | $- | $4,586,341 | 100% | | Total costs and expenses | $14,009,774 | $6,832,729 | $7,177,045 | 105% | | Net loss and comprehensive loss | $(12,495,495) | $(7,118,223) | $(5,377,272) | 76% | | Net loss per share | $(0.78) | $(1.21) | $0.43 | (36)% | - Research and development expenses decreased by **67% ($650,080)** for the three months and **62% ($1,159,285)** for the six months ended June 30, 2025, primarily due to lower product development costs and reduced management/employee time allocated to R&D after FDA approval in July 2024[161](index=161&type=chunk)[162](index=162&type=chunk) - General and administrative expenses increased by **356% ($5,103,834)** for the three months and **143% ($6,995,273)** for the six months ended June 30, 2025, driven by expansion in commercial operations, ZUNVEYL launch, and increased share-based compensation, partially offset by a decrease in consulting fees for capital raising[163](index=163&type=chunk)[164](index=164&type=chunk) - Interest income significantly increased by **19,577% ($422,866)** for the three months and **6,194% ($881,472)** for the six months ended June 30, 2025, reflecting higher interest earned on the Company's cash[165](index=165&type=chunk) - Grant income decreased to **$nil** for the three months ended June 30, 2025 (from **$138,561** in 2024) and to **$71,095** for the six months ended June 30, 2025 (from **$272,340** in 2024)[166](index=166&type=chunk) - The Company recorded a loss of **$5,172,091** on warrant liabilities for the three months ended June 30, 2025 (compared to a gain of **$187,056** in 2024), and a loss of **$4,024,209** for the six months ended June 30, 2025 (compared to a loss of **$432,933** in 2024), primarily due to additional derivatives from the convertible debenture conversion and US IPO in November 2024, and stock price fluctuations[168](index=168&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) - The Company relies on external financing (debt, equity offerings, collaborations) to fund operations and commercialization of ZUNVEYL, as it does not yet generate substantial product revenue[169](index=169&type=chunk)[173](index=173&type=chunk) - Expenses are expected to increase substantially with ZUNVEYL commercialization, R&D, clinical trials, personnel hiring, and public company costs[170](index=170&type=chunk) - Existing cash, cash equivalents, and marketable securities are estimated to fund operations and initial ZUNVEYL commercialization costs for at least the **next 24 months**, but additional capital will be needed to further advance commercialization plans[172](index=172&type=chunk) - On **September 24, 2024**, the Company closed a **$4.545 million bridge financing** through convertible notes and warrants, which automatically converted into common shares and additional warrants upon the **November 13, 2024**, public offering[175](index=175&type=chunk)[176](index=176&type=chunk)[178](index=178&type=chunk)[179](index=179&type=chunk) - On **November 13, 2024**, the Company completed a public offering of **8,695,653 common shares at $5.75 per share**, raising approximately **$50 million in gross proceeds ($46.15 million net)**[177](index=177&type=chunk)[199](index=199&type=chunk) - As of June 30, 2025, approximately **$5.59 million** of the net proceeds from the public offering were spent on ZUNVEYL commercialization, **$1.33 million** on CMC activities, **$0.91 million** on loan repayment, and **$4.02 million** for working capital, with **$34.3 million** remaining[200](index=200&type=chunk) | Cash Flow Activity (Six Months Ended June 30) | 2025 | 2024 | Dollar Change | Percentage Change | | :-------------------------------------------- | :-------------- | :-------------- | :-------------- | :---------------- | | Cash used in operating activities | $(8,183,776) | $(3,873,814) | $(4,309,962) | 111% | | Cash used in investing activities | $(71,585) | $- | $(71,585) | 100% | | Net cash provided by (used in) financing activities | $(845,111) | $3,573,424 | $(4,418,535) | (124)% | [Contractual Obligations and Other Commitments](index=42&type=section&id=Contractual%20Obligations%20and%20Other%20Commitments) - The Company has existing license agreements for ALPHA-1062 and ALPHA-0602 technology and expects to enter into additional agreements for R&D, manufacturing, and collaborations, which may involve upfront payments and long-term capital commitments[185](index=185&type=chunk) [Critical Accounting Estimates](index=42&type=section&id=Critical%20Accounting%20Estimates) - There have been no significant changes to the Company's critical accounting estimates since December 31, 2024[188](index=188&type=chunk) [Emerging Growth Company Status and Smaller Reporting Company Status](index=43&type=section&id=Emerging%20Growth%20Company%20Status%20and%20Smaller%20Reporting%20Company%20Status) - The Company qualifies as an emerging growth company and has elected to use the extended transition period for new or revised accounting standards, adopting them at the same time as private companies[189](index=189&type=chunk) - The Company is also a smaller reporting company, allowing it to take advantage of scaled disclosures[190](index=190&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=43&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) As a smaller reporting company, Alpha Cognition Inc. is not required to provide quantitative and qualitative disclosures about market risk - The Company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[191](index=191&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=43&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Alpha Cognition Inc.'s management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of June 30, 2025, and there have been no material changes in internal control over financial reporting during the period - As of **June 30, 2025**, the CEO and CFO concluded that the Company's disclosure controls and procedures were effective[192](index=192&type=chunk) - There have been no material changes in internal control over financial reporting during the **six months ended June 30, 2025**[193](index=193&type=chunk) [PART II – OTHER INFORMATION](index=44&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [ITEM 1. LEGAL PROCEEDINGS](index=44&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) Alpha Cognition Inc. is not currently a party to any material legal proceedings, though it may be involved in various legal claims in the normal course of business - The Company is not currently a party to any material legal proceedings[195](index=195&type=chunk) [ITEM 1A. RISK FACTORS](index=44&type=section&id=ITEM%201A.%20RISK%20FACTORS) There have been no material changes to the risk factors previously disclosed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes have occurred from the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024[196](index=196&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=44&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) Alpha Cognition Inc. did not engage in any unregistered sales of equity securities or repurchase any equity securities during the six months ended June 30, 2025. The Company has utilized approximately $11.85 million of the net proceeds from its November 2024 public offering for commercialization, CMC activities, loan repayment, and working capital, with $34.3 million remaining - The Company did not repurchase any of its equity securities during the **six months ended June 30, 2025**[198](index=198&type=chunk) - Approximately **$5.59 million** of the net proceeds from the November 2024 public offering were spent on ZUNVEYL commercialization, **$1.33 million** on CMC activities, **$0.91 million** on loan repayment, and **$4.02 million** for working capital and general corporate purposes[200](index=200&type=chunk) - As of June 30, 2025, the Company has approximately **$34.3 million** of the net proceeds remaining[200](index=200&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=44&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) Alpha Cognition Inc. reported no defaults upon senior securities - There were no defaults upon senior securities[201](index=201&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURE](index=44&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURE) This item is not applicable to Alpha Cognition Inc. - This item is not applicable[202](index=202&type=chunk) [ITEM 5. OTHER INFORMATION](index=44&type=section&id=ITEM%205.%20OTHER%20INFORMATION) During the quarter ended June 30, 2025, no directors or officers adopted, modified, or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements - During the **quarter ended June 30, 2025**, none of the Company's directors or officers adopted, modified, or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements[204](index=204&type=chunk) [ITEM 6. EXHIBITS](index=45&type=section&id=ITEM%206.%20EXHIBITS) This section lists all exhibits filed as part of the report, including organizational documents, specimen share certificates, warrant forms, convertible note forms, certifications, and XBRL taxonomy extensions [SIGNATURES](index=46&type=section&id=SIGNATURES) The report is duly signed on behalf of Alpha Cognition Inc. by Michael McFadden, Chief Executive Officer, on August 14, 2025 - The report was signed by Michael McFadden, Chief Executive Officer of Alpha Cognition Inc., on **August 14, 2025**[207](index=207&type=chunk)
What Makes Alpha Cognition Inc. (ACOG) a New Strong Buy Stock
ZACKS· 2025-07-04 17:00
Core Viewpoint - Alpha Cognition Inc. (ACOG) has received a Zacks Rank 1 (Strong Buy) upgrade, indicating a positive outlook on its earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in stock price movements [4]. Recent Performance and Future Outlook - Alpha Cognition Inc. is expected to earn -$1.42 per share for the fiscal year ending December 2025, with no year-over-year change [8]. - Over the past three months, the Zacks Consensus Estimate for Alpha Cognition Inc. has increased by 49.3%, reflecting a positive trend in earnings estimates [8]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - The upgrade of Alpha Cognition Inc. to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, indicating strong potential for near-term price appreciation [10].
Is Alpha Cognition Inc. (ACOG) Outperforming Other Medical Stocks This Year?
ZACKS· 2025-07-01 14:41
Group 1 - Alpha Cognition Inc. (ACOG) is currently ranked 7 in the Zacks Sector Rank among 989 companies in the Medical group, indicating strong performance relative to peers [2] - ACOG has a Zacks Rank of 1 (Strong Buy), suggesting it is poised to outperform the broader market in the next one to three months [3] - Over the past three months, the Zacks Consensus Estimate for ACOG's full-year earnings has increased by 49.3%, reflecting improved analyst sentiment and a positive earnings outlook [4] Group 2 - Year-to-date, ACOG has gained approximately 58.4%, while the average performance of Medical group stocks has declined by about 3.7%, demonstrating ACOG's strong outperformance [4] - ACOG belongs to the Medical - Biomedical and Genetics industry, which includes 497 companies and is currently ranked 85 in the Zacks Industry Rank; this industry has seen an average loss of 3.4% this year, further highlighting ACOG's superior performance [6] - Astellas Pharma Inc. (ALPMY), another stock in the Medical sector, has a year-to-date return of 0.9% and a Zacks Rank of 1 (Strong Buy), with its EPS consensus estimate increasing by 15.2% over the past three months [5][6]
Should You Buy Alpha Cognition Inc. (ACOG) After Golden Cross?
ZACKS· 2025-06-16 14:56
Core Viewpoint - Alpha Cognition Inc. (ACOG) is showing potential for a bullish breakout as it has reached a key support level and experienced a "golden cross" in its moving averages [1]. Group 1: Technical Indicators - ACOG's 50-day simple moving average has crossed above its 200-day simple moving average, indicating a bullish signal known as a "golden cross" [1]. - The golden cross is characterized by three stages: a downtrend followed by a crossover of the shorter moving average over the longer one, and finally an upward price movement [2]. - ACOG's shares have increased by 8.1% over the past four weeks, reinforcing the bullish sentiment [3]. Group 2: Earnings Expectations - ACOG is currently rated 2 (Buy) on the Zacks Rank, suggesting strong potential for a breakout [3]. - There have been two upward revisions in earnings expectations for the current quarter, with no downward changes, indicating positive sentiment among analysts [3]. - The Zacks Consensus Estimate for ACOG has also moved higher, further supporting the bullish outlook [3]. Group 3: Investment Consideration - Given the technical indicators and positive earnings revisions, ACOG should be considered for inclusion on investors' watchlists [5].
Alpha Cognition: Launching A Differentiated Drug Into A Large Alzheimer's Market Opportunity
Seeking Alpha· 2025-05-19 20:35
Core Insights - Alpha Cognition is a relatively unknown pharmaceutical company that launched its first commercial product, Zunveyl (benzgalantamine), in March for the symptomatic treatment of mild-to-moderate Alzheimer's disease [1] - The company received FDA approval for Zunveyl in July 2024, marking a significant milestone in its product development [1] Company Overview - Alpha Cognition operates in the pharmaceutical industry, focusing on treatments for Alzheimer's disease [1] - The launch of Zunveyl represents the company's entry into the market with a product aimed at addressing a critical health issue [1] Product Details - Zunveyl is specifically designed for the symptomatic treatment of mild-to-moderate Alzheimer's disease, indicating a targeted approach to a prevalent condition [1] - The approval from the FDA is a crucial step for the company, as it allows for commercial sales and distribution of Zunveyl [1]
Alpha Cognition Inc. (ACOG) Reports Q1 Loss, Misses Revenue Estimates
ZACKS· 2025-05-15 22:41
Financial Performance - Alpha Cognition Inc. reported a quarterly loss of $0.20 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.58, and an improvement from a loss of $0.75 per share a year ago, representing an earnings surprise of 65.52% [1] - The company posted revenues of $2.93 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 26.78%, compared to zero revenues a year ago [2] Stock Performance - Alpha Cognition Inc. shares have increased approximately 16.5% since the beginning of the year, outperforming the S&P 500's gain of 0.2% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.84 on revenues of $0.96 million, and for the current fiscal year, it is -$2.93 on revenues of $10.03 million [7] - The estimate revisions trend for Alpha Cognition Inc. is currently unfavorable, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Alpha Cognition Inc. belongs, is currently in the top 28% of over 250 Zacks industries, suggesting a favorable industry outlook [8]
Alpha Cognition Inc(ACOG) - 2025 Q1 - Earnings Call Transcript
2025-05-15 21:32
Financial Data and Key Metrics Changes - For Q1 2025, the operating loss decreased to $3.7 million from $4.4 million in Q1 2024, attributed to initial net product revenues from ZUNVEL of $347,000 and recognized licensing revenue of $2.6 million from CMS [10][11] - The net loss for Q1 2025 was reported at $2 million or $0.13 per share, a decrease from a loss of $5 million or $0.87 per share in the same quarter last year, driven by increased interest income and favorable changes in derivative liabilities [11][12] - As of March 31, 2025, the company had approximately $45.5 million in unrestricted cash and cash equivalents, maintaining a debt-free balance sheet [12][13] Business Line Data and Key Metrics Changes - The commercial launch of ZUNVEL for Alzheimer's treatment has begun, with initial positive feedback and prescriptions being written shortly after launch [9][15] - Approximately 500 bottles of ZUNVEL were ordered within the first five weeks post-launch, indicating strong market demand [17] - The company has generated approximately $1 million in net sales through April 30, just four weeks into the launch [18] Market Data and Key Metrics Changes - The company is in advanced discussions for additional business development deals in new territories, expecting modest royalty revenue from the CMS deal in 2026 [5][6] - ZUNVEL became reimbursable by Medicare as of April 1, 2025, facilitating access in the long-term care segment [16] Company Strategy and Development Direction - The company aims to establish ZUNVEL as a core therapy in the long-term care market, focusing on building prescription volume and expanding its sales team gradually [9][10] - The strategy includes engaging with key plans for broader market access and monitoring prescription volume trends to support future contracting efforts [20][38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early commercial traction of ZUNVEL, with qualitative feedback from healthcare professionals being overwhelmingly positive [23][24] - The company anticipates that the capital raised will be sufficient to reach a positive cash flow position by year three if execution aligns with the plan [9][13] Other Important Information - The company has received patent approval for ZUNVEL, adding to its intellectual property portfolio and providing additional protection through 2044 [7][8] - Management is actively engaging in promotional strategies, including digital programs and webinars, to enhance awareness and adoption of ZUNVEL [20][48] Q&A Session Summary Question: Can you provide details on repeat prescribers and their expected evolution? - More than half of the 100 unique accounts that placed orders have already reordered, indicating initial engagement and potential for growth [32] Question: What is the length of time patients have been on therapy? - Patients have been on therapy since April 1, with some on the drug for up to six weeks, and management expects patients to remain on the drug as long as it is effective and tolerated [30] Question: What are the current prior authorization requirements for ZUNVEL? - Prior authorization requirements have been relatively simple, with many plans requiring just a checkbox confirmation rather than extensive documentation [36] Question: What is the company's strategy for contracting in the next few months? - The company is engaged in discussions with key plans and expects to see progress in contracting as they monitor initial utilization trends [39] Question: How does the company view the market beyond Medicare? - Currently, the focus is on Medicare Part D plans, with plans to pursue commercial contracts in the future as the product gains traction [42] Question: What promotional strategies are being considered for ZUNVEL? - The current focus is on maximizing impact within the nursing home setting, with plans for sampling and broader advertising strategies as the company expands into neurology [48]
Alpha Cognition Inc(ACOG) - 2025 Q1 - Earnings Call Transcript
2025-05-15 21:30
Financial Data and Key Metrics Changes - For Q1 2025, the operating loss decreased to $3.7 million from $4.4 million in Q1 2024, attributed to initial net product revenues from ZUNVEL and recognized licensing revenue of $2.6 million from CMS [9][10] - The net loss for Q1 2025 was $2 million or $0.13 per share, a decrease from a loss of $5 million or $0.87 per share in the same quarter last year, driven by increased interest income and favorable changes in derivative liabilities [10][11] - As of March 31, 2025, the company had approximately $45.5 million in unrestricted cash and cash equivalents, maintaining a debt-free balance sheet [11][12] Business Line Data and Key Metrics Changes - The first quarter of 2025 marked the first recorded revenue for ZUNVEL, with initial net product revenues of $347,000 in the last two weeks of March [4][10] - The company anticipates modest royalty revenue from the CMS deal in 2026, with additional business development deals expected to generate revenues in 2026 [5][6] Market Data and Key Metrics Changes - ZUNVEL became reimbursable by Medicare as of April 1, 2025, which is critical for long-term care access [14] - Approximately 66% of top-tier long-term care targets have been engaged by the sales team, with about 1,400 unique homes reached [15] Company Strategy and Development Direction - The company aims to establish ZUNVEL as a core therapy in the long-term care segment, focusing on building a prescription base with gerontology groups [8][19] - The management is optimistic about the commercial launch and plans to continue expanding access and awareness in the coming months [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early uptake of ZUNVEL, noting positive feedback from healthcare professionals and a strong demand for the product [14][21] - The company is focused on executing its strategic priorities and believes it can achieve a positive cash flow position in year three if it executes according to plan [8][12] Other Important Information - The company has received multiple abstracts accepted for presentation at the upcoming AAIC meeting, indicating ongoing research and validation of ZUNVEL [8][19] - Management reiterated that they are not providing revenue guidance at this time but expect to maintain expense guidance in the range of $38 million to $42 million for 2025 [12] Q&A Session Summary Question: Can you provide details on commercial metrics and repeat prescribers? - Management indicated that more than half of the 100 unique accounts that placed orders have already reordered, showing early signs of clinical adoption [31][32] Question: What is the length of time patients have been on therapy? - Patients have been on therapy since April 1, with some on the drug for up to six weeks, and management anticipates patients may remain on the drug for life as long as it is effective and tolerated [29][30] Question: What are the prior authorization requirements for ZUNVEL? - The prior authorization process has been relatively simple, with many plans requiring minimal documentation, which is encouraging for early adoption [33][34] Question: What is the company's strategy for commercial plans beyond Medicare? - The company plans to pursue commercial contracts after establishing a foothold in Medicare and Medicaid, as the long-term care segment primarily relies on Medicare [42][43] Question: How is the company addressing potential pricing pressures? - Management does not anticipate significant impacts from recent U.S. policy developments on pricing power, as they expect consistency in the Alzheimer's category [84][86]
Alpha Cognition Inc(ACOG) - 2025 Q1 - Quarterly Report
2025-05-15 20:02
[PART I – FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Condensed Consolidated Financial Statements](index=4&type=section&id=ITEM%201.%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) Alpha Cognition reported Q1 2025 revenues of $2.93 million and a net loss of $2.01 million, reflecting its commercial-stage transition [Condensed Interim Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Interim%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets were **$48.61 million**, slightly down from **$50.74 million**, driven by reduced cash Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $45,527,197 | $48,546,210 | | Total current assets | $48,118,956 | $50,251,178 | | Total assets | $48,608,419 | $50,736,938 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $2,807,397 | $3,350,752 | | Total liabilities | $7,796,544 | $9,273,893 | | Total stockholders' equity | $40,811,875 | $41,463,045 | | Total liabilities and stockholders' equity | $48,608,419 | $50,736,938 | [Condensed Interim Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2025 total revenue reached **$2.93 million**, improving net loss to **$2.01 million** from **$5.00 million** in Q1 2024 Statement of Operations Summary (Unaudited, For the Three Months Ended March 31) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Total revenue | $2,928,654 | $0 | | - Product, net | $346,929 | $0 | | - Licensing | $2,581,725 | $0 | | Total costs and expenses | $6,615,086 | $4,411,518 | | Selling, general and administrative expenses | $5,365,647 | $3,474,208 | | Research and development | $407,511 | $916,716 | | Net loss and comprehensive loss | $(2,006,543) | $(5,002,711) | | Loss per share, basic and diluted | $(0.13) | $(0.87) | [Condensed Interim Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity decreased to **$40.81 million** as of March 31, 2025, due to a **$2.01 million** net loss, partially offset by share-based compensation - The change in stockholders' equity for Q1 2025 was driven by a net loss of **$2,006,543** and non-cash share-based compensation of **$1,355,373**[11](index=11&type=chunk) [Condensed Interim Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2025 saw **$2.04 million** net cash used in operations, **$0.83 million** in financing, resulting in a **$2.94 million** decrease in cash, ending at **$45.62 million** Cash Flow Summary (Unaudited, For the Three Months Ended March 31) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,044,280) | $(2,471,492) | | Net cash used in investing activities | $(63,270) | $0 | | Net cash provided by (used in) financing activities | $(834,303) | $3,399,981 | | **Change in cash and cash equivalents** | **$(2,941,853)** | **$928,489** | | Cash and cash equivalents, end of period | $45,622,229 | $2,423,062 | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's commercial transition post-FDA approval of ZUNVEYL, covering revenue recognition, licensing, intangible asset life, and warrant liabilities - The company is a commercial-stage biopharmaceutical company focused on neurodegenerative diseases, having received FDA approval for ZUNVEYL in July 2024 for mild-to-moderate Alzheimer's disease[15](index=15&type=chunk)[16](index=16&type=chunk) - In January 2025, the company entered into a license and collaboration agreement with CMS International, granting exclusive rights to commercialize ZUNVEYL in the Asia-Pacific region. The company received a **$3.0 million** upfront payment and is eligible for up to **$41.0 million** in future development, regulatory, and sales milestones, plus royalties[131](index=131&type=chunk)[132](index=132&type=chunk) - Following a new patent grant, the estimated useful life of a related intangible license asset was extended from **5 years** to **19 years**, prospectively reducing amortization expense by approximately **$14,400** for Q1 2025[89](index=89&type=chunk)[90](index=90&type=chunk)[91](index=91&type=chunk) - Certain warrants are classified as derivative liabilities due to features that fail the 'fixed-for-fixed' indexation test under ASC 815. These liabilities are revalued at each reporting period, resulting in a gain of **$1,147,882** in Q1 2025[112](index=112&type=chunk)[115](index=115&type=chunk)[119](index=119&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=34&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) MD&A discusses the company's commercial transition with ZUNVEYL's launch, highlighting new revenue, decreased R&D, increased SG&A, and sufficient liquidity [Overview](index=34&type=section&id=MD%26A_Overview) The company focuses on commercializing ZUNVEYL for Alzheimer's, launched in March 2024 at **$749** per month WAC, and has pre-clinical programs - The company is now focused on the commercial sales of ZUNVEYL oral tablets for Alzheimer's Disease, which was launched on March 17, 2024[171](index=171&type=chunk)[172](index=172&type=chunk) - The Wholesale Acquisition Cost (WAC) for ZUNVEYL has been set at **$749** per month[172](index=172&type=chunk) - The company's common shares began trading on The Nasdaq Capital Market under the symbol 'ACOG' on November 12, 2024, and were delisted from the CSE and OTCQB on December 17, 2024[175](index=175&type=chunk) [Results of Operations](index=39&type=section&id=MD%26A_Results%20of%20Operations) Q1 2025 net loss improved by **60%** to **$2.0 million** due to **$2.9 million** new revenue, **56%** R&D decrease, and **54%** SG&A increase Comparison of Operations for the Three Months Ended March 31 | Metric | 2025 | 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Total revenue | $2,928,654 | $0 | 100% | | Research and development | $407,511 | $916,716 | (56)% | | Selling, general and administrative expenses | $5,365,647 | $3,474,208 | 54% | | Net loss and comprehensive loss | $(2,006,543) | $(5,002,711) | (60)% | - R&D expenses decreased by **$509,205** (**56%**) YoY, mainly due to lower product development costs and reduced allocation of management and employee time to R&D[194](index=194&type=chunk) - General and administrative expenses increased by **$1,891,439** (**54%**) YoY, driven by costs to support the commercial launch of ZUNVEYL, including a **$1.7 million** increase in employee costs and a **$1.06 million** increase in share-based compensation[196](index=196&type=chunk) - A gain on warrant liabilities of **$1,147,882** was recorded in Q1 2025, compared to a loss of **$619,989** in Q1 2024, primarily due to the fluctuation in the company's stock price and the addition of new derivative warrants[204](index=204&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=MD%26A_Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held **$45.6 million** in cash, deemed sufficient for 24 months, bolstered by a November 2024 public offering - The company had **$45.6 million** in cash and cash equivalents as of March 31, 2025, and believes it has sufficient capital to fund operations for at least the next 24 months[178](index=178&type=chunk)[209](index=209&type=chunk) - In November 2024, the company completed a public offering, issuing **8,695,653** common shares for gross proceeds of approximately **$50 million**[216](index=216&type=chunk) - The company expects expenses to increase substantially with the commercialization of ZUNVEYL and may need to raise additional capital to fully execute its plans[207](index=207&type=chunk)[209](index=209&type=chunk) Cash Flow Summary (For the Three Months Ended March 31) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Cash used in operating activities | $(2,044,280) | $(2,471,492) | | Cash used in investing activities | $(63,270) | $0 | | Net cash provided by (used in) financing activities | $(834,303) | $3,399,981 | [Critical Accounting Policies and Estimates](index=47&type=section&id=MD%26A_Critical%20Accounting%20Policies%20and%20Estimates) Critical accounting policies involve significant judgment in valuing share-based payments, warrant liabilities, intangible asset useful lives, and impairment - Key estimates involve valuing equity securities, the fair value of warrant liabilities, useful lives of intangible assets, and impairment assessments[228](index=228&type=chunk) - Share-based compensation and liability-based awards are valued using the Black-Scholes model, which requires subjective inputs like expected volatility and term[236](index=236&type=chunk)[239](index=239&type=chunk) - The company has elected to use the extended transition period for complying with new or revised accounting standards available to emerging growth companies[248](index=248&type=chunk) - Management's going concern analysis concludes that existing cash is sufficient to fund operations and capital expenditures for at least the next 12 months from the date of the Form 10-Q filing[241](index=241&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=52&type=section&id=ITEM%203.%20%E2%80%93%20QUANTIATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) As a smaller reporting company, Alpha Cognition Inc. is exempt from providing market risk disclosures - The company is a smaller reporting company and is not required to provide information under this item[250](index=250&type=chunk) [Controls and Procedures](index=52&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective[251](index=251&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the first quarter of 2025[252](index=252&type=chunk) [PART II – OTHER INFORMATION](index=53&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=53&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is not currently a party to any material legal proceedings, though it may face ordinary course litigation - As of the filing date, the company is not a party to any material legal proceedings[254](index=254&type=chunk) [Risk Factors](index=53&type=section&id=ITEM%201A.%20RISK%20FACTORS) No material changes have occurred to the risk factors previously disclosed in the Annual Report on Form 10-K for 2024 - No material changes have occurred from the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024[255](index=255&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=53&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) No unregistered equity sales occurred; **$5.84 million** of **$46.15 million** public offering net proceeds used for ZUNVEYL commercialization and operations - There were no unregistered sales of equity securities during the quarter[256](index=256&type=chunk) - From the November 2024 public offering net proceeds of **~$46.15M**, the company has used **~$2.27M** for ZUNVEYL commercialization, **~$1M** for CMC activities, and **~$2.57M** for working capital, with **~$40.3M** remaining as of March 31, 2025[258](index=258&type=chunk)[259](index=259&type=chunk) [Other Information](index=53&type=section&id=ITEM%205.%20OTHER%20INFORMATION) No other material information was reported for the quarter, and no Rule 10b5-1 trading arrangements were adopted or modified - During the quarter ended March 31, 2025, no directors or officers adopted, modified, or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements[263](index=263&type=chunk) [Exhibits](index=54&type=section&id=ITEM%206.%20EXHIBITS) This section lists exhibits filed with the Form 10-Q, including corporate articles, warrant forms, and CEO/CFO certifications - The report includes standard exhibits such as articles of incorporation, forms of securities, and CEO/CFO certifications as required by the SEC[264](index=264&type=chunk)
Alpha Cognition Inc(ACOG) - 2024 Q4 - Annual Report
2025-03-31 20:01
PART I [Business](index=8&type=section&id=ITEM%201.%20BUSINESS) The company is a biopharmaceutical firm focused on commercializing its newly FDA-approved Alzheimer's drug, ZUNVEYL™ - The company's lead product, ZUNVEYL™ (formerly ALPHA-1062), received **FDA approval on July 26, 2024**, for the treatment of mild to moderate dementia of the Alzheimer's type[20](index=20&type=chunk) - The commercial strategy for ZUNVEYL focuses on the U.S. long-term care (LTC) market, representing **36% of the acetylcholinesterase inhibitor (AChEI) prescription market**, with a launch announced on March 19, 2025[28](index=28&type=chunk)[57](index=57&type=chunk)[60](index=60&type=chunk) Product Pipeline Overview | Product Candidate | Indication | Development Stage | | :--- | :--- | :--- | | **ZUNVEYL™ (Oral Tablet)** | Mild-to-Moderate Alzheimer's Disease | FDA Approved & Commercial Launch | | **ZUNVEYL™ + Memantine** | Moderate-to-Severe Alzheimer's Disease | Pre-clinical | | **ALPHA-1062 (Sublingual)** | Mild-to-Moderate Alzheimer's (Dysphagia) | Pre-clinical | | **ALPHA-1062IN (Intranasal)** | Cognitive Impairment with mTBI | Pre-clinical | | **ALPHA-0602, 0702, 0802** | ALS and other Neurodegenerative Diseases | Pre-clinical (for out-licensing) | - The company entered an exclusive licensing agreement with China Medical System Holdings Limited (CMS) for ZUNVEYL in Asia, Australia, and New Zealand, with terms totaling **$44 million plus royalties**[59](index=59&type=chunk) - The company possesses a significant intellectual property portfolio for ZUNVEYL, with patents potentially extending protection **beyond 2042**[90](index=90&type=chunk)[92](index=92&type=chunk) [Risk Factors](index=40&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company faces substantial risks in its financial position, product dependency, manufacturing, and regulatory compliance - The company is a commercial development stage entity with a history of significant net losses, reporting a **net loss of approximately $12.4 million** for FY2024 and an **accumulated deficit of approximately $74 million**[191](index=191&type=chunk) - The business is **heavily dependent on the successful commercialization of ZUNVEYL**, its only FDA-approved product, and has no prior commercialization history[193](index=193&type=chunk)[194](index=194&type=chunk)[207](index=207&type=chunk) - **Substantial additional capital will be required** to fund commercialization and development, and failure to raise capital could force program delays or elimination[198](index=198&type=chunk) - The company **relies on third-party suppliers for manufacturing**, including a key manufacturer in Taiwan, exposing it to supply chain, geopolitical, and quality control risks[267](index=267&type=chunk)[268](index=268&type=chunk)[272](index=272&type=chunk) - Success depends on obtaining and maintaining patent protection, which can be challenged, and some key patents are set to expire in 2026[286](index=286&type=chunk)[295](index=295&type=chunk)[303](index=303&type=chunk) - The regulatory approval process is lengthy and unpredictable, and ZUNVEYL remains subject to ongoing regulatory scrutiny and post-marketing requirements[343](index=343&type=chunk)[348](index=348&type=chunk) [Unresolved Staff Comments](index=105&type=section&id=ITEM%201B.%20UNRESOLVED%20STAFF%20COMMENTS) The company reports no unresolved staff comments from the SEC - None[428](index=428&type=chunk) [Cybersecurity](index=105&type=section&id=ITEM%201C.%20CYBERSECURITY) The company manages cybersecurity risks through a program overseen by the CFO and the audit committee, with third-party support - The company utilizes a third-party service provider, under the direction of the CFO, to help identify, assess, and manage cybersecurity threats[430](index=430&type=chunk)[433](index=433&type=chunk) - The audit committee of the board of directors is responsible for overseeing the company's cybersecurity risk management processes[436](index=436&type=chunk)[440](index=440&type=chunk) - The CFO is responsible for implementing and maintaining cybersecurity processes, including managing external providers and reporting incidents to the audit committee[437](index=437&type=chunk)[438](index=438&type=chunk)[439](index=439&type=chunk) [Properties](index=106&type=section&id=ITEM%202.%20PROPERTIES) The company does not own or lease any real estate for its corporate or laboratory facilities - The Company does not own or rent any real estate for its corporate head office and laboratory facilities[441](index=441&type=chunk) - The corporate head office is located at Suite 1200 – 750 West Pender Street, Vancouver, BC, V6C 2T8[442](index=442&type=chunk) [Legal Proceedings](index=106&type=section&id=ITEM%203.%20LEGAL%20PROCEEDINGS) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[443](index=443&type=chunk) [Mine Safety Disclosures](index=106&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to the company - Not applicable[443](index=443&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=107&type=section&id=ITEM%205.%20MARKET%20FOR%20REGISTRANT'S%20COMMON%20EQUITY%2C%20RELATED%20STOCKERHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) The company's common shares began trading on Nasdaq in November 2024, and it does not plan to pay dividends - On November 12, 2024, the company's common shares began trading on Nasdaq under the symbol "ACOG" after a **1-for-25 reverse stock split** on November 5, 2024[445](index=445&type=chunk) - The company has **never paid dividends and does not expect to in the foreseeable future**, intending to reinvest any future earnings into growth[447](index=447&type=chunk) - During fiscal year 2024, the company conducted several unregistered sales of equity securities, including a private placement, convertible notes, and warrants[448](index=448&type=chunk)[455](index=455&type=chunk) [[Reserved]](index=109&type=section&id=ITEM%206.%20%5BRESERVED%5D) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=110&type=section&id=ITEM%207.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDIITION%20AND%20RESULTS%20OF%20OPERATIONS) The company's net loss increased to $14.6 million in 2024 due to commercial launch costs, with sufficient cash for the next year Key Financial Results (Year Ended Dec 31) | Metric | 2024 | 2023 | Change (%) | | :--- | :--- | :--- | :--- | | Research and Development | $3,918,543 | $4,883,973 | (20)% | | General and Administrative | $7,942,112 | $5,054,120 | 57% | | **Net Operating Loss** | **($11,860,655)** | **($9,938,093)** | **19%** | | **Net Loss** | **($14,636,865)** | **($13,763,658)** | **6%** | | Net Loss Per Share | ($2.02) | ($3.84) | (47)% | - As of December 31, 2024, the company had **$48.6 million in cash and cash equivalents** and an **accumulated deficit of $76.3 million**, with sufficient capital for at least the next 12 months[471](index=471&type=chunk)[543](index=543&type=chunk) - The company completed a public offering on November 13, 2024, raising **gross proceeds of approximately $50 million**, which triggered the conversion of $4.545 million in convertible notes[517](index=517&type=chunk)[518](index=518&type=chunk) - Effective August 31, 2023, the company changed its functional currency from the Canadian Dollar (CAD) to the U.S. Dollar (USD)[530](index=530&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=129&type=section&id=ITEM%207A.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLSOURES%20ABOUT%20MARKET%20RISK) This item is not applicable to the company - Not Applicable[552](index=552&type=chunk) [Financial Statements and Supplementary Data](index=130&type=section&id=ITEM%208.%20FINANCIAL%20STATEMENTS%20AND%20SUPPLEMENTARY%20DATA) This section presents the company's audited consolidated financial statements for fiscal years 2024 and 2023 Consolidated Balance Sheet Highlights (As of Dec 31) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | **Total Assets** | **$50,736,938** | **$2,452,170** | | Cash and cash equivalents | $48,546,210 | $1,404,160 | | **Total Liabilities** | **$9,273,893** | **$7,155,865** | | **Total Stockholders' Equity (Deficiency)** | **$41,463,045** | **($4,703,695)** | Consolidated Cash Flow Highlights (Year Ended Dec 31) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Cash used in operating activities | ($7,755,654) | ($8,799,565) | | Net cash provided by financing activities | $54,851,864 | $8,230,015 | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=171&type=section&id=ITEM%209.%20CHANGES%20IN%20AND%20DISAGREEMENTS%20WITH%20ACCOUNTANTS%20ON%20ACCOUNTING%20AND%20FINANCIAL%20DISCLOSURE) The company reports no disagreements with its independent accounting firm on accounting or financial disclosure matters - There have been no disagreements with the company's Independent Registered Public Accounting Firm[727](index=727&type=chunk) [Controls and Procedures](index=171&type=section&id=ITEM%209A.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls were effective, with no material changes to internal controls during the quarter - The CEO and CFO concluded that as of December 31, 2024, the company's **disclosure controls and procedures were effective**[728](index=728&type=chunk) - A management report on internal control over financial reporting is not included due to the transition period for newly public companies[729](index=729&type=chunk) - No material changes were made to the company's internal control over financial reporting during the quarter ended December 31, 2024[730](index=730&type=chunk) [Other Information](index=171&type=section&id=ITEM%209B.%20OTHER%20INFORMATION) The company reports no other information and no new director or officer trading plans were adopted during the quarter - No directors or officers adopted, modified, or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the fourth quarter of 2024[732](index=732&type=chunk) [Disclosure Regarding Foreign Jurisdictions That Prevent Inspections](index=171&type=section&id=ITEM%209C.%20DISCLOSURE%20REGARDING%20FOREIGN%20JURISDICTIONS%20THAT%20PREVENT%20INSPECTIONS) This item is not applicable to the company - Not applicable[731](index=731&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=172&type=section&id=ITEM%2010.%20DIRECTORS%2C%20EXECUTIVE%20OFFIERS%20AND%20CORPORATE%20GOVERNANCE) Required information on directors, officers, and governance is incorporated by reference from the 2025 Proxy Statement - Information is incorporated by reference from the upcoming 2025 Proxy Statement[734](index=734&type=chunk) [Executive Compensation](index=172&type=section&id=ITEM%2011.%20EXECUTIVE%20COMPENSATION) Required information on executive compensation is incorporated by reference from the 2025 Proxy Statement - Information is incorporated by reference from the upcoming 2025 Proxy Statement[735](index=735&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=172&type=section&id=ITEM%2012.%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS) Required information on security ownership is incorporated by reference from the 2025 Proxy Statement - Information is incorporated by reference from the upcoming 2025 Proxy Statement[736](index=736&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=172&type=section&id=ITEM%2013.%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20TRANSACTIONS%2C%20AND%20DIRECTOR%20INDEPENDENCE) Required information on related transactions and director independence is incorporated by reference from the 2025 Proxy Statement - Information is incorporated by reference from the upcoming 2025 Proxy Statement[737](index=737&type=chunk) [Principal Accountant Fees and Services](index=172&type=section&id=ITEM%2014.%20PRINCIPAL%20ACCOUNTANT%20FEES%20AND%20SERVICES) Information on principal accountant fees and services is incorporated by reference from the 2025 Proxy Statement - The company's independent public accounting firm is Manning Elliott, Vancouver, British Columbia, Canada, PCAOB Auditor ID: 1524[738](index=738&type=chunk) - Information on fees and services is incorporated by reference from the upcoming 2025 Proxy Statement[739](index=739&type=chunk) PART IV [Exhibits and Financial Statements Schedules](index=173&type=section&id=ITEM%2015.%20EXHIBITS%20AND%20FINANCIAL%20STATEMENTS%20SCHEDULES) This section lists the financial statements and exhibits filed as part of the annual report - This section lists the consolidated financial statements filed under Item 8 and all exhibits filed with the report, including corporate documents, material contracts, and certifications[742](index=742&type=chunk)[744](index=744&type=chunk) [Form 10-K Summary](index=175&type=section&id=ITEM%2016.%20FORM%2010-K%20SUMMARY) The company has elected not to provide a summary for this item - None[745](index=745&type=chunk)