sec document
As filed with the Securities and Exchange Commission on August 17, 2005
Registration No. 333-______
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM S-8
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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CEPTOR CORPORATION
(Exact Name of Registrant as Specified in Its Charter)
DELAWARE 11-2897392
(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification No.)
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200 INTERNATIONAL CIRCLE
SUITE 5100
HUNT VALLEY, MARYLAND 21030
TELEPHONE: (410) 527-9998
(Address of Principal Executive Offices)
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2004 INCENTIVE STOCK PLAN
FOUNDERS' PLAN
(Full Title of the Plans)
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WILLIAM H. PURSLEY
CHAIRMAN AND CHIEF EXECUTIVE OFFICER
CEPTOR CORPORATION
200 INTERNATIONAL CIRCLE
SUITE 5100
HUNT VALLEY, MARYLAND 21030
TELEPHONE: (410) 527-9998
(Name, Address and telephone number, including area code, of agent for service)
COPY TO:
HARVEY J. KESNER, ESQ.
OLSHAN GRUNDMAN FROME ROSENZWEIG & WOLOSKY LLP
PARK AVENUE TOWER
65 EAST 55TH STREET
NEW YORK, NEW YORK 10022
TELEPHONE: (212) 451-2300
FACSIMILE: (212) 451-2222
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CALCULATION OF REGISTRATION FEE
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Title of Amount To Be Proposed Maximum Proposed Maximum Amount of
Securities to be Registered Registered (1) Offering Price Per Share Aggregate Offering Price Registration Fee
--------------------------------------------------------------------------------------------------------------------------------
Common stock, par value $0.0001 105,195 $2.93 (2) $ 308,221.35 (2) $ 36.28
per share: shares subject
to outstanding options
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Common stock, par value $0.0001 7,500 $1.70 $ 12,750 $ 1.50
per share: restricted shares
issued and outstanding
--------------------------------------------------------------------------------------------------------------------------------
Common stock, par value $0.0001 1,170,435 $1.70 (3) $1,989,739.50 (3) $234.19
per share: shares issuable
under the 2004 Incentive Stock Plan
--------------------------------------------------------------------------------------------------------------------------------
Common stock, par value $0.0001 3,031,943 (5) $0.0001 $ 303.19 $ 0.04
per share: Founders' Plan (4)
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(1) Pursuant to Rule 416, the registration statement also covers such
indeterminate additional shares of common stock as may become issuable as
a result of any future anti-dilution adjustment in accordance with the
terms of the 2004 Incentive Stock Plan and Founders' Plan (collectively,
the "Plans").
(2) Pursuant to Rule 457(h)(1) and (c) under the Securities Act of 1933,
calculated on the basis of the average of the weighted average exercise
price of outstanding options to purchase shares of common stock under the
Plans registered hereunder for resale.
(3) Estimated solely for the purpose of calculating the registration fee
pursuant to Rule 457(h)(1) and (c) under the Securities Act of 1933 on the
basis of the last sale price reported for shares of common stock of the
Registrant on the OTC Bulletin Board on August 15, 2005.
(4) Represents 3,031,943 shares of common stock issued upon the exercise of
options prior to the filing of this Registration Statement.
(5) Represents 3,031,943 shares of common stock issued December 9, 2004
pursuant to the terms of an option granted to William H. Pursley,
Registrant's Chairman and Chief Executive Officer, upon satisfaction of
certain conditions. Issuance of shares of common stock equal to 43.75% of
the registrant's shares were allocated to certain persons by William H.
Pursley under an agreement with Xechem International, Inc., ("Xechem").
Registrant was a wholly-owned subsidiary of Xechem until December 8, 2004.
Includes 265,845 shares of unallocated common stock.
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EXPLANATORY NOTES
CepTor Corporation has prepared this registration statement in
accordance with the requirements of Form S-8 under the Securities Act of 1933,
as amended (the "Securities Act"), to register shares of our common stock, par
value $0.0001 per share, issuable under our 2004 Incentive Stock Plan and
Founders' Plan, which we refer to collectively as the Plans.
This Form S-8 includes a reoffer prospectus prepared in accordance
with Part I of Form S-3 under the Securities Act. The reoffer prospectus may be
utilized for reoffers and resales of shares of our common stock acquired
pursuant to the Plans and consulting agreements, by selling stockholders who
exercised stock options prior to the initial filing of this registration
statement or who may be deemed "affiliates" (as such term is defined in Rule 405
of the Securities Act) of the Company.
PART I
INFORMATION REQUIRED IN THE SECTION 10(a) PROSPECTUS
We will provide documents containing the information specified in
Part I of this Registration Statement on Form S-8 to persons eligible to
participate in the Plans as specified by Rule 428(b)(1) under the Securities
Act. Pursuant to the instructions to Form S-8, we are not required to file these
documents either as part of this registration statement or as prospectuses or
prospectus supplements pursuant to Rule 424 under the Securities Act.
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PROSPECTUS
4,315,073 SHARES
CEPTOR CORPORATION
COMMON STOCK
This prospectus relates to the reoffer and resale by certain selling
stockholders of shares of our common stock that have been or may be issued by us
to the selling stockholders upon the exercise of stock options granted under our
stock option plans or pursuant to other grants of stock options or other awards
made to employees under our employee benefit plans. We have not previously
registered the offer and sale of the shares to the selling stockholders. This
prospectus also relates to certain underlying options and other awards that have
not as of this date been granted. If and when such options or awards are granted
to persons required to use the prospectus to reoffer and resell the shares
underlying such options or awards, we will distribute a prospectus supplement.
The shares are being reoffered and resold for the account of the selling
stockholders. We will not receive any of the proceeds from the resale of the
shares.
The selling stockholders have advised us that the resale of their
shares may be effected from time to time in one or more transactions on the OTC
Bulletin Board, or other stock market or exchange on which we may list our
common stock, in negotiated transactions or otherwise, at market prices
prevailing at the time of the sale or at prices otherwise negotiated. See "Plan
of Distribution." We will bear all expenses in connection with the preparation
of this prospectus.
Our common stock is quoted on the registered quotation service of
the OTC Bulletin Board under the symbol "CEPO.OB". The last reported sale price
on the OTC Bulletin Board for our common stock on August 15, 2005 was $1.70 per
share.
Our principal executive offices are located at 200 International
Circle, Suite 5100, Hunt Valley, Maryland 21030 and our telephone number is
(410) 527-9998.
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INVESTING IN THE COMMON STOCK INVOLVES RISKS THAT ARE DESCRIBED IN THE
"RISK FACTORS" SECTION BEGINNING ON PAGE 2 OF THIS PROSPECTUS.
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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. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
The date of this Prospectus is August 17, 2005.
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TABLE OF CONTENTS
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INCORPORATION BY REFERENCE.....................................................1
THE COMPANY....................................................................2
RISK FACTORS...................................................................2
FORWARD-LOOKING STATEMENTS....................................................18
USE OF PROCEEDS...............................................................19
SELLING STOCKHOLDERS..........................................................19
PLAN OF DISTRIBUTION..........................................................21
LEGAL MATTERS.................................................................21
WHERE YOU CAN FIND MORE INFORMATION...........................................21
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR
SECURITIES ACT LIABILITIES....................................................21
You should rely only on the information contained in this
prospectus. We have not authorized any other person to provide you with
different information. If anyone provides you with different or inconsistent
information, you should not rely on it. The selling stockholders will not make
an offer to sell these securities in any jurisdiction where an offer or sale is
not permitted. You should assume that the information appearing in this
prospectus is accurate as of the date on the front cover of this prospectus
only, regardless of the time of delivery of this prospectus or of any sale of
our common stock. Our business, financial condition, results of operations and
prospects may have changed since that date.
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INCORPORATION BY REFERENCE
The following documents filed by us with the SEC are incorporated by
reference in this prospectus:
(1) Annual Report on Form 10-KSB for the fiscal year ended December
31, 2004, filed April 16, 2005;
(2) Current Report on Form 8-K, filed January 31, 2005;
(3) Current Report on Form 8-K/A, filed February 11, 2005;
(4) Registration Statement on Form SB-2 (SEC File No. 333-122755),
filed February 11, 2005 ("Form SB-2");
(5) Current Report on Form 8-K, filed April 26, 2005;
(6) Quarterly Report on Form 10-QSB for the quarterly period ended
March 31, 2005, filed May 16, 2005;
(7) Current Report on Form 8-K, filed May 20, 2005;
(8) Current Report on Form 8-K, filed July 20, 2005;
(9) Pre-Effective Amendment No. 1 to the SB-2, filed July 21, 2005;
(10) Pre-Effective Amendment No. 2 to the SB-2, filed July 25, 2005;
and
(11) Quarterly Report on Form 10-QSB for the quarterly period ended
June 30, 2005, filed August 15, 2005.
All documents subsequently filed with the SEC by us pursuant to
Sections 13(a), 13(c), 14 and 15(d) of the Securities Exchange Act of 1934, as
amended, prior to the filing of a post-effective amendment which indicates that
all securities offered herein have been sold or which deregisters all securities
then remaining unsold, shall be deemed to be incorporated by reference herein
and to be part hereof from the respective dates of filing of such documents. Any
statement contained herein or in a document incorporated or deemed to be
incorporated by reference herein shall be deemed to be modified or superseded
for purposes hereof or of the related prospectus to the extent that a statement
contained herein or in any other subsequently filed document which is also
incorporated or deemed to be incorporated herein modifies or supersedes such
statement. Any such statement so modified or superseded shall not be deemed,
except as so modified or superseded, to constitute a part of this registration
statement.
You may request a copy of these filings, excluding the exhibits to
such filings which we have not specifically incorporated by reference in such
filings, at no cost, by writing or telephoning us at the following address:
CepTor Corporation
200 International Circle
Suite 5100
Hunt Valley, Maryland 21030
Telephone: (410) 527-9998
Attention: Corporate Secretary
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THE COMPANY
We are a development-stage biopharmaceutical company focusing on the
development of proprietary, cell-targeted therapeutic products for neuromuscular
and neurodegenerative diseases. Our goal is to increase the quality and quantity
of life of people suffering with these diseases. Primary efforts are currently
being focused on moving our lead product, Myodur, into phase I/II clinical
trials for Duchenne's muscular dystrophy. Our broad platform technology also
includes the development of products for multiple sclerosis, retinal
degeneration and epilepsy.
We have developed a unique technology that we believe has broad
application and which may be used to target drugs orally to many human organ and
tissue systems. The basis of this technology is a concept that integrates the
special chemical properties of active, currently available, and naturally
occurring pharmaceuticals and the specific biological characteristics of
targeting drugs to cells. Our technology provides a means for targeting drugs to
the site for which the drug has therapeutic effect. This targeting capability
has the potential effect of reducing, potentially markedly, the amount of drug
that is circulated to other places in the body. Therefore, effective targeting
makes it possible to use much less drug in the patient's body, thereby
drastically decreasing the probability of harmful side effects.
We currently have no revenues from operations and are funding the
development of our products through the sale of our securities and will continue
to fund our activities through sales of securities for the foreseeable future.
Our current emphasis is on filing an investigational new drug ("IND")
application for Myodur, manufacturing supplies required for pre-clinical studies
and initial clinical trials of our proposed product, conducting toxicological
and other pre-clinical studies, pursuing clinical studies and United States Food
and Drug Administration ("FDA") approvals. Currently our available capital
resources are not sufficient to sustain planned operations, which raises
substantial doubt about our ability to continue as a going concern. In the
absence of the availability of such financing on a timely basis, we could be
forced to materially curtail, limit, or cease our operations.
RISK FACTORS
YOU SHOULD CAREFULLY CONSIDER THE RISKS DESCRIBED BELOW BEFORE
MAKING AN INVESTMENT DECISION. IF ANY OF THE FOLLOWING CIRCUMSTANCES OCCUR, OUR
BUSINESS, FINANCIAL CONDITION OR RESULTS OF OPERATIONS COULD BE MATERIALLY
ADVERSELY AFFECTED. IN THAT EVENT, THE TRADING PRICE OF OUR COMMON STOCK COULD
DECLINE, AND YOU MAY LOSE PART OR ALL OF YOUR INVESTMENT. UNLESS OTHERWISE
INDICATED, ALL REFERENCES IN THIS PROSPECTUS TO "CEPTOR," WE," "US" AND "OUR"
REFER TO CEPTOR CORPORATION.
Risks Related to Our Business and Industry
THE FAILURE TO COMPLETE DEVELOPMENT OF OUR TECHNOLOGY, OBTAIN
GOVERNMENT APPROVALS, INCLUDING REQUIRED FDA APPROVALS, OR TO COMPLY WITH
ONGOING GOVERNMENTAL REGULATIONS COULD DELAY OR LIMIT INTRODUCTION OF PROPOSED
PRODUCTS AND RESULT IN FAILURE TO ACHIEVE REVENUES OR MAINTAIN OUR ONGOING
BUSINESS.
Our research and development activities and the manufacture and
marketing of our intended products are subject to extensive regulation for
safety, efficacy, and quality by numerous government authorities in the United
States and abroad. Before receiving FDA clearance to market our proposed
products, we will have to demonstrate that our products are safe and effective
on the patient population and for the diseases that are to be treated. Clinical
trials, manufacturing and marketing of drugs are subject to the rigorous testing
and approval process of the FDA and equivalent foreign regulatory authorities.
The Federal Food, Drug and Cosmetic Act ("FDC Act") and other federal, state,
and foreign statutes and regulations govern and influence the testing,
manufacture, labeling, advertising, distribution, and promotion of drugs and
medical devices. As a result, clinical trials and regulatory approval can take a
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number of years or longer to accomplish and require the expenditure of
substantial financial, managerial, and other resources.
In order to be commercially viable, we must successfully research,
develop, obtain regulatory approval for, manufacture, introduce, market, and
distribute our technologies. For each drug utilized with our drug delivery
technology, and for Myodur and Neurodur, we must successfully meet a number of
critical developmental milestones, including:
o demonstrate benefit from delivery of each specific drug through
our drug delivery technology;
o demonstrate through pre-clinical and clinical trials that our
drug delivery technology and patient specific therapy is safe
and effective;
o establish a viable Good Manufacturing Process capable of
potential scale up.
The time frame necessary to achieve these developmental milestones
may be long and uncertain, and we may not successfully complete these milestones
for any of our intended products in development.
In addition to the risks previously discussed, our technology is
subject to additional developmental risks which include the following:
o the uncertainties arising from the rapidly growing scientific
aspects of drug delivery, therapies, and potential treatments;
o uncertainties arising as a result of the broad array of
potential treatments related to nerve and muscle injury and
disease; and
o anticipated expense and time believed to be associated with the
development and regulatory approval of treatments for nerve and
muscle injury and disease.
In order to conduct clinical trials that are necessary to obtain
approval by the FDA to market a product it is necessary to receive clearance
from the FDA to conduct such clinical trials. The FDA can halt clinical trials
at any time for safety reasons or because our clinical investigators do not
follow the FDA's requirements for conducting clinical trials. If we are unable
to receive clearance to conduct clinical trials or the trials are halted by the
FDA, we would not be able to achieve any revenue from such product, as it is
illegal to sell any drug or medical device in the United States for human
consumption without FDA approval, and many foreign countries are influenced in
granting their own required approvals by the FDA.
DATA OBTAINED FROM CLINICAL TRIALS IS SUSCEPTIBLE TO VARYING
INTERPRETATIONS, WHICH COULD DELAY, LIMIT OR PREVENT REGULATORY CLEARANCES.
Data already obtained, or in the future obtained, from pre-clinical
studies and clinical trials (as of the date of this prospectus no clinical
trials of our technology have been undertaken) do not necessarily predict the
results that will be obtained from later pre-clinical studies and clinical
trials. Moreover, pre-clinical and clinical data is susceptible to varying
interpretations, which could delay, limit or prevent regulatory approval. A
number of companies in the pharmaceutical industry have suffered significant
setbacks in advanced clinical trials, even after promising results in earlier
trials. The failure to adequately demonstrate the safety and effectiveness of an
intended product under development could delay or prevent regulatory clearance
of a potential drug, resulting in delays to commercialization, and could
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materially harm our business. Our clinical trials may not demonstrate sufficient
levels of safety and efficacy necessary to obtain the requisite regulatory
approvals for our drugs, and thus our proposed drugs may not be approved for
marketing. Even after approval, further studies could result in withdrawal of
FDA and other regulatory approvals and voluntary or involuntary withdrawal of
products from the market.
We may encounter delays or rejections based upon additional
government regulation from future legislation or administrative action or
changes in FDA policy during the period of development, clinical trials and FDA
regulatory review. We may encounter similar delays in foreign countries. Sales
of our products outside the U.S. would be subject to foreign regulatory
approvals that vary from country to country. The time required to obtain
approvals from foreign countries may be shorter or longer than that required for
FDA approval, and requirements for foreign licensing may differ from FDA
requirements. We may be unable to obtain requisite approvals from the FDA and
foreign regulatory authorities, and even if obtained, such approvals may not be
on a timely basis, or they may not cover the uses that we request.
In the future, we may select drugs for "molecular binding" using our
drug delivery technology which may contain controlled substances which are
subject to state, federal and foreign laws and regulations regarding their
manufacture, use, sale, importation and distribution. For such drugs containing
controlled substances, we and any suppliers, manufacturers, contractors,
customers and distributors may be required to obtain and maintain applicable
registrations from state, federal and foreign law enforcement and regulatory
agencies and comply with state, federal and foreign laws and regulations
regarding the manufacture, use, sale, importation and distribution of controlled
substances. These regulations are extensive and include regulations governing
manufacturing, labeling, packaging, testing, dispensing, prescription, and
procurement quotas, record keeping, reporting, handling, shipment, and disposal.
Failure to obtain and maintain required registrations or comply with any
applicable regulations could delay or preclude us from developing and
commercializing our drugs containing controlled substances and subject us to
enforcement action. In addition, because of their restrictive nature, these
regulations could limit our commercialization of drugs containing controlled
substances.
OUR DRUGS OR TECHNOLOGY MAY NOT GAIN FDA APPROVAL IN CLINICAL TRIALS
OR BE EFFECTIVE AS A THERAPEUTIC AGENT WHICH COULD AFFECT OUR FUTURE
PROFITABILITY AND PROSPECTS.
In order to obtain regulatory approvals, we must demonstrate that
the procedure is safe and effective for use in humans and functions as a
therapeutic against the effects of injury or disease. To date, we have not
conducted any human pilot study pursuant to Institutional Review Board oversight
in anticipation of our initial FDA submission for patient specific or other
therapy. Further, we have conducted only sporadic and limited animal studies to
observe the effects of our drugs and have not subjected our drugs or
technologies to rigorous testing standards that would be acceptable for
publication in scientific peer review journals.
We may not be able to demonstrate that any potential drug or
technology, including Myodur or Neurodur, although appearing promising in
pre-clinical and animal observations, is safe or effective in advanced clinical
trials that involve human patients. We are also not able to assure that the
results of the tests already conducted and which we intend to repeat will be
consistent with our prior observations or support our applications for
regulatory approval. As a result, our drug and technology research program may
be curtailed, redirected or eliminated at any time.
The diseases and illnesses to which our drugs and technologies are
directed are very complex and may be prone to genetic mutations. These mutations
may prove resistant to currently approved therapeutics or our drugs or
technologies. Even if we gain regulatory approval there may develop resistance
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to our treatment. This could have a material adverse effect on our business,
financial condition, and results of operations.
WE HAVE ACCUMULATED DEFICITS RESULTING FROM EXPENSES INCURRED IN THE
RESEARCH AND DEVELOPMENT OF OUR TECHNOLOGY AND THERE IS NO GUARANTEE THAT WE
WILL EVER GENERATE REVENUE OR BECOME PROFITABLE EVEN IF ONE OR MORE OF OUR DRUGS
ARE APPROVED FOR COMMERCIALIZATION.
Since our inception in 1986, we have incurred operating losses. As
of June 30, 2005, our accumulated deficit amounted to approximately $29,540,000.
In addition, we expect to continue incurring operating losses for the
foreseeable future as we continue to develop our products which will cause us to
incur substantial research and development and clinical trial costs. Our ability
to generate revenue and achieve profitability depends upon our ability, alone or
with others, to complete the development of our proposed products, obtain the
required regulatory approvals and manufacture, market, and sell our proposed
products. Development, including the cost of contract manufacturing of our
proposed products for pre-clinical testing and human clinical trials is
extremely costly and requires significant investment. In the absence of
additional financing we may not be able to continue our development activities.
In addition, we may choose to license the rights to particular drugs or other
technology. License fees may increase our costs.
We have not generated any revenue from the commercial sale of our
proposed products or any drugs and do not expect to receive such revenue in the
near future. Our primary activity to date has been research and development of
our technology. All revenues to date are from grants, both public and private,
and collaborative agreements. A substantial portion of the research results and
observations on which we rely were performed by third-parties at those parties'
sole or shared cost and expense. We cannot be certain as to when or whether to
anticipate commercializing and marketing our proposed products in development,
and do not expect to generate sufficient revenues from proposed product sales to
cover our expenses or achieve profitability in the foreseeable future.
WE HAVE RELIED SOLELY ON THE FACILITIES OF THE STATE UNIVERSITY OF
NEW YORK, HEALTH SCIENCE CENTER AT DOWNSTATE MEDICAL CENTER AND STONY BROOK
UNIVERSITY AS WELL AS OTHER THIRD-PARTY RESEARCH INSTITUTIONS FOR ALL OF OUR
RESEARCH AND DEVELOPMENT, WHICH COULD BE MATERIALLY DELAYED SHOULD WE LOSE
ACCESS TO THOSE FACILITIES.
Although we are in discussions to lease laboratory facilities for
our on-going research and development programs, we currently have no research
and development facilities of our own. We are entirely dependent on third
parties to use their facilities to conduct research and development. To date, we
have primarily relied on the Health Science Center at Downstate Medical Center
and Stony Brook University and other third-party research institutions for this
purpose. Our inability to have continued access to these facilities to conduct
research and development may delay or impair our ability to gain FDA approval
and commercialization of our drug delivery technology and products.
We currently maintain a good working relationship with the Health
Science Center at Downstate Medical Center and Stony Brook University. Although
we are evaluating various facilities in which to establish our laboratories,
should we be required to relocate on short notice, we do not currently have an
alternate facility where we could relocate our research activities. The cost and
time to establish or locate an alternative research and development facility to
develop our technology, other than through the universities, will be substantial
and may delay gaining FDA approval and commercializing our products.
WE ARE DEPENDENT ON OUR COLLABORATIVE AGREEMENTS FOR THE DEVELOPMENT
OF OUR TECHNOLOGIES AND BUSINESS DEVELOPMENT WHICH EXPOSES US TO THE RISK OF
RELIANCE ON THE VIABILITY OF THIRD PARTIES.
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In conducting our research and development activities, we rely and
expect in the future to rely upon numerous collaborative agreements with
universities, governmental agencies, charitable foundations, manufacturers,
contract research organizations, and corporate partners. The loss of or failure
to perform under any of these arrangements, by any of these entities, may
substantially disrupt or delay our research and development activities including
our anticipated clinical trials.
WE ARE EXPOSED TO PRODUCT LIABILITY, CLINICAL AND PRE-CLINICAL
LIABILITY RISKS WHICH COULD PLACE A SUBSTANTIAL FINANCIAL BURDEN UPON US SHOULD
WE BE SUED, BECAUSE WE DO NOT CURRENTLY HAVE PRODUCT LIABILITY INSURANCE ABOVE
AND BEYOND OUR GENERAL INSURANCE COVERAGE.
Our business exposes us to potential product liability and other
liability risks that are inherent in the testing, manufacturing, marketing and
sale of pharmaceutical products. We cannot assure that such potential claims
will not be asserted against us. In addition, the use in our clinical trials of
pharmaceutical products that we may develop and the subsequent sale of these
products by us or our potential collaborators may cause us to bear a portion of
or all product liability risks. A successful liability claim or series of claims
brought against us could have a material adverse effect on our business,
financial condition, and results of operations.
All of our pre-clinical trials have been and all of our proposed
clinical and pre-clinical trials are anticipated to be conducted by
collaborators and third party contractors. We do not currently have any product
liability insurance or other liability insurance relating to clinical trials or
any products or compounds. We intend to seek insurance against such risks before
we initiate clinical trials or before our product sales are commenced. We cannot
assure that we will be able to obtain or maintain adequate product liability
insurance on acceptable terms, if at all, or that such insurance will provide
adequate coverage against our potential liabilities. An inability to obtain
sufficient insurance coverage at an acceptable cost or otherwise to protect
against potential product liability claims could prevent or inhibit the
commercialization of our drug delivery technology. A product liability claim
could also significantly harm our reputation and delay market acceptance of our
intended products. Furthermore, our current and potential partners with whom we
have collaborative agreements or our future licensees may not be willing to
indemnify us against these types of liabilities and may not themselves be
sufficiently insured or have a net worth sufficient to satisfy any product
liability claims. Product liability claims or other claims related to our
intended products, regardless of their outcome, could require us to spend
significant time and money in litigation or to pay significant settlement
amounts or judgments. Any successful product liability or other claim may
prevent us from obtaining adequate liability insurance in the future on
commercially desirable or reasonable terms. Claims or losses in excess of any
product liability insurance coverage that may be obtained by us could have a
material adverse effect on our business, financial condition, and results of
operations.
OUR LIMITED OPERATING HISTORY MAKES EVALUATING OUR BUSINESS MORE
DIFFICULT, AND THEREFORE, INVESTORS HAVE LIMITED INFORMATION UPON WHICH TO RELY.
An investor can only evaluate our business based on a limited
operating history. While we were organized in 1986, our current level of
activity and operations only recently began following our acquisition by Xechem
and subsequent closing on our financing during December 2004 and January and
February 2005. Our operations will continue to change and our costs will
increase dramatically as we evolve from primarily a technology holding company
to a capitalized company with employees and internal operations. Since
inception, we have engaged primarily in research and development, relied to a
great extent on third-party efforts, sought avenues for licensing technology,
sought grants, raised capital, and recruited scientific and management personnel
external to us. We have not generated any meaningful revenue to date, other than
research grants, and have no royalty revenue or products ready for use and in
the marketplace. This limited history may not be adequate to enable an investor
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to fully assess our ability to develop our technologies and proposed products,
obtain FDA approval, and achieve market acceptance of our proposed products, and
respond to competition, or conduct such affairs as are presently contemplated.
ACCEPTANCE OF OUR PRODUCTS IN THE MARKETPLACE IS UNCERTAIN AND
FAILURE TO ACHIEVE MARKET ACCEPTANCE WILL PREVENT OR DELAY OUR ABILITY TO
GENERATE REVENUES.
Our future financial performance will depend, in part, upon the
introduction and customer acceptance of our proposed products. Even if approved
for marketing by the necessary regulatory authorities, our products may not
achieve market acceptance. The degree of market acceptance will depend upon a
number of factors, including:
o the receipt of regulatory clearance of marketing claims for the
uses that we are developing;
o the establishment and demonstration of the advantages, safety
and efficacy of our technologies;
o pricing and reimbursement policies of government and third
party payors such as insurance companies, health maintenance
organizations and other health plan administrators;
o our ability to attract corporate partners, including
pharmaceutical companies, to assist in commercializing our
intended products; and
o our ability to market our products.
Physicians, patients, payors or the medical community in general may
be unwilling to accept, utilize, or recommend any of our products. If we are
unable to obtain regulatory approval, commercialize, and market our proposed
products when planned, we may not achieve any market acceptance or generate
revenue.
WE MAY FACE LITIGATION FROM THIRD PARTIES THAT CLAIM OUR PRODUCTS
INFRINGE ON THEIR INTELLECTUAL PROPERTY RIGHTS, PARTICULARLY BECAUSE THERE IS
SUBSTANTIAL UNCERTAINTY ABOUT THE VALIDITY AND BREADTH OF MEDICAL PATENTS.
We may be exposed to future litigation by third parties based on
claims that our technologies, products, or activities infringe the intellectual
property rights of others or that we have the trade secrets of others. This risk
is exacerbated by the fact that the validity and breadth of claims covered in
medical technology patents and the breadth and scope of trade secret protection
involve complex legal and factual questions for which important legal principles
are unresolved. Any litigation or claims against us, whether or not valid, could
result in substantial costs, could place a significant strain on our financial
and managerial resources, and could harm our reputation. Most of our license
agreements would likely require that we pay the costs associated with defending
this type of litigation. In addition, intellectual property litigation or claims
could force us to do one or more of the following:
o cease selling, incorporating or using any of our technologies
and/or products that incorporate the challenged intellectual
property, which would adversely affect our future revenue;
o obtain a license from the holder of the infringed intellectual
property right, which license may be costly or may not be
available on reasonable terms, if at all; or
o redesign our products, which would be costly and time
consuming.
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We have not engaged in discussions, received any communications, nor
do we have any reason to believe that any third party is challenging or has the
proper legal authority to challenge our intellectual property rights or those of
the actual patent holders. In light of our formation and use of the name CepTor
in commerce many years prior to the formation of Ceptyr and issuance of their
trademark, we believe the demand to cease and desist from future infringement to
be substantially without merit. No further communication has been received since
mid-2004.
CERTAIN UNIVERSITY RELATIONSHIPS ARE IMPORTANT TO OUR BUSINESS AND
OUR SCIENTIFIC ADVISORY BOARD'S UNIVERSITY RELATIONSHIPS MAY POTENTIALLY RESULT
IN CONFLICTS OF INTERESTS.
Dr. Alfred Stracher and Dr. Leo Kesner are the chief scientific
investigators of our technology and have had longstanding associations with the
Health Science Center at Downstate Medical Center and Stony Brook University for
more than the last five years. Dr. Stracher is also Chairman of the Department
of Biochemistry of the Health Science Center at Downstate Medical Center. Dr.
Stracher's and Dr. Kesner's association with those universities may currently or
in the future involve conflicting interests.
IF WE ARE UNABLE TO ADEQUATELY PROTECT OR ENFORCE OUR RIGHTS TO
INTELLECTUAL PROPERTY OR SECURE RIGHTS TO THIRD PARTY PATENTS, WE MAY LOSE
VALUABLE RIGHTS, EXPERIENCE REDUCED MARKET SHARE, ASSUMING ANY, OR INCUR COSTLY
LITIGATION TO PROTECT SUCH RIGHTS.
Our ability to obtain licenses to third-party patents, maintain
trade secret protection, and operate without infringing the proprietary rights
of others will be important to our commercialization of any products under
development. Therefore, any disruption in access to the technology could
substantially delay the development of our technology.
The patent positions of biotechnology and pharmaceutical companies,
including ours, which also involve licensing agreements, are frequently
uncertain and involve complex legal and factual questions. In addition, the
coverage claimed in a patent application can be significantly reduced before the
patent is issued. Consequently, our patent applications and any issued and
licensed patents may not provide protection against competitive technologies or
may be held invalid if challenged or circumvented. Our competitors may also
independently develop drug delivery technologies or products similar to ours or
design around or otherwise circumvent patents issued or licensed to us. In
addition, the laws of some foreign countries may not protect our proprietary
rights to the same extent as U.S. law.
We also rely upon trade secrets, technical know how, and continuing
technological innovation to develop and maintain our competitive position. We
generally require our employees, consultants, advisors and collaborators to
execute appropriate confidentiality and assignment of inventions agreements.
These agreements typically provide that all materials and confidential
information developed or made known to the individual during the course of the
individual's relationship with us is to be kept confidential and not disclosed
to third parties except in specific circumstances, and that all inventions
arising out of the individual's relationship with us shall be our exclusive
property. These agreements may be breached and we may not have an appropriate
remedy available for breach of the agreements. Furthermore, our competitors may
independently develop substantially equivalent proprietary information and
techniques, reverse engineer our information and techniques, or otherwise gain
access to our proprietary technology. We may be unable to meaningfully protect
our rights in trade secrets, technical know how, and other non patented
technology.
-8-
Although our trade secrets and technical know how are important, our
continued access to the patents is a significant factor in the development and
commercialization of our drug delivery technology. Aside from the general body
of scientific knowledge from other drug delivery processes and technology, we
believe these patents, based upon our current scientific data, are the only
intellectual property necessary to develop our short-term plans for our current
drug delivery system using our proposed Myodur, Neurodur and other drugs. We do
not believe that we are or will be violating any other patents in developing our
technology although we anticipate seeking a license from Sigma-Tau in order to
employ a manufacturing method useful for large scale manufacturing of Myodur.
We may have to resort to litigation to protect its rights for
certain intellectual property, or to determine their scope, validity, or
enforceability. Enforcing or defending our rights is expensive, could cause
diversion of our resources, and may not prove successful. Any failure to enforce
or protect our rights could cause us to lose the ability to exclude others from
using our technology to develop or sell competing products.
We currently depend and will continue to depend heavily on third
parties for support in research and development and clinical and pre-clinical
testing. We expect to conduct activities with Downstate Medical Center and other
State University of New York facilities at Stony Brook and Buffalo. We currently
have no significant formal agreement with either of these institutions other
than research and testing agreements entered through the Research Foundation of
the State University of New York. Under certain circumstances, the State
University of New York and others may acquire certain rights in newly developed
intellectual property developed in conjunction with us.
Research and development and clinical trials involve a complex
process, and these universities' facilities may not be sufficient. Inadequate
facilities could delay clinical trials of our drugs and result in delays in
regulatory approval and commercialization of our drugs, either of which would
materially harm our business. We may, if adequate funding is obtained, decide to
establish an independent facility to replace or supplement university
facilities. To date, we have not identified the location, negotiated leases or
equipment purchases, and, accordingly, we are subject to various uncertainties
and risks that may be associated with the potential establishment of a new
facility.
We may rely on third party contract research organizations, service
providers, and suppliers to support development and clinical testing of our
products. Failure of any of these contractors to provide the required services
in a timely manner or on reasonable commercial terms could materially delay the
development and approval of our products, increase our expenses, and materially
harm our business, financial condition, and results of operations.
KEY COMPONENTS OF OUR TECHNOLOGIES MAY BE PROVIDED BY SOLE OR
LIMITED NUMBERS OF SUPPLIERS, AND SUPPLY SHORTAGES OR LOSS OF THESE SUPPLIERS
COULD RESULT IN INTERRUPTIONS IN SUPPLY OR INCREASED COSTS.
Certain components used in our research and development activities
such as leupeptin, carnitine and taurine compounds, are currently purchased or
manufactured for us from a single or a limited number of outside sources. The
reliance on a sole or limited number of suppliers could result in:
o potential delays associated with research and development and
clinical and pre-clinical trials due to an inability to timely
obtain a single or limited source component;
o potential inability to timely obtain an adequate supply of
required components; and
o potential of reduced control over pricing, quality, and timely
delivery.
-9-
We do not have long-term agreements with any of our suppliers, and
therefore the supply of a particular component could be terminated without
penalty to the supplier. Any interruption in the supply of components could
cause us to seek alternative sources of supply or manufacture these components
internally. If the supply of any components is interrupted, components from
alternative suppliers may not be available in sufficient volumes within required
timeframes, if at all, to meet our needs. This could delay our ability to
complete clinical trials, obtain approval for commercialization or commence
marketing, or cause us to lose sales, incur additional costs, delay new product
introductions, or harm our reputation. Further, components from a new supplier
may not be identical to those provided by the original supplier. Such
differences if they exist could affect product formulations or the safety and
effect of our products that are being developed and delay regulatory approvals.
WE HAVE LIMITED MANUFACTURING EXPERIENCE AND ONCE OUR PRODUCTS ARE
APPROVED, IF AT ALL, WE MAY NOT BE ABLE TO MANUFACTURE SUFFICIENT QUANTITIES AT
AN ACCEPTABLE COST.
Our products remain in the research and development and pre-clinical
trial phase of commercialization. Once our products are approved for commercial
sale, if at all, we will need to establish the capability to commercially
manufacture our products in accordance with FDA and other regulatory
requirements. We have limited experience in establishing, supervising, and
conducting commercial manufacturing. If we fail to adequately establish,
supervise, and conduct all aspects of the manufacturing processes, we may not be
able to commercialize our products. We do not presently own manufacturing
facilities necessary to provide clinical or commercial quantities of our
intended products.
We presently plan to rely on third party contractors to manufacture
part or all of our products. This may expose us to the risk of not being able to
directly oversee the production and quality of the manufacturing process.
Furthermore, these contractors, whether foreign or domestic, may experience
regulatory compliance difficulty, mechanic shut downs, employee strikes, or any
other unforeseeable acts that may delay production.
DUE TO OUR LIMITED MARKETING, SALES, AND DISTRIBUTION EXPERIENCE, WE
MAY BE UNSUCCESSFUL IN OUR EFFORTS TO SELL OUR PRODUCTS, ENTER INTO
RELATIONSHIPS WITH THIRD PARTIES, OR DEVELOP A DIRECT SALES ORGANIZATION.
We have yet had to establish any marketing, sales, or distribution
capabilities for our proposed products. Until such time as our products are
further along in the regulatory process, we will not devote any meaningful time
or resources to this effort. At the appropriate time, we intend to enter into
agreements with third parties to sell our products or we may develop our own
sales and marketing force. We may be unable to establish or maintain third party
relationships on a commercially reasonable basis, if at all. In addition, these
third parties may have similar or more established relationships with our
competitors who may exist after our introduction of products, if any.
If we do not enter into relationships with third parties for the
sales and marketing of our products, we will need to develop our own sales and
marketing capabilities. We have limited experience in developing, training, or
managing a sales force. If we choose to establish a direct sales force, we may
incur substantial additional expenses in developing, training, and managing such
an organization. We may be unable to build a sales force on a cost effective
basis or at all. Any such direct marketing and sales efforts may prove to be
unsuccessful. In addition, we will compete with many other companies that
currently have extensive marketing and sales operations. Our marketing and sales
efforts may be unable to compete against these other companies. We may be unable
to establish a sufficient sales and marketing organization on a timely basis, if
at all, and may be unable to engage qualified distributors. Even if engaged,
these distributors may:
-10-
o fail to satisfy financial or contractual obligations to us;
o fail to adequately market our products;
o cease operations with little or no notice; or
o offer, design, manufacture, or promote competing products.
If we fail to develop sales, marketing, and distribution channels,
we would experience delays in product sales and incur increased costs, which
would harm our financial results.
IF WE ARE UNABLE TO CONVINCE PHYSICIANS AS TO THE BENEFITS OF OUR
INTENDED PRODUCTS, WE MAY INCUR DELAYS OR ADDITIONAL EXPENSE IN OUR ATTEMPT TO
ESTABLISH MARKET ACCEPTANCE.
Broad use of our drug delivery technology may require physicians to
be informed regarding our intended products and the intended benefits. The time
and cost of such an educational process may be substantial. Inability to
successfully carry out this physician education process may adversely affect
market acceptance of our products. We may be unable to timely educate physicians
regarding our intended products in sufficient numbers to achieve our marketing
plans or to achieve product acceptance. Any delay in physician education may
materially delay or reduce demand for our products. In addition, we may expend
significant funds towards physician education before any acceptance or demand
for our products is created, if at all.
WE WILL REQUIRE ADDITIONAL FUNDING WHICH WILL BE SIGNIFICANT AND WE
MAY HAVE DIFFICULTY RAISING NEEDED CAPITAL IN THE FUTURE BECAUSE OF OUR LIMITED
OPERATING HISTORY AND BUSINESS RISKS ASSOCIATED WITH OUR COMPANY.
We currently do not generate any revenue from our proposed products
and revenue from grants and collaborative agreements may not be sufficient to
meet our future capital requirements. We do not know when, or if, this will
change. We have expended substantial funds in research and development and will
continue to expend substantial funds in contract manufacturing, research,
development and pre-clinical testing and clinical trials of our drug delivery
technology and compounds. We will require substantial additional funds to
conduct research and development, establish and conduct clinical and
pre-clinical trials, obtain required regulatory approvals and clearances,
establish clinical and, if our products are subsequently considered candidates
for FDA approval, commercial scale manufacturing arrangements, and provide for
the marketing and distribution of our products. Additional funds may not be
available on acceptable terms, if at all. If adequate funds are unavailable or
are not available on terms deemed acceptable by management, we may have to
delay, reduce the scope of or eliminate one or more of our research or
development programs or product or marketing efforts which may materially harm
our business, financial condition, and results of operations. Our long term
capital requirements are expected to depend on many factors, including:
o the number of potential products and technologies in
development;
o continued progress and cost of our research and development
programs;
o progress with pre-clinical studies and clinical trials;
o the time and costs involved in obtaining regulatory clearance;
o costs involved in preparing, filing, prosecuting, maintaining
and enforcing patent claims;
-11-
o costs of developing sales, marketing and distribution channels
and our ability to sell our drugs;
o costs involved in establishing manufacturing capabilities for
clinical trial and commercial quantities of our drugs;
o competing technological and market developments;
o market acceptance of our products;
o costs for recruiting and retaining management, employees, and
consultants; and
o costs for training physicians.
We may consume available resources more rapidly than currently
anticipated, resulting in the need for additional funding. We may seek to raise
any necessary additional funds through the exercise of warrants, equity, or debt
financings, collaborative arrangements with corporate partners, or other
sources. Any such equity financing may be dilutive to existing stockholders and
debt financing, if available, may involve restrictive covenants that would limit
how we conduct our business or finance our operations, or otherwise have a
material effect on our current or future business prospects. In addition, in the
event that additional funds are obtained through arrangements with collaborative
partners or other sources, we may have to relinquish economic and/or proprietary
rights to some of our technologies or products under development that we would
otherwise seek to develop or commercialize by ourselves. If adequate funds are
not available, we may be required to significantly reduce, refocus, or delay our
development efforts with regard to our drug delivery technology, compounds, and
drugs.
THE MARKET FOR OUR PRODUCTS IS RAPIDLY CHANGING AND COMPETITIVE, AND
NEW MECHANISMS, TECHNOLOGIES, NEW THERAPEUTICS, NEW DRUGS, AND NEW TREATMENTS
WHICH MAY BE DEVELOPED BY OTHERS COULD IMPAIR OUR ABILITY TO MAINTAIN AND GROW
OUR BUSINESS AND REMAIN COMPETITIVE.
The pharmaceutical and biotechnology industries are subject to rapid
and substantial technological change. Developments by others may render our
technologies and intended products noncompetitive or obsolete, or we may be
unable to keep pace with technological developments or other market factors.
Technological competition from pharmaceutical and biotechnology companies,
universities, governmental entities and others diversifying into the field is
intense and is expected to increase. Many of these entities have significantly
greater research and development capabilities and budgets than we do, as well as
substantially more marketing, manufacturing, financial and managerial resources.
These entities represent significant competition for us. Acquisitions of, or
investments in, competing pharmaceutical or biotechnology companies by large
corporations could increase such competitors' financial, marketing,
manufacturing, and other resources.
We are a start-up development stage enterprise that heretofore has
operated in all material respects only as a virtual company with no day-to-day
business management, operating as a vehicle to hold certain technology for
possible future exploration, and have been and will continue to be engaged in
the development of novel untested drug delivery and therapeutic technologies. As
a result, our resources are limited and we may experience management,
operational, or technical challenges inherent in such activities and novel
technologies. Other companies, which may become competitors, have developed or
are in the process of developing technologies that could now be, or in the
future become, the basis for competition. Some of these technologies may have an
entirely different approach or means of accomplishing similar therapeutic
effects compared to our technology. Our competitors may develop drug delivery
technologies and drugs that are safer, more effective, or less costly than our
-12-
intended products and, therefore, present a serious competitive threat to us.
The potential widespread acceptance of therapies that are alternatives to ours
may limit market acceptance of our products even if commercialized. Many of our
targeted diseases and conditions can also be treated by other medication or drug
delivery technologies. These treatments may be widely accepted in medical
communities and have a longer history of use. The established use of these
competitive drugs may limit the potential for our technologies and products to
receive widespread acceptance if commercialized.
WE MAY NOT BE SUCCESSFUL IN OBTAINING ORPHAN DRUG STATUS FOR CERTAIN
OF OUR PRODUCTS OR, IF THAT STATUS IS OBTAINED, FULLY ENJOYING THE BENEFITS OF
ORPHAN DRUG STATUS.
Under the Orphan Drug Act, the FDA may grant orphan drug designation
to drugs intended to treat a rare disease or condition generally affecting fewer
than 200,000 people in the United States. We may not be successful in receiving
orphan drug status for certain of our products. Orphan drug designation must be
requested before submitting a NDA. After the FDA grants orphan drug designation,
the generic identity of the therapeutic agent and its potential orphan use are
publicized by the FDA. Under current law, orphan drug status is conferred upon
the first company to receive FDA approval to market the designated drug for the
designated indication. Orphan drug status also grants marketing exclusivity in
the United States for a period of seven years following approval of the NDA,
subject to limitations. Orphan drug designation does not provide any advantage
in, or shorten the duration of, the FDA regulatory approval process. Although
obtaining FDA approval to market a product with orphan drug status can be
advantageous, the scope of protection or the level of marketing exclusivity that
is currently afforded by orphan drug status and marketing approval may not
remain in effect in the future.
Our business strategy involves obtaining orphan drug designation for
certain of the products we have under development. Although we have applied for
certain orphan drug designation with the FDA, we do not know whether any of our
products will receive an orphan drug designation. Orphan drug designation does
not prevent other manufacturers from attempting to develop similar drugs for the
designated indication or from obtaining the approval of an NDA for their drug
prior to the approval of our NDA application. If another sponsor's NDA for a
competing drug in the same indication is approved first, that sponsor is
entitled to exclusive marketing rights if that sponsor has received orphan drug
designation for its drug. In that case, the FDA would refrain from approving an
application by us to market our competing product for seven years, subject to
limitations. Competing products may receive orphan drug designations and FDA
marketing approval before the products under development by us may receive
orphan drug designation.
NDA approval for a drug with an orphan drug designation does not
prevent the FDA from approving the same drug for a different indication, or a
molecular variation of the same drug for the same indication. Because doctors
are not restricted by the FDA from prescribing an approved drug for uses not
approved by the FDA, it is also possible that another company's drug could be
prescribed for indications for which products developed by us have received
orphan drug designation and NDA approval. The prescribing of approved drugs for
alternative uses, commonly referred to as "off label" sales, could adversely
affect the marketing potential of products that have received an orphan drug
designation and NDA approval. In addition, NDA approval of a drug with an orphan
drug designation does not provide any marketing exclusivity in foreign markets.
The possible amendment of the Orphan Drug Act by the U.S. Congress
has been the subject of frequent discussion. Although no significant changes to
the Orphan Drug Act have been made for a number of years, members of Congress
have from time to time proposed legislation that would limit the application of
the Orphan Drug Act. The precise scope of protection that may be afforded by
orphan drug designation and marketing approval may be subject to change in the
future.
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IF USERS OF OUR PRODUCTS ARE UNABLE TO OBTAIN ADEQUATE REIMBURSEMENT
FROM THIRD PARTY PAYORS, OR IF NEW RESTRICTIVE LEGISLATION IS ADOPTED, MARKET
ACCEPTANCE OF OUR PRODUCTS MAY BE LIMITED AND WE MAY NOT ACHIEVE ANTICIPATED
REVENUES.
The continuing efforts of government and insurance companies, health
maintenance organizations, and other payors of healthcare costs to contain or
reduce costs of health care may affect our future revenues and profitability,
and the future revenues and profitability of our potential customers, suppliers
and collaborative partners, and the availability of capital. For example, in
certain foreign markets, pricing or profitability of prescription
pharmaceuticals is subject to government control. In the United States, given
recent federal and state government initiatives directed at lowering the total
cost of health care, the U.S. Congress and state legislatures will likely
continue to focus on health care reform, the cost of prescription
pharmaceuticals, and on the reform of the Medicare and Medicaid systems. While
we cannot predict whether any such legislative or regulatory proposals will be
adopted, the announcement or adoption of such proposals could materially harm
our business, financial condition, and results of operations.
Our ability to commercialize our products will depend in part on the
extent to which appropriate reimbursement levels for the cost of our products
and related treatment are obtained by governmental authorities, private health
insurers and other organizations, such as HMOs. Third party payors are
increasingly challenging the prices charged for medical drugs and services.
Also, the trend toward managed health care in the United States and the
concurrent growth of organizations such as HMOs, which could control or
significantly influence the purchase of health care services and drugs, as well
as legislative proposals to reform health care or reduce government insurance
programs, may all result in lower prices for or rejection of our drugs. The cost
containment measures that health care payors and providers are instituting and
the effect of any health care reform could materially harm our ability to
operate profitably.
OUR BUSINESS INVOLVES ENVIRONMENTAL RISKS RELATED TO HANDLING
REGULATED SUBSTANCES THAT COULD SEVERELY AFFECT OUR ABILITY TO CONDUCT RESEARCH
AND DEVELOPMENT OF OUR DRUG DELIVERY TECHNOLOGY.
In connection with our research and development activities and
manufacture of materials and drugs, we are subject to federal, states and local
laws, rules, regulations, and policies governing the use, generation,
manufacture, storage, air emission, effluent discharge, handling, and disposal
of certain materials, biological specimens, and wastes. Although we believe that
we have complied with the applicable laws, regulations, and policies in all
material respects and have not been required to correct any material
noncompliance, we may be required to incur significant costs to comply with
environmental and health and safety regulations in the future. Our research and
development may in the future involve the controlled use of hazardous materials,
including but not limited to certain hazardous chemicals and narcotics. Although
we believe that our safety procedures for storing, handling, and disposing of
such materials will comply with the standards prescribed by state and federal
regulations, we cannot completely eliminate the risk of accidental contamination
or injury from these materials. In the event of such an occurrence, we could be
held liable for any damages that result and any such liability could exceed our
resources.
WE DEPEND UPON KEY PERSONNEL WHO MAY TERMINATE THEIR EMPLOYMENT WITH
US AT ANY TIME, AND WE WILL NEED TO HIRE ADDITIONAL QUALIFIED PERSONNEL WHICH
MAY BE UNAVAILABLE DUE TO THE NECESSITY OF UNIQUE SKILLS AND RESOURCES.
Our success will depend to a significant degree upon the continued
services of key management, including William H. Pursley (age 51) and Norman W.
Barton (age 57). We maintain directors and officers insurance for our directors
and executive officers and "key man" life insurance for Dr. Barton in the amount
-14-
of $1,000,000. This insurance may not adequately compensate for the loss of Dr.
Barton's services. Our success will depend on the ability to attract and retain
highly skilled personnel. Competition for qualified personnel is intense, and
the process of hiring and integrating such qualified personnel is often lengthy.
We may be unable to recruit such personnel on a timely basis, if at all.
Management and other employees may voluntarily terminate their employment at any
time. The loss of the services of key personnel, or the inability to attract and
retain additional qualified personnel, could result in delays to development or
approval, loss of sales and diversion of management resources. Additionally,
failure to attract and retain highly qualified management personnel would damage
our business prospects.
IF WE CANNOT OBTAIN ADDITIONAL FUNDS WHEN NEEDED, OR ACHIEVE
PROFITABILITY WE MAY NOT BE ABLE TO CONTINUE AS A GOING CONCERN.
Absent additional funding from private or public equity or debt
financings, collaborative or other partnering arrangements, or other sources, we
will be unable to conduct our product development efforts as planned, and we may
need to curtail our development plans, cease operations or sell assets.
Currently our available capital resources are not sufficient to sustain our
planned operations, which raises substantial doubt about our ability to continue
as a going concern.
Risks Related to Our Common Stock
WE HAVE RAISED SUBSTANTIAL AMOUNTS OF CAPITAL IN PRIVATE PLACEMENTS
FROM TIME TO TIME.
The securities offered in such private placements were not
registered under the Securities Act or any state "blue sky" law in reliance upon
exemptions from such registration requirements. Such exemptions are highly
technical in nature and if we inadvertently failed to comply with the
requirements of any of such exemptive provisions, investors would have the right
to rescind their purchase of our securities or sue for damages. If one or more
investors were to successfully seek such rescission or prevail in any such suit,
we could face severe financial demands that could materially and adversely
affect our financial position. Financings that may be available to us under
current market conditions frequently involve sales at prices below the prices at
which our Common Stock currently is reported on the OTC Bulletin Board or
exchange on which our common stock may in the future, be listed, as well as the
issuance of warrants or convertible securities at a discount to market price.
INVESTORS IN OUR SECURITIES MAY SUFFER DILUTION.
The issuance of shares of our Common Stock, or shares of our Common
Stock underlying warrants, options or preferred stock or convertible notes will
dilute the equity interest of existing stockholders who do not have
anti-dilution rights and could have a significant adverse effect on the market
price of our Common Stock. The sale of our Common Stock acquired at a discount
could have a negative impact on the market price of our Common Stock and could
increase the volatility in the market price of our Common Stock. In addition, we
may seek additional financing which may result in the issuance of additional
shares of our Common Stock and/or rights to acquire additional shares of our
Common Stock. The issuance of our Common Stock in connection with such financing
may result in substantial dilution to the existing holders of our Common Stock
who do not have anti-dilution rights. Those additional issuances of our Common
Stock would result in a reduction of an existing holder's percentage interest in
our company.
-15-
HISTORICALLY, OUR COMMON STOCK HAS EXPERIENCED SIGNIFICANT PRICE
FLUCTUATIONS.
There can be no assurance that the market price for our Common Stock
will remain at its current level and a decrease in the market price could result
in substantial losses for investors. The market price of our Common Stock may be
significantly affected by one or more of the following factors:
o announcements or press releases relating to the
bio-pharmaceutical sector or to our own business or prospects;
o regulatory, legislative, or other developments affecting us or
the healthcare industry generally;
o conversion of our preferred stock and convertible debt into
Common Stock at conversion rates based on then current market
prices or discounts to market prices of our Common Stock, and
exercise of options and warrants at below current market
prices;
o sales by those financing our company through convertible
securities the underlying Common Stock of which have been
registered with the SEC and may be sold into the public market
immediately upon conversion; and
o market conditions specific to bio-pharmaceutical companies, the
healthcare industry and general market conditions.
IN ADDITION, IN RECENT YEARS THE STOCK MARKET HAS EXPERIENCED
SIGNIFICANT PRICE AND VOLUME FLUCTUATIONS.
These fluctuations, which are often unrelated to the operating
performance of specific companies, have had a substantial effect on the market
price for many healthcare and life science related technology companies. Factors
such as those cited above, as well as other factors that may be unrelated to our
operating performance, may adversely affect the price of our Common Stock.
WE HAVE NOT HAD EARNINGS, BUT IF EARNINGS WERE AVAILABLE, IT IS OUR
GENERAL POLICY TO RETAIN ANY EARNINGS FOR USE IN OUR OPERATIONS.
We do not anticipate paying any cash dividends on our Common Stock
or Series A Preferred Stock in the foreseeable future despite the recent
reduction of the federal income tax rate on dividends. Any payment of cash
dividends on our Common Stock or Series A Preferred Stock in the future will be
dependent upon our financial condition, results of operations, current and
anticipated cash requirements, preferred rights of holders of preferred stock,
restrictive covenants in debt or other instruments or agreements, plans for
expansion, as well as other factors that our board of directors deems relevant.
We anticipate that any future financing agreements may restrict or prohibit the
payment of dividends without prior consent.
WE ARE SIGNIFICANTLY INFLUENCED BY OUR DIRECTORS, OFFICERS AND
EMPLOYEES.
As of August 12, 2005, our directors, officers and employees
beneficially own an aggregate of approximately 27% (or 20% giving effect to the
rights of currently outstanding Series A Preferred Stock holders) of our
outstanding Common Stock. These stockholders, acting together, would be able to
exert significant influence on substantially all matters requiring approval by
our stockholders, including the election of directors and approval of mergers
and other significant corporate transactions.
-16-
CERTAIN PROVISIONS OF DELAWARE CORPORATE LAWS AND OTHER PROVISIONS
THAT MAY HAVE CERTAIN ANTI-TAKEOVER EFFECTS.
The anti-takeover provisions of the Delaware General Corporation Law
("DGCL") may have the effect of discouraging a future takeover attempt which
individual or Series A Preferred stockholders may deem to be in their best
interests or in which stockholders may receive a substantial premium for their
shares over then-current market prices. We are subject to such anti-takeover
provisions which could prohibit or delay a merger or other takeover or change of
control and may discourage attempts by other companies to acquire us.
Stockholders who might desire to participate in such a transaction may not have
an opportunity to do so.
Following the reincorporation merger, which became effective on
January 31, 2005, our certificate of incorporation and by-laws were amended and
provide additional provisions applicable to a Delaware corporation, including
Section 203 of the DGCL "Business Combinations With Interested Stockholders"
which, in general, restricts a corporation organized under the laws of Delaware
from certain business combinations for a period of three years with an
"interested" stockholder (generally, 15% ownership) without approval of the
board of directors. In addition, our by-laws contain provisions providing for
advance notice of certain stockholder actions, such as the nomination of
directors and stockholder proposals.
OUR BOARD OF DIRECTORS HAS TAKEN UNDER CONSIDERATION AND SOUGHT
ADVICE ON THE ADVISABILITY OF ADOPTION OF A STOCKHOLDER RIGHTS PLAN.
A stockholder rights plan may prevent a change in control or sale of
our company in a manner or on terms not previously approved by our board of
directors.
A stockholder rights plan, in general, is a right granted as a
dividend to existing stockholders as of a record date as a defensive mechanism
to prevent unwanted takeovers and are triggered upon the announcement that a
party has acquired a specified percentage or more of the outstanding voting
stock of a company without approval by the company's board of directors.
THERE MAY BE A LIMITED PUBLIC MARKET FOR OUR SECURITIES; WE MAY FAIL
TO QUALIFY FOR AMEX OR OTHER LISTING.
Although we intend to apply for listing of our Common Stock on
either the AMEX, NASDAQ or other registered stock exchange, there can be no
assurance if and when initial listing criteria could be met or if such
application would be granted, or that the trading of our Common Stock will be
sustained. In the event that our Common Stock fails to qualify for initial or
continued listing on a registered stock exchange or for initial or continued
inclusion in the NASDAQ system, trading, if any, in our Common Stock, would then
continue to be conducted on the NASD's "Electronic Bulletin Board" in the
over-the-counter market and in what are commonly referred to as "pink sheets."
As a result, an investor may find it more difficult to dispose of, or to obtain
accurate quotations as to the market value of our Common Stock, and our Common
Stock would become substantially less attractive for margin loans, for
investment by financial institutions, as consideration in future capital raising
transactions or other purposes. We do not presently satisfy the listing criteria
for the NASDAQ or AMEX markets.
Trading of our Common Stock may be subject to penny stock rules
under the Exchange Act. Unless exempt, for any transaction involving a penny
stock, the regulations require broker-dealers making a market in our Common
Stock to provide risk disclosure to their customers including regarding the
risks associated with our Common Stock, the suitability for the customer of an
investment in our Common Stock, the duties of the broker-dealer to the customer,
information regarding prices for our Common Stock and any compensation the
broker-dealer would receive. The application of these rules may result in fewer
market makers in our Common Stock. Our Common Stock is presently subject to the
-17-
rules on penny stocks, and the liquidity of the Common Stock could be materially
adversely affected so long as we remain subject to such rule.
COMPLIANCE WITH CHANGING REGULATION OF CORPORATE GOVERNANCE AND
PUBLIC DISCLOSURE MAY RESULT IN ADDITIONAL EXPENSES.
Keeping abreast of, and in compliance with, changing laws,
regulations and standards relating to corporate governance and public
disclosure, including the Sarbanes-Oxley Act of 2002, new SEC regulations and,
in the event we are approved for listing on either NASDAQ or a registered
exchange, NASDAQ and stock exchange rules, will require an increased amount of
management attention and external resources. We intend to continue to invest all
reasonably necessary resources to comply with evolving standards, which may
result in increased general and administrative expenses and a diversion of
management time and attention from revenue-generating activities to compliance
activities.
FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements (as defined in
Section 27A of the Securities Act and Section 21E of the Securities Exchange Act
of 1934. To the extent that any statements made in this prospectus contain
information that is not historical, these statements are essentially
forward-looking. Forward-looking statements can be identified by the use of
words such as "expects," "plans" "will," "may," "anticipates," believes,"
"should," "intends," "estimates," and other words of similar meaning. These
statements are subject to risks and uncertainties that cannot be predicted or
quantified and consequently, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such risks and
uncertainties include, without limitation, our ability to raise capital to
finance the development of our products, the effectiveness, profitability and
the marketability of those products, our ability to protect our proprietary
information, general economic and business conditions, the impact of
technological developments and competition, including entry of newly-developed
alternative drug technologies, our expectations and estimates concerning future
financial performance and financing plans, adverse results of any legal
proceedings, the impact of current, pending or future legislation and regulation
on the healthcare industry, our ability to satisfy government and commercial
customers using our technology, our ability to develop manufacturing
capabilities or the inability to enter into acceptable relationships with one or
more contract manufacturers for our products and key components and the ability
of such contract manufacturers to manufacture products or components of an
acceptable quality on a cost-effective basis, the volatility of our operating
results and financial condition, our ability to attract or retain qualified
senior management personnel, including sales and marketing and scientific
personnel and other risks detailed from time to time in our filings with the
SEC. We do not undertake any obligation to publicly update any forward-looking
statements. As a result, you should not place undue reliance on these
forward-looking statements.
We also use market data and industry forecasts and projections
throughout this prospectus, which we have obtained from market research,
publicly available information and industry publications. These sources
generally state that the information they provide has been obtained from sources
believed to be reliable, but that the accuracy and completeness of the
information are not guaranteed. The forecasts and projections are based on
industry surveys and the preparers' experience in the industry, and the
projected amounts may not be achieved. Similarly, although we believe that the
surveys and market research others have performed are reliable, we have not
independently verified this information.
-18-
USE OF PROCEEDS
We will receive the exercise price of the options when exercised by
the holders thereof. Such proceeds will be used for working capital purposes. We
will not receive any of the proceeds from the reoffer and resale of the shares
of common stock by the selling stockholders.
SELLING STOCKHOLDERS
This prospectus relates to the reoffer and resale of shares of our
common stock issued to the stockholders who exercised stock options or who
received awards of stock prior to the initial filing of this registration
statement or that may be issued to the stockholders who are deemed to be
affiliates of our company under the plans or other grants to non-employee
directors.
The following table sets forth (i) the number of shares of our
common stock beneficially owned by each selling stockholder at August 12, 2005
(ii) the number of shares of our common stock to be offered for resale by each
selling stockholder (the total number of shares underlying options held by each
Selling Stockholder irrespective of whether or not presently exercisable within
60 days of August 12, 2005), and (iii) the number and percentage of shares of
our common stock to be held by each selling stockholder after completion of the
offering:
Shares of Shares of Percentage of
Common Stock Shares of Common Stock Common Stock
Owned Prior Common Stock Owned after Owned After
Name and Address to Offering to be Sold(2) the Offering the Offering(1)
---------------- ------------ ------------- ------------ ---------------
William H. Pursley(3) 1,247,428(4) 249,486 997,942 7.6%
Norman W. Barton, M.D., Ph.D.(5) 454,792(6) 90,958 363,834 2.8%
Donald W. Fallon(7) 207,905(8) 41,581 166,324 1.3%
Alfred Stracher, Ph.D.(9) 227,396(10) 45,479 181,917 1.4%
Leo Kesner, Ph.D.(11) 227,396(12) 45,479 181,917 1.4%
Leslie Devos 100,487(13) 20,097 80,390 *
Theresa Michele, M.D. 100,487(14) 20,097 80,390 *
Francis Zbikowski 100,487(15) 20,097 80,390 *
Ted Carver, Ph.D. 100,195(16) 23,949 61,098 *
Mary Brinker 13,860 2,772 11,088 *
Tomoka Davidsen 13,860(17) 2,772 11,088 *
Leonard Mudry(18) 17,000(19) 17,000 0 *
Stephen Burg(20) 2,500(21) 2,500 0 0
Harvey J. Kesner(22) 50,000(23) 10,000 40,000 *
Michael Pennington, Ph.D. 15,000(24) 15,000 0 0
Indeterminate (25) 1,436,280 53,169 1,383,161 10.6%
-----------------------
* Represents less than one percent
-19-
(1) Assumes the conversion of 361.65 shares of our Series A Preferred Stock
outstanding as of August 12, 2005.
(2) Includes shares acquired from the selling stockholder for resale by the
selling stockholder's family members as permitted by General Instruction
A.(5) to Form S-8.
(3) Mr. Pursley is our Chairman and Chief Executive Officer.
(4) Represents 1,247,428 shares of our common stock issued December 9, 2004
under the Founders' Plan. Includes an aggregate of 2,400 shares assigned
to family members pursuant to the terms of the Founders' Plan. Excludes
265,845 shares of our common stock for which Mr. Pursley has a right to
designate awardee(s) under the Founders' Plan, and other shares issued
or to be issued that may revert to the Founders' Plan or be
re-designated for award by Mr. Pursley in certain circumstances as to
which Mr. Pursley disclaims beneficial ownership.
(5) Dr. Barton is our Executive Vice President and Chief Medical Officer.
(6) Includes an aggregate of 2,100 shares assigned to family members
pursuant to the terms of the Founders' Plan.
(7) Mr. Fallon is our Senior Vice President, Finance and Administration,
Chief Financial Officer, and Secretary.
(8) Includes an aggregate of 200 shares assigned to family members pursuant
to the terms of the Founders' Plan.
(9) Dr. Stracher is an original founder of our company, and a former officer
and director and presently serves as a consultant to our company.
(10) Includes an aggregate of 22,739.6 shares assigned to family members
pursuant to the terms of the Founders' Plan.
(11) Dr. Kesner is an original founder of our company, and a former officer
and director and presently serves as a consultant to our company.
(12) Includes an aggregate of 90,000 shares assigned to family members
pursuant to the terms of the Founders' Plan.
(13) Includes an aggregate of 200 shares assigned to family members pursuant
to the terms of the Founders' Plan.
(14) Includes an aggregate of 100 shares assigned to family members pursuant
to the terms of the Founders' Plan.
(15) Includes an aggregate of 800 shares assigned to family members pursuant
to the terms of the Founders' Plan.
(16) Includes (i) an aggregate of 600 shares assigned to family members
pursuant to the terms of the Founders' Plan and (ii) options to purchase
78,195 shares under our 2004 Incentive Stock Plan.
(17) Includes an aggregate of 200 shares assigned to family members pursuant
to the terms of the Founders' Plan.
(18) Mr. Mudry has served as a member of our Board of Directors since January
2004.
(19) Represents (i) 5,000 shares of restricted stock and (ii) options to
purchase 12,000 shares under our 2004 Incentive Stock Plan.
(20) Mr. Burg has served as a member of our Board of Directors from January
2004 through December 2004.
(21) Represents shares of restricted stock granted under our 2004 Incentive
Stock Plan.
(22) Mr. Kesner served as our legal counsel since 1986 and presently is a
partner of Olshan Grundman Frome Rosenzweig & Wolosky LLP.
(23) Excludes an aggregate of 30,000 shares assigned by Leo Kesner to trusts
for family members pursuant to the terms of the Founders' Plan of which
Harvey Kesner is trustee.
(24) Represents options to purchase 15,000 shares under our 2004 Incentive
Stock Plan.
(25) Certain unnamed non-affiliates may offer and sell up to 1,000 shares or
1% of the shares issuable under a plan, under this resale prospectus.
-20-
PLAN OF DISTRIBUTION
It is anticipated that all of the shares of our common stock will be
offered by the selling stockholders from time to time in the open market, either
directly or through brokers or agents, or in privately negotiated transactions.
The selling stockholders have advised us that they are not parties to any
agreement, arrangement or understanding as to such sales.
LEGAL MATTERS
Certain legal matters in connection with the issuance of the shares
of common stock offered by this prospectus have been passed upon for us by
Olshan Grundman Frome Rosenzweig & Wolosky LLP, New York, New York, which firm
holds 23,000 shares of our common stock issued in lieu of legal fees and one of
whose members holds 50,000 shares of our common stock directly and an aggregate
of 30,000 shares of our common stock as a trustee for the benefit of family
members, which are being registered in the registration statement which contains
this prospectus. In addition, a member of the firm is presently trustee of a
trust and exercises voting and dispositive power over 337,845 shares of our
common stock held by such trust.
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration statement on Form S-8,
including exhibits and schedules, under the Securities Act of 1933, as amended,
with respect to the shares of our common stock to be sold in this offering. This
prospectus does not contain all the information contained in the registration
statement. For further information with respect to us and the shares that may be
sold pursuant to the prospectus, we refer you to the registration statement and
the exhibits and schedules attached to the registration statement. Statements
contained in this prospectus as to the contents of any contract, agreement or
other document referred to are not necessarily complete. When we make such
statements, we refer you to the copies of the contracts or documents that are
filed as exhibits to the registration statement because those statements are
qualified in all respects by reference to those exhibits.
We are subject to the information and reporting requirements of the
Securities Exchange Act of 1934, as amended, and file annual, quarterly, and
current reports, proxy statements, and other information with the SEC. You may
read and copy all or any portion of the registration statement or any reports,
statements or other information that we file at the SEC's public reference room
at 450 Fifth Street, N.W., Washington, D.C. 20549. You can request copies of
these documents, upon payment of a duplicating fee, by writing to the SEC.
Please call the SEC at 1-800-SEC-0330 for further information on the operation
of the public reference room. The SEC maintains an internet site that contains
reports, proxy and information statements, and other information regarding
issuers that file electronically with the SEC. Our SEC filings are also
available at the SEC's web site at http://www.sec.gov.
DISCLOSURE OF COMMISSION POSITION ON
INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
Insofar as indemnification for liabilities arising under the
Securities Act of 1933, as amended, may be permitted to our directors, officers
or persons controlling us, we have been advised that it is the SEC's opinion
that such indemnification is against public policy as expressed in the
Securities Act of 1933, as amended, and is, therefore, unenforceable.
-21-
PART II
INFORMATION REQUIRED IN THE REGISTRATION STATEMENT
ITEM 3. INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents filed by CepTor Corporation (the
"Registrant") with the SEC are incorporated by reference in this registration
statement on Form S-8 (the "Registration Statement"):
(1) Annual Report on Form 10-KSB for the fiscal year ended December
31, 2004, filed April 16, 2005;
(2) Current Report on Form 8-K, filed January 31, 2005;
(3) Current Report on Form 8-K/A, filed February 11, 2005;
(4) Registration Statement on Form SB-2 (SEC File No. 333-122755),
filed February 11, 2005 ("Form SB-2");
(5) Current Report on Form 8-K, filed April 26, 2005;
(6) Quarterly Report on Form 10-QSB for the quarterly period ended
March 31, 2005, filed May 16, 2005;
(7) Current Report on Form 8-K, filed May 20, 2005;
(8) Current Report on Form 8-K, filed July 20, 2005;
(9) Pre-Effective Amendment No. 1 to the SB-2, filed July 21, 2005;
(10) Pre-Effective Amendment No. 2 to the SB-2, filed July 25, 2005;
and
(11) Quarterly Report on Form 10-QSB for the quarterly period ended
June 30, 2005, filed August 15, 2005.
All documents subsequently filed with the SEC by the Registrant
pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Securities Exchange Act
of 1934, as amended, prior to the filing of a post-effective amendment which
indicates that all securities offered herein have been sold or which deregisters
all securities then remaining unsold, shall be deemed to be incorporated by
reference herein and to be part hereof from the respective dates of filing of
such documents. Any statement contained herein or in a document incorporated or
deemed to be incorporated by reference herein shall be deemed to be modified or
superseded for purposes hereof or of the related prospectus to the extent that a
statement contained herein or in any other subsequently filed document which is
also incorporated or deemed to be incorporated herein modifies or supersedes
such statement. Any such statement so modified or superseded shall not be
deemed, except as so modified or superseded, to constitute a part of this
registration statement.
ITEM 4. DESCRIPTION OF SECURITIES
We are authorized to issue 100,000,000 shares of common stock, par
value $0.0001 per share, and 20,000,000 shares of preferred stock, par value
$0.0001 per share, 1,000 shares of which have been designated Series A preferred
stock. As of August 12, 2005, there were 9,452,944 shares of Common Stock, and
361.65 shares of Series A Preferred Stock issued and outstanding.
II-1
Common Stock
The holders of Common Stock are entitled to one vote per share. Our
Certificate of Incorporation does not provide for cumulative voting. The holders
of Common Stock are entitled to receive ratably such dividends, if any, as may
be declared by the Board out of legally available funds. However, the current
policy of the Board is to retain earnings, if any, for operations and growth.
Upon liquidation, dissolution or winding-up, the holders of Common Stock are
entitled to share ratably in all assets which are legally available for
distribution, after payment of or provision for all liabilities and the
liquidation preference of any outstanding preferred stock such as the Series A
Preferred Stock. The holders of Common Stock have no preemptive, subscription,
redemption or conversion rights.
ITEM 5. INTERESTS OF NAMED EXPERTS AND COUNSEL.
Olshan Grundman Frome Rosenzweig & Wolosky LLP, our counsel, holds
23,000 shares and one of the members of the firm holds 50,000 shares of our
common stock directly and an aggregate of 30,000 shares of our common stock as a
trustee for the benefit of family members, which are being registered in this
Registration Statement. In addition, a member of the firm is presently trustee
of a trust and exercises voting and dispositive power over 337,845 shares held
by such trust.
ITEM 6. INDEMNIFICATION OF DIRECTORS AND OFFICERS
The Certificate of Incorporation of the Registrant provides that we
shall indemnify to the fullest extent permitted by Delaware General Corporation
Law, or the DGCL, any person whom it may indemnify thereunder, including the
directors, officers, employees and agents of the Registrant. In addition, the
Registrant's Certificate of Incorporation eliminates, to the extent permitted by
the DGCL, personal liability of directors to the Registrant and its stockholders
for monetary damages for breach of fiduciary duty.
The Registrant's authority to indemnify its directors and officers
is governed by the provisions of Section 145 of the DGCL, as follows:
(a) A corporation shall have power to indemnify any person who
was or is a party or is threatened to be made a party to any
threatened, pending or completed action, suit or proceeding, whether
civil, criminal, administrative or investigative (other than an
action by or in the right of the corporation) by reason of the fact
that the person is or was a director, officer, employee or agent of
the corporation, or is or was serving at the request of the
corporation as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise,
against expenses (including attorneys' fees), judgments, fines and
amounts paid in settlement actually and reasonably incurred by the
person in connection with such action, suit or proceeding if the
person acted in good faith and in a manner the person reasonably
believed to be in or not opposed to the best interests of the
corporation, and, with respect to any criminal action or proceeding,
had no reasonable cause to believe the person's conduct was
unlawful. The termination of any action, suit or proceeding by
judgment, order, settlement, conviction, or upon a plea of nolo
contendere or her equivalent, shall not, of itself, create a
presumption that the person did not act in good faith and in a
manner which the person reasonably believed to be in or not opposed
to the best interests of the corporation, and, with respect to any
criminal action or proceeding, had reasonable cause to believe that
the person's conduct was unlawful.
(b) A corporation shall have power to indemnify any person who
was or is a party or is threatened to be made a party to any
threatened, pending or completed action or suit by or in the right
of the corporation to procure a judgment in its favor by reason of
the fact that the person is or was a director, officer, employee or
agent of the corporation, or is or was serving at the request of the
corporation as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise
against expenses (including attorneys' fees) actually and reasonably
II-2
incurred by the person in connection with the defense or settlement
of such action or suit if the person acted in good faith and in a
manner the person reasonably believed to be in or not opposed to the
best interests of the corporation and except that no indemnification
shall be made in respect of any claim, issue or matter as to which
such person shall have been adjudged to be liable to the corporation
unless and only to the extent that the Court of Chancery or the
court in which such action or suit was brought shall determine upon
application that, despite the adjudication of liability but in view
of all the circumstances of the case, such person is fairly and
reasonably entitled to indemnity for such expenses which the Court
of Chancery or such other court shall deem proper.
(c) To the extent that a present or former director or officer
of a corporation has been successful on the merits or otherwise in
defense of any action, suit or proceeding referred to in subsections
(a) and (b) of this section, or in defense of any claim, issue or
matter therein, such person shall be indemnified against expenses
(including attorneys' fees) actually and reasonably incurred by such
person in connection therewith.
(d) Any indemnification under subsections (a) and (b) of this
section (unless ordered by a court) shall be made by the corporation
only as authorized in the specific case upon a determination that
indemnification of the present or former director, officer, employee
or agent is proper in the circumstances because the person has met
the applicable standard of conduct set forth in subsections (a) and
(b) of this section. Such determination shall be made, with respect
to a person who is a director or officer at the time of such
determination, (1) by a majority vote of the directors who are not
parties to such action, suit or proceeding, even though less than a
quorum, or (2) by a committee of such directors designated by
majority vote of such directors, even though less than a quorum, or
(3) if there are no such directors, or if such directors so direct,
by independent legal counsel in a written opinion, or (4) by the
stockholders.
(e) Expenses (including attorneys' fees) incurred by an
officer or director in defending any civil, criminal, administrative
or investigative action, suit or proceeding may be paid by the
corporation in advance of the final disposition of such action, suit
or proceeding upon receipt of an undertaking by or on behalf of such
director or officer to repay such amount if it shall ultimately be
determined that such person is not entitled to be indemnified by the
corporation as authorized in this section. Such expenses (including
attorneys' fees) incurred by former directors and officers or other
employees and agents may be so paid upon such terms and conditions,
if any, as the corporation deems appropriate.
(f) The indemnification and advancement of expenses provided
by, or granted pursuant to, the other subsections of this section
shall not be deemed exclusive of any other rights to which those
seeking indemnification or advancement of expenses may be entitled
under any bylaw, agreement, vote of stockholders or disinterested
directors or otherwise, both as to action in such person's official
capacity and as to action in another capacity while holding such
office.
(g) A corporation shall have power to purchase and maintain
insurance on behalf of any person who is or was a director, officer,
employee or agent of the corporation, or is or was serving at the
request of the corporation as a director, officer, employee or agent
of another corporation, partnership, joint venture, trust or other
enterprise against any liability asserted against such person and
incurred by such person in any such capacity, or arising out of such
person's status as such, whether or not the corporation would have
the power to indemnify such person against such liability under this
section.
(h) For purposes of this section, references to the
"corporation" shall include, in addition to the resulting
corporation, any constituent corporation (including any constituent
of a constituent) absorbed in a consolidation or merger which, if
its separate existence had continued, would have had power and
authority to indemnify its directors, officers, and employees or
agents, so that any person who is or was a director, officer,
employee or agent of such constituent corporation, or is or was
II-3
serving at the request of such constituent corporation as a
director, officer, employee or agent of another corporation,
partnership, joint venture, trust or other enterprise, shall stand
in the same position under this section with respect to the
resulting or surviving corporation as such person would have with
respect to such constituent corporation if its separate existence
had continued.
(i) For purposes of this section, references to "other
enterprises" shall include employee benefit plans; references to
"fines" shall include any excise taxes assessed on a person with
respect to any employee benefit plan; and references to "serving at
the request of the corporation" shall include any service as a
director, officer, employee or agent of the corporation which
imposes duties on, or involves services by such director, officer,
employee, or agent with respect to an employee benefit plan, its
participants or beneficiaries; and a person who acted in good faith
and in a manner such person reasonably believed to be in the
interest of the participants and beneficiaries of an employee
benefit plan shall be deemed to have acted in a manner "not opposed
to the best interests of the corporation" as referred to in this
section.
(j) The indemnification and advancement of expenses provided
by, or granted pursuant to, this section shall, unless otherwise
provided when authorized or ratified, continue as to a person who
has ceased to be a director, officer, employee or agent and shall
inure to the benefit of the heirs, executors and administrators of
such a person.
(k) The Court of Chancery is hereby vested with exclusive
jurisdiction to herein determine all actions for advancement of
expenses or indemnification brought under this section or under any
bylaw, agreement, vote of stockholders or disinterested directors,
or otherwise. The Court of Chancery may summarily determine a
corporation's obligation to advance expenses (including attorneys'
fees).
The Registrant has entered into indemnification agreements with each
of its directors and certain executive officers, whereby it has agreed to
indemnify, to the fullest extent permitted by applicable law, each such director
and officer from and against any and all expenses (including attorneys' fees),
judgments, fines, penalties, excise taxes and amounts paid in settlement or
incurred by such director or officer for or as a result of action taken or not
taken while such director or officer was acting in his capacity as the director
or executive officer of the Registrant or its affiliates.
The Registrant maintains a director and officers insurance policy.
The policy insures directors and officers against unindemnified loss arising
from certain wrongful acts in their capacities and reimburses the Registrant for
such loss for which the Registrant has lawfully indemnified the directors and
officers.
ITEM 7. EXEMPTION FROM REGISTRATION CLAIMED
Exemption for issuance of 3,031,943 shares to certain founders of
the Company is claimed under Section 4(2) of the Securities Act of 1933 inasmuch
as such shares were awarded to fourteen employees and other persons associated
with the Company and did not involve a public offering.
ITEM 8. EXHIBITS
4.1 Form of Registrant's Common Stock Certificate (incorporated herein
by reference to Exhibit 4.1 to the Registrant's Annual Report on
Form 10-KSB for the fiscal year ended December 31, 2004 (the "2004
10-KSB"))
4.2 CepTor Agreement, dated March 31, 2004 (the "CepTor Agreement"), by
and among William Pursley, Xechem and the Registrant (incorporated
herein by reference to Exhibit 4.1 to the Company's Current Report
on Form 8-K, dated December 9, 2004 (the "2004 Form 8-K"))
II-4
4.3 First Amendment to CepTor Agreement effective April 23, 2004, by and
among William Pursley, the Registrant and Xechem (incorporated
herein by reference to Exhibit 4.2 to the 2004 8-K)
4.4 Second Amendment to CepTor Agreement, dated December 9, 2004, by and
among William Pursley, the Registrant and Xechem (incorporated by
reference to Exhibit 4.3 to the 2004 8-K)
4.5 Form of Unit Warrant (incorporated by reference to Exhibit 4.4 to
the Registrant's Registration Statement on Form SB-2 as filed with
the SEC on February 11, 2005 (the "Form SB-2"))
4.6 Form of Amended and Restated Convertible Promissory Note
(incorporated herein by reference to Exhibit 4.7 to the 2004 10-KSB)
4.7 Form of Subscription Agreement (incorporated herein by reference to
Exhibit 4.6 to the Form SB-2)
4.8 Amended and Restated Founders' Plan (incorporated herein by
reference to Exhibit 10.5 to the 2004 10-KSB)
4.9 2004 Incentive Stock Plan (incorporated herein by reference to
Exhibit 10.6 to the Form SB-2)
4.10 Deferred Stock Plan for Non-Employee Directors under the 2004
Incentive Stock Plan (incorporated by reference to Exhibit 10.7 to
the 2004 10-KSB)
4.11 Security Purchase Agreement, dated June 17, 2005, by and between the
Registrant, Xechem and William Pursley (incorporated herein by
reference as Exhibit 99.01 to the Registrant's Current Report on
Form 8-K, filed on June 20, 2005)
5* Opinion of Olshan Grundman Frome Rosenzweig & Wolosky LLP
23.1* Consent of Marcum & Kliegman LLP
23.2* Consent of WithumSmith+Brown, P.C.
23.3* Consent of Olshan Grundman Frome Rosenzweig &Wolosky LLP (contained
in Exhibit 5)
24* Powers of Attorney (included on the signature page of this
Registration Statement)
--------------------------
* Filed herewith
II-5
ITEM 9. UNDERTAKINGS
A. The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being
made, a post-effective amendment to this Registration
Statement to include any material information with respect to
the plan of distribution not previously disclosed in the
Registration Statement or any material change to such
information in the Registration Statement;
(2) That, for the purposes of determining any liability under the
Securities Act of 1933, each such post-effective amendment
shall be deemed to be a new registration statement relating to
the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona
fide offering thereof; and
(3) To remove from registration by means of a post-effective
amendment any of the securities being registered that remain
unsold at the termination of the offering.
B. The undersigned registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each
filing of the registrant's annual report pursuant to Section 13(a)
or 15(d) of the Securities Exchange Act of 1934 (and, where
applicable, each filing of an employee benefit plan's annual report
pursuant to Section 15(d) of the Securities Exchange Act of 1934)
that is incorporated by reference in this Registration Statement
shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at
that time shall be deemed to be the initial bona fide offering
thereof.
C. Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers and
controlling persons of the registrant pursuant to the foregoing
provisions, or otherwise, the registrant has been advised that in
the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the
Securities Act of 1933 and is, therefore, unenforceable. In the
event that a claim for indemnification against such liabilities
(other than the payment by the registrant of expenses incurred or
paid by a director, officer or controlling person of the registrant
in the successful defense of any action, suit or proceeding) is
asserted by such director, officer or controlling person in
connection with the securities being registered, the registrant
will, unless in the opinion of its counsel the matter has been
settled by a controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is
against public policy as expressed in the Securities Act of 1933 and
will be governed by the final adjudication of such issue.
II-6
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
Registrant certifies that it has reasonable grounds to believe that it meets all
of the requirements for filing on Form S-8 and has duly caused this Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Hunt Valley, State of Maryland on the 17th day of
August, 2005.
CEPTOR CORPORATION
By: /s/ William H. Pursley
-------------------------------------
William H. Pursley
Chairman and Chief Executive Officer
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature
appears below constitutes and appoints William H. Pursley and Donald W. Fallon
as his true and lawful attorney-in-fact, each acting alone, with full power of
substitution and resubstitution for him and in his name, place and stead, in any
and all capacities, to sign any and all amendments, including post-effective
amendments to this registration statement, and any related registration
statement filed pursuant to Rule 462(b) of the Act and to file the same, with
exhibits thereto, and other documents in connection therewith, with the
Securities and Exchange Commission, hereby ratifying and confirming all that
said attorneys-in-fact or their substitutes, each acting along, may lawfully do
or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed below by the following persons in the
capacities and on the dates indicated.
SIGNATURE TITLE DATE
--------- ----- ----
/s/ William H. Pursley Chairman of the Board and Chief
-------------------------------- Executive Officer August 17, 2005
William H. Pursley (Principal Executive Officer)
/s/ Donald W. Fallon Chief Financial Officer
-------------------------------- (Principal Financial Officer and August 17, 2005
Donald W. Fallon Principal Accounting Officer)
/s/ Leonard A. Mudry Director August 17, 2005
--------------------------------
Leonard A. Mudry
II-7
EXHIBIT INDEX
4.1 Form of Registrant's Common Stock Certificate (incorporated herein
by reference to Exhibit 4.1 to the Registrant's Annual Report on
Form 10-KSB for the fiscal year ended December 31, 2004 (the "2004
10-KSB"))
4.2 CepTor Agreement, dated March 31, 2004 (the "CepTor Agreement"), by
and among William Pursley, Xechem and the Registrant (incorporated
herein by reference to Exhibit 4.1 to the Company's Current Report
on Form 8-K, dated December 9, 2004 (the "2004 Form 8-K"))
4.3 First Amendment to CepTor Agreement effective April 23, 2004, by and
among William Pursley, the Registrant and Xechem (incorporated
herein by reference to Exhibit 4.2 to the 2004 8-K)
4.4 Second Amendment to CepTor Agreement, dated December 9, 2004, by and
among William Pursley, the Registrant and Xechem (incorporated by
reference to Exhibit 4.3 to the 2004 8-K)
4.5 Form of Unit Warrant (incorporated by reference to Exhibit 4.4 to
the Registrant's Registration Statement on Form SB-2 as filed with
the SEC on February 11, 2005 (the "Form SB-2"))
4.6 Form of Amended and Restated Convertible Promissory Note
(incorporated herein by reference to Exhibit 4.7 to the 2004 10-KSB)
4.7 Form of Subscription Agreement (incorporated herein by reference to
Exhibit 4.6 to the Form SB-2)
4.8 Amended and Restated Founders' Plan (incorporated herein by
reference to Exhibit 10.5 to the 2004 10-KSB)
4.9 2004 Incentive Stock Plan (incorporated herein by reference to
Exhibit 10.6 to the Form SB-2)
4.10 Deferred Stock Plan for Non-Employee Directors under the 2004
Incentive Stock Plan (incorporated by reference to Exhibit 10.7 to
the 2004 10-KSB)
4.11 Security Purchase Agreement, dated June 17, 2005, by and between the
Registrant, Xechem and William Pursley (incorporated herein by
reference as Exhibit 99.01 to the Registrant's Current Report on
Form 8-K, filed on June 20, 2005)
5* Opinion of Olshan Grundman Frome Rosenzweig & Wolosky LLP
23.1* Consent of Marcum & Kliegman LLP
23.2* Consent of WithumSmith+Brown, P.C.
23.3* Consent of Olshan Grundman Frome Rosenzweig &Wolosky LLP (contained
in Exhibit 5)
24* Powers of Attorney (included on the signature page of this
Registration Statement)
--------------------------
* Filed herewith
II-8