Highlights:
* PPTI has completed development of a new surgical sealant for use in
pulmonary, gastrointestinal, and cardiovascular surgery and is
initiating pre-clinical studies in preparation for filing a request
with the FDA to begin human clinical studies
* The License Agreement between the PPTI and Genencor International has
been expanded to include the commercialization of non-medical personal
care products
* Fourth quarter total revenues were $46,000; net loss for the quarter
was $954,000
SAN DIEGO, April 1 /PRNewswire-FirstCall/ -- Protein Polymer Technologies,
Inc. (OTC Bulletin Board: PPTI) reported today financial results for the
fourth quarter and the year ended December 31, 2004.
For the quarter, the Company had a net loss applicable to common
shareholders of $1,511,000 ($0.04 a share), versus a net loss of
$1,964,000 ($0.05 a share) for the comparable period a year ago. For the
year, PPTI had a net loss applicable to common shareholders of
$4,330,000 ($0.11 a share), versus a net loss of $5,055,000 ($0.15 a share)
for the comparable period a year ago. The net loss and the net loss per share
amounts included accumulated and distributed dividends related to the
Company's preferred stock. The net loss in 2004 and 2003 also included
non-cash "imputed dividend" expenses of $765,000 and $2,862,000 respectively
associated with the issuance of convertible preferred stock and warrants to
account for the difference between the fair market value of the common stock
and the conversion price of the preferred stock and the exercise of warrants
into common stock.
Revenues totaled $46,000 for the fourth quarter and $457,000 for the
twelve month period ended December 31, 2004, compared to $312,000 and
$1,617,000, respectively, for the same periods last year. The decrease in
contract and licensing revenue primarily represents a decrease in research and
development payments from Spine Wave, Inc. due to completion of preclinical
studies in support of Spine Wave's Investigational Device Exemption (IDE)
filing with the U.S. Food and Drug Administration requesting permission to
begin human clinical testing. Spine Wave was formed in April 2001 to develop
and commercialize a spinal disc repair product for the treatment of lower back
pain based on technology PPTI licensed to Spine Wave.
Operating expenses for the quarter were $1,000,000, as compared to
$994,000 for the same period in 2003. Operating expenses for the year were
$4,022,000, as compared to $3,811,000 for the same period in 2003. In
general, operating expenses for the past two years have remained low due
primarily to reductions in personnel and expenditures implemented during the
past three years. To the extent that resources become available, expenses are
expected to rise in subsequent quarters due to increased expenditures for
expanded human clinical testing and patient follow-up of PPTI's injectable
hydrogel for the treatment of dermal contour defects, injectable urethral
bulking agent for the treatment of female stress urinary incontinence, and the
preclinical development of its surgical sealant designed to eliminate leaks
following lung, bowel and cardiovascular surgery. However, there can be no
assurance that additional resources will become available.
As of December 31, 2004, PPTI had a negative working capital of
$1,531,000 compared to $1,192,000 as of December 31, 2003. PPTI's cash as of
December 31, 2004 was $82,000, compared to $1,085,000 on December 31, 2003.
Since the end of June 2004, the Company has received $1,050,000 in return for
short term promissory notes and warrants. In combination with anticipated
additional contract and license payments, and revenue projected for the
delivery of clinical testing materials, the Company's cash as of March 31,
2004 is expected to meet the Company's anticipated capital requirements until
the end of April 2005. If additional capital is not obtained in the near
future, the Company will be required to reduce the use of cash through layoffs
and other cost reduction steps.
As previously announced, PPTI has successfully completed the development
of a new surgical sealant designed to prevent air and fluid leaks following
lung, gastrointestinal, and cardiovascular surgery. Following the completion
of required preclinical testing, the Company intends to seek approval for an
Investigational Device Exemption (IDE) with the U.S. Food and Drug
Administration in order to conduct clinical trials in humans. Air and fluid
leaks following surgery are a common source of complications often leading to
further surgery. PPTI's surgical sealant is applied following closure of
tissues with sutures or staples. Using a simple dual-syringe applicator, the
sealant is sprayed over the surgical incision. In less than a minute, a tough
yet flexible barrier -- strongly adherent to the tissue being repaired -- is
formed. As the tissue heals, the sealant gradually resorbs. Ease of use,
strength, flexibility, and resorption are the key product features required
for the targeted applications.
PPTI recently announced the expansion of its license agreement with
Genencor International, Inc. The license agreement was initially established
in December 2000, granting Genencor worldwide exclusive rights to industrial
applications of PPTI's proprietary protein polymer design and production
technology. Under the amended agreement, the licensed rights have been
expanded to include personal care product applications. PPTI continues to
retain all rights to its technology for use in the development and
commercialization of medical products. A $250,000 payment, and additional
annual payments through 2010, are in consideration for the amended license
rights. Royalties will also be payable on sales of products.
Protein Polymer Technologies, Inc. is a San Diego-based company focused on
developing bioactive products to improve medical and surgical outcomes. From
its inception in 1988, PPTI has been a pioneer in protein design and
synthesis, developing an extensive portfolio of proprietary biomaterials.
These genetically engineered biomaterials are high molecular weight proteins,
processed into products with physical and biological characteristics tailored
to specific clinical performance requirements. Targeted products include
urethral bulking agents for the treatment of stress urinary incontinence,
dermal augmentation products for cosmetic and reconstructive surgery, surgical
adhesives and sealants, scaffolds for wound healing and tissue engineering,
and depots for local drug delivery. To date, PPTI has been issued twenty-five
U.S. Patents on its core technology with corresponding issued and pending
patents in key international markets.
This press release contains forward-looking statements that are based on
management's views and expectations. Actual results could differ materially
from those expressed here; further, the Company is not obligated to comment
specifically on those differences. Risks associated with the Company's
activities include raising adequate capital to continue operations scientific
and product development uncertainties, competitive products and approaches,
continuing collaborative partnership interest and funding, regulatory testing
and approvals, and manufacturing scale up. The reader is encouraged to refer
to the Company's 2003 and 2004 Annual Report Form 10-KSB and other recent
filings with the Securities and Exchange Commission, copies of which are
available from the Company, to further ascertain the risks associated with the
above statements.
Protein Polymer Technologies, Inc.
Condensed Financial Statements
(unaudited)
Three months ended Twelve months ended
December 31, December 31,
2004 2003 2004 2003
SUMMARY OF OPERATIONS
Contract revenue $45,099 $307,940 $453,038 $1,597,415
Interest income 875 3,679 3,973 19,903
Product and other
income -- -- 5 --
Total revenues 45,974 311,619 457,016 1,617,318
Total expenses 999,632 994,057 4,022,221 3,810,557
Net loss $(953,658) $(682,438) $(3,565,205) $(2,193,239)
Undeclared and/or
paid dividends
on Preferred Stock 557,060 1,281,313 764,718 2,862,219
Net loss
applicable to
common
shareholders $(1,510,718)$(1,963,751) $(4,329,923) $(5,055,458)
Net loss per
common share --
basic and
diluted $(0.04) $(0.05) $(0.11) $(0.15)
Shares used in
computing net
loss per share --
basic and
diluted 39,318,909 36,796,094 38,212,119 34,362,427
As of As of
Dec. 31, 2004 Dec. 31, 2003
BALANCE SHEET INFORMATION
Cash and cash equivalents $82,000 $1,085,000
Working capital (1,531,000) 1,192,000
Total assets 374,000 1,692,000
Total capital invested 51,425,000 50,021,000
Accumulated deficit $(52,737,000) $(48,684,000)
SOURCE Protein Polymer Technologies
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CONTACT: J. Thomas Parmeter, Chairman, or Janis Y. Neves, Director of Finance & Administration, both of Protein Polymer Technologies, +1-858-558-6064, info@ppti.com
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