Research and development costs
Research and development expenses are the costs incurred in the process of our pre-clinical research and/or our clinical trials. Clinical trial and pre-clinical expenses include regulatory consultant compensation and fees, research expenses, purchase of plasma, the cost of manufacturing IgG and payments to clinical research organizations and to medical centers for patient recruitment and treatment.
During the nine months ended June 30, 2008 and 2007, research and development expenses included, among others, the cost of IgG used in the clinical trials and research work, payments to medical centers and research labs for clinical trial and pre-clinical trial work, regulatory and scientific consultants compensation, costs related to the maintenance of our registered patents, costs related to the filings of patent applications as well as salaries and related expenses of research and development staff.
During the nine months ended June 30, 2008, research and development expenses totaled $1,350,956, compared to $762,778 for the nine months ended June 30, 2007. The increase is attributable to assay development as well as pre-clinical work related to the filing of the IND for VitiGam™ and collection of plasma from donors.
General and administrative expenses
General and administrative expense includes the salaries and related expenses of our management, consulting costs, legal and professional fees, traveling, business development costs, insurance expenses and other general costs.
For the nine months ended June 30, 2008, general and administrative expenses totaled $1,979,379 compared to $2,902,678 for the nine months ended June 30, 2007. Costs incurred related to general and administrative activities in the nine months ended June 30, 2008 reflect a decrease of $683,000 in salary and related expenses due to lower stock based compensation expense and a reduction of headcount, a decrease of $237,000 in stock based compensation expenses for consultants, a decrease of $43,000 in public and investor relations and a decrease of $35,000 in business development, offset by an increase in professional and legal fees and an increase in general expenses such as office rent and maintenance expenses and communication and IT expenses.
Financial income/expense, net
During the nine months ended June 30, 2008 and 2007, we generated interest income on available cash and cash equivalents balance as well as bank charges.
Liquidity and Capital Resources
Through June 30, 2008, we incurred losses in an aggregate amount of $12,265,847. We have financed our operations from the private placements of equity and debt financings. Through June 30, 2008, we raised a total of $9,538,553, net of transaction costs, through private placements of equity. We anticipate that additional financing will be through similar sources. As of June 30, 2008, we had $861,531 available in cash, most of which is deposited in short term, interest bearing, bank deposits. To implement our business plan, as currently
19
contemplated, we anticipate we will need approximately $2 million for the remainder of our fiscal year, and approximately $9 million for the twelve months following July 1, 2008.
Although we do not have material financing commitments, management is engaged in ongoing financing discussions with third party investors and existing shareholders to raise the necessary funds for future research and development activities and general and administrative expenses in the public and private equity markets. Although there is no assurance that we will be successful with these initiatives, management expects to secure the necessary financing as a result of the above ongoing discussions.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements.
Planned Expenditures
The estimated expenses referenced herein are in accordance with our business plan. As our technology is still in the development stage, it can be expected that there will be changes in some budgetary items. Our planned expenditures for the twelve months following July 1, 2008 are as follows:
|
Category
|
|
Amount
|
|
|
|
|
|
|
|
Research & Development
|
|
$
|
6,318,000
|
|
|
General & Administrative Expenses
|
|
|
2,865,000
|
|
|
Finance Income, net
|
|
|
(75,000
|
)
|
|
|
|
|
|
|
|
Total
|
|
$
|
9,108,000
|
|
|
|
|
|
|
|
As previously indicated, we are planning to file an IND with the FDA for VitiGam
TM
. Our ability to proceed with this IND application as well as the commencement of the related clinical trial is dependent on several major factors including the ability to attract sufficient financing on terms acceptable to us.
ITEM 3A(T) - CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
As of June 30, 2008, our management carried out an evaluation, under the supervision of our Chief Executive Officer and the Chief Financial Officer, of the effectiveness of the design and operation of our system of disclosure controls and procedures (as defined by Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “
Exchange Act
”)). Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective, as of the date of their evaluation, for the purposes of recording, processing, summarizing and timely reporting material information required to be disclosed in reports filed by us under the Exchange Act.
20
Changes in internal controls
There
were no changes in our internal controls over financial reporting that occurred
during the quarter ended June 30, 2008 that have materially affected, or
are reasonably likely to materially affect, our internal control over financial
reporting.
21
PART II
ITEM 1 - LEGAL PROCEEDINGS
From time to time we may become subject to litigation incidental to our business. We are not currently a party to any legal proceedings.
ITEM 2 - UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3 - DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4 - SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
ITEM 5 - OTHER INFORMATION
The following disclosure would have otherwise been filed on Form 8-K under the heading “Item 1.01 – Entry into a Material Definitive Agreement” and “Item 3.02 – Unregistered Sales of Equity Securities”.
On
August 11, 2008, we executed an Amendment Agreement with ARP Biomed, Ltd.
(“
ARP
”)
made as of June, 2008 (the “
Amendment
Agreement
”) amending the Share
Purchase Agreement dated November 26, 2007, between the parties
and certain other ancillary agreements entered into at the same time. As
previously reported in our Form 8-K filed with the Commission on December
19, 2007, the Share Purchase Agreement provided that subject to fulfillment
of certain closing conditions, including the receipt of an Israeli tax ruling,
ARP will sell to us 12.5% of the issued and outstanding shares of the Subsidiary
such that at closing we will own 100% of the issued and outstanding shares
of the Subsidiary. In consideration for such sale, we originally agreed
to issue to ARP, at closing, 2,697,535 shares of its common stock, a warrant
to acquire 1,123,973 shares of its common stock and an additional warrant
to acquire 449,589 shares of its common stock. According to the Amendment
Agreement, the number of shares of common stock issuable to ARP at closing
and upon receipt of an Israeli tax ruling has been increased to 3,389,902
shares of our common stock and no warrants will be issued. Further, the Amendment
Agreement amends the Lock-Up Agreement dated as of November 26, 2007 between
ARP and the Company by increasing the number of locked-up shares that can
be sold during the period after May 26, 2009 from one-sixth per month to
one-eight per month. The Amendment Agreement also amends the effective date
of the Agreement to Sale of Intellectual Property Agreement dated as of November
26, 2007 between ARP and the Company to the earlier of the receipt of the
Israeli tax ruling and June 15, 2008.
22
Subsequently on August 13, 2008, we conducted a closing of the Share Purchase Agreement as amended by the Amendment Agreement. The 3,389,902 shares of our common stock issued to ARP at closing were offered and sold in reliance upon exemptions from the registration requirements of the Securities Act of 1933, as amended, by virtue of Section 4(2) thereof and/or Rule 506 of Regulation D promulgated thereunder.
Mr. Yair Aloni, a member of our board of directors, is the Chief Executive Officer of ARP and Professor Yehuda Shoenfeld, M.D., our Chief Scientist of the Subsidiary, is an advisor to ARP.
The foregoing description is a summary and is qualified in its entirety by the Amendment Agreement attached as an exhibit hereto and incorporated by reference herein.
ITEM 6 - EXHIBITS
|
Number
|
|
Exhibit
|
|
|
|
|
10.1
|
|
Amendment Agreement dated as of June, 2008 between ARP Biomed Ltd. and GammaCan International, Inc.
|
|
31.1
|
|
Certification of Principal Executive Officer pursuant to Rule 13a-14 and Rule 15d-14(a), promulgated under the Securities and Exchange Act of 1934, as amended
|
|
31.2
|
|
Certification of Principal Financial Officer pursuant to Rule 13a-14 and Rule 15d 14(a), promulgated under the Securities and Exchange Act of 1934, as amended
|
|
32.1
|
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chief Executive Officer)
|
|
32.2
|
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chief Financial Officer)
|
23
SIGNATURES
In accordance with the requirements of the Securities Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
|
|
|
GAMMACAN INTERNATIONAL, INC.
Registrant
|
|
Date: August 14, 2008
|
|
By:
|
/s/
Limor Zur-Stoller
|
|
|
|
|
|
|
|
|
|
Limor Zur-Stoller
Chief Financial Officer
|
24
Grafico Azioni Greater Cannabis (PK) (USOTC:GCAN)
Storico
Da Nov 2024 a Dic 2024
Grafico Azioni Greater Cannabis (PK) (USOTC:GCAN)
Storico
Da Dic 2023 a Dic 2024
