UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

FORM 10-Q

[X]QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE QUARTERLY PERIOD ENDED JANUARY 31, 2018APRIL 30, 2022

[  ]TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934

Commission File Number 001-14468

PURE Bioscience, Inc.

(Exact name of registrant as specified in its charter)

Delaware33-0530289
(State or other jurisdiction of(I.R.S. Employer
incorporation or organization)Identification No.)

1725 Gillespie Way9669 Hermosa Avenue

El Cajon, Rancho Cucamonga, California

9202091730
(Address of principal executive offices)(Zip Code)

Registrant’s telephone number, including area code: (619)596-8600

Securities registered pursuant to Section 12(b) of the Act: None.

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [  ]

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes [X] No [  ]

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer[  ]Accelerated filer[  ]
Non-accelerated filer[  ]Smaller reporting company[X]
Emerging growth company[  ]

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [  ] No [X]

As of MarchJune 14, 2018,2022, there were 68,057,658 88,023,141 shares of the registrant’s common stock, $0.01 par value per share, outstanding.

 

 

PURE Bioscience, Inc.

Form 10-Q

for the Quarterly Period Ended January 31, 2018April 30, 2022

Table of Contents

Page
PART IFINANCIAL INFORMATION
Item 1.Condensed Financial Statements3
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations1617
Item 3.Quantitative and Qualitative Disclosures about Market Risk24
Item 4.Controls and Procedures25
PART IIOTHER INFORMATION
Item 1.Legal Proceedings26
Item 1A.Risk Factors26
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds27
Item 3.Defaults Upon Senior Securities27
Item 4.Mine Safety Disclosures27
Item 5.Other Information27
Item 6.Exhibits28
Signatures3029

2

Part I - Financial Information

Item 1. Financial Statements

PURE Bioscience, Inc.

Condensed Consolidated Balance Sheets

        
 January 31, 2018  July 31, 2017  April 30, 2022 July 31, 2021 
 (Unaudited)     (Unaudited)    
Assets                
Current assets                
Cash and cash equivalents $2,129,000  $1,640,000  $511,000  $2,390,000 
Accounts receivable  146,000   297,000   198,000   368,000 
Inventories, net  267,000   273,000   301,000   332,000 
Restricted cash  75,000   75,000   75,000   75,000 
Prepaid expenses  104,000   174,000   25,000   32,000 
Total current assets  2,721,000   2,459,000   1,110,000   3,197,000 
Property, plant and equipment, net  515,000   548,000   697,000   740,000 
Patents, net  737,000   822,000   311,000   366,000 
Total assets $3,973,000  $3,829,000  $2,118,000  $4,303,000 
Liabilities and stockholders’ equity                
Current liabilities                
Accounts payable $449,000  $426,000  $416,000  $593,000 
Accrued liabilities  233,000   249,000   134,000   138,000 
Derivative liabilities     1,853,000 
Loan payable     239,000 
Total current liabilities  682,000   2,528,000   550,000   970,000 
Deferred rent  17,000   11,000 
Total liabilities  699,000   2,539,000 
Commitments and contingencies          -     
Stockholders’ equity                
Preferred stock, $0.01 par value: 5,000,000 shares authorized, no shares issued and outstanding        
Common stock, $0.01 par value: 100,000,000 shares authorized, 68,057,658 shares issued and outstanding at January 31, 2018, and 63,093,153 shares issued and outstanding at July 31, 2017  681,000   631,000 
Preferred stock, $0.01 par value: 5,000,000 shares authorized, 0 shares issued and outstanding      
Common stock, $0.01 par value: 150,000,000 shares authorized, 88,023,141 shares issued and outstanding at April 30, 2022, and 87,223,141 shares issued and outstanding at July 31, 2021  881,000   873,000 
Additional paid-in capital  116,441,000   110,141,000   128,738,000   128,253,000 
Accumulated deficit  (113,848,000)  (109,482,000)  (128,051,000)  (125,793,000)
Total stockholders’ equity  3,274,000   1,290,000   1,568,000   3,333,000 
Total liabilities and stockholders’ equity $3,973,000  $3,829,000  $2,118,000  $4,303,000 

See accompanying notes.

3

PURE Bioscience, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

                
 Six Months Ended Three months Ended  Nine Months Ended Three months Ended 
 January 31,  January 31,  April 30, April 30, 
 2018  2017  2018  2017  2022  2021  2022  2021 
Net product sales $875,000  $978,000  $411,000  $447,000  $1,409,000  $2,841,000  $497,000  $556,000 
Royalty revenue  32,000   227,000   27,000   5,000 
Total revenue  1,441,000   3,068,000   524,000   561,000 
Cost of goods sold  553,000   1,250,000   199,000   246,000 
Gross profit  888,000   1,818,000   325,000   315,000 
Operating costs and expenses                                
Cost of goods sold  307,000   399,000   161,000   134,000 
Selling, general and administrative  2,863,000   2,670,000   1,418,000   1,333,000   3,127,000   3,136,000   977,000   1,036,000 
Research and development  264,000   462,000   120,000   214,000   255,000   265,000   107,000   89,000 
Share-based compensation  1,396,000   448,000   740,000   170,000 
Total operating costs and expenses  4,830,000   3,979,000   2,439,000   1,851,000   3,382,000   3,401,000   1,084,000   1,125,000 
Loss from operations  (3,955,000)  (3,001,000)  (2,028,000)  (1,404,000)  (2,494,000)  (1,583,000)  (759,000)  (810,000)
Other income (expense)                                
Inducement to exercise warrants  (876,000)         
Change in derivative liabilities  459,000   300,000      459,000 
Interest expense, net  (2,000)  (3,000)  (1,000)  (2,000)  (3,000)  (3,000)  (1,000)  (1,000)
Other income (expense), net  8,000   25,000   2,000   11,000 
Gain on extinguishment of indebtedness, net  239,000          
Total other income (expense)  (411,000)  322,000   1,000   468,000   236,000   (3,000)  (1,000)  (1,000)
Net loss $(4,366,000) $(2,679,000) $(2,027,000) $(936,000) $(2,258,000) $(1,586,000) $(760,000) $(811,000)
Basic and diluted net loss per share $(0.07) $(0.04) $(0.03) $(0.01) $(0.03) $(0.02) $(0.01) $(0.01)
Shares used in computing basic and diluted net loss per share  66,482,607   64,220,473   68,000,810   63,617,030   87,741,639   87,157,857   87,925,388   87,223,141 

See accompanying notes.

4

PURE Bioscience, Inc.

Condensed Consolidated Statement of Stockholders’ Equity

(Unaudited)

  Nine Months Ended April 30, 2022  Nine Months Ended April 30, 2021 
  Common Stock  Additional
Paid-In
  Accumulated  Total
Stockholders’
  Common Stock  Additional
Paid-In
  Accumulated  Total
Stockholders’
 
  Shares  Amount  Capital  Deficit  Equity  Shares  Amount  Capital  Deficit  Equity 
                               
Balances at beginning of period  87,223,141  $873,000  $128,253,000  $(125,793,000) $3,333,000   87,072,951  $871,000  $127,414,000  $(123,474,000) $4,811,000 
Share-based compensation expense - stock options        431,000      431,000         621,000      621,000 
Share-based compensation expense - restricted stock units        62,000      62,000         62,000      62,000 
                                         
Issuance of common stock upon the exercise of stock options                 150,190   2,000   (2,000)      
                                         
Issuance of common stock for vested restricted stock units  800,000   8,000   (8,000)                     
Net loss           (2,258,000)  (2,258,000)           (1,586,000)  (1,586,000)
Balances at end of period (Unaudited)  88,023,141  $881,000  $128,738,000  $(128,051,000) $1,568,000   87,223,141  $873,000  $128,095,000  $(125,060,000) $3,908,000 

  Three Months Ended April 30, 2022  Three Months Ended April 30, 2021 
  Common Stock  Additional
Paid-In
  Accumulated  Total
Stockholders’
  Common Stock  Additional
Paid-In
  Accumulated  Total
Stockholders’
 
  Shares  Amount  Capital  Deficit  Equity  Shares  Amount  Capital  Deficit  Equity 
                               
Balances at beginning of period (Unaudited)  87,873,141  $879,000  $128,617,000  $(127,291,000) $2,205,000   87,223,141  $873,000  $127,882,000  $(124,249,000) $4,506,000 
Share-based compensation expense - stock options        103,000      103,000         193,000      193,000 
Share-based compensation expense - restricted stock units        20,000      20,000         20,000      20,000 
                                         
Issuance of common stock for vested restricted stock units  150,000   2,000   (2,000)        -    -    -        
Net loss           (760,000)  (760,000)           (811,000)  (811,000)
Balances at end of period (Unaudited)  88,023,141  $881,000  $128,738,000  $(128,051,000) $1,568,000   87,223,141  $873,000  $128,095,000  $(125,060,000) $3,908,000 

See accompanying notes.

5

PURE Bioscience, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

  Six Months Ended 
  January 31, 
  2018  2017 
Operating activities        
Net loss $(4,366,000) $(2,679,000)
Adjustments to reconcile net loss to net cash used in operating activities:        
Share-based compensation  1,396,000   448,000 
Amortization of stock issued for services  81,000   72,000 
Depreciation and amortization  142,000   134,000 
Inventory write-off  26,000    
Change in fair value of derivative liabilities  (459,000)  (300,000)
Inducement to exercise warrants  876,000    
Changes in operating assets and liabilities:        
Accounts receivable  151,000   121,000 
Inventories  (20,000)  10,000 
Prepaid expenses  41,000   (2,000)
Accounts payable and accrued liabilities  7,000   (36,000)
Deferred rent  6,000   10,000 
Net cash used in operating activities  (2,119,000)  (2,222,000)
Investing activities        
Investment in patents  (4,000)  (10,000)
Purchases of property, plant and equipment  (20,000)  (173,000)
Net cash used in investing activities  (24,000)  (183,000)
Financing activities        
Net proceeds from the exercise of warrants  2,632,000    
Net proceeds from the sale of common stock     1,104,000 
Net cash provided by financing activities  2,632,000   1,104,000 
Net increase (decrease) in cash and cash equivalents  489,000   (1,301,000)
Cash and cash equivalents at beginning of period  1,640,000   5,194,000 
Cash and cash equivalents at end of period $2,129,000  $3,893,000 
Supplemental disclosure of cash flow information        
Cash paid for taxes $  $2,000 
Noncash Investing and Financing activities        
Warrant liabilities removed due to settlements $1,394,000  $8,000 
Common stock issued for prepaid services $51,000  $ 
Restricted stock unit cancelation $  $38,000 
         
  Nine Months Ended 
  April 30, 
  2022  2021 
Operating activities        
Net loss $(2,258,000) $(1,586,000)
Adjustments to reconcile net loss to net cash used in operating activities:        
Share-based compensation  493,000   683,000 
Depreciation and amortization  162,000   133,000 
Gain on extinguishment of indebtedness  (239,000)    
Changes in operating assets and liabilities:        
Accounts receivable  170,000   868,000 
Inventories  31,000   (21,000)
Prepaid expenses  7,000   (19,000)
Accounts payable and accrued liabilities  (181,000)  (813,000)
Net cash used in operating activities  (1,815,000)  (755,000)
Investing activities        
Purchases of property, plant and equipment  (64,000)  (504,000)
Net cash used in investing activities  (64,000)  (504,000)
Financing activities        
Net proceeds from payroll protection program loan     239,000 
Net cash provided by financing activities     239,000 
Net decrease in cash, cash equivalents, and restricted cash  (1,879,000)  (1,020,000)
Cash, cash equivalents, and restricted cash at beginning of period  2,465,000   3,914,000 
Cash, cash equivalents, and restricted cash at end of period $586,000  $2,894,000 
         
Reconciliation of cash, cash equivalents, and restricted cash to the condensed consolidated balance sheets        
Cash and cash equivalents $511,000  $2,819,000 
Restricted cash $75,000  $75,000 
Total cash, cash equivalents and restricted cash $586,000  $2,894,000 

See accompanying notes.

56

PURE Bioscience, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

For the three and nine months ended April 30, 2022 and 2021

1. Basis of Presentation

The accompanying unaudited condensed consolidated financial statements include the consolidated accounts of PURE Bioscience, Inc. and its wholly owned subsidiary, ETI H2O Inc., a Nevada corporation. ETI H2O, Inc. currently has no business operations and no material assets or liabilities and there have been no significant transactions related to ETI H2O, Inc. during the periods presented in the condensed consolidated financial statements. All inter-company balances and transactions have been eliminated. All references to “PURE,” “we,” “our,” “us” and the “Company” refer to PURE Bioscience, Inc. and our wholly owned subsidiary.

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, for interim financial information pursuant to the instructions to Form 10-Q and Article 10/Rule 8-03 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three and six monthsquarter ended January 31, 2018April 30, 2022 are not necessarily indicative of the results that may be expected for other quarters or the year ending July 31, 2018.2022. The July 31, 20172021 balance sheet was derived from audited financial statements but does not include all disclosures required by GAAP and included in our Annual Report on Form 10-K. For more complete information, these unaudited financial statements and the notes thereto should be read in conjunction with the audited financial statements for the year ended July 31, 20172021 included in our Annual Report on Form 10-K covering such period filed with the Securities and Exchange Commission, or SEC, on October 26, 2017.28, 2021.

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. Actual results could differ from those estimates.

2. Liquidity &and Going Concern Uncertainty

These unaudited condensed consolidated financial statements have been prepared and presented on a basis assuming we will continue as a going concern. The factors below raise substantial doubt about our ability to continue as a going concern. The condensed consolidated financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.

Since our inception, we have financed our operations primarily through public and private offerings of securities, debt financing, and revenue from product sales and license agreements. We have a history of recurring losses, and as of January 31, 2018,April 30, 2022 we have incurred a cumulative net loss of $113,848,000.

We$128,051,000. During the nine months ended April 30, 2022, we recorded a net loss of $2,258,000 on recorded net revenue of $1,441,000. In addition, during the nine months ended April 30, 2022 we used $1,879,000 in operating and investing activities resulting in a cash balance of $511,000 as of April 30, 2022. Our history of recurring operating losses, and negative cash flows from operating activities give rise to substantial doubt regarding our ability to continue as a going concern. The Company’s independent registered public accounting firm, in its report on the Company’s consolidated financial statements for the year ended July 31, 2021, has also expressed substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not have,include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may never have, significant cash inflowsresult from product sales or from other sources of revenue to fund our operations. As of January 31, 2018, we had $2,129,000 in cash and cash equivalents, and $449,000 of accounts payable. As of January 31, 2018, we have no long-term debt. We do not currently believe that our existing cash resources are sufficient to meet our anticipated needs over the next twelve months from the date hereof and based on our current plans and available resources, we believe we can maintain our current operations through the end of July 2018. As a result,possible inability to continue to fund our ongoing operations, beyond July 2018, we would need to secure significant additional capital. If we were unable to secure additional capital onas a timely basis or at all, we will be required to curtail our current business plans and substantially reduce our expenses and development costs such as reducing our headcount and limiting our sales and marketing efforts and may ultimately be required to cease operations altogether. Moreover, our expenses may exceed our current plans and expectations, which would require us to secure additional capital or wind-down our operations sooner than anticipated. going concern.

Our future capital requirements depend on numerous forward-looking factors. These factors may include, but are not limited to, the following: the acceptance of, and demand for, our products; our success and the success of our partners in selling our products; our success and the success of our partners in obtaining regulatory approvals to sell our products; the costs of further developing our existing products and technologies; the extent to which we invest in new product and technology development; and the costs associated with the continued operation, and any future growth, of our business. The outcome of these and other forward-looking factors will substantially affect our liquidity and capital resources.

Until we can continually generate significantpositive cash flow from operations, we expectwill need to continue to fund our operations with the proceeds of offerings of our equity and debt securities. However, we cannot assure youensure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or to our stockholders. If we raise additional funds from the issuance of equity securities, substantial dilution to our existing stockholders would likely result. If we raise additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to operate our business. Further, any contracts

7

3. Significant Accounting Policies

Revenue Recognition

We account for revenue in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers (“Topic 606”). Under Topic 606, revenue is recognized at an amount that reflects the consideration to which we expect to be entitled in exchange for transferring goods or license arrangementsservices to a customer. This principle is applied using the following 5-step process:

1.Identify the contract with the customer
2.Identify the performance obligations in the contract
3.Determine the transaction price
4.Allocate the transaction price to the performance obligations in the contract
5.Recognize revenue when (or as) each performance obligation is satisfied

Under Topic 606, we enter into to raise funds may require us to relinquish our rightsrecognize revenue when we satisfy a performance obligation by transferring control of the promised goods or services to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services.

Our technology platform is based on patented stabilized ionic silver, and our initial products contain silver dihydrogen citrate, or technology,SDC. SDC is a broad-spectrum, non-toxic antimicrobial agent, which offers 24-hour residual protection and formulates well with other compounds. We sell various configurations and dilutions of SDC direct to customers and through distributors. We currently offer PURE® Hard Surface as a food contact surface sanitizer and disinfectant to restaurant chains, food processors and food transportation companies. We also offer PURE Control® as a direct food contact processing aid.

Contract terms for unit price, quantity, shipping and payment are governed by sales agreements and purchase orders which we cannot assure youconsider to be a customer’s contract in all cases. The unit price is considered the observable stand-alone selling price for the arrangements. Any promotional or sales discounts are applied evenly to the units sold for purposes of calculating standalone selling price.

Product sales generally consist of a single performance obligation that we will be ablesatisfy at a point in time. We recognize product revenue when the following events have occurred: (a) we have transferred physical possession of the products, (b) we have a present right to enter intopayment, (c) the customer has legal title to the products, and (d) the customer bears significant risks and rewards of ownership of the products.

Our direct customer and distributor sales are invoiced based on received purchase orders. Our payment terms on invoiced direct customer and distributor sales range between 30 and 90 days after we satisfy our performance obligation. The majority of our customers are on 30 day payment terms. We currently offer no right of return on invoiced sales and maintain no allowance for sales returns.

Shipping and handling are treated as activities to fulfill promises to customers and any amounts billed to a customer, if applicable, represent revenues earned for the goods provided. Costs related to such contracts or license arrangements on acceptable terms, or at all. Having insufficient funds may require us to delay or scale back our marketing, distributionshipping and other commercialization activities or cease our operations altogether.handling billings are classified as cost of sales.

6

We do not have any unused credit facilitiessignificant categories of revenue that may impact how the nature, amount, timing and uncertainty of revenue and cash flows are affected by economic factors.

A summary of our revenue by product type for the nine months ended April 30, 2022 and 2021 is as follows:

Summary of Revenue by Product

         
  April 30, 
  2022  2021 
PURE Hard Surface $1,158,000  $2,815,000 
SILVÉRION  251,000   26,000 
Total $1,409,000  $2,841,000 

A summary of our revenue by product type for the three months ended April 30, 2022 and 2021 is as follows:

         
  April 30, 
  2022  2021 
PURE Hard Surface $352,000  $556,000 
SILVÉRION  145,000    
Total $497,000  $556,000 

Variable Consideration

We record revenue from customers in an amount that reflects the transaction price we expect to be entitled to after transferring control of those goods or other sources of capital availableservices. From time to us at this time. We intend to secure additional working capital throughtime, we offer sales of additional debt or equity securities. Our intended financing initiatives are subject to risk, and we cannot provide any assurance about the availability or terms of these or any future financings.

If we are unable to obtain sufficient capital, it will have a material adverse effectpromotions on our business and operations. It could cause usproducts such as discounts. Variable consideration is estimated at contract inception only to fail to execute our business plan, fail to take advantagethe extent that it is probable that a significant reversal of future opportunities, or fail to respond to competitive pressures or customer requirements. It also may require us to significantly modify our business model and operations to reduce spending to a sustainable level, which may include delaying, scaling back or eliminating some or allrevenue will not occur.

8

Use of our ongoing and planned investments in corporate infrastructure, research and development projects, regulatory submissions, business development initiatives, and sales and marketing activities, among other investments. If adequate funds are not available when needed, we may be required to reduce or cease operations altogether.Estimates

The condensedpreparation of consolidated financial statements do notin conformity with accounting principles generally accepted in the United States of America, or GAAP, requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements, and the disclosures made in the accompanying notes to the consolidated financial statements. Actual results could differ materially from those estimates. Those estimates and assumptions include any adjustment relating to recoverability or classificationestimates for reserves of uncollectible accounts, inventory obsolescence, depreciable lives of property and equipment, analysis of impairments of recorded long-term tangible and intangible assets, realization of deferred tax assets, accruals for potential liabilities and classification of recorded liabilities.assumptions made in valuing stock instruments issued for services.

3. Net Loss Per Share

Basic net loss per common share is computed as net loss divided by the weighted average number of common shares outstanding for the period. Our diluted net loss per common share is the same as our basic net loss per common share because we incurred a net loss during each period presented, and the potentially dilutive securities from the assumed exercise of all outstanding stock options, restricted stock units, and warrants would have an anti-dilutive effect. As of January 31, 2018April 30, 2022 and 2017, the number of2021, stock options, warrants and shares issuable upon the exercise of stock options, the vesting ofunder restricted stock units,unit awards of 7,391,625 and the exercise of warrants, none of which are included in10,358,765, respectively, have been excluded from the computation of basic net loss per common share, was 11,280,939 and 11,980,795, respectively.diluted shares outstanding.

Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share

  April 30, 
  2022  2021 
Common stock options  6,179,125   8,018,500 
Restricted stock units  1,212,500   2,012,500 
Warrants     327,765 
Total  7,391,625   10,358,765 

4. Comprehensive LossInventory

Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on marketable securities and foreign currency translation adjustments. For the three and six months ended January 31, 2018 and 2017, our comprehensive loss consisted only of net loss.

5. Inventory

Inventories are stated at the lower of cost or net realizable value, and net of a valuation allowance for potential excess or obsolete material. Cost is determined using the average cost method. Depreciation related to manufacturing is systematically allocated to inventory produced, and expensed through cost of goods sold at the time inventory is sold.

Inventories consist of the following:

Schedule of Inventories

        
 January 31, 2018  July 31, 2017  

April 30,

2022

 

July 31,

2021

 
Raw materials $54,000  $82,000  $17,000  $17,000 
Finished goods  213,000   191,000   284,000   315,000 
 $267,000  $273,000 
Inventories $301,000  $332,000 

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During November of 2017, we wrote-off $26,000 of inventory destroyedShare-Based Compensation

We periodically issue stock options and restricted stock awards to employees and non-employees in a third-party warehouse fire. Subsequentnon-capital raising transactions for services and for financing costs. We account for such grants issued and vesting to January 31, 2018, we received $45,000 from an insurance claim foremployees based on ASC 718, whereby the replacement costvalue of the inventory destroyed inaward is measured on the fire.date of grant and recognized as compensation expense on the straight-line basis over the vesting period.

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We estimate the fair value of share-based payment awards at the date of grant using the Black-Scholes option valuation model. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and expected life of the option. Share-based compensation expense is based on awards ultimately expected to vest, and therefore is reduced by expected forfeitures.

6. Impairment of Long-Lived Assets

In accordance with GAAP, if indicators of impairment exist, we assess the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. If impairment is indicated, we measure the amount of such impairment by comparing the carrying value of the asset to the fair value of the asset and we record the impairment as a reduction in the carrying value of the related asset and a charge to operating results. Estimating the undiscounted future cash flows associated with long-lived assets requires judgment, and assumptions could differ materially from actual results. During the three and sixnine months ended January 31, 2018April 30, 2022 and 2017,2021, no impairment of long-lived assets was indicated or recorded.

7. Fair ValueConcentrations

Gross product sales. For the three months ended April 30, 2022, three individual customers accounted for 29%, 14% and 11% of Financial Instrumentsour net product sales, respectively. For the nine months ended April 30, 2022, three customers accounted for 14%, 12% and 10% of our net product sales, respectively. For the three months ended April 30, 2021, three individual customers accounted for 25%, 12% and 11% of our net product sales. For the nine months ended April 30, 2021, two customers accounted for 18% and 10% of our net product sales, respectively.

Fair valueAccounts receivable. As of April 30, 2022, we had accounts receivable from four customers that comprised of 15%, 14%, 12 and 11% of total accounts receivable, respectively. As of April 30, 2021, we had accounts receivable from three customers that comprised 22%, 15% and 13% of total accounts receivable, respectively.

Purchases. For the three months ended April 30, 2022, two vendors accounted for 26% and 12% of our purchases, respectively. For the nine months ended April 30, 2022, one vendor accounted for 21% of our purchases. For the three months ended April 30, 2021, two vendors accounted for 23% and 12% of our purchases, respectively. For the nine months ended April 30, 2021, one vendor accounted for 35% of our purchases.

Accounts payable. As of April 30, 2022, our largest vendor accounted for 25% of the total accounts payable. As of April 30, 2021, our largest three vendors accounted for 36%, 17% and 14% of the total trade accounts payable, respectively.

Segments

We operate in 1 segment for the manufacture and distribution of our products. In accordance with the “Segment Reporting” Topic of the ASC, our chief operating decision maker has been identified as the Chief Executive Officer and President, who reviews operating results to make decisions about allocating resources and assessing performance for the entire Company. Existing guidance, which is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would usea management approach to segment reporting, establishes requirements to report selected segment information quarterly and to report annually entity-wide disclosures about products and services, major customers, and the countries in pricing an asset or liability. As a basiswhich the entity holds material assets and reports revenue. All material operating units qualify for considering such assumptions,aggregation under “Segment Reporting” due to their similar customer base and similarities in: economic characteristics; nature of products and services; and procurement, manufacturing and distribution processes. Since the authoritative guidance establishes a three-tier value hierarchy, which prioritizesCompany operates in one segment, all financial information required by “Segment Reporting” can be found in the inputs used in measuring fair value as follows:accompanying financial statements

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 Level 1 – Quoted prices in active markets for identical assets or liabilities.
Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

4. Recent Accounting Pronouncements

In connectionJune 2016, the FASB issued ASU No. 2016-13, Credit Losses - Measurement of Credit Losses on Financial Instruments (“ASC 326”). The standard significantly changes how entities will measure credit losses for most financial assets, including accounts and notes receivable. The standard will replace today’s “incurred loss” approach with the October and November 2015 Private Placements, we issued warrants with derivative features. These instruments were accounted for as derivative liabilities (See Note 8 to these condensed consolidated financial statements).

We used Level 3 inputs for the valuation methodology of the derivative liabilities. The estimated fair values were computed using a Monte Carlo option pricingan “expected loss” model , under which companies will recognize allowances based on various assumptions. Our derivative liabilities are adjustedexpected rather than incurred losses. Entities will apply the standard’s provisions as a cumulative-effect adjustment to reflect estimated fair value at each period end, with any decrease or increase in the estimated fair value being recorded in other income or expense accordingly,retained earnings as adjustments to the fair value of the derivative liabilities. Various factors are considered in the pricing models we use to value the warrants, including the Company’s current stock price, the remaining life of the warrants, the volatility of the Company’s stock price, and the risk free interest rate.

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The following table provides a reconciliation of the beginning and ending balances of the derivative liabilitiesfirst reporting period in which the guidance is effective. As small business filer, the standard will be effective for us for interim and annual reporting periods beginning after December 15, 2022. The Company is currently assessing the six months ended January 31, 2018:impact of adopting this standard on the Company’s financial statements and related disclosures.

Fair Value of Significant Unobservable Inputs (Level 3)

  Warrant 
  Liabilities 
Balance at July 31, 2017 $1,853,000 
Issuances   
Settlement of warrant liabilities  (1,394,000)
Adjustments to estimated fair value  (459,000)
Balance at January 31, 2018 $ 

8. Derivative Liabilities

On October 23, 2015, we completed a first closing of a private placement financing (the “2015 Private Placement Financing”), where weIn August 2020, the FASB issued among other securities, a warrant to purchase up toASU No. 2020-06 (“ASU 2020-06”) “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an aggregate of 6,666,666 shares of common stock with a term of five years and a warrant to purchase up to an aggregate of 8,666,666 shares of common stock with a term of six months.

On November 23, 2015, we completed a second and final closing of the 2015 Private Placement Financing, where we issued, among other securities, a warrant to purchase up to an aggregate of 2,222,217 shares of common stock with a term of five years and a warrant to purchase up to an aggregate of 2,820,670 shares of common stock with a term of six months.

We accounted for the combined 20,376,219 warrants issued in connection with the 2015 Private Placement Financing in accordance withEntity’s Own Equity.” ASU 2020-06 will simplify the accounting guidance for derivatives. The applicableconvertible instruments by reducing the number of accounting guidance sets forth a two-step modelmodels for convertible debt instruments and convertible preferred stock. Limiting the accounting models will result in fewer embedded conversion features being separately recognized from the host contract as compared with current GAAP. Convertible instruments that continue to be applied in determining whether a financial instrument is indexedsubject to an entity’s own stock, which would qualify such financial instruments for a scope exception. This scope exception specifiesseparation models are (1) those with embedded conversion features that aare not clearly and closely related to the host contract, that would otherwise meet the definition of a derivative, financial instrument wouldand that do not be consideredqualify for a scope exception from derivative accounting and (2) convertible debt instruments issued with substantial premiums for which the premiums are recorded as such ifpaid-in capital. ASU 2020-06 also amends the contract is both (i) indexed toguidance for the derivatives scope exception for contracts in an entity’s own stock and (ii) classified inequity to reduce form-over-substance-based accounting conclusions. ASU 2020-06 will be effective January 1, 2024, for the stockholders’ equity sectionCompany. Early adoption is permitted, but no earlier than January 1, 2021, including interim periods within that year. Management is currently evaluating the effect of the entity’s balance sheet. We determinedadoption of ASU 2020-06 on the warrants were ineligibleconsolidated financial statements, but currently does not believe ASU 2020-06 will have a significant impact on the Company’s accounting.

In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for equity classification dueCertain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). ASU 2021-04 provides guidance as to anti-dilution provisions set forth therein.

During the fiscal year ended July 31, 2016, (i) all 2,820,670how an issuer should account for a modification of the six-month warrants issued in the second and final closing were exercised, (ii) the six-month warrants issued in the first closing expired and (iii) the five-year warrants issued in the first closing were cancelled.

On September 25, 2017, we completed the first closingterms or conditions or an exchange of a tender offer (the “Tender Offer”) to amend and exercise outstanding warrants to purchase sharesfreestanding equity-classified written call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of our common stock held by the investors participating inoriginal instrument for a new instrument. An issuer should measure the 2015 Private Placement Financing and our 2014 and 2017 private placement financingseffect of a modification or exchange as the investors participating in our 2014, 2015 and 2017 private placement financings. As a result, 1,599,135 warrants issued in connection withdifference between the 2015 Private Placement Financing were exercised for cash. In addition, there was a net exercise on 118,057 warrants which resulted in the issuance of 63,811 shares of our common stock. The net exercised warrants were issued in connection with the 2015 Private Placement Financing. The change in fair value of the modified or exchanged warrant liabilitiesand the fair value of that warrant immediately before modification or exchange and then apply a recognition model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 is effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on September 25, 2017or after the effective date. Early adoption is permitted for all entities, including adoption in an interim period. If an entity elects to early adopt ASU 2021-04 in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period. The adoption of ASU 2021-04 is not expected to have any impact on the Company’s consolidated financial statement presentation or disclosures.

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Recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statement presentation or disclosures.

5. Debt

Receipt of CARES funding

In April 2021, we were funded $239,000 under the Payroll Protection Program (“PPP”) through California Bank and Trust. The PPP was established as part of the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) and is administered by the U.S. Small Business Administration. The CARES Act was established in order to enable small businesses to pay employees during the economic slowdown caused by COVID-19 by providing forgivable loans to qualifying businesses for up to 2.5 times their average monthly payroll costs. The amount borrowed under the CARES Act is eligible to be forgiven provided that (a) the Company uses the PPP Funds during the eight week period after receipt thereof, and (b) the PPP Funds are only used to cover payroll costs (including benefits), rent, mortgage interest, and utility costs. The amount of loan forgiveness will be reduced if, among other reasons, the Company does not maintain staffing or payroll levels. Principal and interest payments on any unforgiven portion of the PPP Funds (the “PPP Loan”) will be deferred for six months and will accrue interest at a fixed annual rate of 1.0% and carry a two year maturity date. There is no prepayment penalty on the CARES Act Loan.

During the nine months ended April 30, 2022, we applied and received loan forgiveness under the provisions of the CARES Act for the entire $239,000 loan. This amount was recorded as a change in derivative liabilities in the condensed consolidated statementsgain on extinguishment of operations. The fair valueindebtedness on the exercise date was returned to additional paid in capital and is reflected inCondensed Consolidated Statement of Operations during the settlement of warrant liability section on the table in Note 7. The following assumptions were used as inputs to the fair value model at September 25, 2017: stock price of $1.00 per share and a warrant exercise price of $0.45 per share as of the valuation date; our historical stock price volatility of 70.00%; risk free interest rate on U.S. treasury notes of 1.6%; warrant expiration of 3.2 years (See Note 9 to these condensed consolidated financial statements).nine months ended April 30, 2022.

912

On October 10, 2017, we completed a second and final closing of the Tender Offer. As a result, 268,909 warrants issued in connection with the 2015 Private Placement Financing were exercised. The change in fair value of the warrant liabilities on October 10, 2017 was recorded as a change in derivative liabilities in the condensed consolidated statements of operations. The fair value on the exercise date was returned to additional paid in capital and is reflected in the settlement of warrant liability section on the table in Note 7. The following assumptions were used as inputs to the fair value model at October 10, 2017: stock price of $1.03 per share and a warrant exercise price of $0.45 per share as of the valuation date; our historical stock price volatility of 70.00%; risk free interest rate on U.S. treasury notes of 1.6%; warrant expiration of 3.1 years (See Note 9 to these condensed consolidated financial statements).

During the six months ended January 31, 2018, all remaining warrants containing derivative features issued in connection with the 2015 Private Placement Financing were exercised.

As of January 31, 2018, the total value of the derivative liabilities was zero. The change in fair value of the warrant liabilities for the six months ended January 31, 2018 and 2017, was a decrease of $459,000 and $300,000, respectively, which was recorded as a change in derivative liabilities in the condensed consolidated statements of operations. The change in fair value of the warrant liabilities for the three months ended January 31, 2018 and 2017, was zero and a decrease $459,000, respectively, which was recorded as a change in derivative liabilities in the condensed consolidated statements of operations.

9. Stockholders’ Equity

Preferred Stock

As of January 31, 2018, the Company’s Board of Directors is authorized to issue 5,000,000 shares of preferred stock with a par value of $0.01 per share, in one or more series. As of January 31, 2018 and July 31, 2017, there were no shares of preferred stock issued and outstanding.

Common Stock

As of January 31, 2018, 100,000,000 shares of common stock with a par value of $0.01 per share are authorized for issuance.

Schedule TO and Warrant Exercises

On October 10, 2017, we closed the Tender Offer. Specifically, we filed a Schedule TO with the SEC on August 25, 2017 offering to (i) reduce the exercise price of the warrants to purchase 4,104,980 shares of Common Stock issued to investors participating in our private placement financing completed on August 29, 2014, as amended (the “2014 Warrants”) from $0.75 per share to $0.60 per share of Common Stock in cash, (ii) reduce the exercise price of outstanding warrants to purchase 1,986,101 shares of Common Stock issued to investors participating in our private placement financing completed on November 23, 2015 (the “2015 Warrants”) from $0.45 per share to $0.40 per share of Common Stock in cash, (iii) reduce the exercise price of the outstanding warrants to purchase 1,572,941 shares of Common Stock issued to investors participating in our private placement financing completed on January 23, 2017 (the “2017 Warrants”, together with the 2014 Warrants and 2015 Warrants, the “Original Warrants”) from $1.25 per share to $0.85 per share of Common Stock in cash, (iv) shorten the exercise period of the Original Warrants so that they expired concurrently with the expiration of the Offer to Amend and Exercise at 5:00 p.m. (Pacific Time) on September 25, 2017 (“Expiration Date”) unless extended until the Subsequent Expiration Date (as defined below), (v) delete the cashless exercise provisions in the Original Warrants and (vi) delete the price-based anti-dilution provisions contained in the 2015 Warrants.

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Additionally, we requested the holders of a majority of the shares issuable upon exercise of the 2014 Warrants (the “2014 Requisite Majority”), 2015 Warrants (the “2015 Requisite Majority”) and 2017 Warrants (the “2017 Requisite Majority”) to approve an amendment of all of the outstanding 2014 Warrants, 2015 Warrants and 2017 Warrants, respectively, to amend such Original Warrants in the same manner as set forth above (the “Aggregate Warrant Amendment”), except the Expiration Date would be extended until October 10, 2017 (the “Subsequent Expiration Date”) if such Aggregate Warrant Amendment was approved with respect to such class of Original Warrants. The 2015 Requisite Majority approved an amendment of all of the outstanding 2015 Warrants and holders of 2015 Warrants had until the Subsequent Expiration Date to exercise their 2015 Warrants (the “Subsequent Offer Period”).6. Stockholders’ Equity

The Offer to Amend and Exercise with respect to the 2014 Warrants and 2017 Warrants expired on the Expiration Date of September 25, 2017. As of September 25, 2017, 1,491,649 shares of Common Stock were issued upon exercise of 2014 Warrants, 1,599,135 shares of Common Stock were issued upon exercise of 2015 Warrants and 1,396,470 shares of Common Stock were issued upon exercise of 2017 Warrants, for aggregate gross proceeds to us of approximately $2,720,000. During the Subsequent Offer Period, 2015 Warrants to purchase 268,909 shares of Common Stock were exercised for aggregate gross proceeds to us of approximately $107,000. 2014 Warrants to purchase 2,533,331 shares of Common Stock and 2017 Warrants to purchase 176,471 shares of Common Stock at exercise prices of $0.75 per share and $1.25 per share, respectively, continue to remain outstanding and no 2015 Warrants remain outstanding.

Original Warrants (including 2015 Warrants exercised during the Subsequent Offer Period) to purchase an aggregate of 4,756,163 shares of Common Stock were tendered and exercised in the Offer to Amend and Exercise for aggregate net proceeds to us of approximately $2,632,000. Garden State Securities Inc. assisted the Company as warrant solicitation agents with respect to the 2017 Warrants.

Due to the reduction in exercise price for the Original Warrants issued in connection with the Schedule TO, we determined it was appropriate to record $876,000 of expense in the condensed consolidated statement of operations for the inducement to exercise the Original Warrants.

Additional Warrant Exercise

During the six months ended January 31, 2018, there was a net exercise on 573,057 warrants which resulted in the issuance of 158,342 shares of our common stock. As these warrants were net exercised, as permitted under the respective warrant agreement, we did not receive any cash proceeds. 198,057 of the warrants exercised during the period were issued in connection with the Original Warrants discussed above.

Other Activity

On October 1, 2017, we entered into a two-year service agreement for business development services. In accordance with the agreement we issued 50,000 shares of common stock, with a value of $51,000. The value was capitalized to prepaid expense and is being amortized over the term of the agreement. During the three and six months ended January 31, 2018, we recognized $6,000 and $8,000 of expense related to these services, respectively.

On April 13, 2016, we entered into a two-year service agreement for general financial advisory services. In accordance with the agreement we issued 250,000 shares of common stock, with a value of $290,000. The value was capitalized to prepaid expense and is being amortized over the term of the agreement. During the three and six months ended January 31, 2018, we recognized $36,000 and $73,000 of expense related to these services, respectively. In addition, during the three and six months ended January 31, 2017, we recognized $36,000 and $72,000 of expense related to these services, respectively.

10. Share-Based Compensation

Restricted Stock Units

During the six months ended January 31, 2018, the Compensation Committee of the Board of Directors authorized the issuance of 300,000 Restricted Stock UnitsThe Company issues restricted stock unit awards (“RSUs”) to newly appointed members of our board of directors.key management and as compensation for services to consultants and others. The RSUs typically vest over a two-year period and carry a ten-year term. Each RSU represents the right to receive one share of common stock, issuable at the time the RSU is delivered and subsequently settles, as set forth in the Restricted Stock Unit Agreement.The breakdown isCompany determines that fair value of those awards at the date of grant, and amortizes those awards as follows:an expense over the vesting period of the award. The shares earned under the grant are usually issued when the award settles at the end of the term.

Janet Risi Field RSU Award: We granted Ms. Risi an award consisting of one hundred fifty thousand (150,000) RSUs. 50% of the RSUs vested on January 15, 2018. The remaining 50% of the RSUs will vest on the earlier of the date of our annual meeting of stockholders held in 2019 or January 15, 2019.
Elisabeth Hagen, M.D. RSU Award: We granted Dr. Hagen an award consisting of one hundred fifty thousand (150,000) RSUs. 50% of the RSUs vested on January 15, 2018. The remaining 50% of the RSUs will vest on the earlier of the date of our annual meeting of stockholders held in 2019 or January 15, 2019.

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On October 4, 2018, the Board of Directors appointed Tom Myers as the Company’s Chief Operating Officer. In connection with Mr. Myers appointment, the Board agreed to grant him 500,000 RSUs upon the achievement by the Company of profitability for a fiscal quarter, after which such RSUs shall vest annually over the following three years. In May 2020, the 500,000 RSUs were formally granted to Mr. Myers due to the Company’s profitable April 30, 2020 fiscal quarter. During the sixnine months ended January 31, 2018, we issued 300,000 RSUs to purchase common stock to third-party consultants for business development services. The RSUs vest based on performance conditions if sales milestones are achieved. We currently do not expect the 300,000 RSUs to vest.April 30, 2022 there were no Restricted Stock Units granted.

Of the 2,260,000 unvested RSUs outstanding, we currently expect 1,075,000 to vest. As of JanuaryJuly 31, 2018,2021, the Company had granted 2,012,500 RSU’s of which 1,679,167 had vested. As of July 31, 2021, 333,333 RSU’s with a fair value of $144,000, remained unvested. None of the shares vested under the RSUs had been issued as of July 31, 2021.

During the nine months ended April 30, 2022 and 2021, the Company recognized $62,000 of compensation cost relating to RSU’s previously granted to Mr. Tom Myers, the Company’s Chief Operating Officer, which are being amortized over their three year vesting term. As of April 30, 2022, there was $1,160,000$82,000 of unrecognized non-cash compensation cost related to the remaining 333,333 RSUs we expect to vest, which will be recognized over a weighted average period of 2.86 years. 1.0 year.

During the three and sixnine months ended January 31, 2018, 375,000April 30, 2022, 800,000 RSUs were issued and 425,000 RSUs vested, based on service conditions, respectively.delivered. Of the 425,0001,212,500 RSUs that vested during the six months ended January 31, 2018, 375,000 shares have not been delivered and remain outstanding as set forthof April 30, 2022, 879,167 RSUs are vested and issuable. These RSUs are issued upon settlement date which is defined as “for each Vested Unit, the earliest of (i) the ten-year anniversary of the Grant Date; (ii) sixty days after the date the Grantee’s Service ceases for any reason and such cessation constitutes a “separation from service” within the meaning of Section 409A of the Code; (iii) the date of Grantee’s death or (iv) the date of a Change in Control that constitutes a “change in control event” within the RSU agreements.meaning of Section 409A of the Code”.

For the three months ended January 31, 2018 and 2017, share-based compensation expense for RSUs was $284,000 and $24,000, respectively. For the six months ended January 31, 2018 and 2017, share-based compensation expense for outstanding RSUs was $545,000 and $75,000, respectively.

RSU Termination

On December 13, 2016, we entered into an RSU Cancellation Agreement with our officers and directors who received RSUs in October 2013 as compensation for their continued services to us over a required vesting period. Under this Agreement, our officers and directors agreed to cancel RSUs representing the right to receive an aggregate of 3.9 million vested sharesA summary of our common stock. Pursuant to the termsrestricted stock unit activity and related data is as follows:

Schedule of the cancelled RSUs, we would have been required to settle and deliver these vested shares to the individual officers and directors prior to January 1, 2017, which would have triggered a taxable event. Our officers and directors, in their individual capacities, voluntarily agreed to cancel their respective RSUs based on their determination that cancelling the RSUs would be in the best interests of the Company and our stockholders. The individual officers and directors reached this conclusion for the following reasons:Restricted Stock Activity

  Total RSU
Shares
  Vested and
Issuable
 
Outstanding at July 31, 2021  2,012,500   1,679,167 
Granted      
Issued  (800,000)  (800,000)
Forfeited      
Outstanding at April 30, 2022  1,212,500   879,167 

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 1.Conserved our Additional Available Cash Resources. The RSUs held by our officers provide these individuals with the right to require us to pay the applicable state and federal taxes due upon the settlement and delivery of their vested RSU shares in exchange for the individual cancelling and returning to us that number of shares of common stock equal in value to the contractual tax payment obligation. By agreeing to cancel the RSUs, we were not required to utilize our available cash resources to pay the tax payments on behalf of our officers, and as a result, we were able to conserve our cash resources to support the continued implementation of our business plan.
2.Reduced Pressure on Our Stock Price. The RSUs held by our non-employee directors provide these individuals with the right to immediately sell into the public market that number of shares of common stock sufficient to cover the applicable state and federal taxes payable as a result of the settlement and delivery of their vested RSU shares. Our common stock has a limited daily trading volume, and the sale or the potential sale of a substantial number of shares of common stock by our officers and directors to cover their federal and state tax obligations would have adversely affected the market price of our common stock, which in turn, could have harmed our ability to raise funds to support our operations or require us to raise funds at terms and valuations that would be more dilutive to our existing stockholders.

Each of our officers and directors who are parties to the RSU Cancellation Agreement agreed to cancel their RSUs and the shares of common stock underlying the RSUs in their individual capacities as stockholders and equity award holders, and without any agreement or promise from us or our officers or directors to issue them equity, equity-based awards or cash compensation in the future in exchange for entering into the Agreement.

During the six months ended January 31, 2017, $87,000 of pre-vest expense was reversed as a result of the RSU cancelation.

Stock Option Plans

2007 Equity Incentive Plan

In February 2016, we amended and restated our 2007 Equity Incentive Plan, the (“2007 Plan”), to, among other changes, increase the number of shares of common stock issuable under the 2007 Plan by 4,000,000 shares and extend the term of the 2007 Plan until February 4, 2026.2026. The 2007 Plan provides for the grant of incentive and non-qualified stock options, as well as other share-based payment awards, to our employees, directors, consultants and advisors. These awards have up to a 10-year10-year contractual life and are subject to various vesting periods, as determined by the Compensation Committee of the Board of Directors. As of January 31, 2018,April 30, 2022, there were approximately 561,0001,552,000 shares available for issuance under the 2007 Plan.

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2017 Equity Incentive Plan

Approved byIn January 2021, we amended and restated our shareholders in January 2018, the 2017 Equity Incentive Plan, the (“2017 Plan”), has a share reserveto, among other changes, increase the number of 5,000,000 shares of common stock which were registeredissuable under a Form S-8 filed with the SEC in February 2018.2017 Plan by 5,000,000 shares and extend the term of the 2007 Plan until January 2031. The 2017 Plan provides for the grant of incentive and non-qualified stock options, as well as other share-based payment awards, to our employees, directors, consultants and advisors. These awards have up to a 10-year10-year contractual life and are subject to various vesting periods, as determined by the Compensation Committee of the Board of Directors. As of January 31, 2018,April 30, 2022, there were 5,000,000approximately 3,755,000 shares available for issuance under the 2017 Plan.

During the sixnine months ended January 31, 2018, the Compensation Committee of the Board of DirectorsApril 30, 2022, we authorized the issuance of 400,000170,000 stock options to newly appointed members of our board of directors.Each option represents the right to receive one share of common stock, issuable at the time the option is exercised, as set forth in the option agreement. The breakdown is as follows:

Janet Risi Field Option Award: We granted Ms. Risi an award consisting of an option to purchase two hundred thousand (200,000) shares of common stock. 50% of the options vested on January 15, 2018. The remaining 50% of the options will vest on the earlier of the date of our annual meeting of stockholders held in 2019 or January 15, 2019.
Elisabeth Hagen, M.D. Option Award: We granted Dr. Hagen an award consisting of an option to purchase two hundred thousand (200,000) shares of common stock. 50% of the options vested on January 15, 2018. The remaining 50% of the options will vest on the earlier of the date of our annual meeting of stockholders held in 2019 or January 15, 2019.

During the six months ended January 31, 2017, we issued 100,000 options to purchase common stock to a member of our Scientific Advisory Board.new employees. The options vested quarterly over have a fair value of $36,000 as determined by the Black Scholes option pricing model, vest between one year and three years and carry a five-yearten year term.

None During the nine months ended April 30, 2021, we authorized the issuance of the60,000 stock options granted to our directors were granted pursuant to any compensatory, bonus, or similar plan maintained or otherwise sponsoreda consultant with a fair value of $48,000 as determined by the Company.Black Scholes option pricing model. The options vest quarterly over one year and carry a five year term. There were no stock option grants during the three months ended April 30, 2022 and 2021.

A summary of our stock option activity is as follows:

Schedule of Stock Option Activity

  Shares  Weighted- Average Exercise Price  Aggregate Intrinsic Value 
Outstanding at July 31, 2017  5,759,843  $1.25  $1,120,000 
Granted  400,000  $1.16     
Exercised    $     
Cancelled    $     
Outstanding at January 31, 2018  6,159,843  $1.25  $58,000 
  Shares  Weighted-
Average
Exercise
Price
  Aggregate
Intrinsic
Value
 
Outstanding at July 31, 2021  8,644,125  $0.76  $124,000 
Granted  170,000  $0.29   2,000 
Exercised    $    

Expired

  (2,635,000) $1.05    
Outstanding at April 30, 2022  6,179,125  $0.62  $ 

The weighted-average remaining contractual term of options outstanding at January 31, 2018April 30, 2022 was 5.456.64 years.

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At January 31, 2018,April 30, 2022, options to purchase 4,072,3435,466,625 shares of common stock were exercisable. These options had a weighted-average exercise price of $1.28, an aggregate intrinsic value of $58,000,$0.64 and a weighted average remaining contractual term of 3.826.31 years. The weighted average grant date fair value for options granted during the six months ended January 31, 2018 was $0.81. The total unrecognized compensation cost related to unvested stock option grants as of January 31, 2018April 30, 2022 was approximately $1,406,000$150,000 and the weighted average period over which these grants are expected to vest is 3.130.83 years.

For the threenine months ended January 31, 2018 and 2017,April 30, 2022 share-based compensation expense for stock options that vested during the period was $456,000 and $234,000 respectively.$431,000. For the sixnine months ended January 31, 2018 and 2017,April 30, 2021 share-based compensation expense for stock options that vested during the period was $851,000 and $460,000 respectively.$621,000.

We use the Black-Scholes valuation model to calculate the fair value of stock options. Stock-based compensation expense is recognized over the vesting period using the straight-line method. The fair value of stock options was estimated at the grant date using the following weighted average assumptions:

Schedule of Fair Value Assumptions

 Three
Months Ended January 31, 2018
 Three
Months Ended January 31, 2017
 Six
Months Ended January 31, 2018
 Six
Months Ended January 31, 2017
  

Nine

Months Ended April 30, 2022

 

Nine

Months Ended April 30, 2021

 
Volatility  84.89%    —%  85.94%  74.71%  88.35.%  104.93.%
Risk-free interest rate  2.03%      —%  1.91%  0.93% 1.17% 0.18%
Dividend yield  0.0%      —%  0.0%  0.0% 0.0% 0.0%
Expected life  5.35       5.40 years    2.81 years  5.59 years 2.81 years 

Volatility is the measure by which our stock price is expected to fluctuate during the expected term of an option. Volatility is derived from the historical daily change in the market price of our common stock, as we believe that historical volatility is the best indicator of future volatility.

The risk-free interest rates used in the Black-Scholes calculations are based on the prevailing U.S. Treasury yield as determined by the U.S. Federal Reserve.

We have never paid dividends on our common stock and do not anticipate paying dividends on our common stock in the foreseeable future. Accordingly, we have assumed no dividend yield for purposes of estimating the fair value of our share-based compensation.

The weighted average expected life of options was estimated using the average ofbetween the contractual term and the weighted average vesting term of the options. Certain options granted

7. Related Party Transactions

As of April 30, 2022 and April 30, 2021, accounts payable include $136,000 and $63,600 in board fees due to consultants are subject to variable accounting treatment and are required to be revalued until vested.

Stock-based compensation expense is based on awards ultimately expected to vest, and therefore is reduced by expected forfeitures. We have not had significant forfeitures of stock options granted to employeesofficers and directors, as a significant number of our historical stock option grants were fully vested at issuance or were issued with short vesting provisions. Therefore, we have estimated the forfeiture rate of our outstanding stock options as zero.respectively.

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11. Recent Accounting Pronouncements

In July 2017, the Financial Accounting Standards Board (“FASB”) issued a two-part Accounting Standards Update (“ASU”) No. 2017-11, I. Accounting for Certain Financial Instruments With Down Round Features and II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests With a Scope Exception (“ASU 2017-11”). ASU 2017-11 amends guidance in FASB ASC 260, Earnings Per Share, FASB ASC 480, Distinguishing Liabilities from Equity, and FASB ASC 815, Derivatives and Hedging. The amendments in Part I of ASU 2017-11 change the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features. The amendments in Part II of ASU 2017-11 re-characterize the indefinite deferral of certain provisions of Topic 480 that now are presented as pending content in the Codification, to a scope exception. Those amendments do not have an accounting effect. ASU 2017-11 is effective for public business entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. We are evaluating the effect that this update will have on our consolidated financial statements and related disclosures.

In May 2014, the FASB issued ASU 2014-09,Revenue from Contracts with Customers (Topic 606) which amended the existing accounting standards for revenue recognition. ASU 2014-09 establishes principles for recognizing revenue upon the transfer of promised goods or services to customers, in an amount that reflects the expected consideration received in exchange for those goods or services. In July 2015, the FASB deferred the effective date for annual reporting periods beginning after December 15, 2017. We will adopt ASU 2014-09 in the first fiscal quarter of 2019. We currently do not have any material revenue contracts with customers and will review any new contracts entered into prior to the adoption of the new standard. We are evaluating the effect that this update will have on our consolidated financial statements and related disclosures.

In December 2017, the United States (“U.S.”) enacted the Tax Cuts and Jobs Act (the “2017 Act”), which changes existing U.S. tax law and includes various provisions that are expected to affect public companies. The 2017 Act (i) changes U.S. corporate tax rates, (ii) generally reduces a company’s ability to utilize accumulated net operating losses, and (iii) requires the calculation of a one-time transition tax on certain previously unrepatriated foreign earnings and profits (“E&P”). The 2017 Act will also impact estimates of a company’s deferred tax assets and liabilities. We are currently in the early stages of evaluating the financial statement impact of the 2017 Act. Based on initial assessments, we expect significant adjustments to our gross deferred tax assets and liabilities; however, we also expect to record a corresponding offset to our estimated full valuation allowance against our net deferred tax assets, which should result in minimal net effect to our provision for income taxes. In accordance with SEC issued guidance under Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act (“SAB 118”), we have not recorded any provisional income tax effects of the 2017 Act in our financial statements as our anticipated impact is minimal and we do not have the necessary information available, prepared or analyzed (including computations) in reasonable detail to complete accounting for the change in tax law.

12. Subsequent Events

None.

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8. Commitments and Contingencies

COVID-19

The COVID-19 pandemic has led to severe disruptions in general economic activities, as businesses and federal, state, and local governments take increasingly broad actions to mitigate this public health crisis. While we have experienced some delays related to final third-party validation of certain of our products and product rollouts by customers using PURE Control, we have not experienced a material disruption to our business. In addition, we previously benefited from increased demand from our customers for our PURE Hard Surface product due to a focus on surface disinfecting in response to attempting to prevent COVID-19 transmission. We subsequently experienced an abatement in such demand and cannot assure you that demand will stabilize. Additionally, we are beginning to experience supply chain issues with our various plastic packaging configurations and citric acid. Further, on a go-forward basis, we cannot guarantee the overall economic conditions will not affect our business, as these conditions may significantly negatively impact all aspects of our business. Our business is dependent on the continued health and productivity of our employees, including our sales staff and corporate management team.

Additionally, our liquidity could be negatively impacted if these conditions continue for a significant period of time and we may be required to pursue additional sources of financing to obtain working capital, maintain appropriate inventory levels, and meet our financial obligations. Currently, capital and credit markets have been disrupted by the crisis and our ability to obtain any required financing is not guaranteed and largely dependent upon evolving market conditions and other factors. Depending on the continued impact of the crisis, further actions may be required to improve our cash position and capital structure.

The extent to which the COVID-19 pandemic ultimately impacts our business, sales, results of operations and financial condition will depend on future developments, which are highly uncertain and cannot be predicted, including, but not limited to, the duration and spread of the outbreak, its severity, the actions to contain the virus or treat its impact, and how quickly and to what extent normal economic and operating conditions resume and, more specifically, the effect it has on our customers and suppliers. Even after the COVID-19 pandemic has subsided, we may experience significant impacts to our business as a result of its global economic impact, including any economic downturn or recession that has occurred or may occur in the future.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

All references in this Item 2 and elsewhere in this Quarterly Report to “PURE,” “we,”“we”, “our,” “us” and the “Company” refer to PURE Bioscience, Inc., a Delaware corporation, and our wholly owned subsidiary, ETI H2O, Inc., a Nevada corporation. ETI H2O, Inc. currently has no business operations and no material assets or liabilities and there have been no significant transactions related to ETI H2O, Inc. during the periods presented in the condensed consolidated financial statements contained elsewhere in this Quarterly Report.

The discussion in this section contains forward-looking statements. These statements relate to future events or our future financial performance. We have attempted to identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “should,” “would” or “will” or the negative of these terms or other comparable terminology, but their absence does not mean that a statement is not forward-looking. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which could cause our actual results to differ from those projected in any forward-looking statements we make. Several risks and uncertainties we face are discussed in more detail under “Risk Factors” in Part II, Item 1A of this Quarterly Report or in the discussion and analysis below. You should, however, understand that it is not possible to predict or identify all risks and uncertainties and you should not consider the risks and uncertainties identified by us to be a complete set of all potential risks or uncertainties that could materially affect us. You should not place undue reliance on the forward-looking statements we make herein because some or all of them may turn out to be wrong. We undertake no obligation to update any of the forward-looking statements contained herein to reflect future events and developments, except as required by law. The following discussion should be read in conjunction with the condensed consolidated financial statements and the notes to those condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Overview

We are focused on developing and commercializing proprietary antimicrobial products that provide safe and cost-effective solutions to the health and environmental challenges of pathogen and hygienic control. Our technology platform is based on patented stabilized ionic silver, and our initial products contain silver dihydrogen citrate, or SDC. SDC is a broad-spectrum, non-toxic antimicrobial agent, which offers 24-hour residual protection and formulates well with other compounds. As a platform technology, we believe SDC is distinguished from existing products in the marketplace because of its superior efficacy, reduced toxicity, non-causticity and the inability of bacteria to form a resistance to it.

We do not currently believe that our existing cash resources are sufficient to meet our anticipated needs over the next twelve months from the date hereof and based on our current plans and available resources, we believe we can maintain our current operations through the end of July 2018.  As a result, to continue to fund our ongoing operations, beyond July 2018, we would need to secure significant additional capital. If we were unable to secure additional capital on a timely basis or at all, we will be required to curtail our current business plans and substantially reduce our expenses and development costs such as reducing our headcount and limiting our sales and marketing efforts and may ultimately be required to cease operations altogether. Moreover, our expenses may exceed our current plans and expectations, which would require us to secure additional capital or wind-down our operations sooner than anticipated. 

Business Overview

Our SDC-based technology platform has potential application in a number of industries. Our near-term focus is on offering products that address food safety risks across the food industry supply chain. In 2011, the Centers for Disease Control and Prevention (CDC) reported that foodborne illnesses affect more than 48 million people annually in the U.S., causing 128,000 hospitalizations and 3,000 fatalities. The CDC estimated that more than 9 million of these foodborne illnesses were attributed to major pathogens. The CDC reported that contaminated produce was responsible for approximately 46% of the foodborne illnesses caused by pathogens and 23% of the foodborne illness-related deaths in the US between 1998 and 2008. Among the top pathogens contributing to foodborne illness in the U.S. are Norovirus,Salmonella,Campylobacter,Staphylococcus, Shiga toxin–producingEscherichia coli andListeria.Salmonella is the leading cause of hospitalization, followed by Norovirus, and is the leading cause of deaths related to foodborne illness.

Based on these statistics, we believe there is a significant market opportunity for our safe, non-toxic, non-caustic and effective SDC-based solutions. We currently offer PURE® Hard Surface as a food contact surface sanitizer and disinfectant to restaurant chains, food processors and food transportation companies. We also offer PURE Control® as a direct food contact processing aid. We received the required FDA approvals to market PURE Control as a direct food contact processing aid for raw poultry and fresh produce in December 2015 and January 2016, respectively. Because additional USDA approval was not required, we began marketing PURE Control as a direct food contact processing aid for fresh produce following our receipt of FDA approval in January 2016.

In July 2016, we received a “No Objection Letter” from the USDA’s Food Safety and Inspection Service (FSIS) granting approval for SDC-based PURE Control to be used as a spray or dip applied to poultry carcasses, parts and organs in pre-OLR (on-line reprocessing) and post chill processing of fresh poultry. In January 2017, we submitted an additional FCN to the FDA to allow use of higher SDC concentrations in poultry processing, allowing the flexibility to adjust to varying plant and processing conditions. In May 2017, we received a Final Letter from the FDA for this FCN as well as a “No Objection Letter” from the USDA’s Food Safety and Inspection Service (FSIS) granting approval for the higher concentrations of SDC-based PURE Control to be used as a spray or dip applied to poultry carcasses, parts and organs in pre-OLR (on-line reprocessing) and post chill processing of fresh poultry. We are currently focused on completing in-plant validation trials for PURE Control in pre- and post OLR poultry processing applications, which represents approximately 65 to 75% of the total processing aid market for poultry processing. We are also conducting in-plant trials to optimize the application of PURE Control in OLR to attempt to gain USDA approval for use in this stage of poultry processing.

Subject to the results of our focused in-plant validation efforts for our approved produce and poultry solutions, we intend to seek approval to utilize PURE Control as a direct food contact processing aid for raw meats, including beef and pork. In addition to our direct sales efforts with PURE Hard Surface and PURE Control, we market and sell our SDC-based products indirectly through third-party distributors.distributors supporting various industries.

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Business Strategy

Our goal is to become a sustainable company by commercializing the SDC-based products we have developed with our proprietary technology platform. We are focused on delivering leading antimicrobial products that address food safety risks across the food industry supply chain. Key aspects of our business strategy include:

Expanding sales and distribution for our products into the food industry with a focus on a dual track of food safety market opportunities:

Hard Surface Disinfectant- commercializing our current EPA registered PURE Hard Surface disinfectant and sanitizer for use in foodservice operations, food manufacturing and food transportation.
Direct Food Contact - commercializing FDA approved PURE Control as a direct food contact processing aid for fresh produce; commercializing FDA approved PURE Control as a food processing and intervention aid for food processors treating raw poultry in pre and post OLR applications. We also intend to continue our on-going in plant trials to optimize the application of PURE Control in OLR to attempt to gain USDA approval for use in this stage of poultry processing. Additionally, subject to the results of our focused in-plant validation efforts for our approved produce and poultry solutions, we intend to seek approval to utilize PURE Control as a direct food contact processing aid for raw meats, including beef and pork.on-line reprocessing.

EstablishingContinuing to grow and establish new strategic alliances to maximize the commercial potential of our technology platform;
Continuing to partner with third parties who are seeking, or intend to seek, approvals to market SDC-based products in markets outside the U.S.
Developing additional proprietary products and applications; and
Protecting and enhancing our intellectual property.

In addition to our current products addressing food safety, we intend to leverage our technology platform through licensing and distribution collaborations in order to develop new products and enter into new markets that could potentially generate multiple sources of revenue.

Liquidity & Going Concern UpdateFinancial Overview

This financial overview provides a general description of our revenue and expenses.

Net Product Sales

We contract manufacture and sell SDC-based products for end use, and as a raw material for manufacturing use. We recognize revenue when we satisfy a performance obligation by transferring control of the promised goods or services to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. Any amounts received prior to satisfying revenue recognition criteria are recorded as deferred revenue. See “Critical Accounting Policies and Estimates – Revenue Recognition”.

Cost of Goods Sold

Cost of goods sold for product sales includes direct and indirect costs to manufacture products, including materials consumed, manufacturing overhead, shipping costs, salaries, benefits, reserved inventory, and related expenses of operations. Depreciation related to manufacturing is systematically allocated to inventory produced, and expensed through cost of goods sold at the time inventory is sold.

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Selling, General and Administrative

Selling, general and administrative expense consists primarily of salaries and other related costs for personnel in business development, sales, finance, accounting, information technology, and executive functions. Other selling, general and administrative costs include product marketing, advertising, and trade show costs, as well as public relations and investor relations, facility costs, and legal, accounting and other professional fees.

Research and Development

Our condensedresearch and development activities are focused on leveraging our technology platform to develop additional proprietary products and applications. Research and development expense consists primarily of personnel and related costs, product registration expenses, and third-party testing. We expense research and development costs as incurred.

Other Income (Expense)

We record interest income, interest expense, the change in derivative liabilities, as well as other non-operating transactions, as other income (expense) in our consolidated statements of operations.

COVID-19

The COVID-19 pandemic has led to severe disruptions in general economic activities, as businesses and federal, state, and local governments take increasingly broad actions to mitigate this public health crisis. While we have experienced some delays related to final third-party validation of certain of our products and product rollouts by customers using PURE Control, we have not experienced a material disruption to our business. In addition, we previously benefited from increased demand from our customers for our PURE Hard Surface product due to a focus on surface disinfecting in response to attempting to prevent COVID-19 transmission. We subsequently experienced an abatement in such demand and cannot assure you that demand will stabilize. Additionally, we are beginning to experience supply chain issues with our various plastic packaging configurations and citric acid. Further, on a go-forward basis, we cannot guarantee the overall economic conditions will not affect our business, as these conditions may significantly negatively impact all aspects of our business. Our business is dependent on the continued health and productivity of our employees, including our sales staff and corporate management team.

Additionally, our liquidity could be negatively impacted if these conditions continue for a significant period of time and we may be required to pursue additional sources of financing to obtain working capital, maintain appropriate inventory levels, and meet our financial statementsobligations. Currently, capital and credit markets have been prepareddisrupted by the crisis and presented on a basis assuming we will continue as a going concern. The factors below raise substantial doubt about our ability to continueobtain any required financing is not guaranteed and largely dependent upon evolving market conditions and other factors. Depending on the continued impact of the crisis, further actions may be required to improve our cash position and capital structure.

The extent to which the COVID-19 pandemic ultimately impacts our business, sales, results of operations and financial condition will depend on future developments, which are highly uncertain and cannot be predicted, including, but not limited to, the duration and spread of the outbreak, its severity, the actions to contain the virus or treat its impact, and how quickly and to what extent normal economic and operating conditions resume and, more specifically, the effect it has on our customers and suppliers. Even after the COVID-19 pandemic has subsided, we may experience significant impacts to our business as a going concern. The condensed consolidated financial statementsresult of its global economic impact, including any economic downturn or recession that has occurred or may occur in the future.

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Results of Operations

Fluctuations in Operating Results

Our results of operations have fluctuated significantly from period to period in the past and are likely to continue to do so in the future. We anticipate that our results of operations will be affected for the foreseeable future by several factors that may contribute to these periodic fluctuations, including fluctuations in the buying patterns of our current or potential customers for which we have no visibility, the mix of product sales including a change in the percentage of higher or lower margin formulations and packaging configurations of our products, the cost of product sales including component costs, our inability for any reason to be able to meet demand, the achievement and timing of research and development and regulatory milestones, unforeseen changes in expenses, including non-cash expenses such as the fair value of equity awards granted and the fair value change of derivative liabilities, the calculation of which includes several variable assumptions, and unforeseen manufacturing or supply issues, among other issues. Due to these fluctuations, we believe that the period-to-period comparisons of our operating results are not include any adjustments that might be necessary froma reliable indication of our future performance. As of the outcomedate of this uncertainty.filing, we are not aware of any trends in these factors or events or conditions that we believe are reasonably likely to impact our results of operations in the future.

SinceComparison of the Three Months Ended April 30, 2022 and 2021

Net Product Sales

Net product sales were $497,000 and $556,000 for the three months ended April 30, 2022 and 2021, respectively. The decrease of $59,000 was attributable to decreased sales across our inception,distribution network servicing the food processing, transportation and janitorial industry. Our top three customers accounted for $269,000 of net product sales for the three months ended April 30, 2022.

For the three months ended April 30, 2022, three individual customers accounted for 29%, 14% and 11% of our net product sales, respectively. No other individual customer accounted for 10% or more of our net product sales. All of our net product sales were U.S. based sales.

For the three months ended April 30, 2021, three individual customers accounted for 25%, 12% and 11% of our net product sales, respectively. No other individual customer accounted for 10% or more of our net product sales. All of our net product sales were U.S. based sales.

During the three months ended April 30, 2022 and 2021, we have financedrecognized $27,000 and $5,000 in royalties from a nonexclusive third-party distributor, respectively.

Cost of Goods Sold

Cost of goods sold was $199,000 and $246,000 for the three months ended April 30, 2022 and 2021, respectively. The decrease of $47,000 was primarily attributable to decreased product sales.

Gross margin as a percentage of net product sales, or gross margin percentage, was 60% and 56% for the three months ended April 30, 2022 and 2021, respectively. The increase in gross margin percentage was primarily attributable to the sale of higher margin formulations and packaging configurations of our products during the quarter ended April 30, 2022 as compared with the prior period.

Selling, General and Administrative Expense

Selling, general and administrative expense was $977,000 and $1,036,000 for the three months ended April 30, 2022 and 2021, respectively. The decrease of $59,000 was primarily attributable to decreased personnel costs and facilities expenses. These decreases were partially offset by increased marketing, travel and professional service expense.

Share-based compensation expense, included in selling, general and administrative expense, was $123,000 and $213,000 for the three months ended April 30, 2022 and 2021, respectively. The decrease of $90,000 is primarily due to the prior year vesting of stock options and restricted stock units granted to employees, directors and consultants supporting our selling, general and administrative functions.

Research and Development Expense

Research and development expense, primarily consisting of third-party fees and personnel costs, was $107,000 and $89,000 for the three months ended April 30, 2022 and 2021, respectively. The increase of $18,000 was due to increased personnel costs.

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Comparison of the Nine Months Ended April 30, 2022 and 2021

Net Product Sales

Net product sales were $1,409,000 and $2,841,000 for the nine months ended April 30, 2022 and 2021, respectively. During the prior year the Company experienced a significant increase in sales due to the onset of the COVID-19 pandemic. There was no such increase during the current period. As a result, our comparable nine month product revenue decreased by $1,432,000. The decrease was attributable to decreased sales across our distribution network servicing the food processing, transportation and janitorial industry. Our top five customers accounted for $739,000 of net product sales for the nine months ended April 30, 2022.

For the nine months ended April 30, 2022, three individual customers accounted for 14%, 12% and 10% of our net product sales, respectively. No other individual customer accounted for 10% or more of our net product sales. All of our net product sales were U.S. based sales.

For the nine months ended April 30, 2021, two individual customers accounted for 18% and 10% of our net product sales, respectively. No other individual customer accounted for 10% or more of our net product sales. All of our net product sales were U.S. based sales.

During the nine months ended April 30, 2022 and 2021, we recognized $32,000 and $227,000 in royalties from a nonexclusive third-party distributor, respectively.

Cost of Goods Sold

Cost of goods sold was $553,000 and $1,250,000 for the nine months ended April 30, 2022 and 2021, respectively. The decrease of $697,000 was primarily attributable to decreased product sales.

Gross margin as a percentage of net product sales, or gross margin percentage, was 61% and 56% for the nine months ended April 30, 2022 and 2021, respectively. The increase in gross margin percentage was primarily attributable to the sale of higher margin formulations and packaging configurations of our products during the nine months ended April 30, 2022, as compared with the prior period.

Selling, General and Administrative Expense

Selling, general and administrative expense was $3,127,000 and $3,136,000 for the nine months ended April 30, 2022 and 2021, respectively. The decrease of $9,000 was primarily attributable to decreased personnel costs and legal fees. These decreases were partially offset by increased professional service costs, travel and marketing expense and board fees.

Share-based compensation expense, included in selling, general and administrative expense, was $493,000 and $683,000 for the nine months ended April 30, 2022 and 2021, respectively. The decrease of $190,000 is primarily due to the prior year vesting of stock options and restricted stock units granted to employees, directors and consultants supporting our selling, general and administrative functions.

Research and Development Expense

Research and development expense was $255,000 and $265,000 for the nine months ended April 30, 2022 and 2021, respectively. The decrease of $10,000 was due to a reduction in third-party fees.

Other Income (Expense)

In April 2021, we were funded $239,000 under the Payroll Protection Program (“PPP”) through California Bank and Trust. The PPP was established as part of the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) and is administered by the U.S. Small Business Administration. During the nine months ended April 30, 2022, we received loan forgiveness under the provisions of the CARES Act for the entire $239,000 loan. This amount was recorded as a gain on extinguishment of indebtedness on the Condensed Consolidated Statement of Operations during the nine months ended April 30, 2022.

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Liquidity and Capital Resources

As of April 30, 2022, we had $511,000 in cash and cash equivalents compared with $2,390,000 in cash and cash equivalents as of July 31, 2021. The net decrease in cash and cash equivalents was primarily attributable to the use of cash to fund our operations and investments in property, plant and equipment. Additionally, as of April 30, 2022, we had $550,000 of current liabilities, including $416,000 in accounts payable, compared with $970,000 of current liabilities, including $593,000 in accounts payable as of July 31, 2021. The net decrease in current liabilities was primarily through publicdue to trade payables due to our contract manufacture and private offeringsthe forgiveness of securities, debt financing, and revenue from product sales and license agreements. the PPP Loan discussed above.

We have a history of recurring losses, and as of January 31, 2018,April 30, 2022 we have incurred a cumulative net loss of $113,848,000.

We$128,051,000. During the nine months ended April 30, 2022, we recorded a net loss of $2,258,000 on recorded net revenue of $1,441,000. In addition, during the nine months ended April 30, 2022 we used $1,879,000 in operating and investing activities resulting in a cash balance of $511,000 as of April 30, 2022. Our history of recurring operating losses, and negative cash flows from operating activities give rise to substantial doubt regarding our ability to continue as a going concern. The financial statements do not have,include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may never have, significant cash inflowsresult from product sales or from other sources of revenue to fund our operations. As of January 31, 2018, we had $2,129,000 in cash and cash equivalents, and $449,000 of accounts payable. As of January 31, 2018, we have no long-term debt. In October 2017, we completed the Tender Offer, resulting in net receipts of approximately $2.6 million in cash proceeds from the exercise of 4,756,163 outstanding warrants. We do not currently believe that our existing cash resources are sufficient to meet our anticipated needs over the next twelve months from the date hereof and based on our current plans and available resources, we believe we can maintain our current operations through the end of the July 2018.  As a result,possible inability to continue to fund our ongoing operations, beyond July 2018, we would need to secure significant additional capital. If we were unable to secure additional capital onas a timely basis or at all, we will be required to curtail our current business plans and substantially reduce our expenses and development costs such as reducing our headcount and limiting our sales and marketing efforts and may ultimately be required to cease operations altogether.  Moreover, our expenses may exceed our current plans and expectations, which would require us to secure additional capital or wind-down our operations sooner than anticipated.going concern.

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Our future capital requirements depend on numerous forward-looking factors. These factors may include, but are not limited to, the following: the acceptance of, and demand for, our products; our success and the success of our partners in selling our products; our success and the success of our partners in obtaining regulatory approvals to sell our products; the costs of further developing our existing products and technologies; the extent to which we invest in new product and technology development; and the costs associated with the continued operation, and any future growth, of our business. The outcome of these and other forward-looking factors will substantially affect our liquidity and capital resources.

Until we can continually generate significantpositive cash flow from operations, we expectwill need to continue to fund our operations with the proceeds of offerings of our equity and debt securities. However, we cannot assure you that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or to our stockholders. If we raise additional funds from the issuance of equity securities, substantial dilution to our existing stockholders would likely result. If we raise additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to operate our business. Further, any contracts or license arrangements we enter into to raise funds may require us to relinquish our rights to our products or technology, and we cannot assure you that we will be able to enter into any such contracts or license arrangements on acceptable terms, or at all. Having insufficient funds may require us to delay or scale back our marketing, distribution and other commercialization activities or cease our operations altogether.

We do not have any unused credit facilities or other sources of capital available to us at this time. We intend to secure additional working capital through sales of additional debt or equity securities. Our intended financing initiatives are subject to risk, and we cannot provide any assurance about the availability or terms of these or any future financings.

If we are unable to obtain sufficient capital, it will have a material adverse effect on our business and operations. It could cause us to fail to execute our business plan, fail to take advantage of future opportunities, or fail to respond to competitive pressures or customer requirements. It also may require us to significantly modify our business model and operations to reduce spending to a sustainable level, which may include delaying, scaling back or eliminating some or all of our ongoing and planned investments in corporate infrastructure, research and development projects, regulatory submissions, business development initiatives, and sales and marketing activities, among other investments. If adequate funds are not available when needed, we may be required to reduce or cease operations altogether.

Financial Overview

This financial overview provides a general description of our revenue and expenses.

Revenue

We contract manufacture and sell SDC-based products for end use, and as a raw material for manufacturing use. We also license our products and technology to development and commercialization partners. Revenue is recognized when realized or realizable and earned. Any amounts received prior to satisfying revenue recognition criteria are recorded as deferred revenue.

Cost of Goods Sold

Cost of goods sold for product sales includes direct and indirect costs to manufacture products, including materials consumed, manufacturing overhead, shipping costs, salaries, benefits, reserved inventory, and related expenses of operations. Depreciation related to manufacturing is systematically allocated to inventory produced, and expensed through cost of goods sold at the time inventory is sold.

Selling, General and Administrative

Selling, general and administrative expense consists primarily of salaries and other related costs for personnel in business development, sales, finance, accounting, information technology, and executive functions. Other selling, general and administrative costs include product marketing, advertising, and trade show costs, as well as public relations and investor relations, facility costs, and legal, accounting and other professional fees.

Research and Development

Our research and development activities are focused on leveraging our technology platform to develop additional proprietary products and applications. Research and development expense consists primarily of personnel and related costs, product registration expenses, and third-party testing. We expense research and development costs as incurred.

Other Income (Expense)

We record interest income, interest expense, the change in derivative liabilities, as well as other non-operating transactions, as other income (expense) in our condensed consolidated statements of operations.

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Results of Operations

Fluctuations in Operating Results

Our results of operations have fluctuated significantly from period to period in the past and are likely to continue to do so in the future. We anticipate that our results of operations will be affected for the foreseeable future by several factors that may contribute to these periodic fluctuations, including the demand for our products, the timing and amount of our product sales, and the progress and timing of expenditures related to sales and marketing, as well as product development. Due to these fluctuations, we believe that the period-to-period comparisons of our operating results are not a reliable indication of our future performance.

Comparison of the Three Months Ended January 31, 2018 and 2017

Net Product Sales

Net product sales were $411,000 and $447,000 for the three months ended January 31, 2018 and 2017, respectively. The decrease of $36,000 was primarily attributable to sales fluctuations within our existing legacy customer base.

For the three months ended January 31, 2018, three individual customers accounted for 33%, 19% and 12% of our net product sales. No other individual customer accounted for 10% or more of our net product sales. The geographic breakdown of net product sales was as follows: 100% U.S.

For the three months ended January 31, 2017, one individual customer accounted for 56% of our net product sales. No other individual customer accounted for 10% or more of our net product sales. The geographic breakdown of net product sales was as follows: 100% U.S.

Cost of Goods Sold

Cost of goods sold was $161,000 and $134,000 for the three months ended January 31, 2018 and 2017, respectively. The increase of $27,000 was primarily attributable to an inventory write-down caused by a fire in a third-party warehouse (See Note 5 to the condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q).

Gross margin as a percentage of net product sales, or gross margin percentage, was 61% and 70% for the three months ended January 31, 2018 and 2017, respectively. Gross margin percentage, excluding the inventory write-down discussed above, was 67% and 70% for the three months ended January 31, 2018 and 2017, respectively. The decrease in gross margin percentage was primarily attributable to the sale of lower margin formulations and packaging configurations of our products during the quarter ended January 31, 2018, as compared with the prior period.

Selling, General and Administrative Expense

Selling, general and administrative expense was $1,418,000 and $1,333,000 for the three months ended January 31, 2018 and 2017, respectively. The increase of $85,000 was primarily attributable to increased business development, marketing and travel expenses.

Research and Development Expense

Research and development expense was $120,000 and $214,000 for the three months ended January 31, 2018 and 2017, respectively. The decrease of $94,000 was primarily attributable to reduced personnel costs and reduced spending on research supporting our FDA approvals.

Share-Based Compensation

Share-based compensation expense was $740,000 and $170,000 for the three months ended January 31, 2018 and 2017, respectively. The increase of $570,000 is primarily due to the vesting of stock options and restricted stock units granted to employees, directors and consultants supporting our selling, general and administrative, and research and development functions.

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Change in Derivative Liabilities

Change in derivative liabilities for the three months ended January 31, 2018 was zero. All warrant containing derivative features were exercised during the three months ended October 31, 2017 (See Notes 8 and 9 to the condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q). Change in derivative liabilities for the three months ended January 31, 2017 was a decrease of $459,000. The overall decrease in the derivative liability was due to updates to the assumptions used in the fair value pricing model at the end of the reporting period.

Interest Expense

Interest expense for the three months ended January 31, 2018 and 2017 was $1,000 and $2,000, respectively.

Other Income (Expense)

Other income for the three months ended January 31, 2018 and 2017 was $2,000 and $11,000, respectively.

Comparison of the Six Months Ended January 31, 2018 and 2017

Net Product Sales

Net product sales were $875,000 and $978,000 for the six months ended January 31, 2018 and 2017, respectively. The decrease of $103,000 was primarily attributable to reduced food safety sales and fluctuations within our existing legacy customer base.

For the six months ended January 31, 2018, three individual customers accounted for 41%, 11% and 10%, of our net product sales, respectively. No other individual customer accounted for 10% or more of our net product sales. The geographic breakdown of net product sales was as follows: 100% U.S.

For the six months ended January 31, 2017, two individual customers accounted for 35% and 26%, of our net product sales, respectively. No other individual customer accounted for 10% or more of our net product sales. The geographic breakdown of net product sales was as follows: 100% U.S.

Cost of Goods Sold

Cost of goods sold was $307,000 and $399,000 for the six months ended January 31, 2018 and 2017, respectively. The decrease of $92,000 was primarily attributable to decreased product sales offset by an inventory write-down caused by a fire in a third-party warehouse (See Note 5 to the condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q).

Gross margin as a percentage of net product sales, or gross margin percentage, was 65% and 59% for the six months ended January 31, 2018 and 2017, respectively. Gross margin percentage, excluding the inventory write-down discussed above, was 68% and 59% for the six months ended January 31, 2018 and 2017, respectively. The increase in gross margin percentage was primarily attributable to the sale of higher margin formulations and packaging configurations of our products during the six months ended January 31, 2018 as compared with the prior period.

Selling, General and Administrative Expense

Selling, general and administrative expense was $2,863,000 and $2,670,000 for the six months ended January 31, 2018 and 2017, respectively. The increase of $193,000 was primarily attributable to increased business development and board of director’s expense, as well as, personnel costs.

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Research and Development Expense

Research and development expense was $264,000 and $462,000 for the six months ended January 31, 2018 and 2017, respectively. The decrease of $198,000 was primarily attributable to reduced personnel costs and reductions in third-party testing and research supporting our FDA approval efforts.

Share-Based Compensation

Share-based compensation expense was $1,396,000 and $448,000 for the six months ended January 31, 2018 and 2017, respectively. The increase of $948,000 is primarily due to the vesting of stock options and restricted stock units granted to employees, directors and consultants supporting our selling, general and administrative, and research and development functions.

Change in Derivative Liability

Change in derivative liabilities for the six months ended January 31, 2018 and 2017 was a decrease of $459,000 and $300,000, respectively. The overall decrease in the derivative liability is due to updates to the assumptions used in the fair value pricing model for warrants at the date the warrants were exercised (See Notes 8 and 9 to the condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q).

Inducement to exercise warrants

During the six months ended January 31, 2018, we completed a tender offer to amend outstanding warrants held by the investors participating in our 2014, 2015 and 2017 private placement financings. In accordance with the terms of the tender offer the strike price for all three series of warrants was reduced. As a result, we recorded a one-time inducement expense of $876,000.

Interest Expense

Interest expense for the six months ended January 31, 2018 and 2017 was $2,000 and $3,000, respectively.

Other Income (Expense)

Other income for the six months ended January 31, 2018 and 2017 was $8,000 and $25,000, respectively.

Liquidity and Capital Resources

Our condensed consolidated financial statements have been prepared and presented on a basis assuming we will continue as a going concern. The factors below raise substantial doubt about our ability to continue as a going concern. The condensed consolidated financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.

Since our inception, we have financed our operations primarily through public and private offerings of securities, debt financing, and revenue from product sales and license agreements. We have a history of recurring losses, and as of January 31, 2018 we have incurred a cumulative net loss of $113,848,000.

We do not have, and may never have, significant cash inflows from product sales or from other sources of revenue to fund our operations. As of January 31, 2018, we had $2,129,000 in cash and cash equivalents compared with $1,640,000 in cash and cash equivalents as of July 31, 2017. The net increase in cash and cash equivalents was primarily attributable to the successful closing of the tender offer. Additionally, as of January 31, 2018, we had $682,000 of current liabilities, including $449,000 in accounts payable, compared with $2,528,000 of current liabilities, including $426,000 in accounts payable as of July 31, 2017. The net decrease in current liabilities was primarily due to the removal of the derivative liability incurred from the issuance of warrants associated with our November 2015 financing(See Notes 8 and 9to the condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q).

While we completed a tender offer to amend and exercise outstanding warrants held by the investors participating in our 2014, 2015 and 2017 private placement financings, resulting in net receipts of approximately $2.6 million in cash proceeds from the exercise of 4,756,163 outstanding warrants, we do not currently believe that our existing cash resources are sufficient to meet our anticipated needs over the next twelve months from the date hereof and based on our current plans and available resources, we believe we can maintain our current operations through the end of July 2018. As a result, to continue to fund our ongoing operations, beyond July 2018, we would need to secure significant additional capital. If we were unable to secure additional capital on a timely basis or at all, we will be required to curtail our current business plans and substantially reduce our expenses and development costs such as reducing our headcount and limiting our sales and marketing efforts and may ultimately be required to cease operations altogether.  Moreover, our expenses may exceed our current plans and expectations, which would require us to secure additional capital or wind-down our operations sooner than anticipated. 

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In addition, from time to time we have entered into employment agreements with our executives that, under certain cases, provide for the continuation of salary and certain other benefits if these executives are terminated under specified circumstances. These agreements generally expire upon termination for cause or when we have met our obligations under these agreements. As of January 31, 2018, no events have occurred resulting in the obligation of any such payments.

Our future capital requirements depend on numerous forward-looking factors. These factors may include, but are not limited to, the following: the acceptance of, and demand for, our products; our success and the success of our partners in selling our products; our success and the success of our partners in obtaining regulatory approvals to sell our products; the costs of further developing our existing products and technologies; the extent to which we invest in new product and technology development; and the costs associated with the continued operation, and any future growth, of our business. The outcome of these and other forward-looking factors will substantially affect our liquidity and capital resources.

Until we can generate significant cash from operations, we expect to continue to fund our operations with the proceeds of offerings of our equity and debt securities. However, we cannot assure you that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or to our stockholders. If we raise additional funds from the issuance of equity securities, substantial dilution to our existing stockholders would likely result. If we raise additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to operate our business. Further, any contracts or license arrangements we enter into to raise funds may require us to relinquish our rights to our products or technology, and we cannot assure you that we will be able to enter into any such contracts or license arrangements on acceptable terms, or at all. Having insufficient funds may require us to delay or scale back our marketing, distribution and other commercialization activities or cease our operations altogether.

We do not have any unused credit facilities or other sources of capital available to us at this time. We intend to secure additional working capital through sales of additional debt or equity securities. Our intended financing initiatives are subject to risk, and we cannot provide any assurance about the availability or terms of these or any future financings.

If we are unable to obtain sufficient capital, it will have a material adverse effect on our business and operations. It could cause us to fail to execute our business plan, fail to take advantage of future opportunities, or fail to respond to competitive pressures or customer requirements. It also may require us to significantly modify our business model and operations to reduce spending to a sustainable level, which may include delaying, scaling back or eliminating some or all of our ongoing and planned investments in corporate infrastructure, research and development projects, regulatory submissions, business development initiatives, and sales and marketing activities, among other investments. If adequate funds are not available when needed, we may be required to reduce or cease operations altogether.

Critical Accounting Policies and Estimates

The discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, expenses, and related disclosures. We evaluate our estimates on an ongoing basis. We base our estimates on historical experience and on other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

In addition, the condensed consolidated financial statements included in this Quarterly Report have been prepared and presented on a basis assuming we will continue as a going concern. Until we can generate significant cash from operations, we expect to continue to fund our operations with the proceeds of offerings of our equity and debt securities. However, we cannot assure you that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or to our stockholders. If we raise additional funds from the issuance of equity securities, substantial dilution to our existing stockholders would likely result. If we raise additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to operate our business. Further, any contracts or license arrangements we enter into to raise funds may require us to relinquish our rights to our products or technology, and we cannot assure you that we will be able to enter into any such contracts or license arrangements on acceptable terms, or at all. Having insufficient funds may require us to delay or scale back our marketing, distribution and other commercialization activities or cease our operations altogether. Our condensed consolidated financial statements do not include any adjustment relating to recoverability or classification of recorded assets and classification of recorded liabilities.

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We believe the following accounting policies and estimates are critical to aid you in understanding and evaluating our reported financial results.

Revenue Recognition

We recognize revenue in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers (“Topic 606”). Under Topic 606, revenue is recognized at an amount that reflects the consideration to which we expect to be entitled in exchange for transferring goods or services to a customer. This principle is applied using the following 5-step process:

1.Identify the contract with the customer
2.Identify the performance obligations in the contract
3.Determine the transaction price
4.Allocate the transaction price to the performance obligations in the contract
5.Recognize revenue when (or as) each performance obligation is satisfied

Under Topic 606, we recognize revenue when we satisfy a performance obligation by transferring control of the promised goods or services to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services.

Our technology platform is based on patented stabilized ionic silver, and our initial products contain silver dihydrogen citrate, or SDC. SDC is a broad-spectrum, non-toxic antimicrobial agent, which offers 24-hour residual protection and formulates well with other compounds. We sell various configurations and dilutions of SDC direct to customers and through distributors. We currently offer PURE® Hard Surface as a food contact surface sanitizer and disinfectant to restaurant chains, food processors and food transportation companies. We also offer PURE Control® as a direct food contact processing aid.

Contract terms for unit price, quantity, shipping and payment are governed by sales agreements and purchase orders which we consider to be a customer’s contract in all cases. The unit price is considered the observable stand-alone selling price for the arrangements. Any promotional or sales discounts are applied evenly to the units sold for purposes of calculating standalone selling price.

Product sales generally consist of a single performance obligation that we satisfy at a point in time. We recognize product revenue when the following events have occurred: (a) we have transferred physical possession of the products, (b) we have a present right to payment, (c) the customer has legal title to the products, and (d) the customer bears significant risks and rewards of ownership of the products.

Our direct customer and distributor sales are invoiced based on received purchase orders. Our payment terms on invoiced direct customer and distributor sales range between 30 and 90 days after we satisfy our performance obligation. The majority of our customers are on 30 day payment terms. We currently offer no right of return on invoiced sales and maintain no allowance for sales returns.

Shipping and handling are treated as activities to fulfill promises to customers and any amounts billed to a customer, if applicable, represent revenues earned for the goods provided. Costs related to such shipping and handling billings are classified as cost of sales.

We do not have significant categories of revenue that may impact how the nature, amount, timing and uncertainty of revenue and cash flows are affected by economic factors.

We do not allow for returns, except for damaged products when the damage occurred pre-fulfillment. Damaged product returns have historically been insignificant. Because of this, the stand-alone nature of our products, and our assessment of performance obligations and transaction pricing for our sales contracts, we do not currently maintain a contract asset or liability balance for obligations. We assess our contracts and the reasonableness of our conclusions on a quarterly basis.

The Company’s licensing contracts typically provide for royalties based on the licensee’s sales of various configurations of PURE Hard Surface. The Company records its royalty revenue in the month in which the licensee sold our products to distributors and end users. Payments are generally received in the subsequent month.

Variable Consideration

We record revenue whenfrom customers in an amount that reflects the transaction price we sellexpect to be entitled to after transferring control of those goods or services. From time to time, we offer sales promotions on our products to our customers, rather than when our customers resell products to third parties. When we sell products to our customers, we reduce the balance of our inventory with a corresponding charge to cost of goods sold. We do not currently have any consignment sales.

Terms of our product sales are generally FOB shipping point. Product sales are recognized when delivery of the products has occurred (whichsuch as discounts. Variable consideration is generallyestimated at the time of shipment), title has passedcontract inception only to the customer, the selling priceextent that it is fixed or determinable, collectability is reasonably assured and we have no further obligations. Any amounts received prior to satisfying theseprobable that a significant reversal of revenue recognition criteria are recorded as deferred revenue. We record product sales net of discounts at the time of sale and report product sales net of such discounts.will not occur.

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We also license our products and technology to development and commercialization partners. License fee revenue consists of product and technology license fees earned. If multiple-element arrangements require on-going services or performance, then upfront product and technology license fees under such arrangements are deferred and recognized over the period of such services or performance. Non-refundable amounts received for substantive milestones are recognized upon achievement of the milestone. Any amounts received prior to satisfying these revenue recognition criteria are recorded as deferred revenue.

Share-Based Compensation

We grant equity-based awards under share-based compensation plans or stand-alone contracts. We estimate the fair value of share-based payment awards using the Black-Scholes option valuation model. This fair value is then amortized over the requisite service periods of the awards. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and expected life of the option. Share-based compensation expense is based on awards ultimately expected to vest, and therefore is reduced by expected forfeitures. Changes in assumptions used under the Black-Scholes option valuation model could materially affect our net loss and net loss per share.

Impairment of Long-Lived Assets

In accordance with GAAP, if indicators of impairment exist, we assess the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. If impairment is indicated, we measure the amount of such impairment by comparing the carrying value of the asset to the fair value of the asset and we record the impairment as a reduction in the carrying value of the related asset and a charge to operating results. Estimating the undiscounted future cash flows associated with long-lived assets requires judgment, and assumptions could differ materially from actual results.

For purposes of testing impairment, we group our long-lived assets at During the lowest level for which there are identifiable cash flows independent of other asset groups. Currently, there is only one level of aggregation for our intangible assets. We assess thethree and nine months ended April 30, 2022 and 2021, no impairment of long-lived assets consisting of property, plant, and equipment and our patent portfolio, whenever eventswas indicated or circumstances indicate that the carrying value may not be recoverable. Examples of such events or circumstances include:recorded.

an asset group’s ability to continue to generate income from operations and positive cash flow in future periods;

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loss of legal ownership or title to the asset(s);
significant changes in our strategic business objectives and utilization of the asset(s); and
the impact of significant negative industry or economic trends.

Additionally, on a quarterly basis we review the significant assumptions underlying our impairment assessment to determine whether our previous conclusions remain valid.

Recoverability of assets to be held and used in operations is measured by a comparison of the carrying amount of an asset to the future net cash flows expected to be generated by the assets. The factors used to evaluate the future net cash flows, while reasonable, require a high degree of judgment and the results could vary if the actual results are materially different than the forecasts. In addition, we base useful lives and amortization or depreciation expense on our subjective estimate of the period that the assets will generate revenue or otherwise be used by us. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. Assets to be disposed of are reported at the lower of the carrying amount or fair value less selling costs.

We also periodically review the lives assigned to our intangible assets to ensure that our initial estimates do not exceed any revised estimated periods from which we expect to realize cash flows from the assets. If a change were to occur in any of the above-mentioned factors or estimates, the likelihood of a material change in our reported results would increase.

Derivative Financial Instruments

We do not use derivative instruments to hedge exposures to cash flow or market or foreign currency risks.

We review the terms of the common stock, warrants and convertible debt we issue to determine whether there are derivative instruments, including embedded conversion options that are required to be bifurcated and accounted for separately as derivative financial instruments. In circumstances where the host instrument contains more than one embedded derivative instrument, including a conversion option, that is required to be bifurcated, the bifurcated derivative instruments are accounted for as a single, compound derivative instrument.

Derivatives are initially recorded at fair value and are then revalued at each reporting date with changes in the fair value reported as non-operating income or expense. When the equity or convertible debt instruments contain embedded derivative instruments that are to be bifurcated and accounted for as liabilities, the total proceeds received are first allocated to the fair value of all the bifurcated derivative instruments. The remaining proceeds, if any, are then allocated to the host instruments themselves, usually resulting in those instruments being recorded at a discount from their face value.

Recent Accounting Pronouncements

See Note 114 to the condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q.

Off Balance Sheet Arrangements

We do not have any off balance sheet arrangements.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

As a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, or the Exchange Act, and as provided in Item 10(f)(1) of Regulation S-K, we are electing scaled disclosure reporting obligations and therefore are not required to provide the information requested by this Item.

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Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified by the rules and forms of the Securities and Exchange Commission, or SEC, and that such information is accumulated and communicated to our management, including our Principal Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives.

As required by Rule 13a-15(b) under the Exchange Act, our management conducted an evaluation, under the supervision and with the participation of our Principal Executive Officer and our Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report. Based on the foregoing evaluation, our Principal Executive Officer and Principal Financial Officer concluded that as of the end of the period covered by this report our disclosure controls and procedures were effective.

Changes in Internal Control Over Financial Reporting

In connection with the evaluation required by Exchange Act Rule 13a-15(d), our management, under the supervision and with the participation of our Principal Executive Officer and our Principal Financial Officer, concluded that there were no changes in our internal controls over financial reporting during the threenine months ended January 31, 2018April 30, 2022 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.

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PART II – Other Information

Item 1. Legal Proceedings

From time to time, we may become involved in various lawsuits and legal proceedings that arise in the ordinary course of our business. The impact and outcome of litigation, if any, is subject to inherent uncertainties, and any adverse result in these or other matters may arise from time to time that could harm our business. We are not currently aware of any such legal proceedings or claims to which we or our wholly owned subsidiary is a party or of which any of our property is subject that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations.

Item 1A. Risk Factors

In evaluating us and our common stock, we urge you to carefully consider the risks and other information in this Quarterly Report on Form 10-Q, including the risk factor included below, as well as the risk factors disclosed in Item 1A. to Part I of our Annual Report on Form 10-K for the fiscal year ended July 31, 2017,2021, which we filed with the SEC on October 26, 201728, 2021 (the “Form 10-K”). Other than the risk factor included below, the risks and uncertainties described in “Item 1A — Risk Factors” of our Form 10-K have not materially changed. Any of the risks discussed in this Quarterly Report on Form 10-Q, including the risk factor included below, or any of the risks disclosed in “Item 1A — Risk Factors” of our Form 10-K, as well as additional risks and uncertainties not currently known to us or that we currently deem immaterial, could materially and adversely affect our results of operations, financial condition or prospects.

Risks Related to Our Business and Industry

As a result of our historical lack of financial liquidity, we do not currently have sufficient working capital to fund our planned operations and may not be able to continue as a going concern beyond July 2018.concern.

We have a history of recurring losses, and as of January 31, 2018,April 30, 2022 we have incurred a cumulative net loss of $113,848,000. As of January 31, 2018, we had $2,129,000 in cash and cash equivalents and $449,000 in accounts payable.$128,051,000. During the sixnine months ended January 31, 2018, ourApril 30, 2022, we recorded a net loss of $2,258,000 on recorded net revenue of $1,441,000. In addition, during the nine months ended April 30, 2022 we used $1,879,000 in operating and investing activities resulting in a cash outflows for operating activities and for investments in patents and fixed assets were $2.14 million.balance of $511,000 as of April 30, 2022. As a result, our existing cash resources are not sufficient to meet our anticipated needs over the next twelve months from the date hereof, and we will need to raise additional capital to continue our operations and to implement our business plan, which capital may not be available on acceptable terms or at all. Based on our current plans and available resources, we believe we can maintain our current operations through the end of July 2018.  As a result, to continue to fund our ongoing operations, beyond July 2018, we would need to secure significant additional capital. If we were unable to secure additional capital on a timely basis or at all, we will be required to curtail our current business plans and substantially reduce our expenses and development costs such as reducing our headcount and limiting our sales and marketing efforts and may ultimately be required to cease operations altogether.  Moreover, our expenses may exceed our current plans and expectations, which would require us to secure additional capital or wind-down our operations sooner than anticipated.

Our capital requirements will depend on many factors, including, among others:

the market acceptance of, and demand for, our products;
the timing and costs of executing our sales and marketing strategies;
our ability to successfully complete the in-plant validation trials requested by potential customers and our ability to convert these trials into customer orders for our products;
the costs and time required to obtain the necessary regulatory approvals for our products, including the required USDA approval for use of PURE Control in OLR processing of raw poultry;approvals:
the extent to which we invest in new testing and product development, including in-plant optimization trials;
the extent to which our customers continue to place product orders as expected and expand their existing use of our products;

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the cost and time to satisfy unique customer requirements regarding validation trials or to support the value proposition and benefits of our products;
the timing of vendor payments and the collection of receivables, among other factors affecting our working capital;
our ability to control the timing and amount of our operating expenses, including the costs to attract and retain personnel with the skills required to implement our business plan; and
the costs to file, prosecute and defend our intellectual property rights.

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The above factors, along with our history and near term forecast of incurring net losses and negative operating cash flows, raise substantial doubt about our ability to continue as a going concern beyond July 2018.concern. If we do not obtain additional capital from external sources, we will not have sufficient working capital to fund our planned operations or be able to continue as a going concern. We cannot assure you that additional financing will be available when needed or that, if available, we can obtain financing on terms favorable to us or to our stockholders. If we raise additional funds from the issuance of equity securities, substantial dilution to our existing stockholders would likely result. If we raise additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to operate our business. Further, any contracts or license arrangements we enter into to raise funds may require us to relinquish our rights to our products or technology, and we cannot assure you that we will be able to enter into any such contracts or license arrangements on acceptable terms, or at all. Having insufficient funds may require us to delay or scale back our marketing, distribution and other commercialization activities or cease our operations altogether.

The currently evolving situation related to the COVID-19 pandemic could adversely affect our business, financial condition and results of operations.

The COVID-19 pandemic has led to severe disruptions in general economic activities, as businesses and federal, state, and local governments take increasingly broad actions to mitigate this public health crisis. While we have experienced some delays related to final third-party validation of certain of our products and product rollouts by customers using PURE Control, we have not experienced a material disruption to our business. In addition, we previously benefited from increased demand from our customers for our PURE Hard Surface product due to a focus on surface disinfecting in response to attempting to prevent COVID-19 transmission. We subsequently experienced an abatement in such demand and cannot assure you that demand will stabilize. Additionally, we are beginning to experience supply chain issues with our various plastic packaging configurations and citric acid. Further, on a go-forward basis, we cannot guarantee the overall economic conditions will not affect our business, as these conditions may significantly negatively impact all aspects of our business. Our business is dependent on the continued health and productivity of our employees, including our sales staff and corporate management team.

Additionally, our liquidity could be negatively impacted if these conditions continue for a significant period of time and we may be required to pursue additional sources of financing to obtain working capital, maintain appropriate inventory levels, and meet our financial obligations. Currently, capital and credit markets have been disrupted by the crisis and our ability to obtain any required financing is not guaranteed and largely dependent upon evolving market conditions and other factors. Depending on the continued impact of the crisis, further actions may be required to improve our cash position and capital structure.

The extent to which the COVID-19 pandemic ultimately impacts our business, sales, results of operations and financial condition will depend on future developments, which are highly uncertain and cannot be predicted, including, but not limited to, the duration of the outbreak, its severity, the actions to contain the virus or treat its impact, and how quickly and to what extent normal economic and operating conditions resume and, more specifically, the effect it has on our customers and suppliers. Even after the COVID-19 pandemic has subsided, we may experience significant impacts to our business as a result of its global economic impact, including any economic downturn or recession that has occurred or may occur in the future.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not Applicable.

Item 5. Other Information

None.

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Item 6. Exhibits

The following Exhibits are filed as part of this report pursuant to Item 601 of Regulation S-K:

3.1Certificate of Incorporation of PURE Bioscience, Inc. (incorporated by reference to Exhibit 3.1 of the Annual Report on Form 10-K filed with the SEC on October 29, 2012)
3.1.1Certificate of Amendment to Certificate of Incorporation of PURE Bioscience, Inc. (incorporated by reference to Exhibit 3.1.1 of the Annual Report on Form 10-K filed with the SEC on October 29, 2012)
3.23.1.2Certificate of Amendment to Certificate of Incorporation of PURE Bioscience, Inc. (incorporated by reference to Exhibit 3.1 of the Current Report on Form 8-K filed with the SEC on May 19, 2021).
3.2Bylaws of PURE Bioscience, Inc. (incorporated by reference to Exhibit 3.2 to the Annual Report on Form 10-K, filed with the SEC on October 29, 2012)
3.2.1Amendment to the Bylaws of PURE Bioscience, Inc. (incorporated by reference to Exhibit 3.2.1 to the Annual Report on Form 10-K, filed with the SEC on October 29, 2012)
4.1Form of Investor Warrant (incorporated by reference to Exhibit 4.5 to the Current Report on Form 8-K, filed with the SEC on September 2, 2009)
4.2Wharton Capital Markets LLC Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, filed with the SEC on March 16, 2012)
4.3Form of Underwriter’s Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, filed with the SEC on September 13, 2012)
4.4Morrison & Foerster LLP Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, filed with the SEC on January 31, 2013)
4.5Form of Investor Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, filed with the SEC April 23, 2013)
4.6Form of Investor Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, filed with the SEC August 27, 2014)
4.7Form of Investor Warrant in 2016 Private Placement Financing (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K, filed with the SEC December 7, 2016)
4.8Form of Placement Agent Warrant in 2016 Private Placement Financing (incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K, filed with the SEC December 7, 2016)

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31.1 *Certification of Chief Executive Officer, pursuant to Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2 *Certification of Principal Financial Officer, pursuant to Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1 *Certification of Chief Executive Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2 *Certification of Principal Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101 *The following materials from the Company’s Quarterly Report on Form 10-Q for the quarterly period ended January 31, 2018,April 30, 2022, formatted in XBRL (eXtensibleiXBRL (Inline eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets at January 31, 2018April 30, 2022 and July 31, 2017;2021; (ii) Condensed Consolidated Statements of Operations for the three and sixnine months ended January 31, 2018April 30, 2022 and 2017;2021; (iii) Condensed Consolidated Statements of Stockholders’ equity for the three and nine months ended April 30, 2022 and 2021 ;(iv) Condensed Consolidated Statements of Cash Flows for the sixnine months ended January 31, 2018April 30, 2022 and 2017;2021; and (iv)(v) Notes to Condensed Consolidated Financial Statements.
104*Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

*Filed herewith.

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Signatures

Pursuant to the requirement of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

PURE BIOSCIENCE, INC.
Date: MarchJune 14, 20182022By:/s/ HENRY R. LAMBERTTOM Y. LEE

Henry R. Lambert,Tom Y. Lee, Chief Executive Officer

(Principal Executive Officer)

Date: MarchJune 14, 20182022By:/s/ MARK S. ELLIOTT
Mark S. Elliott, Vice President, Finance
(Principal Financial and Accounting Officer)

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