Alpha Cognition Inc(ACOG)

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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)
Alpha Cognition Inc(ACOG) - 2024 Q3 - Quarterly Report
2024-11-14 21:05
PART I – FINANCIAL INFORMATION [Condensed Consolidated Financial Statements](index=4&type=section&id=ITEM%201.%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) This section presents the unaudited interim consolidated financial statements for Alpha Cognition Inc. as of September 30, 2024, and for the three and nine-month periods then ended, including balance sheets, statements of operations, statements of stockholders' deficiency, and statements of cash flows, along with detailed notes explaining the company's financial position, operational results, and significant accounting policies, covering key events such as FDA approval of ZUNVEYL, recent financing activities, and a change in functional currency to USD [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2024, the company's total assets increased to $5.03 million from $2.45 million at year-end 2023, primarily due to a rise in cash and cash equivalents, while total liabilities also increased to $7.95 million from $7.16 million, driven by the issuance of convertible debentures, with the company remaining in a stockholders' deficiency position, which improved from a deficiency of $4.70 million to $2.92 million Condensed Consolidated Balance Sheet Data (Unaudited) | Balance Sheet Items | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Total Assets** | **$5,028,072** | **$2,452,170** | | Cash and cash equivalents | $3,666,389 | $1,404,160 | | **Total Liabilities** | **$7,947,703** | **$7,155,865** | | Convertible debentures, net | $1,002,874 | - | | Warrant liabilities | $2,449,478 | $4,455,747 | | **Total Stockholders' Deficiency** | **($2,919,631)** | **($4,703,695)** | [Condensed Interim Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the nine months ended September 30, 2024, the company reported a net loss of $9.0 million, or ($1.51) per share, compared to a net loss of $8.0 million, or ($2.23) per share, for the same period in 2023, with the increased loss driven by higher general and administrative expenses, partially offset by lower research and development costs as the company transitions towards commercialization Statement of Operations Highlights (Unaudited) | Metric | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Research and development | $2,879,945 | $3,773,880 | | General and administrative expenses | $6,440,568 | $3,744,162 | | **Net Operating Loss** | **($9,320,513)** | **($7,518,042)** | | **Net Loss** | **($8,978,129)** | **($8,030,256)** | | **Net Loss Per Share** | **($1.51)** | **($2.23)** | [Condensed Interim Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2024, net cash used in operating activities was $5.5 million, while net cash provided by financing activities was $7.7 million, primarily from the issuance of units for cash and proceeds from convertible debentures, resulting in a net increase in cash and cash equivalents of $2.3 million, ending the period with a balance of $3.8 million Cash Flow Summary (Unaudited) | Cash Flow Activity | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($5,451,927) | ($6,769,171) | | Net cash provided by financing activities | $7,730,753 | $5,613,412 | | **Change in cash and cash equivalents** | **$2,278,826** | **($1,175,332)** | | **Cash and cash equivalents, end of period** | **$3,773,399** | **$908,364** | [Notes to Condensed Interim Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Interim%20Consolidated%20Financial%20Statements) The notes provide critical details on the company's operations, accounting policies, and financial items, including the **FDA approval for ZUNVEYL**, a reverse stock split, a significant public offering subsequent to the reporting period, and the company's assessment of its going concern status, which management believes is secured for the next 12 months following the recent financing, along with other significant notes detailing R&D grants, related party transactions, convertible debentures, and commitments related to technology licenses - The company is a commercial-stage biopharmaceutical firm focused on neurodegenerative diseases, receiving **FDA approval for ZUNVEYL** for treating mild-to-moderate Alzheimer's disease on July 29, 2024[15](index=15&type=chunk)[16](index=16&type=chunk) - On November 13, 2024, the company completed a public offering, issuing 8,695,653 common shares at $5.75 per share for gross proceeds of approximately **$50 million**, which is expected to cover liabilities and commitments for the next 12 months[18](index=18&type=chunk)[19](index=19&type=chunk) - Effective August 31, 2023, the company changed its **functional currency from Canadian Dollar (CAD) to U.S. Dollar (USD)**, reflecting a shift in its primary economic environment and funding sources[23](index=23&type=chunk) - In September 2024, the company issued **$4.545 million in convertible debentures**, which automatically converted into common shares upon the completion of the November 2024 public offering[79](index=79&type=chunk)[158](index=158&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=39&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the company's transition to a commercial-stage entity following the FDA approval of ZUNVEYL, analyzing operational results by comparing the third quarter and first nine months of 2024 to the same periods in 2023, detailing reasons for shifts in R&D and G&A expenses, outlining liquidity and capital resources including recent financing activities, and discussing critical accounting policies and estimates - Following FDA approval, the company is focused on the **commercial launch of ZUNVEYL, anticipated in Q1 2025**, with a commercial strategy targeting long-term care facilities and a **Wholesale Acquisition Cost (WAC) set at $649 per month**[160](index=160&type=chunk) - The company's pipeline includes **ZUNVEYL in combination with memantine**, **sublingual and intranasal formulations of ALPHA-1062**, and **Progranulin assets (ALPHA-0602/0702/0802)** which it intends to out-license[160](index=160&type=chunk)[162](index=162&type=chunk) - Management states that with the net proceeds of approximately **$46.42 million** from the November 2024 public offering, existing cash will be **sufficient to fund operations and commercialization costs for at least the next 24 months**[199](index=199&type=chunk)[235](index=235&type=chunk) [Results of Operations](index=43&type=section&id=Results%20of%20Operations) For the nine months ended September 30, 2024, total operating expenses increased by 24% to $9.3 million, primarily due to a 72% rise in G&A expenses related to IPO preparations and consulting fees, partially offset by a 24% decrease in R&D expenses as costs for the ALPHA-1062 NDA submission declined, resulting in the net loss for the period widening to $9.0 million from $8.0 million in the prior year Comparison of Nine Months Ended September 30, 2024 and 2023 | Expense Category | Nine Months 2024 | Nine Months 2023 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $2,879,945 | $3,773,880 | (24)% | | General and administrative | $6,440,568 | $3,744,162 | 72% | | **Total operating expenses** | **$9,320,513** | **$7,518,042** | **24%** | - R&D expenses **decreased by $0.9 million (24%)** for the nine months ended Sep 30, 2024, mainly due to lower product development costs for ALPHA-1062 following the NDA submission in September 2023[182](index=182&type=chunk) - G&A expenses **increased by $2.7 million (72%)** for the nine months ended Sep 30, 2024, primarily driven by $2.3 million in consulting fees related to the Spartan Consulting Agreement and increased professional and filing fees for the US IPO[185](index=185&type=chunk) [Liquidity and Capital Resources](index=48&type=section&id=Liquidity%20and%20Capital%20Resources) The company has historically relied on external financing, with recent capital raises including the multi-tranche Q2 2023 private placement totaling $8.45 million, a $4.545 million bridge financing in September 2024, and a subsequent public offering in November 2024 raising approximately $50 million in gross proceeds, which are expected to support the commercial launch of ZUNVEYL and ongoing operations - On November 13, 2024, the company completed a public offering for gross proceeds of approximately **$50 million**, significantly strengthening its capital position[210](index=210&type=chunk) - In September 2024, the company closed a **$4.545 million bridge financing** via convertible notes, which subsequently converted to equity upon the closing of the public offering[209](index=209&type=chunk)[211](index=211&type=chunk) Cash Flow Summary (Nine Months Ended) | Cash Flow Activity | September 30, 2024 | September 30, 2023 | | :--- | :--- | :--- | | Cash used in operating activities | ($5,451,927) | ($6,769,171) | | Net cash provided by financing activities | $7,730,753 | $5,613,412 | [Critical Accounting Policies and Estimates](index=54&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Management highlights several critical accounting policies, including the use of estimates, functional currency determination, grant accounting, fair value measurements, and share-based compensation, with the going concern assessment being a key estimate where management concludes that the proceeds from the November 2024 public offering are sufficient to fund operations for at least the next 12 months - The going concern assessment concludes that after the November 2024 public offering, the company has **sufficient capital to fund operations and commercialization costs for at least the next 12 months**[235](index=235&type=chunk) - The company uses the **Black-Scholes model** for valuing share-based payments and liability-based awards, which requires subjective assumptions about volatility, expected term, and interest rates[229](index=229&type=chunk)[232](index=232&type=chunk) [Controls and Procedures](index=58&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of September 30, 2024, with no material changes to the company's internal control over financial reporting during the quarter - The CEO and CFO concluded that as of September 30, 2024, the company's disclosure controls and procedures were **effective**[244](index=244&type=chunk) - **No changes in internal control over financial reporting** occurred during the nine months ended September 30, 2024, that materially affected, or are reasonably likely to materially affect, internal controls[245](index=245&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=59&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is not currently a party to any material legal proceedings - As of the report date, the company is **not involved in any material legal proceedings**[247](index=247&type=chunk) [Risk Factors](index=59&type=section&id=ITEM%201A.%20RISK%20FACTORS) There have been no material changes from the risk factors previously disclosed in the company's Registration Statement on Form S-1 filed on July 30, 2024 - **No material changes to risk factors** have occurred since the Form S-1 filing on July 30, 2024[248](index=248&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=59&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) This section discloses unregistered sales of equity, including the issuance of 14,000 common shares from warrant exercises, and details the use of proceeds from the November 2024 public offering, noting that approximately $46.42 million in net proceeds were received, of which about $502,000 has been used for consulting fees, leaving a remainder of approximately $45.9 million - In July 2024, the company issued **14,000 common shares** from the exercise of warrants at $10.00 per share, for proceeds of **$140,000**[250](index=250&type=chunk) - From the November 13, 2024 public offering, the company received net proceeds of approximately **$46.42 million**, and as of the filing date, about **$502,000** has been used, with **$45.9 million remaining**[252](index=252&type=chunk)[253](index=253&type=chunk)[254](index=254&type=chunk) [Defaults Upon Senior Securities](index=59&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) None [Mine Safety Disclosure](index=59&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURE) Not applicable [Other Information](index=59&type=section&id=ITEM%205.%20OTHER%20INFORMATION) The company reports no other material information for the period and confirms that no directors or officers adopted, modified, or terminated any Rule 10b5-1 trading arrangements during the quarter - During the quarter ended September 30, 2024, **no directors or officers adopted, modified, or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements**[257](index=257&type=chunk) [Exhibits](index=60&type=section&id=ITEM%206.%20EXHIBITS) This section lists the exhibits filed as part of the Form 10-Q, including articles of incorporation, forms of securities, material agreements, and officer certifications
Alpha Cognition Inc(ACOG) - 2024 Q2 - Quarterly Report
2024-08-12 20:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 333-278997 Securities registered pursuant to Section 12(b) of the Act: None Indicate by checkmark whether the registrant (1) filed a ...