ALZN Alzamend Neuro Inc.

1.46
-0.01  -1%
Previous Close 1.47
Open 1.5
52 Week Low 1.25
52 Week High 33.55
Market Cap $129,721,523
Shares 88,850,358
Float 58,463,136
Enterprise Value $120,936,241
Volume 1,513,607
Av. Daily Volume 4,335,470
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Drug Pipeline

Drug Stage Notes
AL001
Alzheimer’s disease
Phase 1/2
Phase 1/2
Phase 1 top-line data reported salicylate plasma concentrations were observed to be well tolerated and consistently within safe limits and the safety profiles of both AL001 and the marketed lithium carbonate capsule were benign, noted December 17, 2021. Phase 2 trial to be initiated in 2Q 2022.
AL002
Alzheimer's disease
Phase 1/2
Phase 1/2
Phase 1/2 clinical trial expected to initiate 1Q 2022. IND filing by the end of November 2021 - noted September 30, 2021.

Latest News

  1. Data shows that AL001 is bioequivalent to the marketed lithium carbonate product and the shapes of the lithium plasma concentration versus time curves are similar

    Alzamend Neuro, Inc. (NASDAQ:ALZN) ("Alzamend"), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it has received positive topline data from its Phase 1 clinical trial for AL001. The purpose of the Phase 1 first-in-human study was to determine the pharmacokinetics, safety and tolerability of AL001 so as to target doses for a planned Phase 2 multiple ascending dose study in Alzheimer's patients. AL001 is a lithium-delivery system; it is a lithium-salicylate-L-proline…

    Data shows that AL001 is bioequivalent to the marketed lithium carbonate product and the shapes of the lithium plasma concentration versus time curves are similar

    Alzamend Neuro, Inc. (NASDAQ:ALZN) ("Alzamend"), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it has received positive topline data from its Phase 1 clinical trial for AL001. The purpose of the Phase 1 first-in-human study was to determine the pharmacokinetics, safety and tolerability of AL001 so as to target doses for a planned Phase 2 multiple ascending dose study in Alzheimer's patients. AL001 is a lithium-delivery system; it is a lithium-salicylate-L-proline engineered ionic co-crystal under development as an oral treatment for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer's disease.

    During this Phase 1 first-in-human trial, participants received a single dose of AL001 containing lithium in an amount equivalent to 150 mg lithium carbonate; this is the dose proposed by the inventors as likely appropriate for Alzheimer's treatment when given three times daily. Currently, marketed immediate-release lithium carbonate 300 mg are given three times daily; for example, lithium carbonate 300 mg three times daily is a dose commonly used for bipolar affective disorders. It can be difficult to set the appropriate dose of lithium carbonate and other lithium products due to the small margin between effective and toxic blood levels and to avoid side effects or inadequate treatment outcomes.

    "This is amazing news," said Stephan Jackman, Chief Executive Officer of Alzamend. "We see the possibility of providing the benefits from lithium at up to 50% of the currently approved lithium carbonate dosage, with the potential for better outcomes and with elimination of the need for lithium therapeutic drug monitoring. Moreover, the data confirms AL001's potential as a replacement of the current lithium-based treatments and may provide a treatment to the over 40 million Americans suffering from Alzheimer's and other neurodegenerative diseases and psychiatric disorders."

    Dose-adjusted relative bioavailability analyses of the rate and extent of lithium absorption indicate that AL001 is bioequivalent to the marketed 300 mg lithium carbonate product and the shapes of the lithium plasma concentration versus time curves are similar. AL001 salicylate plasma concentrations were observed to be well tolerated and consistently within safe limits and the safety profiles of both AL001 and the marketed lithium carbonate capsule were benign.

    Such findings may allow the Company to reduce or eliminate the need for Phase 2 and Phase 3 studies of efficacy and/or safety of AL001 in such indications as bipolar/affective disorders in which lithium efficacy has been established. Bioequivalence may have utility for AL001 when seeking approval for the indications of currently marketed lithium products, and for new indications as a benchmark for safety. Given the systemic pharmacokinetic similarity to marketed immediate-release lithium carbonate products, AL001 may be dosed three times daily in the planned Phase 2 study, a multiple ascending dose safety study in Alzheimer's patients.

    Mr. Jackman added, "We look forward to swiftly initiating a Phase 2 multiple ascending dose study involving Alzheimer's patients in the second quarter of 2022. Additionally, we look forward to pursuing investigational new drug applications with the United States Food and Drug Administration during 2022 for bipolar disorder, depression, and post-traumatic stress disorder indication, and given the major unfilled public health need in these indications, we intend to seek expedited regulatory interaction."

    About AL001

    AL001 is a patented ionic cocrystal technology delivering lithium via a therapeutic crystal-engineered combination of lithium, L-proline and salicylate, known as AL001 or LiProSal, through two royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.

    Based on preclinical data, AL001 treatment prevents cognitive deficits, depression, and irritability in APPSWE/PS1dE9 mice, and has shown an improvement of associative learning and memory and irritability compared with lithium carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer's disease and psychiatric disorders. Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well-characterized, potentially allowing Alzamend to rely upon this existing data, potentially reducing the regulatory burden for safety data.

    About Alzamend Neuro

    Alzamend Neuro is an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, including Alzheimer's. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 - a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, proline and salicylate, and AL002 - a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient's immunological system to combat Alzheimer's. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

    Forward-Looking Statements

    This press release contains "forward looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "believes," "plans," "anticipates," "projects," "estimates," "expects," "intends," "strategy," "future," "opportunity," "may," "will," "should," "could," "potential," or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend's business and financial results are included in Alzamend's filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend's website at www.Alzamend.com.

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  2. IND Submission for Combined AL002 Phase 1/2 Clinical Trial Expected in Second Quarter of 2022

    Alzamend Neuro, Inc. (NASDAQ:ALZN) ("Alzamend"), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it has received confirmation that topline data for its Phase 1 clinical trial for AL001 for dementia related to Alzheimer's will be delivered mid- to late-December 2021. The Phase 1 first-in-human study is for the purpose of determining potential clinically safe and appropriate dosing for AL001 in a planned Phase 2 multiple ascending dose study. AL001 is a lithium-delivering ionic cocrystal under development as an oral…

    IND Submission for Combined AL002 Phase 1/2 Clinical Trial Expected in Second Quarter of 2022

    Alzamend Neuro, Inc. (NASDAQ:ALZN) ("Alzamend"), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it has received confirmation that topline data for its Phase 1 clinical trial for AL001 for dementia related to Alzheimer's will be delivered mid- to late-December 2021. The Phase 1 first-in-human study is for the purpose of determining potential clinically safe and appropriate dosing for AL001 in a planned Phase 2 multiple ascending dose study. AL001 is a lithium-delivering ionic cocrystal under development as an oral treatment for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer's.

    "We are very excited about this important milestone for Alzamend," said Stephan Jackman, Chief Executive Officer of Alzamend. "We believe these data will confirm AL001's potential as a replacement of the current lithium-based treatments and may provide a treatment to the over 40 million Americans suffering from Alzheimer's and other neurodegenerative diseases and psychiatric disorders. We look forward to utilizing these data to move swiftly into a Phase 2 multiple ascending dose study involving Alzheimer's patients in the first quarter of 2022."

    In late September 2021, Alzamend received positive feedback from the U.S. Food and Drug Administration ("FDA") regarding the AL002 clinical development plan, including Alzamend's proposal, to which the FDA agreed, to conduct a combined Phase 1/2 study. AL002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient's immunological system to combat Alzheimer's. The FDA agreeing to the combined Phase 1/2 study has extended the timeline for the submission on the investigational new drug ("IND") application to be submitted to the FDA.

    "We have augmented our clinical trial preparations and executions related to the AL002 combined Phase 1/2 study," said Stephan Jackman. "The unique nature of our therapeutic is difficult to produce and has required an extended timeline to identify the right manufacturing partner to provide our study drug materials. We also appreciate the FDA's thorough response, which provided us with significant clarity and advice. We believe it is important to incorporate all of the FDA's recommendations and guidance, and now anticipate submitting our IND for AL002 in the second quarter of 2022 and commencing a combined Phase 1/2 clinical trial as soon as possible after approval of the IND from the FDA."

    About AL001

    AL001 is a patented ionic cocrystal technology delivering lithium via a therapeutic crystal-engineered combination of lithium, proline and salicylate, known as AL001 or LiProSal, through two royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.

    Based on preclinical data, AL001 treatment prevents cognitive deficits, depression, and irritability in APPSWE/PS1dE9 mice, and has shown an improvement of associative learning and memory and irritability compared with lithium carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer's disease and psychiatric disorders. Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well-characterized, potentially allowing Alzamend to rely upon this existing data, potentially reducing the regulatory burden for safety data.

    About AL002

    AL002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that reduces beta-amyloid plaque and seeks to restore the ability of the patient's immunological system to combat Alzheimer's. This therapy is intended to work by stimulating the body's own immune system to prevent the formation and breakdown of beta amyloids, which build up in the brain to form a plaque and subsequently block the neurological brain signals, ultimately leading to the symptoms and onset of Alzheimer's.

    About Alzamend Neuro

    Alzamend Neuro is an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, including Alzheimer's. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 - a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, proline and salicylate, and AL002 - a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient's immunological system to combat Alzheimer's. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

    Forward-Looking Statements

    This press release contains "forward looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "believes," "plans," "anticipates," "projects," "estimates," "expects," "intends," "strategy," "future," "opportunity," "may," "will," "should," "could," "potential," or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend's business and financial results are included in Alzamend's filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend's website at www.Alzamend.com.

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  3. Ault Global Holdings, Inc. (NYSE:DPW) a diversified holding company (the "Company"), today announced its financial results for the three and nine months ended September 30, 2021.

    Nine months ended September 30, 2021 highlights:

    • Revenue of $44.6 million, an increase of 167% from $16.7 million in the prior nine-month period;
    • Revenue from lending and trading activities of $19.6 million due to the allocation of capital to DP Lending;
    • Revenues from our trading activities during the nine months ended September 30, 2021 included significant net gains on equity securities, including unrealized gains and losses from market price changes. These gains and losses have caused and will continue to cause, significant volatility in our periodic earnings…

    Ault Global Holdings, Inc. (NYSE:DPW) a diversified holding company (the "Company"), today announced its financial results for the three and nine months ended September 30, 2021.

    Nine months ended September 30, 2021 highlights:

    • Revenue of $44.6 million, an increase of 167% from $16.7 million in the prior nine-month period;
    • Revenue from lending and trading activities of $19.6 million due to the allocation of capital to DP Lending;
    • Revenues from our trading activities during the nine months ended September 30, 2021 included significant net gains on equity securities, including unrealized gains and losses from market price changes. These gains and losses have caused and will continue to cause, significant volatility in our periodic earnings.
    • Revenue from lending and trading activities includes an approximate $6.4 million unrealized gain from the Company's investment in Alzamend Neuro, Inc. (NASDAQ:ALZN) ("Alzamend"), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders;
    • Revenue from cryptocurrency mining of $693,000 as the Company resumed cryptocurrency mining operations during March 2021; and
    • Net income of $1.3 million compared to a net loss of $24.7 million in the prior nine-month period.

    Three months ended September 30, 2021 highlights:

    • Revenue decreased $36.5 million to negative $30.8 million from positive revenue of $5.7 million in the prior third fiscal quarter;
    • Revenue from lending and trading activities includes unrealized gains and losses and, due to stock price volatility, can result in the Company reporting negative revenue. For the three months ended September 30, 2021, the Company reported negative revenue from lending and trading activities of $(38.9) million, including a $(33.4) million unrealized loss from the Company's investment in Alzamend;
    • Revenue from cryptocurrency mining of $272,000 as the Company resumed cryptocurrency mining operations during March 2021;
    • Net loss of $42.9 million for the quarter;
    • Positive working capital of $93.9 million;
    • Total assets of $225.7 million; and
    • Cash of $44.0 million, marketable securities of $49.9 million and other investments of $62.6 million as of September 30, 2021.

    Revenues

    Revenues by segment for the three months ended September 30, 2021 and 2020 were as follows:

    For the Three Months Ended

    September 30,

    Increase

    2021

     

    2020

     

    (Decrease)

     

    %

     

    Gresham Worldwide

    $ 6,373,000

     

    $ 4,329,000

     

    $ 2,044,000

     

    47%

    TurnOnGreen

    1,094,000

    1,376,000

    (282,000)

    -20%

    Ault Alliance:

     

     

     

     

     

     

     

    Revenue, cryptocurrency mining

    238,000

    -

    238,000

    Revenue, lending and trading activities

    (38,868,000)

     

    (29,000)

     

    (38,839,000)

     

    133,928%

    Other

    369,000

    369,000

    Total revenue

    $ (30,794,000)

     

    $ 5,676,000

     

    $(36,470,000)

     

    -643%

    Gresham Worldwide ("GWW")

    GWW revenues increased by $2.0 million, or 47%, to $6.4 million for the three months ended September 30, 2021, from $4.3 million for the three months ended September 30, 2020. GWW revenue in 2021 includes $1.8 million from Relec, which was acquired on November 30, 2020. In the prior year period, revenue was constrained by working capital issues. The increase in revenue from our GWW segment for customized solutions for the military markets reflects the benefit of our improved liquidity in 2021, as we were able to allocate additional funds to our defense business to improve their ability to fulfill backlog.

    TurnOnGreen

    TurnOnGreen revenues decreased by $282,000 or 20%, to $1.1 million for the three months ended September 30, 2021, from $1.4 million for three months ended September 30, 2020. The decrease is primarily attributable to supply chain disruptions during the quarter.

    Ault Alliance

    Revenues from our cryptocurrency mining operations were $238,000 for the three months ended September 30, 2021, compared to nil for the three months ended September 30, 2020, as we resumed our cryptocurrency mining operations during the first quarter of 2021. Our decision to resume cryptocurrency mining operations in 2021 was based on several factors, which had positively affected the number of active miners we operated, including the market prices of digital currencies, and favorable power costs available at our Michigan data center.

    Revenues from our lending and trading activities decreased to a loss position of $(38.9) million for the three months ended September 30, 2021, from negative revenues of $(29,000) for the three months ended September 30, 2020. Revenues from our trading activities during the three months ended September 30, 2021 included significant unrealized losses from market price changes of Alzamend's common stock. Unrealized gain and losses have caused, and will continue to cause, significant volatility in our periodic earnings.

    At September 30, 2021, the fair value of Alzamend's common stock was $3.08, the shares' closing price that day. Based upon the fair value of Alzamend common stock at September 30, 2021, during the three months ended September 30, 2021, we recorded an unrealized loss of $27.4 million related to our investment in Alzamend common stock. During the three months ended September 30, 2021, we recorded an unrealized loss on our investment in warrants of Alzamend of $6.0 million. Our investment in Alzamend will be revalued on each balance sheet date.

    Gross margins

    Gross margins were negative $36.0 million or 117.1% for the three months ended September 30, 2021 compared to 35.3% for the three months ended September 30, 2020. Our gross margins have typically ranged between 33% and 37%, with slight variations depending on the overall composition of our revenue.

    Our gross margins during the three months ended September 30, 2021, were impacted by the unfavorable margins from our lending and trading activities. Excluding the effects of margin from our lending and trading activities, our adjusted gross margins for the three months ended September 30, 2021, would have been 34.7%, consistent with our historical range.

    Operating expenses

    Operating expenses increased to $13.8 million for the three months ended September 30, 2021, representing an increase of $10.2 million compared to $3.6 million for the three months ended September 30, 2020.

    The increase in operating expenses from the three months ended September 30, 2020 is attributable to the following:

    • Research and development expenses increased by $55,000 to $524,000 for the three months ended September 30, 2021, from $469,000 for the three months ended September 30, 2020. The increase in research and development expenses is due to costs incurred at GWW related to the development of products for defense applications.
    • Selling and marketing expenses were $2.0 million for the three months ended September 30, 2021, compared to $260,000 for the three months ended September 30, 2020, an increase of $1.7 million, or 667%. The increase was the result of greater personnel costs directly attributed to an increase in sales and marketing personnel and consultants primarily at Ault Alliance related to digital marketing and digital learning. The increase is also attributable to costs incurred at TurnOnGreen to grow our selling and marketing infrastructure related to our electric vehicle charger products.
    • General and administrative expenses were $11.3 million for the three months ended September 30, 2021, compared to $2.8 million for the three months ended September 30, 2020, an increase of $8.5 million or 298%. General and administrative expenses increased from the comparative prior period, mainly due to:
      • non-cash stock compensation costs of $4.1 million;
      • the accrual of an $859,000 performance bonus related to realized gains on trading activities during the period;
      • general and administrative costs of $385,000 from Relec, which was acquired on November 30, 2020;
      • increased costs related to our Michigan data center, operated by Alliance Cloud Services; and
      • higher consulting, audit, legal and insurance costs.

    The Company's Chief Financial Officer, Kenneth S. Cragun, said, "The financial results for the third quarter of 2021 reflected significant unrealized losses from market price changes of our investments. At the end of each quarter, we value our investments in certain companies based on the trading price of their stock, which has resulted in significant volatility in both revenue and operating results over the last two quarters. On a year-to-date basis, however, we did see significant revenue growth and improved operating results, with revenue up 167% over the prior year period and net income of $1.3 million compared to a net loss of $24.7 million for the nine months ended September 30, 2020. During the third quarter of 2021, we were able to make significant investments in our BitNile subsidiary and ended the quarter with $20.4 million in Bitcoin mining equipment, which will contribute to both revenue growth and improved profitability in future periods."

    The Company's Founder and Executive Chairman, Milton "Todd" Ault, III said, "In spite of the volatility of our quarterly financial results, we believe the future prospects for the Company are extremely promising. Quite simply, we are in a strong financial position, and we are investing for the future. We have grown assets to $225.7 million and have announced key investments in our Michigan data center and Bitcoin mining equipment. We would like to acknowledge our GWW defense team as during the third quarter of 2021 they grew revenues by 47% compared to the prior third fiscal quarter. As a holding company, we have made investments in the sectors of Bitcoin mining, data center operations, defense, electric vehicle chargers, power electronic businesses, lending and investment platform, and we continue to believe the road ahead is bright."

    Reminder - Company to hold special stockholder conference call and webcast for major corporate announcement

    As previously announced, on Monday, November 22, 2021 at 6:00 a.m. Pacific time, the Company's Executive Chairman, Milton "Todd" Ault, III and its CEO, William Horne will be hosting a conference call and webcast to discuss a major corporate announcement along with the financial performance and outlook of the Company and its subsidiaries. Joining Mr. Ault and Mr. Horne will be Kenneth Cragun, the Company's CFO. The Company encourages all stockholders to attend this meeting, if possible.

    Stockholders, investors and interested parties who desire to participate in the webcast must use the following link to register prior to 6:00 a.m. Pacific time on November 22, 2021:

    https://zoom.us/webinar/register/WN_a3zZ_BmyRrK4fBqAc6-hvg

    For more information on Ault Global Holdings and its subsidiaries, the Company recommends that stockholders, investors and any other interested parties read the Company's public filings and press releases available under the Investor Relations section at www.AultGlobal.com or available at www.sec.gov.

    About Ault Global Holdings, Inc.

    Ault Global Holdings, Inc. is a diversified holding company pursuing growth by acquiring undervalued businesses and disruptive technologies with a global impact. Through its wholly and majority-owned subsidiaries and strategic investments, the Company provides mission-critical products that support a diverse range of industries, including defense/aerospace, industrial, automotive, telecommunications, medical/biopharma, and textiles. In addition, the Company extends credit to select entrepreneurial businesses through a licensed lending subsidiary. Ault Global Holding's headquarters are located at 11411 Southern Highlands Parkway, Suite 240, Las Vegas, NV 89141; www.AultGlobal.com.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "believes," "plans," "anticipates," "projects," "estimates," "expects," "intends," "strategy," "future," "opportunity," "may," "will," "should," "could," "potential," or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and the Company undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect the Company's business and financial results are included in the Company's filings with the U.S. Securities and Exchange Commission, including, but not limited to, the Company's Forms 10-K, 10-Q, and 8-K. All filings are available at www.sec.gov and on the Company's website at www.AultGlobal.com.

    AULT GLOBAL HOLDINGS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited)

    September 30,

    December 31,

     

    2021

     

    2020

    ASSETS

     

    CURRENT ASSETS

     

     

     

    Cash and cash equivalents

    $

    105,391,000

    $

    18,680,000

    Marketable equity securities

     

    30,172,000

     

     

    2,563,000

    Accounts receivable

     

    4,730,000

     

    3,852,000

    Accounts and other receivable, related party

     

    1,196,000

     

     

    1,196,000

    Accrued revenue

     

    1,594,000

     

    1,696,000

    Inventories

     

    2,900,000

     

     

    3,374,000

    Prepaid expenses and other current assets

     

    5,373,000

     

    2,988,000

    TOTAL CURRENT ASSETS

     

    151,356,000

     

     

    34,349,000

     

    Intangible assets, net

     

    4,175,000

     

     

    4,390,000

    Goodwill

     

    9,589,000

     

    9,646,000

    Property and equipment, net

     

    7,262,000

     

     

    2,123,000

    Right-of-use assets

     

    4,605,000

     

    4,318,000

    Investment in promissory notes, related parties

     

    13,913,000

     

     

    10,668,000

    Investments in common stock and warrants, related parties

     

    60,355,000

     

    6,139,000

    Investments in debt and equity securities

     

    4,013,000

     

     

    262,000

    Investment in limited partnership

     

    1,869,000

     

    1,869,000

    Loans receivable

     

    572,000

     

     

    750,000

    Other investments, related parties

     

    788,000

     

    803,000

    Other assets

     

    604,000

     

     

    326,000

    TOTAL ASSETS

    $

    259,101,000

    $

    75,643,000

     

     

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

     

    CURRENT LIABILITIES

    Accounts payable and accrued expenses

    $

    7,784,000

     

    $

    10,579,000

    Accounts payable and accrued expenses, related party

     

     

    36,000

    Operating lease liability, current

     

    876,000

     

     

    524,000

    Revolving credit facility

     

    103,000

     

    125,000

    Notes payable, net

     

    1,808,000

     

     

    4,048,000

    Notes payable, related parties

     

     

    188,000

    Convertible notes payable, related party

     

     

     

    400,000

    Warrant liability

     

    4,580,000

     

    4,192,000

    Income taxes payable

     

    2,770,000

     

     

    Other current liabilities

     

    5,572,000

     

     

    1,790,000

    TOTAL CURRENT LIABILITIES

    $

    23,493,000

    $

    21,882,000

    AULT GLOBAL HOLDINGS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS (continued)

    (Unaudited)

    September 30,

    December 31,

     

    2021

     

     

    2020

     

    LONG TERM LIABILITIES

    Operating lease liability, non-current

     

    3,792,000

     

     

     

    3,855,000

     

    Notes payable

     

     

     

    336,000

     

    Notes payable, related parties

     

     

     

     

    52,000

     

    Convertible notes payable

     

    427,000

     

     

    386,000

     

     

    TOTAL LIABILITIES

     

    27,712,000

     

     

    26,511,000

     

     

    COMMITMENTS AND CONTINGENCIES

     

     

     

     

    STOCKHOLDERS' EQUITY

     

     

     

    Series A Convertible Preferred Stock, $25.00 stated value per share,

     

     

     

     

    $0.001 par value – 1,000,000 shares authorized; 7,040 shares

    issued and outstanding at September 30, 2021 and December 31, 2020

    (redemption amount and liquidation preference of $176,000

    as of September 30, 2021 and December 31, 2020)

    Series B Convertible Preferred Stock, $10 stated value per share,

     

     

     

     

     

    $0.001 par value – 500,000 shares authorized; 125,000 shares issued

     

     

     

    and outstanding at September 30, 2021 and December 31, 2020 (liquidation

     

     

     

    preference of $1,250,000 at September 30, 2021 and December 31, 2020)

     

     

     

    Class A Common Stock, $0.001 par value – 500,000,000 shares authorized;

     

    56,000

     

     

    28,000

     

    56,159,963 and 27,753,562 shares issued and outstanding at September 30,

    2021 and December 31, 2020, respectively

    Class B Common Stock, $0.001 par value – 25,000,000 shares authorized;

     

     

     

     

     

    nil shares issued and outstanding at September 30, 2021 and December 31,

    2020

     

     

     

    Additional paid-in capital

     

    311,760,000

     

     

    171,397,000

     

    Accumulated deficit

     

    (77,190,000

    )

     

     

    (121,397,000

    )

    Accumulated other comprehensive gain (loss)

     

    (4,601,000

    )

     

    (1,718,000

    )

    TOTAL AULT GLOBAL HOLDINGS STOCKHOLDERS' EQUITY

     

    230,025,000

     

     

     

    48,310,000

     

     

    Non-controlling interest

     

    1,364,000

     

     

     

    822,000

     

     

    TOTAL STOCKHOLDERS' EQUITY

     

    231,389,000

     

     

     

    49,132,000

     

     

    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

    $

    259,101,000

     

     

    $

    75,643,000

     

    AULT GLOBAL HOLDINGS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED STATEMENTS OF INCOME AND COMPREHENSIVE INCOME (LOSS) (Unaudited)

    For the Three Months Ended

    For the Nine Months Ended

    September 30,

    September 30,

     

    2021

     

     

     

    2020

     

     

     

    2021

     

     

     

    2020

     

    Revenue

    $

    8,564,000

     

     

    $

    5,435,000

     

     

    $

    16,469,000

     

     

    $

    11,004,000

     

    Revenue, cryptocurrency mining

     

    291,000

     

     

     

     

    421,000

     

     

     

    Revenue, lending and trading activities

     

    53,274,000

     

     

     

    (34,000

    )

     

     

    58,485,000

     

     

     

    2,000

     

    Total revenue

     

    62,129,000

     

     

    5,401,000

     

     

    75,375,000

     

     

    11,006,000

     

    Cost of revenue

     

    6,278,000

     

     

     

    3,496,000

     

     

     

    11,386,000

     

     

     

    7,349,000

     

    Gross profit

     

    55,851,000

     

     

    1,905,000

     

     

    63,989,000

     

     

    3,657,000

     

     

    Operating expenses

     

     

     

     

     

     

     

    Research and development

     

    531,000

     

     

    462,000

     

     

    1,133,000

     

     

    903,000

     

    Selling and marketing

     

    1,505,000

     

     

     

    295,000

     

     

     

    2,747,000

     

     

     

    633,000

     

    General and administrative

     

    7,992,000

     

     

    2,918,000

     

     

    13,084,000

     

     

    5,821,000

     

    Provision for credit losses

     

     

     

     

    (1,000,000

    )

     

     

     

     

     

     

    Total operating expenses

     

    10,028,000

     

     

    2,675,000

     

     

    16,964,000

     

     

    7,357,000

     

    Income (loss) from continuing operations

     

    45,823,000

     

     

     

    (770,000

    )

     

     

    47,025,000

     

     

     

    (3,700,000

    )

    Other income (expenses)

    Interest income

     

    14,000

     

     

     

    36,000

     

     

     

    51,000

     

     

     

    36,000

     

    Interest expense

     

    (22,000

    )

     

    (963,000

    )

     

    (337,000

    )

     

    (2,049,000

    )

    Change in fair value of marketable equity securities

     

    (1,915,000

    )

     

     

    337,000

     

     

     

    45,000

     

     

     

    (29,000

    )

    Realized gain on marketable securities

     

     

     

     

     

    397,000

     

     

     

    Gain (loss) on extinguishment of debt

     

    447,000

     

     

     

    (12,000

    )

     

     

    929,000

     

     

     

    (475,000

    )

    Change in fair value of warrant liability

     

    290,000

     

     

    (10,000

    )

     

    (388,000

    )

     

    (6,000

    )

    Total other income (expenses), net

     

    (1,186,000

    )

     

     

    (612,000

    )

     

     

    697,000

     

     

     

    (2,523,000

    )

    Income (loss) from continuing operations before income taxes

     

    44,637,000

     

     

     

    (1,382,000

    )

     

    47,722,000

     

     

    (6,223,000

    )

    Income tax (expense) benefit

     

    (3,504,000

    )

     

     

    6,000

     

     

     

    (3,510,000

    )

     

     

    12,000

     

    Net income (loss) from continuing operations

     

    41,133,000

     

     

    (1,376,000

    )

     

    44,212,000

     

     

    (6,211,000

    )

    Net loss from discontinued operations, net of taxes

     

     

     

     

     

     

     

     

     

     

    (1,698,000

    )

    Net income (loss)

     

    41,133,000

     

     

    (1,376,000

    )

     

    44,212,000

     

     

    (7,909,000

    )

    Net loss attributable to non-controlling interest

     

    1,083,000

     

     

     

     

     

     

    3,000

     

     

     

     

    Net income (loss) attributable to Ault Global Holdings

     

    42,216,000

     

     

    (1,376,000

    )

     

    44,215,000

     

     

    (7,909,000

    )

    Preferred dividends

     

    (4,000

    )

     

     

    (3,000

    )

     

     

    (9,000

    )

     

     

    (7,000

    )

    Net income (loss) available to common stockholders

    $

    42,212,000

     

    $

    (1,379,000

    )

    $

    44,206,000

     

    $

    (7,916,000

    )

     

     

     

     

     

     

     

     

    Basic net income (loss) per common share:

     

     

     

     

     

     

     

    Continuing operations

    $

    0.82

     

    $

    (0.24

    )

    $

    0.97

     

    $

    (1.20

    )

    Discontinued operations

     

     

     

     

     

     

     

     

     

     

    (0.33

    )

    Net income (loss) per common share

    $

    0.82

     

    $

    (0.24

    )

    $

    0.97

     

    $

    (1.52

    )

     

     

     

     

     

     

     

     

    Diluted net income (loss) per common share:

     

     

     

     

     

     

     

    Continuing operations

    $

    0.79

     

    $

    (0.24

    )

    $

    0.91

     

    $

    (1.20

    )

    Discontinued operations

     

     

     

     

     

     

     

     

     

     

    (0.33

    )

    Net income (loss) per common share

    $

    0.79

     

    $

    (0.24

    )

    $

    0.91

     

    $

    (1.52

    )

    Weighted average basic common shares outstanding

     

    50,783,000

     

     

     

    5,864,000

     

     

     

    45,052,000

     

     

     

    5,199,000

     

    Weighted average diluted common shares outstanding

     

    52,780,000

     

     

    5,864,000

     

     

    47,574,000

     

     

    5,199,000

     

     

     

     

     

     

     

     

     

    Comprehensive income (loss)

     

     

     

     

     

     

     

    Net income (loss) available to common stockholders

    $

    42,212,000

     

    $

    (1,379,000

    )

    $

    44,206,000

     

    $

    (7,916,000

    )

    Other comprehensive income (loss)

     

     

     

     

     

     

     

    Foreign currency translation adjustment

     

    134,000

     

     

    97,000

     

     

    41,000

     

     

    (51,000

    )

    Net unrealized gain (loss) on derivative securities of related party

     

    (5,893,000

    )

     

     

    761,000

     

     

     

    (2,924,000

    )

     

     

    (481,000

    )

    Other comprehensive income (loss)

     

    (5,759,000

    )

     

    858,000

     

     

    (2,883,000

    )

     

    (532,000

    )

    Total comprehensive income (loss)

    $

    36,453,000

     

     

    $

    (521,000

    )

     

    $

    41,323,000

     

     

    $

    (8,448,000

    )

    AULT GLOBAL HOLDINGS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)

    For the Nine Months Ended September 30,

     

    2021

     

     

    2020

     

     

    Cash flows from operating activities:

     

     

     

    Net income (loss)

    $

    44,212,000

     

    $

    (7,909,000

    )

    Less: Net loss from discontinued operations

     

     

     

     

    (1,698,000

    )

    Net income (loss) from continuing operations

     

    44,212,000

     

     

    (6,211,000

    )

    Adjustments to reconcile net income (loss) to net cash used in

    operating activities:

     

     

    Depreciation

     

    446,000

     

     

    260,000

     

    Amortization

     

    191,000

     

     

     

    167,000

     

    Amortization of right-of-use assets

     

    441,000

     

     

    247,000

     

    Amortization, related party

     

    15,000

     

     

     

     

    Interest expense – debt discount

     

    40,000

     

     

    908,000

     

    Gain on extinguishment of debt

     

    (929,000

    )

     

     

     

    Change in fair value of warrant liability

     

    (290,000

    )

     

    10,000

     

    Accretion of original issue discount on notes receivable – related party

     

    (4,000

    )

     

     

    15,000

     

    Accretion of original issue discount on notes receivable

     

    (955,000

    )

     

    (4,000

    )

    Increase in accrued interest on notes receivable – related party

     

    (1,000

    )

     

     

     

    Stock-based compensation

     

    584,000

     

     

    143,000

     

    Realized losses on other investments

     

     

     

     

    28,000

     

    Realized gains on sale of marketable securities

     

    (12,283,000

    )

     

    (15,000

    )

    Unrealized gains on marketable equity securities

     

    (3,483,000

    )

     

     

    (52,000

    )

    Unrealized (gains) losses on equity securities – related party

     

    (39,852,000

    )

     

    65,000

     

    Unrealized (gains) losses on equity securities

     

    (1,224,000

    )

     

     

    73,000

     

    Changes in operating assets and liabilities:

     

     

     

    Marketable equity securities

     

    (9,616,000

    )

     

     

    Accounts receivable

     

    (887,000

    )

     

     

    199,000

     

    Accrued revenue

     

    78,000

     

     

    34,000

     

    Inventories

     

    485,000

     

     

     

    (35,000

    )

    Prepaid expenses and other current assets

     

    (2,537,000

    )

     

    181,000

     

    Other assets

     

    (246,000

    )

     

     

    (39,000

    )

    Accounts payable and accrued expenses

     

    (2,651,000

    )

     

    1,365,000

     

    Accounts payable, related parties

     

    (36,000

    )

     

     

    (24,000

    )

    Income taxes payable

     

    2,770,000

     

     

     

    Other current liabilities

     

    4,472,000

     

     

    660,000

     

    Lease liabilities

     

    (439,000

    )

     

     

    (234,000

    )

    Net cash used in continuing operating activities

     

    (21,699,000

    )

     

    (2,259,000

    )

    Net cash provided by discontinued operating activities

     

     

     

     

    1,000

     

    Net cash used in operating activities

     

    (21,699,000

    )

     

    (2,258,000

    )

     

     

     

     

    Cash flows from investing activities:

     

     

     

    Purchase of property and equipment

     

    (5,590,000

    )

     

    (190,000

    )

    Investment in promissory notes, related parties

     

    (4,040,000

    )

     

     

    (199,000

    )

    Investments in common stock and warrants, related parties

     

    (16,483,000

    )

     

    (10,000

    )

    Investment in real property, related party

     

    (2,670,000

    )

     

     

     

    Proceeds from sale of investment in real property, related party

     

    2,670,000

     

     

     

    Purchase of marketable equity securities

     

     

     

     

     

    Sales of marketable equity securities

     

    430,000

     

     

    110,000

     

    Proceeds from loans receivable

     

     

     

     

    140,000

     

    Investments in debt and equity securities

     

    (4,054,000

    )

     

    (3,000

    )

    Net cash used in investing activities

    $

    (29,737,000

    )

     

    $

    (152,000

    )

    AULT GLOBAL HOLDINGS, INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (continued)

    For the Nine Months Ended September 30,

     

    2021

     

     

    2020

     

     

    Cash flows from financing activities:

     

     

     

    Gross proceeds from sales of common stock

    $

    144,044,000

     

    $

     

    Financing cost in connection with sales of equity securities

     

    (4,541,000

    )

     

     

     

    Proceeds from convertible notes payable

     

     

     

    100,000

     

    Proceeds from notes payable

     

    500,000

     

     

     

    3,148,000

     

    Proceeds from short-term advances – related party

     

     

     

    604,000

     

    Payments on short-term advances – related party

     

     

     

     

    (98,000

    )

    Payments on notes payable

     

    (1,917,000

    )

     

    (186,000

    )

    Payments on advances on future receipts

     

    -

     

     

     

    (20,000

    )

    Payments of preferred dividends

     

    (9,000

    )

     

    (7,000

    )

    Payments on revolving credit facilities, net

     

    (23,000

    )

     

     

    68,000

     

     

     

    Net cash provided by financing activities

     

    138,054,000

     

     

    3,609,000

     

     

     

     

     

    Effect of exchange rate changes on cash and cash equivalents

     

    93,000

     

     

     

    9,000

     

     

    Net increase in cash and cash equivalents

     

    86,711,000

     

     

     

    1,208,000

     

     

    Cash and cash equivalents at beginning of period

     

    18,680,000

     

     

     

    483,000

     

     

     

    Cash and cash equivalents at end of period

    $

    105,391,000

     

    $

    1,691,000

     

     

     

     

     

    Supplemental disclosures of cash flow information:

    Cash paid during the period for interest

    $

    658,000

     

     

    $

    71,000

     

     

    Non-cash investing and financing activities:

     

     

     

    Cancellation of convertible notes payable into shares of common stock

    $

     

    $

    2,689,000

     

    Cancellation of notes payable into shares of common stock

    $

    449,000

     

     

    $

     

    Payment of accounts payable with digital currency

    $

    119,000

     

    $

     

    Issuance of common stock in payment of liability

    $

     

     

    $

    229,000

     

    Cancellation of short-term advances, related party into shares

    of common stock

    $

     

    $

    740,000

     

    Issuance of notes payable and convertible notes payable in

     

     

     

    payment of accrued expenses

    $

     

     

    $

    420,000

     

    Conversion of debt and equity securities to marketable securities

    $

    2,656,000

     

    $

     

    Conversion of loans to debt and equity securities

    $

    150,000

     

     

    $

     

    Conversion of convertible notes payable, related party into shares

    of common stock

    $

    400,000

     

     

    $

     

     

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  4. FDA Agrees to Alzamend's Plan to Conduct a Combined Phase 1 and 2 Clinical Trial for AL002

    Alzamend Neuro, Inc. (NASDAQ:ALZN) ("Alzamend"), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it has received a written response to its meeting request relating to its Type B Pre‑Investigational New Drug ("IND") application from the U.S. Food and Drug Administration (the "FDA") providing a path for Alzamend's planned clinical development of AL002. AL002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient's immunological system…

    FDA Agrees to Alzamend's Plan to Conduct a Combined Phase 1 and 2 Clinical Trial for AL002

    Alzamend Neuro, Inc. (NASDAQ:ALZN) ("Alzamend"), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it has received a written response to its meeting request relating to its Type B Pre‑Investigational New Drug ("IND") application from the U.S. Food and Drug Administration (the "FDA") providing a path for Alzamend's planned clinical development of AL002. AL002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient's immunological system to combat Alzheimer's.

    "We appreciate the thorough and meaningful response from the FDA, which provides us with the information and clarity needed to submit the IND application to initiate a clinical trial for AL002," said Stephan Jackman, Alzamend's Chief Executive Officer. "Preclinical work supports AL002 being associated with a positive anti-inflammatory response and a decrease in brain amyloid contents. Based on AL002's positive toxicology results, the biologic nature of this product and the urgent need to deliver treatments for Alzheimer's to patients, Alzamend proposed, and the FDA agreed, to conduct a combined Phase 1/2 study. We appreciate the FDA's recommendations, guidance and other helpful advice. We plan to augment our proposed clinical trial protocols and proceed accordingly."

    Based on the FDA's written feedback, Alzamend anticipates filing the IND by the end of November 2021 and initiating the clinical trial of AL002 in the first quarter of 2022.

    About AL002

    AL002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that reduces beta-amyloid plaque and seeks to restore the ability of the patient's immunological system to combat Alzheimer's disease. This therapy is intended to work by stimulating the body's own immune system to prevent the formation and breakdown of beta amyloids, which build up in the brain to form a plaque that subsequently block the neurological brain signals, ultimately leading to the symptoms and onset of Alzheimer's.

    About Alzamend Neuro

    We are early clinical stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, including Alzheimer's. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 - a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, proline and salicylate, and AL002 - a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient's immunological system to combat Alzheimer's. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

    Forward-Looking Statements

    This press release contains "forward looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "believes," "plans," "anticipates," "projects," "estimates," "expects," "intends," "strategy," "future," "opportunity," "may," "will," "should," "could," "potential," or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend's business and financial results are included in Alzamend's filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend's website at www.Alzamend.com.

    View Full Article Hide Full Article
  5. Company Achieves Milestone of Dosing First Group of Participants in Six-Month Comparative Study with Lithium-Delivering Ionic Cocrystal Oral Treatment

    Alzamend Neuro, Inc. (NASDAQ:ALZN) ("Alzamend"), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that the first group of healthy participants have been dosed in a six-month Phase I relative bioavailability study for AL001 for dementia related to Alzheimer's disease. The Phase I first-in-human study is for the purpose of determining potential clinically safe and appropriate dosing for AL001 in future studies. AL001 is a lithium-delivering ionic cocrystal under development…

    Company Achieves Milestone of Dosing First Group of Participants in Six-Month Comparative Study with Lithium-Delivering Ionic Cocrystal Oral Treatment

    Alzamend Neuro, Inc. (NASDAQ:ALZN) ("Alzamend"), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that the first group of healthy participants have been dosed in a six-month Phase I relative bioavailability study for AL001 for dementia related to Alzheimer's disease. The Phase I first-in-human study is for the purpose of determining potential clinically safe and appropriate dosing for AL001 in future studies. AL001 is a lithium-delivering ionic cocrystal under development as an oral treatment for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer's disease.

    "Advancing AL001 into the clinic as planned marks an important milestone for Alzamend," said Stephan Jackman, Chief Executive Officer of Alzamend. "We believe AL001 could potentially provide clinicians with a major improvement over current lithium-based treatments and may constitute a means of treating over 40 million Americans suffering from Alzheimer's and other neurodegenerative diseases and psychiatric disorders. We look forward to completing the Phase I study and advancing the clinical studies of this promising potential therapeutic."

    Overview of the Phase I Clinical Study

    The Phase I study will investigate the pharmacokinetics (the movement of drug through the body) of lithium following a single dose of AL001 (the "study drug") compared to a typical single dose of a marketed 300 mg immediate-release lithium carbonate capsule (the "comparator" – currently indicated to treat mood disorders) in healthy male and female subjects. The lithium and salicylate components of AL001 will be given within the amounts already approved for use in patients. The purpose of the research study is to test the safety, tolerability, and bioavailability (how much and when drug gets in the body) of the study drug, AL001, compared to the currently marketed formulation of the comparator, lithium carbonate. This is expected to ascertain what AL001 doses should be given, and how often, in subsequent Phase 2 safety and efficacy trials involving Alzheimer's disease patients. At least 24 healthy male and female human subjects will complete the Phase I trial.

    About AL001

    AL001 is a patented ionic cocrystal technology delivering lithium via a therapeutic crystal-engineered combination of lithium, proline and salicylate, known as AL001 or LiProSal, through two royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.

    Based on preclinical data, AL001 treatment prevents cognitive deficits, depression, and irritability in APPSWE/PS1dE9 mice, and has shown an improvement of associative learning and memory and irritability compared with lithium carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer's disease and psychiatric disorders. Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well characterized, potentially allowing Alzamend to rely upon this existing data, potentially reducing the regulatory burden for safety data.

    About Alzamend Neuro

    We are an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, including Alzheimer's disease. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 – a patented ionic cocrystal technology delivering lithium via a therapeutic crystal-engineered combination of lithium, proline and salicylate, and AL002 – a patented therapeutic mutant peptide sensitized cell-based therapeutic vaccine that is targeted to augment the ability of a patient's immune system to combat Alzheimer's disease. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

    Forward-Looking Statements

    This press release contains "forward looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "believes," "plans," "anticipates," "projects," "estimates," "expects," "intends," "strategy," "future," "opportunity," "may," "will," "should," "could," "potential," or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend's business and financial results are included in Alzamend's filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend's website at www.Alzamend.com.

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