<PAGE>
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-QSB
/x/ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934 for the quarterly period ended June 30, 1999
Commission File Number 0-23553
PHOTOGEN TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
NEVADA 36-4010347
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
7327 OAK RIDGE HIGHWAY, SUITE B
KNOXVILLE, TN 37931
(Address of principal executive offices)(Zip Code)
(423) 769-4012
(Registrant's telephone number including area code)
Check whether the issuer (1) has filed all reports required to be filed by
section 13 or 15(d) of the Securities Exchange Act of 1934 during the past 12
months (or for such shorter period that the Registrant was required to file such
reports), and (2) has been subject to such filing requirements for the past 90
days:
YES: /x/ NO: / /
State the number of shares outstanding of each of the issuer's classes of
common equity, as of the latest practicable date: 36,875,020 SHARES OF COMMON
STOCK, $.001 PAR VALUE PER SHARE, ISSUED AND OUTSTANDING AS OF AUGUST 9, 1999.
NO SHARES OF PREFERRED STOCK, $.01 PAR VALUE PER SHARE, WERE ISSUED OR
OUTSTANDING AS OF THAT DATE.
Transitional Small Business Disclosure Format:
YES: / / NO: /x/
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
<PAGE>
INDEX
PAGE
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (UNAUDITED) . . . . . . . . . . . . 1
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION OR PLAN OF OPERATION . . . . . . 6
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF
SECURITY HOLDERS . . . . . . . . . . . . . . . . . . 13
PART II - OTHER INFORMATION . . . . . . . . . . . . . . . . . .. . . . . . . 13
ITEM 5. OTHER INFORMATION . . . . . . . . . . . . . . . . . . . 13
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K . .. . . . . . . . . . 17
i
<PAGE>
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
PHOTOGEN TECHNOLOGIES, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED CONDENSED BALANCE SHEETS
<TABLE>
<CAPTION>
June 30, 1999 December 31, 1998
------------- -----------------
(Unaudited) (Audited)
<S> <C> <C>
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 760,394 $ 652,226
Interest receivable 47,811 121,471
Prepaid expenses 230,109 435,395
---------- ----------
TOTAL CURRENT ASSETS 1,038,314 1,209,092
UNITED STATES TREASURY NOTES, TOTAL
FACE VALUE $3,510,000 and $5,660,000 3,519,406 5,682,105
EQUIPMENT AND LEASEHOLD IMPROVEMENTS 1,270,557 1,169,388
---------- ----------
TOTAL ASSETS $5,828,277 $8,060,585
---------- ----------
---------- ----------
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts Payable $458,659 $ 804,248
Current portion of obligations under
capital leases 49,104 111,769
---------- ----------
TOTAL CURRENT LIABILITIES 507,763 916,017
---------- ----------
OBLIGATION UNDER CAPITAL LEASES - 35,990
---------- ----------
---------- ----------
SHAREHOLDERS' EQUITY
Preferred stock; par value
$.01 per share; 5,000,000
shares authorized; none issued - -
Common stock; par value $.001
per share; 150,000,000 shares
authorized; 36,875,020 shares issued and
outstanding 36,875 36,875
Additional paid-in capital 9,666,171 9,602,097
Deficit accumulated during
development stage after
recapitalization (4,382,532) (2,530,394)
---------- ----------
TOTAL SHAREHOLDERS' EQUITY 5,320,514 7,108,578
---------- ----------
$ 5,828,277 $8,060,585
---------- ----------
---------- ----------
</TABLE>
1
<PAGE>
PHOTOGEN TECHNOLOGIES, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
<TABLE>
<CAPTION>
Three Months Three Months Six Months Six Months Cumulative Amounts
ended ended Ended Ended From
June 30, 1999 June 30, 1998 June 30, 1999 June 30, 1998 November 3, 1996
------------- --------------- ------------- ------------- ------------------
(Unaudited) (Unaudited) (Unaudited) (Unaudited) (Unaudited)
<S> <C> <C> <C> <C> <C>
REVENUES
Investment Income 47,287 94,611 $119,307 $150,182 $ 619,039
EXPENSES
General and administrative 1,070,675 476,391 1,971,445 900,824 5,001,571
---------- ---------- ---------- ---------- ----------
NET LOSS (1,023,388) (381,780) (1,852,138) (750,642) (4,382,532)
---------- ---------- ---------- ----------- ----------
---------- ---------- ---------- ----------- ----------
BASIC AND DILUTED NET
LOSS PER COMMON SHARE (.03) (.01) (.05) (.02)
---------- ---------- ---------- -----------
---------- ---------- ---------- -----------
WEIGHTED AVERAGE
NUMBER OF COMMON
SHARES OUTSTANDING 36,875,020 36,531,768 36,875,020 36,531,768
---------- ---------- ---------- -----------
---------- ---------- ---------- -----------
</TABLE>
2
<PAGE>
PHOTOGEN TECHNOLOGIES, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOW
(UNAUDITED)
<TABLE>
<CAPTION>
Cumulative
Six Months Ended Six Months Ended Amounts From
June 30, 1999 June 30, 1998 November 3, 1996
---------------- ---------------- ----------------
(Unaudited) (Unaudited) (Unaudited)
<S> <C> <C> <C>
OPERATING ACTIVITIES
Net income (loss) $(1,852,138) (750,642) $(4,382,532)
Depreciation 90,258 12,699 256,535
United States Treasury Notes
Amortization 18,191 - 49,820
Loss on Securities - 9,238 (20,499)
Stock Option Compensation 64,074 - 109,520
Changes in operating assets and liabilities:
Prepaid expense 205,286 8,164 138,536
Interest receivable 73,660 11,175 (416,456)
Accounts payable (345,589) (87,918) 458,659
---------- ----------- -----------
NET CASH PROVIDED (USED) BY
OPERATING ACTIVITIES (1,746,258) (797,284) (3,806,417)
---------- ----------- -----------
INVESTING ACTIVITIES
Sale of marketable securities - 400,000 2,164,464
Purchase of marketable securities - - (2,182,967)
Purchase of United States Treasury Notes (857,540) (7,795,816) (17,419,170)
Sale of United States Treasury Notes 3,002,048 1,507,052 14,985,596
Purchase of capital assets (191,427) (191,341) (1,198,053)
Patent cost - ( 48,368) (37,335)
---------- ----------- -----------
NET CASH PROVIDED (USED)
BY INVESTING ACTIVITIES 1,953,081 (6,128,473) (3,687,465)
---------- ----------- -----------
FINANCING ACTIVITIES
Proceeds from issuance of common stock - 7,000,000 6,956,313
Proceeds from capital contributions by
stockholders - - 1,911,674
Cost of recapitalization - - (371,111)
Principal payments on capital lease
obligations (98,655) (9,769) (242,600)
---------- ----------- -----------
NET CASH PROVIDED (USED) BY
FINANCING ACTIVITIES (98,655) 6,990,231 8,254,276
---------- ----------- -----------
NET INCREASE (DECREASE) IN CASH
AND CASH EQUIVALENTS 108,168 64,474 760,394
CASH AND CASH EQUIVALENTS AT
BEGINNING OF PERIOD 652,226 82,631 -
---------- ----------- -----------
CASH AND CASH
EQUIVALENTS AT END OF PERIOD $760,394 $ 147,105 $ 760,394
---------- ----------- -----------
---------- ----------- -----------
</TABLE>
3
<PAGE>
PHOTOGEN TECHNOLOGIES, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED CONDENSED STATEMENTS OF SHAREHOLDERS' EQUITY
(UNAUDITED)
<TABLE>
<CAPTION>
Deficit
Accumulated
Common Stock Additional During The
------------------- Members Paid-In Development
Shares Amount Capital Capital Stage Total
------ ------ ------- ---------- ----------- --------
<S> <C> <C> <C> <C> <C>
CONTRIBUTION OF CAPITAL $ 7,268 $ 7,268
NET LOSS FOR THE PERIOD - - (1,779) - - (1,779)
------------ ------- --------- ---------- ----------- ---------
BALANCE AT
DECEMBER 31, 1996 - - 5,489 - - 5,489
NET LOSS AND CAPITAL
CONTRIBUTIONS FOR THE
PERIOD JANUARY 1, 1997
TO MAY 15, 1997 - - 3,511 - (3,511) -
------------ ------- --------- ---------- ----------- ---------
BALANCE AT MAY 15, 1997 $ - $ - $ 9,000 $ - ($ 3,511) 5,489
ISSUANCE OF STOCK FOR
CASH 6,312,833 6,313 - 1,797,137 - 1,803,450
EFFECT OF
RECAPITALIZATION
AND MERGER 29,687,167 29,687 ( 9,000) 1,181,500 1,732 1,203,919
COST ASSOCIATED WITH
RECAPITALIZATION
AND MERGER - - - (371,111) - (371,111)
NET LOSS FOR THE
PERIOD MAY 16, 1997
TO DECEMBER 31, 1997 - - - - ($554,702) (554,702)
------------ ------- --------- ---------- ----------- ---------
BALANCE AT
DECEMBER 31, 1997 36,000,000 36,000 - 2,607,526 (556,481) 2,087,045
ISSUANCE OF COMMON
STOCK 875,020 875 - 6,999,125 - 7,000,000
COST ASSOCIATED WITH
COMMON STOCK ISSUANCE - - - (50,000) - (50,000)
OPTIONS ISSUED TO
CONSULTANTS - - - 45,446 - 45,446
NET LOSS FOR THE YEAR
ENDED DECEMBER 31, 1998 - - - - (1,973,913) (1,973,913)
------------ ------- --------- ---------- ----------- ---------
BALANCE AT DECEMBER 31,
1998 36,875,020 36,875 - 9,602,097 (2,530,394) 7,108,578
OPTIONS ISSUED TO
CONSULTANTS - - - 64,074 - 64,074
NET LOSS FOR SIX
MONTHS ENDED
JUNE 30, 1999 - - - - (1,852,138) (1,852,138)
------------ ------- --------- ---------- ----------- ---------
BALANCE AT
JUNE 30, 1999 $ 36,875,020 $36,875 $ - $9,666,171 ($4,382,532) $5,320,514
------------ ------- --------- ---------- ----------- ---------
------------ ------- --------- ---------- ----------- ---------
</TABLE>
4
<PAGE>
PHOTOGEN TECHNOLOGIES, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
June 30, 1999
1. BASIS OF PRESENTATION
The accompanying unaudited condensed financial statements have been
prepared in accordance with generally accepted accounting principles for
interim financial information pursuant to Regulation S-B. Accordingly, they
do not include all of the information and footnotes required by generally
accepted accounting principles for complete financial statements. In the
opinion of management, all adjustments (consisting of normal recurring
accruals) considered necessary for a fair presentation have been included.
Operating results for the six months ended June 30, 1999 are not necessarily
indicative of the results that may be expected for the year ended December
31, 1999.
5
<PAGE>
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION OR PLAN OF
OPERATION
UNCERTAINTIES RELATING TO PHOTOGEN. Photogen Technologies, Inc. and its
wholly-owned subsidiary Photogen, Inc. are collectively referred to as
"Photogen," the "Company," "we," or "us." Portions of the discussion in this
Item 2 contain forward-looking statements and are subject to the Risk Factors
described in Item 5 below.
RESULTS OF OPERATIONS. We are a development stage company engaged in the
development of advanced photodynamic therapies using drugs and medical devices.
We have not completed development of any product or process at this time and
have no revenues from operations. We have not generated revenues from the sale
of any proposed products or other operations, and we continue to experience
losses. Our net loss for the six month period ended June 30, 1999 was
$1,852,138, compared to a loss of $750,642 for the six month period ended June
30, 1998. Our net loss for the three month period ended June 30, 1999 was
$1,023,388, compared to a loss of $381,780 for the three month period ended June
30, 1998. The increase in losses is attributable primarily to expenses related
to designing and acquiring equipment, conducting studies pursuant to preclinical
research agreements and other research, and other general and administrative
costs.
We expect to continue to incur increasing losses for at least the next
several years as we intensify research and development, clinical testing,
regulatory approval activities and engage in the manufacture and/or sale of any
products that we may develop. In particular, we are presently a party to three
research contracts with various third parties that will require an expenditure
of a total of $96,996 over the remaining terms of those contracts for the
protocols currently under investigation. See "Plan of Operation," below.
Our revenue for the six month period ended June 30, 1999 was $119,307,
compared to $150,182 of revenue for the six month period ended June 30, 1998.
Our revenue for the three month period ended June 30, 1999 was $47,287, compared
to $94,611 of revenue during the three months ended June 30, 1998. The revenue
resulted primarily from investment income on the proceeds from the sale of
common stock in our 1998 private placement and 1997 restructuring. The proceeds
of the sales of our common stock are invested primarily in United States
Government obligations. Because we have no revenues from operations at this
time, investment of such funds in that manner is necessary to avoid becoming
subject to the Investment Company Act of 1940.
RESEARCH, PATENT, AND OPERATIONAL MATTERS. We are continuing to pursue
patent protection for our proprietary technologies with the U.S. Patent and
Trademark Office, and in various foreign jurisdictions. We recently filed
patent applications covering inventions in the following areas:
- Radiocontrast (x-ray contrast) agents and methods for treating tissue
using those agents
6
<PAGE>
- Radiosensitizer, agents and methods for treating tissue using a
radiosensitizer
- Multiphoton activation technology
- Methods and apparatus for imaging and treating tissue using
photodynamic therapies
- Additional photodynamic therapy methods and apparatus for topical
treatment of disease
- Methods and apparatus for treatment of tissue containing an endogenous
pigment (for example, melanoma destruction)
We continue to pursue development of proprietary technologies as a result
of our research in chemistry, photochemistry, and biochemistry. Our
technologies embrace a broad definition of photodynamic therapy processes,
predominantly from the standpoint of the use of a wide spectrum of light
sources. Our technological applications are based on using ultrafast-pulsed,
near infrared light, visible green light, and x-rays (high energy photons),
generated by ultrafast-pulsed lasers (using our proprietary simultaneous two
photon excitation and multi-photon excitation processes) and other means. We
have been concentrating our research in the following applications:
ophthalmology, oncology, dermatology, imaging and related fields. We will be
evaluating the data obtained from these research projects with a view to
designing future human clinical trials in one or more of these applications. We
are currently working on the following research projects:
1. MACULAR DEGENERATION OF THE EYE. In October 1998, we executed a
research agreement with Massachusetts Eye and Ear Infirmary ("MEEI"), a teaching
affiliate of Harvard Medical School. Joan W. Miller, M.D. was the Principal
Investigator. This agreement had a term ending in June 1999 and covered
preclinical research that evaluated the technology for treatments of age-related
macular degeneration ("AMD") of the eye. AMD is a leading cause of reduced
eyesight in the senior population by progressively damaging the center portion
of the retina. Patients lose the ability to see straight ahead and distinguish
fine detail or read small print, and must eventually rely on peripheral vision.
Eighty percent of the AMD cases are the "dry" form, which cannot be treated and
cause gradual vision loss. The remaining cases are the more severe "wet" form,
in which abnormal blood vessels grow under the retina. It is the "wet" form
that our research with MEEI addressed. We tested a number of photodynamic drugs
with our prototype ultra-fast pulsed lasers and an ophthalmic slit-lamp. We are
evaluating the results of this preclinical research. Subject to the terms of
the agreement, MEEI has the right to patent any new inventions arising out of
the agreement, and we have the right to obtain an exclusive license concerning
any such invention.
2. OCULAR MELANOMA. In December 1998, we executed a second research
agreement with MEEI. This agreement covers preclinical research to evaluate our
technology for the treatment of ocular melanoma. Lucy H. Young, Ph.D., M.D., is
the Principal Investigator. While ocular melanoma is a relatively rare disease
(about 2,000 cases per year in the United States), it is the most prominent
primary cancer of the eye in adults and there are few treatments for this
condition. This research agreement will evaluate our technology as a basis for
an alternative treatment that we believe could offer advantages over current
radiotherapy or surgical
7
<PAGE>
treatment options. We intend to use the data gained through this evaluation
to determine whether our technology is effective in the destruction of ocular
melanoma. This agreement provides that research extensions may be undertaken
by MEEI by agreement with us, and the agreement was amended June 8, 1999 to
extend the term to end in November 1999. Subject to the terms of the
agreement, MEEI has the right to patent any new inventions arising out of
this agreement, and we have the right to obtain an exclusive license
concerning any invention.
3. PROSTATE AND LUNG CANCER. In October 1998, we executed an
agreement with Massachusetts General Hospital for work to be carried out at
its Center for Imaging and Pharmaceutical Research ("CIPR") which will
initially involve preclinical research on the treatment of prostate and lung
cancer using our simultaneous two-photon excitation technology. Gerald L.
Wolf, Ph.D., M.D., is the Principal Investigator. The research under the
first protocol is expected to be completed in 1999. This agreement is
expected to terminate when Dr. Wolf moves his laboratory as discussed below.
Subject to the terms of the agreement, Massachusetts General Hospital has the
right to patent any new inventions arising out of the research agreement and
we have the right to obtain an exclusive license concerning any such
invention.
Dr. Wolf is joining the Photogen staff as Medical Director to head
research and development in the oncology area. Dr. Wolf is also moving his
laboratory to a Photogen sponsored facility located at a well-known
university research center (while maintaining an affiliation as an Emeritus
professor at Harvard Medical School) to complete animal preclinical work. We
plan to expand this research to cover breast cancer, in addition to cancers
of the lung and prostate. We granted Dr. Wolf options to acquire 750,000
shares of common stock, 150,000 shares of which vest over time and the
balance vest when we achieve certain milestones of progress toward product
development, such as FDA approvals.
4. LYMPHOGRAPHY. Our work with Dr. Wolf will also cover lymphography
using contrast agents and CT imaging. This approach uses a high resolution
image of the lymph nodes surrounding a primary tumor to be generated for
mapping and potential diagnosis and treatment. Potential benefits include a
non-invasive procedure and use as a tool to monitor progression of the
disease.
5. CUTANEOUS MELANOMA. In our laboratory, we performed research
assessing the use of ultra-short pulsed light to directly activate melanin
and its precursors to kill melanoma cells. We announced preliminary results
of that research in September 1998. Tumors produced in mice were treated by
scanning the affected area with light from an ultra-short pulsed laser.
Tumors ranging in size from 6 to 10 millimeters (mm) in diameter and up to 3
mm deep, when treated with ultra-short pulsed laser light using simultaneous
two photon excitation, produced a visible "blanching" effect, resulting from
the interaction between melanin and the light. After treatment, tumor volume
was reduced by 100 percent with little or no scarring. We are completing
work to identify the optimum wavelength for use in treating melanoma. We
have conducted experiments at 730 nanometers (nm), 800 nm and 1047 nm. To
date, results at 1047 nm appear superior to 800 nm and 730 nm. We will be
comparing performance at 1047 nm to 800 nm during our preclinical
ocular-melanoma study at MEEI.
8
<PAGE>
6. TREATMENT SYSTEMS. We have been working with a laser manufacturer to
design ultra-short pulsed laser systems for photodynamic treatment of melanoma
and age-related macular degeneration. Two prototype systems have been assembled
that include a beam scanning and focusing device. In addition, we have
developed laser control software. Our scientists are working on a third
prototype system to be used for surface treatments such as hair removal.
7. BARRETTS ESOPHAGUS. Barretts esophagus is a precancerous condition of
the esophagus created by chronic acid reflux. The esophagus is the thin-walled
tube that conveys food to the stomach. Because of its thin walls and multiple
tissue structures, successful photodynamic therapy must avoid penetrating the
esophagus and damaging deeper tissue layers. Problems with conventional
photodynamic therapy have included burning of the esophageal wall caused by the
laser light, and deep tissue damage creating post treatment strictures. In our
laboratory, we demonstrated selective targeting of a drug topically applied in
murine esophageal tissue. The potential benefits of this approach in humans may
be reduced treatment cost and improved safety and efficacy. We began
preclinical trials in July, 1999 in canines for treatment of Barretts esophagus
through our research agreement with the University of Tennessee School of
Veterinary Medicine.
8. RADIOSENSITIZER STUDY. We recently demonstrated that a new class of
photodynamic therapy agents may potentially be successful radiosensitizers. A
drug injected directly into a tumor grown on the side of a laboratory mouse was
retained in the tumor for many days with small amounts of leakage and produced
enough x-ray contrast to clearly identify the tumor images on a conventional CT
scan. We believe these early results indicate that the drug may be sufficient
for use in imaging tumor margins and as a radiosensitizer. Ideally, use of this
agent should enable significant reduction in the x-ray dosage required to kill
the target tissue. Availability of such an agent would allow redefinition of
radiation therapy. The safety risks of radiation would be significantly reduced
with reduced dosage, and efficacy may be improved through the use of the
radiosensitizer. These developments could expand the use of radiation therapy
and, when used as a contrast agent that more clearly identifies tumor margins,
could allow surgeons to improve surgical removal of tumors. This new
photoactive agent interacts with high-energy photons comprising x-ray beams and
extends our capacity to use photodynamic therapy across a broad range of the
light spectrum. The ability to use light and/or x-rays may enable Photogen's
process to treat non-invasive tumors anywhere in the body.
9. PSORIASIS. Psoriasis is an inflammatory dermatologic condition
characterized by red scaling plaques on the skin. It is estimated that
approximately 1.5 to 2% of the U.S. population is affected by this disease,
which contributes to approximately 10 to 15% of all visits to dermatologists and
approximately $1.6 billion per year in treatment costs in the U.S. Treatment
options for psoriasis include topical agents applied to the plaques as well as
various systemic treatments, including oral steroids, antibiotics, and vitamin
D3 analogs. These treatments typically work adequately for control of minor
inflammation. However, the most severe 10-20% of cases typically require
photodynamic therapy using psoralen (a photodynamic
9
<PAGE>
drug) and UV-A light (PUVA). While effective, PUVA therapy may exhibit
significant side effects, including induction of skin cancer. We believe
that our photodynamic treatment, based on a relatively benign topical
photosensitizer and green light illumination, may provide a safer, more
effective alternative to PUVA treatment. Pilot studies undertaken in our
laboratories appear to show broad applicability of such treatments to various
skin disorders, including acute psoriasis. We intend to conduct pilot
studies of safety and efficacy of its psoriasis treatment on human patients
exhibiting stable plaques beginning in the fourth quarter of 1999.
10. HAIR REMOVAL STUDY. In our laboratory, we are investigating the use
of ultra-short pulsed laser light to remove hair. Photogen's photochemical
approach may be the only laser procedure we know of that is useful in removing
certain kinds of hair.
11. DIAGNOSTIC EXPERIMENTS. In our laboratory, we are experimenting
with the diagnostic capabilities of simultaneous two-photon excitation. We
conducted initial experiments on a chicken breast (used to simulate tissue).
We demonstrated the capability to retrieve signals through 5 mm of chicken
breast using the common dye fluorescein. We are attempting to improve the
signal-to-noise ratio, through the use of our proprietary modulation
technologies. If successful, this improvement could result in faster
imaging, better resolution and increased depth at which diagnosis could be
conducted.
We cannot guarantee that our research will lead to the development of new
patentable technology, or that commercial products will be developed from our
technologies and successfully sold. We plan to continue to pursue preclinical
and clinical testing of proposed products in the areas of chemistry,
photochemistry and biochemistry. However, we cannot assure investors that we
will receive any grant monies, will be able to successfully develop and obtain
proprietary protection for new technologies, or that we can develop products
from these technologies that can be commercialized. We have not entered into
any collaborative agreements for the development of any specific product and we
do not expect to do so until further research and clinical trials are concluded.
We are occupying approximately 4,000 square feet of office and laboratory
space in Knoxville, Tennessee. As of August 1, we will pay a monthly rental of
$5,330 for the facility (including certain equipment) plus charges for utilities
and similar items. We are proceeding to equip our laser research and
development laboratory with certain laser equipment systems made available by a
large laser manufacturer. We have received, installed and started-up three
ultra-short pulsed laser systems required for conduct of animal studies for use
in the photodynamic treatment of melanoma and age-related macular degeneration.
We anticipate taking delivery of another laser system for use in hair removal in
mid-1999. We have completed development of a software package for use in the
control and operation of these laser systems.
LIQUIDITY; CAPITAL RESOURCES. We have used, and expect over the next 12
months to use, the gross proceeds from the March 13, 1998 private placement and
from the sale of stock in our 1997 restructuring for corporate overhead and
operating expenses, animal trials,
10
<PAGE>
the purchase or lease of scientific and laboratory equipment and related
facilities, legal and regulatory consulting fees and for other working
capital purposes, assuming we have no revenues during that period. Our use
of cash and capital resources for the first seven months of the 1999 fiscal
year averaged about $380,000 per month. At that rate, taking into account
presently anticipated expenditures, we will exhaust our current funds by
approximately March through May 2000 (depending upon the timing of certain
expenditures for our preclinical research projects).
We plan to raise additional capital in the fourth quarter of 1999. To
that end, we intend to offer preferred stock in a private placement, and we have
received a binding commitment from certain principal shareholders to provide up
to $5 million in additional debt and equity financing.
PLAN OF OPERATION. During the next twelve months, we will focus our
efforts on completing preclinical studies, beginning human trials, preparing for
the design and assembly of laser treatment devices, preparing to manufacture
clinical quantities of our drug agent, preparation of required filings to FDA
and foreign regulatory bodies.
During the next twelve months, we will continue with animal studies and
evaluation of proprietary photoactive agent candidates, pursuing patent
protection and seeking potential research and development and collaboration
candidates. During the six months ended June 30, 1999, we spent approximately
$520,941 to acquire equipment necessary to support animal clinical trials, and
on development of our proprietary photoactive agent and targeting systems.
During the second quarter of 1999, we purchased approximately $185,175 of
laboratory equipment. We anticipate increased spending during the third quarter
for clinical equipment and clinical work provided by third-party researchers.
During the next twelve months we expect to spend approximately $340,000 to
acquire new equipment. The three research contracts to which we are currently a
party in the aggregate will require us to spend $96,996 during the next twelve
months for the projects presently contemplated under those agreements.
Additional projects may be undertaken with those institutions for compensation
to be agreed upon at that time.
We are evaluating our future needs for laboratory and office space and for
scientific, managerial and support personnel. See "Risk Factors" in Item 5,
below. We have exercised our renewal option under the portion of our lease that
would have expired, which resulted in an increase in rent of about $.50 per
square foot; and we intend to link expansion of facilities and staff to
completion of technical and financial milestones. We presently anticipate
slowly adding additional personnel to support our current activities, while
deferring any substantial growth in hiring and acquisition of space and
equipment until the final results of preclinical and human trials are known.
However, we will consider faster growth if that would present opportunities to
increase our product pipeline, or opportunities for more rapid FDA approval or
to attain licensing revenues. We intend to structure our research and
development and collaborative arrangements to make the fullest possible use of
personnel and facilities provided by the parties with whom we may contract.
11
<PAGE>
With the funds we will receive through our fourth quarter, 1999 financing,
we believe we will have enough cash resources for our current commitments during
the next 12 months. However, as we progress toward human clinical trials, our
use of capital will increase and will continue to do so at an accelerating pace.
Greater capital resources would enable us to quicken and expand our research and
development activities over that 12-month period; and our failure to raise
additional capital will (absent a suitable collaborative agreement providing for
a third party to take over these functions) significantly impair our ability to
conduct further research and development activities beyond those currently
contracted for and our ability to seek regulatory approval for any possible
product resulting from that research. Under the present circumstances, we
expect to exhaust our current capital by approximately March through May 2000.
In any event, complete development and commercialization of our technology will
require substantial additional funds. Accordingly, we are continuously
evaluating capital formation activities and opportunities, either as part of
collaborative arrangements with third parties or through offerings of equity or
debt unrelated to collaborations. See "Risk Factors" in Item 5, below.
YEAR 2000 ISSUES. The "Year 2000 issue" is the problem resulting from the
use of a two-digit date to identify the year in computer software.
Consequently, computer programs may not accurately reflect the appropriate date,
confusing "00" as the year 1900 rather than the year 2000. Year 2000 is a
pervasive problem affecting many information technology systems and embedded
technologies (operating and control systems that rely on embedded chip systems
such as microprocessors in communication systems) in all companies and in all
industries.
We have completed assessment of the impact of Year 2000 on our operations
and important systems. We also inquired about the Year 2000 readiness of our
material vendors, research institutions under contract with us, and other
material third parties on which we rely.
With respect to our information technology systems, we believe that with
upgrades to our existing computer software, all of which should be readily
available in the market, the Year 2000 issue will not have a material adverse
affect on our financial position or results of operations. We expect to have
these upgrades completed by the end of 1999 and do not expect the cost of the
upgrades to be material (less than $5,000). With respect to embedded
technologies, we believe they are either Year 2000 compliant or will not be
materially effected by the Year 2000 problem because they do not significantly
rely upon date sensitive software.
To date, we do not believe most third parties' Year 2000 issues will have a
material adverse impact on our operations. However, we have not been able to
verify that the Massachusetts Eye and Ear Infirmary ("MEEI"), with which we have
two research agreements, will have addressed its own Year 2000 issues. If the
Year 2000 issue causes an interruption in the research MEEI is performing for
us, we may (depending on the circumstances) agree to delay some or all of the
research or transfer the research to another institution. This could delay the
progress of research on those projects for as much as six to nine months and
would correspondingly delay the commencement of human clinical trials and any
resulting product.
12
<PAGE>
However, much of MEEI's research may be completed before the end of 1999 and
would not be affected by the Year 2000 issue.
We believe that a "worst case" scenario would result where the systems of
third parties are not timely converted and a third party fails to remediate its
own Year 2000 issues. In a worst case scenario, we could incur an adverse
affect due to interruption of third party systems. However, we currently
believe that any adverse effect would involve primarily disruption to sponsored
research operations which we believe could be transferred to alternative third
parties who were Year 2000 compliant. Any such transfer could result in a delay
of research operations. At present we cannot estimate the likelihood or
potential cost of such third party failures.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Photogen held its Annual Meeting of Shareholders on May 27, 1999.
Proxies for the Annual Meeting were solicited by Photogen pursuant to
Regulation 14A under the Securities Exchange Act of 1934. John T. Smolik,
Eric A. Wachter, Craig Dees, Walter G. Fisher, Robert J. Weinstein, and
Lester H. McKeever, Jr., nominees for the election to the Board of Directors
as listed in Photogen's Proxy Statement for the meeting, were elected by a
vote of 34,791,178 for, 0 against and 1,535 abstentions.
In addition to the election of directors, the shareholders also
ratified the appointment of BDO Seidman, LLP as independent certified public
accountants for Photogen for the year ending December 31, 1999 by a vote of
34,790,738 for, 1,550 against and 1,975 abstentions.
PART II - OTHER INFORMATION
ITEM 5. OTHER INFORMATION
RISK FACTORS
Photogen and its business involve a high degree of risk. You should
carefully consider the risks listed below and all of the information contained
in this Form 10-QSB and our other filings with the Securities and Exchange
Commission. The risks listed below are not all of the risks facing Photogen.
There may be additional risks and uncertainties that we currently are not aware
of or have deemed not material, all of which could have a negative impact on our
business, financial condition and results of operations. "We" and "our" refer to
Photogen Technologies, Inc. and its wholly owned subsidiary Photogen, Inc.
This Form 10-QSB and other filings, announcements and documents of
Photogen and oral statements of our representatives contain "forward-looking
statements," within the meaning of the Private Securities Litigation Reform Act
of 1995. Forward-looking statements involve risks, uncertainties and other
factors that may cause our actual results or performance to differ materially
from any results or performance expressed or implied by those statements.
Examples of forward-looking statements include predictive statements, statements
that depend on or refer to future events or conditions, which include words such
as "expects," "anticipates," "intends," "plans," "believes," "estimates,"
"should," "may" or similar expressions, or statements that involve hypothetical
events.
Forward-looking statements discuss future events or circumstances,
including future revenues, earnings or growth rates, ongoing business strategies
or prospects, and our possible future actions. These statements are based on
current expectations and projections about future events and are subject to
risks, uncertainties, and assumptions about Photogen, economic and market
factors and the industries in which we do business, and other factors.
Forward-looking statements are not guaranties of future performance and actual
events and results may differ materially from those expressed or forecasted in
forward-looking statements. We have no specific intention to update these
statements.
The following are some of the key risk factors that may affect Photogen's
future results:
13
<PAGE>
WE ARE A DEVELOPMENT STAGE COMPANY AND DO NOT HAVE ANY PRODUCTS OR REVENUES FROM
SALES.
Our company and our technology are in an early stage of development. We
have not generated revenues from sales or operations, and we do not expect
to generate any revenues for at least several years. The products we
currently contemplate developing will require significant additional
research and development, preclinical and clinical testing and regulatory
approval before they can be manufactured and sold. As a result of changing
economic considerations, market, clinical or regulatory conditions, or
clinical trial results, we may shift our focus or determine not to continue
one or more of the projects we are currently pursuing.
WE HAVE A HISTORY OF LOSSES AND MAY NOT ACHIEVE OR MAINTAIN FUTURE PROFITS
OR PAYMENT OF DIVIDENDS.
We have incurred losses since the beginning of our operations. As of
June 30, 1999, we have incurred total losses of $4,382,532. We expect our
losses to increase in the future as our financial resources are used for
research and development, preclinical and clinical testing, regulatory
activities, manufacturing, marketing and other related expenses. We may not
be able to achieve or maintain profitability in the future. We have never
declared or paid any cash dividends to stockholders, and do not expect to do
so in the foreseeable future.
WE MUST OBTAIN SIGNIFICANT ADDITIONAL FINANCING.
Under the present circumstances, we will exhaust our available capital
by approximately March through May 2000. We will need substantial
additional financing for our research, clinical testing, product
development and marketing programs. We cannot accurately estimate the
amount of additional financing required; however, the amount could be at
least an additional $50 million. Depending on market conditions, we will
attempt to raise additional capital through stock and debt offerings,
collaborative relationships and other available sources. Additional funds
may not be available on acceptable terms, if at all, and existing
stockholders may be diluted as a result of those offerings.
WE ARE HIGHLY DEPENDENT UPON A SMALL NUMBER OF EMPLOYEES AND CONSULTANTS WHO
PROVIDE SCIENTIFIC AND MANAGEMENT EXPERTISE.
These individuals have entered into employment or consulting
agreements, confidentiality and/or non-competition agreements. We could
suffer competitive disadvantage, loss of intellectual property rights or
other material adverse effects on our business and results of operations if
any employee or consultant violates or terminates these agreements or
terminates their association with us.
OUR PROPOSED PRODUCTS ARE SUBJECT TO EXTENSIVE TESTING AND GOVERNMENT REGULATION
AND APPROVAL, INCLUDING BY THE FOOD AND DRUG ADMINISTRATION.
Our proposed drug and device products have not begun or completed the
FDA's extensive approval process which must be completed before proposed
products can be
14
<PAGE>
manufactured or sold. This process includes preclinical and clinical testing
for effective use and safety in animals and humans. The time frame necessary
to perform these tasks for any individual product is long and uncertain, and
we may encounter problems or delays which we cannot predict at this time.
Even if clinical trials are successful, our proposed products may not
demonstrate sufficient effectiveness or safety to warrant approval by the
FDA or other domestic or foreign regulatory authorities. Any regulatory
approval may not cover the clinical symptoms or circumstances that we may
seek.
BECAUSE WE DO NOT HAVE, AND DO NOT INTEND TO DEVELOP, INTERNAL RESEARCH,
MANUFACTURING OR CLINICAL TESTING FACILITIES OR MARKETING RESOURCES FOR OUR
PROPOSED PRODUCTS, WE WILL HAVE TO RELY ON THIRD PARTIES AND COLLABORATIVE
RELATIONSHIPS.
We must enter into collaborative relationships with third parties for
research and development, preclinical and clinical testing, manufacturing,
marketing and distribution of our proposed products. We will also be
dependent on third parties for the supply of laser products and for supplies
of photodynamic drugs. We have several research agreements with third
parties. However, we may not be able to negotiate other acceptable
collaborative and supply arrangements in the future.
Collaborative relationships may limit or restrict our operations or may
not result in an adequate supply of necessary resources. Our collaborative
partners could also pursue alternative technologies as a means of developing
or marketing products for the diseases targeted by our collaborative
programs. Failure of a collaborative partner to perform under its agreement
or its failure to meet regulatory standards could delay or prematurely
terminate clinical testing of our proposed products.
LOSS OF PATENT AND OTHER INTELLECTUAL PROPERTY PROTECTION WOULD HAVE A MATERIAL
ADVERSE EFFECT ON OUR BUSINESS, RESULTS OF OPERATIONS AND FINANCIAL CONDITION.
Our success will depend, in part, on our ability to obtain, assert and
defend our patents, protect trade secrets and operate without infringing
upon the intellectual property of others. Our patent applications may not
result in issued patents. Moreover, any issued patents may not provide us
with adequate protection of our intellectual property or competitive
advantages. Patented inventions may be "reverse engineered" by our
competitors, and third parties may challenge our existing patents and seek
to hold them invalid or unenforceable. Existing or future patents or patent
applications (and the products or methods they cover) of our competitors
may interfere, invalidate, conflict or infringe with our patents or
patent applications. Similarly, our use of the methods or technologies
contained in our patents and other intellectual property may conflict or
infringe the rights of others.
Litigation over patents and other intellectual property rights occurs
frequently in our industry, and there is a risk that we may not prevail in
that litigation. Those disputes can be expensive and time consuming, even if
we win. Intellectual property disputes are often settled through licensing
arrangements that could be costly to us. In any intellectual property
litigation, it is possible that licenses necessary to settle the dispute
would not be available, or that we would not be able to redesign our
technologies to avoid any claimed infringement.
15
<PAGE>
Confidentiality agreements covering our intellectual property may be
violated and we may not have adequate remedies for any violation. Also, our
intellectual property may in other ways become known or be independently
discovered by competitors.
OUR POTENTIAL MARKETS ARE EXTREMELY COMPETITIVE.
We face substantial competition from competitors with greater
financial, technical and human resources and with greater experience in
developing products, conducting preclinical or clinical testing, obtaining
regulatory approvals, manufacturing and marketing. Our competitors include
firms in the field of photodynamic therapy as well as other fields generally
relating to the diagnosis and treatment of disease using different
technologies or scientific and medical approaches. Examples of those
technologies are novel drugs, hyperthermic and ultrasound procedures. Some
of these firms have drugs or devices that have completed or are in advanced
stages of clinical trials and regulatory approvals.
Our competitors may develop technologies and obtain patent protection
that could render our technologies or products obsolete or less competitive
or our patents invalid or unenforceable. Due to the inherent risk of
failure associated with the testing, development and production of new
and innovative technologies, our technologies and products may be found
to be ineffective, have unanticipated limitations or otherwise be
unsuccessful in the marketplace.
A SMALL GROUP OF STOCKHOLDERS CONTROLS PHOTOGEN.
A small group of our officers, directors and others control
approximately 85% of our outstanding common stock. Several of our principal
stockholders are also parties to a Voting Agreement concerning the election
of certain designees to the Board of Directors of Photogen Technologies,
Inc. and Photogen, Inc. This group of stockholders can significantly
influence Photogen and the direction of our business and affairs. This
concentration of ownership may delay or prevent a change in control of
Photogen, and may also result in a small supply of shares available for
purchase in the public securities markets. These factors may affect the
market and the market price for our common stock in ways that do not reflect
the intrinsic value of the stock.
OUR STOCK PRICE IS VOLATILE.
Our stock price and trading volume has fluctuated and is likely to
continue to fluctuate significantly for reasons that may not have any
relationship to our operating performance or other factors that
traditionally determine a company's value. The following factors may have an
impact on the price of our stock:
- announcements by us or others regarding scientific discoveries,
technological innovations, commercial products, patents or
proprietary rights;
- the progress of preclinical or clinical trials;
16
<PAGE>
- changes in government regulation;
- public concern about the safety of devices or drugs; and
- changes in our financial performance from period to period;
securities analysts' reports; and general market conditions.
Our stock trades in the over-the-counter bulletin board market but is
not listed or traded on any stock exchange at this time. State securities
laws may also limit the extent to which brokers in a number of states may
solicit transactions in our stock.
COMPUTER PROBLEMS RESULTING FROM THE YEAR 2000 ISSUE PRESENT POTENTIAL
UNCERTAINTIES.
We may incur delays in research and other material problems if the
computer systems and other information technology systems that we use or
that are used by certain third parties upon whom we rely for services do not
accurately and adequately address the Year 2000 issue. We may not be able to
identify and address all Year 2000 issues, including those of third parties.
Failure to identify and correct unknown Year 2000 issues by us or important
third parties on whom we rely could have a material adverse effect on our
business, results of operations and financial condition. See "Management's
Discussion and Analysis of Financial Condition or Plan of Operation -- Year
2000 Issues," above.
WE CANNOT PREDICT THE EFFECT OF CHANGES IN HEALTH CARE REIMBURSEMENT AND
LEGISLATIVE REFORM ON OUR BUSINESS.
Our success will depend, in part, on the extent to which health
insurers, managed care entities and similar organizations, provide coverage
or reimbursement for the medical procedures and devices we plan to develop.
These third party payors are increasingly challenging the price of medical
procedures and services and establishing guidelines that may limit
physicians' selections of innovative products and procedures. We also cannot
predict the effect of any current or future legislation or regulations
relating to third party coverage or reimbursement on our business. We may
not be able to achieve market acceptance of our proposed products or
maintain price levels sufficient to achieve or maintain any profits on our
proposed products if adequate reimbursement coverage is not available.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits. The following is a list of exhibits filed as part of this Form
10-QSB. Exhibits that were previously filed are incorporated by reference. For
exhibits incorporated by reference, the location of the exhibit in the previous
filing is indicated in parenthesis.
EXHIBIT NO. DESCRIPTION
17
<PAGE>
<TABLE>
<S> <C>
3.1 Restated Articles of Incorporation of Photogen Technologies, Inc.
(Filed as exhibit 3.1 to the Company's Current Report on Form 8-K
dated June 17, 1998 and incorporated herein by reference.)
3.2 Bylaws of Photogen Technologies, Inc. (Filed as exhibit 3.2 to the
Company's Registration Statement on Form 10-SB dated December 24,
1997 and incorporated herein by reference.)
3.3 Charter of Photogen, Inc. (Filed as exhibit 3.3 to the Company's
Registration Statement on Form 10-SB dated December 24, 1997 and
incorporated herein by reference.)
3.4 Amended and Restated Bylaws of Photogen, Inc. (Filed as exhibit
3.4 to the Company's Form 10-KSB dated March 30, 1999 and
incorporated herein by reference.)
27 Financial Data Schedule of Photogen Technologies, Inc.
</TABLE>
(b) Reports on Form 8-K.
The following reports on Form 8-K were filed in the three month period
ended June 30, 1999:
1. Report on Form 8-K dated April 28, 1999, disclosing, among other
things, Photogen's discovery of the use of a chemical as a
radiosensitizer.
2. Report on Form 8-K dated April 28, 1999 disclosing that Merrill
Biel, M.D., Ph.D., had joined the Photogen Scientific Advisory
Council.
3. Report on Form 8-K dated May 25, 1999 disclosing the preliminary
results of an animal feasibility study of Photogen's proprietary
phototherapeutic technology for use in the treatment of ocular
melanoma, a cancer of the eye.
18
<PAGE>
SIGNATURES
In accordance with the requirements of the Exchange Act, the Registrant
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
Photogen Technologies, Inc.
/s/ John T. Smolik
---------------------------------------
Date: August 13, 1999 John T. Smolik, President
19
<PAGE>
EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT NO. DESCRIPTION
<S> <C>
+3.1 Restated Articles of Incorporation of Photogen Technologies,
Inc. (Filed as exhibit 3.1 to the Company's Current Report on
Form 8-K dated June 17, 1998 and incorporated herein by
reference.)
+3.2 Bylaws of Photogen Technologies, Inc. (Filed as exhibit 3.2 to
the Company's Registration Statement on Form 10-SB dated
December 24, 1997 and incorporated herein by reference.)
+3.3 Charter of Photogen, Inc. (Filed as exhibit 3.3 to the Company's
Registration Statement on Form 10-SB dated December 24, 1997 and
incorporated herein by reference.)
+3.4 Amended and Restated Bylaws of Photogen, Inc. (Filed as exhibit
3.4 to the Company's Form 10-KSB dated March 30, 1999 and
incorporated herein by reference.)
*27 Financial Data Schedule of Photogen Technologies, Inc.
</TABLE>
+ Incorporated by reference from the filing indicated.
* Filed herewith.
20
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM FORM 10-QSB
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 1999 AND IS QUALIFIED IN ITS ENTIRETY BY
REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1,000
<S> <C>
<PERIOD-TYPE> 6-MOS
<FISCAL-YEAR-END> DEC-31-1999
<PERIOD-START> JAN-01-1999
<PERIOD-END> JUN-30-1999
<CASH> 760,394
<SECURITIES> 3,519,406
<RECEIVABLES> 0
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 1,038,314
<PP&E> 1,489,819
<DEPRECIATION> (219,262)
<TOTAL-ASSETS> 5,828,277
<CURRENT-LIABILITIES> 507,763
<BONDS> 0
0
0
<COMMON> 36,875
<OTHER-SE> 5,283,639
<TOTAL-LIABILITY-AND-EQUITY> 5,828,277
<SALES> 0
<TOTAL-REVENUES> 119,307
<CGS> 0
<TOTAL-COSTS> 1,971,445
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (1,852,138)
<INCOME-TAX> 0
<INCOME-CONTINUING> (1,852,138)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (1,852,138)
<EPS-BASIC> (.05)
<EPS-DILUTED> (.05)
</TABLE>
