UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Form 10-Q
|X| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2005
OR
|_| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from _________ to _________
Commission File No. 000-30603
HIV-VAC, INC.
(Exact name of registrant as specified in its charter)
Nevada 86-0876846
------ ----------
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
14 Laurel Blvd,
|
Collingwood, Ontario Canada L9Y 5A8
(Address of principal executive offices, Including zip code)
(705) 446-7242
Registrant's telephone number, including area code
Indicate by check mark whether the registrant: (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes |_| No |X|
Indicate by check mark whether the registrant has submitted electronically and
posted on its corporate Web site, if any, every Interactive Data File required
to be submitted and posted pursuant to Rule 405 of Regulation S-T (Section
232.405 of this chapter) during the preceding 12 months (or for such shorter
period that the registrant was required to submit and post such files). Yes |_|
No |_|
Indicate by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company, as
defined by Rule 12b-2 of the Exchange Act: (Check one):
Large accelerated filer |_| Accelerated filer |_|
Non-accelerated filer |_| Smaller reporting company |X|
Indicate by a check mark whether the registrant is a shell company (as defined
in Rule 12b-2 of the Exchange Act. Yes |_| No |X|
The number of shares of Common Stock outstanding was 10,430,652 as of September
02, 2010.
HIV-VAC, INC.
(A Development Stage Company)
INDEX TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
PAGE
----
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CONDENSED BALANCE
SHEET AS OF MARCH 31, 2005 (UNAUDITED) 3
CONDENSED STATEMENTS OF OPERATIONS
|
THREE MONTHS ENDED MARCH 31, 2005 AND 2004 AND
SIX MONTHS ENDED MARCH 31, 2005 AND 2004 AND
PERIOD FROM JANUARY 10, 1997 (DATE OF INCEPTION) TO
MARCH 31, 2005 (UNAUDITED) 4
CONDENSED STATEMENTS OF CASH FLOWS
SIX MONTHS ENDED MARCH 31, 2005 AND 2004 AND
PERIOD FROM JANUARY 10, 1997 (DATE OF INCEPTION) TO
MARCH 31, 2005 (UNAUDITED) 5-6
NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED) 7-11
ITEM 2. MANAGEMENT DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION 12-13
AND RESULTS OF OPERATIONS
ITEM 3. QUANTATIVE AND QUALATIVE DISCLOSURE ABOUT MARKET RISK 14
ITEM 4. CONTROLS AND PROCEDURES 14
PART II-- OTHER INFORMATION 15
ITEM 1. LEGAL PROCEEDINGS 15
ITEM 1A RISK FACTORS 15
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS 15
ITEM 3. DEFAULTS UPON SENIOR SECURITIES 15
ITEM 4. REMOVED OR RESERVED 15
ITEM 5. OTHER INFORMATION 15
ITEM 6. EXHIBITS 15
Exhibit 31.1
Exhibit 32.1
2
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
HIV-VAC, INC.
(A Development Stage Company)
BALANCE SHEETS (Unaudited)
ASSETS
March 31, September 30,
2005 2004
------------- -------------
Current Assets
Cash and equivalents $ 924 $ 2,609
Prepaid expenditure 71,851 22,105
------------- -------------
Total current assets 72,775 24,714
------------- -------------
Furniture and equipment, net
6,952 7,434
------------- -------------
Other Assets
Intangible assets, net 92,503 100,211
------------- -------------
Total assets $ 172,230 $ 132,359
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current Liabilities
Accrued liabilities:
Accounts Payable 427,717 200,659
Accrued Liabilities 56,309 14,000
Advances from related parties 528,193 515,094
------------- -------------
Total Current Liabilities 1,012,219 879,231
------------- -------------
Stockholders' Equity (Deficit)
Preferred stock, $0.01 par value;
10,000,000 shares authorized Series A,
non-preferential; 10,000 issued and
Outstanding 100 100
Series B, convertible, non-preferential;
1,000,000 and -0- shares issued and
outstanding, respectively 10,000 10,000
Common stock, $0.001 par value;
500,000,000 shares authorized;
9,831,669 and 9,831,669 shares issued
and outstanding, respectively 9,832 9,832
Additional paid in capital 6,435,925 6,435,926
Deficit accumulated during the
development stage (7,233,299) (7,153,064)
Treasury stock, at cost; 1,016 common stock
and 700,000 Preferred Stock, Series B (8,767) (8,767)
Accumulated other comprehensive loss (53,780) (40,899)
------------- -------------
Total stockholders' equity (deficit) (839,989) (746,872)
------------- -------------
Total liabilities and stockholders'
equity (deficit) $ 172,230 $ 132,359
============= =============
|
See accompanying notes to unaudited condensed financial statements.
3
HIV-VAC, INC.
(A Development Stage Company)
STATEMENTS OF OPERATIONS
Period from
January 10,
1997
Three Months Ended Six Months Ending (Inception)
------------------------ ------------------------ to
March 31, March 31, March 31, March 31, March 31,
2005 2004 2005 2004 2005
---------- ---------- ---------- ---------- -----------
Expenses
Research and development costs 5,950 24,898 11,884 79,176 1,716,171
Royalty Fees 23,950 22,377 46,055 42,348 1,785,963
General and administrative 7,286 7,673 14,107 18,393 731,912
Depreciation and amortization 4,094 6,154 8,189 12,308 133,961
Legal fees -- -- -- -- 1,500,028
Licensing fees -- -- -- -- 635,500
Loss from disposal of assets -- -- -- -- 30,195
---------- ---------- ---------- ---------- -----------
41,280 62,602 80,235 168,225 6,533,730
---------- ---------- ---------- ---------- -----------
Loss from operations (41,280) (62,602) (80,235) (168,225) (6,533,730)
---------- ---------- ---------- ---------- -----------
Other Income (Expense)
Other expenses -- -- -- -- (261,162)
Interest income -- -- -- -- 3,774
---------- ---------- ---------- ---------- -----------
Total other income (expense) -- -- -- -- (257,388)
---------- ---------- ---------- ---------- -----------
Loss from continuing operations (41,280) (62,062) (80,235) (168,225) (6,791,118)
Loss from discontinued operations -- -- -- -- --
Loss from Discontinued Operations -- -- -- -- (432,181)
---------- ---------- ---------- ---------- -----------
Net loss (41,280) (62,062) (80,235) (168,225) (7,223,299)
========== ========== ========== ========== ===========
Foreign Currency
Translation Adjustment 6,158 (9,022) (12,881) (22,633) (53,780)
---------- ---------- ---------- ---------- -----------
Comprehensive Loss (35,122) (71,084) (93,116) (190,858) (7,277,079)
========== ========== ========== ========== ===========
Loss per weighted average number
of Shares outstanding -
basic and diluted 0.01 0.01 0.01 0.02
---------- ---------- ---------- ----------
Weighted average number of common
shares outstanding during
period - basic and diluted 9,831,669 9,831,669 9,831,669 9,753,136
========== ========== ========== ==========
|
See accompanying notes to unaudited condensed financial statements.
4
HIV-VAC, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
FOR THE SIX MONTHS ENDED MARCH 31, 2005 AND 2004 AND FOR THE PERIOD
FROM JANUARY 10, 1997 (INCEPTION) TO MARCH 31, 2005 (UNAUDITED)
Period from
January 10,
1997
(Inception) For the Six Months Ended
to --------------------------
March 31, March 31, March 31,
2005 2005 2004
----------- ----------- -----------
Cash Flows From Operating Activities:
Net loss $(7,223,299) $ (80,235) $ (168,225)
Adjustments to reconcile net loss to
net cash used in operating activities:
Amortization and depreciation 133,961 8,189 12,308
Officers' compensation capitalized 100,000 -- --
Other expenses relating to Noveaux acquisition 261,163 -- --
Issuance of stock for licensing fees 2,135,500 -- --
Issuance of stock for directors and
officers compensation 110,100 -- --
Issuance of stock for fees and current debt 2,439,300 -- 42,500
Issuance of stock for note payable 140,000 -- --
Increase in prepaid expenditure (71,850) (49,745) (47,161)
(Decrease) in notes payable (140,000) -- --
Increase in payables and accrued liabilities 416,767 107,007 116,161
----------- ----------- -----------
Net Cash Used in Operating Activities (1,698,358) (14,784) (44,417)
----------- ----------- -----------
Cash Flow From Investing Activities:
Purchase of patent rights (85,000) -- --
Purchase of furniture and equipment (48,416) -- --
Cash acquired in acquisition 120,272 -- --
----------- ----------- -----------
Net Cash Used in Investing Activities (13,144) -- --
----------- ----------- -----------
Cash Flows from Financing Activities:
Proceeds from issue of preferred stock series B 10,000 -- --
Proceeds from issuance of common stock 689,164 -- --
Purchase of treasury stock (11,767) -- --
Proceeds from notes payable 140,000 -- --
Proceeds from advances from related parties 528,193 13,099 43,325
Proceeds from sale of treasury stock and
warrants 15,000 -- --
Payment of stockholder's loan (272) -- --
Proceeds from additional paid in capital 342,108 -- --
----------- ----------- -----------
Net Cash Provided by Financing Activities 1,712,426 13,099 43,325
----------- ----------- -----------
Net increase (decrease) in cash 924 (1,685) (1,092)
Cash and equivalents at beginning of period -- 2,609 3,706
----------- ----------- -----------
Cash and equivalents at end of period $ 924 $ 927 $ 2,614
=========== =========== ===========
See accompanying notes to unaudited condensed financial statements.
5
|
HIV-VAC, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
FOR THE SIX MONTHS ENDED MARCH 31, 2005 AND 2004 AND FOR THE PERIOD
FROM JANUARY 10, 1997 (INCEPTION) TO MARCH 31, 2005 (UNAUDITED)
Period from
January 10,
1997
(Inception) For the Six Months Ended
to --------------------------
March 31, March 31, March 31,
2005 2005 2004
----------- ----------- -----------
Supplemental Disclosure of Cash Flow Information:
Cash paid during the period for:
Issuance of common shares for Noveaux merger $ 106,525 $ -- $ --
=========== =========== ===========
Issuance of common shares for LifePlan merger $ 50,000 $ -- $ --
=========== =========== ===========
Preferred B stock dividend $ 10,000 $ -- $ --
=========== =========== ===========
Forgiveness of stockholder debt $ 7,227 $ -- $ --
=========== =========== ===========
|
See accompanying notes to unaudited condensed financial statements.
6
HIV-VAC, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONDENSED FINANCIAL STATEMENTS
MARCH 31, 2005.
(UNAUDITED)
The unaudited condensed financial statements of HIV-VAC, Inc. included herein
have been prepared by HIV-VAC pursuant to the rules and regulations of the
Securities and Exchange Commission. Certain information or footnote disclosures
normally included in financial statements prepared in accordance with accounting
principles generally accepted in the United States of America have been
condensed or omitted pursuant to such rules and regulations. In the opinion of
HIV-VAC's management, the accompanying unaudited condensed financial statements
contain all adjustments, consisting only of normal recurring adjustments,
necessary to present fairly the financial information included herein. These
financial statements should be read in conjunction with HIV-VAC's audited
financial statements contained in its Annual Report on Form 10-K for the year
ended September 30, 2004.
NOTE 1 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Organization and Operations: HIV-VAC, Inc. (the "Company"), formerly known as
Personna Records, Inc. (Personna) was incorporated on January 10,1997 in the
State of Nevada. Personna (originally known as Sonic Records, Inc.) was engaged
in the production and distribution of musical records. In April 1998, Personna
merged with Nouveaux Corporation whereby Personna became the surviving
corporation. We changed our name to Grupo International Inc. on September 2,
2010.
Development Stage Enterprise: HIV-VAC Inc reverted to a development stage
enterprise when it disposed of its music recording assets (March 1999) and
commenced the research and development of its HIV vaccine. The Company's
principal activities since March 1999 have included defining and conducting
research programs, conducting animal clinical trials, raising capital and
researching ways to enhance the company's intellectual property. The Company has
not yet commenced human trials.
Going Concern: The Company's financial statements are presented on a going
concern basis, which contemplates the realization of assets and satisfaction of
liabilities in the normal course of business. The Company has experienced
recurring losses since inception and has negative net working capital and cash
flows from operations. For the years ended September 30, 2004 and 2003, the
Company experienced a net loss of $282,180 and $510,449, respectively.
The Company's ability to continue as a going concern is contingent upon its
ability to secure additional financing, initiate sale of its product, and attain
profitable operations.
Management is pursuing various sources of equity financing. Although the Company
plans to pursue additional financing, there can be no assurance that the Company
will be able to secure financing or obtain financing on terms beneficial to the
Company.
The financial statements do not include any adjustments to reflect the possible
future effects on the recoverability and classification of assets or the amounts
and classification of liabilities that may result from the possible inability of
the Company to continue as a going concern.
Fixed Assets: Fixed assets are stated at cost. Maintenance and repairs are
expensed in the period incurred; major renewals and betterments are capitalized.
When items of property are sold or retired, the related costs are removed from
the accounts and any gain or loss is included in income. Depreciation is
computed using the straight-line method over the estimated economic useful lives
of 5 years for office equipment and 7 years for office furniture.
Intangible Assets: Intangible assets consist of licensing rights. The licensing
rights are being amortized using the straight-line method over the remaining
estimated economic useful life of 12 years commencing April 1999. The Company
reviews its long-lived assets for impairment whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be
recoverable. An impairment loss would be recognized when estimated future cash
flows expected to result from the use of the asset and its eventual disposition
are less than its carrying amount
7
HIV-VAC, INC.
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
NOTE 1 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES CONTINUED
Cash and Cash Equivalents: For purposes of the cash flow statement, the Company
considers all highly liquid investments with maturities of three months or less
at the time of purchase to be cash equivalents
Fair Value of Financial Instruments: The carrying amounts reported in the
balance sheets for cash and cash equivalents, accounts receivable, and accounts
payable approximate fair value because of the immediate or short-term maturity
of these financial instruments.
Income Taxes: The Company accounts for income taxes under Financial Accounting
Standards Board of Financial Accounting Standards No. 109, "Accounting for
Income Taxes." Under Statement 109, 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 basis. Deferred tax assets and liabilities are measured
using enacted tax rates expected to apply to taxable income in the years in
which those temporary differences are expected to be recovered or settled. Under
Statement 109, 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. No current or deferred income tax expense or benefit were recognized due
to the Company not having any material operations for the periods ended March
31, 2005 and 2004.
Use of Estimates: The preparation of financial statements in conformity with
generally accepted accounting principles requires management to make estimates
of assets and liabilities and disclosure of contingent assets and liabilities at
the date of the finical statements and reported amounts of revenues and expenses
during the reporting period. Actual results could differ from those estimates.
Net Loss Per Common Share: Basic and diluted net loss per common share for the
periods ended March 31 2005, and 2004 are computed based on the weighted average
common shares outstanding as defined by Statement of Financial Accounting
Standards No. 128, "Earnings Per Share". Common stock equivalents have not been
included in the computation of diluted loss per share since the effect would be
anti-dilutive.
Foreign Currency: Assets and liabilities recorded in foreign currencies are
translated at the exchange rate on the balance sheet date. Revenue and expenses
are translated at average rates of exchange prevailing during the year.
Translation adjustments resulting from this process are charged or credited to
other comprehensive income.
Recent Accounting Announcements: The Company has evaluated the recent accounting
announcements and has determined that there are no recent announcements that
will have a material effect on the the Company's financial statements.
Stock Issued For Services: The company enters into transactions in which goods
or services are the consideration received for the issue of equity instruments.
The value of these transactions are measured and accounted for, based on the
fair value of the equity instrument issued or the value of the services,
whichever is more reliably measurable. The services are expensed in the periods
that they are rendered.
8
HIV-VAC, INC.
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
NOTE 2 - FIXED ASSETS Fixed Assets consisted of the following:
March 31, September 30,
2005 2004
------------- -------------
Furniture $ 936 $ 936
Equipment 47,480 47,480
------------- -------------
48,416 48,416
Less accumulated depreciation (41,464) (40,982)
------------- -------------
Net $ 6,952 $ 7,434
============= =============
|
Depreciation expense for the six months ended March 31, 2005 and the year ended
September 30, 2004, was $481 and $9,200 respectively
NOTE 3 - INTANGIBLE ASSETS Intangible Assets consisted of the following:
March 31, September 30,
2005 2004
------------- -------------
Licensing Rights $ 185,000 $ 185,000
Less accumulated amortization (92,497) (84,789)
------------- -------------
Net $ 92,503 $ 100,211
============= =============
|
Amortization expense for the six months ended March 31, 2005 and the year ended
September 30, 2004, was $7,708 and $15,418 respectively.
NOTE 4 - LICENSING AGREEMENT
On March 15, 1999, the Company entered into an agreement with Intracell Vaccines
Limited (Intracell) whereby the Company issued 57,500 shares of Common Stock,
10,000 Preferred Stock and $85,000 for an aggregate amount of $185,000 in
exchange for the worldwide licensing rights to an AIDS/HIV vaccine developed by
The University of Birmingham, UK. The company also issued stock options to the
shareholders of Intracell to purchase a total of 300,000 shares of the Company's
Common Stock, conditional on the outcome of three separate events. The options
expired on December 31, 2004 without being exercised. The Company also agreed to
make advance minimum royalty payments of (pound)50,000 ( $80,500) to the
University of Birmingham Research and Development Limited commencing January 1,
2002. The minimum payments are for the duration of the patents. The Company had
been unable to make these payments as of the date of this report. The Company
terminated the licence agrement in December 2007 as it did not believe that it
could commercialize the vaccine prior to the expiration of the patents in 2011.
In April 6, 1999, this agreement was amended to include an anti-dilution clause
which provided for Intracell and its shareholders to maintain an equity position
of 60% of the common shares of the Company until the company had raised $5
million. Specifically, when the Company issues stock to others, the
anti-dilution clause requires the Company to issue additional stock to Intracell
so that Intracell maintains its 60% interest in the Company.
The Company failed to attract financing as agreed under the agreement with
Intracell Vaccine Ltd, and on August 7, 2001 the Company amended the agreement
with Intracell , whereby Intracell agreed to waive its right to terminate the
assignment of license agreement provided that the Company issue an additional
3,000,000 of its common shares to Intracell and 7,500,000 options to purchase
shares of common stock of the Company. Such options vest in blocks of 2,500,000
upon the occurrence of certain events.(See Commitments and Contingencies). The
market value of the shares issued to Intracell which amounted to $1.5 million
was expensed to patent fees.
9
HIV-VAC, INC.
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
NOTE 5 - STOCKHOLDERS' EQUITY
The Company did not issue any stock during the period
NOTE 6 - COMMITMENTS AND CONTINGENCIES
a) Operating lease. On April 1, 2004, the Company entered into a lease
agreement for office facility expiring on April 30, 2005. The lease
is now on a month to month basis. The rent payable under the lease
is $925 per quarter. Rent expense for the year ended September 30,
2004, was $9,540.
b) Stock Options.
On August 7, 2001, the Company provided Intracell with three options
to acquire a total of of 7,500,000 shares as follows:
1. 2,500,000 shares of common stock at $0.50 per share when
Phase I human trials begin.
2. 2,500,000 shares of common stock at $1.00 per share when
Phase 3 human trials begin.
3. 2,500,000 shares of common stock at $2.00 per share when
the Company receives a product licence from any
recognized government.
None of the contingencies had been met at December 31, 2002.
The options expire on September 1, 2007.
Royalty Payments under Licensing Agreement - The Company has committed to make
minimum royalty payments of (pound)50,000 ($80,500) per annum, in advance to the
University of Birmingham Research and Development Limited, commencing January 1,
2002. The minimum payments will remain in effect for the duration of the
utilisation of the patents which expire in 2011. As of May 31, 2005, the Company
had not made the above payments.
Consulting Agreement - Pursuant to the consulting agreement with Intracell
Vaccines, the Company is committed to pay Intracell Vaccines a consulting fee of
$5,000 per quarter. Intracell Vaccines has the right, due to the company's
failure to make these payments, to terminate the consulting agreement.
10
HIV-VAC, INC.
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
NOTE 7 - INCOME TAXES
Due to net operating losses and the uncertainty of realization, no tax benefit
has been recognized for operating losses. At March 31, 2005, net operating
losses of approximately $5,945,000 are available for carry forward against
future years' taxable income and begin expiring in the year 2014. The Company's
ability to utilize its net operating loss carry forwards is uncertain and thus
no valuation reserve has been provided against the Company's net deferred tax
assets.
NOTE 8 - RELATED PARTY TRANSACTIONS
The Company incurred consulting fees to certain controlling stockholders in the
amounts of $10,000 for the six month period ended March 31, 2005 and $40,000 for
the six month period ended March 31, 2004. As of March 31, 2005 and September
30, 2004, the balance due to related party stockholders arising from the normal
course of business was $528,193 and $515,094 respectively.
NOTE 9 - SUBSEQUENT EVENTS
a) The License Agreement was terminated effective December 1, 2007.
Under the termination agreement, the $566,005 in outstanding royalty
payments were forgiven.
b) On August 23, 2010, the Company entered into an irrevocable
agreement to acquire 80% of the issued and outstanding share capital
of Richard Y Lange, a Mexican corporation, through the issue of
8,000,000 of the Company's common shares valued at $0.25 per common
share. Under the agreement, Richard Y Lange warrants that
shareholders equity in Richard Y Lange will not be less than
70,000,000 pesos ($5,995,000). Richard Y Lange is involved in
construction, property development and product distribution. It also
owns a block plant and a sand pit. The agreement will close as soon
as Richard Y Lange has verified its assets through audit or as
agreed to by the parties. The Company represents, at Closing, there
will be 10,421,916 common shares and 300,000 Preferred "B" shares
outstanding. Thus the Company has agreed to reduce their common
shares by 8,736 shares.
c) The Company changed its name to Grupo International Inc. on
September 2, 2010.
11
ITEM 2. MANAGAMENT DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
Plan of Operation
We were incorporated in January of 1997, and do not have any significant
operating history or financial results. We began our vaccine development and
marketing operations, including the pre-clinical testing in Russia of our
proposed vaccine designed to combat HIV/AIDS, building an infrastructure and
researching our proposed vaccine. We have been unable to raise sufficient
working capital to commence trials. As a result, research and development costs
for the three months ended March 31, 2005 decreased by $18,948 from $24,898 for
the three months ended March 31, 2004 to $5,950 for the three months ended March
31, 2005. Administrative expenditure decreased marginally by $387 from $7,673
for the quarter ended March 31, 2004 to $7,286 for the quarter ended March 31,
2005. The reduction in research and development expenditure was due to a
reduction in consulting fees and premises costs. The Company received no
interest income during the quarters ended March 31, 2005 and March 31, 2004. We
incurred a net loss of $41,280 or $(0.01) per share based on 9,831,669 weighted
average shares outstanding for the quarter ended March 31, 2005 compared to a
loss of $62,602 or $(0.01) per share based on 9,831,669 weighted average shares
outstanding for the quarter ended March 31, 2004. Research and development costs
for the six months ended March 31, 2005 reduced by $67,292 from $79,176 for the
six months ended March 31, 2004 to $11,884 for the six months ended March 31,
2005. The reduction of expenditure was a result of reduced consulting and
premises costs. General and Administration expenditure decreased by $4,286, from
$18,393 for the six months ended March 31, 2004 to $14,107 for the six months
ended March 31, 2005. The reduction in costs was a result of reduced aidit and
office costs. We did not conduct any operations of a commercial nature during
the period from January 10, 1997 (date of inception) to March 31, 2005. We have
relied on advances of approximately $528,193 from our principal stockholders,
trade payables of approximately $360,458, proceeds of $1,196,272 from the sale
of common stock and the issue of stock for fees and/or services in the amount of
$4,665,600 to support our limited operations. As of March 31, 2005, we had
approximately $924 of cash and cash equivalents. Operations for the six months
ended March 31, 2005 have been financed through a loan from Intracell Vaccines
Limited, an increase in payables and through the utilization of $1,685 in cash
on hand. We seek additional equity or debt financing of up to $7 million which
we plan to use to use for working capital and to continue implementing
pre-clinical and Phase I/II testing of our proposed vaccine. If we do not get
sufficient financing, we may not be able to continue as a going concern and we
may have to curtail or terminate our operations and liquidate our business (see
Note 1 to financial statements).
We terminated our license agreement with the University in 2007 as we
did not believe that we would be able to commercialize the vaccine prior to the
expiration of the patents in 2011. We plan to continue development of the
vaccine and believe that it may be possible to establish new patents, depending
on the outcome of our research. Our business plan requires at least $6,000,000
to implement, and cannot be implemented until funding for this amount has been
achieved. When the funding has been achieved, we plan, in the first year, to
implement a PhaseI/II trial with the Medical Control Agency in The United
Kingdom through the application for a CTX exemption to commence a Phase I/II
trial. We plan to apply for a CTX exemption using the Clade B strain of the
virus as soon as a vaccine using the local Clade B strain is made available. The
manufacture of the vaccine will be contracted out and the Company to a company
or organization that specializes manufacturer of vaccines. We have previously
manufactured vaccine in Russia and the UK.
We also plan, subject to financing, in the future, to initiate further
animal trials in either Russia, in conjunction with The Russia Federal Aids
Center, a department of The Central Institute of Epidemiology, Moscow, Russia,
or other European counties. We intend to institute studies of the efficacy of
the vaccine in non-human primates in parallel or preceding Phase I trials of the
vaccine in human subjects in Moscow, Russia.
12
In addition, and subject to financing, we anticipate initiating a Phase
I/II trial in Sub-Sahara Africa using the local African HIV sub-type. These
trials will be done in conjunction with local Government and would commence
after a satisfactory pre-clinical trial has completed the evaluation of toxicity
and immunogenicity of the local strain. However, we cannot initiate the
pre-clinical or Phase I/II trials until such time as we have raised at least $6
million, which is the minimum amount we anticipate we will need for these
trials. Furthermore, in addition to restrictions due to lack of funding, we also
need to manufacture a batch of the vaccine to initiate these trials. We cannot
manufacture a batch until we have an agreement in place with a country in Africa
that is prepared to work with us. It is estimated that these pre-clinical trials
would take approximately twelve months to complete once we have an agreement in
place. If these trials take place, we intend to invite the Division of AIDS of
National Institute of Allergy and Infectious Diseases to monitor the African
trials.
No trials are currently scheduled to take place in the United States.
However, it is our intention to invite the National Institute of Health (NIH)
through the offices of The Division of AIDS (DIADS) to assist in the planning
and execution of the trials and monitor the trials described above.
We estimate that we will require approximately $6 million to $7 million
to conduct our vaccine development activities through a period of two years.
This amount will be used to pay for vaccine manufacture, vaccine trial costs and
testing, equipment and corporate overhead. We are hoping to raise a minimum of
$6 million through one or more private offerings pursuant to Rule 506 or
Regulation D or through an offshore offering pursuant to Regulation S; however,
nothing in this quarterly report shall constitute an offer of any securities for
sale. Such shares if sold will not have been registered under the Act and may
not be offered or sold in the United States absent registration or an applicable
exemption from registration requirements. In addition we are looking at other
financing methods including finding joint venture partners who might provide
substantial funding to the project or the granting of sub-licenses on payment of
upfront fees with the payment of on-going royalties on sales. We are also
looking at the possibility of acquiring other technologies or business which
might assist in financing.
If we are unable to raise $6 million, we will most likely cease all
activity related to our vaccine development and marketing, or at the very least,
proceed on a reduced scale. We have to date relied on a small number of
investors to provide us with financing for the commencement of our development
program, including Intracell Vaccines Limited. Amounts owed to these individuals
are payable upon demand.
Subject to financing, we expect to purchase approximately $500,000 in
equipment to be used for research and expanding testing laboratories. In
addition, with available funding, we expect to hire an additional fifteen
employees for both research and administrative support over the duration of the
research.
13
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not applicable for a smaller reporting company.
Item 4. Controls and Procedures.
During the six months ended March 31, 2005, there were no changes in our
internal controls over financial reporting (as defined in Rule 13a- 15(f) and
15d-15(f) under the Exchange Act) that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
Evaluation of Disclosure Controls and Procedures:
Our chief executive officer and chief financial officer have concluded that the
disclosure controls and procedures were not effective as of March31, 2005. These
controls are meant to ensure that information required to be disclosed by the
issuer in the reports that it files or submits under the Act is recorded,
processed, summarized and reported, within the time periods specified in the
Commission's rules and forms and to ensure that information required to be
disclosed by an issuer in the reports that it files or submits under the Act is
accumulated and communicated to the issuer's management, including its principal
executive and principal financial officers, or persons performing similar
functions, as appropriate to allow timely decisions regarding required
disclosure.
The registrant has been delinquent in its SEC filing. Management has only
recently prepared the required reports for filing. Management intends to
implement internal controls to ensure that similar situations do not occur in
the future and that required SEC filings will be timely.
Management's Annual Report on Internal Control over Financial Reporting:
Our management is responsible for establishing and maintaining adequate internal
control over financial reporting. Our internal control over financial reporting
is the process designed by and under the supervision of Kevin Murray, chief
financial officer, or the persons performing similar functions, to provide
reasonable assurance regarding the reliability of our financial reporting and
the preparation of our financial statements for external reporting in accordance
with accounting principles generally accepted in the United States of America.
Mr. Murray has evaluated the effectiveness of our internal control over
financial reporting using the criteria set forth by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO) in Internal Control over
Financial Reporting - Guidance for Smaller Public Companies.
The chief financial officer and chief executive officer has assessed the
effectiveness of our internal control over financial reporting as of March 31,
2005, and concluded that it is not effective for the reasons discussed above.
This annual report does not include an attestation report of the registrant's
registered public accounting firm regarding internal control over financial
reporting. Management's report was not subject to attestation by the
registrant's registered public accounting firm pursuant to temporary rules of
the Securities and Exchange Commission that permit the registrant to provide
only management's report in this annual report.
Evaluation of Changes in Internal Control over Financial Reporting:
Our chief executive officer and chief financial officer have evaluated changes
in our internal controls over financial reporting that occurred during the
period ended March 31, 2005. Based on that evaluation, our chief executive
officer and chief financial officer did not identify any change in our internal
control over financial reporting that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
14
Important Considerations:
The effectiveness of our disclosure controls and procedures and our internal
control over financial reporting is subject to various inherent limitations,
including cost limitations, judgments used in decision making, assumptions about
the likelihood of future events, the soundness of our systems, the possibility
of human error, and the risk of fraud. Moreover, projections of any evaluation
of effectiveness to future periods are subject to the risk that controls may
become inadequate because of changes in conditions and the risk that the degree
of compliance with policies or procedures may deteriorate over time. Because of
these limitations, there can be no assurance that any system of disclosure
controls and procedures or internal control over financial reporting will be
successful in preventing all errors or fraud or in making all material
information known in a timely manner to the appropriate levels of management.
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are not currently subject to any legal proceedings or claims.
Item 1A. Risk Factors
Not applicable for smaller reporting company
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. REMOVED AND RESERVED
None.
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS.
31.1 Certification of Chief Executive Officer pursuant to Section 302
of the Sarbanes-Oxley Act of 2002.
31.2 Certification of Chief Financial Officer pursuant to Section 302
of the Sarbanes-Oxley Act of 2002.
32.1 Certification of Chief Executive Officer pursuant to Section 906
of the Sarbanes-Oxley Act of 2002.
32.2 Certification of Chief Financial Officer pursuant to Section 906
of the Sarbanes-Oxley Act of 2002.
SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized, this 2nd day of September 2010.
HIV-VAC, INC.
/s/ Kevin W. Murray
-------------------------------
Kevin W. Murray
President and CEO
|
15
GRUPO (CE) (USOTC:GRPI)
Historical Stock Chart
From Feb 2025 to Mar 2025
GRUPO (CE) (USOTC:GRPI)
Historical Stock Chart
From Mar 2024 to Mar 2025