-----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, DAPGak/G5KUf+eTvi6fPf7EYVwO8jnEMUXtfd2JCC5fbJ4cqmvMAYm4d7Sm0AH7O Xhag0q31cX/h0oUx/Yz7cA== 0001104659-08-014837.txt : 20080304 0001104659-08-014837.hdr.sgml : 20080304 20080303183911 ACCESSION NUMBER: 0001104659-08-014837 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080228 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080304 DATE AS OF CHANGE: 20080303 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PONIARD PHARMACEUTICALS, INC. CENTRAL INDEX KEY: 0000755806 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 911261311 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-16614 FILM NUMBER: 08661235 BUSINESS ADDRESS: STREET 1: 7000 SHORELINE COURT STREET 2: SUITE 270 CITY: SO. SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 2062817001 MAIL ADDRESS: STREET 1: 300 ELLIOTT AVENUE WEST STREET 2: SUITE 500 CITY: SEATTLE STATE: WA ZIP: 98119-4114 FORMER COMPANY: FORMER CONFORMED NAME: NEORX CORP DATE OF NAME CHANGE: 19920703 8-K 1 a08-7040_18k.htm 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

 

February 28, 2008

Date of Report (Date of earliest event reported)

 

Poniard Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Washington

(State or Other Jurisdiction
of Incorporation)

 

0-16614

(Commission File No.)

 

91-1261311

(IRS Employer
Identification No.)

 

7000 Shoreline Court, Suite 270, South San Francisco CA

94080

(Address of principal executive offices)

(Zip Code)

 

(650) 583-5727

(Registrant’s telephone number, including area code)

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

                Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨    Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 



 

Section 1 — Registrant’s Business and Operations

 

Item 1.01.                                          Entry into a Material Definitive Agreement.

 

(a)           On February 29, 2008, Poniard Pharmaceuticals, Inc. entered into amended and restated change of control and key executive severance agreements with the following company officers: Jerry McMahon, Chief Executive Officer; Caroline M. Loewy, Chief Financial Officer; Ronald A. Martell, President & Chief Operating Officer; David A. Karlin, Senior Vice President, Clinical Development & Regulatory; Anna L. Wight, Vice President, Legal; and Cheni Kwok, Vice President, Business Development. These agreements amend and replace the existing severance and change of control agreements between the company and the named officers. The amended and restated change of control agreements modify certain benefits payable to the named officers in the circumstances described in those agreements. The amended and restated severance agreements address Internal Revenue Code Section 409A compliance matters and do not otherwise modify the benefits payable to the named officers.

 

The amended and restated change of control agreements provide each of the named officers with termination compensation if, within two years following a change of control of the company, the officer’s employment with the company or an affiliated company is terminated without cause or the officer terminates his or her employment for good reason. In such case, each officer, other than Dr. McMahon, is entitled to the annual performance bonus (prorated for the number of days served during the year of termination); twelve months of medical and dental insurance benefits; severance pay equal to one times the annual performance bonus and one times annual base salary; and full acceleration of stock option vesting. Dr. McMahon is entitled to the annual performance bonus (prorated for the number of days served during the year of termination); eighteen months of medical and dental insurance benefits; severance pay equal to one times the annual performance bonus and two times annual base salary; and full acceleration of stock option vesting.

 

A “change of control” is triggered upon the occurrence of certain mergers, consolidations or reorganizations of the company; the liquidation or dissolution of the company or the sale of substantially all of the company’s assets; acquisition of beneficial ownership of 20% or more of the outstanding common stock or voting power of the company by a person or group of related persons, if such acquisition is approved in advance by a majority of the incumbent directors; acquisition of beneficial ownership of 33% or more of the outstanding common stock or voting power of the company by a person or group of related persons, if such acquisition is approved in advance by a majority of the incumbent directors; or the failure of incumbent board members (or persons nominated or appointed by incumbent board members) to hold a majority of the seats on the company’s board of directors. The definitions of “cause” and “good reason” under the change of control agreements are substantially the same as those in the amended and restated executive severance agreements described below. Each amended and restated change of control agreement runs for an initial one-year term and renews automatically for successive one-year periods unless either party gives 90 days’ prior written notice of non-renewal, except that Dr. McMahon’s amended and restated change of control agreement has an initial two-year term and renews for successive two-year periods. If a change of control occurs, each agreement automatically renews and runs for a period of two additional years.

 

The amended and restated key executive severance agreement of Mr. Martell, Ms. Loewy, Dr. Karlin, Ms. Wight and Dr. Kwok each provide that, if the Company terminates the officer’s employment without cause, or if he or she terminates his or her employment for good reason, the officer is entitled to receive a severance payment of 75% of his or her current annual base salary and up to nine months’ medical and dental insurance benefits and, if applicable, reimbursement of excise taxes. Cash severance payments are in the form of salary continuation, payable at normal payroll intervals during the nine months following the date of termination. Each agreement runs for an initial one-year term and renews automatically for successive one-year periods unless either party gives nine months’ prior written notice or non-renewal. Dr. McMahon’s executive severance agreement provides for a severance payment equal to 100% of current annual base salary, payable in the form

 

1



 

 

of salary continuation for one year following the date of termination, up to one year’s medical and dental insurance benefits and, if applicable, reimbursement of excise taxes. Dr. McMahon’s severance agreement runs for an initial term of four years and renews automatically for successive two-year periods unless either party gives 90 days’ prior notice of non-renewal. In all cases, as a condition to receiving any severance payment, each officer must execute a general release of claims against the company in a form satisfactory to the company in its sole discretion. To the extent that severance payments and benefits under the amended and restated change of control agreements described below are payable to an officer, no payments will be made to such officer under his or her severance agreement.

 

The amended and restated severance agreements define “cause” as: a clear refusal to carry out any of the officer’s material lawful duties; persistent failure to carry out any of the officer’s lawful duties after reasonable notice and an opportunity to correct the failure; violation by the officer of a state or federal criminal law involving a crime against the company or any other crime involving moral turpitude; the officer’s current abuse of alcohol or controlled substances; deception, fraud, misrepresentation or dishonesty by the officer; any incident materially compromising the officer’s reputation or ability to represent the company with the public; or any other material violation of the agreement after notice and an opportunity to cure. “Good reason” includes a reduction of the officer’s annual salary below the level in effect on the date of the agreement, regardless of any change in the officer’s duties; the assignment of the officer to any duties inconsistent with or resulting in a diminution of the officer’s position, duties or responsibilities (excluding actions of the company not taken in bad faith and promptly remedied); requiring the officer to be based at any office or location more than a designated number of miles from the city in which the officer currently is employed; the company’s failure to properly assign the agreement to a successor; or any other material violation of any provision of the agreement after notice and an opportunity to cure.

 

Copies of the amended and restated change of control agreements and the amended and restated key employee severance agreements will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ending March 31, 2008.

 

Item 2 — Financial Information

 

Item 2.02.                                          Results of Operations and Financial Condition.

 

The Company issued a press release dated February 28, 2008, announcing the financial results for the quarter and year ended December 31, 2007. The full text of the press release is set forth in Exhibit 99.1 attached hereto. The press release should be read in conjunction with the note regarding forward-looking statements, which is included in the text of the press release.

 

The information in this Item 2.02 and attached Exhibit 99.1 to this report will not be treated as “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section. This information will not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or into another filing under the Exchange Act, unless that filing expressly incorporates this information by reference.

 

Item 9.01.                                          Financial Statements and Exhibits.

 

                                                (d)           Exhibits

 

Exhibit 99.1                                                                               Press release dated February 28, 2008

 

2



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

Poniard Pharmaceuticals, Inc.

 

 

 

 

Dated: March 3, 2008

By:

/s/Anna Lewak Wight

 

 

Anna Lewak Wight

 

 

Vice President, Legal

 

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EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release dated February 28, 2008

 

4


EX-99.1 2 a08-7040_1ex99d1.htm EX-99.1

 

Exhibit 99.1

 

 

Poniard Pharmaceuticals Reports Fourth Quarter and Year-End 2007

Financial Results and Corporate Update

 

Conference Call Today at 5:00 p.m. Eastern Time —

 

South San Francisco, Calif. (February 28, 2008) — Poniard Pharmaceuticals, Inc. (NASDAQ: PARD), a biopharmaceutical company focused on oncology, today reported on its corporate progress and financial results for the fourth quarter and year ended December 31, 2007.

 

“Our 2007 fourth quarter accomplishments capped a productive year in which we made significant advancements in all aspects of our clinical development program for picoplatin, our lead product candidate,” said Jerry McMahon, Ph.D., chairman and CEO of Poniard. “We initiated a Phase 2 trial in metastatic colorectal cancer and completed patient enrollment in a Phase 2 trial in hormone-refractory prostate cancer — two solid tumor malignancies for which there is significant medical need. We also continued to advance our pivotal SPEAR trial in small cell lung cancer and believe that we will have top-line data from this trial in mid-2009. Our progress and continued focus demonstrate our dedication to developing picoplatin as a new generation chemotherapy agent with the potential to become a platform product addressing multiple indications, combinations and formulations.”

 

Fourth Quarter and Recent Highlights

 

Picoplatin and Development Pipeline

 

·                  Presented safety data from a Phase 1 dose-escalation study of picoplatin in patients with metastatic colorectal cancer (mCRC) at the American Society of Clinical Oncology’s (ASCO) 2008 Gastrointestinal Cancers Symposium. Results showed that none of the patients treated with picoplatin exhibited a Grade 2 or higher neuropathy. Mild nephrotoxicity and ototoxicity were observed infrequently. The dose limiting toxicity was most frequently hematological with neutropenia and thrombocytopenia.

 

·                  Initiated a Phase 2 clinical trial for the first-line treatment of mCRC evaluating the use of intravenous picoplatin as a replacement for oxaliplatin. This randomized, 100-patient trial is evaluating whether picoplatin given once every four weeks in combination with standard dose 5-fluorouracil and leucovorin in the FOLPI regimen demonstrates trends toward equivalent or better efficacy than oxaliplatin in combination with 5-fluorouracil and leucovorin in the FOLFOX regimen without the substantial neurotoxicity associated with oxaliplatin.

 

·                  Presented encouraging safety and efficacy data from a Phase 1 dose-escalation study of picoplatin in patients with hormone-refractory prostate cancer (HRPC), at ASCO’s 2008 Genitourinary Cancers Symposium. Results showed that 65 percent of the 31 evaluable patients exhibited positive prostate specific antigen (PSA) response in patients treated with picoplatin and full-dose docetaxel and prednisone, the current standard of care. These encouraging results compare with published PSA response rates of 45 percent with docetaxel and prednisone alone. These results support the Company’s ongoing

 



 

Phase 2 trial of picoplatin in HRPC, data from which will be presented this year at scientific conferences.

 

·                  Completed enrollment in a Phase 2 trial of intravenous picoplatin in approximately 30 patients for the treatment of metastatic HRPC in combination with full-dose docetaxel (Taxotere®) and prednisone, the standard of care in the first-line setting.

 

·                  Announced preliminary data from an ongoing Phase 1 clinical trial of oral picoplatin in patients with advanced solid tumor malignancies showing that picoplatin can achieve oral bioavailability of 30 to 40 percent in doses tested to date, which is consistent with earlier preclinical oral bioavailability studies. In addition, the Company expanded the study, based on promising findings, to include additional dose levels to enhance data analysis.

 

·                  Continued to open sites and advance our ongoing pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of intravenous picoplatin. This registrational trial is being conducted under a Special Protocol Assessment from the U.S. Food and Drug Administration and is evaluating overall survival as the primary endpoint.

 

·                  Received orphan medicinal product designation from the Committee for Orphan Medicinal Products of the European Medicines Agency for picoplatin for the treatment of small cell lung cancer (SCLC).

 

Management Appointments

 

·                  Appointed Robert De Jager, M.D., as chief medical officer of the Company.

 

2007 Financial Results

 

The Company reported a net loss of $9.6 million ($0.28 diluted loss per share on a loss applicable to common shares of $9.7 million) for the fourth quarter of 2007 compared to a net loss of $6.1 million ($0.27 diluted loss per share on a loss applicable to common shares of $6.2 million) for the same period in 2006. Net loss for the year ended December 31, 2007 was $32.8 million ($1.08 diluted loss per share on a loss applicable to common shares of $33.3 million) compared to a net loss of $23.3 million ($1.37 diluted loss per share on a loss applicable to common shares of $23.8 million) for the year ended December 31, 2006.

 

There was no revenue for the quarter and year ended December 31, 2007, nor was there revenue for the quarter and year ended December 31, 2006.

 

Total operating expenses for the fourth quarter of 2007 increased 61 percent to $10.4 million, from $6.5 million for the fourth quarter of 2006, due primarily to higher clinical costs associated with the Company’s picoplatin trials and the recognition of stock option expense. Total operating expenses increased 66 percent to $35.4 million for the year ended December 31, 2007, from $21.2 million for the same period in 2006.

 

Research and development (R&D) expenses increased 66 percent to $7.0 million for the fourth quarter of 2007, from $4.2 million for the fourth quarter of 2006, and increased 75 percent to $23.4 million for the year ended December 31, 2007, from $13.4 million for the same period in 2006. The increase in R&D expenses for the quarter and year ended December 31, 2007 resulted from higher clinical costs associated with the Company’s picoplatin trials and increased costs for other R&D efforts.

 

General and administrative (G&A) expenses increased 90 percent to $3.5 million for the fourth quarter of 2007, compared with $1.8 million for the fourth quarter of 2006 and increased 60 percent to $12.1 million for the year ended December 31, 2007, from $7.5 million for the same

 

2



 

period in 2006. The increases in G&A costs for the quarter and year ended December 31, 2007 are primarily due to the recording of stock options expense and increased personnel costs.

 

Cash and investment securities as of December 31, 2007 was $92.6 million, compared with $53.7 million at December 31, 2006. Management currently believes the existing cash and investment securities will provide adequate resources to fund the Company’s operations at least through the second quarter of 2009.

 

Based on updated analysis and projections of the timelines for the Phase 3 SPEAR trial for SCLC, the Company currently expects that top-line data from this trial will be available in mid-2009.

 

During 2008 the Company intends to:

 

·                  Fully enroll the Phase 2 mCRC trial in the first half of 2008, and present clinical data from the Phase 2 mCRC trial at scientific meetings throughout the year,

 

·                  Present clinical data from the Phase 2 HRPC trial at scientific meetings this year

 

·                  Present data from the Phase 1 oral picoplatin study at scientific meetings this year and

 

·                  Advance the Phase 3 SPEAR trial in SCLC

 

Conference Call Details

To participate in today’s live call by telephone, please dial 877-604-9669 from the U.S. or +1-719-325-4913 for international callers. In addition, the live conference call is being webcast and can be accessed on the “Events” page of the “News & Events” section of the Company’s website at www.poniard.com. A replay will also be available online for 14 days following the live presentation.

 


About Poniard Pharmaceuticals

Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative oncology products to impact the lives of people with cancer. Picoplatin, the Company’s lead platform product candidate, is a new generation platinum therapy with an improved safety profile relative to existing platinum-based cancer therapies. Picoplatin is designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors, and is being studied in multiple cancer indications, combinations and formulations. Clinical trials of intravenous picoplatin include a Phase 3 trial in small cell lung cancer and Phase 2 trials in metastatic colorectal and hormone-refractory prostate cancer, as well as a clinical trial of oral picoplatin in solid tumors. Picoplatin has not been approved by regulatory authority for use in humans. For additional information please visit www.poniard.com.

 

3



 

Poniard Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except per share data)

(Unaudited)

 

 

 

Three Months Ended December 31,

 

Twelve Months Ended December 31,

 

 

 

2007

 

2006

 

2007

 

2006

 

Revenues

 

$

 

$

 

$

 

$

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

7,011

 

4,221

 

23,373

 

13,356

 

General and administrative

 

3,501

 

1,845

 

12,085

 

7,548

 

Realized gain on equipment disposal

 

(105

)

 

(105

)

(73

)

Asset impairment

 

 

403

 

 

403

 

Total operating expenses

 

10,407

 

6,469

 

35,353

 

21,234

 

Loss from operations

 

(10,407

)

(6,469

)

(35,353

)

(21,234

)

Other income (expense), net

 

841

 

348

 

2,571

 

(2,060

)

Net loss

 

(9,566

)

(6,121

)

(32,782

)

(23,294

)

 

 

 

 

 

 

 

 

 

 

Preferred stock dividends

 

(125

)

(125

)

(500

)

(500

)

Loss applicable to common shares

 

$

(9,691

)

$

(6,246

)

$

(33,282

)

$

(23,794

)

 

 

 

 

 

 

 

 

 

 

Loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.28

)

$

(0.27

)

$

(1.08

)

$

(1.37

)

 

 

 

 

 

 

 

 

 

 

Shares used in calculation of loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

34,660

 

22,808

 

30,762

 

17,376

 

 

Condensed Consolidated Balance Sheets

(In thousands)

(Unaudited)

 

 

 

December 31, 2007

 

December 31, 2006

 

ASSETS:

 

 

 

 

 

Cash and investment securities

 

$

92,621

 

$

53,710

 

Cash - restricted

 

281

 

136

 

Facilities and equipment, net

 

1,121

 

525

 

Assets held for sale

 

 

2,624

 

Licensed products, net

 

10,021

 

11,236

 

Other assets

 

1,096

 

836

 

Total assets

 

$

105,140

 

$

69,067

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY:

 

 

 

 

 

Current liabilities

 

$

9,474

 

$

12,201

 

Long term liabilities

 

6,561

 

9,975

 

Shareholders’ equity

 

89,105

 

46,891

 

Total liabilities and shareholders’ equity

 

$

105,140

 

$

69,067

 

 

4



 

This release contains forward-looking statements, including statements regarding the Company’s financial condition and results of operations,  business objectives and strategic goals, drug development plans, timing and results of clinical trials and the potential safety and efficacy of its products in development. The Company’s actual results may differ materially from those indicated in these forward-looking statements based on a number of factors, including risks and uncertainties associated with the Company’s research and development activities; the results of pre-clinical and clinical testing; the receipt and timing of required regulatory approvals; the market’s acceptance of the Company’s proposed products; the Company’s anticipated operating losses, need for future capital and ability to obtain future funding; competition from third parties; the Company’s ability to preserve and protect intellectual property rights; the Company’s dependence on third-party manufacturers and suppliers; the Company’s lack of sales and marketing experience; the Company’s ability to attract and retain key personnel; changes in technology, government regulation and general market conditions; and the risks and uncertainties described in the Company’s current and periodic reports filed with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2006, as amended, and most current Quarterly Report on Form 10-Q, as well as the Company’s Annual Report on Form 10-K for the year ended December 31, 2007, which will be filed with the SEC on or before March 17, 2008. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement to reflect new information, events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.

© 2008 Poniard Pharmaceuticals, Inc. All Rights Reserved.

 

Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.

 

For Further Information:

 

Brendan Doherty

Poniard Pharmaceuticals

Corporate Communications

7000 Shoreline Court, Suite 270

South San Francisco, CA 94080

650-745-4425

bdoherty@poniard.com

 

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