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 22, 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 July 22, 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 July 22, 2003, Pain Therapeutics, Inc. issued a press release
announcing its results for the quarterly period ending June 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: July 22, 2003
By: /s/ Peter S. Roddy
-----------------------
Peter S. Roddy
Chief Financial Officer
EXHIBIT INDEX
Exhibit
Number Description
------- ----------------------------------------------
99.1 Press Release, Dated July 22, 2003
Exhibit 99.1
For More Information Contact:
Christi Waarich
Manager of Investor Relations
Pain Therapeutics, Inc.
cwaarich@paintrials.com
650-825-3324
FOR IMMEDIATE RELEASE
- ---------------------
PAIN THERAPEUTICS ANNOUNCES
SECOND QUARTER 2003 FINANCIAL RESULTS
SOUTH SAN FRANCISCO, Calif. - July 22, 2003 - Pain Therapeutics, Inc. (Nasdaq:
PTIE), a medical research company, today reported financial results for the
three and six months ended June 30, 2003.
The net loss for the quarter ended June 30, 2003 was $4.3 million, or $0.16 per
share, compared to a net loss of $3.7 million, or $0.14 per share in the second
quarter of 2002. The net loss for the six months ended June 30, 2003 was $9.0
million, or $0.33 per share, compared to a net loss of $7.7 million, or $0.29
per share for the same period in 2002.
Cash and cash equivalents totaled $42.5 million at June 30, 2003. The Company
continues to expect its cash requirements for 2003 to be approximately $20
million. The increase in cash requirements in the second half of 2003 will be in
connection with an increase in clinical trial activity.
"We achieved several important clinical milestones this quarter with both of our
lead drug candidates," said Remi Barbier president and chief executive officer.
"In June, we announced successful clinical results with Oxytrex(TM), our
investigational new drug for chronic pain. In a 350 patient Phase II study,
Oxytrex(TM) met the primary endpoint of reducing chronic pain with statistical
significance against both oxycodone (p=0.006) and placebo (p<0.001) during a
21-day treatment period. As a result of these data, we recently announced the
initiation of a pivotal Phase III study with Oxytrex(TM). Our pipeline also
includes PTI-901, an investigational new drug to treat patients with Irritable
Bowel Syndrome. In late May, we announced encouraging clinical results with
PTI-901 in a 50 patient open-label study. We remain committed to the goal of
initiating a 600 patient Phase III study with PTI-901 later this year."
Research and development expenses for the second quarter of 2003 increased to
$3.7 million from $2.7 million for the same three-month period in 2002. Research
and development expenses for the six months ended June 30, 2003 increased to
$7.5 million from $5.5 million for the same 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 safety study and the initiation of the
Phase III study with Oxytrex(TM).
General and administrative expenses for the second quarter of 2003 decreased to
$0.8 million from $1.3 million for the same period in 2002. General and
administrative expenses for the six months ended June 30, 2003 decreased to $1.7
million from $2.8 million for the same period in 2002. The decrease in general
and administrative expenses resulted primarily from lower non-cash equity
related expenses.
About Opioid Drugs
- ------------------
Opioid drugs (sometimes called `narcotic painkillers') are derived from the
opium poppy plant. These drugs are widely used throughout the world to treat
severe pain. In the United States, for example, sales of opioid drugs exceed $3
billion per year. Despite widespread use, opioid drugs have debilitating effects
that limit their true potential to treat pain. Acute use often results in side
effects, such as nausea or vomiting. Chronic use may lead to tolerance,
dependence, abuse, or, more rarely, addiction. As a result, some patients prefer
to suffer through pain rather than to endure the ill effects of opioid drugs.
The under-treatment of chronic pain is a serious and growing problem in the U.S.
For example, according to the National Institutes of Health, over 40 million
Americans are unable to find relief from their pain.
About Pain Therapeutics, Inc.
- -----------------------------
We are a medical research company specializing in the discovery and development
of novel proprietary painkillers. We believe one of our lead drug candidates,
Oxytrex(TM), may offer more pain relief (with no increase in side-effects) or
lower tolerance/dependence, withdrawal effects or addiction potential compared
to conventional forms of oxycodone. The market for oxycodone exceeded $1.5
billion in the United States in 2002. Another drug candidate, PTI-901, is aimed
at treating patients who suffer from abdominal pain associated with Irritable
Bowel Syndrome (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 and it is Pain Therapeutics' intent that such statements be
protected by the safe harbor created thereby. Examples of such statements
include, but are not limited to, any statements relating to the timing, breadth
or anticipated results of the Company's clinical development of its drug
candidates, the potential benefits of the Company's drug candidates, the
expected cash requirements for 2003 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 July 18, 2003.
-Financial Tables Follow-
PAIN THERAPEUTICS, INC.
(A Development Stage Enterprise)
CONDENSED STATEMENTS OF OPERATION
(in thousands except per share data)
(Unaudited)
Three months ended Six months ended
June 30, June 30,
----------------------------- --------------------
2003 2002 2003 2002
-------- -------- -------- --------
Operating expenses (1):
Research and development $ 3,715 $ 2,674 $ 7,503 $ 5,490
General and administrative 751 1,307 1,720 2,812
-------- -------- -------- --------
Total operating expenses 4,466 3,981 9,223 8,302
-------- -------- -------- --------
Operating loss (4,466) (3,981) (9,223) (8,302)
Other income:
Interest income 120 266 261 561
-------- -------- -------- --------
Net loss $ (4,346) $ (3,715) $ (8,962) $ (7,741)
======== ======== ======== ========
Basic and diluted loss per share $ (0.16) $ (0.14) $ (0.33) $ (0.29)
======== ======== ======== ========
Weighted-average shares used in computing
basic and diluted loss per share 27,334 27,037 27,250 26,973
======== ======== ======== ========
(1) Included in research and development and general and administrative expenses
are stock-based compensation expenses (reduction in expenses) of ($16) and $191
for the three months ended June 30, 2003 and 2002, respectively, and $87 and
$533 for the six months ended June 30, 2003 and 2002.
PAIN THERAPEUTICS, INC.
(A Development Stage Enterprise)
BALANCE SHEETS
(in thousands)
(Unaudited)
June 30, December 31,
2003 2002
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Assets
Current assets:
Cash and cash equivalents $ 42,546 $ 50,091
Interest receivable 38 55
Prepaid expenses 41 1,101
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Total current assets 42,625 51,247
Property and equipment, net 1,831 2,003
Other assets 75 75
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Total assets $ 44,531 $ 53,325
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Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 1,731 $ 2,648
Accrue compensation and benefits 541 273
Accrued liabilities 123 180
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Total liabilities 2,395 3,101
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Stockholders' equity
Common stock 27 27
Additional paid-in-capital 103,770 103,254
Deferred compensation (58) (304)
Notes receivable from stockholders (10) (122)
Deficit accumulated during the development stage (61,593) (52,631)
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Total stockholders' equity 42,136 50,224
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Total liabilities and stockholders' equity $ 44,531 $ 53,325
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