-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, VnYiydZA62/n3WLZDbcJ8Lur0kucy++DM+gJhD82pn36L9mMrarB9CHwDCYfRMvW aR2uhLOyAtHT1NeqCWP7Zw== 0000891092-03-001631.txt : 20030723 0000891092-03-001631.hdr.sgml : 20030723 20030722214056 ACCESSION NUMBER: 0000891092-03-001631 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030722 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20030723 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PAIN THERAPEUTICS INC CENTRAL INDEX KEY: 0001069530 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 911911336 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29959 FILM NUMBER: 03797321 BUSINESS ADDRESS: STREET 1: 250 EAST GRAND AVENUE STREET 2: SUITE 70 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 6506248200 MAIL ADDRESS: STREET 1: 250 EAST GRAND AVENUE STREET 2: SUITE 70 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 8-K 1 e15252_8k.txt FORM 8-K 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 EX-99.1 3 e15252ex99_1.txt PRESS RELEASE 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 --------- ------------ Assets Current assets: Cash and cash equivalents $ 42,546 $ 50,091 Interest receivable 38 55 Prepaid expenses 41 1,101 --------- --------- Total current assets 42,625 51,247 Property and equipment, net 1,831 2,003 Other assets 75 75 --------- --------- Total assets $ 44,531 $ 53,325 ========= ========= Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 1,731 $ 2,648 Accrue compensation and benefits 541 273 Accrued liabilities 123 180 --------- --------- Total liabilities 2,395 3,101 --------- --------- 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) --------- --------- Total stockholders' equity 42,136 50,224 --------- --------- Total liabilities and stockholders' equity $ 44,531 $ 53,325 ========= =========
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