UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
----------
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) July 20, 2004
Pain Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
Delaware 000-29959 91-1911336
(State or other jurisdiction (Commission File Number) (I.R.S. Employer
of incorporation) Identification Number)
416 Browning Way, South San Francisco 94080
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (650) 624-8200
N/A
(Former name or former address, if changed since last report)
TABLE OF CONTENTS
Item 7. Financial Statements and Exhibits.
Item 12. Results of Operations and Financial Condition
SIGNATURE
EXHIBIT INDEX
EX - 99.1 Press release
Item 7. Financial Statements and Exhibits.
(c) Exhibits
The following exhibits are filed with this report on Form 8-K:
Exhibit
Number Description
------- -------------------------------------------------
99.1 Press Release, dated July 20, 2004
Item 12. Results of Operations and Financial Condition
On July 20, 2004, Pain Therapeutics, Inc. issued a press release
announcing its results for the quarterly period ending June 30, 2004. A copy of
this press release is attached hereto as Exhibit 99.1.
The information in this Form 8-K and the Exhibit attached hereto shall not
be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of
1934, as amended, nor shall it be deemed incorporated by reference in any filing
under the Securities Act of 1933, except as shall be expressly set forth by
specific reference in such filing.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the registrant has duly caused this report to be signed on its behalf
by the undersigned thereunto duly authorized.
PAIN THERAPEUTICS, INC.
a Delaware corporation
Date: July 20, 2004 By: /s/ Peter S. Roddy
------------------------
Peter S. Roddy
Chief Financial Officer
EXHIBIT INDEX
Exhibit
Number Description
- ------- -----------------------------------------------------
99.1 Press Release, Dated July 20, 2004
Exhibit 99.1
Pain Therapeutics Announces Second Quarter 2004 Financial Results
SOUTH SAN FRANCISCO, Calif., July 20 /PRNewswire-FirstCall/ -- Pain
Therapeutics, Inc. (Nasdaq: PTIE), a biopharmaceutical company, today reported
financial results for the three and six months ended June 30, 2004.
The net loss for the quarter ended June 30, 2004 was $9.1 million, or
$0.26 per share, compared to a net loss of $4.3 million, or $0.16 per share,
in the second quarter of 2003. The net loss for the six months ended June 30,
2004 was $19.2 million, or $0.54 per share, compared to a net loss of
$9.0 million, or $0.33 per share, for the same period in 2003. The increase in
net loss in 2004 was primarily due to an increase in Phase III clinical trial
activities for Oxytrex(TM) and PTI-901 and development activities for
Remoxy(TM).
Cash, cash equivalents and marketable securities were $61.0 million at
June 30, 2004. The Company continues to expect its cash requirements for 2004
to be approximately $37 million, plus or minus 10 percent.
"We achieved a number of milestones this quarter with our drug
candidates," said Remi Barbier, president and chief executive officer. "We
recently announced positive clinical results in two anti-abuse studies with
Remoxy, our abuse-resistant version of time-release oxycodone. We remain
committed to the goal of initiating a Phase III study with Remoxy by year-end.
Our Oxytrex and PTI-901 programs are in line with our expectations. In
addition, we presented positive pre-clinical results in neuropathic pain at
the American Pain Society meeting this past May."
Research and development expenses for the second quarter of 2004 increased
to $8.2 million from $3.7 million for the same three-month period in 2003.
Research and development expenses for the six months ended June 30, 2004
increased to $17.7 million from $7.5 million for the same period in 2003. The
increase in research and development expenses was primarily due to Phase III
clinical trial activities for Oxytrex and PTI-901 and development activities
for Remoxy in 2004.
General and administrative expenses for the second quarter of 2004
increased to $1.1 million from $0.8 million for the same period in 2003.
General and administrative expenses for the six months ended June 30, 2004
increased to $2.0 million from $1.7 million for the same period in 2003. The
increase in general and administrative expenses resulted primarily from higher
non-cash equity related expenses.
About Pain Therapeutics, Inc.
We are a biopharmaceutical company that develops novel drugs. Our drugs
target severe chronic pain, such as pain associated with osteoarthritis,
low-back pain or irritable bowel syndrome. We have three unique drug
candidates in clinical development: Oxytrex, Remoxy and PTI-901. Our two most
advanced drugs, Oxytrex and PTI-901, are in Phase III clinical trials. We
believe the target market for our three drug candidates exceeds $3 billion per
year. We currently retain commercial rights to our drug candidates.
For more information please visit our website at www.paintrials.com.
Note Regarding Forward-Looking Statements: This press release contains
forward-looking statements for purposes of the Private Securities Litigation
Reform Act of 1995 (the "Act"). PTI disclaims any intent or obligation to
update these forward-looking statements, and claims the protection of the Safe
Harbor for forward-looking statements contained in the Act. Examples of such
statements include, but are not limited to, any statements relating to the
timing or scope of the Company's clinical development of its drug candidates,
the Company's expected cash requirements for 2004, the potential benefits of
the Company's drug candidates and the size of the potential market for the
Company's products. Such statements are based on management's current
expectations, but actual results may differ materially due to various factors.
Such statements involve risks and uncertainties, including, but not limited
to, those risks and uncertainties relating to difficulties or delays in
development, testing, regulatory approval, production and marketing of the
Company's drug candidates, unexpected adverse side effects or inadequate
therapeutic efficacy of the Company's drug candidates that could slow or
prevent product approval or market acceptance (including the risk that current
and past results of clinical trials are not necessarily indicative of future
results of clinical trials), the uncertainty of patent protection for the
Company's intellectual property or trade secrets, the Company's ability to
obtain additional financing if necessary and unanticipated research and
development and other costs. For further information regarding these and
other risks related to the Company's business, investors should consult the
Company's filings with the Securities and Exchange Commission, including its
Form 10-K/A for the year ended December 31, 2003 and its subsequent periodic
filings.
PAIN THERAPEUTICS, INC.
(A Development Stage Enterprise)
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2004 2003 2004 2003
Operating expenses (1):
Research and
development $8,181 $3,715 $17,677 $7,503
General and
administrative 1,106 751 2,044 1,720
Total operating
expenses 9,287 4,466 19,721 9,223
Operating loss (9,287) (4,466) (19,721) (9,223)
Other income:
Interest income 221 120 491 261
Net loss $(9,066) $(4,346) $(19,230) $ (8,962)
Basic and diluted
loss per common share $(0.26) $(0.16) $(0.54) $(0.33)
Weighted-average shares
used in computing basic
and diluted loss per
common share 35,499 27,334 35,463 27,250
(1) Included in research and development and general and administrative
expenses are stock based compensation expenses of $259
thousand and ($16) thousand for the three-month periods ended
June 30, 2004 and 2003, respectively, and $312 thousand and $87
thousand for the six-month periods ending June 30, 2004 and 2003,
respectively.
PAIN THERAPEUTICS, INC.
(A Development Stage Enterprise)
BALANCE SHEETS
(in thousands)
June 30, December 31,
2004 2003(2)
Assets
Current assets:
Cash, cash equivalents and marketable
securities $60,992 $77,429
Prepaid expenses 46 1,321
Total current assets 61,038 78,750
Property and equipment, net 1,791 1,688
Other assets 75 75
Total assets $62,904 $80,513
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $817 $2,231
Accrued development expense 3,566 1,210
Accrued compensation and benefits 643 369
Other accrued liabilities 135 141
Total liabilities 5,161 3,951
Stockholders' Equity:
Common stock 36 35
Additional paid-in-capital 151,451 150,732
Deferred compensation -- (7)
Accumulated other comprehensive income (loss) (267) 50
Deficit accumulated during the development
stage (93,477) (74,248)
Total stockholders' equity 57,743 76,562
Total liabilities and stockholders' equity $62,904 $80,513
(2) Derived from audited financial statements.
SOURCE Pain Therapeutics, Inc.
-0- 07/20/2004
/CONTACT: Christi Waarich, Senior Manager of Investor Relations of Pain
Therapeutics, Inc., +1-650-825-3324, or cwaarich@paintrials.com; or media,
Kathy Nugent, Ph.D. of Burns McClellan, +1-212-213-0006, for Pain
Therapeutics, Inc./
/Web site: http://www.paintrials.com /
(PTIE)
CO: Pain Therapeutics, Inc.
ST: California
IN: HEA BIO MTC
SU: ERN ERP