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) October 21, 2003
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 9. Regulation FD Disclosure (pursuant to "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 October 21, 2003
Item 9. Regulation FD Disclosure (pursuant to "Item 12. Results of Operations
and Financial Condition")
In accordance with SEC Release No. 33-8216, the following information,
intended to be furnished under "Item 12. Results of Operations and Financial
Condition," is instead furnished under "Item 9. Regulation FD Disclosure." 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, 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.
On October 21, 2003, Pain Therapeutics, Inc. issued a press release
announcing its results for the quarterly period ending September 30, 2003. A
copy of this press release is attached hereto as Exhibit 99.1.
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: October 21, 2003
By: /s/ Peter S. Roddy
-----------------------------
Peter S. Roddy
Chief Financial Officer
EXHIBIT INDEX
Exhibit
Number Description
- ------- -----------------------------------------------
99.1 Press Release, Dated October 21, 2003
Exhibit 99.1
Pain Therapeutics Announces Third Quarter 2003 Financial Results
SOUTH SAN FRANCISCO, Calif., Oct. 21 /PRNewswire-FirstCall/ -- Pain
Therapeutics, Inc. (Nasdaq: PTIE), a biopharmaceutical company, today reported
financial results for the three and nine months ended September 30, 2003.
The net loss for the quarter ended September 30, 2003 was $6.0 million, or
$0.21 per share, compared to a net loss of $3.1 million, or $0.11 per share in
the third quarter of 2002. The net loss for the nine months ended September
30, 2003 was $14.9 million, or $0.54 per share, compared to a net loss of
$10.8 million, or $0.40 per share for nine months ended September 30, 2002.
Cash, cash equivalents and marketable securities totaled $83.2 million at
September 30, 2003, including net proceeds of approximately $46.3 million from
the September 2003 follow-on offering of 7.65 millions shares of common stock.
The Company continues to expect its cash requirements for 2003 to be
approximately $20 million.
"These financial results are in line with all of our clinical and
corporate milestones," said Remi Barbier, president and chief executive
officer. "We believe our current cash position will enable us to develop two
drug candidates through late-stage development while continuing to own
worldwide commercial rights to these drugs."
Research and development expenses for the third quarter of 2003 increased
to $5.4 million from $2.1 million for the same three-month period in 2002.
Research and development expenses for the nine months ended September 30, 2003
increased to $12.9 million from $7.6 million for the same nine-month period in
2002. The increase in research and development expenses was primarily due to
costs related to the completion of the Oxytrex(TM) 21-day Phase II study, the
initiation of one Phase III study with Oxytrex in June, and formulation-
related development expenses.
General and administrative expenses for the second quarter of 2003
decreased to $0.7 million from $1.2 million for the same period in 2002.
General and administrative expenses for the nine months ended September 30,
2003 decreased to $2.5 million from $4.0 million for the same period in 2002.
The decrease in general and administrative expenses resulted primarily from
lower non-cash equity related expenses as well as a reclassification of
occupancy and other expenses to research and development in 2003.
Conference Call and Webcast Information
Pain Therapeutics will be hosting a conference call today at 11:00 a.m.
Pacific Time/2:00 p.m. Eastern Time to discuss these results, including the
Company's clinical programs. Participants can listen to the conference call
via webcast on the Company's website, www.paintrials.com or by dialing 303-
262-2050 or 800-218-0204. A replay of the webcast will remain on the
Company's site for at least 30 days.
About Pain Therapeutics, Inc.
We are a biopharmaceutical company specializing in the clinical
development of novel painkillers. We believe our unique insights into the
biology and biochemistry of pain will allow us to develop new drugs that
address unmet needs in pain management. Our lead candidate, Oxytrex, a small
molecule drug to treat severe chronic pain, is currently in Phase III clinical
development. Our clinical studies indicate that Oxytrex offers more pain
relief with no increase in side-effects, compared to oxycodone. The market
for oxycodone exceeded $1.5 billion in the United States in 2002. Another drug
candidate, PTI-901 is a small molecule drug to treat IBS. We believe a safe
and efficacious drug to treat IBS represents a $1 billion market opportunity.
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, scope or expected outcome of the Company's clinical development of its
drug candidates, the Company's expected cash requirements in 2003 and through
late-stage development of its drug candidates, 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 S-3 as amended, filed September 22, 2003.
PAIN THERAPEUTICS, INC.
(A Development Stage Enterprise)
CONDENSED STATEMENTS OF OPERATIONS
(in thousands except per share data, unaudited)
Three months ended Nine months ended
September 30, September 30,
2003 2002 2003 2002
Operating expenses (1):
Research and
development $5,358 $2,130 $12,861 $7,620
General and
administrative 735 1,159 2,456 3,972
Total operating
expenses 6,093 3,289 15,317 11,592
Operating loss (6,093) (3,289) (15,317) (11,592)
Interest income 124 239 385 801
Net loss $(5,969) $(3,050) $(14,932) $(10,791)
Basic and diluted
loss per share $(0.21) $(0.11) $(0.54) $(0.40)
Weighted-average shares
used in computing basic
and diluted loss per
share 27,999 27,094 27,502 27,014
(1) Included in research and development and general and administrative
expenses are stock-based compensation expenses (reduction in
expenses) of ($27) and ($393) for the three months ended September
30, 2003 and 2002, respectively, $60 and $141 for the nine months
ended September 30, 2003 and 2002, respectively and $11,850 for the
period from May 4, 1998 (inception) through September 30, 2003.
BALANCE SHEETS
(in thousands, unaudited)
September 30, December 31,
2003 2002
Assets
Current assets:
Cash and cash equivalents $46,900 $50,091
Marketable securities 36,290 55
Prepaid and other expenses 1,626 1,101
Total current assets 84,816 51,247
Property and equipment, net 1,747 2,003
Other assets 75 75
Total assets $86,638 $53,325
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $3,537 $2,648
Accrued compensation and benefits 359 273
Other accrued liabilities 122 180
Total liabilities 4,018 3,101
Stockholders' equity:
Common stock 35 27
Additional paid-in-capital 150,149 103,254
Deferred compensation (26) (304)
Notes receivable from stockholders (10) (122)
Accumulated other comprehensive income 35 --
Deficit accumulated during the development
stage (67,563) (52,631)
Total stockholders' equity 82,620 50,224
Total liabilities and stockholders' equity $86,638 $53,325
SOURCE Pain Therapeutics, Inc.
-0- 10/21/2003
/CONTACT: Christi Waarich, Manager of Investor Relations of Pain
Therapeutics, Inc., +1-650-825-3324, or cwaarich@paintrials.com/
/Web site: http://www.paintrials.com/
(PTIE)
CO: Pain Therapeutics, Inc.
ST: California
IN: HEA MTC BIO
SU: ERN CCA