PROTEO, INC. AND SUBSIDIARY
SEE ACCOMPANYING NOTES TO THESE CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
SEE ACCOMPANYING NOTES TO THESE CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
PROTEO, INC. AND SUBSIDIARY
SEE ACCOMPANYING NOTES TO THESE CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2016 (UNAUDITED)
1. NATURE OF BUSINESS AND BASIS OF PRESENTATION
BASIS OF PRESENTATION
The accompanying condensed consolidated balance
sheet as of December 31, 2015, which has been derived from audited financial statements, and the accompanying interim condensed
consolidated financial statements as of June 30, 2016 and for the three-month and six-month periods ended June 30, 2016 and 2015,
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 six-month periods ended
June 30, 2016 are not necessarily indicative of the results that may be expected for the year ending December 31, 2016, 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, 2015 filed with the SEC on March 30, 2016.
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.
Since its inception, the Company has primarily
been engaged in the research and development of its proprietary product Elafin. The Company intends to seek the various governmental
regulatory approvals for the marketing of Elafin. Management believes that none of its planned products will produce sufficient
revenues in the near future. As a result, the Company intends to generate revenue by out-licensing and marketing activities. There
are no assurances, however, that the Company will be able to develop such products, or if produced, that they will be accepted
in the marketplace.
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
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.
PROTEO, INC. AND SUBSIDIARY
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2016 (UNAUDITED)
OTHER RISKS AND UNCERTAINTIES
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. 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.
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 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.
PROTEO, INC. AND SUBSIDIARY
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2016 (UNAUDITED)
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 June 30, 2016 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 six-month periods ended June 30, 2016 and 2015, did not have any assets or liabilities that were measured at fair value on
a non-recurring basis.
REVENUE RECOGNITION
It is the Company's intent to recognize revenues
from future product sales at the time of product delivery.
As more fully described in Note 5, amounts
received under the Development Agreement 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
In the opinion of management, neither the FASB,
its Emerging Issues Task Force, the AICPA, nor the SEC have issued any additional accounting pronouncements since the Company filed
its December 31, 2015 Form 10-K that are expected to have material impact on the Company's future consolidated financial statements.
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 loss by the weighted average shares outstanding assuming all dilutive potential common shares were issued. There were
no dilutive potential common shares outstanding at June 30, 2016 and 2015. As such, basic and diluted income (loss) per common
share equals net 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' equity.
Accumulated other comprehensive income approximated $13,000 and $1,000 at June 30, 2016 and December 31, 2015, respectively.
PROTEO, INC. AND SUBSIDIARY
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2016 (UNAUDITED)
4. FOREIGN CURRENCY TRANSACTIONS
The Company records payables related to a certain
licensing agreement (Note 6) in accordance with the Foreign Currency Matters Topic of the Codification. Quarterly commitments under
such agreement are denominated in Euros. 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 ($22,000) and $119,000 for the six-month periods ended June 30, 2016 and 2015, respectively,
which are included in interest and other income (expense), net in the accompanying condensed consolidated statements of operations
and comprehensive 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 8-K filing to the SEC as of 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 Euros. Through June 30, 2016, the Company received approximately 1.4 million
Euros 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 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 Euros, 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
will be explored by the Company.
For the three-month and six-month periods
ended June 30, 2016 and 2015, the Company recognized approximately $45,000 and $80,000 and $133,000 and $307,000, respectively, of
development income under the Development Agreement, which is included in revenues in the accompanying condensed consolidated
statements of operations. Deferred revenues approximated $259,000 and $212,000 at June 30, 2016 and December 31, 2015,
respectively. As of June 30, 2016, the third party was behind in making payments approximating $98,000.
PROTEO, INC. AND SUBSIDIARY
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2016 (UNAUDITED)
6. LONG-TERM LIABILITIES
ACCRUED LICENSING FEES
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 Euros 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, in February 2012, February
2013, and again in June 2014, 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 Euros is due on April
30, 2018. While the total amount owed does not currently bear interest, the Amendment provides that any late payment shall be 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 June 30, 2016.
At June 30, 2016, the Company has accrued approximately
$633,000 of licensing fees payable to Dr. Wiedow, which are included in long-term liabilities. This is an increase over the
respective accrual of approximately $622,000 at December 31, 2015, which was solely due to changes in foreign currency exchange
rates.
OTHER LIABILITIES
Other liabilities at June 30, 2016 and at December
31, 2015 consist of employee compensation that was incurred in 2015 but for which payment was agreed to be deferred until 2018.
The increase is due to strengthening of the Euro compared to US Dollar.
7. GRANTS
In June 2016, the German State of Schleswig-Holstein
granted PBAG approximately 874,000 Euros (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, 2018. PBAG submitted for the reimbursement of eligible expenses through June 30, 2016 approximating 74,000 Euros. As such,
research and development expenses for the three-month and six-month periods ended June 30, 2016 have been reduced by approximately
$82,000, and a grant funds receivable is included on the accompanying condensed consolidated balance sheet as of June 30, 2016.
PROTEO, INC. AND SUBSIDIARY
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
JUNE 30, 2016 (UNAUDITED)
8. 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.
There is no material income tax expense recorded
for the periods ended June 30, 2016 and 2015, 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 June 30, 2016, there were no increases or decreases to liability for income taxes associated with
uncertain tax positions.
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, after the launch of the Company's products, 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.
Proteo 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 NIH and the British
MRC, supported preclinical and clinical studies on Elafin with high volume grants.
Proteo currently focuses on the clinical development
of Elafin for prophylactic treatment of acute postoperative inflammatory complications in the surgical therapy of esophageal cancer.
Clinical development for further indications and preclinical research into new fields of application are 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, 2015 filed with the SEC on March 30, 2016.
In January 2015, our subsidiary signed a contract
with a contract research organization (“CRO”) for conducting a pivotal clinical trial with Elafin for the prophylactic
treatment of acute postoperative complications after resection of esophageal cancer (“POSTCOM TRIAL”). In addition,
our subsidiary commissioned the GMP manufacturing of the study drug. In December 2015, the EMA pediatric committee (“PDCO”)
agreed that no investigations in pediatric populations will be performed, as children are almost not affected by this kind of cancer.
We plan to conduct the POSTCOM TRIAL at up to 10 sites in the European Union and it is expected to enroll 80 patients.
In September 2015, we received a
Pre-Investigational New Drug Application (“PIND”) Meeting Request Granted Letter from the US Food and Drug
Administration (“FDA”) for discussing the development strategies for Elafin to be used for the treatment of
pulmonary arterial hypertension (“PAH”) within the framework of our collaboration with Dr. Rabinovitch at
Stanford University. A face-to-face meeting occurred in November 2015. There are no updates at this time.
In February 2016, the results of a biodistribution
study with radiolabeled Elafin were published (Kaschwich et al., Drug Metab Pharmacokinet 2016). The researchers found high accumulation
in the kidney and concluded that this could be of great importance in the future as within the treatment of reperfusion injury
of the kidney.
In March 2016, a third-party entered into
a letter of intent with the Company to purchase a yet to be negotiated amount of the Company’s Preferred Stock.
Additionally, in the first quarter 2016, the Company obtained a 500,000 Euro funding commitment from a third-party investment
company. There are no updates at this time.
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 EUR 874,000 (approx. US$ 1 million) and will be used for the R&D program to develop a new formulation of Proteo's lead
compound Elafin. A new Elafin formulation will allow Proteo to extend the development pipeline to treat chronic diseases, such
as pulmonary arterial hypertension (PAH).
RESULTS OF OPERATIONS
REVENUES
Revenue
reported represent income recognized under the Development Agreement, as described above and in Note 5 to the
accompanying condensed consolidated financial statements. Approximately $80,000 and $307,000 was recognized as development
income during the six-month periods ended June 30, 2016 and 2015, respectively, and $45,000 and $133,000 was recognized as
development income during the three-month periods ended June 30, 2016 and 2015, respectively. The decrease in revenues was
due to a decrease in research activities in 2016, as well as a decrease in the recognition rate.
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 Euros, 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 expenses
was due to additional clinical indicators that will be explored by the Company. Revenues continued to be recognized at 43% of
related expenses for the six-month period ended June 30, 2016.
OPERATING EXPENSES
The Company's operating expenses for the three-month
and six-month periods ended June 30, 2016 approximated $21,000 and $103,000, respectively, a decrease of approximately $107,000
and $206,000 over the respective periods of the prior year. General and administrative expenses (mostly professional and legal
fees) for the three-month and six-month periods increased (decreased) $12,000 and ($6,000) respectively. Research and development
expenses decreased $118,000 and $200,000 over the same periods. The decrease in research and development expenses was primarily
due to $82,000 of Grant funds recorded in 2016, which were netted against research and development expenses, as well as decreases
to research related salaries and expenditures in preparation for the POSTCOM TRIAL in 2016.
INTEREST AND OTHER INCOME (EXPENSE)
Interest and other income (expense), net for
the three-month and six-month periods ended June 30, 2016 approximated $39,000 and ($13,000), respectively, compared to $(17,000)
and $119,000 for the respective periods in 2015, a net increase (decrease) of approximately $56,000 and ($131,000), respectively.
The changes are driven primarily by fluctuating foreign currency transaction gains and losses due to a fluctuations of the Euro
compared to the U.S. Dollar. Foreign currency transaction gains and losses were primarily driven by unrealized gains and losses
on accrued licensing fees related to the Licensing Agreement, which is denominated in Euros.
INCOME TAXES
There is no material income tax expense recorded
for the periods ended June 30, 2016 and 2015, due to the Company's net losses. The Company has a deferred tax asset of
$2,293,000 at June 30, 2016 relating primarily to tax net operating loss carryforwards, as discussed below, 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) of approximately ($21,000) and $119,000 related to foreign currency translation adjustments during the six-month
periods ended June 30, 2016 and 2015, 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
Proteo is a holding company that owns 100%
of Proteo Biotech AG, its operating subsidiary in Germany (the “Subsidiary”). There were no undistributed earnings
of the Subsidiary to repatriate to the U.S. parent (i.e. the Company).
The Company received approximately 175,000
Euros and 70,000 Euros under the Development Agreement during the six-month periods ended June 30, 2016
and 2015, respectively. The Company expects to receive approximately 2.0 million Euros in future periods under this agreement.
In June 2016, the German State of Schleswig-Holstein
granted PBAG approximately 874,000 Euros (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, 2018. PBAG submitted for the reimbursement of eligible expenses through June 30, 2016 approximating 74,000 Euros. As such approximately
$82,000 was accrued as a grant funds receivable on the accompanying condensed consolidated balance sheet as of June 30, 2016.
In June 2014, Dr. Wiedow agreed in writing
to waive any non-payment defaults under the License Agreement and to defer all current payments to April 2018. See Note 6 to the
condensed consolidated financial statements included elsewhere for the payment terms under the License Agreement.
The Company has cash approximating $208,000
as of June 30, 2016 to support current and future operations. This is a decrease of $29,000 over the December 31, 2015 cash balance
of approximately $237,000. Such cash is held by the Subsidiary in Germany in Euros. 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
over the next few years. 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 has sufficient cash on hand
to cover its operations for the next 2 to 3 years. As for periods beyond the next 3 years, the Company expects to continue to
direct the majority of research and development expenses towards the development of Elafin, although it is extremely difficult
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:
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the uncertainty of future clinical trial results;
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the uncertainty of the ultimate number of patients to be treated in any current or future clinical trial;
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the uncertainty of the applicable regulatory bodies allowing our studies to move forward;
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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;
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the uncertainty of terms related to potential future partnering or licensing arrangements;
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the uncertainty of protocol changes and modifications in the design of our clinical trial studies, which may increase or decrease our future costs,
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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.
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As a result of the foregoing, the Company's
success will largely depend on its ability to generate revenues from outside licensing activities and secure additional funding
through the sale of its Common/Preferred Stock and/or debt securities. There can be no assurance, however, that the Company will
be able to generate revenues from outside 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.
RESEARCH SUPPLIES
The Company’s capitalized research supplies,
which are all held by PBAG in Germany, have increased from $236,000 at December 31, 2015 to $238,000 at June 30, 2016, primarily
due to a strengthening of the Euro compared to the US Dollar.
GRANT FUNDS RECEIVABLE
As noted previously, in June the Company received
a Grant covering eligible research and development costs. PBAG submitted for the reimbursement of eligible expenses through June
30, 2016 approximating 74,000 Euros. As such approximately $82,000 was accrued as a grant funds receivable on the accompanying
condensed consolidated balance sheet as of June 30, 2016.
RECEIVABLES FROM DEVELOPMENT AGREEMENT
Receivables related to the Development Agreement
approximating $71,000 at December 31, 2015 were collected during the six-month period ended June 30, 2016.
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES
Accounts payable and accrued liabilities decreased
from $304,000 at December 31, 2015 to $247,000 at June 30, 2016, primarily due to the payment of 2015 year-end audit and legal
fees during the six-month period ended June 30, 2016.
DEFERRED REVENUES
Deferred revenues related to the Development
Agreement had a translated balance of approximately $258,000 at June 30, 2016, a $46,000 increase from the balance at December
31, 2015. The increase was driven by additional deferrals, partly offset by the recognition of revenues of $80,000.
ACCRUED LICENSING FEES
Accrued licensing fees increased from $622,000
at December 31, 2015 to $633,000 at June 30, 2016, due to a strengthening of the Euro compared to US Dollar. The Licensing Agreement
is denominated in Euros, and the accrued licensing fee was 570,000 Euros at both June 30, 2016 and December 31, 2015.
OTHER LIABILITIES
Other liabilities at June 30, 2016 and at
December 31, 2015 consist of employee compensation that was incurred in 2015 but for which payment was agreed to be deferred until
2018. The decrease is due to strengthening of the Euro compared to US Dollar.
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
a) 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 June 30, 2016. Based on that evaluation, Ms. Bargmann
concluded that as of June 30, 2016, 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.
b) Changes in Internal Control Over Financial Reporting
Our management, with the participation of
the 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 has materially affected, or is 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.
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
ITEM 5. OTHER INFORMATION.
None.
ITEM 6. EXHIBITS.
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Exhibits:
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31.1
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Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
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31.2
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Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
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32
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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.
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101.INS
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XBRL Instance Document
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101.SCH
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XBRL Schema Document
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101.CAL
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XBRL Calculation Linkbase Document
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101.DEF
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XBRL Definition Linkbase Document
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101.LAB
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XBRL Label Linkbase Document
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101.PRE
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XBRL Presentation Linkbase Document
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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.
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PROTEO, INC.
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Dated: August 5, 2016
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By:
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/s/ Birge Bargmann
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Birge Bargmann
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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)
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