Alzamend Neuro, Inc.

Climate Impact & Sustainability Data (2017, 2018, 2019, 2022)

Short-term Goals:

Submit an Investigational New Drug Application (IND) with the FDA in the first half of 2018.
Launch a First Stage Clinical Trial with up to 20 human patients.

The company is in the early stage of development, with virtually no operating history.
Significant influence by officers, directors, and affiliated entities.
Financial situation creates doubt about the company's ability to continue as a going concern.
High rate of failure for drug candidates in clinical trials.
Expensive and time-consuming regulatory approval process.
Substantial competition from large and small pharmaceutical and biotechnology companies.
Potential for serious adverse events or safety risks.
Uncertainty regarding reimbursement from third-party payers.
Difficulty in attracting and retaining qualified personnel.
Risks related to legal proceedings and product liability lawsuits.
Vulnerability of information technology systems.
Compliance with U.S. Foreign Corrupt Practices Act and other anti-corruption laws.
Potential for intellectual property disputes and infringement claims.
Challenges in protecting trade secrets and proprietary information.

The company plans to retain an experienced FDA consulting firm and establish advisory boards.
The company intends to raise additional capital to fund operations.
The company is working to manage the growth of its operations and implement improved systems and controls.
The company is taking precautions to avoid significant liability from product liability lawsuits.
The company is taking measures to protect its information technology systems.
The company is committed to complying with all applicable anti-corruption laws.
The company is relying on a combination of patents, trade secret protection, and confidentiality agreements to protect its intellectual property.

Short-term Goals:

File an IND with the FDA with respect to CAO22W in the second quarter of 2019 and prepare to conduct a Phase 1 Clinical Trial at Emory University Alzheimer’s Disease Research Center starting in the latter half of 2019.

The Company has incurred recurring losses and reported losses for the year ended April 30, 2018 of $931,663.
The Company’s financial situation creates substantial doubt whether we will continue as a going concern.
The Company has not generated revenues and has incurred losses since inception.
The Company expects to continue to incur losses for the foreseeable future and needs to raise additional capital until it is able to generate revenues from operations sufficient to fund its development and commercial operations.

The Company expects to continue to successfully obtain additional equity and debt financing.
Management believes that the Company has access to capital resources through potential public or private issuance of debt or equity securities.

Short-term Goals:

The company has virtually no operating history.
Significant influence by officers, directors, and affiliated entities.
Substantial doubt about the ability to continue as a going concern due to recurring losses and insufficient working capital.
Early stage of development with no revenue and uncertain profitability.
Need to effectively manage operational growth.
Dependence on successful development and commercialization of product candidates.
Potential for market acceptance issues.
Manufacturing process risks and regulatory compliance challenges.
High rate of failure for drug candidates in clinical trials.
Uncertain regulatory approval process.
Intense competition from established pharmaceutical companies.
Potential for serious adverse events or safety risks.
Need for adequate reimbursement from third-party payers.
Challenges in expanding the product pipeline.
Risks of product recalls or inventory losses.
Risks related to legal proceedings and intellectual property.
Vulnerability of information technology systems.
Compliance risks related to anti-corruption laws and export controls.

Seeking additional funding through public or private issuances of debt or equity securities.
Outsourcing manufacturing to third-party contractors with specialized capabilities.
Developing and implementing improved internal management systems and controls.
Engaging experienced regulatory consultants.
Building strategic alliances and partnerships.
Implementing robust risk management strategies.
Developing and maintaining a strong intellectual property portfolio.
Implementing measures to protect trade secrets and confidential information.
Maintaining compliance with all applicable regulatory requirements.

Short-term Goals:

Material weakness in internal control over financial reporting related to insufficient accounting personnel and ineffective ITGCs.
Limited operating history.
Dependence on securing funding on satisfactory terms.
Dependence on successful development and commercialization of AL001 and AL002.
Potential for serious adverse events or safety risks.
Dependence on attracting and retaining senior management and key scientific personnel.
Risks related to intellectual property rights.
Risks related to affiliates and related party transactions.
Potential delisting from Nasdaq Capital Market.
Volatile market price of common stock.
Concentration of stock ownership.

Implementing measures to improve internal control over financial reporting, including formalizing internal control documentation, strengthening supervisory reviews, adding accounting personnel, and strengthening ITGC access controls.
Developing and commercializing therapeutics to improve lives of individuals afflicted by Alzheimer's, bipolar disorder, MDD, and PTSD.
Outsourcing manufacturing to third-party contractors with GMP capabilities.
Seeking strategic partnerships for commercialization.
Focusing on translational and functional endpoints to efficiently develop product candidates.
Seeking breakthrough therapy designation and Section 505(b)(2) regulatory pathway for AL001 and AL002.
Implementing measures to attract and retain qualified personnel.