| SEC Info | Home | Search | My Interests | Help | Sign In | Please Sign In | ||||||||||||||||||||
As Of Filer Filing As/For/On Docs:Pgs Issuer Agent 10/16/02 Oragenics Inc SB-2 45:186 Northwest Filers Inc/FA
Document/Exhibit Description Pages Size
1: SB-2 Oragenics, Inc. Form SB-2 Registration Statement HTML 376K
2: EX-1 Letter of Intent With Haywood Securities Inc. HTML 43K
3: EX-1 Agency Agreement With Haywood Securities Inc. HTML 130K
4: EX-3 Articles of Incorporation HTML 20K
5: EX-3 Bylaws HTML 41K
6: EX-3 Amended Articles of Incorporation HTML 21K
7: EX-3 Amended Articles of Incorporation HTML 15K
8: EX-4 Specimen Stock Certificate HTML 16K
9: EX-4 Specimen Series A Warrant Certificate HTML 30K
10: EX-4 Specimen Series B Warrant Certiifcate HTML 31K
11: EX-4 Specimen Agent's Warrant Certificate HTML 25K
12: EX-5 Opinion of Conrad C. Lysiak, Esq. Regarding the HTML 22K
Legality of the Securities Being
Registered
13: EX-10 License Agreement HTML 66K
14: EX-10 Amendment to License Agreement HTML 19K
15: EX-10 Second Amendment to License Agreement HTML 16K
16: EX-10 Third Amendment to License Agreement HTML 19K
17: EX-10 License Agreement HTML 69K
18: EX-10 Amendment to the License Agreement HTML 17K
19: EX-10 Second Amendment to License Agreement HTML 19K
20: EX-23 Consent of Ernst & Young Llp HTML 13K
21: EX-23 Consent of Conrad C. Lysiak, Esq. HTML 13K
22: EX-99 Employment Agreement With Mento Soponis HTML 32K
23: EX-99 Employment Agreement With Jeffrey D. Hillman HTML 32K
24: EX-99 Amendment to Employment Agreement With Jeffrey D. HTML 13K
Hillman
25: EX-99 Employee Proprietary Information and Invention HTML 45K
Agreement
26: EX-99 Incubator License Agreement - Office Lease HTML 64K
27: EX-99 Amendment No. 1 - Change in Licensed Space HTML 19K
28: EX-99 Second Amendment to Incubator License Agreement HTML 17K
29: EX-99 Renewal Term for Incubator License Agreement HTML 19K
30: EX-99 Warrant Indenture HTML 194K
31: EX-99 Escrow Agreement HTML 62K
32: EX-99 Value Escrow Agreement HTML 78K
33: EX-99 Pooling Agreement HTML 60K
34: EX-99 Investment Banking Agreement Between Ourselves and HTML 20K
Cornet Capital Corp.
35: EX-99 Escrow Agreement Between Ourselves, Cornet Capital HTML 31K
Corp. and Sutherland, Asbill and Brennan
36: EX-99 Amendment to Financing Agreement HTML 14K
37: EX-99 Stock Option Plan HTML 112K
38: EX-99 Transfer Agent, Registrar and Dividend Disbursing HTML 42K
Agent Agreement for Common Stock
39: EX-99 Warrant Agent and Registrar Agreement HTML 37K
40: EX-99 Registration Rights Agreements Between Ourselves HTML 71K
and Cleo Christine Allan, James Butler,
Quickswood Ltd., and Angel Investment
Company Ltd.
41: EX-99 Registration Rights Agreements Between Ourselves HTML 70K
and Amelia Investments Ltd.
42: EX-99 Registration Rights Agreement Between Ourselves HTML 70K
and Ernest Mario
43: EX-99 Consultancy Agreement Between Us and Era HTML 41K
Consulting (Usa) Llc
44: EX-99 Proprietary Information Agreements Between HTML 23K
Ourselves and Brian Anderson, Brian
McAlister, Robert Zahradnik and Howard
Kuramitsu
45: EX-99 Confidential Information Agreement Between Us and HTML 20K
Paul Hassie
| SB-2 | 1st "Page" of 72 | TOC | Top | Previous | Next | Bottom | Just 1st |
|---|
| Oragenics, Inc. SB-2 Registration Statement |
|
As filed with the Securities and Exchange Commission on ________________________. |
Registration No. 333-____________ |
====================================================================================
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
-------------------------------
FORM SB-2
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
-------------------------------
ORAGENICS, INC.
|
Florida |
2836 |
59-3410522 |
|
(State or Other Jurisdiction of Organization) |
(Primary Standard Industrial Classification Code) |
(IRS Employer Identification #) |
|
ORAGENICS, INC. |
Conrad C. Lysiak, Esq. |
|
(Address and telephone of registrant's executive office) |
(Name, address and telephone number of agent for service) |
Copies of all communications and notices to:
|
Mento A. Soponis, President and CEO |
Ronald A. Fleming, Jr. |
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
The later of the effective date of this Registration Statement and the date of issue of an MRRS Decision Document evidencing the issue of receipts for the Canadian prospectus in Alberta and British Columbia by the British Columbia Securities Commission.
If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended (the "Securities Act") check the following box. [x]
If this Form is filed to register additional securities for an offering under Rule 462(b) of the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.
If this Form is a post-effective amendment filed under Rule 462(c) of the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.
If this Form is a post-effective amendment filed under Rule 462(d) of the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. [ ]
If delivery of the prospectus is expected to be made under Rule 434, please check the following box. [ ]
| SB-2 | 2nd "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 2nd |
|---|
CALCULATION OF REGISTRATION FEE
|
|
Amount to be Registered |
Offering Price Per Share [1] |
Aggregate Offering Price [1] |
Registration Fee [1] |
|||
|
Units consisting of: |
2,400,000 |
$ |
1.25 |
$ |
3,000,000 |
$ |
276.00 |
|
One share of common stock |
2,400,000 |
|
|
|
|
|
|
|
One half of one Series A warrant |
1,200,000 |
|
|
|
|
|
|
|
One half of one Series B warrant |
1,200,000 |
|
|
|
|
|
|
|
Shares of common stock issuable upon exercise of Series A warrants |
|
|
|
|
|
|
|
|
Shares of common stock issuable upon exercise of Series B warrants |
|
|
|
|
|
|
|
|
Redeemable agent's warrants [2] |
500,000 |
|
|
|
|
|
|
|
Shares of common stock issuable upon exercise of redeemable agent's warrants |
|
|
|
|
|
|
|
|
Shares of common stock to be issued to agent [2] |
|
|
|
|
|
|
|
|
TOTALS |
10,700,000 |
|
|
|
9,625,000 |
$ |
885.50 |
[1] Estimated solely for purposes of calculating the registration fee under Rule 457(c)
[2] In connection with the sale of the units, the registrant will issue to the agent under the offering 100,000 shares of common stock and warrants to purchase 500,000 shares of common stock.
REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF THE SECURITIES ACT OF 1933, OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING UNDER SAID SECTION 8(A), MAY DETERMINE.
-2-
| SB-2 | 3rd "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 3rd |
|---|
SUBJECT TO COMPLETION DATED OCTOBER 16, 2002
The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities in any state where the offer or sale is not permitted.
-3-
| SB-2 | 4th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 4th |
|---|
Prospectus
ORAGENICS, INC.
2,400,000 Units
Consisting of One Share of Common Stock,
One Half of One Series A Warrant and
One Half of One Series B Warrant
Before this offering, there has been no public market for the common stock.
Each unit consists of one share of common stock, one half of one non-transferable Series A warrant and one half of one non-transferable Series B warrant. Each whole Series A warrant entitles the holder to purchase one share of common stock at a price of $2.00 for 6 months from the date of closing of the offering of the units. Each whole Series B warrant entitles the holder to purchase one share of common stock at a price of $3.00 for 9 months from the closing date. If the warrants are not exercised by such times, they will expire and cannot be exercised thereafter. We are offering 2,400,000 units in the Canadian provinces of British Columbia and Alberta only through our agent, Haywood Securities Inc. The offering price is $1.25 per unit. Our offering is subject to the sale of all the units. The offering will commence on the later of the effective date of this Registration Statement and the date of issue of a MRRS Decision Document evidencing the issue of receipts for the Canadian prospectus in Alberta and British Columbia by the British Columbia Securities Commission, and will continue for a period of 90 days from the date of issue of the MRRS Decision Document.
Our units will be sold by our agent, Haywood Securities Inc.
Investing in our common stock involves risks. See "Risk Factors."
|
Price to Public [1] |
Agent=s Commission [2] |
Proceeds to Us [3] |
||||
|
Per unit |
$ |
1.25 |
$ |
0.09375 |
$ |
1.15625 |
|
Total |
$ |
3,000,000 |
$ |
225,000 |
$ |
2,775,000 |
[1] The price per unit was established by negotiation between us and our agent, Haywood Securities Inc.
[2] We will pay our agent a commission of 7.5% of the gross proceeds of the offering. We will also issue 500,000 warrants each exercisable for two years from the closing date to purchase one share of our common stock, at a price of $1.25 per share, and 100,000 shares of our common stock, to our agent. This prospectus qualifies the issue of those warrants and shares of common stock to our agent. See
APlan of Distribution.@[3] Before expenses of the offering, estimated at $275,000
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS IS TRUTHFUL OR COMPLETE. IT IS ILLEGAL TO TELL YOU OTHERWISE.
The information in this prospectus is not complete and may be changed. We will not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell securities, and is not soliciting an offer to buy these securities, in any jurisdiction where the offer or sale is not permitted.
Until _______________, 2003, all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealers= obligation to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.
The date of this prospectus is ____________________.
HAYWOOD SECURITIES INC.
-4-
| SB-2 | 5th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 5th |
|---|
|
SUMMARY OF OUR OFFERING |
10 |
|
|
|
Our Business |
10 |
|
RISK FACTORS |
12 |
|
|
|
Risks Associated with our company: |
12 |
|
|
Our auditors have issued a going concern opinion. This means we may not be able to achieve our objectives and may have to suspend or cease operations. |
|
|
|
We have experienced a history of losses and expect to incur future losses. If we are unable to fund our operations, we will cease doing business. |
|
|
|
Because we are spending money on research and development and cannot sell products to the public at the present time, we are not generating revenues. Consequently, we must continue to raise money from investors to fund our operations. If we are unable to fund our operations, we will cease doing business. |
|
|
|
If we are unable to obtain regulatory clearance or approval for our technologies, we will be unable to generate revenues and will have to cease operations. |
|
|
|
The scientific ideas upon which our licensed, patented technologies are based are theoretical. |
13 |
|
|
Your investment may be lost based upon failure of our science. |
14 |
|
|
The success of our research and development activities is uncertain. If they do not succeed, we will be unable to generate revenues from our operations and we will have to cease doing business. |
|
|
|
It is possible that our Replacement Therapy technology will be less effective in humans than it has been shown to be in animals. If our Replacement Therapy technology is not shown to be effective or is shown to be harmful in humans, we will be unable to generate revenues from it. |
|
|
|
It is possible we will be unable to find a method to produce our antibiotic in commercial quantities. If we cannot, we will be unable to undertake the pre-clinical and clinical trials which are required in order to obtain FDA permission to sell it, and we will be unable to generate revenues from it. |
|
|
|
It is possible our antibiotic technology will be shown to be ineffective or harmful in humans. |
15 |
|
|
We must spend at least $ 1 million annually on development of our technologies under our license agreements with the University of Florida Research Foundation, Inc. We may be unable to raise the financing necessary to do so. |
|
|
|
The government and the public may not accept our licensed patented technologies. |
15 |
|
|
We may be exposed to product liability claims if products based on our technologies are marketed and sold. |
15 |
|
|
We intend to rely on third parties to pay the majority of the costs of regulatory approvals necessary to manufacture and sell products using our technologies. |
|
|
|
We expect significant competition for each of our technologies. Competition may make it impossible for us to generate sufficient revenues to operate profitably. |
|
|
|
We can offer you no assurance that the market will accept products based on our technologies. |
16 |
|
|
Because there is uncertainty relating to favorable third-party reimbursement, we may be adversely affected if we can't achieve the third party reimbursement. |
|
|
|
We are highly dependent on the services of our management and scientific staff. If we lose their services, this could delay or prevent us from achieving our scientific and business objectives. |
|
|
|
Because we do not have key personnel insurance on the lives of our key scientific and management officers, the death of one or more of our officers could have an adverse affect on our operations. |
|
|
|
Because we have limited liability insurance coverage, if a judgment is rendered against us in excess of the amount of our coverage, we may be forced to cease operations. |
|
|
|
Because our licenses may not give us adequate protection third parties could infringe on them, which could result in less revenue to us. |
|
|
|
Because there is no public trading market for our common stock, you may not be able to resell your stock. |
17 |
|
|
Because our common stock is a penny stock, you may not be able to resell your shares in the United States. |
18 |
|
|
Sales of shares of our common stock which are presently subject to escrow and other resale restrictions could reduce the market price of our common stock when the resale restrictions expire. |
|
|
|
In order for you to exercise your Series A and B warrants, we must have a current, effective registration statement on file with the Securities and Exchange Commission in the United States. |
|
|
|
Special Note Regarding Forward-Looking Statements. |
19 |
|
USE OF FUNDS AVAILABLE |
19 |
|
|
DETERMINATION OF OFFERING PRICE |
21 |
|
|
CAPITALIZATION |
21 |
|
|
DILUTION OF THE PRICE YOU PAY FOR YOUR SHARES |
22 |
|
|
PLAN OF DISTRIBUTION: TERMS OF THE OFFERING |
23 |
|
|
|
Section 15(g) of the Exchange Act |
24 |
|
BUSINESS |
25 |
|
|
|
Corporate |
25 |
|
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND PLAN OF OPERATIONS |
37 |
|
|
|
Overview |
37 |
|
MANAGEMENT |
42 |
|
|
|
Officers and Directors |
42 |
|
SCIENTIFIC ADVISORY BOARD |
46 |
|
|
|
Howard K. Kuramitsu, Ph.D. |
46 |
|
EXECUTIVE COMPENSATION |
46 |
|
|
|
Long-Term Incentive Plan Awards |
48 |
|
DESCRIPTION OF SECURITIES |
52 |
|
|
|
Common Stock |
52 |
|
ESCROWED SECURITIES |
54 |
|
|
|
National Escrow Policy |
54 |
|
CERTAIN TRANSACTIONS |
57 |
|
|
LITIGATION |
58 |
|
|
EXPERTS |
59 |
|
|
LEGAL MATTERS |
59 |
|
|
FINANCIAL STATEMENTS |
59 |
|
|
|
Contents |
59 |
You should rely only on the information contained in this prospectus. We have not authorized anyone to provide you with information different from that contained in this prospectus. This prospectus may only be used where it is legal to sell these securities. The information contained in this prospectus may only be accurate on the date of this prospectus.
-9-
| SB-2 | 6th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 6th |
|---|
SUMMARY OF OUR OFFERING
The following is a summary of the principal features of this offering and should be read together with the more detailed information and financial data and statements contained elsewhere in this prospectus. You should read the entire prospectus carefully, especially the discussion of the risks of purchasing our securities in "Risk Factors."
Our Business
We are a biotechnology research and development company seeking to commercialize two technologies developed by our founder and Chief Scientific Officer, Dr. Jeffrey Hillman. Dr. Hillman is a Harvard-trained Professor at the University of Florida College of Dentistry. He is presently on indefinite leave from his post at the University of Florida. He did the early development work on our technologies at the Forsyth Dental Center and the University of Florida. The technologies are the property of the University, and the University has obtained patents relating to the technologies. We have obtained exclusive licenses of the technologies from the University.
The first technology is a genetically altered strain of a species of bacteria called S. mutans which occurs naturally on teeth in human beings. We refer to this technology as Replacement Therapy. The strains of this species of bacteria which occur naturally produce lactic acid from sugar in our diets. Lactic acid is the principal cause of tooth decay. Our licensed, patented strain of this bacteria produces harmless chemicals instead of lactic acid, and therefore does not cause tooth decay.
The second technology is an antibiotic known as mutacin 1140 which is produced by our licensed, patented strain of bacteria. Mutacin 1140 has demonstrated effectiveness in the laboratory against all tested Gram-positive bacteria. Gram-positive bacteria cause many human ailments, such as pneumonia, pharyngitis and others.
If we are successful in obtaining regulatory approval for one or both of our licensed, patented technologies, we will attempt to license other technologies, from the University of Florida or elsewhere, to which we believe members of our team such as Dr. Hillman can add value.
As of today, we have generated limited revenues from our operations. The revenues we have generated were received under a sponsored research agreement which has expired. There is no assurance that we will generate revenues in the future. Before we can sell products based on our licensed, patented technologies, we must obtain regulatory approvals which will require extensive pre-clinical and clinical trials.
We were incorporated in Florida in 1996. Our executive office is located at 12085 Research Drive, Alachua, Florida 32615. This is also our mailing address. Our telephone number is (386) 418-4018. Our corporate website is at www.oragenics.com. We do not intend the reference to our web address to incorporate by reference in this prospectus the information on our website. The information on our website is not intended to be part of this prospectus and you should not rely on it when making a decision to invest in our securities.
-10-
| SB-2 | 7th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 7th |
|---|
The Offering
Following is a brief summary of this offering:
|
Securities being offered by us |
2,400,000 units. Each unit consists of one share of common stock, one half of one Series A warrant, and one half of one Series B warrant. Each whole Series A warrant may be exercised to purchase a further share of common stock at a price of $2.00 per share for 6 months from the closing of the offering. Each whole Series B warrant may be exercised to purchase a further share of common stock at a price of $3.00 per share for 9 months from the closing of the offering. |
|
Offering price per unit |
$1.25 |
|
Offering period |
The units are being offered for a period not to exceed 90 days from the date of issue of an MRRS Decision Document evidencing issue of receipts for the Canadian prospectus in Alberta and British Columbia by the British Columbia Securities Commission. Closing of our offering will be subject to receiving subscriptions for all of the units before the end of this period. |
|
Risk Factors |
Investment in the units involves a high degree of risk. You should not consider purchasing units unless you can afford to lose your entire investment. Refer to "Risk Factors" for information you should consider. |
|
Net proceeds to us |
$2,775,000, before expenses of the Offering, estimated at $275,000. |
|
Use of proceeds |
We will use the proceeds to pay the expenses of this offering, the costs of our operations and some of the costs related to the regulatory approvals we must obtain before we may sell products based on our licensed, patented technologies. |
|
Number of shares outstanding |
9,425,704 |
|
Number of shares outstanding |
11,925,704 [1] |
[1] Excludes shares which may be issued on exercise of outstanding options, the Series A and B warrants, and the warrants we will issue to our agent.
-11-
| SB-2 | 8th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 8th |
|---|
Selected Financial Data
The following selected financial data for the three years ended December 31, 2001 are derived from our audited financial statements, which have been audited by Ernst & Young LLP, independent certified public accountants. Ernst & Young LLP's report on the financial statements for the three years ended December 31, 2001, which appears elsewhere herein, includes an explanatory paragraph which describes an uncertainty about our ability to continue as a going concern. The financial data for the six month period ended June 30, 2002 is derived from unaudited financial statements. The unaudited financial statements include all adjustments, consisting of normal recurring accruals, which we consider necessary for a fair presentation of the financial position and the results of operations for these periods.
Operating results for the six months ended June 30, 2002 are not necessarily indicative of the results that may be expected for the entire year ending December 31, 2002. The data should be read in conjunction with the financial statements, related notes, and other financial information included herein.
|
|
December 31, |
|||||||
|
Balance Sheet |
|
|
|
|
|
|
|
|
|
Income Statement |
|
(0.04) |
|
|
|
|
|
|
[1] Our financial statements, which have been prepared in accordance with United States generally accepted accounting principles, conform in all material respects with accounting principles generally accepted in Canada.
RISK FACTORS
An investment in our securities involves significant risks. Please consider the following risk factors before deciding to invest in our securities.
Risks associated with our company:
1. Our auditors have issued a going concern opinion. This means we may not be able to achieve our objectives and may have to suspend or cease operations.
Our auditors have issued a going concern opinion. This means that there is doubt that we can continue as an ongoing business. At September 30, 2002 we had estimated working capital of $98,067.
-12-
| SB-2 | 9th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 9th |
|---|
2. We have experienced a history of losses and expect to incur future losses. If we are unable to fund our operations, we will cease doing business.
We have recorded minimal revenue to date and we have incurred a cumulative operating loss of approximately $354,000 through June 30, 2002. Our losses have resulted principally from costs incurred in research and development activities related to our efforts to develop our technologies and from the associated administrative costs. We expect to incur significant operating losses and negative cash flows over the next several years due to the costs of expanded research and development efforts and pre-clinical and clinical trials and hiring additional personnel. We will need to generate significant revenues in order to achieve and maintain profitability. We may not be able to generate these revenues or achieve profitability in the future. Even if we do achieve profitability, we may not be able to sustain or increase profitability.
3. Because we are spending money on research and development and cannot sell products to the public at the present time, we are not generating revenues. Consequently, we must continue to raise money from investors to fund our operations. If we are unable to fund our operations, we will cease doing business.
We do not have the cash we need for operations during the next twelve months. That is because we are spending money on research and development of our technologies, but cannot sell products to the public at the present time. Consequently, we must raise money from investors to fund our operations. If we can't fund our operations through investments by third parties, we will have to cease operations. Our business operations are subject to all of the risks inherent in a new business enterprise.
4. If we are unable to obtain regulatory clearance or approval for our technologies, we will be unable to generate revenues and will have to cease operations.
Our technologies have not been cleared for marketing by the FDA or foreign regulatory authorities and cannot be commercially distributed in the United States or any international markets until such clearance is obtained. Before regulatory approvals can be obtained, our technologies will be subject to extensive pre-clinical and clinical testing. We can offer you no assurance that such trials will demonstrate the safety or effectiveness of our technologies. There is a risk that our Replacement Therapy and antibiotic technologies may be found to be unsafe or ineffective or otherwise fail to satisfy regulatory requirements. If we fail to obtain FDA clearance for one of our technologies we may have to cease operations.
5. The scientific ideas upon which our licensed, patented technologies are based are theoretical.
Although we have current data which indicates the promise of the concept of our Replacement Therapy and mutacin 1140 technologies, we can offer you no assurance that the technologies will be effective at a level sufficient to support a profitable business venture. Our current data is based upon a limited number of samplings. True scientific conclusions must be based on a large population sample. We have made our conclusions about our science based on limited data, and these conclusions may not be borne out by the more extensive testing we intend to pay for from the proceeds of this offering. If they are not, we will not be able to create a marketable product. If we are unable to do so, we will not generate revenues, we will have to cease operations and you will lose your entire investment.
-13-
| SB-2 | 10th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 10th |
|---|
6. Your investment may be lost based upon failure of our science.
The science on which our Replacement Therapy and mutacin 1140 technologies are based may fail due to flaws or inaccuracies on which the data are based, or because the data is totally or partially incorrect, or not predictive of future results. The science upon which our business is based may prove to be totally or partially incorrect. Because our science may be flawed or incorrect, we may never be able to create a marketable product. If we are unable to do so, we will not generate revenues, we will have to cease operations and you will lose your entire investment.
7. The success of our research and development activities is uncertain. If they do not succeed, we will be unable to generate revenues from our operations and we will have to cease doing business.
We intend to continue with research and development of our technologies for the purpose of obtaining regulatory approval to produce and market them. Research and development activities, by their nature, preclude definitive statements as to the time required and costs involved in reaching certain objectives. Actual costs may exceed the amounts we have budgeted and actual time may exceed our expectations. If research and development requires more funding than we anticipate, then we may have to reduce technological development efforts or seek additional financing from loans or the sale of our stock. There can be no assurance that we will be able to secure any necessary additional financing or that such financing would be available on favorable terms. If we are unable to receive additional financing, you may lose all or a portion of your investment. Equity financing could result in substantial dilution to existing shareholders. We anticipate we will remain engaged in research and development for a considerable period of time.
8. It is possible that our Replacement Therapy technology will be less effective in humans than it has been shown to be in animals. If our Replacement Therapy technology is not shown to be effective or is shown to be harmful in humans, we will be unable to generate revenues from it.
Testing of our Replacement Therapy technology has to date been undertaken solely in animals. Those studies have proven our genetically altered strain of S. mutans to be effective in preventing tooth decay. It is possible that our strain of S. mutans will be shown to be less effective in preventing tooth decay in humans in clinical trials. If our Replacement Therapy technology is shown to be ineffective in preventing tooth decay in humans, we will be unable to commercialize and generate revenues from this technology. If we are unable to generate revenues from this technology, our business will suffer and you may lose all or a portion of your investment.
9. It is possible we will be unable to find a method to produce our antibiotic in commercial quantities. If we cannot, we will be unable to undertake the pre-clinical and clinical trials which are required in order to obtain FDA permission to sell it, and we will be unable to generate revenues from it.
Our antibiotic technology, mutacin 1140, is a substance produced by our genetically altered strain of S. mutans. To date, it has been produced only in laboratory cultures. In order for us to conduct the pre-clinical and Phase I clinical studies which we must complete in order to find a partner who will sub-license this technology from us and finance the Phase II and III clinical studies we must complete in order to obtain FDA approvals necessary to sell products based on this technology, we must demonstrate a method of producing commercial quantities of this substance at economical rates. We have not yet been able to find such a method and it is possible we will be unable to find one. If we are not able to find such a method, we will be unable to generate revenues from this technology and our business will suffer. You may lose all or a portion of your investment.
-14-
| SB-2 | 11th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 11th |
|---|
10. It is possible our antibiotic technology will be shown to be ineffective or harmful in humans.
Testing of our antibiotic substance, mutacin 1140, has to date been undertaken solely in the laboratory. We have not yet conducted animal or human studies of mutacin 1140. It is possible that when we conduct these studies, they will show that mutacin 1140 is ineffective or harmful. If mutacin 1140 is shown to be ineffective or harmful, we will be unable to commercialize it and generate revenues from sales of mutacin 1140. If we are unable to generate revenues from mutacin 1140, our business will suffer, and you may lose all or a portion of your investment.
11. We must spend at least $ 1 million annually on development of our technologies under our license agreements with the University of Florida Research Foundation, Inc. We may be unable to raise the financing necessary to do so.
We hold our Replacement Therapy and mutacin 1140 technologies under licenses from the University of Florida Research Foundation, Inc. Under the licenses, we must spend at least $1 million on the development of those technologies in each calendar year before the first commercial sale of products derived from those technologies. If we do not, our licenses may be terminated. Until commercial sales of such products take place, we will not be earning revenues from the sale of products. We will therefore have to raise the money we must spend on development of our technologies by other means, such as the sale of our common stock. We can offer you no assurance we will be able to raise the financing necessary to meet our obligations under our licenses.
12. The government and the public may not accept our licensed patented technologies.
The commercial success of our Replacement Therapy and mutacin 1140 licensed technologies, which have been developed through biotechnology, will depend in part on government and public acceptance of their production, distribution and use. Biotechnology has enjoyed and continues to enjoy substantial support from the scientific community, regulatory agencies and many governmental officials around the world (including in the United States). Future scientific developments, media coverage and political events may diminish such support. Public attitudes may be influenced by claims that health products produced with biotechnology are unsafe for consumption or pose unknown risks to the environment or to traditional social or economic practices. Securing governmental approvals for, and consumer confidence in, such products poses numerous challenges, particularly outside the United States. The market success of technologies developed through biotechnology, such as ours, could be delayed or impaired in certain geographical areas because of such factors. If market success of our technologies is delayed or impaired, that could have a material, adverse effect on our business, financial condition and results of operations, and on the performance of your investment.
13. We may be exposed to product liability claims if products based on our technologies are marketed and sold.
Because we are testing new technologies, and will be involved either directly or indirectly in the manufacturing and distribution of the technologies, we are exposed to the financial risk of liability claims in the event that the use of the technologies results in personal injury or death. There can be no assurance that we will not experience losses due to product liability claims in the future, or that adequate insurance will be available in sufficient amounts, at an acceptable cost, or at all. A product liability claim, product recall or other claim, or claims for uninsured liabilities or in excess of insured liabilities, may have a material adverse effect on our business, financial condition and results of operations, and upon the performance of your investment.
-15-
| SB-2 | 12th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 12th |
|---|
14. We intend to rely on third parties to pay the majority of the costs of regulatory approvals necessary to manufacture and sell products using our technologies.
We intend to sublicense our licensed, patented technologies to pharmaceutical companies after completion of Phase I clinical studies. If we are successful in doing so, our sublicensees will pay the costs of Phase II and III clinical trials, and manufacture and market our technologies. If we are unable to sublicense our technologies, we will have to pay for the costs of Phase II and III trials and NDAs ourselves. We would also have to set up our own manufacturing facilities, and find our own distribution channels. This would greatly increase our future capital requirements, and we can offer no assurance we would be able to obtain the necessary financing. If we are successful in sublicensing our technologies, there is no assurance their marketing, sales and distribution of products derived from our technologies will be effective. If it is not, we will receive less revenue and the performance of your investment will suffer.
15. We expect significant competition for each of our technologies. Competition may make it impossible for us to generate sufficient revenues to operate profitably.
The pharmaceutical and biotechnology industries are characterized by intense competition, rapid product development and technological change. Competition is intense among manufacturers of dental therapeutics and prescription pharmaceuticals. Most of our potential competitors are large, well established pharmaceutical, chemical or healthcare companies with considerably greater financial, marketing, sales and technological resources than are available to us. Academic institutions, government agencies and other public and private research organizations may also conduct research, seek patent protection and establish collaborative arrangements for discovery, research and clinical development of technologies and products similar to ours. Many of our potential competitors have research and development capabilities that may allow them to develop new or improved products that may compete with products based on our technologies. Products developed from our technologies could be rendered obsolete or made uneconomical by the development of new products to treat the conditions to be treated by products developed from our technologies, technological advances affecting the cost of production, or marketing or pricing actions by our potential competitors. This could materially affect our business, financial condition and results of operations. We cannot assure you that we will be able to compete successfully.
16. We can offer you no assurance that the market will accept products based on our technologies.
If we are successful in obtaining the governmental approvals necessary to produce and sell products based on our Replacement Therapy and mutacin 1140 technologies, there is no assurance that the market will accept them. Products based on our technologies may compete with a number of traditional dental therapies and drugs manufactured and marketed by major pharmaceutical companies and other biotechnology companies. Market acceptance of products based on our technologies will depend on a number of factors, including potential advantage over alternative treatment methods. We can offer you no assurance that dentists, physicians, patients or the medical and dental communities in general will accept and utilized products developed from our technologies. If they do not, our financial condition and results of operations will suffer. This would adversely affect the performance of your investment.
-16-
| SB-2 | 13th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 13th |
|---|
17. Because there is uncertainty relating to favorable third-party reimbursement, we may be adversely affected if we can't achieve the third party reimbursement.
In the United States, success in obtaining payment for a new product from third parties such as insurers depends greatly on the ability to present data which demonstrates positive outcomes and reduced utilization of other products or services as well as cost data which shows that treatment costs using the new product are equal to or less than what is currently covered for other products. Our failure to present such clinical data would adversely affect our ability to obtain favorable third party reimbursement as well as the commercial success of products based on our technologies.
18. We are highly dependent on the services of our management and scientific staff. If we lose their services, this could delay or prevent us from achieving our scientific and business objectives.
Competition among biotechnology and biopharmaceutical companies for qualified employees is intense, and there can be no assurance we will be able to attract and retain qualified individuals. If we fail to do so, this would have a material, adverse effect on the results of our operations and the performance of your investment.
19. Because we do not have key personnel insurance on the lives of our key scientific and management officers, the death of one or more of our officers could have an adverse affect on our operations.
We do not maintain any life insurance on the lives of any of our officers and directors. We are highly dependent on the services of our directors and officers, particularly on those of Jeffrey Hillman and Chuck Soponis. If one or all of our officers or directors die or otherwise become incapacitated, our operations could be interrupted or terminated.
20. Because we have limited liability insurance coverage, if a judgment is rendered against us in excess of the amount of our coverage, we may be forced to cease operations.
Although we carry $1,000,000 in general liability insurance, such insurance may not be sufficient to cover any potential liability. We could be sued for a large sum of money and held liable in excess of our liability coverage. If we cannot pay the judgment and become insolvent, or do not have the funds to defend a lawsuit, we could be forced to stop doing business.
21. Because our licenses may not give us adequate protection third parties could infringe on them, which could result in less revenue to us.
We have licenses to sell products made using the Replacement Therapy and mutacin 1140 technologies. The licenses were granted to us by the University of Florida Research Foundation, Inc., which owns the patents to our technologies. There is no assurance, however, that third parties will not infringe on our licenses or their patents. In order to protect our license rights and their patents, we or the University of Florida Research Foundation, Inc. may have to file lawsuits and obtain injunctions. If we do that, we will have to spend large sums of money for attorney fees in order to obtain the injunctions. Even if we do obtain the injunctions, there is no assurance that those infringing on our licenses or the University of Florida Research Foundation's patents will comply with the injunctions. Further, we may not have adequate funds available to prosecute actions to protect or to defend the licenses and patents, in which case those infringing on the licenses and patents could continue to do so in the future.
-17-
| SB-2 | 14th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 14th |
|---|
22. Because there is no public trading market for our common stock, you may not be able to resell your stock.
There is currently no public trading market for our common stock. Therefore there is no central place, such as stock exchange or electronic trading system, to resell the shares comprised in the units and which may be obtained upon exercise of the Series A and B warrants. If you do want to resell your shares, you will have to locate a buyer and negotiate your own sale. We have applied to list our shares of common stock on the TSX Venture Exchange. Listing will be subject to our fulfilling all of the listing requirements of the TSX Venture Exchange.
23. Because our common stock is a penny stock, you may not be able to resell your shares in the United States.
Our common stock is defined as a "penny stock" under the Securities and Exchange Act of 1934, and its rules. Because our common stock is a penny stock, you may not be able to resell your shares in the United States. This is because the Exchange Act and the penny stock rules impose additional sales practice and disclosure requirements on broker/dealers who sell our securities to persons other than accredited investors. As a result, fewer broker/dealers are willing to make a market in our stock.
24. Sales of shares of our common stock which are presently subject to escrow and other resale restrictions could reduce the market price of our common stock when the resale restrictions expire.
On completion of this offering, the majority of our common stock will be subject to escrow and other restrictions on resale. These restrictions will fall away over time. As they fall away, more of our common stock may be resold in the market. Increased supply could depress the market price of our common stock.
25. In order for you to exercise your Series A and B warrants, we must have a current, effective registration statement on file with the Securities and Exchange Commission in the United States.
Applicable United States securities laws require that, in the absence of an available exemption, we must register the shares which you may acquire upon exercise of your Series A and B warrants in order to legally issue them. We have promised in our agreement with our agent, Haywood Securities Inc., to keep this registration statement effective for the term of such warrants; however, we can offer you no assurance that we will be able to do so. If we are not able to do so, you may be unable to exercise your warrants. If you are not able to exercise your warrants, you will lose a portion of your investment.
-18-
| SB-2 | 15th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 15th |
|---|
26. Special Note Regarding Forward-Looking Statements
This prospectus contains forward-looking statements that reflect our current views with respect to future events and financial performance. In some cases, you can identify forward-looking statements by words like "believe," "expect," "estimate," "anticipate," "intend," "project," "plan," "may," "will," "should," "potential" and "continue." These statements are only predictions, and apply only as of the date of this prospectus. You should not consider that they are made with certainty. These statements are subject to risks and uncertainties, including those set out above and others, that could cause actual results to differ materially from historical results or our predictions. Although we believe that the expectations referred to in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. We are under no duty to update forward-looking statements to conform them to actual results after the date of this prospectus.
USE OF FUNDS AVAILABLE
We intend to spend the funds available to us as stated in this prospectus. There may be circumstances, however, where, for sound business reasons, a reallocation of funds may be necessary.
Our offering is being made in the Canadian provinces of British Columbia and Alberta through our agent, Haywood Securities Inc. We have agreed to pay our agent a commission of 7.5% of the gross proceeds of the sale of the units, and to reimburse our agent for its reasonable expenses in connection with the offering. In addition to our agent's commission, we anticipate incurring further expenses in connection with the offering of $275,000. Our estimated working capital as at September 30, 2002 is $99,067. Our estimated working capital together with the net proceeds of our offering yields the funds available to us.
-19-
| SB-2 | 16th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 16th |
|---|
The table below sets forth the calculation of the amount of our available funds.
|
Gross proceeds |
$ |
3,000,000 |
|
Commission |
|
225,000 |
|
Offering expenses |
|
275,000 |
|
Net proceeds |
|
2,500,000 |
|
Working capital as at September 30, 2002 |
|
99,067 |
|
Funds available to us |
$ |
2,599,067 |
We will use our available funds as follows:
Our available funds will be used to pay the commission and offering expenses, to fund the costs of certain of the pre-clinical and clinical trials of our technologies we must undertake before we can obtain FDA approval to sell products based on our technologies, and for working capital.
The amounts we will pay from our available funds for expenses of the offering are: $1,000 (estimated) for SEC filing fees; $1,500 (estimated) for Alberta and British Columbia Securities Commission filing fees; $8,500 (estimated) for TSX Venture Exchange listing fees, $25,000 for our agent's expenses, $131,500 (estimated) for United States and Canadian legal fees; $4,000 for printing our prospectus; $85,000 for accounting fees; $2,000 for our transfer agent and warrant agent fees; and $16,500 for miscellaneous unforeseen expenses relating to the offering.
We will use our available funds as follows: $100,000 to the University of Florida for patent expenses; $100,000 for 2 years of regulatory consulting firm fees; $180,000 for 2 years salary for the Director of Regulatory Affairs we intend to hire; $100,000 for 2 years salary for the Clinical Trials Manager we intend to hire; $20,000 for pre-clinical studies relating to our Replacement Therapy technology; $20,000 for the costs of amending our Investigational New Drug Application for our Replacement Therapy technology; $400,000 for the costs of Phase I clinical trials for our Replacement Therapy technology; $180,000 for 2 years salary for the scientist we intend to hire to help us develop a method of producing mutacin 1140 in commercial quantities; $50,000 for 1 year of peptide production research; $300,000 for pre-clinical studies relating to our antibiotic technology; $20,000 for the costs of the Investigational New Drug Application we intend to make for our antibiotic technology; $350,000 for the costs of Phase I clinical trials for our antibiotic technology; and $680,000 for salaries of our current employees for 1.5 years. We will reserve $99,067 for working capital.
The table below sets forth the use of our available funds:
|
Patent expenses |
$ |
100,000 |
|
Regulatory |
|
280,000 |
|
Product research & production |
|
230,000 |
|
Pre clinical research |
|
320,000 |
|
Clinical trials |
|
850,000 |
|
IND Applications |
|
40,000 |
|
Other research and administration salaries |
|
680,000 |
|
Working capital reserve |
|
99,067 |
|
|
$ |
2,599,067 |
-20-
| SB-2 | 17th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 17th |
|---|
DETERMINATION OF OFFERING PRICE
Before this offering, there has been no public market for our common stock. The price of the units we are offering was determined by negotiation between ourselves and our agent in order for us to raise $3,000,000 in this offering. The offering price bears no relationship whatsoever to our assets, earnings, book value or other criteria of value, and we cannot assure you will be able to resell the shares of common stock comprised in the units, or any shares of common stock you may obtain upon exercise of the Series A or B warrants, above the offering price of the units or at all. Among the factors considered were:
|
|
* |
our lack of operating history |
|
|
* |
the proceeds to be raised by the offering |
|
|
* |
the amount of capital to be contributed by purchasers in this offering in proportion to the amount of stock to be retained by our existing shareholders, and |
|
|
* |
our relative cash requirements. |
CAPITALIZATION
Our authorized capital is 100,000,000 shares of common stock with par value of $.001 per share, and 20,000,000 shares of preferred stock without par value, of which 9,425,704 shares of common stock and no shares of preferred stock are outstanding at June 30, 2002.
The following table sets forth our capitalization at June 30, 2002 on a historical basis and as adjusted to reflect the sale of the shares comprised in the units and the issuance of 100,000 shares of common stock to our agent.
This table should be read in conjunction with the section entitled, Management's Discussion and Analysis of Financial Condition and Plan of Operations, our Financial Statements and Notes, and other financial and operating data included elsewhere in this prospectus.
|
|
|
|
|
As Adjusted After Offering |
|
Stockholder's Equity: Common Stock: 100,000,000 shares authorized par value $0.001 |
|
|
|
|
|
9,425,704 issued and outstanding |
$ |
9,426 |
|
|
|
11,925,704 issued and outstanding |
|
|
$ |
11,926 |
|
Additional Paid-in Capital |
|
628,234 |
|
3,125,734 |
|
Accumulated Deficit |
|
(361,255) |
|
(361,255) |
|
TOTAL STOCKHOLDERS' EQUITY |
$ |
276,405 |
$ |
2,776,405 |
-21-
| SB-2 | 18th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 18th |
|---|
DILUTION OF THE PRICE YOU PAY FOR YOUR SHARES
Dilution represents the difference between the offering price and the net tangible book value per share immediately after completion of this offering. Net tangible book value is the amount that results from subtracting total liabilities and intangible assets from total assets. Dilution arises mainly as a result of our arbitrary determination of the offering price of the units. Dilution of the value of the shares comprised in the units you purchase is also a result of the lower book value of the shares held by our existing stockholders.
As of June 30, 2002, the net tangible book value of our shares of common stock was $276,405 or approximately $0.03 per share based upon 9,425,704 shares outstanding.
Upon completion of this offering, the net tangible book value of the 11,925,704 shares which will be outstanding will be $2,776,405, or approximately $0.23 per share. The amount of dilution you will incur will be $1.02 per share. The net tangible book value of the shares held by our existing stockholders will be increased by $0.20 per share without any additional investment on their part. You will incur an immediate dilution from $1.25 per share to $0.23 per share.
After completion of this offering, you will own approximately 20.1% of the total number of shares then outstanding, shares for which you will have made a cash investment of $3,000,000, or $1.25 per share. Our existing stockholders will own approximately 79.0% of the total number of shares then outstanding, for which they have made contributions of cash, services and other assets totaling $822,860 or approximately $0.09 per share.
The foregoing figures assume that none of the Series A and B warrants comprised in the units, or any of our agent's warrants, will be exercised, and that none of our existing stock options will be exercised.
The following table compares the differences of your investment in our shares with the investment of our existing stockholders.
Existing Stockholders:
|
Price per unit |
$ |
1.25 |
|
Net tangible book value per share before offering |
$ |
0.03 |
|
Gain to existing shareholders |
$ |
0.20 |
|
Net tangible book value per share after offering |
$ |
0.23 |
|
Increase to present stockholders in net tangible book value per share after offering |
$ |
0.20 |
|
Capital contributions |
$ |
-0- |
|
Number of shares outstanding before the offering |
|
9,425,704 |
|
Number of shares after offering held by existing stockholders |
|
9,425,704 |
|
Percentage of ownership after offering |
|
79.0% |
-22-
| SB-2 | 19th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 19th |
|---|
Purchasers of Units in this Offering:
|
Price per unit |
$ |
1.25 |
|
Dilution per share |
$ |
1.02 |
|
Capital contributions |
$ |
3,000,000 |
|
Number of shares after offering held by public investors |
|
2,400,000 |
|
Percentage of ownership after offering |
|
20.1% |
PLAN OF DISTRIBUTION: TERMS OF THE OFFERING
We are offering through our agent, Haywood Securities Inc., 2.4 million units, at a price of $1.25 per unit. Our offering will be made only in the Canadian provinces of British Columbia and Alberta. Each unit consists of one share of common stock of the Company, one half of one non-transferable Series A warrant and one half of one non-transferable Series B warrant. One whole Series A warrant may be exercised for 6 months from the date of closing of the offering to acquire a further share of common stock at a price of $2.00 per share. One whole Series B warrant may be exercised for 9 months from the closing date to acquire a further share of common stock at $3.00 per share. For so long as our United States registration statement remains effective, this prospectus qualifies the issue of shares of our common stock upon exercise of the Series A and B Warrants in the United States.
We have entered into an agency agreement dated ______________, 2002 with Haywood. Haywood has agreed to offer our units for sale to the public in British Columbia and Alberta, on a "commercially reasonable efforts" basis. We will pay Haywood a sales commission equal to 7.5% of the selling price for each unit sold to an investor under our offering. We will issue to Haywood 500,000 warrants, each exercisable for two years from the closing date to purchase one share of our common stock, at a price of $1.25 per share. We will also issue 100,000 shares of our common stock to Haywood under the agency agreement. We will reimburse Haywood for its reasonable expenses in connection with our offering. For so long as our United States registration statement remains effective, this prospectus qualifies the resale of the shares we will issue to our agent, and the shares which may be acquired on exercise of the agent's warrants, by Haywood in the United States.
Haywood may form a selling group of registered dealers to assist with sales of the units as subagents. The offering will take place during the period commencing on the later of the date this Registration Statement is declared effective by the SEC, and the date an MRRS decision document evidencing the issue of receipts for the Canadian prospectus in Alberta and British Columbia is issued by the British Columbia Securities Commission. We expect that the offering will be closed on or about ______________, 2003. The offering must be completed within 90 days from the issuance of an MRRS decision document for the Canadian prospectus, unless such time period is extended by the British Columbia Securities Commission. Completion of our offering is subject to obtaining subscriptions for all of the units.
While Haywood has agreed to use its commercially reasonable efforts to sell the units, Haywood is not obliged to purchase any units that are not sold. Haywood may terminate its obligations under the agency agreement, and Haywood may withdraw all subscriptions on behalf of investors, at its discretion, on the basis of Haywood's assessment of the state of the financial markets or upon the occurrence of certain stated events. Pursuant to the agency agreement, we have agreed to indemnify Haywood upon the occurrence of certain events.
-23-
| SB-2 | 20th "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 20th |
|---|
Haywood has informed us that it does not expect to confirm sales of units offered under this prospectus to any accounts over which it exercises discretionary authority.
Applicable United States securities laws require that we register the shares which you may acquire upon exercise of your Series A and B warrants and the shares which our agent may acquire on exercise of the warrants we will issue to it, or use an available exemption in order to legally issue them. We have promised in our agency agreement with Haywood to keep this registration statement effective for the term of such warrants; however, we can offer you no assurance that we will be able to do so. If we are not able to do so, you may be unable to exercise your warrants. If you are not able to exercise your warrants, you will lose a portion of your investment.
We have applied to list our common stock on the TSX Venture Exchange. Listing will be subject to us fulfilling all of the listing requirements of the TSX Venture Exchange. We do not intend to list our common stock on any exchange or quotation system in the United States. Our Series A and B warrants are non-transferable and will not be listed on any stock exchange or quotation service.
Section 15(g) of the Exchange Act
Our shares of common stock are covered by Section 15(g) of the Securities Exchange Act of 1934, as amended, and Rules 15g-1 through 15g-6 promulgated thereunder. They impose additional sales practice requirements on United States broker/dealers who sell our securities to persons other than established customers and accredited investors (generally institutions with assets in excess of $5,000,000 or individuals with net worth in excess of $1,000,000 or annual income exceeding $200,000 or $300,000 jointly with their spouses). While Section 15(g) and Rules 15g-1 through 15g-6 apply to broker/dealers, they do not apply to us.
Rule 15g-1 exempts a number of specific transactions from the scope of the penny stock rules.
Rule 15g-2 declares unlawful broker/dealer transactions in penny stocks unless the broker/dealer has first provided to the customer a standardized disclosure document.
Rule 15g-3 provides that it is unlawful for a broker/dealer to engage in a penny stock transaction unless the broker/dealer first discloses and subsequently confirms to the customer current quotation prices or similar market information concerning the penny stock in question.
Rule 15g-4 prohibits broker/dealers from completing penny stock transactions for a customer unless the broker/dealer first discloses to the customer the amount of compensation or other remuneration received as a result of the penny stock transaction.
Rule 15g-5 requires that a broker/dealer executing a penny stock transaction, other than one exempt under Rule 15g-1, disclose to its customer, at the time of or prior to the transaction, information about the sales person=s compensation.
Rule 15g-6 requires broker/dealers selling penny stocks to provide their customers with monthly account statements.
Our shares are subject to the foregoing rules in the United States. The foregoing rules apply to broker/dealers. They do not apply to us in any manner whatsoever. The application of the penny stock rules may affect your ability to resell your shares in the United States because some broker/dealers may not be willing to make a market in our common stock because of the burdens imposed upon them by the penny stock rules.
-24-
| SB-2 | 21st "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 21st |
|---|
BUSINESS
Corporate
Oragenics, Inc. was incorporated under the laws of Florida on November 6, 1996. Our registered office is located at 4730 S.W. 103rd Way, Gainsville, Florida 36208, and our head office is located at 12085 Research Drive, Alachua, Florida 32615.
We amended our articles of incorporation on May 8, 2002, in order to change our name from Oragen, Inc. to Oragenics, Inc. and to increase our authorized capital from 100,000 shares of common stock to 100,000,000 shares of common stock and 20,000,000 shares of preferred stock.
General
We are a biotechnology research and development company created and operating to attempt to commercialize two new technologies. Our licensed, patented Replacement Therapy technology holds the promise of eliminating the principal cause of tooth decay. Our licensed, patented mutacin 1140 technology has demonstrated potency in the laboratory against all Gram-positive bacteria against which it has been tested. Gram- positive bacteria cause a wide variety of human ailments. Before products incorporating our licensed, patented technologies may be produced or sold in the United States, we must obtain FDA approval. If we are successful in obtaining regulatory approval, for one or both of our licensed, patented technologies, we will attempt to license other technologies, from the University of Florida or elsewhere, to which we believe members of our team such as Dr. Hillman can add value.
Federal Food and Drug Administration Regulation
General
The steps required before a new drug may be produced and marketed in the United States are:
|
|
1. |
investigational new drug application (IND) |
On January 11, 1993, the FDA approved new procedures to accelerate the approval of certain new drugs and biological products directed at serious or life-threatening illnesses. These procedures expedite the approvals for patients suffering from terminal illness when the drugs provide a therapeutic advantage over existing treatments. We believe that our licensed, patented mutacin 1140 technology may fall under the FDA guidelines for accelerated approval for drugs and biological products directed at serious and life-threatening disease because our mutacin 1140 technology is a potential treatment for life-threatening disease.
-25-
| SB-2 | 22nd "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 22nd |
|---|
Pre-Clinical Trials and IND
Pre-clinical tests are conducted in the laboratory, and usually involve animals. They are done to evaluate the safety and efficacy of the potential product. The results of the pre-clinical tests are submitted as part of the IND application and are fully reviewed by the FDA prior to granting the applicant permission to commence clinical trials in humans.
Clinical Trials
Clinical trials are conducted in three phases, normally involving progressively larger numbers of patients.
Phase I
Phase I clinical trials consist of administering the drug and testing for safety and tolerated dosages as well as preliminary evidence of efficacy in humans. They are concerned primarily with learning more about the safety of the drug, though they may also provide some information about effectiveness. Phase I testing is normally performed on healthy volunteers. The test subjects are paid to submit to a variety of tests to learn what happens to a drug in the human body; how it is absorbed, metabolized and excreted, what effect it has on various organs and tissues; and what side effects occur as the dosages are increased. The principal objective is to determine the drug's toxicity. Phase I trials generally involve 20-40 people at an estimated cost of $10,000 per patient, taking six months to one year to complete.
Phase II
Assuming the results of Phase I testing present no toxicity or unacceptable safety problems, Phase II trials may begin. In many cases Phase II trials may commence before all the Phase I trials are completely evaluated if the disease is life threatening and preliminary toxicity data in Phase I shows no toxic side effects. In life threatening disease, Phase I and Phase II trials are sometimes combined to show initial toxicity and efficacy in a shorter period of time. Phase II trials involve a study to evaluate the effectiveness of the drug for a particular indication and to determine optimal dosages and dose interval and to identify possible adverse side effects and risks in a larger patient group. The primary objective of this stage of clinical testing is to show whether the drug is effective in treating the disease or condition for which it is intended. Phase II studies may take several months or longer and involve a few hundred patients in randomized controlled trials that also attempt to disclose short-term side effects and risks in people whose health is impaired. A number of patients with the disease or illness will receive the treatment while a control group will receive a placebo. At the conclusion of Phase II trials, we and the FDA will have a clear understanding of the short-term safety and effectiveness of our technologies and their optimal dosage levels.
-26-
| SB-2 | 23rd "Page" of 72 | TOC | 1st | Previous | Next | Bottom | Just 23rd |
|---|
Phase III
Phase III clinical trials will generally begin after the results of Phase II are evaluated. If a product is found to be effective in Phase II, it is then evaluated in Phase III clinical trials. The objective of Phase III is to develop information that will allow the drug to be marketed and used safely. Phase III trials consist of expanded multi-location testing for efficacy and safety to evaluate the overall benefit or risk index of the investigational drug in relation to the disease treated. Phase III trials will involve thousands of people with the objective of expanding on the clinical evidence.
Some objectives of Phase III trials are to discover optimum dose rates and schedules, less common or even rare side effects, adverse reactions, and to generate information that will be incorporated into the drug's professional labeling and the FDA-approved guidelines to physicians and others about how to properly use the drug.
Pharmaceutical Development
The method of formulation and manufacture may affect the efficacy and safety of a drug. Therefore, information on manufacturing methods and standards and the stability of the drug substance and dosage form must be presented to the FDA and other regulatory authorities. This is to ensure that a product that may eventually b