Nevada
|
41-2118656
|
(State or Other Jurisdiction of
|
(I.R.S. Employer Identification No.)
|
Incorporation or Organization)
|
4452 Beltway Drive
Addison, Texas
|
75001
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
Large accelerated filer
|
o
|
Accelerated filer
|
o
|
|||
Non-accelerated filer
|
o
|
Smaller reporting company
|
þ
|
|||
Emerging growth company
|
o
|
Page
|
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3
|
||
I
TEM
1.
|
Financial Statements.
|
June 30, 2017
|
December 31, 2016
|
|||||||
(Unaudited)
|
(Audited)
|
|||||||
ASSETS
|
||||||||
Current Assets
|
||||||||
Cash and cash equivalents
|
$ | 5,454,561 | $ | 36,615 | ||||
Accounts receivable, net
|
2,611 | 61,788 | ||||||
Inventory
|
549,824 | 559,600 | ||||||
Prepaid expenses and deferred charges
|
37,436 | 135,394 | ||||||
Total Current Assets
|
6,044,432 | 793,397 | ||||||
Property, Equipment and Leasehold Improvements, net
|
64,684 | 126,741 | ||||||
Other Assets
|
||||||||
Intangible asset - patents, net
|
198,411 | 216,781 | ||||||
Intangible asset - licensing rights, net
|
3,866,498 | 3,181,087 | ||||||
Deposits
|
18,069 | 18,069 | ||||||
Total Other Assets
|
4,082,978 | 3,415,937 | ||||||
TOTAL ASSETS
|
$ | 10,192,094 | $ | 4,336,075 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current Liabilities
|
||||||||
Accounts payable
|
$ | 2,174,138 | $ | 2,026,671 | ||||
Accrued liabilities
|
161,628 | 315,300 | ||||||
Accrued interest
|
36,644 | 53 | ||||||
Promissory note payable, current portion
|
--- | 20,000 | ||||||
Deferred revenue, current portion
|
34,294 | 45,764 | ||||||
Total Current Liabilities
|
2,406,704 | 2,407,788 | ||||||
Long Term Liabilities
|
||||||||
Convertible notes payable, net of unamortized debt discount and debt issuance costs
|
390,714 | --- | ||||||
Deferred revenue, net of current portion
|
355,604 | 358,462 | ||||||
Total Long Term Liabilities
|
746,318 | 358,462 | ||||||
TOTAL LIABILITIES
|
3,153,022 | 2,766,250 | ||||||
COMMITMENTS AND CONTINGENCIES
|
--- | --- | ||||||
STOCKHOLDERS' EQUITY
|
||||||||
Preferred Stock - $0.001 par value; 20,000 shares authorized;
|
||||||||
Preferred Stock Series A, 1,000 shares designated; no shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively
|
--- | --- | ||||||
Preferred Stock Series B, 1,250 shares designated; 1,250 and nil shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively
|
1 | --- | ||||||
Common Stock - $0.001 par value; 200,000,000 shares authorized;
|
||||||||
76,349,431 and 62,974,431 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively
|
76,349 | 62,974 | ||||||
Additional paid-in capital
|
68,682,507 | 62,220,850 | ||||||
Accumulated (deficit)
|
(61,719,785 | ) | (60,713,999 | ) | ||||
TOTAL STOCKHOLDERS’ EQUITY
|
7,039,072 | 1,569,825 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 10,192,094 | $ | 4,336,075 | ||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
|
Three Months Ended June 30,
|
Six months Ended June 30,
|
|||||||||||||||
2017
|
2016
|
2017
|
2016
|
|||||||||||||
Revenues
|
||||||||||||||||
License fees
|
$ | 1,436 | $ | 259,813 | $ | 2,858 | $ | 361,089 | ||||||||
Product sales, net
|
2,878 | 4,520 | 218,573 | 12,036 | ||||||||||||
Total Revenues
|
4,314 | 264,333 | 221,431 | 373,125 | ||||||||||||
Costs and Expenses
|
||||||||||||||||
Cost of product sold
|
345 | 528 | 82,279 | 1,451 | ||||||||||||
Research and development
|
48,192 | 135,331 | 108,321 | 271,490 | ||||||||||||
Selling, general and administrative
|
329,923 | 384,900 | 724,530 | 703,701 | ||||||||||||
Amortization of intangible assets
|
113,027 | 199,526 | 202,334 | 398,162 | ||||||||||||
Depreciation
|
32,842 | 33,165 | 65,558 | 66,330 | ||||||||||||
Total Costs and Expenses
|
524,329 | 753,450 | 1,183,022 | 1,441,134 | ||||||||||||
Operating (Loss)
|
(520,015 | ) | (489,117 | ) | (961,591 | ) | (1,068,009 | ) | ||||||||
Other Income (Expense)
|
||||||||||||||||
Interest and miscellaneous income
|
2 | 515 | 4 | 537 | ||||||||||||
Interest expense
|
(133,864 | ) | (44,445 | ) | (155,141 | ) | (91,203 | ) | ||||||||
Foreign currency transaction gain (loss)
|
(3,181 | ) | (3,196 | ) | (3,071 | ) | 1,090 | |||||||||
Gain on settlement of liability
|
114,013 | --- | 114,013 | --- | ||||||||||||
Accommodation fee due on promissory note
|
--- | --- | --- | (25,000 | ) | |||||||||||
(Loss) Before Income Taxes
|
(543,045 | ) | (536,243 | ) | (1,005,786 | ) | (1,182,585 | ) | ||||||||
Income taxes
|
--- | --- | --- | --- | ||||||||||||
Net (Loss)
|
$ | (543,045 | ) | $ | (536,243 | ) | $ | (1,005,786 | ) | $ | (1,182,585 | ) | ||||
Basic and diluted net (loss) per common share
|
$ | (0.01 | ) | $ | (0.01 | ) | $ | (0.01 | ) | $ | (0.02 | ) | ||||
Weighted average number of common shares outstanding
|
76,349,431 | 62,974,431 | 69,772,774 | 50,316,681 | ||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
|
Six Months Ended June 30,
|
||||||||
2017
|
2016
|
|||||||
OPERATING ACTIVITIES :
|
||||||||
Net loss
|
$ | (1,005,786 | ) | $ | (1,182,585 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Amortization of intangible assets
|
202,334 | 398,162 | ||||||
Depreciation
|
65,558 | 66,330 | ||||||
Share-based compensation for stock and options issued to employees
|
8,697 | 15,913 | ||||||
Share-based compensation for options issued to non-employees
|
--- | 30,102 | ||||||
Amortization of debt discount on promissory note
|
87,006 | 26,012 | ||||||
Amortization of debt issuance costs
|
1,916 | 18,658 | ||||||
Change in operating assets and liabilities:
|
||||||||
Accounts receivable
|
59,177 | 39,080 | ||||||
Inventory
|
9,776 | (50,618 | ) | |||||
Prepaid expenses and deferred charges
|
97,958 | 72,080 | ||||||
Deposits
|
--- | (2,895 | ) | |||||
Accounts payable
|
147,467 | 31,190 | ||||||
Accrued liabilities
|
(153,672 | ) | (115,457 | ) | ||||
Accrued interest
|
36,591 | 2,864 | ||||||
Deferred revenue
|
(14,328 | ) | (321,089 | ) | ||||
Total
|
548,480 | 210,332 | ||||||
Net Cash Used in Operating Activities
|
(457,306 | ) | (972,253 | ) | ||||
INVESTING ACTIVITIES :
|
||||||||
Purchase of equipment
|
(3,501 | ) | --- | |||||
Net Cash Used in Investing Activities
|
(3,501 | ) | --- | |||||
FINANCING ACTIVITIES :
|
||||||||
Proceeds from issuance of convertible notes and warrant, net
|
983,092 | --- | ||||||
Proceeds from sale of preferred stock, net
|
4,915,661 | --- | ||||||
Proceeds from sale of common stock and warrants, net
|
--- | 1,732,338 | ||||||
Offering costs associated with acquisition of licensing rights in 2015
|
--- | (21,950 | ) | |||||
Additional principle due on promissory note due to accommodation fee
|
--- | 25,000 | ||||||
Proceeds from issuance of promissory notes
|
120,000 | --- | ||||||
Repayment of principle due on promissory notes
|
(140,000 | ) | (225,000 | ) | ||||
Net Cash Provided by Financing Activities
|
5,878,753 | 1,510,388 | ||||||
Net Increase in Cash
|
5,417,946 | 538,135 | ||||||
Cash, beginning of period
|
36,615 | 180,000 | ||||||
Cash, end of period
|
$ | 5,454,561 | $ | 718,135 | ||||
SUPPLEMENTAL CASH FLOW DISCLOSURE:
|
||||||||
Cash paid for interest
|
$ | 2,672 | $ | 14,239 | ||||
Non-cash investing and financing activities:
|
||||||||
Issuance of common stock for acquisition of licensing rights
|
$ | 869,375 | --- | |||||
Issuance of common stock for principle due on promissory note
|
--- | $ | 45,000 | |||||
Issuance of common stock for interest due on promissory note
|
--- | $ | 2,239 | |||||
Issuance of common stock for services
|
--- | $ | 36,000 | |||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
|
NOTE 1.
|
COMPANY OVERVIEW AND BASIS OF PRESENTATION
|
NOTE 2.
|
SIGNIFICANT ACCOUNTING POLICIES
|
NOTE 3.
|
THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS
|
NOTE 4.
|
SEGMENT INFORMATION
|
Three Months Ended June 30,
|
Six months Ended June 30,
|
|||||||||||||||||||||||||||||||
Revenues
|
2017
|
%
|
2016
|
%
|
2017
|
%
|
2016
|
%
|
||||||||||||||||||||||||
Domestic
|
$ | 2,878 | 67 | % | $ | 4,520 | 2 | % | $ | 5,415 | 2 | % | $ | 12,036 | 3 | % | ||||||||||||||||
International
|
1,436 | 33 | % | 259,813 | 98 | % | 216,016 | 98 | % | 361,089 | 97 | % | ||||||||||||||||||||
Total
|
$ | 4,314 | 100 | % | $ | 264,333 | 100 | % | $ | 221,431 | 100 | % | $ | 373,125 | 100 | % |
NOTE 5.
|
INVENTORY
|
Inventory
|
June 30, 2017
|
December 31, 2016
|
||||||
Raw materials
|
$ | 32,532 | $ | 35,800 | ||||
Work-in-progress
|
414,106 | 424,741 | ||||||
Finished goods
|
103,186 | 99,059 | ||||||
Total
|
$ | 549,824 | $ | 559,600 |
NOTE 6.
|
PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS
|
Property, equipment and leasehold improvements
|
June 30, 2017
|
December 31, 2016
|
||||||
Laboratory equipment
|
$ | 424,888 | $ | 424,888 | ||||
Manufacturing equipment
|
1,604,894 | 1,604,894 | ||||||
Computers, office equipment, and furniture
|
154,781 | 151,280 | ||||||
Computer software
|
4,108 | 4,108 | ||||||
Leasehold improvements
|
95,841 | 95,841 | ||||||
2,284,512 | 2,281,011 | |||||||
Less: accumulated depreciation and amortization
|
(2,219,828 | ) | (2,154,270 | ) | ||||
Property, equipment and leasehold improvements, net
|
$ | 64,684 | $ | 126,741 |
NOTE 7.
|
INTANGIBLE ASSETS
|
Intangible assets – patents
|
June 30, 2017
|
December 31, 2016
|
||||||
Patent - Amlexanox (Aphthasol®)
|
$ | 2,090,000 | $ | 2,090,000 | ||||
Patent - Amlexanox (OraDisc™ A)
|
6,873,080 | 6,873,080 | ||||||
Patent - OraDisc™
|
73,000 | 73,000 | ||||||
Patent - Hydrogel nanoparticle aggregate
|
589,858 | 589,858 | ||||||
9,625,938 | 9,625,938 | |||||||
Less: accumulated amortization
|
(7,400,217 | ) | (7,381,847 | ) | ||||
Less: reserve for impairment
|
(2,027,310 | ) | (2,027,310 | ) | ||||
Intangible assets - patents, net
|
$ | 198,411 | $ | 216,781 |
Calendar Years
|
Future Amortization
Expense
|
|||
2017 (Six months)
|
$ | 18,674 | ||
2018
|
37,044 | |||
2019
|
37,044 | |||
2020
|
37,145 | |||
2021
|
37,044 | |||
2022 & Beyond
|
31,460 | |||
Total
|
$ | 198,411 |
Intangible assets - licensing rights
|
June 30, 2017
|
December 31, 2016
|
||||||
Intangible assets – licensing rights, gross
|
$ | 4,381,881 | $ | 3,512,506 | ||||
Less: accumulated amortization
|
(515,383 | ) | (331,419 | ) | ||||
Intangible assets - licensing rights, net
|
$ | 3,866,498 | $ | 3,181,087 |
Calendar Years
|
Future Amortization
Expense
|
|||
2017 (Six months)
|
$ | 209,862 | ||
2018
|
416,303 | |||
2019
|
416,303 | |||
2020
|
416,303 | |||
2021
|
416,303 | |||
2022 & Beyond
|
1,991,424 | |||
Total
|
$ | 3,866,498 |
NOTE 8.
|
ACCRUED LIABILITIES
|
Accrued Liabilities
|
June 30, 2017
|
December 31, 2016
|
||||||
Accrued compensation/benefits
|
$ | 121,170 | $ | 274,874 | ||||
Accrued insurance payable
|
5,916 | 40,422 | ||||||
Accrued property taxes
|
2,700 | --- | ||||||
Accrued royalties
|
31,797 | --- | ||||||
Product rebates/returns
|
45 | 4 | ||||||
Total accrued liabilities
|
$ | 161,628 | $ | 315,300 |
NOTE 9.
|
PROMISSORY NOTES PAYABLE
|
NOTE 10.
|
CONVERTIBLE DEBT
|
As of June 30, 2017
|
|||||||||||||||||||||||||||||
Transaction
|
Initial
Principal
Amount
|
Interest
Rate
|
Maturity
Date
|
Conversion Price
|
Principal
Balance
|
Unamortized
Debt
Discount
|
Unamortized Debt Issuance Costs
|
Carrying
Value
|
|||||||||||||||||||||
Initial Note
|
$ | 500,000 | 12.5 | % |
02/27/2019
|
$ | 0.04 | $ | 500,000 | $ | 297,147 | $ | 7,496 | $ | 195,357 | ||||||||||||||
Second Note
|
$ | 500,000 | 12.5 | % |
03/31/2019
|
$ | 0.04 | $ | 500,000 | $ | 297,147 | $ | 7,496 | $ | 195,357 | ||||||||||||||
Total
|
$ | 1,000,000 | $ | 1,000,000 | $ | 594,294 | $ | 14,992 | $ | 390,714 |
NOTE 11.
|
EQUITY TRANSACTIONS
|
NOTE 12.
|
STOCKHOLDERS’ EQUITY
|
Number of Shares of Common Stock Subject to Exercise
|
Weighted – Average
Exercise Price
|
|||||||
Balance as of December 31, 2016
|
26,179,560 | $ | 0.11 | |||||
Warrants issued
|
57,055,057 | $ | 0.04 | |||||
Warrants exercised
|
--- | --- | ||||||
Warrants cancelled
|
--- | --- | ||||||
Balance as of June 30, 2017
|
83,234,617 | $ | 0.06 |
Date of Expiration
|
Number of Warrant Shares of Common Stock Subject to Expiration
|
|||
March 14, 2018
|
660,000 | |||
January 15, 2019
|
80,000 | |||
April 30, 2020
|
194,118 | |||
March 30, 2021
|
25,245,442 | |||
March 31, 2027
|
57,055,057 | |||
Total
|
83,234,617 |
NOTE 13.
|
EARNINGS PER SHARE
|
June 30, 2017
|
December 31, 2016
|
|||||||
Warrants to purchase Common Stock
|
83,234,617 | 26,179,560 | ||||||
Stock options to purchase Common Stock
|
227,403 | 691,237 | ||||||
Common stock issuable upon the assumed conversion of our convertible promissory notes (1)
|
31,250,000 | --- | ||||||
Common stock issuable upon the assumed conversion of our Series B preferred stock (2)
|
125,000,000 | --- | ||||||
Total
|
239,712,020 | 26,870,797 |
(1)
|
As part of the Initial Note and the Second Note, at the holder’s option, all unpaid principle and interest due under each convertible promissory note may be converted into shares of Common Stock based on a conversion price of $0.04 per share. The Initial Note and the Second Note matures on February 27, 2019 and March 31, 2019, respectively, and on each maturity date each convertible promissory note, and accrued interest thereon, is subject to mandatory conversion based on a conversion price of $0.04 per share. For the purposes of this Table, we have assumed that all outstanding principal and interest will be converted on each applicable maturity date.
|
(2)
|
Pursuant to the March 2017 Offering, Velo LLC purchased 1,250 shares of Series B Convertible Preferred Stock of the Company for $5,000,000. The Series B Convertible Preferred Stock that was issued in the March 2017 Offering, (a) voted together with the Common Stock as a single class (subject to standard protective provisions for the Series B Convertible Preferred Stock), (b) had the same dividend rights as the Common Stock, (c) had a liquidation preference equal to the greater of its purchase price and its as converted-to-Common Stock value, (d) automatically converted into Common Stock when the number of authorized shares of Common Stock was increased within 190 days of the second closing as necessary to permit all outstanding convertible or exercisable securities (including the Series B Convertible Preferred Stock) to convert to Common Stock, and (e) was convertible into Common Stock at the discretion of the holder, subject to the availability of authorized shares, at an as-converted-to-Common Stock purchase price of $0.04 per share. On August 1, 2017, all 1,250 outstanding shares of Series B Convertible Preferred Stock converted into 125,000,000 shares of Common Stock as a result of the approval by the stockholders at the 2017 Annual Meeting of Stockholders held on July 25, 2017, and the filing in July 2017, of an amendment increasing our authorized shares of Common Stock to 750,000,000 shares.
|
NOTE 14.
|
SHARE BASED COMPENSATION
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2017
|
2016
|
2017
|
2016
|
|||||||||||||
Research and development
|
$ | 1,682 | $ | 323 | $ | 3,345 | $ | 8,993 | ||||||||
Selling, general and administrative
|
2,691 | 17,825 | 5,352 | 37,022 | ||||||||||||
Total share-based compensation expense
|
$ | 4,373 | $ | 18,148 | $ | 8,697 | $ | 46,015 |
Stock Options
|
Weighted Average Exercise Price per Share
|
|||||||
Outstanding as of December 31, 2016
|
691,237 | $ | 1.94 | |||||
Granted
|
--- | --- | ||||||
Forfeited/cancelled
|
(463,834 | ) | $ | 1.16 | ||||
Exercised
|
--- | --- | ||||||
Outstanding as of June 30, 2017
|
227,403 | $ | 3.54 |
Options Outstanding
|
Options Exercisable
|
|||||||||||||||||
Stock Options Outstanding
|
Weighted Average Exercise Price per Share
|
Weighted Average Remaining Contractual Life in Years
|
Stock Options Exercisable
|
Weighted Average Exercise Price per Share
|
||||||||||||||
140,000 | $ | 0.33 | 5.7 | 140,000 | $ | 0.33 | ||||||||||||
65,000 | 1.15 | 7.2 | 65,000 | 1.15 | ||||||||||||||
22,403 | 30.48 | 0.8 | 22,403 | 30.48 | ||||||||||||||
227,403 | $ | 3.54 | 5.7 | 227,403 | $ | 3.54 |
NOTE 15.
|
FAIR VALUE MEASUREMENTS
|
Level 1
|
—
|
Valuations based on quoted prices (unadjusted) for identical assets or liabilities in active markets.
|
Level 2
|
—
|
Valuations based on observable inputs other than quoted prices in Level 1, such as quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, and other inputs that are observable or can be corroborated by observable market data.
|
Level 3
|
—
|
Valuations based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by other market participants.
|
Description
|
June 30, 2017
|
December 31, 2016
|
||||||
Liabilities:
|
||||||||
Convertible promissory note – March 2017
|
$ | 500,000 | --- | |||||
Convertible promissory note – February 2017
|
$ | 500,000 | --- | |||||
Promissory note – December 2016
|
--- | $ | 20,000 | |||||
Total
|
$ | 1,000,000 | $ | 20,000 |
NOTE 16.
|
INCOME TAXES
|
NOTE 17.
|
COMMITMENTS AND CONTINGENCIES
|
Calendar Years
|
Future Lease Expense
|
|||
2017 (Six months)
|
$ | 60,601 | ||
2018
|
29,199 | |||
2019
|
--- | |||
2020
|
--- | |||
Total
|
$ | 89,800 |
NOTE 18.
|
LEGAL PROCEEDINGS
|
NOTE 19.
|
SUBSEQUENT EVENTS
|
ITEM 2.
|
M
anag
ement’s Discussion and Analysis of Financial Condition and Results of Operations.
|
Consolidated Cash Flow Data
|
||||||||
Six Months Ended June 30,
|
||||||||
Net Cash Provided by (Used in)
|
2017
|
2016
|
||||||
Operating activities
|
$ | (457,000 | ) | $ | (972,000 | ) | ||
Investing activities
|
(4,000 | ) | --- | |||||
Financing activities
|
5,879,000 | 1,510,000 | ||||||
Net increase in cash and cash equivalents
|
$ | 5,418,000 | $ | 538,000 |
§
|
our ability to successfully commercialize our wound management products and the market acceptance of these products;
|
§
|
our ability to establish and maintain collaborative arrangements with business partners for the development and commercialization of certain product opportunities;
|
§
|
scientific progress in our development programs;
|
§
|
the marketing and sales efforts of our distributors and sub-distributors;
|
§
|
the costs involved in filing, prosecuting and enforcing patent claims and our maintenance of patent rights;
|
§
|
competing product developments;
|
§
|
the trading volume and price of our capital stock;
|
§
|
the actions of parties whose consents, waivers or prompt responses are required for approval of a financing (such as parties with rights of first refusal or consent rights);
|
§
|
our general financial situation, including our revenues, liquidity, capitalization and other factors; and
|
§
|
the cost of manufacturing and production scale-up.
|
Payments Due By Period
|
||||||||||||||||||||
Contractual Cash Obligations
|
Total
|
Less Than
1 Year
|
1-2
Years
|
3-5
Years
|
After 5
Years
|
|||||||||||||||
Operating leases
|
$ | 89,800 | $ | 89,800 | $ | --- | $ | --- | $ | --- | ||||||||||
Total contractual cash obligations
|
$ | 89,800 | $ | 89,800 | $ | --- | $ | --- | $ | --- |
ITEM 3.
|
Qu
ant
itative and Qualitative Disclosures About Market Risk.
|
ITEM 4.
|
Contro
ls and Procedures.
|
ITEM 1.
|
Legal
Proceedings.
|
ITEM 1A.
|
ITEM 2.
|
U
nregis
tered Sales of Equity Securities and Use of Proceeds.
|
ITEM 3.
|
D
efault
s Upon Senior Securities.
|
ITEM 4.
|
Mine Safety
Disclosures.
|
ITEM 5.
|
O
ther
Information.
|
ITEM 6.
|
E
xhib
its.
|
Exhibit
Number
|
Description
|
|
* | ||
3.2
|
Amended and Restated Bylaws dated December 5, 2008. (1)
|
|
101.INS
|
***
|
XBRL Instance Document
|
101.SCH
|
***
|
XBRL Taxonomy Extension Schema Document
|
101.CAL
|
***
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF
|
***
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB
|
***
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE
|
***
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
---------------------------------------------------
|
||
(1)
|
Incorporated by reference to the Company’s Form 8-K filed on December 11, 2008.
|
|
*
|
Filed herewith.
|
|
**
|
Filed herewith. This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section nor shall it be deemed incorporated by reference in any filings under the Securities Act of 1933 or the Securities and Exchange Act of 1934.
|
|
***
|
Pursuant to Rule 406T of Regulation S-T, the XBRL-related information in Exhibit 101 to this Quarterly Report on Form 10-Q is deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, and otherwise is not subject to liability under these sections.
|
|
#
|
Management contract or compensation plan arrangement
|
ULURU Inc.
|
||||
Date: August 14, 2017
|
By:
|
/s/ Vaidehi Shah
|
||
Vaidehi Shah
|
||||
Chief Executive Officer
|
||||
(Principal Executive Officer)
|
||||
Date: August 14, 2017
|
By:
|
/s/ Terrance K. Wallberg
|
||
Terrance K. Wallberg
|
||||
Chief Financial Officer and Vice President
|
||||
(Principal Financial and Accounting Officer)
|
(i)
|
A merger or consolidation in which the Corporation is a constituent party, except any such merger or consolidation involving the Corporation or a subsidiary in which the shares of capital stock of the Corporation outstanding immediately prior to such merger or consolidation continue to represent, or are converted into or exchanged for shares of capital stock that represent, immediately following such merger or consolidation, at least a majority, by voting power, of the capital stock of (1) the surviving or resulting corporation; or (2) if the surviving or resulting corporation is a wholly owned subsidiary of another corporation immediately following such merger or consolidation, the parent corporation of such surviving or resulting corporation;
|
(iii)
|
The sale, lease, transfer, license or other disposition, in a single transaction or series of related transactions, by the Corporation or any subsidiary of the Corporation of all or substantially all the assets of the Corporation and its subsidiaries taken as a whole, or the sale or disposition (whether by merger, consolidation or otherwise) of one or more subsidiaries of the Corporation if substantially all of the assets of the Corporation and its subsidiaries taken as a whole are held by such subsidiary or subsidiaries, except where such sale, lease, transfer, license or other disposition is to a wholly owned subsidiary of the Corporation.
|
(i)
|
As promptly as reasonably practicable following any adjustment of the Conversion Price, but in any event not later than ten (10) days thereafter, the Corporation shall furnish to each holder of record of Series B Preferred Stock at the address specified for such holder in the books and records of the Corporation (or at such other address as may be provided to the Corporation in writing by such holder) a certificate of an executive officer setting forth in reasonable detail such adjustment and the facts upon which it is based and certifying the calculation thereof.
|
(ii)
|
As promptly as reasonably practicable following any adjustment of the Conversion Price, but in any event not later than ten (10) days thereafter, the Corporation shall furnish to such holder a certificate of an executive officer certifying the Conversion Price then in effect and the number of Conversion Shares or the amount, if any, of other shares of stock, securities or assets then issuable to such holder upon conversion of the shares of Series B Preferred Stock held by such holder.
|
(i)
|
that the Corporation shall take a record of the holders of its Common Stock (or other capital stock or securities at the time issuable upon conversion of the Series B Preferred Stock) for the purpose of entitling or enabling them to receive any dividend or other distribution, to vote at a meeting (or by written consent), to receive any right to subscribe for or purchase any shares of capital stock of any class or any other securities, or to receive any other security; or
|
(ii)
|
of any capital reorganization of the Corporation, any reclassification of the Common Stock, any Liquidation (including a Deemed Liquidation Event) or any other consolidation or merger of the Corporation with or into another Person, or sale of all or substantially all of the Corporation's assets to another Person; or
|
(iii)
|
of the voluntary or involuntary dissolution, liquidation or winding-up of the Corporation;
|
Certificate of Amendment
(PURSUANT TO NRS 78.385 AND 78.390)
|
ULURU Inc.
|
2.
|
The articles have been amended as follows:
(provide article numbers, if available)
|
RESOLVED, that the third paragraph of Article IV of the Restated Articles of Incorporation be, and it hereby is, amended by deleting such paragraph in entirety and substituting the following in its place:
The total number of shares of stock which the corporation shall have authority to issue is Seven Hundred Fifty Million and Twenty Thousand (750,020,000) shares, of which Seven Hundred Fifty Million (750,000,000) shall be Common Stock, $0.001 par value per share, and Twenty Thousand (20,000) shares shall be Preferred Stock, $0.001 par value per share (the “Preferred”).
|
4.
|
Effective date and time of filing: (optional) | July 26, 2017 |
|
5.
|
Signature: (required)
|
To the Company:
|
||||
ULURU Inc.
|
||||
4452 Beltway Drive
|
||||
Addison, TX 75001
|
||||
Attention: Chief Financial Officer
|
To the Consultant
|
||||
Velocitas GmbH
|
||||
Landhausgasse 2/4
|
||||
1010 Vienna, Austria
|
||||
Attention: Geschäftsführer
|
(i)
|
Construction
. A reference to a Section or a Schedule shall mean a Section in or Schedule to this Agreement unless otherwise expressly stated. The titles and headings herein are for reference purposes only and shall not in any manner limit the construction of this Agreement which shall be considered as a whole. The words “
include
,” “
includes
” and “
including
” when used herein shall be deemed in each case to be followed by the words “without limitation.” Whenever the context may require, any pronouns used herein shall include the corresponding masculine, feminine or neuter forms, and the singular form of names and pronouns shall include the plural and vice-versa.
|
ULURU Inc.
|
||||
By:
|
/s/ Terrance K. Wallberg
|
|||
Name:
|
Terrance K. Wallberg
|
|||
Title:
|
Vice President and Chief Financial Officer
|
|||
Consultant:
|
||||
By:
|
/s/ Oksana Tiedt
|
|||
Name:
|
Oksana Tiedt
|
|||
Title:
|
Managing Director
|
·
|
Present, promote and sell products/services to existing and prospective customers
|
·
|
Establish and nurture relationships with KOLs in key markets
|
·
|
Set up and organize training events with KOLs and sales partners
|
·
|
Organize and support observation and other studies and publications in key markets
|
·
|
Perform cost-benefit and needs analysis of existing/potential customers
|
·
|
Establish, develop and maintain positive business and customer relationships
|
·
|
Reach out to customer leads through cold calling or follow up from existing leads
|
·
|
Travel as required to develop new markets, customers, product sales as well as evaluate and monitor existing distribution partners
|
·
|
Expedite the resolution of customer problems and complaints to maximize satisfaction
|
·
|
Coordinate sales effort with team members and other departments
|
·
|
Analyze the territory / market’s potential, track sales and distributor / partner performance, invoices and detailed status reports
|
·
|
Source new products for acquisition, license or distribution
|
·
|
Keep abreast of best practices and promotional trends
|
·
|
Develop growth strategies and related business plans focused both on financial gain and customer satisfaction
|
·
|
Conduct research to identify new markets and customer needs
|
·
|
Prepare and negotiate sales contracts ensuring adherence to law-established rules and guidelines
|
·
|
Provide trustworthy feedback and after-sales support
|
·
|
Prepare marketing materials
|
·
|
Organize promotional campaigns and events
|
·
|
Develop and document required regulatory practices and procedures. Ensure adherence to regulatory standards during all business practices
|
·
|
Provide oversight of the manufacturing processes
|
·
|
Coordinate efforts of all manufacturing partners and ensure adherence to required manufacturing and documentation processes
|
·
|
Coordinate logistics and manage the entire supply chain
|
(a)
|
Consulting fees.
|
Consultant will be paid a monthly fee of $20,833.00 for providing Consulting Services. Consultant shall invoice the Company monthly for Consulting Services rendered during the prior monthly period, and any amounts owed by the Company shall be paid within thirty (30) days after receipt of such invoices via wire transfer.
|
|
(b)
|
Expenses
.
|
Consultant will be paid a monthly fixed business expenses fee in the amount of $5,000 for reimbursement of fixed Consultant overhead expenses. In addition, the Consultant shall be reimbursed by the Company for all reasonable, appropriate, or necessary expenses incurred in the performance of their duties hereunder that are
pre-approved
by an officer of the Company, including: (i) transportation expenses including air fare, car rentals or fuel expenses and taxi fare to and from all in-person meetings; (ii) reasonable hotel accommodations (as reasonably necessary in connection with in-person meetings); (iii) meals, and (iv) communications expenses such as wifi and phone charges. Consultant employee requesting reimbursement will present to the Company for approval an itemized expense voucher, in a form prescribed by ULURU together with receipts or other reasonable evidence or substantiation of these expenses as determined by the Company. Consultant shall invoice the Company for any such out of pocket expenses on a monthly basis and any amounts owed by the Company shall be paid within thirty (30) after receipt of such invoices.
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of ULURU Inc.;
|
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have:
|
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report, based on such evaluation; and
|
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: August 14
, 2017
|
/s/ Vaidehi Shah
|
||
Vaidehi Shah
|
|||
Chief Executive Officer
|
|||
(Principal Executive Officer)
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of ULURU Inc.;
|
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have:
|
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report, based on such evaluation; and
|
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: August 14
, 2017
|
/s/ Terrance K. Wallberg
|
||
Terrance K. Wallberg
|
|||
Vice President and Chief Financial Officer
|
|||
(Principal Financial and Accounting Officer)
|
(1.)
|
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2.)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: August 14, 2017
|
/s/ Vaidehi Shah
|
||
Vaidehi Shah
|
|||
Chief Executive Officer
|
|||
(Principal Executive Officer)
|
(1.)
|
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2.)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: August 14
, 2017
|
/s/ Terrance K. Wallberg
|
||
Terrance K. Wallberg
|
|||
Vice President and Chief Financial Officer
|
|||
(Principal Financial and Accounting Officer)
|