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 September 30, 2008
Commission File No. 000-27237
GENETHERA, INC.
(Exact name of small Business Issuer as specified in its Charter)
Nevada 65-0622463
(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification Number)
3930 Youngfield Street, Wheat Ridge CO 80033
(Address of principal executive offices) (Zip Code)
Issuer's telephone number, including area code: (303) 463-6371
Check whether the issuer (1) 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 issuer was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days [ X ] 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. See definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer [ ]
Accelerated filer [ ]
Non-accelerated filer [ ]
Smaller reporting company [X ]
(Do not check if a smaller reporting company)
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act):
Yes [ ]
No [ X ]
State the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date: 559,594 Shares of $.001 par value Common Stock outstanding as of September 30, 2008 and Series A 4,600 Shares, and Series B 7, 470,000 shares of $.001 par value Preferred Stock outstanding as of September 30, 2008.
PART 1 - FINANCIAL INFORMATION
Item 1. Financial Statements
GENETHERA, INC.
AND SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2008
UNAUDITED
W. T. UNIACK & CO. CPA’S, P.C.
CERTIFIED PUBLIC ACCOUNTANTS
1003 Weatherstone Pkwy., Ste. 320 12600 Deerfield Pkwy., Ste 100
Woodstock, GA 30188 Alpharetta, GA 30004
Phone: 770-592-3233 Phone: 678-566-3774
_____________________________________________________________________________________
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors
GeneThera, Inc.
White Ridge, CO
We have reviewed the accompanying balance sheet of GeneThera, Inc. as of September 30, 2008, and the related statements of operations and cash flows for the three to nine month periods ended September 30, 2008. These financial statements are the responsibility of the Company’s management.
We conducted our review in accordance with the standards of the Public Company Accounting Oversight Board (United States). A review of interim financial information consists principally of applying analytical procedures and making inquiries of persons responsible for financial and accounting matters. It is substantially less in scope than an audit conducted in accordance with standards of the Public Company Accounting Oversight Board (United States), the objective of which is the expression of an opinion regarding the financial statements taken as a whole. Accordingly, we do not express such an opinion.
Based on our review, we are not aware of any material modifications that should be made to the accompanying interim financial statements referred to above for them to be in conformity with accounting principles generally accepted in the United States of America.
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1, conditions exist which raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of the uncertainty.
W.T. UNIACK & CO, CPA’s, P.C.
November 19, 2008
TABLE OF CONTENTS
Page No.
Consolidated Balance Sheet September 30, 2008
3
Consolidated Statements of Operations for September 30, 2008 and 2007
5
Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the
Period ended September 30, 2008
6
Consolidated Statements of Cash Flows for September 30, 2008 and 2007
7
Notes to Consolidated Financial Statements
8
Genethera, Inc. And Subsidiary
Consolidated Balance Sheets
Assets | |||
|
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|
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| Unaudited |
|
|
| September 30, 2008 |
| December 31, 2007 |
|
|
|
|
Current Assets |
|
|
|
Cash | $ 22 |
| $ 196 |
Accounts receivable - less reserve for uncollectible amount | 822 |
| 68,267 |
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|
|
Total Current Assets | 844 |
| 68,463 |
|
|
|
|
Property and equipment | 727,428 |
| 727,428 |
Accumulated Depreciation | (489,871) |
| (436,864) |
Property and equipment, net | 237,557 |
| 290,564 |
|
|
|
|
Other Assets |
|
|
|
Deposits | 5,278 |
| 5,278 |
|
|
|
|
Total Other Assets | 5,278 |
| 5,278 |
|
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|
Total Assets | $ 243,679 |
| $ 364,305 |
|
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|
Read report and notes to financial statements
Genethera, Inc. And Subsidiary
Consolidated Balance Sheets
Liabilities and Stockholders' Equity | |||
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| Unaudited |
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|
| September 30, 2008 |
| December 31, 2007 |
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Current Liabilities |
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|
Accounts payable | $ 239,526 |
| $ 582,869 |
Accrued expenses | 930,408 |
| 968,702 |
Note payable | - |
| 150,290 |
|
|
|
|
Total Current Liabilities | 1,169,934 |
| 1,701,861 |
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Total Liabilities | 1,169,934 |
| 1,701,861 |
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Stockholders' Equity |
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Preferred stock, $.001 par value, 20,000,000 shares authorized; |
|
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|
Series A 4,600 shares issued and outstanding $.001 par value | 5 |
| 5 |
Series B 7,470,000 shares issued and outstanding $.001 par value | 7,470 |
| 3,000 |
Common stock $.001 par value, 100,000,000 shares authorized; |
|
|
|
559,594 shares issued and outstanding | 560 |
| 10 |
Additional paid in capital | 18,963,209 |
| 15,069,221 |
Deficit accumulated during development stage | (19,897,499) |
| (16,409,792) |
|
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|
|
Total Stockholders' Equity | (926,255) |
| (1,337,556) |
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|
Total Liabilities & Stockholders' Equity | $ 243,679 |
| $ 364,305 |
Read report and notes to financial statements
Genethera, Inc. and Subsidiary
Consolidated Statements of Operations
For the Period from October 5, 1998 (Inception) to September 30, 2008
Unaudited
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| For the period from |
| 3 month period ended September 30, |
| 9 month period ended September 30, |
| October 5, 1998 | ||||
| 2008 |
| 2007 |
| 2008 |
| 2007 |
| (inception) to |
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| September 30, 2008 |
Income |
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Sales | $ - |
| $ 30,000 |
| $ 10,822 |
| $ 60,000 |
| $ 527,471 |
Research fees |
|
|
|
| - |
| - |
| 188,382 |
Total income | - |
| 30,000 |
| 10,822 |
| 60,000 |
| 715,853 |
|
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|
Cost of sales | 0 |
| 0 |
| - |
| - |
| (30,352) |
|
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|
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|
Gross profit | - |
| 30,000 |
| 10,822 |
| 60,000 |
| 685,501 |
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Expenses |
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Other compensation | - |
|
|
| - |
| - |
| 3,283,009 |
Consulting | 2,880,055 |
| 14,404 |
| 2,957,139 |
| 222,765 |
| 7,777,733 |
General and administrative expenses | 163,076 |
| 87,759 |
| 312,560 |
| 307,777 |
| 4,204,278 |
Payroll expenses | 58,500 |
| 58,500 |
| 175,500 |
| 176,850 |
| 2,280,119 |
Depreciation | 17,206 |
| 18,050 |
| 53,007 |
| 54,512 |
| 489,871 |
Settlement expense | - |
| - |
| - |
| - |
| 82,625 |
Impairment of long-lived asset | - |
| - |
| - |
| - |
| 55,714 |
Bad debt expense |
|
|
|
|
|
|
|
| - |
Lab expenses | 99 |
| 149 |
| 323 |
| 160 |
| 16,303 |
Total expenses | 3,118,936 |
| 178,862 |
| 3,498,529 |
| 762,064 |
| 18,484,392 |
|
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Loss from operations | (3,118,936) |
| (148,862) |
| (3,487,707) |
| (702,064) |
| (17,798,891) |
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Other income (expenses) |
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Beneficial conversion expense | - |
|
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| - |
| - |
| - |
Interest expense |
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| - |
| - |
| (1,987,991) |
Gain on settlements |
|
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|
| - |
| - |
| (46,758) |
Other income (expenses), net |
|
| (100) |
| - |
| (100) |
| 58,203 |
|
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Net loss from continuing operations | (3,118,936) |
| (148,962) |
| (3,487,707) |
| (702,164) |
| (19,775,437) |
Gain (loss) from disposal of subs |
|
|
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| - |
Loss from discontinued operations |
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| - |
| - |
| (122,065) |
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Net loss | $ (3,118,936) |
| $ (148,962) |
| $ (3,487,707) |
| $ (702,164) |
| $ (19,897,499) |
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Loss per common share Basic & Diluted | $ (13.981) |
| $ (15.777) |
| $ (42.316) |
| $ (83.057) |
|
|
Weight Average Shares | 223,085 |
| 9,442 |
| 82,421 |
| 8,454 |
|
|
Read report and notes to financial statements
GeneThera, Inc. and Subsidiary
Consolidated Statements of Changes in Stockholders’ equity (Deficit)
For the period ended September 30, 2008
Unaudited
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| Development |
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| Stage |
|
| Preferred Stock A | Preferred Stock B | Common Stock | Paid in | Subscription | Accumulated |
| |||
| Shares | Amount | Shares | Amount | Shares | Amount | Capital | Agreement | Deficit | Total |
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Balance December 31, 2007 | 4,600 | $ 5 | 3,000,000 | $ 3,000 | 10,305 | $ 51,527 | $ 15,017,704 | $ - | $ (16,409,792) | (1,337,556) |
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Shares issued for consulting services |
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| 850 | 4,251 | 82,223 |
|
| 86,474 |
|
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|
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| - |
Shares issued for rent |
|
|
|
| 144 | 718 | 13,645 |
|
| 14,363 |
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Shares issued for rent |
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| 328 | 1,642 | 16,781 |
|
| 18,423 |
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Shares issued for consulting services |
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|
|
| 968 | 4,839 | 469,052 |
|
| 473,891 |
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Additional paid in Capital - Reverse Split |
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| (62,964) | 62,964 |
|
| - |
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Shares issued to Officer |
|
| 4,500,000 | 4,500 |
|
| 175,500 |
|
| 180,000 |
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Shares issued for rent |
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|
|
| 1,231 | 1 | 15,964 |
|
| 15,965 |
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Shares issued for consulting services |
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| 245,768 | 246 | 3,109,646 |
|
| 3,109,892 |
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Converted Shares |
|
| (30,000) | (30) | 300,000 | 300 | -270 |
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Net Loss September 30, 2008 |
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| (3,487,707) | (3,487,707) |
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Balance September 30, 2008 | 4,600 | $ 5 | 7,470,000 | $ 7,470 | 559,594 | $ 560 | $ 18,963,209 | $ - | $ (19,897,499) | $ (926,255) |
Read report and notes to financial statements
GeneThera, Inc. and Subsidiary
(Development Stage Company)
Consolidated Statements of Cash Flows
For the period from October 5, 1998 (Inception) to September 30, 2008
Unaudited
|
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| |
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| For the period from |
| 9 month period ended September 30, |
| October 5, 1998 | ||
|
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| (inception) to |
| 2008 |
| 2007 |
| September 30, 2008 |
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Cash flows from operating activities: |
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Net loss | $ (3,487,707) |
| $ (702,164) |
| $ (19,897,499) |
|
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Adjustments to reconcile net loss to net |
|
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cash provided by (used in) operating activities: |
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Depreciation and amortization | 53,007 |
| 54,512 |
| 489,871 |
Bad Debt Expense |
|
| (90,000) |
| 0 |
Compensation in exchange for common stock | 3,719,008 |
| 463,833 |
| 12,867,007 |
Beneficial conversion feature | - |
| - |
| 1,987,990 |
Changes in operating assets and liabilities |
|
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(Increase) Decrease in: |
|
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Accounts receivable | 67,445 |
| (117,267) |
| 820 |
Accounts receivable Related Parties | - |
| (11,360) |
| 0 |
Reserve for Uncollectible |
|
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|
|
|
Inventory | - |
| - |
| 0 |
Prepaid expenses | - |
| (110) |
| 0 |
Other assets | - |
| - |
| 5,278 |
(Increase) Decrease in account payable |
|
|
|
|
|
and accrued liabilites | (381,637) |
| 196,304 |
| 1,169,934 |
|
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Total adjustments | 3,457,823 |
| 675,912 |
| 16,520,900 |
|
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Net cash used in operating activities | (29,884) |
| (26,252) |
| (3,376,599) |
|
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Cash flows from investing activities: |
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Cash payments for the purchase of property | - |
| - |
| (299,072) |
|
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Cash flows from financing activities: |
|
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Bank overdraft | - |
| - |
| - |
Capital contributed as equipment | - |
| - |
| 272,376 |
Principal payments on notes & leases payable | - |
| (10,210) |
| (240,119) |
Payment of lease payable |
|
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Payment for Accrued Salaries |
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Proceeds from issuance of stock | 180,000 |
| - |
| 2,088,882 |
Proceeds from Payments of loans payable | (150,290) |
| 21,384 |
| 1,482,500 |
Proceeds from Subscription Recievable | - |
| - |
| 100,040 |
Repurchase of Common Stock | - |
| - |
| (1,610) |
Reciept of APIC | - |
| - |
| 20,000 |
Payment of Perfered Dividends | - |
| - |
| (46,338) |
Sale of Preferred |
|
| 15,000 |
|
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Net cash provided by financing activities | 29,710 |
| 26,174 |
| 3,675,731 |
|
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Net increase (decrease) in cash | (174) |
| (78) |
| 60 |
|
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Cash, beginning of year | 196 |
| 234 |
|
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Cash, end of year | $ 22 |
| $ 156 |
| $ 22 |
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Supplemental disclosures of cash flow information: |
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Cash paid during the period for interest expense | $ - |
| $ - |
| $ 46,758 |
Cash paid during the period for Taxes | $ - |
| $ - |
| - |
Read report and notes to financial statements
GENETHERA, INC. AND SUBSIDIARY
A DEVELOPMENT STAGE COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2008
UNAUDITED
NOTE 1
PRINCIPLES OF CONSOLIDATION
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiary, GeneThera, Inc. (Colorado). All significant inter-company balances and transactions have been eliminated.
NOTE 2
BASIS OF PRESENTATION
The interim financial information included herein is unaudited; however, such information reflects all adjustments which are, in the opinion of management, necessary for a fair presentation of the Company’s financial position, results of operations, changes in stockholders’ equity (deficit) and cash flows for the interim periods. All such adjustments are of a normal, recurring nature. The results of operations for the first three months of the year are not necessarily indicative of the results of operations which might be expected for the entire year.
The accompanying consolidated financial statements of the Company have been prepared in accordance with the instructions to Form 10-Q and, therefore, omit or condense certain footnotes and other information normally included in financial statements prepared in accordance with generally accepted accounting principles. It is suggested that these condensed financial statements should be read in conjunction with the Company's financial statements and notes thereto included in the Company's audited financial statements on Form 10-KSB/A as amended for the fiscal year ended December 31, 2007.
NOTE 3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Stock Based Compensation
The Company has adopted the use of Statement of Financial Accounting Standards No. 123R , “Share-Based Payment”, (SFAS No. 123R) This Statement requires an entity to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award (with limited exceptions). That cost is recognized over the period during which an employee is required to provide service in exchange for the award—the requisite service period (usually the vesting period). No compensation cost is recognized for equity instruments for which employees do not render the requisite service. This Statement supersedes APB Opinion No. 25, “Accounting for Stock Issued to Employees”, and its related implementation guidance and eliminates the alternative to use Opinion 25’s intrinsic value method of accounting that was provided in Statement 123 as originally issued.
GENETHERA, INC. AND SUBSIDIARY
A DEVELOPMENT STAGE COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2008
UNAUDITED
NOTE 3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES – continued
Earnings per Share
Basic earnings per share are computed based on the weighted average number of common shares outstanding during each year. Diluted earnings per share are computed based on the weighted average number of common shares outstanding during the period, there is no Diluted earnings per share for any periods in which there is a loss as it would be anti-dilutive.
NOTE 4
PROPERTY AND EQUIPMENT
Property and equipment consisted of the following:
September 30,
2008
Computers
$ 42,987
Office Equipment
39,891
Furniture & fixtures
1,465
Laboratory equipment
643,084
727,428
Less accumulated depreciation
(489,871)
$237,557
Depreciation expense for the nine months ended September 30, 2008 and 2007 was $53,007 and $54,512 respectively.
NOTE 5 NOTE PAYABLE
For the periods ended September 30, 2008 and December 31, 2007, the Company had a balance in note payable of $0 and $150,290 respectively. The note was paid down with the last contract the Company had with NIH issued of common stock after the split.
NOTE 6 COMMITMENTS AND CONTINGENCIES
During the quarter a judgment was levied against the Company. The amount is still undetermined however, it’s the Company’s belief that it will approximate a loss of at least $500.000 plus. This has not been accrued in the financial statements.
GENETHERA, INC. AND SUBSIDIARY
A DEVELOPMENT STAGE COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2008
UNAUDITED
NOTE 7
STOCKHOLDERS’ EQUITY
Common Stock
In January 2008, the Company issued 347 shares valued at $34,690 to consulting services of operations and resulted in an immediate charge to operations.
In February 2008, the Company issued 129 shares valued at $14,375 to consulting services of operations and resulted in an immediate charge to operations.
In February 2008, the Company issued 44 shares valued at $4,363 for rent of the facility of operations and resulted in an immediate charge to operations.
In March 2008, the Company issued 374 shares valued at $37,408 to consulting services of operations and resulted in an immediate charge to operations.
In March 2008, the Company issued 100 shares valued at $10,000 for rent and yearly maintenance of the facility of operations and resulted in an immediate charge of operations.
In April 2008, the Company issued 40 shares valued at $4,000 for rent of the facility of operations and resulted in an immediate charge to operations.
In April 2008, the Company issued 139 shares valued at $13,933 to consulting services of operations and resulted in an immediate charge to operations.
In May 2008, the Company issued 143 shares valued at $7,150 for rent of the facility of operations and resulted in an immediate charge to operations.
In May 2008, the Company issued 688 shares valued at $452,958 to consulting services of operations and resulted in an immediate charge to operations.
In June 2008, the Company issued 145 shares valued at $7,273 for rent of the facility of operations and resulted in an immediate charge to operations.
In June 2008, the Company issued 140 shares valued at $7,000 for consulting services of operations and resulted in an immediate charge to operations.
In July 2008, the Company issued 134 shares valued at $2,412 for rent of the facility of operations and resulted in an immediate charge to operations.
In July 2008, the Company issued 35,134 shares valued at $647,484 for consulting services of operations and resulted in an immediate charge to operations.
In August 2008, the Company issued 134 shares valued at $2,479 for rent of the facility of operations and resulted in an immediate charge to operations.
GENETHERA, INC. AND SUBSIDIARY
A DEVELOPMENT STAGE COMPANY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2008
UNAUDITED
In August 2008, the Company issued 8,231 shares valued at $134,774 for consulting services of operations and resulted in an immediate charge to operations.
In September 2008, the Company issued 963 shares valued at $11,075 for rent of the facility of operations and resulted in an immediate charge to operations.
In September 2008, the Company issued 202,403 shares valued at $2,327,634 for consulting services of operations and resulted in an immediate charge to operations.
As of September 30, 2008, there were 559,594 shares of our common stock issued and outstanding.
Preferred Stock
As of September 30, 2008, there were 4,600 shares of our Series A, Convertible Preferred Stock (“Series A”) issued and outstanding, and 7,470,000 shares of our Series B, Convertible Preferred Stock (“Series B”) were issued and outstanding.
Reverse Stock Split
As of July 9, 2008, the Company did a reverse stock split of one-for-five thousand (1:5,000) reverse split of it common stock. After the reverse split, the Company has 12,595 shares outstanding. All Per Share amounts in the accompanying financial statements have been adjusted for the reverse split.
Converted Stock
As of July 11, 2008, the Company converted 20,000 Preferred B Stock to 200,000 Common Stock.
As of September 26, 2008, the Company converted 10,000 Preferred B Stock to 100,000 shares of Common Stock.
NOTE 8
GOING CONCERN UNCERTAINTY
These financial statements are presented assuming the Company will continue as a going concern. For the periods ended September 30, 2008 and 2007, the Company showed operating losses of $3,487,707 and $702,164 respectively. The accompanying financial statements indicate that current liabilities exceed current assets by $1,169,090 for the nine months ended September 30, 2008.
These factors raise substantial doubt about its ability to continue as a going concern. Management’s plan with regard to these matters includes raising working capital and significant assets and resources to assure the Company’s viability, through private or public equity offering, and/or debt financing, and/or through the acquisition of new business or private ventures.
Item 2. Management's Discussion and Analysis and Results of Operation
The following discussion and analysis should be read in conjunction with the financial statements and notes thereto that appear elsewhere herein.
FORWARD-LOOKING AND CAUTIONARY STATEMENTS
Sections of this Form 10-Q, including the Management's Discussion and Analysis or Plan of Operation, contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), Section 21E of the Securities and Exchange Act of 1934, as amended (the "Exchange Act"), and the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements are subject to risks and uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the results, performance or achievements expressed or implied by the forward-looking statements. You should not unduly rely on these statements. Forward-looking statements involve assumptions and describe our plans, strategies, and expectations. You can generally identify a forward-looking statement by words such as "may," "will," "should," “would," could," "plan," "goal," "potential," "expect," "anticipate," "estimate," "believe," "intend," "project," and similar words and variations thereof. This report contains forward-looking statements that address, among other things,
* our financing plans,
* regulatory environments in which we operate or plan to operate, and
* trends affecting our financial condition or results of operations, the impact of competition, the start-up of certain operations and acquisition opportunities.
Factors, risks, and uncertainties that could cause actual results to differ materially from those in the forward-looking statements ("Cautionary Statements") include, among others,
* our ability to raise capital,
* our ability to execute our business strategy in a very competitive environment,
* our degree of financial leverage,
* risks associated with our acquiring and integrating companies into our own,
* risks relating to rapidly developing technology,
* regulatory considerations;
* risks related to international economies,
* risks related to market acceptance and demand for our products and services,
* the impact of competitive services and pricing, and
* other risks referenced from time to time in our SEC filings.
All subsequent written and oral forward-looking statements attributable to us, or anyone acting on our behalf, are expressly qualified in their entirety by the cautionary statements. We do not undertake any obligations to publicly release any revisions to any forward-looking statements to reflect events or circumstances after the date of this report or to reflect unanticipated events that may occur.
RESULTS OF OPERATIONS
Gross profits for the nine-month period ended September 30, 2008 were $10,822 compared to $60,000 for the same period last year. Personnel (salaries) decrease from $176,850 for the prior nine month period ending September 30, 2007 to $175,500 for the nine month period ending September 30, 2008. Professional expenses (consulting and professional fees) comparing the nine month period ending September 30, 2008, to the nine month period ending June 30, 2007, increase from $222,765 to $2,957,139 with the increase attributable to stock issued for consulting and professional services received throughout the quarter.
LIQUIDITY AND CAPITAL RESOURCES
The Company had a cash balance of $22 as of September 30, 2008. Accounts receivable as of September 30, 2008 was $822. It is estimated that it will require outside capital for the remainder of fiscal year 2008 for the commercialization of GeneThera's molecular assays as well as the development of their therapeutic vaccines. The Company intends to raise these funds by means of one or more private offerings of debt or equity securities or both and also generating revenue from Mexico. Currently the company is in discussions with one group to obtain financing through either debt and/or equity. No definitive agreements have been signed. There are no guarantees whether the Company will be able to secure such a financing, and if the financing is secured, there are no guarantees whether the Company can achieve the goals laid out in its business plan fully. We will require significant additional funding in order to achieve our business plan.
Our longer-term working capital and capital requirements will depend upon numerous factors, including revenue and profit generation, pre-clinical studies and clinical trials, the timing and cost of obtaining regulatory approvals, the cost of filing, prosecuting, defending, and enforcing patent claims and other intellectual property rights, competing technological and market developments, collaborative arrangements. Additional capital will be required in order to attain such goals. Such additional funds may not become available on acceptable terms and we cannot give any assurance that any additional funding that we do obtain will be sufficient to meet our needs in the long term.
Item 3. GENETHERA PLAN OF OPERATION
Background
In November 2007, GeneThera, Inc. reincorporated in the State of Nevada due to a third party which purchased the GeneThera Florida Charter in order to blackmail our Company for $80,000. We had a special meeting with three shareholders where it was unanimously resolved for GeneThera to transfer its Charter to the State of Nevada as soon as possible in order to recognize our new incorporation on our next SEC filing. The reinstatement was completed by January 2008. GeneThera has developed proprietary diagnostic assays for use in the agricultural and veterinary markets. Specific assays for Chronic Wasting Disease (among elk and deer) and Mad Cow Disease (among cattle) have been developed and are available currently on a limited basis. E.coli (predominantly cattle) and Johne's disease (predominantly dairy cattle and bison) diagnostics are in development. GeneThera is making a pivotal shift from a Research and Development organization into a product marketing and revenue generating entity. The company strategy that we maintained from inception to our recent reverse split (July, 2008) had been one of research only. We focused all our energies, talent, and resources to the incubation and growth of new ideas in the realm of genetically engineered disease detection and vaccination. We feel that with recent announcements the company is positioned to move from a developmental stage to a product oriented stage.
GeneThera provides genetics-based diagnostic and is currently working on vaccine solutions to meet the growing demands of today's veterinary industry and tomorrow's agriculture and healthcare industries. The company is organized and operated both to continually apply its scientific research to more effective management of diseases and, in so doing, realize the commercial potential of molecular biotechnology.
The Company believes it will require significant additional funding in order to achieve its business plan. Over the next 12 months, in order to have the capability of achieving its business plan, the Company will require at least $5,000,000. There are no guarantees whether the Company will be able to secure such a financing, and if the financing is secured, there are no guarantees whether the Company can achieve the goals laid out in its business plan fully.
RESEARCH AND DEVELOPMENT
We anticipate that research and development (R&D) will be the source for both assay development and vaccine design/development. If we are able to develop assays for different diseases, we intend to formalize the procedure into a commercial application through a series of laboratories to be owned and operated by GeneThera. To date, we have introduced our diagnostic solution for Chronic Wasting Disease and Mad Cow Disease on a very limited basis. We anticipate that R&D will be ongoing during the life of the Company, as this is the source for new products to be introduced to the market. Our plan is to seek new innovations in the biotechnology field. We cannot assure you that we will be successful in developing or validating any new assays or, if we are successful in developing and validating any such assays, that we can successfully commercialize them or earn profits from sales of those assays. Furthermore, we cannot assure you that we will be able to design, develop, or successfully commercialize any vaccines as a result of our research and development efforts.
COMMERCIAL DIAGNOSTIC TESTING
In the event that we are able to develop assays for the detection of diseases in animals, we intend to establish a series of diagnostic testing laboratories geographically proximate to the primary sources of individual diseases and/or according to specific available operating efficiencies. The specific number of labs to be built and operated will be based on assay demand (demand facilitated by the number of specific disease assays GeneThera develops), our ability to obtain the capital to build the labs, and our ability to successfully manage them from our principal office. As of the date of this filing, we are in negotiation to establish one diagnostic testing laboratory outside of our Colorado facility.
LICENSING
Through our third division, Licensing, we intend to manage the marketing and sale of the vaccines developed by GeneThera's Research & Development division. As GeneThera does not intend to be a vaccine manufacturer, we plan to use our Licensing division to license the technology related to any vaccines that may be developed and to manage the revenue potential available from the successful development and validation of specific vaccines. We cannot provide any assurance that we will develop any vaccines or that, if they are developed, we will be able to license them successfully or that any such license will produce significant revenues.
R&D SERVICES
Molecular, Cellular, Viral Biology Research, and Consulting Services. We provide independent research services to scientists in academia, the pharmaceutical industry, and the biotechnology industry. Primarily, GeneThera's expertise focuses on technology relevant to animal and human immunotherapy. These services are backed by the cumulative experiences of greater than 50 years of research and development in both government and industry by GeneThera's senior scientists. GeneThera intends to develop a commercial-scale implementation of Adenovector Purification Process to support R&D material production. Furthermore, GeneThera intends to evaluate and test commercially available expression vectors and incorporate them into its vector repertoire. These technologies are well established within the repertoire of GeneThera's scientific staff. We cannot provide any assurance, however, that we will be able to successfully offer these services or that, if offered, we can provide them profitably.
Research & Development Services:
Molecular Biology:
Synthetic cDNA Construction
Prokaryotic Expression Vector Construction & Development
E.coli Expression Strain Evaluation
Pilot Scale Fermentation
Mammalian Expression Vector Construction & Development
Baculovirus Expression
Protein Isolation
Protein Engineering: Complement Determining Region Conjugated Proteins
Monoclonal Antibody Production Chimerization & Humanization
Vector design for Prokaryotic Expression of Antibody Fragments (Fab) and Single Chain Antibody (ScFv)
Pilot Scale-up Development
Process Purification & Characterization
Assay Development & Quality Control Pharmaceutical Dosage and Formulation
Gene Therapy Testing Services. GeneThera offers GLP (Good Laboratory Procedure) testing programs for somatic cell, viral and naked DNA-based gene therapies. Our scientists have over nine years experience in providing fully integrated bio-safety testing programs for the cell and gene therapy fields. To date, the Company has not generated any revenues with regard to these services, and there is no assurance that we will generate any revenues from such services.
Replication-Competent Viral Vector Testing. Sensitive in vitro cell culture assays are used to detect replication-competent retroviruses or adenoviruses. GeneThera can work with clients to provide custom replication-competent virus detection assays for the particular vector construct.
Complete Somatic Cell and Viral Vector Packaging and Producer Cell Line Characterization. GeneThera offers all of the assays mandated by regulatory authorities worldwide for the bio-safety analysis and characterization of cells and cell lines used in gene therapy products.
Vector Stock Characterization. Custom purity and potency testing is available for gene therapy viral vector stocks.
Vector Purification Process Validation for Viral Clearance. Most biopharmaceuticals require viral clearance studies to validate the removal of potential contaminants, such as those from bovine components or from helper viruses (adenovirus in AAV production). GeneThera can provide custom design and performance of viral studies for various vector purification processes.
Custom Bio-safety Testing Programs for Somatic Cell, Ex Vivo Cell, and Tissue Therapies. GeneThera can guide our clients through the unique process of designing and implementing a bio-safety testing program that meets the needs of each specific project.
GeneThera is currently seeking contracts for these services and is in the final negotiation stage with a publicly traded company to perform these services on an annual basis. There is no assurance that any contracts will be signed or that the company will generate significant revenues or profits from any such contracts.
BUSINESS MODEL
Summary. GeneThera's animal disease assay development business is based on its Integrated Technology Platform (ITP) that combines a proprietary diagnostic solution called Gene Expression Assay (GES) with PURIVAXTM, its system for analyzing large-scale DNA sequencing. The first part of this platform is the ongoing development of molecular diagnostic assays solutions using real time Fluorogenic Polymerase Chain Reaction (F-PCR) technology to detect the presence of infectious disease from the blood of live animals. The second part of the ITP is the development of therapeutic vaccines using RNA interference technology. It also allows for the efficient, effective, and continuous testing, management and treatment of animal populations. These facts distinguish the technology from any alternative testing and management methodology available to agriculture today -- all of which require the destruction of individual animals and even entire herds. Our testing and data analysis processes also allow us not only to separate infected from clean animals, but also to gain knowledge vital to development of preventative vaccines.
Each individual assay utilizes the proprietary Field Collection System (FCS) for the collection and transportation of blood samples to GeneThera's laboratory. The FCS allows GeneThera to maintain the integrity of each sample by the addition of specific reagents to test tubes contained in the system. GeneThera's FCS is designed to be an easy-to-use method of gathering blood samples from harvested or domesticated animals. It ensures consistency of samples as well as increased assurance of each sample's integrity.
To date, GeneThera has successfully developed the ability to detect Chronic Wasting Disease, a disease affecting elk and deer in North America. The release of commercialized Field Collection Systems and laboratory diagnostic testing occurred in October of 2003 as a marketing trial. GeneThera has also successfully developed an assay for the detection of Mad Cow Disease, a disease recently found in the United States, but which has been in Europe for many years. The Field Collection Systems are available for purchase from the Company. Chronic Wasting Disease and Mad Cow Disease are both in the family of diseases called Transmissible Spongiform Encephalopathy (TSE). Diagnostic assays for E.coli O157:H7 and Johne's disease are in the final stages of development.
The Company, through GeneThera, is also developing vaccines for Chronic Wasting Disease and E.coli O157:H7. The Company will need the approval of the USDA before the vaccines can be manufactured or sold. The approval process for animal vaccines is time-consuming and expensive. We anticipate that such approval, if it is obtained, may require more than $5 million and may require more than two years for each vaccine for which approval is sought. Currently we do not have the capital necessary to seek approval of any of our candidate vaccines, and we cannot provide any assurance that we will be able to raise the capital necessary for such approval on terms that are acceptable to us, if at all. In addition, even if we are successful in raising the capital necessary to seek approval of any vaccine, there are no assurances that such an approval will be granted, or if granted, whether we will be able to produce and sell such vaccines following such an approval in commercial quantities or to make a profit from such production and sales.
Our recent developments include the progress we are making in regards to our Johne's Disease validation trials scheduled to begin in collaboration with the Universidad National Autonoma de Mexico, a prominent state university in Mexico City. Our joint venture with Nutricion Avanzada, (the joint venture created a new company Applied Genetics. Applied Genetics is the marketing arm of GeneThera for the Mexican marketing of our Johne's Disease testing service and subsequent Vaccine, (which is currently under development) has been in contact with several major ranchers throughout Mexico, and the overwhelming response from the ranchers has been an outcry for help in detecting and eliminating Johne's Disease which is running rampant in their herds. Government approval and recommendation is expected to occur quickly once the validation trials are complete. The validation trials should be complete within 3-4 months from start. We will be conducting paid testing on a limited basis during the validation trials.
The recent signing of our agreement with STC.UNM (the technology development arm of The University of New Mexico) for the genetic vaccine they have developed and patented for E.Coli 0157:h7 has thrust GeneThera into the global spotlight. The vaccine acts on a genetic level to inhibit the growth and shedding of the deadly E.Coli 0157:h7 bacteria from cattle. The vaccine has already passed initial animal trials and is now set to enter the clinical trial phase. We are currently seeking partnerships for the completion of the clinical trials and subsequent taking of the finished vaccine to market. Due to the specific genetic makeup of the vaccine, we expect the clinical trials to be completed within 9-12 months from start. This is 3 to 5 times faster than a standard vaccine might take.
GeneThera is working with The Goldsmith Group LLC for continued improvement of the company image and support for its shareholders. The Goldsmith Group is a private PR and Marketing firm whose members have extensive experience in the managing and marketing of both private and publicly traded firms throughout the US and Canada. They have been charged with improving the company website, creating new marketing and information materials for shareholders and partners, and presenting our company to a new group of potential shareholders.
ITEM 4.
CONTROLS AND PROCEDURES.
As required by Rule 13a-15 under the Securities Exchange Act of 1934 (The “Exchange Act”), we carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures within the 90 days prior to the filing date of this report. This evaluation was carried out under the supervision and with the participation of our Chief Executive Officer, Consulting Chief Financial Officer, and Controller. We concluded that our internal controls are ineffective. We will be working on them to improve its effectiveness.
There will be significant changes in our internal controls and in other factors that will definitely affect internal controls positively subsequent to the date we carried out our evaluation.
Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
On or about July 23, 2004, Sisu Media sued the Company in Jefferson County District Court for breach of an alleged contract for website services for which the plaintiff seeks compensatory damages, plus costs, interest, and attorney’s fees in amounts to be determined at trial. Trial was held on August 4, 2005, wherein the court determined that Sisu Media was entitled to compensation based only upon the breach of contract claim. Plaintiff’s claims in quantum meruit and for unjust enrichment were dismissed. The court also dismissed defendant GeneThera, Inc.’s claim of aiding and abetting a breach of fiduciary duty by third party. Entry of judgment was entered in favor of the plaintiff in the amount of $49,000.00. On February 9, 2006, the Company appealed this judgment and on January 9, 2008, the Appellate Committee’s decision was in favor of the plaintiff due to lack of adequate legal representation. An additional judgment of $6,237.31 was awarded for their attorney’s fees. The Company has not paid the abovementioned judgment(s).
On October 11, 2006, MAG Capital, a California Limited Liability Company (Mercator Momentum III, LP; Mercator Momentum Fund LP; Monarch Pointe Fund, Ltd; a British Virgin Islands Corporation), filed litigation against GeneThera, Inc., GTI Corporate Transfer Agents, LLC, a Colorado limited liability company, Antonio Milici, an individual, Tannya L. Irizarry, and Laura Bryan, individuals in the Superior Court State Complaint for breach of written contract. The Company retained legal counsel from Mark A. Shoemaker. In January 2008, MAG Capital dismissed the claims except the anticipatory breach of contract for which the Company’s legal counsel filed an appeal dated February 19, 2008.
Item 2. Changes in Securities
None.
Item 3. Defaults upon Senior Securities
No defaults upon senior securities.
Item 4. Submission of Matters to a Vote of Security Holders
No matters were submitted to a vote of security holders as of September 30, 2008.
Item 5. Other Information
None.
Item 6. Exhibits and Reports on Form 10-Q
(A) Financial Statements
Reference is made to the financial statements listed on the Index to Financial Statements in this Form 10-Q.
(B)
Exhibits
A.1
Certification pursuant to section 302 of the Sarbanes-Oxley act of 2002
A.2
Certification pursuant to section 302 of the Sarbanes-Oxley act of 2002
99.1 Certification of the President and Chief Executive Officer
99.2 Certification of the Chief Financial Officer
Signatures
Pursuant to the requirements of the Securities Act of 1933 the Registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in Wheat Ridge, Colorado on this 19Th day of November, 2008.
GENETHERA, INC.
By: s/ Antonio Milici
Name: Antonio Milici
Title: President and Chief Executive Officer
Pursuant to the requirements of the Securities Act of 1933 this Registration Statement has been signed by the following persons in the capacities indicated on November 19, 2008:
Signature | Title(s) |
/s/ Antonio Milici Antonio Milici | President, Chief Executive Officer and Director |
|
|
/s/ Thomas Slaga Thomas Slaga | Director |
EXHIBIT 31.1
CERTIFICATION PURSUANT TO SECTION 302
OF THE SARBANES-OXLEY ACT OF 2002
I, Antonio Milici, certify that:
1. I have reviewed this Form 10-Q for the fiscal quarter ended September 30,
2008 of GeneThera, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of
a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of
the small business issuer as of, and for, the periods presented in this
report;
4. The small business issuer’s other certifying officer(s) and I are
responsible for establishing and maintaining disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for
the small business issuer and have:
a) Designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the small
business issuer, including its consolidated subsidiaries, is made
known to us by others within those entities, particularly during the
period in which this report is being prepared;
b) Evaluated the effectiveness of the small business issuer's disclosure
controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures as
of the end of the period covered by this report based on such
evaluation; and
c) Disclosed in this report any change in the small business issuer's
internal control over financial reporting that occurred during the
small business issuer's most recent fiscal quarter (the small business
issuer's fourth fiscal quarter in the case of an annual report) that
has materially affected, or is reasonably likely to materially affect,
the small business issuer's internal control over financial reporting;
and
5. The small business issuer's other certifying officer(s) and I have
disclosed, based on our most recent evaluation of internal control over
financial reporting, to the small business issuer's auditors and the audit
committee of the small business issuer's board of directors (or persons
performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the small business issuer's
ability to record, process, summarize and report financial
information; and
b) Any fraud, whether or not material, that involves management or other
employees who have a significant role in the small business issuer's
internal control over financial reporting.
Date: November 19, 2008
/s/ Antonio Milici
--------------------------
Antonio Milici
President/Director
EXHIBIT 31.2
CERTIFICATION PURSUANT TO SECTION 302
OF THE SARBANES-OXLEY ACT OF 2002
I, Tannya L Irizarry, certify that:
1. I have reviewed this Form 10-QSB for the fiscal year ended September 30,
2008 of GeneThera, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of
a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of
the small business issuer as of, and for, the periods presented in this
report;
4. The small business issuer’s other certifying officer(s) and I are
responsible for establishing and maintaining disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for
the small business issuer and have:
a) Designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the small
business issuer, including its consolidated subsidiaries, is made
known to us by others within those entities, particularly during the
period in which this report is being prepared;
b) Evaluated the effectiveness of the small business issuer's disclosure
controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures as
of the end of the period covered by this report based on such
evaluation; and
c) Disclosed in this report any change in the small business issuer's
internal control over financial reporting that occurred during the
small business issuer's most recent fiscal quarter (the small business
issuer's fourth fiscal quarter in the case of an annual report) that
has materially affected, or is reasonably likely to materially affect,
the small business issuer's internal control over financial reporting;
and
5. The small business issuer's other certifying officer(s) and I have
disclosed, based on our most recent evaluation of internal control over
financial reporting, to the small business issuer's auditors and the audit
committee of the small business issuer's board of directors (or persons
performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the small business issuer's
ability to record, process, summarize and report financial
information; and
b) Any fraud, whether or not material, that involves management or other
employees who have a significant role in the small business issuer's
internal control over financial reporting.
Date: November 19, 2008
/s/ Tannya L. Irizarry
--------------------------
Tannya L. Irizarry
Chief Financial Officer (Interim)
Exhibit 32.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
I, Antonio Milici, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report on Form 10-Q of GeneThera, Inc. for the quarterly period ended September 30, 2008, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that the information contained in the Quarterly Report on Form 10-Q fairly presents in all material respects the financial condition and results of operations of GeneThera, Inc.
By: /s/ Antonio Milici
Name:
Antonio Milici
Title:
Chief Executive Officer
Date:
November 19, 2008
Exhibit 32.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
I, Tannya L. Irizarry, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report on Form 10-Q of GeneThera, Inc. for the quarterly period ended September 30, 2008, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that the information contained in the Quarterly Report on Form 10-Q fairly presents in all material respects the financial condition and results of operations of GeneThera, Inc.
By: /s/ Tannya L Irizarry
Name:
Tannya L Irizarry
Title:
Chief Financial Officer (Interim)
Date:
November 19, 2008