Highlights:
* PPTI announced the appointment of Donald S. Kaplan, Ph.D., former
Senior Vice President, Operations and Technology at U.S. Surgical, as
President and Chief Operating Officer
* PPTI obtained FDA approval to expand pilot clinical studies for the
correction of dermal contour deficiencies
* First quarter total revenues were $191,000; net loss for the quarter
was $851,000
SAN DIEGO, May 13 /PRNewswire-FirstCall/ -- Protein Polymer Technologies,
Inc. (OTC Bulletin Board: PPTI), announced today financial results for the
first quarter ended March 31, 2004.
The net loss applicable to common shareholders for the quarter ended
March 31, 2004 was $921,000 ($0.02 per share), compared to a net loss of
$1,744,000 ($0.06 per share), for the same period in 2003. This net loss and
the per share amounts include accumulated dividends related to the Company's
preferred stock, and "imputed dividend" charges pertaining to its recent sale
of Series I Convertible Preferred Stock.
Total revenue was $191,000 for the quarter ended March 31, 2004, compared
to $453,000 for the same period in 2003. The contract and licensing revenue
primarily represents research and development payments and receivables from
Spine Wave, Inc. for the development of an injectable spinal disc repair
product for the treatment of lower back pain. The decrease in contract
revenue from the same period in 2003, is due to the completion of the majority
of work, including preclinical testing, required to support Spine Wave's
initiation of human clinical testing of the injectable spinal disc nucleus
product.
Operating expenses for the quarter were $1,042,000, as compared to
$822,000 for the same period in 2003. The increase in operating expense was
due principally to increases in rent and utilities, increased laboratory
supplies and services related to manufacturing process improvements, and
increased Board of Director expenses. When additional capital becomes
available, expenses are expected to rise in subsequent quarters due to the
increased expenditures for expanded human clinical testing and patient
follow-up of the Company's lead product candidates currently in development.
As of March 31, 2004, PPTI had $595,000 in working capital compared to
$1,192,000 as of December 31, 2003. PPTI's cash as of March 31, 2004 was
$755,000, compared to $1,085,000 on December 31, 2003. In combination with
anticipated additional contract payments, and revenue projected for the
delivery of clinical testing materials, the Company's cash is expected to meet
the Company's anticipated capital requirements until July 2004.
J. Thomas Parmeter, Chairman and Chief Executive Officer of Protein
Polymer Technologies, commented, "Recent events have positioned PPTI to make
significant progress toward commercialization, and increased our ability to
capitalize on our large intellectual property portfolio. In April, we
announced the appointment of Donald S. Kaplan, Ph.D. as President and Chief
Operating Officer. For the past year, Dr. Kaplan has directed our surgical
adhesive and sealant product development where he has successfully advanced
the initial sealant product through its research and formulation development.
As President and Chief Operating Officer, he will lead Protein Polymer through
its next stage of development with a primary focus on the completion of the
clinical trials for our tissue augmentation products, scale up of our
manufacturing process, and the continued development and testing of our
surgical sealant and adhesive products. His past experience makes him
uniquely qualified to lead these efforts. Previously, Dr. Kaplan was Senior
Vice President, Operations and Technology at United States Surgical
Corporation (now a subsidiary of Tyco, Inc.), where he was responsible for
research and development, quality control, regulatory affairs and
manufacturing."
Mr. Parmeter added, "We continue to focus on the clinical trials of our
injectable hydrogel for the treatment of dermal contour defects such as scars,
wrinkles and lines, and for the treatment of female stress urinary
incontinence. During the first quarter, we received FDA approval to expand
the pilot clinical trial for the dermal augmentation product for the treatment
of dermal contour deficiencies. The additional human data will be used in
support of an application to conduct a projected pivotal clinical study.
Injected as a liquid into the dermal tissue, the protein polymer solution
rapidly transitions into a durable, flexible hydrogel that is then shaped by
the physician for the desired appearance. The expansion will include up to 20
additional patients. Enrollment in these expanded trials began last month."
"In addition, Spine Wave's recent completion of its Series B financing
provides assurance that sufficient resources will be available to maintain a
focused development effort for its spine product designed to repair spinal
discs damaged by injury or aging. Spine Wave, which is preparing to begin
human clinical testing of the injectable disc nucleus product developed from
our tissue adhesive technology, holds a license to our technology for spinal
applications, and contracts with PPTI for product development and
manufacturing services."
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
dermal augmentation products for cosmetic and reconstructive surgery, urethral
bulking agents for the treatment of stress urinary incontinence, 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 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
March 31,
2004 2003
SUMMARY OF OPERATIONS
Contract and licensing revenue $189,050 $450,983
Product and other income 1,958 1,583
Interest income 6 --
Total revenues 191,014 452,566
Total expenses 1,042,401 822,287
Net loss (851,387) (369,721)
Undeclared and/or paid
dividends on Preferred Stock 69,220 1,373,831
Net loss applicable to common
shareholders $(920,607) $(1,743,552)
Net loss per common share --
basic and diluted $(0.02) $(0.06)
Shares used in computing net
profit/loss per share --
basic and diluted 37,313,282 29,792,399
As of As of
Mar. 31, 2004 Dec. 31, 2003
BALANCE SHEET INFORMATION
Cash and cash equivalents $755,000 $1,085,000
Working capital 595,000 1,192,000
Total assets 1,107,000 1,692,000
Total capital invested 49,058,000 48,809,000
Accumulated deficit $(48,324,000) $(47,473,000)
SOURCE Protein Polymer Technologies, Inc.
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CONTACT:
J. Thomas Parmeter, Chairman, jtp@ppti.com,
or Janis Y. Neves, Director of Finance, jneves@ppti.com, both of
Protein Polymer Technologies, Inc., +1-858-558-6064
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