S-1/A: Alzamend Neuro Files Amendment to Registration Statement for Resale of 75.8 Million Shares

Alzamend Neuro is filing an amendment to its registration statement to allow a selling stockholder to resell up to 75,775,110 shares of common stock.

Summary

• Alzamend Neuro, Inc. has filed a Pre-Effective Amendment No. 1 to its Form S-3 registration statement, converting it to a Form S-1.
• The amendment pertains to the resale of up to 75,775,110 shares of common stock by Orchid Finance LLC, the selling stockholder.
• These shares include those to be issued upon conversion of preferred stock and exercise of a warrant held by the selling stockholder.
• Alzamend Neuro will not receive any proceeds from the sale of these shares by the selling stockholder, except if the warrant is exercised.
• The company's common stock trades on the Nasdaq Capital Market under the symbol ALZN, with the last reported sales price on March 26, 2025, being $1.00 per share.
• Alzamend Neuro is classified as a smaller reporting company and an emerging growth company.
• The company is developing therapeutics for Alzheimers, bipolar disorder, major depressive disorder, and PTSD, with two drug candidates: AL001 and ALZN002.
• The company plans to initiate five clinical trials to determine relative increased lithium levels in the brain compared to a marketed lithium salt for healthy subject and patients diagnosed with mild to moderate Alzheimers, BD, MDD and PTSD.
• The company has partnered with Massachusetts General Hospital to serve as the CRO for these clinical trials.
• The company submitted an IND application to the FDA for ALZN002 and received a study may proceed letter on October 31, 2022.
• The company received notice from Biorasi, LLC that Biorasi was terminating our contract with them.
• The company requires additional capital to fund its operations and continue its clinical trials.
• The company entered into a Purchase Agreement with the Selling Stockholder, pursuant to which the Selling Stockholder has committed to purchase up to $5 million of Preferred Shares, subject to the satisfaction of certain conditions in the Purchase Agreement.

Sentiment

Score: 5

Explanation: The document presents a mix of positive and negative aspects. The company is advancing its clinical trials and has partnered with Massachusetts General Hospital, but it also faces financial challenges and potential dilution of existing stockholders. The termination of the contract with Biorasi is also a negative factor.

Positives

• The company has identified a maximum tolerated dose (MTD) for development of AL001 from a multiple-ascending dose study as assessed by an independent safety review committee.
• The company submitted an IND application to the FDA for ALZN002 and received a study may proceed letter on October 31, 2022.
• The company has partnered with Massachusetts General Hospital to serve as the CRO for these clinical trials.
• The company's novel AL001 formulation is designed to overcome the toxicities associated with conventional lithium salts, promising a next-generation lithium treatment with an enhanced safety profile and advantageous distribution to brain and brain structures.

Negatives

• The company will not receive any proceeds from the sale of shares of Common Stock by the Selling Stockholder, provided, that we would receive certain proceeds in the event that the Selling Stockholder elects to exercise its Warrant.
• The Preferred Shares are convertible into Common Stock at a discount to the market price, potentially diluting existing stockholders.
• The company received notice from Biorasi, LLC that Biorasi was terminating our contract with them.
• The company requires additional capital to fund its operations and continue its clinical trials.
• The company may not have access to the full amount available under the Purchase Agreement with the Selling Stockholder within the foreseeable future, if at all.

Risks

• Investing in the Common Stock is highly speculative and involves a high degree of risk.
• The company needs substantial additional funding to finance its operations and complete development to seek FDA approval for AL001 and ALZN002 before commercialization.
• The company's inability to access a portion or the full amount available under the Purchase Agreement, in the absence of any other financing sources, could have a material adverse effect on our business.
• Sales of substantial numbers of such shares in the public market could adversely affect the market price of our Common Stock.
• The company may not receive any additional funds upon the exercise of the Warrant.
• The company has never paid cash dividends on our Common Stock and do not plan to pay any cash dividends in the foreseeable future.

Future Outlook

The company intends to develop and commercialize therapeutics and vaccines that are better than existing treatments and have the potential to significantly improve the lives of individuals afflicted by Alzheimers, BD, MDD and PTSD.

Industry Context

The company operates in the pharmaceutical industry, specifically focusing on developing treatments for neurodegenerative and neuropsychiatric disorders. The industry is characterized by high research and development costs, lengthy regulatory approval processes, and intense competition.

Comparison to Industry Standards

• Alzamend is developing AL001, a novel lithium formulation, to address the limitations of existing lithium treatments, such as chronic toxicity and poor brain bioavailability.
• Compared to passive immunization treatment approaches that use foreign blood products (such as monoclonal antibodies), active immunization with ALZN002 is anticipated to offer a more robust and long-lasting effect on the clearance of amyloid.
• The company's approach to targeting beta-amyloid plaque via ALZN002 is based on a novel therapeutic approach.

Stakeholder Impact

• Shareholders may experience dilution due to the potential conversion of preferred stock into common stock.
• The company's ability to continue its clinical trials and develop new treatments depends on securing additional funding.
• The success of the company's drug candidates could have a significant impact on patients suffering from Alzheimers, bipolar disorder, major depressive disorder, and PTSD.

Next Steps

• The company plans to initiate five clinical trials to determine relative increased lithium levels in the brain compared to a marketed lithium salt for healthy subject and patients diagnosed with mild to moderate Alzheimers, BD, MDD and PTSD.
• The company is currently pursuing the engagement of a replacement CRO.
• The company needs to raise additional capital to fund its operations and continue its clinical trials.

Key Dates

Keywords

Alzamend Neuro, common stock, preferred stock, resale, AL001, ALZN002, Orchid Finance LLC, registration statement, warrant, clinical trials