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 December 31, 2008
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 issuer has two classes of stock with 10,430,652 common shares and 300,000
preferred "B" outstanding as of September 30, 2011.
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 DECEMBER 2008 (UNAUDITED) 3
CONDENSED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED DECEMBER 31, 2008 AND 2007
PERIOD FROM JANUARY 10, 1997 (DATE OF INCEPTION) TO
DECEMBER 31, 2008 (UNAUDITED) 4
CONDENSED STATEMENTS OF CASH FLOWS
|
THREE MONTHS ENDED DECEMBER 31, 2008 AND 2007 AND
PERIOD FROM JANUARY 10, 1997 (DATE OF INCEPTION) TO
DECEMBER 31, 2008 (UNAUDITED) 5-6
NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED) 7-10
ITEM 2. MANAGEMENT DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION 11
AND RESULTS OF OPERATIONS
ITEM 4. CONTROLS AND PROCEDURES 12
PART II-- OTHER INFORMATION 13
ITEM 1. LEGAL PROCEEDINGS 13
ITEM 1A RISK FACTORS 13
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS 13
ITEM 3. DEFAULTS UPON SENIOR SECURITIES 13
ITEM 4. REMOVED OR RESERVED 13
ITEM 5. OTHER INFORMATION 13
ITEM 6. EXHIBITS 13
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
December 31, September 30,
2008 2008
------------ -------------
Current Assets
Cash and equivalents $ 841 $ 897
------------ -------------
Total current assets 841 897
------------ -------------
Furniture and equipment, net 4,154 4,289
------------ -------------
Total assets $ 4,995 $ 5,186
============ =============
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current Liabilities
Accrued liabilities:
Related parties 539,078 538,899
Accrued Liabilities 194,471 184,971
Accounts payable 74,749 92,508
------------ -------------
Total Current Liabilities 808,298 $ 816,378
------------ -------------
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 3,000 3,000
Common stock, $0.001 par value;
500,000,000 shares authorized;
9,830,652 and 9,830,652 shares issued
and outstanding, respectively 9,831 9,831
Additional paid in capital 6,434,160 6,434,160
Deficit accumulated during
the development stage (7,172,771) (7,162,226)
Accumulated other comprehensive loss (77,623) (96,057)
------------ -------------
Total stockholders' equity (deficit) (803,303) (811,192)
------------ -------------
Total liabilities and
stockholders' equity (deficit) $ 4,995 $ 5,186
============ =============
|
See accompanying notes to unaudited condensed financial statements.
3
HIV-VAC, INC.
(A Development Stage Company)
STATEMENTS OF OPERATIONS
FOR THE QUARTERS ENDED DECEMBER 31, 2008, 2007 AND FOR THE PERIOD FROM
JANUARY 10, 1997 (INCEPTION) TO DECEMBER 31, 2008
Period from
January 10,
1997
Quarter Quarter (Inception)
Ended Ended to
December 31, December 31, December 31,
2008 2007 2008
------------ ------------ ------------
Expenses
Write down of intangible asset -- 53,963 53,963
Patent fees -- 24,489 2,045,239
Research and development costs 5,230 5,024 1,798,500
General and administrative 5,180 4,680 800,482
Depreciation and amortization 135 156 175,300
Legal fees -- -- 1,500,028
Licensing fees -- -- 635,500
Loss from disposal of assets -- -- 30,195
------------ ------------ ------------
10,545 88,312 7,039,207
------------ ------------ ------------
Loss from operations (10,545) (88,312) (7,039,207)
------------ ------------ ------------
Other Income (Expense)
Other expenses -- -- (261,162)
Interest income -- 566,005 569,779
------------ ------------ ------------
Total other income (expense) -- 566,005 308,617
------------ ------------ ------------
Loss from continuing operations (10,545) 477,693 (6,730,590)
Loss from discontinued operations -- -- (432,181)
------------ ------------ ------------
Net profit (loss) (10,545) 477,693 (7,162,771)
============ ============ ============
Foreign Currency
Translation Adjustment (18,576) 1,863 (77,622)
------------ ------------ ------------
Comprehensive Loss (29,121) 479,556 (7,240,393)
============ ============ ============
Profit(Loss) per weighted number
of outstanding shares- basic
and diluted $ 0.00 $ 0.05
============ ============
Weighted average number of common
shares outstanding during period
- basic and diluted 9,830,653 9,830,653
============ ============
|
See accompanying notes to unaudited condensed financial statements.
4
HIV-VAC, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED DECEMBER 30, 2008 AND 2007 AND FOR THE PERIOD
FROM JANUARY 10, 1997 (INCEPTION) TO DECEMBER 31, 2008 (UNAUDITED)
Period from
January 10,
1997
(Inception) For the Three Months Ended
to ----------------------------
December 31, December 31, December 31,
2008 2008 2007
------------ ------------ ------------
Cash Flows From Operating Activities:
Net profit (loss) $ (7,162,771) $ (10,545) $ 477,693
Adjustments to reconcile net loss to
net cash used in operating activities:
Amortization and depreciation 175,300 135 157
Officers' compensation capitalized 100,000 -- --
Other expenses relating to Noveaux and
LifePlan acquisitions 261,163 -- --
Issuance of stock for services 2,439,300 -- --
Issuance of stock for licensing fees 2,135,500 -- --
Issuance of stock for directors and
officers compensation 110,100 -- --
Issuance of stock for note payable 140,000 -- --
Gain on forgiveness of debt (566,005) -- (566,005)
(Decrease) in notes payable (140,000) -- --
Write-down of intangible asset 53,963 -- 53,963
Increase (decrease) in accrued liabilities 744,124 10,175 9,516
------------ ------------ ------------
Net Cash Used in Operating Activities (1,709,326) (235) (187)
------------ ------------ ------------
Cash Flow From Investing Activities:
Purchase of patent rights (85,000) -- --
Purchase of furniture and equipment (48,416) -- --
Purchase of treasury stock (11,767) -- --
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 539,078 179 179
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 1,723,311 179 179
------------ ------------ ------------
Net increase (decrease) in cash 841 (56) (8)
Cash and equivalents at beginning of period -- 897 952
------------ ------------ ------------
Cash and equivalents at end of period $ 841 $ 841 $ 944
============ ============ ============
See accompanying notes to unaudited condensed financial statements.
5
|
HIV-VAC, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED DECEMBER 30, 2008 AND 2007 AND FOR THE PERIOD
FROM JANUARY 10, 1997 (INCEPTION) TO DECEMBER 31, 2008 (UNAUDITED)
Period from
January 10,
1997
(Inception) For the Three Months Ended
to ----------------------------
December 31, December 31, December 31,
2008 2008 2007
------------ ------------ ------------
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 $ -- $ --
============ ============ ============
Cancellation of treasury stock $ (8,767) $ -- $ --
============ ============ ============
|
See accompanying notes to unaudited condensed financial statements.
6
HIV-VAC, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONDENSED FINANCIAL STATEMENTS
DECEMBER 31, 2008.
(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, 2008.
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. The Company changed its name to Grupo International Inc on
September 30, 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, 2008 , the Company
experienced a net gain of $445,805, after accounting for a gain on the
forgiveness of debt amounting to $566,005. For the year ended December 31, 2007,
the Company recorded a loss of $153,870 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 diminishing balance method using 15%pa for office equipment
and 10% pa for office furniture.
Intangible Assets: Intangible assets consisted of licensing rights. 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. The licensing rights were returned to the
license holder effective December 1, 2007. The Company recognized an impairment
loss for the book value of the intangible asset at that time.
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.
7
HIV-VAC, INC.
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
NOTE 1 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES CONTINUED
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 December
31, 2008 and 2007.
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 December 31 2008, and 2007 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 reviewed the recent accounting
pronouncements and has determined that there are no recent accounting
pronouncements that will have a material effect on 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.
NOTE 2 - FIXED ASSETS Fixed Assets consisted of the following:
December 31, September 30,
2008 2008
------------- -------------
Furniture $ 936 $ 936
Equipment 47,480 47,840
------------- -------------
48,416 48,416
Less accumulated depreciation (44,262) (44,127)
------------- -------------
Net $ 4,154 $ 4,289
============= =============
|
Depreciation expense for the three months ended December 31, 2008 and the year
ended September 30, 2008, was $135 and $722 respectively.
8
HIV-VAC, INC.
NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)
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 agreed to make advance
minimum royalty payments of $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 not made any payments as at the date of
this report.
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 expired on September 1,
2007. The market value of the shares issued to Intracell which amounted to $1.5
million was expensed to patent fees.
Because it was unlikely that the company would commercialize the patents prior
to their expiration in 2011, the Company terminated the license agreement with
the University of Birmingham on December 01, 2007. Under the termination
agreement, the University agreed to waive past royalty payments outstanding in
the amount of $566,005.
NOTE 5 - STOCKHOLDERS' EQUITY
No shares were issued by the Company during the quarters ended December 31, 2008
and December 31, 2007 reporting period
NOTE 6 - COMMITMENTS AND CONTINGENCIES
Royalty Payments under Licensing Agreement - The Company was 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 Company did not make any of the payments. The License agreement was
mutually terminated on December 01, 2007. Under the agreement, the licensor
agreed to forgo $ 566,005 in license fees. The Company is committed to pay the
licensor a cancellation fee of $47,741 when funds become available.
9
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 December 31, 2008, net operating
losses of approximately $6,000,000 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 accrued $9,000 in directors fees for certain controlling
stockholders for the three month period ended December 31, 2008 and $8,000 for
the three months ended December 31, 2007. As of December 31, 2008 and September
30, 2007, the balance due to related party stockholders arising from the normal
course of business was $539,078 and $538,999 respectively.
NOTE 9 - SUBSEQUENT EVENTS
a) 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 the
number of common shares by 8,736.
b) The Company changed its name to Grupo International Inc. on September
2, 2010.
10
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. In 2000 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 general research.. To date, we have been unable to obtain the
funding that we need to move forward to a phase I trial. We returned the License
that we held for the vaccine back to the licensor, as the license expires in
2011 and we did not believe that we would be able to commercialize the vaccine
prior to the expiration of the patents. Under the termination agreement, the
licensor agreed to forgo $566,005 in outstanding royalty payments, and the
Company agreed to pay a cancelation fee of $34,357 when funds become available.
Research and development costs for the three months ended December 31,
2008 increased by $106 from $5,024 for the three months ended December 31, 2007
to $5,230 for the three months ended December 31, 2008. The increase in
expenditure was due to a weaker US dollar. Administrative expenditure increased
by $500 from $4,680 for the three months ended December 31, 2007 to $5,180 for
the three months ended 31 December 2008. For the quarter ended December 31,
2007, we incurred a gain of $566,005 from the forgiveness of debt by the
licensor. We also incurred an impairment charge of $53,963 on the intangible
assets. We achieved a loss of $10,545 or $(0.00) per share based on 9,830,653
weighted average shares outstanding for the quarter ended December 31, 2008
compared to a gain of $477,693 or $0.05 per share based on 9,830,653 weighted
average shares outstanding for the quarter ended December 31, 2007. We did not
conduct any operations of a commercial nature during the period from January 10,
1997 (date of inception) to December 31, 2008. Through December 31, 2008 we have
relied on advances of approximately $539,078 from our principal stockholders,
trade payables of approximately $549,653, proceeds of $1,196,000 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 December 31, 2008, we had
$841 of cash and cash equivalents. Operations for the three months ended
December 31, 2008 have been financed through a loan from related parties and an
increase in payables. 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 will 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).
Our business plan requires at least $6,000,000 to implement, and cannot
be implemented until funding for this amount has been achieved. If the funding
is 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 is currently evaluating various different manufacturers in
Russia, the UK and the USA.
We also plan, subject to financing, in the future, to initiate further
trials in Russia, in conjunction with The Russia Federal Aids Center, a
department of The Central Institute of Epidemiology, Moscow, Russia. 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. We expect the regulatory approval process to take up to six months to
complete. The proposed vaccine could be manufactured in Russia, under the
supervision and quality control of various parties within and without Russia,
including the Federal Russia AIDS Centre in Moscow and laboratories in
Birmingham and London, U.K.
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.
11
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. The results
of the proposed trials in Russia and/or Africa and the UK cannot be predicted.
We estimate that we will require approximately $6 million to $7 million
to conduct our vaccine development activities through the next 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 for grants from governments and organisations involved in HIV work. We
are also looking at the possibility of acquiring other technologies 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 in the next two years 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 next five years.
Item 3. Controls and Procedures.
(a) Disclosure controls and procedures . Within 90 days before filing this
report, the Company evaluated the effectiveness of the design and operation of
its disclosure controls and procedures. The Company's disclosure controls and
procedures are the controls and other procedures that it designed to ensure that
it records, processes, summarizes and reports in a timely manner the information
it must disclose in reports that it files with or submits to the Securities and
Exchange Commission. Kevin W. Murray, the Company's Chief Executive Officer and
Chief Financial Officer, supervised and participated in this evaluation. Based
on this evaluation, Mr. Murray concluded that, as of the date of their
evaluation, the Company's disclosure controls and procedures were effective.
(b) Internal controls. Since the date of the evaluation described above, there
have not been any significant changes in the Company's internal accounting
controls or in other factors that could significantly affect those controls.
12
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are not currently subject to any legal proceedings or claims.
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS
No securities were issued during the period under review.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. SUBMISSION OF MATTER TO A VOTE OF SECURITY HOLDERS
None.
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.
(a) Exhibits: Exhibits required to be attached by Item 601 of Regulation S-B are
listed below:
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.
|
(b) Reports on Form 8-K: No reports on Form 8-K were filed during the period
covered by this Form 10Q-SB.
13
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 30th day of September 2011.
HIV-VAC, INC.
/s/ Kevin W. Murray
-----------------------------
Kevin W. Murray
President and CEO
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14
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