GRPI GRUPO International Inc (CE)

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, 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,

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 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 31, 2005 (UNAUDITED) 3

 CONDENSED STATEMENTS OF OPERATIONS
 THREE MONTHS ENDED DECEMBER 31, 2005 AND 2004
 PERIOD FROM JANUARY 10, 1997 (DATE OF INCEPTION) TO
 DECEMBER 31, 2005 (UNAUDITED) 4

 CONDENSED STATEMENTS OF CASH FLOWS

THREE MONTHS ENDED DECEMBER 31, 2005 AND 2004 AND PERIOD FROM JANUARY 10, 1997 (DATE OF INCEPTION) TO DECEMBER 31, 2005 (UNAUDITED) 5-6

NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED) 7-10

ITEM 2. MANAGEMENT DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 11

ITEM 3. QUANTATIVE AND QUALATIVE DISCLOSURE ABOUT MARKET RISK 12

ITEM 4. CONTROLS AND PROCEDURES 13

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

PART I - FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS
HIV-VAC, INC.

(A Development Stage Company)

BALANCE SHEETS
(Unaudited)

ASSETS

 December 31, September 30,
 2005 2004
 ------------- -------------
Current Assets
 Cash and equivalents $ 900 $ 906
 Prepaid expenditure -- 23,950
 ------------- -------------
 Total current assets 900 24,856
 ------------- -------------

Furniture and equipment, net 6,263 6,471
 ------------- -------------
Other Assets
 Intangible assets, net 80,941 84,795
 ------------- -------------
Total assets $ 88,104 $ 116,122
 ============= =============

 LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current Liabilities
 Accrued liabilities:
 Related parties 535,223 535,044
 Accrued Liabilities 89,471 80,971
 Accounts payable 381,451 389,866
 ------------- -------------
 Total Current Liabilities 1,006,145 $ 1,005,901
 ------------- -------------
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;
 9,831,669 and 9,831,669 shares issued
 and outstanding, respectively 9,831 9,831
 Additional paid in capital 6,434,159 6,434,160
 Deficit accumulated during the
 development stage (7,348,237) (7,310,685)
 Accumulated other comprehensive loss (16,894) (26,185)
 ------------- -------------
 Total stockholders' equity (deficit) (918,041) (889,779)
 ------------- -------------
 Total liabilities and
 stockholders' equity (deficit) $ 88,104 $ 116,122
 ============= =============

See accompanying notes to unaudited condensed financial statements.

HIV-VAC, INC.
(A Development Stage Company)

STATEMENTS OF OPERATIONS
FOR THE QUARTERS ENDED DECEMBER 31, 2005, 2004 AND FOR THE PERIOD FROM
JANUARY 10, 1997 (INCEPTION) TO DECEMBER 31, 2005

 Period from
 January 10,
 1997
 Quarter Quarter (Inception)
 Ended Ended to
 December 31, December 31, December 31,
 2005 2004 2005
 ------------ ------------ ------------
Expenses
 Royalty fees 23,950 22,105 1,857,813
 Research and development costs 4,860 5,934 1,737,812
 General and administrative 4,680 6,821 741,107
 Depreciation and amortization 4,062 4,094 146,213
 Legal fees -- -- 1,500,028
 Licensing fees -- -- 635,500
 Loss from disposal of assets -- -- 30,195
 ------------ ------------ ------------
 37,552 38,954 6,648,668
 ------------ ------------ ------------

 Loss from operations (37,552) (38,954) (6,648,668)
 ------------ ------------ ------------
Other Income (Expense)
 Other expenses -- -- (261,162)
 Interest income -- -- 3,774
 ------------ ------------ ------------
 Total other income (expense) -- -- (257,388)
 ------------ ------------ ------------

 Loss from continuing operations (37,552) (38,954) (6,906,056)

Loss from discontinued operations -- -- (432,181)
 ------------ ------------ ------------

Net loss (37,552) (38,954) (7,338,237)
 ============ ============ ============


 Foreign Currency
 Translation Adjustment 9,291 (19,039) (16,894)
 ------------ ------------ ------------

Comprehensive Loss (28,261) (57,993) (7,355,131)
 ============ ============ ============
 Loss per weighted number of
 outstanding shares- basic
 and diluted $ (0.00) $ (0.00)
 ============ ============

Weighted average number of
 common shares outstanding
 during period - basic and diluted 9,831,669 9,831,669
 ============ ============

See accompanying notes to unaudited condensed financial statements.

 HIV-VAC, INC.
 (A Development Stage Company)
 CONDENSED STATEMENTS OF CASH FLOWS
 FOR THE THREE MONTHS ENDED DECEMBER 30, 2004 AND 2003 AND FOR THE PERIOD
 FROM JANUARY 10, 1997 (INCEPTION) TO DECEMBER 31, 2004 (UNAUDITED)


 Period from
 January 10,
 1997
 (Inception) For the Three Months Ended
 to ----------------------------
 December 31, December 31, December 31,
 2005 2005 2004
 ------------ ------------ ------------
Cash Flows From Operating Activities:
 Net loss $ (7,338,237) $ (37,552) $ (38,954)
 Adjustments to reconcile net loss to
 net cash used in operating activities:
 Amortization and depreciation 146,213 4,062 4,094
 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 -- --
 Decrease in prepaid expenditure -- 23,950 22,105
 (Decrease) in notes payable (140,000) -- --
 Increase in payables and
 accrued liabilities 440,560 9,356 7,451
 ------------ ------------ ------------

Net Cash Used in Operating Activities (1,705,401) (184) (5,304)
 ------------ ------------ ------------
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 -- --
 Payment of stockholder's loan 535,222 178 5,320
 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 1,719,445 178 5,320
 ------------ ------------ ------------


Net increase (decrease) in cash 900 6 16

Cash and equivalents at beginning of period -- 906 2,609
 ------------ ------------ ------------
Cash and equivalents at end of period $ 900 $ 900 $ 2,625
 ============ ============ ============



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, 2004 AND 2003 AND FOR THE PERIOD
 FROM JANUARY 10, 1997 (INCEPTION) TO DECEMBER 31, 2004 (UNAUDITED)
 (Continued)


 Period from
 January 10,
 1997
 (Inception) For the Three Months Ended
 to ----------------------------
 December 31, December 31, December 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 $ -- $ --
 ============ ============ ============
 Forgiveness of stockholder debt $ 7,227 $ -- $ --
 ============ ============ ============
 Preferred B stock dividend $ 10,000 $ -- $ --
 ============ ============ ============

See accompanying notes to unaudited condensed financial statements.

HIV-VAC, INC.
(A DEVELOPMENT STAGE ENTERPRISE)

NOTES TO CONDENSED FINANCIAL STATEMENTS
DECEMBER 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, 2005.

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.

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, 2005 and 2004, the Company experienced a net loss of $157,621 and $282,183, 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 diminishing balance method using 15%pa for office equipment and 10% pa 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

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

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, 2004 and 2005.

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 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 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,
 2005 2005
 ------------- -------------

Furniture $ 936 $ 936
Equipment 47,480 47,840
 ------------- -------------
 48,416 48,416
Less accumulated depreciation (42,153) (41,945)
 ------------- -------------

 Net $ 6,263 $ 6,471
 ============= =============

Depreciation expense for the three months ended December 31, 2005 and the year ended September 30, 2005, was $208 and $962 respectively

HIV-VAC, INC.

NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)

NOTE 3 - INTANGIBLE ASSETS

Intangible Assets consisted of the following:

 December 31, September 30,
 2005 2005
 ------------- ------------

Licensing Rights $ 185,000 $ 185,000

Less accumulated amortization (104,509) (100,205)
 ------------- ------------
 Net $ 80,491 $ 84,795
 ============= ============

Amortization expense for the three months ended December 31, 2005 and the year ended September 30, 2005, was $3,854 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.(See Commitments and Contingencies). The options have not been valued because they are subject to contingencies. 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 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.

The licence agreement was terminated in December 2007 as the Company did not believe that it would be able to commercialize the vaccine prior to the expiration of the patents in 2011.

NOTE 5 - STOCKHOLDERS' EQUITY

No stock was issued 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 agreement is now on a month to month basis. Rent payable under the lease is approximately $900 per quarter.

b) Stock Options.

On August 7, 2001, the Company provided Intracell with three options to acquire a total 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.

HIV-VAC, INC.

NOTES TO THE FINANCIAL STATEMENTS (CONTINUED)

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, 2005. 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. As of the date of this report, the Company had not made the above payments.

Consulting Agreement - Pursuant to a consulting agreement with Intracell Vaccines, the Company was committed to pay Intracell Vaccines a consulting fee of $5,000 per quarter. The Company terminated the consulting agreement in July 2005.

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, 2005, net operating losses of approximately $5,920,000 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 did not incur any consulting fees from certain controlling stockholders for of the three month period ended December 31, 2005 and $5,000 for the three month period December 31, 2004. As of December 31, 2005 and September 30, 2005, the balance due to related party stockholders arising from the normal course of business was $535,223 and $535,044 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.

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. As a result, research and development costs for the three months ended December 31, 2004 decreased by $1,074 from $5,934 for the three months ended December 31, 2004 to $4,860 for the three months ended December 31, 2005. The decrease in expenditure was due to a reduction in consulting costs to Intracell Vaccines Ltd. Administrative expenditure decreased by $2,141 from $6,821 for the quarter ended December 31, 2004 to $4,680 for the quarter ended December 31, 2005. The decrease was primarily due to a reduction in audit fees. We incurred a net loss of $37,552 or $(0.00) per share based on 9,831,669 weighted average shares outstanding for the quarter ended December 31, 2005 compared to $38,954 or $(0.00) per share based on 9,831,669 weighted average shares outstanding for the quarter ended December 31, 2004. We did not conduct any operations of a commercial nature during the period from January 10, 1997 (date of inception) to December 31, 2005. Through December 31, 2005 we have relied on advances of approximately $535,223 from our principal stockholders, trade payables of approximately $351,089, 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 December 31, 2005, we had $900 of cash and cash equivalents. Operations for the three months ended December 31, 2005 have been financed through a loan from Intracell Vaccines Limited 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).

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. 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.

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 supervised and participated in this evaluation. Based on this evaluation, Messrs. 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.

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 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.

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 CFO

GRUPO (CE) (USOTC:GRPI)
과거 데이터 주식 차트
부터 2월(2) 2025 으로 3월(3) 2025

GRUPO (CE) (USOTC:GRPI)
과거 데이터 주식 차트
부터 3월(3) 2024 으로 3월(3) 2025