UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 11, 2014
PURE BIOSCIENCE, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-14468 |
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33-0530289 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(IRS Employer
Identification No.) |
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1725 Gillespie Way
El Cajon, California |
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92020 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants telephone number, including area code: (619) 596-8600
Not applicable
(Former
name or former address, if changed since last report)
Check the appropriate box below
if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. |
Results of Operations and Financial Condition. |
On December 11, 2014, PURE Bioscience, Inc. (the
Company) issued a press release announcing financial results for the first fiscal quarter ended October 31, 2014 and related information. A copy of the press release is attached as Exhibit 99.1.
The information in this Item 2.02 is being furnished and shall not be deemed filed for the purposes of Section 18 of the Securities
Exchange Act of 1934 or otherwise subject to the liabilities of that Section. The information in this Item 2.02 shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange
Commission.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits
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99.1 |
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Press Release, dated December 11, 2014. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
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PURE BIOSCIENCE, INC. |
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Dated: December 11, 2014 |
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By: |
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/s/ Henry R. Lambert |
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Henry R. Lambert |
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Chief Executive Officer |
EXHIBIT INDEX
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Exhibit Number |
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Description |
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99.1 |
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Press Release, dated December 11, 2014. |
Exhibit 99.1
PURE Bioscience Reports Fiscal First Quarter 2015 Financial Results
August Financing Provides Foundation for National Sales Rollout Program of
PURE® Hard Surface Disinfectant to SUBWAY® Restaurants and Expanding Sales Network for Food Processors/Manufacturers
SAN DIEGO, CA (December 11, 2014) PURE Bioscience, Inc. (OTCQB: PURE), creator of the patented silver dihydrogen citrate
(SDC) antimicrobial, today reported financial results for the fiscal first quarter ended October 31, 2014 (Fiscal Q1 2015).
Overview
Fiscal Q1 2015 to Present
The PURE management team continues to build upon the significant progress made over the last sixteen months to
advance its focused business strategy to commercialize its SDC-based technology as a food safety solution:
Quick Service Restaurant (QSR)
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October 2014 SUBWAY® Restaurants* authorized PURE® Hard Surface disinfectant to be sold for
use in all of its 27,000 U.S. stores. |
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Executing to plan for phased national sales rollout. |
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November 2014 Initiated product production to support phased sales rollout in select markets. |
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Initial, modest sales orders began in November. |
Food Processors/Manufacturers
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This week announced White Paper results of Listeria remediation of a food processing facility with use of PURE® Hard Surface disinfectant to decontaminate
shuttered plant. |
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Plant and equipment cleared by FDA for future use in food manufacturing. |
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Rollout plans in development with food processors/manufacturers for in-plant adoption. |
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Broadening market reach through selective sales collaboration with food plant sanitation service companies. |
Direct Food Contact Processing Aid
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November 2014 Withdrew, without prejudice, our Food Contact Notification (FCN) to the FDA for raw poultry processing (test results indicated the ability to reduce Salmonella below detectable levels).
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Communications on-going with FDA to assess additional data needed for FCN re-submission. |
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October 2014 Submitted Food Contact Notification (FCN) to the FDA for produce processing, which also will be subject to our on-going discussions with the FDA to assess the additional data that may be required to
support this FCN. |
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Test results indicated over a 100-fold improvement over current industry practices in reducing pathogens such as Listeria, E.coli and Salmonella. |
* |
SUBWAY® is a registered trademark of Doctors Associates, Inc. |
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September 2014 Commenced initial testing for use as a processing aid for beef and pork. |
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Subject to updated guidance from the FDA, we expect to submit a Food Contact Notification (FCN) to the FDA for beef and pork processing in 2015. |
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Obtaining necessary FDA and USDA approvals would create access to an estimated addressable $1+ billion U.S. market for this new application for poultry, produce and meats. |
Fundraising Success
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In August 2014 Closed a total of $7.9 million in an equity placement (includes $4 million from strategic investor Franchise Brands, LLC, created by the founders of SUBWAY® Restaurants). This financing provided adequate capital: |
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To fund operations for at least the next twelve months enabling the Company to focus on commercialization and revenue generation. |
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Help position PURE to pursue its stated objective of up-listing to a national exchange. |
Summary of Results
of Operations
Revenues for the first fiscal quarter of 2015 were $117,000, comparable with revenues of $115,000 for the first fiscal quarter of 2014.
Total operating costs and expenses, excluding share-based compensation, other share-based expenses, and restructuring costs, for the first fiscal quarter of 2015 and 2014, were $1.4 million and $1.2 million, respectively. The fiscal first quarter
2015 net loss was ($1.9 million) compared with ($3.8 million) for fiscal first quarter 2014. Our pro forma net loss, adjusted for significant items, for fiscal first quarter 2014 and fiscal first quarter 2013 was ($1.3 million) and ($1.1
million), respectively.
Cash and cash equivalents, reported as of October 31, 2014, was $5.3 million. Total adjusted liabilities, excluding
restructuring liabilities, were $686,000, a net reduction of $833,000, or 55%, compared with Fiscal Year 2014 adjusted total liabilities of $1,519,000.
As the Company continues to build on the early successes of its new business strategy, it intends to:
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Accelerate and expand sales and distribution for its products into the food industry with a focus on a dual track of food safety market opportunities: |
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Hard Surface and Food Contact Surface disinfectant commercialize the current EPA registered PURE® Hard Surface disinfectant and sanitizer for use in food
service operations and food manufacturing. |
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Direct Food Contact commercialize, subject to receiving both FDA and USDA approval, the use of SDC as a food processing and intervention aid for food processors for treating poultry, produce, beef and pork.
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Establish strategic alliances to maximize the commercial potential of our technology platform. |
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Develop additional proprietary products and applications; and |
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Protect and enhance our intellectual property estate. |
Calendar 2015 Goals
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Secure customer adoption in food safety with 2+ national restaurant chains and 10+ national food processors; |
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Leverage outsourcing of operations and supply chain; |
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Provide incremental cost savings and increase production scale. |
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Subject to updated new guidelines from the FDA, submit and secure FDA and USDA authorization for use of SDC as a direct food contact/processing aid for poultry, produce, beef and pork; |
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License PURE distribution and SDC applications to non-core markets; and |
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Seek up-listing to a national stock exchange. |
Hank R. Lambert, Chief Executive Officer, said that,
We were gratified that after extensive validation of our SDC technology, SUBWAY® authorized PURE Hard Surface for use in all of their U.S. stores. The phased national sales rollout is
underway with encouraging initial results.
We have also begun capitalizing on this important validation of our product in our ongoing sales efforts
to introduce additional restaurant chains to the superior efficacy of SDC. We continue to see a growing interest in testing our products from multiple branded chains.
We are experiencing success in positioning SDC as a preventive sanitation solution with a growing number of food processors. We intend to leverage the
white paper we released yesterday detailing the successful use of PURE Hard Surface in remediating Listeria contamination in a closed processing plant, to accelerate this initiative.
Lambert continued, We have had no further update from the FDA since it advised us last month to withdraw our FCN for poultry without prejudice while the
agency continues to evaluate new, non-SDC silver-related data. While we do not yet have an estimate of when we will be in a position to re-submit our FCN, in the meantime, we are being proactive and have initiated testing using additional processes
and protocols that we are optimistic will further reduce residual silver levels.
2014 Fiscal First Quarter Financial Results Conference Call
The Company will host an investor conference call on Thursday, December 11, 2014 at 1:30pm PST (4:30pm EST).
The Participant Dial-In Number for the conference call is 1-631-982-4565. Participants should dial in to the call at least five minutes before 1:30pm PST
(4:30pm EST) on December 11, 2014. The call can also be accessed live online at http://public.viavid.com/index.php?id=112054.
A
replay of the webcast will be available on the Companys website (http://www.purebio.com/about/investor_relations). Also, a replay of the conference call will be available by dialing 1-877-870-5176 (international participants dial
1-858-384-5517) starting December 11, 2014, at 7:30pm EST through December 25, 2014 at 11:59 pm EST. Please use PIN Number 90612.
About PURE Bioscience, Inc.
PURE Bioscience, Inc. is focused on developing and commercializing our proprietary antimicrobial products primarily in the food safety arena providing
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, SDC is distinguished from existing products in the marketplace because of its superior efficacy, reduced
toxicity and the inability of bacteria to form a resistance to it. PURE is headquartered in El Cajon, California (San Diego metropolitan area). Additional information on PURE is available at www.purebio.com.
Forward-looking Statements
Any statements contained
in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements inherently involve risks and
uncertainties that could cause our actual results to differ materially from the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the Companys cash position and liquidity
requirements; the Companys failure to implement or otherwise achieve the benefits of its proposed business initiatives and plans; acceptance of the Companys current and future products and services in the marketplace, including
acceptance of the Companys PURE Hard Surface disinfectant by SUBWAY® franchisees; the ability of the Company to develop effective new products and receive regulatory approvals of such
products, including the required regulatory approvals to use its SDC-based technology as a direct food contact processing aid; competitive factors; dependence upon third-party vendors, including to manufacture its products; and other risks detailed
in the Companys periodic report filings with the Securities and Exchange Commission, including our quarterly report on Form 10-Q filed on December 11, 2014. You should not place undue reliance on these forward-looking statements, which
speak only as of the date of this press release. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release.
Contacts:
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Peter C. Wulff, CFO & COO PURE
Bioscience, Inc. 619-596-8600 ext.111
pwulff@purebio.com |
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Terri MacInnis, VP of IR Bibicoff + MacInnis,
Inc. 818-379-8500 terri@bibimac.com |
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Tom Hemingway Redwood Investment Group
714-978-4425 tomh@redwoodfin.com |
-Continued-
Pure Bioscience, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
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Three months ended October 31, |
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2014 |
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2013 |
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Net product sales |
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$ |
117,000 |
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$ |
115,000 |
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Operating costs and expenses |
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Cost of goods sold |
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45,000 |
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36,000 |
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Selling, general and administrative |
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1,192,000 |
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925,000 |
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Research and development |
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176,000 |
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213,000 |
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Share-based compensation |
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503,000 |
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89,000 |
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Other share-based expenses |
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131,000 |
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Restructuring costs |
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2,684,000 |
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Total operating costs and expenses |
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2,047,000 |
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3,947,000 |
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Loss from operations |
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(1,930,000 |
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(3,832,000 |
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Other income (expense) |
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Change in derivative liability |
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(1,000 |
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(58,000 |
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Interest expense, net |
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(2,000 |
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(3,000 |
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Other income (expense), net |
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(1,000 |
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49,000 |
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Total other income (expense) |
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(4,000 |
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(12,000 |
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Net loss |
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$ |
(1,934,000 |
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$ |
(3,844,000 |
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Basic and diluted net loss per share |
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$ |
(0.05 |
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$ |
(0.19 |
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Shares used in computing basic and diluted net loss per share |
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37,029,203 |
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20,701,547 |
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Pure Bioscience, Inc.
Condensed Consolidated Balance Sheets
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October 31, 2014 |
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July 31, 2014 |
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(Unaudited) |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
5,331,000 |
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$ |
86,000 |
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Accounts receivable, net |
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47,000 |
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47,000 |
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Inventories, net |
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231,000 |
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249,000 |
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Prepaid expenses |
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154,000 |
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96,000 |
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Total current assets |
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5,763,000 |
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478,000 |
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Property, plant and equipment, net |
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28,000 |
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36,000 |
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Patents, net |
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1,305,000 |
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1,345,000 |
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Total assets |
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$ |
7,096,000 |
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$ |
1,859,000 |
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Liabilities and stockholders equity |
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Current liabilities |
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Accounts payable |
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$ |
510,000 |
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$ |
1,096,000 |
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Restructuring liability |
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201,000 |
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323,000 |
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Accrued liabilities |
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154,000 |
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401,000 |
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Derivative liability |
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10,000 |
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9,000 |
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Total current liabilities |
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875,000 |
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1,829,000 |
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Deferred rent |
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12,000 |
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13,000 |
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Total liabilities |
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887,000 |
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1,842,000 |
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Commitments and contingencies (See Note 6) |
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Stockholders equity |
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Preferred stock, $0.01 par value: 5,000,000 shares authorized, no shares issued |
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Common stock, $0.01 par value: 100,000,000 shares authorized, 39,788,465 shares issued and outstanding at October 31, 2014,
and 29,394,940 shares issued and outstanding at July 31, 2014 |
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398,000 |
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295,000 |
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Additional paid-in capital |
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88,966,000 |
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80,943,000 |
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Accumulated deficit |
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(83,155,000 |
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(81,221,000 |
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Total stockholders equity |
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6,209,000 |
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17,000 |
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Total liabilities and stockholders equity |
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$ |
7,096,000 |
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$ |
1,859,000 |
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Pure Bioscience, Inc.
Reconciliation of Non-GAAP Financial Measures
(Unaudited)
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Three months ended October 31, |
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2014 |
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2013 |
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Net loss, as reported |
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$ |
(1,934,000 |
) |
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$ |
(3,844,000 |
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Add back significant items: |
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Share-based compensation |
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503,000 |
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89,000 |
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Other share-based expenses |
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131,000 |
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Restructuring costs |
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2,684,000 |
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Net loss, as adjusted for significant items |
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$ |
(1,300,000 |
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$ |
(1,071,000 |
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