|
|
|
|
|
|
|
|
|
NOVEMBER 22,
|
|
|
|
|
|
|
|
|
|
|
2000
|
|
|
|
|
|
|
|
|
|
|
(INCEPTION)
|
|
|
|
|
SIX MONTHS ENDED
|
|
|
THROUGH
|
|
|
|
|
JUNE 30,
|
|
|
June 30,
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(367,548
|
)
|
|
$
|
(511,029
|
)
|
|
$
|
(6,283,934
|
)
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
28,416
|
|
|
|
29,054
|
|
|
|
363,094
|
|
|
Loss on disposal of equipment
|
|
|
-
|
|
|
|
-
|
|
|
|
4,518
|
|
|
Unrealized foreign currency transaction (gains) losses
|
|
|
(2,940
|
)
|
|
|
115,779
|
|
|
|
180,462
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research supplies
|
|
|
(6,654
|
)
|
|
|
(1,498
|
)
|
|
|
(137,346
|
)
|
|
Prepaid expenses and other current assets
|
|
|
51,909
|
|
|
|
57,992
|
|
|
|
(138,310
|
)
|
|
Accounts payable and accrued liabilities
|
|
|
(33,024
|
)
|
|
|
(59,152
|
)
|
|
|
58,951
|
|
|
Deferred revenue
|
|
|
-
|
|
|
|
-
|
|
|
|
120,341
|
|
|
Accrued licensing fees
|
|
|
-
|
|
|
|
-
|
|
|
|
660,713
|
|
|
NET CASH USED IN OPERATING ACTIVITIES
|
|
|
(329,841
|
)
|
|
|
(368,854
|
)
|
|
|
(5,171,511
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition of property and equipment
|
|
|
(17,823
|
)
|
|
|
-
|
|
|
|
(631,129
|
)
|
|
Cash of reorganized entity
|
|
|
-
|
|
|
|
-
|
|
|
|
27,638
|
|
|
NET CASH USED IN INVESTING ACTIVITIES
|
|
|
(17,823
|
)
|
|
|
-
|
|
|
|
(603,491
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock
|
|
|
-
|
|
|
|
-
|
|
|
|
1,792,610
|
|
|
Proceeds from subscribed common stock and issuance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
of preferred stock to related party
|
|
|
335,383
|
|
|
|
1,132,502
|
|
|
|
4,880,969
|
|
|
NET CASH PROVIDED BY FINANCING ACTIVITIES
|
|
|
335,383
|
|
|
|
1,132,502
|
|
|
|
6,673,579
|
|
|
EFFECT OF FOREIGN CURRENCY EXCHANGE RATE CHANGES ON CASH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AND CASH EQUIVALENTS
|
|
|
28,503
|
|
|
|
109,070
|
|
|
|
355,095
|
|
|
NET INCREASE IN CASH AND CASH EQUIVALENTS
|
|
|
16,222
|
|
|
|
872,718
|
|
|
|
1,253,672
|
|
|
CASH AND CASH EQUIVALENTS--BEGINNING OF PERIOD
|
|
|
1,237,450
|
|
|
|
802,745
|
|
|
|
-
|
|
|
CASH AND CASH EQUIVALENTS--END OF PERIOD
|
|
$
|
1,253,672
|
|
|
$
|
1,675,463
|
|
|
$
|
1,253,672
|
|
SEE ACCOMPANYING NOTES TO THESE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
PROTEO, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2009 (UNAUDITED)
1. NATURE OF BUSINESS AND BASIS OF PRESENTATION
BASIS OF PRESENTATION
The accompanying condensed consolidated balance sheets as of December 31, 2008, which has been derived from audited financial statements, and the accompanying interim condensed consolidated financial statements as of June
30, 2009,
for the three-month and six-month periods ended June 30, 2009 and 2008 and for the period
from November 22, 2000 (Inception) through June 30, 2009 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 period ended June 30, 2009 are not necessarily indicative of the results
that may be expected for the year ending December 31, 2009 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. The
accompanying 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, 2008 filed
with the SEC on March 30, 2009.
NATURE OF BUSINESS
The Company intends to develop, manufacture, promote and market pharmaceuticals
and other biotech products. The Company is focused on the development of
pharmaceuticals
based on the human protein Elafin which naturally occurs in
human skin, lungs and mammary glands. The Company believes Elafin may be useful
in the treatment of cardiac infarction, serious injuries caused by accidents,
post surgery damage to tissue, complications
resulting from organ
transplantations and pulmonary arterial hypertension.
The products that the Company is developing are considered drugs or biologics,
and hence 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. Once the research and development
phase
is complete, the Company intends to manufacture and 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
plans to identify and develop other
potential products. 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.
Proteo, Inc.'s common stock is currently quoted on the OTC Bulletin Board of the
Financial Industry Regulatory Authority under the symbol "PTEO".
DEVELOPMENT STAGE AND GOING CONCERN CONSIDERATIONS
The Company has been in the development stage since it began operations on
November 22, 2000, and has not generated any significant revenues from
operations.
Management plans to generate revenues from product sales, but there
is no commitment by any persons for purchase of any of the proposed products and
there is no assurance of any future revenue. The Company will require
substantial additional funding for continuing
research and development,
obtaining regulatory approvals and for the commercialization of its product.
There can be 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.
PROTEO, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2009 (UNAUDITED)
Management has taken action to address these matters, which include:
|
|
·
|
Retention of experienced management personnel with particular skills in the development of such products;
|
|
|
·
|
Attainment of technology to develop biotech products; and
|
|
|
·
|
Raising additional funds through the sale of debt and/or equity securities.
|
In the absence of significant sales and profits, the Company may seek to raise
funds to meet its future working capital requirements through the additional
sales
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.
These circumstances, among others, raise concerns about the Company's ability to
continue as a going concern. The accompanying condensed consolidated financial
statements
do not include any adjustments that might result from the outcome of
this uncertainty.
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.
Proteo, Inc.'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.
OTHER RISKS AND UNCERTAINTIES
Proteo, Inc.'s line of future pharmaceutical products being developed by its
German subsidiary are considered drugs or biologics, and as such, 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 in Germany
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, its
wholly
owned subsidiary. All significant intercompany accounts and transactions
have been eliminated in consolidation.
On January 1, 2009, the Company adopted SFAS 160, “Noncontrolling Interests in
Consolidated Financial Statements, an amendment of ARB No. 51,” which requires
the Company to make certain changes to the presentation of the
Company's
financial statements. This standard requires the Company to classify
noncontrolling interests (previously referred to as "minority interest") as part
of consolidated net earnings
and
to include the accumulated amount of noncontrolling interests
as part of stockholders' equity
. The net loss amounts the Company
has previously reported are now presented as "Net loss attributable to Proteo,
Inc"
and, as required by SFAS 160, earnings per share continues to reflect
amounts attributable only to the Company. Similarly, in the presentation of
stockholders' equity, the Company distinguishes between equity amounts
attributable to the Company's stockholders and
amounts attributable to the
noncontrolling interests - previously classified as minority interest outside of
stockholders' equity. In addition to these financial reporting changes, SFAS 160
provides for significant changes in accounting related to noncontrolling
interests;
specifically, increases and decreases in the Company's controlling
financial interests in consolidated subsidiaries will be reported in equity
similar to treasury stock transactions. If a change in ownership of a
consolidated subsidiary results in loss of control
and deconsolidation, any
retained ownership interests are remeasured with the gain or loss reported in
net earnings. Except for presentation, the adoption of SFAS 160 did not have a
material effect on the Company's consolidated financial statements because a substantive
contractual
arrangement specifies the attribution of net earnings and loss not to exceed the
noncontrolling interest.
PROTEO, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2009 (UNAUDITED)
FAIR VALUE OF FINANCIAL INSTRUMENTS AND CERTAIN OTHER ASSETS/LIABILITIES
Statement of Financial Accounting Standards ("SFAS") No. 107 "DISCLOSURES ABOUT FAIR VALUE OF FINANCIAL INSTRUMENTS" 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 December 31, 2008 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, 2009 and 2008 and for the period
from November 22, 2000 (Inception)
through June 30, 2009, did not have any assets or liabilities that were measured at fair value on a non-recurring basis. The measurements referenced in the preceding sentence refer to those described in SFAS No. 157 ("Fair Value Measurements"), as amended.
SIGNIFICANT RECENT ACCOUNTING PRONOUNCEMENTS
In April 2009, the Financial Accounting Standards Board (“FASB”) issued FASB Staff Position (“FSP”) FAS 107-1/APB 28-1 (“FSP 107-1”), “Interim Disclosures about Fair Value of Financial Instruments”. This pronouncement amended SFAS No 107, “Disclosures
about Fair Value of Financial Instruments”, to require disclosure of the carrying amount and the fair value of all financial instruments for interim reporting periods and annual financial statements of publicly traded companies (even if the financial instrument is not recognized in the balance sheet), including the methods and significant assumptions used to estimate the fair values and any changes in such methods and assumptions. FSP 107-1 also amended APB Opinion No. 28, “Interim Financial
Reporting”, to require disclosures in summarized financial information at interim reporting periods.
The FASB also issued FSP FAS 157-4 (“FSP 157-4”), “Determining Fair Value When the Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying Transactions That Are Not Orderly” in April 2009. FSP 157-4 generally applies to all assets and liabilities
within the scope of any accounting pronouncements that require or permit fair value measurements. This pronouncement, which does not change SFAS No. 157, “Fair Value Measurements” (“SFAS 157”) guidance regarding Level 1 inputs, requires the entity to (i) evaluate certain factors to determine whether there has been a significant decrease in the volume and level of activity for the asset or liability when compared with normal market activity, (ii) consider whether the
preceding indicates that transactions or quoted prices are not determinative of fair value and, if so, whether a significant adjustment thereof is necessary to estimate fair value in accordance with SFAS No. 157, and (iii) ignore the intent to hold the asset or liability when estimating fair value. FSP 157-4 also provides guidance to consider in determining whether a transaction is orderly (or not orderly) when there has been a significant decrease in the volume and level of activity for the asset
or liability, based on the weight of available evidence.
In April 2009, the FASB issued FSP FAS 115-2 and 124-2 (“FSP 115-2/124-2”), “Recognition and Presentation of Other-Than-Temporary Impairments,” which amends the other-than-temporary impairment (“OTTI”) recognition guidance in certain existing U.S. GAAP (including SFAS No. 115 and
130, FSP FAS 115-1/FAS 124-1, and EITF Issue 99-20) for debt securities classified as available-for-sale and held-to-maturity. FSP 115-2/124-2 requires the entity to consider (i) whether the entire amortized cost basis of the security will be recovered (based on the present value of expected cash flows), and (ii) its intent to sell the security. Based on the factors described in the preceding sentence, this pronouncement also explains the process for determining the OTTI to be recognized
in “other comprehensive income” (generally, the impairment charge for other than a credit loss) and in earnings. FSP 115-2/124-2 does not change existing recognition or measurement guidance related to OTTI of equity securities.
PROTEO, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2009 (UNAUDITED)
SIGNIFICANT RECENT ACCOUNTING PRONOUNCEMENTS (continued)
FSP 107-1, FSP 157-4 and FSP 115-2/124-2 were all effective for the interim period ended June 30, 2009. The adoption of such standards had no material impact on the accompanying condensed consolidated financial statements.
In May 2009, the FASB issued SFAS No. 165 entitled
Subsequent Events
. The objective of this Statement is to establish general standards of accounting for and disclosure of events that occur after the balance sheet date but before financial statements are issued or are available
to be issued. In particular, this Statement sets forth the period after the balance sheet date during which management of a reporting entity should evaluate events or transactions that may occur for potential recognition or disclosure in the financial statements, the circumstances under which an entity should recognize events or transactions occuring after the balance sheet date in its financial statements, and the disclosures that an entity should make about events or transactions that occurred after the balance
sheet date. This Statement is effective for financial statements issued for interim and annual periods ending after June 15, 2009 and did not have any impact on the Company's consolidated financial statements. The Company evaluated subsequent events through the filing date of our quarterly 10-Q with the Securities and Exchange Commission on August
6
, 2009.
In June 2009, the FASB issued Statement No. 168, "The FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles - a replacement of FASB Statement No. 162"
("FAS 168"). The Codification will
become the source of authoritative GAAP recognized by the FASB to be applied by nongovernmental entities. Rules and interpretive releases of the SEC under authority of federal securities laws are also sources of authoritative GAAP for SEC registrants. On the effective date of FAS 168, the Codification will supersede all then-existing non-SEC accounting and reporting standards.
All other nongrandfathered non-SEC accounting literature
not included in the Codification will become nonauthoritative. FAS 168 is effective for financial statements issued for interim and annual periods ending after September 15, 2009. FAS 168 is not expected to have a material impact on our consolidated financial position, results of operations, or cash flows.
Except as described above, in the opinion of management, neither the Financial
Accounting Standards Board, its Emerging Issues Task Force, the AICPA, nor the
SEC
have issued any additional accounting pronouncements since the Company filed
its December 31, 2008, Form 10-K that are expected to have material impact on
the Company's future consolidated financial statements.
2. STOCK SUBSCRIPTIONS RECEIVABLE AND OTHER EQUITY TRANSACTIONS
The Company is authorized to issue 10,000,000 shares of preferred stock, $0.001
par value. Except as described below, the Board of Directors has not designated any liquidation value, dividend rates or other rights or preferences with
respect to any shares of preferred stock.
The Board of Directors has designated 750,000 preferred shares as non-voting Series A Preferred Stock.
As more fully described in the Company’s Form 8-K filed with the SEC on June 11, 2008.
Holders
of Series A Preferred Stock are entitled to receive preferential dividends, if and when declared, at the per share rate of twice the per share amount of any cash or non-cash dividend distributed to holders of the Company's common stock. If no dividend is distributed to common stockholders, the holders of Series A Preferred Stock are entitled to an annual stock dividend payable at the rate of one share of Series A Preferred Stock for each twenty shares of Series A Preferred Stock owned by each holder of Series
A Preferred Stock. The annual stock dividend shall be paid on June 30 of each year commencing in 2009 and no stock dividends will be paid after December 31, 2011.
On June 9, 2008, the Company entered into a Preferred Stock Purchase Agreement
("Stock Purchase Agreement") with FIDEsprit (the “Investor”), a common stockholder and related party. Pursuant to the Stock Purchase
Agreement,
the Company sold and issued to the Investor 600,000 shares of Series A Preferred
Stock at a price of $6.00 per share, for an aggregate price of $3,600,000
("Purchase Price"). In payment of the Purchase Price, the Investor delivered to the
Company a promissory note
in the amount of $3,600,000 (the “Note”), maturing on March 31, 2009.
The Note is guaranteed by a principal of the Investor (the “Guaranty”).
During the six-month periods ended June 30, 2009 and 2008,
the Company received payments approximating
$335,000 and $1,133,000,
respectively, in connection with the Stock Purchase Agreement.
The unpaid principal balance of the Series A Preferred Stock
note receivable as of June 30, 2009 approximated $1,910,000.
Of
this amount approximately $35,000 was received in July 2009.
The Series A Preferred Stock note receivable is reported as a reduction of
stockholders' equity at June 30, 2009.
On July 6, 2009, the Company and Investor entered into a Forbearance Agreement and General Release (the “Forbearance Agreement”) to renegotiate the terms of the Note. Pursuant to the Forbearance Agreement, the Investor acknowledged and agreed that, as of July 6, 2009, it was obligated to the
Company under the Note for the aggregate sum of $1,940,208 (the “Indebtedness”), which represents the unpaid principal amount as of such date plus a late charge equal to three percent (3%) of the unpaid principal amount. In exchange for the Company’s agreement to forbear from exercising its rights under the Note and Guaranty, the Investor has agreed to pay the Indebtedness by making monthly payments in the amount of $140,000 commencing on the first business day of September 2009 and
continuing on the first business day of each succeeding month thereafter until the Indebtedness is paid in full.
The other information required by Item 701 of Regulation S-K relating to the
transactions described in the preceding paragraphs were included in the Company's
Forms
8-K filed with the SEC on June 11, 2008 and July 8, 2009.
PROTEO, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2009 (UNAUDITED)
Effective June 30, 2009, the Company declared a stock dividend of 30,000 shares of Series A Preferred Stock payable to its Series A Preferred Stock holders.
There were no issuances of common stock during the six-month period ended
June 30, 2009, nor have any stock options been granted from inception to date.
3. LOSS PER COMMON SHARE
The Company computes loss per common share using
SFAS No. 128, "EARNINGS PER SHARE." Basic loss per
common share is computed based on the weighted
average number of shares
outstanding for the period. Diluted loss per common share is computed by
dividing net loss attributable to common stockholders 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, 2009 or 2008. Additionally, there were no
adjustments to net loss to determine net loss available to common shareholders.
As such, basic and diluted loss per common share equals net loss, as reported,
divided
by the weighted average common shares outstanding for the respective
periods.
4. 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 comprehensive income approximated $308,000 at
June 30, 2009 and $279,000 at December 31, 2008.
5. FOREIGN CURRENCY TRANSACTIONS
The Company records payables related to a certain licensing agreement (Note 7)
in accordance with SFAS No. 52, "FOREIGN CURRENCY TRANSLATION." 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. The Company has made no payments under this licensing agreement
during the six-month periods ended June 30, 2009 and 2008, and, therefore,
has not realized any significant foreign currency exchanges gains or losses
during
these periods.
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 unrealized gain or loss that
is currently recognized. The Company
recorded an unrealized foreign currency
transaction gain of approximately $3,000 and an unrealized foreign currency
transaction loss of $116,000 for the six-month periods ended June 30, 2009 and 2008,
respectively, which are included in interest and other income
(expense), net in
the accompanying condensed consolidated statements of operations and
comprehensive loss.
6. SEGMENTS OF AN ENTERPRISE AND RELATED INFORMATION
SFAS No. 131, "DISCLOSURES ABOUT SEGMENTS OF AN ENTERPRISE AND RELATED
INFORMATION," establishes standards for how public companies report information
about
segments of their business in their annual financial statements and
requires them to disclose selected segment information in their quarterly
reports issued to shareholders. It also requires entity-wide disclosures about
the products and services an entity provides,
the countries in which it holds
material assets and reports material revenues and its major customers. The
Company considers itself to operate in one segment and has not generated any
significant operating revenues since its inception. All of the Company's
property
and equipment is located in Germany.
PROTEO, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2009 (UNAUDITED)
7. DR. WIEDOW LICENSE AGREEMENT
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. No
payments were made through fiscal
year 2003. In 2004, the License Agreement was
amended to require the Company to make annual payments of 30,000 Euros, to be
paid on July 15 of each year, beginning in 2004. Such annual payment could be
increased to 110,000 Euros by June 1 of each year based on an
assessment of the
Company's financial ability to make such payments. In December 2007 the Company
paid Dr. Wiedow 30,000 Euros. The License Agreement was again amended by an
Amendment Agreement to the License Agreement (the "Amendment") dated December
23,
2008. Pursuant to the Amendment, the Company and Dr. Wiedow have agreed that
the Company would pay the outstanding balance of 630,000 Euros to Dr. Wiedow as
follows: for fiscal years 2008 to 2012, the Company shall pay Dr. Wiedow 30,000
Euros per year, and for fiscal
years 2013 to 2016, the Company shall pay Dr.
Wiedow 120,000 Euros per year. The foregoing payments shall be made on or before
December 31 of each fiscal year. In December 2008 the Company paid Dr. Wiedow
30,000 Euros. 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 (1.6% as of January 1, 2009)
plus six percent. In the event that the Company's financial condition improves,
the
parties can agree to increase and/or accelerate the payments.
The Amendment also modified the royalty payment such that from the date of the
Amendment the Company will not only pay Dr. Wiedow a three percent royalty on
gross
revenues from the Company's sale of products based on the licensed
technology but also three percent of the license fees (including upfront and
milestone payments and running royalties) received by the Company or its
subsidiary from their sublicensing of the licensed
technology.
At June 30, 2009 and December 31, 2008, the Company has accrued approximately
$843,000 and $846,000, respectively, of licensing fees payable to Dr. Wiedow of
which approximately $42,000
is included in current
liabilities as of both periods and $801,000 and $804,000, respectively, is included in long-term
liabilities. The difference in amounts at June 30, 2009 compared to December
31, 2008 is attributable to the unrealized foreign currency transaction
gain
described in Note 5.
Dr. Wiedow, who is a director of the Company, beneficially owned approximately
45% of the Company's outstanding common stock as of June 30, 2009.
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, 2009 or 2008, due to the Company's net losses and related changes to the valuation allowance for deferred tax assets.
As of June 30, 2009, the Company has a deferred tax asset and an equal amount of valuation allowance of approximately $1,721,000, relating primarily to federal and foreign net operating loss carryforwards of approximately $363,000 and $1,072,000, respectively, as discussed below, and timing differences related to the recognition of accrued
licensing fees of approximately $286,000.
PROTEO, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2009 (UNAUDITED)
The Company has federal and foreign net operating loss carry forwards in the amount of $1,068,000 and $4,289,000, respectively at June 30, 2009, which is expected to begin expiring in 2025 for federal purpose and has indefinite life for foreign purpose.
Utilization of the net operating losses (“NOL”) carry forwards may be subject to a substantial annual limitation due to ownership change limitations that may have occurred or that could occur in the future, as required by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), as well as similar
state and foreign provisions. These ownership changes may limit the amount of NOL carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change” as defined by Section 382 of the Code results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percentage points of the market value of a company by certain stockholders or public groups. Due to the existence
of the valuation allowance, future changes in the Company’s unrecognized tax benefits will not impact its effective tax rate. Any carry forwards that may expire prior to utilization as a result of such limitations will be removed, if applicable, from deferred tax assets with a corresponding reduction of the valuation allowance.
The Company adopted the provisions of Financial Accounting Standards Board (“FASB”) Interpretation No. 48, “Accounting for Uncertainty in Income Taxes — an Interpretation of FASB Statement No. 109” (“FIN 48”) on January 1, 2007. Based on management’s evaluation, 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 a result of adopting FIN 48. As of June 30, 2009, 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.
Since inception, the Company has generated a relatively minor amount of
non-operating revenue from its licensing activities and does not expect to
report
any significant operating revenue until the successful development and
marketing of its planned pharmaceutical and other biotech products.
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
The Company specializes in the research, development and marketing of drugs for
inflammatory diseases with Elafin as its first project. Management deems Elafin
to
be one of the most prospective substances in the treatment of serious tissue
and muscle damage. Independently conducted animal experiments have indicated
that Elafin may have benefits in the treatment of tissue and muscle damage
caused by insufficient oxygen supply
and therefore may be useful in the
treatment of heart attacks, serious injuries and in the course of organ
transplants. Other applications have yet to be determined.
The Company intends to implement Elafin as a drug in the treatment of
inflammatory diseases, and plans to seek governmental approval in Europe first. C
urrently,
management estimates that it will take approximately four years to
achieve its first governmental approval for the use of Elafin as a drug for the
first indication.
The Company's success will depend on its ability to prove that Elafin is well
tolerated by humans and its efficacy in the indicated treatment. There can be no
assurance
that the Company will be able to develop feasible production
procedures in accordance with Good Manufacturing Practices ("GMP") standards, or
that Elafin will receive any governmental approval for its use as a drug in any
of the intended applications.
After developing a production procedure for Elafin, Proteo has initiated
clinical trials to achieve governmental approval for the use of Elafin as a drug
in
Europe. For this purpose, Proteo has contracted Eurogentec, an experienced
Contract Manufacturing Organization (“CMO”) located in Belgium to produce Elafin
in accordance with GMP standards as required for clinical trials.
In September 2006 the Company filed an application with the EMEA (European Medicines
Agency) to obtain orphan drug status in the European markets for Elafin to be u
sed in the
treatment of pulmonary hypertension. Subsequent to December 31,
2006, the Committee for Orphan Medical Products of the EMEA adopted a positive
opinion recommending the granting of orphan medicinal product designation for
Elafin for treatment of pulmonary arterial
hypertension and chronic
thromboembolic pulmonary hypertension. The orphan drug designation became
effective on March 20, 2007 upon adoption of the recommendation by the European
Commission.
In July 2007, the Company entered into an agreement with the University of Alberta,
Canada to cooperate in research on Elafin for the treatment of pulmonary
diseases
in neonates. Proteo will initially provide support for animal
experiments with its lead product on newborn rats to be carried out by Dr.
Bernard Thebaud, Associate Professor at the Department of Pediatrics and
Neonatology and a recognized authority in this area,
with profound knowledge of
animal models and substantial clinical experience.
In August 2007, the Company's subsidiary entered into an agreement with
Minapharm for clinical development, production and marketing of Elafin. We have
granted
Minapharm the right to exclusively market Elafin in Egypt and certain
Middle Eastern and African countries. Proteo received an upfront payment in 2007
and has deferred additional amounts received, and will receive milestone-
payments and royalties on net product
sales. In addition, Minapharm will take
over the funding of clinical research activities for the designated region. In
December 2008 the responsible authority in Cairo granted approval for a Phase II
clinical trial to study the efficacy of Elafin on kidney transplant
patients.
In January 2008 the Company entered into an agreement with Stanford University in
California, to cooperate in preclinical studies related to Elafin treatment of
pulmonary
arterial hypertension. Proteo will provide support for animal
experiments conducted by Marlene Rabinovitch, Research Director of the Vera
Moulton Wall Center for Pulmonary Vascular Disease at Stanford University who is
a renowned expert in the field, and her group
at the university.
In August 2008 the Company's subsidiary received the approval for a Phase II
clinical trial with Elafin by the German Federal Institute for Drugs and Medical
Devices
(BfArM). In this randomized, placebo-controlled Phase II trial the
effect of Elafin on inflammatory parameters will be investigated in patients
undergoing esophagectomy for esophagus carcinoma. The trial will be performed at
the Department of General and Thoracic
Surgery, University Medical Center
Schleswig-Holstein, Campus Kiel. Patient recruitment started in November 2008 and is ongoing.
The excellent tolerability of Elafin in human subjects was demonstrated in a
Phase I clinical single dose escalating study.
The Company's
goal is to obtain the first governmental regulatory approval for the first
indication of the initial product in 2012.
It should be noted that the first
indication, if successfully developed, would have a market potential
substantially smaller than the overall market of Elafin for more widespread
applications such as for the treatment of cardiac infarction.
RESULTS OF OPERATIONS
OPERATING EXPENSES
The Company's operating expenses for the six month period ended June 30, 2009
were approximately $460,000, a decrease of approximately $2,000 over the same
period
of the prior year.
The Company's operating expenses for the three month period ended June 30, 2009
were approximately $280,000, an increase of approximately $68,000 over the same
period
of the prior year. This increase is due primarily to an increase in
general and administrative expenses during the current year quarter of
approximately $81,000 and a decrease in research and development expenses of
approximately $13,000. The increase in general
and administrative expenses is
primarily due to an increase in professional fees related to public financial
reporting in the current year.
INTEREST AND OTHER EXPENSE
Interest and other income (expenses) for the six-month and three-month periods
ended June 30, 2009 were approximately $93,000, and $36,000, respectively,
an
increase of approximately $142,000 and $23,000 over the same periods of
the prior year. The increases are due primarily to an increase in the unrealized
foreign currency transaction loss described in Note 5 to the Company's condensed
consolidated financial statements
included elsewhere herein.
INCOME TAXES
There is no material income tax expense recorded for the periods ended June 30,
2009 or 2008, due to the Company's net losses.
As of June 30, 2009, the Company has a deferred tax asset and an equal amount
of valuation allowance of approximately $1,721,000, relating primarily to
federal
and foreign net operating loss carryforwards of approximately $363,000
and $1,072,000, respectively, as discussed below, and timing differences related
to the recognition of accrued licensing fees of approximately $286,000.
As of June 30, 2009, the Company had tax net operating loss carryforwards
("NOLs") of approximately $1,068,000 and $4,289,000 (3,053,000 Euros) available to
offset
future taxable Federal and foreign income, respectively. 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 tax NOLs could
be severely restricted.
FOREIGN CURRENCY TRANSLATION ADJUSTMENTS
We experienced a net gain of approximately $29,000 and $150,000 in foreign
currency translation adjustments during the six-month and three-month
periods
ended June 30, 2009, respectively. This represents a decrease of
approximately $114,000 over the six-month period in 2008 and an increase of $91,000 over the three-month period in
2008. 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
Since our inception we have raised a total of (i) approximately $4,983,000 from
the sale of 20,065,428 shares of our common stock, of which 6,585,487 shares,
300,000
shares and 1,500,000 shares have been sold at $0.40 per share, $0.84 per
share and $0.60 per share, respectively, under stock subscription agreements in
the amount of approximately $2,035,000, $252,000 and $900,000, respectively, and
(ii) $1,419,000 from the sale
of 600,000 shares of the Company's non-voting
Series A Preferred Stock. The balance of the purchase price for the Series A
Preferred Stock is evidenced by a promissory note which, as of June 30, 2009,
had a principal balance of $1,910,000. See Note 2 to the condensed
consolidated
financial statements included elsewhere herein for the payment terms under the
promissory note.
The Company has cash approximating $1,254,000 as of June 30, 2009 to support
current and future operations. This is an increase of $17,000 over the December 31, 2008
cash
balance of approximately $1,237,000.
Management believes that the Company will not generate any significant revenues
in the next few years, nor will it have sufficient cash to fund future
operations.
As a result, the Company's success will largely depend on its
ability to secure additional funding through the sale of its common stock, preferred stock and/or
debt securities. There can be no assurance, however, that the Company will be
able to consummate a debt
or equity financing in a timely manner, or on terms
favorable to the Company, if at all.
GOING CONCERN
The Company's independent registered public accounting firm stated in their
Auditors’ Report included in our Form 10-K for the year ended December 31, 2008
dated
March 30, 2009, that the Company will require a significant amount of
additional capital to advance the Company's products to the point where they may
become commercially viable and has incurred significant losses since inception.
These conditions, among others,
raise substantial doubt about the Company's
ability to continue as a going concern.
Therefore, the Company will be required to seek
additional funds to finance its long-term operations. The successful outcome of
future activities
cannot be determined at this time and there is no assurance
that if achieved, the Company will have sufficient funds to execute its intended
business plan or generate positive operating results.
OFF BALANCE SHEET ARRANGEMENTS
The Company does not currently have any off balance sheet arrangements.
CAPITAL EXPENDITURES
None significant.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES 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 4T. 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, 2009. Based on that evaluation, Ms.
Bargmann concluded that as of June 30, 2009, 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.
SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
None.
ITEM 5.
OTHER INFORMATION.
None.
ITEM 6.
EXHIBITS.
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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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
6
, 2009
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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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18
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