Table of Contents

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

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

 

For the quarterly period ended September 30, 2018

 

OR

 

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

 

For the transition period from _______________ to _______________

 

Commission file number 000-30728

 

PROTEO, INC.

(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)

 

NEVADA	90-0019065
(STATE OR OTHER JURISDICTION OF INCORPORATION OR ORGANIZATION)	(I.R.S. EMPLOYER IDENTIFICATION NO.)
2102 BUSINESS CENTER DRIVE, IRVINE, CALIFORNIA	92612
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES)	(ZIP CODE)

 

(949) 253-4155

(Registrant's telephone number, including area code)

 

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  o.

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes  x  No  o.

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 o	Accelerated filer o
Non-accelerated filer o	Smaller reporting company x
Emerging growth company  o

 

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. o

 

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

 

Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date.

 

CLASS		NUMBER OF SHARES OUTSTANDING
Common Stock, $0.001 par value		23,879,350 shares of common stock at October 15, 2018

 

 

 

 

 

 

PROTEO, INC.

AND SUBSIDIARY

 

TABLE OF CONTENTS

 

		Page
PART I. FINANCIAL INFORMATION
Item 1.	Financial Statements:	3
	Condensed Consolidated Balance Sheets as of September 30, 2018 (Unaudited) and December 31, 2017	3
	Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the Three-month and Nine-month Periods Ended September 30, 2018 and 2017 (Unaudited)	4
	Condensed Consolidated Statements of Cash Flows for the Nine-month Periods Ended September 30, 2018 and 2017 (Unaudited)	5
	Notes to Condensed Consolidated Financial Statements (Unaudited)	6
Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	12
Item 3.	Quantitative and Qualitative Disclosure About Market Risk	17
Item 4.	Controls and Procedures	17
PART II. OTHER INFORMATION
Item 1.	Legal Proceedings	18
Item 1A.	Risk Factors	18
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	18
Item 3.	Defaults Upon Senior Securities	18
Item 4.	Mine Safety Disclosures	18
Item 5.	Other Information	18
Item 6.	Exhibits	18
SIGNATURES		19

 

 

 

 

 

 

PART I. FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

 

PROTEO, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

 

ASSETS
		September 30,				December 31,
		2018				2017
		(Unaudited)
CURRENT ASSETS
Cash and cash equivalents		$	122,680			$	113,915
Research supplies			110,653				114,225
Grant funds receivable			24,615				11,438
Development Agreement receivables			–				5,990
Prepaid expenses and other current assets			16,221				17,691
Total current assets			274,169				263,259
PROPERTY AND EQUIPMENT, NET			5,408				7,053
Total assets		$	279,577			$	270,312
LIABILITIES AND STOCKHOLDERS' DEFICIT
CURRENT LIABILITIES
Accounts payable and accrued liabilities		$	92,794			$	222,704
Deferred revenues			–				82,553
Total current liabilities			92,794				305,257
LONG TERM LIABILITIES
Accrued licensing fees - related party			661,466				682,833
Other liabilities			143,387				148,019
Total long term liabilities			804,853				830,852
Total liabilities			897,647				1,136,109
COMMITMENTS AND CONTINGENCIES (Note 6)
STOCKHOLDERS' DEFICIT
Non-voting preferred stock, par value $0.001 per share; 10,000,000 shares authorized; 823,590 shares and 723,590 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively			824				724
Common stock, par value $0.001 per share; 300,000,000 shares authorized; 23,879,350 shares issued and outstanding			23,880				23,880
Additional paid-in capital			9,104,965				8,988,125
Accumulated other comprehensive income			42,472				74,072
Accumulated deficit			(9,790,211	)			(9,952,598	)
Total stockholders' deficit			(618,070	)			(865,797	)
Total liabilities and stockholders' deficit		$	279,577			$	270,312

 

 

SEE ACCOMPANYING NOTES TO THESE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

  

 

PROTEO, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

FOR THE THREE-MONTH AND NINE-MONTH PERIODS ENDED SEPTEMBER 30, 2018 AND 2017

(UNAUDITED)

 

		THREE MONTHS ENDED								NINE MONTHS ENDED
		SEPTEMBER 30,								SEPTEMBER 30,
		2018				2017				2018				2017
REVENUES
Development Agreement		$	22,533			$	46,802			$	100,227			$	142,837
Net Grant revenue			–				–				113,386				–
TOTAL REVENUES			22,533				46,802				213,613				142,837
EXPENSES
General and administrative			32,715				38,678				109,610				138,927
Research and development, net of grants			16,551				20,260				–				40,420
TOTAL OPERATING EXPENSES			49,266				58,938				109,610				179,347
INCOME (LOSS) FROM OPERATIONS			(26,733	)			(12,136	)			104,003				(36,510	)
INTEREST AND OTHER INCOME (EXPENSE), NET			17,031				(49,927	)			58,384				(160,433	)
NET INCOME (LOSS)		$	(9,702	)		$	(62,063	)		$	162,387			$	(196,943	)
FOREIGN CURRENCY TRANSLATION ADJUSTMENTS			(7,028	)			25,855				(31,600	)			85,628
COMPREHENSIVE INCOME (LOSS)		$	(16,730	)		$	(36,208	)		$	130,787			$	(111,315	)
BASIC AND DILUTED NET INCOME (LOSS) PER SHARE		$	(0.00	)		$	(0.00	)		$	0.01			$	(0.01	)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC AND DILUTED			23,879,350				23,879,350				23,879,350				23,879,350

 

 

 

 

 

 

SEE ACCOMPANYING NOTES TO THESE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

 

 

PROTEO, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE NINE-MONTH PERIODS ENDED SEPTEMBER 30, 2018 AND 2017

(UNAUDITED)

 

		NINE MONTHS ENDED
		SEPTEMBER 30,
		2018				2017
CASH FLOWS FROM OPERATING ACTIVITIES
Net income (loss)		$	162,387			$	(196,943	)
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Depreciation			1,425				1,327
Foreign currency transaction (gain) loss			(48,818	)			165,210
Changes in operating assets and liabilities:
Grant funds receivable			(13,560	)			19,380
Development Agreement receivables			5,813				27,848
Prepaid expenses and other current assets			19,970				(1,318	)
Accounts payable and accrued liabilities			(88,684	)			(6,051	)
Deferred revenue			(80,114	)			(59,293	)
Other liabilities			–				18,737
NET CASH USED IN OPERATING ACTIVITIES			(41,581	)			(31,103	)
CASH FLOWS FROM INVESTING ACTIVITIES
Acquisition of property and equipment			–				(1,868	)
NET CASH USED IN INVESTING ACTIVITIES			–				(1,868	)
CASH FLOWS FROM FINANCING ACTIVITIES
Issuance of preferred stock			60,090				–
Proceeds from related party loan			61,434				–
Repayment of related party loan			(58,172	)			–
NET CASH PROVIDED BY FINANCING ACTIVITIES			63,352				–
EFFECT OF FOREIGN CURRENCY EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS			(13,006	)			17,138
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS			8,765				(15,833	)
CASH AND CASH EQUIVALENTS--BEGINNING OF PERIOD			113,915				141,668
CASH AND CASH EQUIVALENTS--END OF PERIOD		$	122,680			$	125,835

 

 

SEE ACCOMPANYING NOTES TO THESE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

 

 

PROTEO, INC. AND SUBSIDIARY

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2018 (UNAUDITED)

 

1.   NATURE OF BUSINESS AND BASIS OF PRESENTATION

 

BASIS OF PRESENTATION

 

The accompanying condensed consolidated balance sheet as of December 31, 2017, which has been derived from audited financial statements, and the accompanying interim condensed consolidated financial statements as of September 30, 2018 and for the three-month and nine-month periods ended September 30, 2018 and 2017, have been prepared by management pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC") for interim financial reporting. These interim condensed consolidated financial statements are unaudited and, in the opinion of management, include all adjustments (consisting only of normal recurring adjustments and accruals) necessary to present fairly the financial condition, results of operations and cash flows of Proteo, Inc. and its wholly owned subsidiary (hereinafter collectively referred to as the "Company") as of and for the periods presented in accordance with accounting principles generally accepted in the United States of America ("GAAP"). Operating results for the three-month and nine-month periods ended September 30, 2018 are not necessarily indicative of the results that may be expected for the year ending December 31, 2018, or for any other interim period during such year. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been omitted in accordance with the rules and regulations of the SEC, although the Company believes that the disclosures made are adequate to make the information not misleading. The accompanying condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2017 filed with the SEC on April 27, 2018.

 

NATURE OF BUSINESS

 

The Company is a clinical stage drug development company focusing on the development of anti-inflammatory treatments for rare diseases with significant unmet needs. The Company's management deems its lead drug candidate Tiprelestat (also known as Elafin) for intravenous use to be one of the most prospective treatments of acute postoperative inflammatory complications, in particular after esophageal cancer surgery. Elafin appears to be also a promising compound for the treatment of pulmonary arterial hypertension. The clinical development is currently focused in Europe with the intention to receive the primary approval in Europe.

 

The products that the Company is developing, to the extent they are considered drugs or biologics, are governed by the Federal Food, Drug and Cosmetics Act (in the United States) and the regulations of State and various foreign government agencies. The Company's proposed pharmaceutical products to be used by humans are subject to certain clearance procedures administered by the above regulatory agencies.

 

From time to time, the Company enters into collaborative arrangements for the research and development (R&D), manufacture and/or commercialization of products and product candidates. These collaborations may provide for non-refundable, upfront license fees, R&D and commercial performance milestone payments, cost sharing, royalty payments and/or profit sharing. The Company's collaboration agreements with third parties are generally performed on a “best efforts” basis with no guarantee of either technological or commercial success.

 

Proteo, Inc.'s common stock is currently quoted on the OTC QB under the symbol "PTEO".

  

 

 

 

 

CONCENTRATIONS

 

The Company maintains substantially all of its cash in bank accounts at a German private commercial bank. The Company's bank accounts at this financial institution are presently fully protected by the voluntary "Deposit Protection Fund of The German Private Commercial Banks". The Company has not experienced any losses in these accounts.

  

The Company's operations, including research and development activities and most of its assets, are located in Germany. The Company's operations are subject to various political, economic, and other risks and uncertainties inherent in Germany and the European Union.

 

LIQUIDITY

 

Management expects existing cash to be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these interim financial statements.

 

The Company will require substantial additional funding for continuing research and development, obtaining regulatory approval, and for the commercialization of its products. Management plans to generate revenues from product sales, but there are no purchase commitments for any of the proposed products. Additionally, the Company may generate revenues from out-licensing activities. There can be no assurance that further out-licensing may be achieved or whether such will generate significant profit. In the absence of significant sales and profits, the Company may seek to raise additional funds to meet its working capital requirements through the additional placement of debt and/or equity securities, entering into revenue sharing arrangements and obtaining government grants. There is no assurance that the Company will be able to obtain sufficient additional funds when needed, or that such funds, if available, will be obtainable on terms satisfactory to the Company.

 

OTHER RISKS AND UNCERTAINTIES

  

The Company's line of future pharmaceutical products being developed by its German subsidiary, to the extent they may be considered drugs or biologics, are governed by the Federal Food, Drug and Cosmetics Act (in the United States) and by the regulations of State agencies and various foreign government agencies. There can be no assurances that the Company will obtain the regulatory approvals required to market its products. The pharmaceutical products under development will be subject to more stringent regulatory requirements because they are recombinant products for humans. The Company has no experience in obtaining regulatory clearance on these types of products. Therefore, the Company will be subject to the risks of delays in obtaining or failing to obtain regulatory clearance and other uncertainties, including financial, operational, technological, regulatory and other risks associated with an emerging business, including the potential risk of business failure.

 

The Company is exposed to risks related to fluctuations in foreign currency exchange rates. Management does not utilize derivative instruments to hedge against such exposure. 

 

PRINCIPLES OF CONSOLIDATION

 

The condensed consolidated financial statements have been prepared in accordance with GAAP and include the accounts of Proteo, Inc. and Proteo Biotech AG (“PBAG”), its wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. 

 

 

 

 

 

RESEARCH AND DEVELOPMENT ACTIVITIES

 

The Company capitalizes the cost of supplies used in its research and development activities if such supplies are deemed to have alternative future uses, usually in other research and development projects. Such costs are expensed as used to research and development expenses in the accompanying condensed consolidated statements of operations.

 

Nonrefundable advance payments for goods or services that have the characteristics that will be used or rendered for future research and development activities are deferred and capitalized as prepaid expenses. Such amounts are expensed to research and development as the related goods and services are received.

 

The costs of materials that are acquired for a particular research and development project and that have no alternative future uses (in other research and development projects or otherwise) and therefore no separate economic values are expensed as research and development costs at the time the costs are incurred.

 

The Company may receive grants from the German government which are used to fund research and development activities (see Note 7). Grant funds received or to be received for the reimbursement of qualified research and development expenses are offset against such expenses in the accompanying condensed consolidated statements of operations and comprehensive income (loss) when the related expenses are incurred.

  

FAIR VALUE MEASUREMENTS

 

The Fair Value Measurements and Disclosures Topic of the Financial Accounting Standard Board’s (“FASB”) Accounting Standards Codification (“ASC” or “Codification”) requires disclosure of fair value information about financial instruments when it is practicable to estimate that value. Management believes that the carrying amounts of the Company's financial instruments, consisting primarily of cash, accounts payable and accrued expenses, approximate their fair value at September 30, 2018 due to their short-term nature. The Company does not have any assets or liabilities that are measured at fair value on a recurring basis and, during the three-month and nine-month periods ended September 30, 2018 and 2017, did not have any assets or liabilities that were measured at fair value on a non-recurring basis.

  

REVENUE RECOGNITION

 

On January 1, 2018, the Company adopted Topic 606 using the modified retrospective method applied to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with the Company’s historic accounting under Topic 605.

 

Adoption of the new standard did not result in any change to the Company’s opening retained earnings as of January 1, 2018 as no cumulative impact to the adoption of ASC 606 was noted as result of the Company’s assessment of the comparative revenue recognized since inception of the contracts under the new revenue standard ASC 606 and historic standard ASC 605.

 

As more fully described in Note 5, amounts received under the Development Agreement (as defined below) are initially deferred and recognized as revenue over the projected performance period under the Development Agreement in relation to development expenses incurred.

 

SIGNIFICANT RECENT ACCOUNTING PRONOUNCEMENTS

 

During the nine months ended September 30, 2018, there have been no changes to the Company’s significant accounting policies as described in the Annual Report on Form 10-K for the fiscal year ended December 31, 2017.

 

 

 

 

2.   INCOME (LOSS) PER COMMON SHARE

 

Basic income (loss) per common share is computed based on the weighted average number of shares outstanding for the period. Diluted income (loss) per common share is computed by dividing net income (loss) by the weighted average shares outstanding assuming all dilutive potential common shares were issued. There were no dilutive potential common shares outstanding at September 30, 2018 and 2017. As such, basic and diluted income (loss) per common share equals net income (loss), as reported, divided by the weighted average number of common shares outstanding for the respective periods.

 

3.   FOREIGN CURRENCY TRANSLATION

 

Assets and liabilities of the Company's German operations are translated from Euros (the functional currency) into U.S. dollars (the reporting currency) at period-end exchange rates; equity transactions are translated at historical rates; and income and expenses are translated at weighted average exchange rates for the period. Net foreign currency exchange gains or losses resulting from such translations are excluded from the results of operations but are included in other comprehensive income and accumulated in a separate component of stockholders' deficit. Accumulated other comprehensive income approximated $42,000 and $74,000 at September 30, 2018 and December 31, 2017, respectively. 

 

4.   FOREIGN CURRENCY TRANSACTIONS

 

The Company records payables related to a certain licensing agreement (see Note 6) in accordance with the Foreign Currency Matters Topic of the Codification. Quarterly commitments under such agreement are denominated in Euro. For each reporting period, the Company translates the quarterly amount to U.S. dollars at the exchange rate effective on that date. If the exchange rate changes between when the liability is incurred and the time payment is made, a foreign exchange gain or loss results.

 

Additionally, the Company computes a foreign exchange gain or loss at each balance sheet date on all recorded transactions denominated in foreign currencies that have not been settled. The difference between the exchange rate that could have been used to settle the transaction on the date it occurred and the exchange rate at the balance sheet date is the gain or loss that is currently recognized. The Company recorded foreign currency transaction gains (losses) of approximately $10,000 and ($51,000) for the three-month periods ended September 30, 2018 and 2017, respectively, and $49,000 and ($165,000) for the nine-month periods ended September 30, 2018 and 2017, respectively, which are included in interest and other income (expense), net in the accompanying condensed consolidated statements of operations and comprehensive income (loss).

  

5.  DEFERRED REVENUES

 

On May 16, 2014, the Company entered into a funding and revenue sharing agreement (the “Development Agreement”) with an unrelated third party (disclosed in the Company’s Current Report on 8-K filed with the SEC on May 22, 2014). The third party will fund operational expenses of the Company as well as the development costs related to the clinical development program aimed at receiving regulatory approval for the use of Elafin for the intravenous treatment of patients undergoing esophageal cancer surgery in the European Union. Total payments by the third party to the Company shall not exceed 3.5 million Euro (approximately $4.1 million). Through September 30, 2018, the Company received approximately 1,633,000 Euro ($1,989,000) of the 3.5 million Euro maximum. Revenue participation right payments will be made to the party when and if Elafin is commercialized within the European Union for the intravenous treatment of patients undergoing esophageal cancer surgery. 

 

The Development Agreement will terminate after the earlier of 15 years or 10 complete and consecutive years after the first regulatory approval of Elafin for this indication. Under no circumstances are the payments refundable, even if the drug is never commercialized. As no revenue sharing payments will be made unless Elafin is commercialized, the payments received are being accounted for as payments for the Company to use reasonable efforts to complete development, obtain regulatory approvals, and to commercialize Elafin (i.e. the performance period). Therefore, amounts received from the third party will be deferred and recognized as revenue over the projected performance period under the Development Agreement in relation to expenses incurred.

  

 

 

 

 

From inception of the Development Agreement through September 30, 2015, management estimated total Elafin related development expenses at 3.5 million Euro. As revenues to be received also totaled 3.5 million Euro, revenue was recognized at 100% of the related expenses incurred. Beginning October 1, 2015, management increased their estimate of remaining development expenses by 3.5 million Euro and began recognizing revenues at 43% of related expenses. The increase in estimated total development expenses was due to additional clinical indicators that are being explored by the Company.

 

For the three-month and nine-month periods ended September 30, 2018 and 2017, the Company recognized approximately $23,000 and $100,000 and $47,000 and $143,000, respectively, of development income under the Development Agreement, which is included in revenues in the accompanying condensed consolidated statements of operations. Deferred revenues approximated $0 and $83,000 at September 30, 2018 and December 31, 2017, respectively.

 

6.   COMMITMENTS AND CONTINGENCIES

 

ACCRUED LICENSING FEES - RELATED PARTY

 

On December 30, 2000, the Company entered into a thirty-year license agreement, beginning January 1, 2001 (the "License Agreement"), with Dr. Oliver Wiedow, MD, the owner and inventor of several patents, patent rights and technologies related to Elafin. Pursuant to the License Agreement, the Company agreed to pay Dr. Wiedow an annual license fee of 110,000 Euro for a period of six years. The License Agreement was amended in December 2008 to waive non-payment defaults and to defer the due dates of each payment. In July 2011, February 2012, February 2013, June 2014, and again in April 2017, Dr. Wiedow agreed in writing to waive the non-payment defaults and agreed to defer the due dates of the payments for the outstanding balance of 570,000 Euro. As a result, the outstanding balance of 570,000 Euro is due on June 30, 2020. While the total amount owed does not currently bear interest, any late payment is subject to interest at an annual rate equal to the German Base Interest Rate plus six percent. In the event that the Company's financial condition improves, the parties can agree to increase and/or accelerate the payments. Dr. Wiedow, who is a director of the Company, beneficially owned approximately 27% of the Company's outstanding common stock as of September 30, 2018.

 

At September 30, 2018, the Company has accrued approximately $661,000 of licensing fees payable to Dr. Wiedow, which are included in long-term liabilities. This is a decrease over the respective accrual of approximately $683,000 at December 31, 2017, which was solely due to changes in foreign currency exchange rates.

 

OTHER LIABILITIES

 

Other liabilities at September 30, 2018 and December 31, 2017 consist of employee compensation that was incurred in 2015 to 2017, but for which payment was agreed to be deferred until 2020.

  

7.   GRANTS

 

In June 2016, the German State of Schleswig-Holstein granted PBAG approximately 874,000 Euros (approximately $1,021,000) for further research and development of the Company's pharmaceutical product Elafin (the “Grant”). The Grant, as amended, covers 50% of eligible research and development costs incurred from December 1, 2015 through November 30, 2019. Research and development expenses for the three-month periods ended September 30, 2018 and 2017 were reduced by approximately $37,000 and $49,000, respectively, for Grant funds received and accrued during those periods. For the nine-month periods ended September 30, 2018 and 2017, research and development expenses were reduced by Grant funds of approximately $270,000 and $150,000, respectively. During the nine-months ended September 30, 2018, the Company submitted $284,000 for reimbursement, received $257,000 (including $11,000 accrued at the beginning of the period), and accrued $25,000 for amounts not reimbursed at September 30, 2018, which is included in the accompanying consolidated balance sheet as grant funds receivable.

 

During the three months ended March 31, 2018, the company received approval from the government to submit certain expenses for reimbursement that had been previously expensed under GAAP. These expenses amounted to $177,000 and resulted in grant revenue exceeding grant expenses for the quarter. This has resulted in the presentation of net Grant revenue for the nine-months ended September 30, 2018.

 

 

 

 

 

8. RELATED PARTY LOAN

 

In March 2018, the Company’s president provided a short-term loan of 50,000 Euro ($62,000) to the Company. If repayment is made by July 15, 2018, no interest will be charged; thereafter interest accrues at 5% per annum. During July 2018 and before July 15, 2018, the Company repaid the short-term loan.

 

9.   INCOME TAXES

 

The Company accounts for income taxes under the asset and liability method, whereby deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Management evaluates the need to establish a valuation allowance for deferred tax assets based upon the amount of existing temporary differences, the period in which they are expected to be recovered and expected levels of taxable income. A valuation allowance to reduce deferred tax assets is established when it is “more likely than not” that some or all of the deferred tax assets will not be realized. Management has determined that a full valuation allowance against the Company’s net deferred tax assets is appropriate at September 30, 2018 and December 31, 2017.

 

There is no material income tax expense recorded for the nine-month periods ended September 30, 2018 and 2017, due to the Company's net losses and related changes to the full valuation allowance for deferred tax assets.

  

Based on management’s evaluation of uncertainty in income taxes, the Company concluded that there were no significant uncertain tax positions requiring recognition in its financial statements or related disclosures. Accordingly, no adjustments to recorded tax liabilities or accumulated deficit were required. As of September 30, 2018, there were no increases or decreases to liability for income taxes associated with uncertain tax positions.

 

10.  STOCK PURCHASE AGREEMENT AND OTHER CAPITAL EQUITY TRANSACTIONS

 

On September 9, 2016, the Company entered into a Preferred Stock Purchase Agreement (the “Agreement”) with a third-party (“Investor”). Pursuant to the Agreement, the Company agreed to issue and sell to the Investor 1,000,000 shares of the Company’s Series B-1 Preferred Stock at the price of 1.00 Euro per share, for an aggregate purchase price of 1,000,000 Euro and the Investor agreed to purchase such shares no later than March 31, 2017. Further details are described in the Company's Current Report on Form 8-K filed with the SEC on September 13, 2016.

 

The Company received deposits totalling 100,000 Euro ($117,000) through September 30, 2018, including 50,000 Euro ($60,000) received during the nine-months ended September 30, 2018. As conditions for the initial closing were met, 100,000 shares of Series B-1 Preferred Stock were issued during September 2018. The Company is currently negotiating with the Investor to complete the transaction, but at this time the Company believes that it is unlikely that the full transaction will close in the near future.

 

No shares of preferred stock were issued during 2017.

 

 

 

 

 

ITEM 2.   MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

CAUTIONARY STATEMENTS

 

This Quarterly Report on Form 10-Q contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). The Company intends that such forward-looking statements be subject to the safe harbors created by such statutes. The forward-looking statements included herein are based on current expectations that involve a number of risks and uncertainties. Accordingly, to the extent that this Quarterly Report contains forward-looking statements regarding the financial condition, operating results, business prospects or any other aspect of the Company, please be advised that the Company's actual financial condition, operating results and business performance may differ materially from that projected or estimated by management in forward-looking statements.

 

Such differences may be caused by a variety of factors, including but not limited to adverse economic conditions, intense competition, including intensification of price competition and entry of new competitors and products, adverse federal, state and local government regulation, inadequate capital, unexpected costs and operating deficits, increases in general and administrative costs and other specific risks that may be alluded to in this Quarterly Report or in other reports issued by the Company. In addition, the business and operations of the Company are subject to substantial risks that increase the uncertainty inherent in the forward-looking statements. The inclusion of forward looking statements in this Quarterly Report should not be regarded as a representation by management or any other person that the objectives or plans of the Company will be achieved.

 

The Company currently generates revenue under a development agreement. Additionally, assuming the Company's products receive approval for marketing in the future, there can be no assurance that the Company will generate positive cash flow and there can be no assurances as to the level of revenues, if any, the Company may actually achieve from its planned principal operations.

 

OVERVIEW

 

Proteo is a clinical stage drug development company focusing on the development of anti-inflammatory treatments for rare diseases with significant unmet needs. The Company's management deems its lead drug candidate Elafin for intravenous use to be one of the most prospective treatments of acute postoperative inflammatory complications, in particular after esophageal cancer surgery. Elafin also appears to be a promising compound for the treatment of pulmonary arterial hypertension and for preventing complications of organ transplantation.

 

The Company's success will depend on its ability to prove that Elafin is well tolerated by humans and its efficacy in the indicated diseases in order to demonstrate a favorable benefit/risk balance. There can be no assurance that the Company will receive government approval for the use of Elafin in further clinical trials or its use as a drug in any of the intended applications.

 

The Company has obtained Orphan drug designations within the European Union for the use of Elafin for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension as well as for the treatment of esophageal cancer. The latter indication, especially the postoperative inflammation, the main reason for postoperative morbidity, will be targeted by Elafin treatment. Within the United States, Proteo has obtained Orphan drug designations for the use of Elafin for the treatment of pulmonary arterial hypertension as well as for the prevention of inflammatory complications of transthoracic esophagectomy.

 

For the development of its lead product Elafin, Proteo has established a network of globally renowned research institutes, physicians and hospitals in Europe and the US. The development of Elafin has been widely supported by public grants. Worldwide leading funding bodies, such as the American National Institute of Health (“NIH”) and the British MRC, supported preclinical and clinical studies on Elafin with high volume grants.

 

The Company currently focuses on the clinical development of Elafin for prophylactic treatment of acute postoperative inflammatory complications in the surgical therapy of esophageal cancer and Elafin for chronical treatment of pulmonary arterial hypertension (“PAH”). Future clinical trials for PAH will be conducted in cooperation with third parties.

 

 

 

 

 

 

The tolerability of Elafin in healthy male subjects was demonstrated in a Phase I clinical single dose escalating study. A placebo-controlled Phase II clinical trial on the effect of Elafin on the postoperative inflammatory reactions and postoperative clinical course was conducted in patients undergoing transthoracic esophagectomy for esophageal cancer. A further Phase II study, EMPIRE (Elafin Myocardial Protection from Ischemia Reperfusion Injury), an investigator-initiated trial at Edinburgh University, was conducted to investigate the safety and efficacy of Elafin in coronary bypass surgery. The result from the EMPIRE trial which indicates that Elafin has cardioprotective properties by reducing the cardiac troponin I release has been published in 2015 (Alam et al., Heart 2015). Further details are described in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2017 filed with the SEC on April 27, 2018.

  

In June 2016, we announced that our subsidiary has been awarded a BFEI grant (the “Grant”) from the German State of Schleswig-Holstein. The Grant has a volume of up to Euro 874,000 and will be used for the R&D program to develop a new formulation of Proteo's lead compound Elafin. If effective, a new Elafin formulation would allow Proteo to extend the development pipeline to treat chronic diseases, such as pulmonary arterial hypertension ("PAH"). In June 2018, we received approval from the German State of Schleswig-Holstein to extend the project under the BFEI grant for a further 12 months until November 30, 2019.

 

In September 2016, we entered into a Preferred Stock Purchase Agreement (the “Agreement”) with a third-party (“Investor”). Pursuant to the Agreement, the Company agreed to issue and sell to the Investor 1,000,000 shares of the Company’s Series B-1 Preferred Stock at the price of Euro 1.00 per share, for an aggregate purchase price of Euro 1,000,000. The initial Euro 100,000 (approximately $117,000) deposit was fully received by September 2018, with $60,000 received during the nine-months ended September 30, 2018 and 100,000 shares of Series B-1 Preferred Stock were issued during September 2018. We are currently negotiating with the Investor to complete the transaction, but at this time we believe it is unlikely that the full transaction will close in the future. See Note 10 to the accompanying consolidated financial statements for additional information.

 

In April 2017 and August 2017, we received final reports from a respiratory safety pharmacology study and a 28-day toxicity study of Elafin subcutaneous dosage in rats. These studies are part of the animal toxicity program that was discussed at a Pre-Investigational New Drug Application ("PIND") meeting with the US Food and Drug Administration ("FDA") on development strategies for Elafin in pulmonary arterial hypertension ("PAH") and were partially funded by NIH within the framework of our collaboration with Marlene Rabinovitch at Stanford University. Both studies were conducted by a third-party laboratory in the US. They were conducted in accordance with the FDA “Good Laboratory Practice for Nonclinical Laboratory Studies” (GLP). All tested doses were well tolerated.

 

In August 2017, the Company submitted a Drug Master File (“DMF”) for Elafin to the FDA for use in clinical trials within the United States. The DMF supports the investigator-initiated Investigational New Drug (“IND”) application of Marlene Rabinovitch at Stanford University. At the end of September 2017, the FDA completed its safety review of the IND application and concluded that Marlene Rabinovitch at Stanford University may proceed with the proposed clinical investigation with Elafin for the treatment of pulmonary arterial hypertension. The conduct of a clinical phase I trial (subcutaneous administration, 7 days in healthy volunteers) will be financed by a new NIH-funded project of our cooperation partners and is planned to start in the second half of 2018. During the three-month period ended September 30, 2018, our cooperation partners received the approval letters from the responsible Institutional Review Boards. In September 2018, we entered into a Clinical Material Transfer Agreement with our cooperation partners within the framework of the clinical phase I trial, and as well into a Material Transfer Agreement with a third-party laboratory in the US.

 

In July 2018, the company announced the publication of research results by Alcazar et al. from Stanford University on a new mechanism by which Elafin rescues lung cell survival in the lung of newborn mice subjected to mechanical ventilation (Alejandre Alcazar et al., American Journal of Respiratory Cell and Molecular Biology, 2018). Since 2008, the Company has been cooperating with scientists at Stanford University in California with respect to the preclinical development in the field of pulmonary arterial hypertension and ventilator-induced injury. The new experimental findings, coupled with the research group’s observation of significantly increased plasma elastase levels in preterm infants with evolving neonatal chronic lung disease, support the notion that Elafin treatment might be effective in mitigating or preventing neonatal lung injury caused by mechanical ventilation.

 

During the nine-month period ended September 30, 2018, the Company continued its discussions to make its Elafin technology available for licensing and partnership with external partners. In 2017, the Company entered into an agreement with an external advisor for the procurement of equity capital or partnering with a fee model on a performance-related basis. The advisor supports companies from the areas of the pharmaceutical industry and medical technology to successfully develop and implement a business model, to scale it, to realize innovative projects and to place it on the market. This also includes the acquisition of capital and the search for strategic partners. During the three-month period ended June 30, 2018, the Company entered into an agreement with an additional external advisor for the procurement of equity capital or partnering with a fee model on a performance-related basis.

 

 

 

 

 

RESULTS OF OPERATIONS

 

REVENUES

 

Revenue includes income recognized under the Development Agreement, as described above and in Note 5 to the accompanying condensed consolidated financial statements. Approximately $23,000 and $47,000 was recognized as development income during the three-month periods ended September 30, 2018 and 2017, respectively. Approximately $100,000 and $143,000 was recognized as development income during the nine-month periods ended September 30, 2018 and 2017, respectively. The decreases are consistent with the decreases to operating expenses, as discussed below.

 

Revenue also includes net Grant funds received or accrued in excess of research and development expenses incurred during the period. As more fully discussed below, Grant funds, net of R&D expenses for the nine-months ended September 30, 2018 approximated $113,000, while R&D expenses exceeded Grant funds for the three-months ended September 30, 2018 and the three and nine-month periods ended September 30, 2017.

 

OPERATING EXPENSES

 

The Company's operating expenses for the three-month and nine-month periods ended September 30, 2018 were approximately $49,000 and $110,000, respectively, a decrease of approximately $10,000 and $70,000, respectively, over the same periods of the prior year. General and administrative expenses (mostly accounting and professional fees) for the three-month and nine-month periods ended September 30, 2018 decreased $6,000 and $29,000, respectively, due primarily to a reduction in patent costs compared to the same periods in 2017. As Elafin has not received regulatory approval, all patent costs are expensed as incurred. Research and development expenses decreased $4,000 and $40,000 over the same three-month and nine-month periods, respectively. The decrease in research and development expenses was primarily due to $270,000 of Grant funds recorded during the nine months ended September 30 2018, which were netted against $157,000 of research and development expenses and presented as net Grant revenue, while during the nine months ended September 30 2017, Grant funds of $150,000 were netted against $191,000 of R&D expense and presented as research and development, net of grants. For the three-months ended September 30, 2018, Grant funds of $37,000 were $17,000 less than R&D costs in that period, which is not significantly different from the same period in 2017. Certain research expenses that were expensed in prior periods under GAAP were not eligible for reimbursement under the Grant until the first quarter of 2018, resulting in more grant funds being recognized than current period expenses incurred.

 

INTEREST AND OTHER INCOME (EXPENSE)

 

Interest and other income (expense), net for the three-month and nine-month periods ended September 30, 2018, respectively, increased by approximately $67,000 and $219,000 over the same periods in 2017. The increases were driven primarily by foreign currency transaction gains during 2018, due to a strengthening of the U.S. Dollar compared to the Euro, compared to losses in the same periods in 2017. Foreign currency transaction gains and losses were primarily due to unrealized gains and losses on accrued licensing fees related to the Licensing Agreement, which is denominated in Euro.

 

INCOME TAXES

 

There is no material income tax expense recorded for the nine-month periods ended September 30, 2018 and 2017, due to the Company's net losses. The Company had a deferred tax asset of $2,026,000 at September 30, 2018 relating primarily to tax net operating loss carryforwards and temporary differences related to the recognition of accrued licensing fees. Full valuation allowances have been established against these deferred tax assets as it is likely that the Company will not be able to utilize them.

 

The Federal NOL expires in varying years through 2025. The foreign net operating loss relates to Germany and does not have an expiration date. In the event the Company were to experience a greater than 50% change in ownership, as defined in Section 382 of the Internal Revenue Code, the utilization of the Company's Federal NOLs could be restricted.

 

 

 

 

FOREIGN CURRENCY TRANSLATION ADJUSTMENTS

 

The Company experienced other comprehensive gains (losses) related to foreign currency translation adjustments of approximately ($7,000) and $26,000 during the three-month periods ended September 30, 2018 and 2017, respectively and ($32,000) and $86,000 during the nine-month periods ended September 30, 2018 and 2017, respectively. The changes are primarily due to a fluctuating U.S. Dollar (our reporting currency) compared to the Euro (our functional currency) during the periods.

 

LIQUIDITY AND CAPITAL RESOURCES

 

The Company owns 100% of Proteo Biotech AG, its operating subsidiary in Germany (the “Subsidiary”). To date the Subsidiary has not had any significant earnings, and it does not expect to have any significant earnings for several years pending the approval of its first product candidate. In this regard, there were no undistributed earnings of the Subsidiary to repatriate to the Company.

 

The Company received approximately 20,000 Euro ($24,000) and 100,000 Euro ($120,000) under the Development Agreement during the nine-month periods ended September 30, 2018 and 2017, respectively. The Company expects to receive approximately 1.9 million Euro (approximately $2.2 million) in future periods under this agreement.

 

In June 2016, the German State of Schleswig-Holstein granted PBAG approximately 874,000 Euro (the “Grant”) for further research and development of the Company's pharmaceutical product Elafin. The Grant covers 50% of eligible research and development costs incurred from December 1, 2015 through November 30, 2019. Grant funds approximating $257,000 and $170,000 were received during the nine-month periods ended September 30, 2018 and 2017, respectively. PBAG submitted for the reimbursement of additional eligible expenses approximating $25,000. The Company expects to receive approximately 301,000 Euro ($350,000) in future periods under this Grant.

 

In September 2016, the Company entered into a Preferred Stock Purchase Agreement (the “Agreement”) with a third-party (“Investor”). Pursuant to the Agreement, the Company agreed to issue and sell to the Investor 1,000,000 shares of the Company’s Series B-1 Preferred Stock at the price of 1.00 Euro per share, for an aggregate purchase price of 1,000,000 Euro. The initial 100,000 Euro (approximately $117,000) deposit was fully received by September 2018, with $60,000 received during the nine-months ended September 30, 2018. As conditions for the initial closing were met, 100,000 shares of Series B-1 Preferred Stock were issued during September 2018. See Note 10 to the accompanying consolidated financial statements for additional information.

 

In April 2017, Dr. Wiedow agreed in writing to waive any non-payment defaults under the License Agreement and to defer all current payments to June 2020. See Note 6 to the accompanying consolidated financial statements for the payment terms under the License Agreement.

 

The Company has cash approximating $123,000 as of September 30, 2018, which management expects to be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these interim financial statements. This is an increase of $9,000 over the December 31, 2017 cash balance of approximately $114,000. Such cash is held by the Subsidiary in Germany in Euro. The Company does not intend to repatriate any amount of this cash to the United States as it will be used to fund the Subsidiary’s continued operations. Management believes that the Company will generate sufficient revenues under the Development Agreement to fund its development activities through 2019. Given the Company's current cash on hand, anticipated collections under the Development Agreement and collections under the Grant of the German State of Schleswig-Holstein management believes the Company will have sufficient cash resources to cover its operations through 2019. As for periods beyond 2019, we expect to continue to direct the majority of our research and development expenses towards the development of Elafin. It is extremely difficult for us to reasonably estimate all future research and development costs associated with Elafin due to the number of unknowns and uncertainties associated with preclinical and clinical trial development.

 

 

 

 

These unknown variables and uncertainties include, but are not limited to:

 

	·	the uncertainty of future clinical trial results;
	·	the uncertainty of the ultimate number of patients to be treated in any current or future clinical trial;
	·	the uncertainty of the applicable regulatory bodies allowing our studies to move forward;
	·	the uncertainty of the rate at which patients are enrolled into any current or future study. Any delays in clinical trials could significantly increase the cost of the study and would extend the estimated completion dates;
	·	the uncertainty of terms related to potential future partnering or licensing arrangements;
	·	the uncertainty of protocol changes and modifications in the design of our clinical trial studies, which may increase or decrease our future costs,
	·	the uncertainty of our ability to raise additional capital to support our future research and development efforts; and the uncertainty of our ability to collect the remaining payments owed under the Development Agreement.

 

As a result of the foregoing, the Company's success will largely depend on its ability to generate revenues from out-licensing activities, secure additional funding through the sale of its Common/Preferred Stock and/or the sale of debt securities. There can be no assurance, however, that the Company will be able to generate revenues from out-licensing activities and/or to consummate debt or equity financing in a timely manner, or on a basis favorable to the Company, if at all. If we are unable to secure additional financing when needed, we may choose to delay or reduce other spending including Elafin research and development spending.

 

RESEARCH SUPPLIES

 

The Company’s capitalized research supplies, which are all held by PBAG in Germany, decreased from $114,000 at December 31, 2017 to $111,000 at September 30, 2018, primarily due to a strengthening U.S. Dollar relative to the Euro.

 

GRANT FUNDS RECEIVABLE

 

Grant funds receivable increased from $11,000 at December 31, 2017 to $25,000 at September 30, 2018. The Company received approximately $257,000 during the nine-month period ended September 30, 2018 and submitted an additional $25,000 for reimbursement.

 

LONG TERM ASSETS

 

The Company’s capitalized property and equipment, which are all located in Germany, decreased during 2018, primarily due to amortization.

 

ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

 

Accounts payable and accrued liabilities decreased from $223,000 at December 31, 2017 to $93,000 at September 30, 2018, primarily due to conversion of a deposit payable into the issuance of preferred shares and the payment of trade payables.

  

DEFERRED REVENUES

 

Deferred revenues related to the Development Agreement had a translated balance of $0 at September 30, 2018, a $83,000 decrease from the balance at December 31, 2017. The decrease was driven by the recognition of revenues during the period with no new funds coming in.

 

RELATED PARTY LOAN

 

In March 2018, the Company’s president provided a short-term loan of 50,000 Euro ($62,000) to the Company. If repayment is made by July 15, 2018, no interest will be charged; thereafter interest accrues at 5% per annum. In July 2018, and before July15, 2018, the Company repaid the short-term loan.

 

 

 

 

ACCRUED LICENSING FEES - RELATED PARTY

 

Accrued licensing fees decreased from $683,000 at December 31, 2017 to $661,000 at September 30, 2018, due to a strengthening of the U.S. Dollar compared to Euro. The Licensing Agreement is denominated in Euro, and the accrued licensing fee was 570,000 Euro at both September 30, 2018 and December 31, 2017.

 

OTHER LIABILITIES

        

Other liabilities at September 30, 2018 and December 31, 2017 consist of employee compensation that was incurred in 2015 to 2017, but for which payment was agreed to be deferred until 2020.

  

OFF BALANCE SHEET ARRANGEMENTS

 

The Company does not currently have any off-balance sheet arrangements.

 

CAPITAL EXPENDITURES

 

None significant.

 

ITEM 3.   QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

 

A smaller reporting company ("SRC") is not required to provide any information in response to Item 305 of Regulation S-K.

  

ITEM 4.   CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) that are designed to ensure that information required to be disclosed in Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms, and that such information is accumulated and communicated to our management, including to Birge Bargmann our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure.

 

As required by Rule 13a-15 under the Exchange Act, our management, including Birge Bargmann our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of September 30, 2018. Based on that evaluation, Ms. Bargmann concluded that as of September 30, 2018, and as of the date that the evaluation of the effectiveness of our disclosure controls and procedures was completed, our disclosure controls and procedures were effective.

 

Changes in Internal Control Over Financial Reporting

 

Our management, with the participation of Birge Bargmann, our Chief Executive Officer and Chief Financial Officer, has concluded there were no significant changes in our internal controls over financial reporting that occurred during our last fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

 

 

 

PART II - OTHER INFORMATION

 

ITEM 1.  LEGAL PROCEEDINGS.

 

None.

 

ITEM 1A. RISK FACTORS.

 

Not required for SRCs.

 

ITEM 2.  UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

 

On September 27, 2018, the Company issued 100,000 shares of Series B-1 Preferred Stock in exchange for Euro 100,000 (approximately $117,000) pursuant to the terms of that certain Preferred Stock Purchase Agreement between the Company and a third-party (“Investor”) dated September 9, 2016. The transaction was exempt from the registration requirements of the Securities Act of 1933, as amended, by virtue of the exemptions available under Regulation S and the rules promulgated thereunder.

 

ITEM 3.  DEFAULTS UPON SENIOR SECURITIES.

 

None.

 

ITEM 4.  MINE SAFETY DISCLOSURES.

 

Not applicable.

 

ITEM 5.  OTHER INFORMATION.

 

None.

 

ITEM 6.  EXHIBITS.

 

Exhibits:

 

31.1	Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2	Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32	Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS	XBRL Instance Document
101.SCH	XBRL Schema Document
101.CAL	XBRL Calculation Linkbase Document
101.DEF	XBRL Definition Linkbase Document
101.LAB	XBRL Label Linkbase Document
101.PRE	XBRL Presentation Linkbase Document

  

 

 

 

 

 

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 thereunto duly authorized.

	PROTEO, INC.
Dated: October 31, 2018	By:	/s/ Birge Bargmann
		Birge Bargmann
		Principal Executive Officer and Chief Financial Officer (signed both as an Officer duly authorized to sign on behalf of the Registrant and Principal Financial Officer and Chief Accounting Officer)