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Alpha Cognition Inc. (CSE: ACOG, OTCQB: ACOGF) is a clinical-stage biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases. The company is primarily focused on addressing conditions like Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (mTBI), which currently lack approved treatment options.
Alpha Cognition's flagship product, ALPHA-1062, is a patented new chemical entity in development as a next-generation acetylcholinesterase inhibitor for the treatment of mild-to-moderate Alzheimer’s disease. Designed to minimize gastrointestinal side effects, ALPHA-1062's active metabolite is differentiated from existing therapies like donepezil and rivastigmine. The compound binds to neuronal nicotinic receptors, notably the alpha-7 subtype, which is known to positively affect cognition. ALPHA-1062 is also being developed in combination with memantine for moderate to severe Alzheimer’s dementia and as an intranasal formulation for Cognitive Impairment with mTBI.
In recent developments, Alpha Cognition has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ALPHA-1062, with an expected approval date in the second half of 2024. This milestone underscores the company's commitment to advancing patient care and highlights their robust pipeline of innovative treatments.
Alpha Cognition has also received significant recognition in the form of patents and grants. The company was recently awarded a $750,000 research and development grant from the U.S. Department of Defense to study ALPHA-1062's potential in treating mTBI. Additionally, the company holds multiple patents for ALPHA-1062, including a new composition-of-matter patent that extends protection into 2044.
The company's financial strategy includes successfully raising gross proceeds of $8.45 million through private placements, which will be used for research and development, general and administrative matters, and working capital. This funding is crucial for furthering the development and potential commercialization of their lead product, ALPHA-1062.
Alpha Cognition's commercialization strategy aims to initially target the Long Term Care (LTC) market, followed by the broader Neurology segment once payer reimbursement is established. This approach is expected to maximize the impact of ALPHA-1062 in the Alzheimer’s treatment landscape.
Overall, Alpha Cognition Inc. is poised for a transformational year with significant advancements in their pipeline, financial health, and strategic positioning to bring innovative therapies to market for neurodegenerative diseases.
Alpha Cognition announces a planned US$25 million public offering of common shares and pre-funded warrants in connection with its application to uplist to the Nasdaq Capital Market. The company will implement a 1-for-25 reverse stock split to meet Nasdaq's minimum share price requirements. Proceeds will support the company's New Drug Application, commercialization of ZUNVEYL for Alzheimer's disease, pipeline development, CMC activities, and general corporate purposes. The offering will be conducted through Titan Partners Group, pending SEC registration statement effectiveness and Nasdaq listing approval.
Alpha Cognition Inc. (CSE: ACOG) (OTCQB: ACOGF), a biopharmaceutical company focused on developing therapies for neurodegenerative disorders, has appointed Henry Du as VP of Finance and Accounting and interim Chief Financial Officer (CFO). Du brings over 20 years of experience in corporate accounting and finance, with a strong background in the life science industry.
Prior to joining Alpha Cognition, Du held senior positions at Amplify Surgical and HUYABIO International, where he played key roles in achieving financial goals and establishing accounting policies. He also served in leadership roles at Eledon Pharmaceuticals, United Auto Credit, and Avanir Pharmaceuticals.
CEO Michael McFadden stated that Du's appointment is important as the company prepares for commercialization. Du expressed excitement about joining Alpha Cognition at this critical juncture, emphasizing the opportunity to contribute to a company on the verge of a major product launch.
Alpha Cognition Inc. (CSE: ACOG) (OTCQB: ACOGF) has received a Notice of Allowance from the USPTO for a composition-of-matter patent covering tablet forms of benzgalantamine (ZUNVEYL), their treatment for mild to moderate Alzheimer's disease. This patent, once issued, will provide protection for ZUNVEYL's current formulation in the United States through 2044.
The Notice of Allowance signifies that the USPTO has determined the claimed invention is patentable and a patent should be granted. This milestone strengthens Alpha Cognition's ability to extend patent life beyond 2042 to 2044 in the U.S. market. The company plans to pursue similar patent approvals globally.
CEO Michael McFadden stated that this allowance provides an important layer of proprietary intellectual property protection for ZUNVEYL, their FDA-approved medication for mild to moderate Alzheimer's disease.
Alpha Cognition Inc. (CSE: ACOG) (OTCQB: ACOGF), a biopharmaceutical company focused on neurodegenerative disorders, has announced changes in its financial leadership. Don Kalkofen has resigned as Chief Financial Officer to pursue other opportunities. The company's CEO, Michael McFadden, expressed gratitude for Kalkofen's contributions over the past two years, highlighting significant progress including the approval of ZUNVEYL for mild-to-moderate Alzheimer's Disease.
Alpha Cognition has appointed Jay Yoo to assume interim accounting leadership responsibilities. Yoo brings 16 years of experience as a CPA and CFA, with expertise in accounting, finance, and SEC filings. The company expects to announce a new permanent Accounting and Finance leader later in the quarter, maintaining its outsourced finance model to ensure continuity in accounting and regulatory filings.
Alpha Cognition Inc. (CSE: ACOG) (OTCQB: ACOGF) has closed a $4.545 million bridge financing through convertible notes and warrants. The financing, led by existing and new investors, was placed by The Benchmark Company, The notes are convertible at $0.422 per share, mature on September 24, 2026, and bear 10% annual interest. They are subject to mandatory conversion in a Qualified Offering of at least $10 million with uplisting to a U.S. national exchange.
Investors received warrants to purchase shares at $0.422 for five years, with additional warrants upon a Qualified Offering. Proceeds will fund commercialization of ZUNVEYL™, payer pricing, contracting, and product manufacturing. The company also entered a registration rights agreement for the resale of shares from note conversion and warrant exercise.
Alpha Cognition Inc. (CSE: ACOG) (OTCQB: ACOGF) has received a Notice of Allowance from the USPTO for a new patent application covering an additional novel crystalline solid form of ZUNVEYL, their lead asset for treating mild to moderate Alzheimer's disease. This patent, titled "Solid Forms of ALPHA-1062 Gluconate," complements existing patents and extends protection for ZUNVEYL in the U.S. market through 2042.
The Notice of Allowance signifies that the USPTO has determined the claimed invention is patentable. This milestone strengthens Alpha Cognition's intellectual property position and provides an additional layer of protection for ZUNVEYL, an FDA-approved medication. CEO Michael McFadden emphasized the importance of this composition-of-matter patent in building on the company's existing patent protection for ZUNVEYL.
Alpha Cognition (CSE: ACOG) (OTCQB: ACOGF), a biopharmaceutical company developing treatments for neurodegenerative disorders, has delayed its planned capital raise and NASDAQ uplisting due to challenging market conditions. The company is exploring alternative funding strategies to better protect shareholder value while advancing its objectives.
CEO Michael McFadden stated that the company's priority remains executing its business plan and preparing for ZUNVEYL commercialization. Alpha Cognition has received interest for bridge funding to continue critical activities, including commercial supply manufacturing and pricing work, aiming for a Q1 2025 U.S. market launch of ZUNVEYL. The company is also pursuing non-dilutive capital options and potential partnerships to support its growth objectives.
Alpha Cognition (CSE: ACOG) (OTCQB: ACOGF) announces FDA approval of ZUNVEYL® (benzgalantamine) for treating mild-to-moderate Alzheimer's disease. ZUNVEYL is the second oral therapy approved this decade for AD, which affects nearly 7 million people in the US. Its dual mechanism of action is designed to eliminate drug absorption in the GI tract, potentially addressing tolerability issues with leading AD medications, while maintaining the efficacy of galantamine.
ZUNVEYL targets AD symptoms to provide long-lasting benefits to cognitive and global function. Clinical studies showed minimal adverse events, with GI adverse events less than 2% and no insomnia observed. The drug will be available by prescription nationwide in Q1 2025.
Alpha Cognition (CSE: ACOG, OTCQB: ACOGF) reported its first quarter 2024 financial results and provided a corporate update. Key highlights include: completion of a $8.45 million PPM financing, ongoing FDA review for ALPHA-1062 as a treatment for mild-to-moderate Alzheimer’s disease, and advancements in manufacturing stability for ALPHA-1062. R&D expenses decreased to $0.9 million from $1.1 million year-over-year, while G&A expenses surged to $3.2 million from $0.7 million due to higher consulting fees. The company recorded a comprehensive net loss of $5.0 million, up from $1.9 million in the previous year, and ended the quarter with $2.4 million in cash and equivalents. Additionally, an amendment to the promissory note increased the interest rate to 7% and extended the maturity date to July 2025.