−Removed: MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
+Added: MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY
Market Information
−Removed: Our common stock is listed on The NASDAQ Capital Market under the symbol
−Removed: The following table sets forth our high and low sale prices per share of our common stock as reported by www.nasdaq.com on the NASDAQ
−Removed: Capital Market from June 15, 2021 through the date indicated below.
−Removed: Fiscal Year Ending April 30, 2022
−Removed: First Quarter of 2022 through July 28, 2021
−Removed: July 28, 2021, the last sales price per share of our common stock was $5.22.
+Added: Our common stock began trading
+Added: on The NASDAQ Capital Market under the symbol “ALZN” on June 15, 2021.
+Added: Prior to that date, there was no public trading market
+Added: for our common stock.
+Added: Holders of Record
+Added: As of July 19, 2022, there were approximately
+Added: 133 stockholders of record of our common stock.
+Added: The actual number of stockholders is greater than this number of record holders and includes
+Added: stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees.
+Added: This number of holders
+Added: of record also does not include stockholders whose shares may be held in trust or by other entities.
Dividend Policy
9 unchanged sentences
Equity Compensation Information
−Removed: information required by this item regarding equity compensation plans is incorporated by reference to the information set forth in Item 13
−Removed: of this Annual Report on Form 10-K.
+Added: The information
+Added: required by this item regarding equity compensation plans is incorporated by reference to the information set forth in Item 12 of
+Added: this Annual Report on Form 10-K.
Recent Sales of Unregistered Securities
−Removed: Not applicable.
+Added: April 26, 2022, we issued and sold 2,666,667 shares of our common stock to Digital Power Lending, LLC (“DPL”) for $4 million,
+Added: or $1.50 per share, and issued to DPL warrants to acquire 1,333,333 shares of its common stock with an exercise price of $3.00 per share
+Added: pursuant to the March 12, 2021 securities purchase agreement.
Use of Proceeds
−Removed: June 14, 2021, our Registration Statement on Form S-1 (file No.
−Removed: 333-255955) was declared effective by the SEC for our initial public offering
−Removed: of common stock, or IPO.
−Removed: On June 17, 2021, we sold an aggregate of 2,875,000 shares of common stock, including 375,000 shares pursuant
−Removed: to the underwriter’s exercise of their option to purchase additional shares, each at an offering price of $5.00 per share, for aggregate
−Removed: gross proceeds of approximately $14.4 million.
−Removed: After deducting underwriting discounts, commissions and offering costs incurred by us of
−Removed: approximately $1.1 million, the net proceeds from the offering were approximately $13.3 million.
−Removed: The sole managing underwriter for the
−Removed: offering was Spartan Capital Securities, LLC.
−Removed: No offering costs were paid or are payable, directly or indirectly, to our directors or
−Removed: officers, to persons owning 10% or more of any class of our equity securities, or to any of our affiliates.
−Removed: There has been no material change in the expected use of the net proceeds
−Removed: from our IPO as described in our final prospectus filed with the SEC on June 15, 2021.
−Removed: Upon receipt, the net proceeds from our IPO were
−Removed: held in cash, cash equivalents and short-term investments.
−Removed: As of April 30, 2021, we did not use any of the net proceeds from the IPO,
−Removed: as the reporting period ended prior to the date of the IPO.
−Removed: Pending such uses, we plan to continue investing the unused proceeds from
−Removed: the IPO in fixed, non-speculative income instruments and money market funds.
−Removed: SELECTED FINANCIAL DATA.
−Removed: As a Smaller Reporting Company,
−Removed: we are electing to follow scaled disclosure reporting obligations and therefore are not required to provide the information requested
−Removed: by this Item.
−Removed: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
−Removed: You should read the following discussion
−Removed: and analysis of our financial condition and results of our operations together with our financial statements and the notes thereto appearing
−Removed: elsewhere in this Annual Report.
−Removed: This discussion contains forward-looking statements reflecting our current expectations, whose actual
−Removed: outcomes involve risks and uncertainties.
−Removed: Actual results and the timing of events may differ materially from those stated in or implied
−Removed: by these forward-looking statements due to a number of factors, including those discussed in the sections entitled “Risk Factors”
−Removed: and “Special Note Regarding Forward-Looking Statements,”
−Removed: and elsewhere in this Annual Report.
−Removed: We were incorporated on February
−Removed: 26, 2016 as Alzamend Neuro, Inc.
−Removed: under the laws of the State of Delaware.
−Removed: We were formed to acquire and commercialize patented intellectual
−Removed: property and know-how to prevent, treat and cure the crippling and deadly Alzheimer’s.
−Removed: Existing Alzheimer’s treatments only
−Removed: temporarily relieve symptoms but do not slow or halt the underlying worsening of the disease.
−Removed: We have developed a novel approach in an
−Removed: attempt to combat Alzheimer’s through immunotherapy.
−Removed: Critical Accounting Policies and Estimates
−Removed: Research and Development
−Removed: Research and development costs are expensed as incurred.
−Removed: Research and development costs consist of scientific consulting
−Removed: fees and lab supplies, as well as fees paid to other entities that conduct certain research and development activities on behalf of our
−Removed: We have acquired and may continue
−Removed: to acquire the rights to develop and commercialize new product candidates from third parties.
−Removed: The upfront payments to acquire license,
−Removed: product or rights, as well as any future milestone payments, are immediately recognized as research and development expense provided that
−Removed: there is no alternative future use of the rights in other research and development projects.
−Removed: Stock-Based Compensation.
−Removed: We maintain a stock-based compensation plan as a long-term incentive for employees, non-employee directors and consultants.
−Removed: plan allows for the issuance of incentive stock options, non-qualified stock options, restricted stock units, and other forms of equity
−Removed: We recognize stock-based compensation
−Removed: expense for stock options on a straight-line basis over the requisite service period and account for forfeitures as they occur.
−Removed: Our stock-based
−Removed: compensation costs are based upon the grant date fair value of options estimated using the Black-Scholes option pricing model.
−Removed: extent any stock option grants are made subject to the achievement of a performance-based milestone, management evaluates when the achievement
−Removed: of any such performance-based milestone is probable based on the relative satisfaction of the performance conditions as of the reporting
−Removed: The Black-Scholes option pricing
−Removed: model utilizes inputs which are highly subjective assumptions and generally require significant judgment.
−Removed: These assumptions include:
−Removed: Fair Value of Common Stock.
−Removed: the subsection titled “–
−Removed: Common Stock Valuations”
−Removed: Risk-Free Interest Rate.
−Removed: The risk-free
−Removed: interest rate is based on the U.S.
−Removed: Treasury zero coupon issues in effect at the time of grant for periods corresponding with the expected
−Removed: term of the option.
−Removed: Expected Volatility.
−Removed: do not have an extensive trading history for our common stock, the expected volatility was estimated based on the average volatility for
−Removed: comparable publicly traded life sciences companies over a period equal to the expected term of the stock option grants.
−Removed: The comparable
−Removed: companies were chosen based on the similar size, stage in life cycle or area of specialty.
−Removed: We will continue to apply this process until
−Removed: a sufficient amount of historical information regarding the volatility of our own stock price becomes available.
−Removed: Expected Term.
−Removed: The expected term
−Removed: represents the period that the stock-based awards are expected to be outstanding and is determined using the simplified method (based
−Removed: on the mid-point between the vesting date and the end of the contractual term), as we do not have sufficient historical data to use any
−Removed: other method to estimate expected term.
−Removed: Expected Dividend Yield.
−Removed: We have never paid dividends on our
−Removed: common stock and have no plans to pay dividends on our common stock.
−Removed: Therefore, we used an expected dividend yield of zero.
−Removed: Certain of such assumptions
−Removed: involve inherent uncertainties and the application of significant judgment.
−Removed: As a result, if factors or expected outcomes change and we
−Removed: use significantly different assumptions or estimates, our stock-based compensation could be materially different.
−Removed: Common Stock Valuations.
−Removed: Prior to our initial public offering in June 2021, there was no public market for our common stock, and, as a result, the fair
−Removed: value of the shares of common stock underlying our share-based awards was estimated on each grant date by our Board of Directors.
−Removed: the fair value of our common stock underlying option grants, our Board of Directors considered, among other things, input from management,
−Removed: and our Board of Directors’
−Removed: assessment of additional objective and subjective factors that it believed were relevant, and factors
−Removed: that may have changed from the date of the most recent valuation through the date of the grant.
−Removed: These factors included, but were not limited
−Removed: our results of operations and financial position, including our levels of
−Removed: available capital resources;
−Removed: our stage of development and material risks related to our business;
−Removed: progress of our research and development activities;
−Removed: our business conditions and projections;
−Removed: the valuation of publicly traded companies in the life sciences and biotechnology
−Removed: sectors, as well as recently completed mergers and acquisitions of peer companies;
−Removed: the lack of marketability of our common stock as a private company;
−Removed: the prices at which we sold shares of our common stock to outside investors
−Removed: in arms-length transactions;
−Removed: the likelihood of achieving a liquidity event for our security holders, such
−Removed: as an initial public offering or a sale of our company, given prevailing market conditions;
−Removed: trends and developments in our industry;
−Removed: external market conditions affecting the life sciences and biotechnology
−Removed: industry sectors.
−Removed: Following the closing of our
−Removed: initial public offering, our Board of Directors will determine the fair market value of our common stock based on the closing price of
−Removed: our common stock as reported on the date of grant.
−Removed: Emerging Growth Company
−Removed: The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS
−Removed: Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to
−Removed: the enactment of the JOBS Act, until such time as those standards apply to private companies.
−Removed: The Company has elected to use this extended
−Removed: transition period for complying with new or revised accounting standards that have different effective dates for public and private companies
−Removed: until the earlier of the date that it (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the
−Removed: extended transition period provided in the JOBS Act.
−Removed: As a result, these financial statements may not be comparable to companies that comply
−Removed: with the new or revised accounting pronouncements as of public company effective dates.
−Removed: Plan of Operations
−Removed: Our plan of operations is currently focused on the development of both
−Removed: our therapeutic candidates which are at different stages of development.
−Removed: We submitted an IND application for AL001 to the FDA on June
−Removed: On July 28, 2021, the FDA responded to our IND that we are safe to proceed and we will be able to commence Phase I clinical
−Removed: trials in humans.
−Removed: We have an additional preclinical
−Removed: candidate for Alzheimer’s, AL002, which has transitioned from early-stage development to an extensive program of preclinical study
−Removed: and evaluation, which was completed on May 31, 2021 and was followed by a comprehensive report prepared by Charles River Laboratories,
−Removed: Inc., an independent preclinical service provider, received on July 23, 2021.
−Removed: Our preclinical program included a toxicologic evaluation,
−Removed: histopathology study and brain beta amyloid analysis and, after we received additional financing in March 2021, was expanded to include
−Removed: an immunoglobulin analysis and biodistribution study.
−Removed: In November 2018, we adopted
−Removed: a Charter for our Scientific Advisory Board and have appointed two members, Dr.
−Removed: Thomas Wisniewski (Director of the NYU Pearl I.
−Removed: Center for Memory Evaluation and Treatment) and Dr.
−Removed: Eric McDade (Associate Director of the Dominantly Inherited Alzheimer Network Trials
−Removed: Unit (“DIAN-TU”)).
−Removed: The Scientific Advisory Board members have clinical specializations, including extensive experience with
−Removed: Alzheimer’s and other neurological diseases.
−Removed: We intend to rely on this advisory group of experts to help guide our therapies through
−Removed: the related scientific and manufacturing initiatives.
−Removed: The continuation of our current
−Removed: plan of operations with respect to completing our IND application and beginning the series of human clinical trials for each of our therapeutics
−Removed: requires us to raise additional capital to fund our operations.
−Removed: Because our working capital
−Removed: requirements depend upon numerous factors, including the progress of our preclinical and clinical testing, timing and cost of obtaining
−Removed: regulatory approvals, changes in levels of resources that we devote to the development of manufacturing and marketing capabilities, competitive
−Removed: and technological advances, status of competitors, and our ability to establish collaborative arrangements with other organizations, we
−Removed: will require additional financing to fund future operations.
−Removed: Results of Operations
−Removed: Year Ended April 30, 2021 Compared to Year Ended April 30, 2020
−Removed: The following table summarizes
−Removed: the results of our operations for the year ended April 30, 2021 and 2020.
−Removed: For the Year Ended April 30,
−Removed: OPERATING EXPENSES
−Removed: Research and development
−Removed: General and administrative
−Removed: Total operating expenses
−Removed: Loss from operations
−Removed: OTHER INCOME (EXPENSE), NET
−Removed: Gain on extinguishment of debt
−Removed: Interest expense
−Removed: Interest expense - related party
−Removed: Interest income - related party
−Removed: Total other income (expense), net
−Removed: $ (5,046,567 )
−Removed: $ (4,410,236 )
−Removed: Basic and diluted net loss per common share
−Removed: Basic and diluted weighted average common
−Removed: shares outstanding
−Removed: We were formed on February
−Removed: 26, 2016 to acquire and commercialize patented intellectual property and know-how to prevent, treat and cure the crippling and deadly
−Removed: disease, Alzheimer’s.
−Removed: We currently have only two product candidates, AL001 and AL002.
−Removed: These products are in the preclinical stage
−Removed: of development and will require extensive clinical study, review and evaluation, regulatory review and approval, significant marketing
−Removed: efforts and substantial investment before either or both of them, and any respective successors, will provide us with any revenue.
−Removed: did not generate any revenues during the year ended April 30, 2021 and 2020, and we do not anticipate that we will generate revenue for
−Removed: the foreseeable future.
−Removed: General and administrative expenses
−Removed: General and administrative
−Removed: expenses for the year ended April 30, 2021 and 2020 were $3.6 million and $3.4 million, respectively.
−Removed: As reflected in the table below,
−Removed: general and administrative expenses primarily consisted of the following expense categories:
−Removed: stock compensation expense, professional
−Removed: fees, as well as salaries and benefits.
−Removed: The remaining general and administrative expenses of $166,000 and $120,000, respectively, primarily
−Removed: consisted of payments for advertising and promotion, transfer agent fees, travel, and other office expenses, none of which is significant
−Removed: individually.
−Removed: For the Year Ended April 30,
−Removed: Stock compensation expense
−Removed: Professional fees
−Removed: Salary and benefits
−Removed: Other general and administrative expenses
−Removed: Total general and administrative expenses
−Removed: Stock compensation expense
−Removed: During the year ended April
−Removed: 30, 2021 and 2020, we incurred general and administrative stock compensation expense of $2.3 million and $1.9 million, respectively,
−Removed: related to stock option grants to executives, employees and consultants as well as shares issued for services to Spartan Capital.
−Removed: option grants are granted at the per share fair value on the grant date.
−Removed: Vesting of options differs based on the terms of each option.
−Removed: We valued the options at their date of grant utilizing the Black Scholes option pricing model.
−Removed: We valued the shares issued for services
−Removed: at their intrinsic value on the date of issuance.
−Removed: Stock-based compensation is a non-cash expense because we settle these obligations by
−Removed: issuing shares of our common stock from authorized shares instead of settling such obligations with cash payments.
−Removed: Professional fees
−Removed: The second largest component
−Removed: of our general and administrative expenses is professional fees.
−Removed: During the year ended April 30, 2021 and 2020, we reported professional
−Removed: fees of $700,000 and $861,000, respectively, which are principally comprised of the following items:
−Removed: Year Ended April 30, 2021
−Removed: In June 2017, we entered into a five-year consulting agreement with Spartan
−Removed: Capital pursuant to which Spartan Capital has agreed to provide consulting services with respect to general corporate matters, including,
−Removed: but not limited to, advice and input with respect to raising capital, potential merger and acquisition transactions, identifying suitable
−Removed: personnel for management, developing corporate structure and finance strategies, assisting us with strategic introductions, assisting
−Removed: management with enhancing corporate and shareholder value and introducing us to potential investors.
−Removed: In December 2017, since the maximum
−Removed: amount was raised in the prior private placement, we paid to Spartan Capital a consulting fee of $1.4 million for the services to
−Removed: be rendered over the 60-month term of this consulting agreement.
−Removed: During the year ended April 30, 2021, we recorded an expense of $280,000
−Removed: as a result of this consulting agreement.
−Removed: In June 2019, we entered into an uplisting agreement with Spartan Capital
−Removed: pursuant to which Spartan Capital has agreed to provide consulting services with respect to an IPO, merger, acquisition or sale of stock
−Removed: or assets, joint venture, strategic alliance or other similar transaction.
−Removed: We paid to Spartan Capital a consulting fee of $475,000 and
−Removed: issued Spartan 500,000 shares of our common stock for the services to be rendered over the 24-month term of the uplisting agreement.
−Removed: the year ended April 30, 2021, we recorded an expense of $263,000 as a result of this consulting agreement.
−Removed: The uplisting agreement was
−Removed: terminated on March 3, 2021.
−Removed: During the year ended April 30, 2021, we incurred $26,000 in legal fees.
−Removed: During the year ended April 30, 2021, we incurred $125,000 in audit fees.
−Removed: Year Ended April 30, 2020
−Removed: In June 2017, we entered into a five-year consulting agreement with Spartan
−Removed: Capital pursuant to which Spartan Capital agreed to provide consulting services with respect to general corporate matters, including,
−Removed: but not limited to, advice and input with respect to raising capital, potential merger and acquisition transactions, identifying suitable
−Removed: personnel for management, developing corporate structure and finance strategies, assisting us with strategic introductions, assisting
−Removed: management with enhancing corporate and shareholder value and introducing us to potential investors.
−Removed: In December 2017, since the maximum
−Removed: amount was raised in a prior private placement, we paid to Spartan Capital a consulting fee of $1.4 million for the services to be rendered
−Removed: over the five-year term of this consulting agreement.
−Removed: During the year ended April 30, 2020, we recorded an expense of $280,000 in
−Removed: connection with this consulting agreement.
−Removed: In June 2019, we entered into a two-year uplisting agreement with Spartan
−Removed: Capital pursuant to which Spartan Capital agreed to provide consulting services with respect to a potential public offering.
−Removed: under this agreement consisted of a cash payment in the amount of $475,000 and the issuance of 500,000 shares of our common stock.
−Removed: are amortizing the cost of these services over the two-year term of the uplisting agreement.
−Removed: During the year ended April 30, 2020,
−Removed: we recorded an expense of $104,000 in connection with the uplisting agreement.
−Removed: The uplisting agreement was terminated on March 3, 2021.
−Removed: During the year ended April 30, 2020, we incurred $244,000 in legal fees.
−Removed: During the year ended April 30, 2020, we incurred $76,000 in audit fees.
−Removed: Salaries and Benefits
−Removed: During the year ended April
−Removed: 30, 2021 and 2020, we incurred $452,000 and $427,000, respectively, in employee-related expenses.
−Removed: As of April 30, 2021, we had one full-time
−Removed: and three part-time employees.
−Removed: We appointed Stephan Jackman, who is a full-time employee, as Chief Executive Officer as of November 30,
−Removed: 2018, Kenneth S.
−Removed: Cragun as Chief Financial Officer on December 15, 2018, and Henry C.W.
−Removed: Nisser as Executive Vice President and General
−Removed: Counsel on May 1, 2019.
−Removed: Research and development expenses
−Removed: Research and development expenses for the year ended April 30, 2021
−Removed: and 2020, were $1.3 million and $1.1 million, respectively.
−Removed: As reflected in the table below, research and development expenses primarily
−Removed: consisted of professional fees, licenses and fees, as well as stock compensation expense.
−Removed: For the Year Ended April 30,
−Removed: Professional fees
−Removed: Licenses and fees
−Removed: Stock compensation expense
−Removed: Total research and development expenses
−Removed: Licenses and fees
−Removed: There are certain initial
−Removed: license fees and milestone payments required to be paid to the University of South Florida and the USF Research Foundation, for the licenses
−Removed: of the technologies, pursuant to the terms of the License Agreement with Sublicensing Terms (the “License Agreement”) with
−Removed: the Licensor and a direct support organization of the University.
−Removed: During the year ended April
−Removed: 30, 2021, we incurred $50,000 in license fees related to achieving the milestone of conducting pre-IND discussions with the FDA regarding
−Removed: AL001 under the new license agreements entered into on June 10, 2020 for the treatment of neurodegenerative diseases excluding Alzheimer’s
−Removed: and for the treatment of psychiatric diseases/disorders.
−Removed: During the year ended April
−Removed: 30, 2020, we incurred $50,000 in license fees related to achieving the milestone of conducting pre-IND discussions with the FDA regarding
−Removed: Professional fees
−Removed: During the year ended April
−Removed: 30, 2021 and 2020, we reported professional fees of $1.2 million and $709,000, respectively, which are principally comprised of professional
−Removed: fees attributed to various types of scientific services, including FDA consulting services.
−Removed: The increase relates to professional fees
−Removed: incurred related to AL001 chemistry, manufacturing and controls.
−Removed: Stock compensation expense
−Removed: During the year ended April
−Removed: 30, 2021 and 2020, we incurred $87,000 and $309,499, respectively, in research and development stock compensation expense related to stock
−Removed: option grants to consultants.
−Removed: All option grants are granted at the per share fair value on the grant date.
−Removed: Vesting of options differs
−Removed: based on the terms of each option.
−Removed: We valued the options at their date of grant utilizing the Black Scholes option pricing model.
−Removed: compensation is a non-cash expense because we settle these obligations by issuing shares of our common stock from authorized shares instead
−Removed: of settling such obligations with cash payments.
−Removed: Other income (expense), net
−Removed: Gain on extinguishment of debt
−Removed: In May 2020, we received loan
−Removed: proceeds in the amount of $62,000 under the Paycheck Protection Program (“PPP”).
−Removed: The PPP, established as part of the Coronavirus
−Removed: Aid, Relief and Economic Security Act (“CARES Act”), provides for loans to qualifying businesses for amounts up to 2.5 times
−Removed: of the average monthly payroll expenses of the qualifying business.
−Removed: The loans and accrued interest are forgivable after the earlier of
−Removed: (i) 24 weeks after the loan disbursement date and (ii) December 31, 2020 as long as the borrower uses the loan proceeds for eligible purposes,
−Removed: including payroll, benefits, rent and utilities, and maintains its payroll levels.
−Removed: We used the proceeds for purposes
−Removed: consistent with the PPP.
−Removed: In December 2020, we met the conditions and received forgiveness of the loan and recorded the benefit as a gain
−Removed: on extinguishment of debt.
−Removed: Interest expense
−Removed: Interest expense was $142,000
−Removed: for the year ended April 30, 2021 related to the convertible promissory note issued in August 2020 including non-cash interest expense
−Removed: of $124,000 recorded from the amortization of debt discount.
−Removed: Interest expense –
−Removed: related party
−Removed: Interest expense –
−Removed: party was $16,000 for the year ended April 30, 2021 related to the convertible promissory note –
−Removed: related party issued in August
−Removed: 2020 including non-cash interest expense of $14,000 recorded from the amortization of debt discount.
−Removed: Interest income –
−Removed: related party
−Removed: During the year ended April
−Removed: 30, 2021 and 2020, we reported interest income, related party of $2,000 and $14,000, respectively, relating to a promissory note from
−Removed: Current and deferred income taxes
−Removed: As of April 30, 2021 and 2020,
−Removed: we had deferred tax assets, prior to valuation allowance, of $4,354,645 and $2,844,294, respectively.
−Removed: We considered the scheduled reversal
−Removed: of deferred tax items, historic generation of taxable losses, projected future taxable losses, available tax planning strategies, and
−Removed: other factors in determining whether the Company will realize its deferred tax assets.
−Removed: Based on available evidence, we believe it is not
−Removed: more likely than not that the Company’s deferred tax assets will be realized.
−Removed: Accordingly, we maintain a full valuation allowance
−Removed: and did not record an income tax benefit during the years ended April 30, 2021 and 2020.
−Removed: Liquidity and Capital Resources
−Removed: The accompanying financial
−Removed: statements have been prepared on the basis that our company will continue as a going concern.
−Removed: As of April 30, 2021, we had cash of $1.9
−Removed: million and an accumulated deficit of $16.8 million.
−Removed: We have incurred recurring losses and reported losses for the year ended April 30,
−Removed: 2021 totaling $5.0 million.
−Removed: In the past, we have financed our operations principally through issuances of promissory notes and equity
−Removed: In March of 2021, the Company
−Removed: entered into a securities purchase agreement with Digital Power Lending, a California limited liability company and wholly owned subsidiary
−Removed: of Ault Global, or DPL, pursuant to which the Company agreed to sell an aggregate of 6,666,667 shares of its common stock for an aggregate
−Removed: of $10 million, or $1.50 per share, which sales will be made in tranches.
−Removed: On March 9, 2021, DPL paid $4 million, less the $1.8 million
−Removed: in advances and the surrender for cancellation of the $50,000 convertible promissory note, each as described below, for an aggregate of
−Removed: 2,666,667 shares of the Company’s common stock.
−Removed: According to the securities purchase agreement, DPL will purchase an additional
−Removed: (i) 1,333,333 shares of the Company’s common stock once the FDA shall have approved the Company’s IND for the Company’s
−Removed: phase 1a clinical trials for a purchase price of $2 million, and (ii) 2,666,667 shares of the Company’s common stock once the Company
−Removed: has completed these phase 1a clinical trials for a purchase price of $4 million.
−Removed: The Company further agreed to issue DPL warrants to purchase
−Removed: a number of shares of its common stock equal to 50% of the shares of common stock purchased under the securities purchase agreement at
−Removed: an exercise price of $3.00 per share.
−Removed: Finally, the Company agreed that for a period of eighteen months following the date of the payment
−Removed: of the final tranche of $4 million, DPL will have the right to invest an additional $10 million on the same terms, except that no specific
−Removed: milestones have been determined with respect to the additional $10 million as of the date of this Annual Report.
−Removed: On June 17, 2021 we announced
−Removed: the closing of our initial public offering of 2,500,000 shares of our common stock and full exercise of the underwriter’s over-allotment
−Removed: option to purchase 375,000 additional shares of our common stock at a price to the public of $5.00 per share.
−Removed: The gross proceeds from
−Removed: the offering to our company, before deducting the underwriting discounts and estimated offering expenses, were approximately $14.4 million.
−Removed: Our common stock is listed on The Nasdaq Capital Market under the ticker symbol “ALZN”.
−Removed: We expect to continue to incur
−Removed: losses for the foreseeable future and needs to raise additional capital until we are able to generate revenues from operations sufficient
−Removed: to fund our development and commercial operations.
−Removed: However, based on our current business plan, we believe that our cash and cash equivalents
−Removed: at April 30, 2021, together with the funds received from our June 2021 initial public offering, are sufficient to meet our anticipated
−Removed: cash requirements during the twelve-month period subsequent to the issuance of the financial statements included in this Annual Report.
−Removed: Impact of Coronavirus on Our Operations
−Removed: In March 2020, the World Health
−Removed: Organization declared the outbreak of COVID-19 as a pandemic which continues to spread throughout the United States and the world.
−Removed: are monitoring the outbreak of COVID-19 and the related business and travel restrictions and changes to behavior intended to reduce its
−Removed: spread, and its impact on our operations, financial position, cash flows, supply chains, and the industry in general, in addition to the
−Removed: impact on our employees.
−Removed: Due to the rapid development and fluidity of this situation, the magnitude and duration of the pandemic and its
−Removed: impact on our operations and liquidity is uncertain as of the date of this Annual Report.
−Removed: The continuing presence of
−Removed: COVID-19 has adversely impacted our business.
−Removed: Our drug development and manufacturing activities for A001 were delayed by eight weeks due
−Removed: to a shutdown at our third-party manufacturing facility during the months of March to May 2020, which resulted in about a one month overall
−Removed: delay in our clinical protocol development and IND development and submission as a result of a lack of labor and equipment.
−Removed: COVID-19 also
−Removed: delayed our nonclinical studies for AL002 by 12 weeks during the months of March to May 2020 due to shutdowns at our third-party lab facilities
−Removed: where we were not granted access to perform research.
−Removed: Moreover, COVID-19 has affected our ability to raise capital due to uncertain capital
−Removed: We continue to assess and monitor our business operations and system supports and the impact COVID-19 may continue to have on
−Removed: our operations and financial condition, but there can be no assurance that this analysis will enable us to avoid part or all of any impact
−Removed: from the spread of COVID-19 or its consequences, including downturns in business sentiment generally or in our sector in particular.
−Removed: Our operations are located in Orange County, CA and Tampa, FL, and
−Removed: certain members of our senior management work in Atlanta, GA and New York, NY.
−Removed: We have been following the recommendations of local health
−Removed: authorities to minimize exposure risk for our employees, including the temporary closures of our offices where certain of our employees
−Removed: work and having employees work remotely to the extent possible, has not negatively impacted their efficiency.
−Removed: Currently, we and our third-party
−Removed: facilities are working closely to pre-COVID-19 levels and expect normal operations for the balance of the calendar year.
−Removed: Contractual Obligations
−Removed: On May 1, 2016, we entered
−Removed: into a Standard Exclusive License Agreement for AL002 with Sublicensing Terms with the University of South Florida Research Foundation,
−Removed: Inc., as licensor, pursuant to which the licensor granted us a royalty bearing exclusive worldwide license limited to the field of Alzheimer’s
−Removed: Immunotherapy and Diagnostics, under United States Patent No.
−Removed: 8,188,046, entitled “Amyloid Beta Peptides and Methods of Use,”
−Removed: filed April 7, 2009 and granted May 29, 2012.
−Removed: In addition to royalty payments
−Removed: of 4% on net sales of products developed from the licensed technology, we were required to pay a license fee of $100,000 on June 25, 2016,
−Removed: and December 31, 2016.
−Removed: As an additional licensing fee for the license of the AL001 technologies, the licensor received 2,227,923 shares
−Removed: of our common stock.
−Removed: Additionally, we are required to pay milestone payments on the due dates to the licensor for the license of the technology,
−Removed: Original AL001 License:
−Removed: Pre-IND meeting
−Removed: IND application filing
−Removed: 12 months from IND filing date
−Removed: Upon first dosing of patient in a clinical trial
−Removed: 12 months from first patient dosing
−Removed: Upon completion of first clinical trial
−Removed: 24 months from completion of the first clinical trial
−Removed: Upon first patient treated in a Phase III clinical trial
−Removed: 8 years from the effective date of the agreement
−Removed: Upon FDA Approval
−Removed: AL002 License:
−Removed: January 1, 2022
−Removed: Upon IND application filing
−Removed: 12 months from IND application filing date
−Removed: Upon first dosing of patient in first Phase I clinical trial
−Removed: 12 months from first patient dosed in Phase I
−Removed: Upon completion of first Phase I clinical trial
−Removed: 24 months from completion of first Phase I clinical trial
−Removed: Upon completion of first Phase II clinical trial
−Removed: 12 months from completion of the first Phase II clinical trial
−Removed: Upon first patient treated in a Phase III clinical trial
−Removed: 7 years from the effective date of the agreement
−Removed: Upon FDA BLA approval
−Removed: We have met the Pre-IND meeting
−Removed: and IND application filing milestones encompassing AL001.
−Removed: If we fail to meet a milestone by its specified date, the licensor may terminate
−Removed: the license agreement.
−Removed: The licensor was also granted
−Removed: a preemptive right to acquire such shares or other equity securities that may be issued from time to time by us while the licensor remains
−Removed: the owner of any equity securities of our company.
−Removed: There are certain license
−Removed: fees and milestone payments required to be paid pursuant to the terms of the Standard Exclusive license agreements with Sublicensing Terms,
−Removed: both effective July 2, 2018, (the “AL001 license agreements”) with the licensor and the University of South Florida.
−Removed: a royalty payment of 3% is required pursuant to License #18110 while License #1811 requires a royalty payment of 1.5% on net sales of
−Removed: products developed from the licensed technology.
−Removed: For the two AL001 licenses, in the aggregate, we were required to pay initial license
−Removed: fees of $50,000 no later than July 31, 2018, and $150,000 no later than October 31, 2018.
−Removed: As an additional licensing fee, the licensor
−Removed: is entitled to receive that number of shares of our common stock equal to 3% of the sum of the total number of issued and outstanding
−Removed: Additionally, we are required to pay milestone payments on the due dates to the licensor for the license of the technology, as
−Removed: Additional AL001 Licenses:
−Removed: Upon first pre-IND meeting
−Removed: Pre-IND meeting
−Removed: December 31, 2022
−Removed: IND application filing
−Removed: 12 months from IND filing date
−Removed: Upon first dosing of patient in a clinical trial
−Removed: 12 months from first patient dosing
−Removed: Upon completion of first clinical trial
−Removed: 36 months from completion of the first Phase II clinical trial
−Removed: Upon first patient treated in a Phase III clinical trial
−Removed: August 1, 2029
−Removed: First commercial sale
−Removed: Off-Balance Sheet Arrangements
−Removed: We do not have any off-balance
−Removed: sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial
−Removed: condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.
−Removed: Recent Accounting Standards
−Removed: For information about recent
−Removed: accounting pronouncements that may impact our financial statements, please refer to Note 3 of Notes to Financial Statements under the
−Removed: heading “Recent Accounting Standards.”
−Removed: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
−Removed: we are a smaller reporting company, this section is not applicable.
−Removed: FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
−Removed: financial statements required by this Item 8 are included in this Annual Report following Item 16 hereof.
−Removed: As a smaller reporting company,
−Removed: we are not required to provide supplementary financial information.
−Removed: CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
+Added: June 15, 2021, we issued and sold 2,875,000 shares of our common stock in the initial public offering (“IPO”) at a public
+Added: offering price of $5.00 per share, resulting in net proceeds of $12.9 million after deducting underwriting discounts and commissions and
+Added: offering expenses paid by us.
+Added: has been no material change in our planned use of the net proceeds from our IPO as described in our final prospectus filed pursuant to
+Added: Rule 424(b)(4) under the Securities Act with the SEC.
+Added: As of April 30, 2022, we have used $6.8 million of the net proceeds from the IPO.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.