-----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, MJnFnmLMUy/MxWd5K6lFZeI/oIH7eX3VBlCQIBDqLQRFwrFktFnJyBq7zhDFLnQl 7hHcwMX/GVilSfkz9Yf4lg== 0001104659-07-034205.txt : 20070501 0001104659-07-034205.hdr.sgml : 20070501 20070501132551 ACCESSION NUMBER: 0001104659-07-034205 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20070430 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070501 DATE AS OF CHANGE: 20070501 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: 07804827 BUSINESS ADDRESS: STREET 1: 300 ELLIOTT AVENUE WEST STREET 2: SUITE 500 CITY: SEATTLE STATE: WA ZIP: 98119-4114 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 a07-12718_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

April 30, 2007

Date of Report (Date of
earliest event reported)

Poniard Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

Washington

 

0-16614

 

91-1261311

(State or Other Jurisdiction
of Incorporation)

 

(Commission File No.)

 

(IRS Employer
Identification No.)

 

7000 Shoreline Court, Suite 270, South San Francisco, California 94080

(Address of principal executive offices) (Zip Code)

 

(650) 583-3774

(Registrant’s telephone number, including area code)

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:

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

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

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

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

 




Item 8.01.              Other Events.

On April 30, 2007, Poniard Pharmaceuticals, Inc. (the “Company”) announced that it closed its previously announced underwritten public offering of 11,848,341 shares of its common stock, which number of shares included the underwriters’ exercise in full of their option to purchase up to 1,545,436 shares to cover over-allotments, at a public offering price of $6.33 per share.  The net proceeds to the Company from the sale of the shares were approximately $70.0 million.

On May 1, 2007, the Company announced the treatment of the first patient in its pivotal Phase 3 clinical trial in small cell lung cancer.

Copies of the Company’s press releases dated April 30, 2007 and May 1, 2007 are attached as Exhibit 99.1 and Exhibit 99.2 hereto, respectively, and are incorporated herein by reference.

Item 9.01.              Financial Statements and Exhibits.

(d)           Exhibits.

                99.1         Press Release dated April 30, 2007.

                99.2         Press Release dated May 1, 2007.

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: May 1, 2007

 

By:

/s/ Caroline M. Loewy

 

 

Name: Caroline M. Loewy

 

 

Title: Chief Financial Officer

 

3




EXHIBIT INDEX

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release dated April 30, 2007.

 

 

 

99.2

 

Press Release dated May 1, 2007.

 

4



EX-99.1 2 a07-12718_1ex99d1.htm EX-99.1

Exhibit 99.1

Poniard Pharmaceuticals Completes
$75 Million Public Offering of Common Stock

South San Francisco, Calif. (April 30, 2007) — Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) announced today the completion of its public offering of 11,848,341 shares of its common stock, which number of shares included the underwriters’ exercise in full of their option to purchase up to 1,545,436 shares to cover over-allotments, at a public offering price of $6.33 per share.  The net proceeds to the company from the sale of shares of its common stock in this offering will be approximately $70 million, after payment of underwriting discounts and commissions and estimated offering expenses.   CIBC World Markets Corp. and Lazard Capital Markets LLC acted as joint book-running managers in this offering.  Pacific Growth Equities, LLC, Leerink Swann & Co., Inc. and Fortis Securities LLC acted as co-managers.

“This financing represents an important milestone for Poniard because it provides us with significant resources to continue the clinical development of picoplatin, including our ongoing clinical trials in small cell lung cancer, colorectal cancer and prostate cancer, as well as our clinical study evaluating an oral formulation of picoplatin,” said Jerry McMahon, Ph.D., chairman, president and CEO of Poniard.  “We believe that the growing use of platinum-based chemotherapeutics in the treatment of solid tumors, especially when given in combination with new targeted therapies, creates an exciting potential market opportunity for our picoplatin product candidate.  Based on clinical data to date, we believe that picoplatin will effectively treat tumors resistant to existing platinum-based drugs and will be better tolerated by cancer patients.”

Poniard is evaluating intravenous picoplatin in an ongoing Phase 2 clinical trial in small cell lung cancer (SCLC) and in Phase 1/2 clinical trials in colorectal and hormone-refractory prostate cancers.  A Phase 1 trial is also underway evaluating an oral formulation of picoplatin in patients with solid tumor malignancies.  The Company plans to initiate the pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of intravenous picoplatin for the treatment of SCLC in the first half of 2007.

About Poniard Pharmaceuticals

Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative oncology products to impact the lives of people with cancer.  Picoplatin, the Company’s lead product candidate, is a new generation platinum therapy with an improved safety profile.  Picoplatin is designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors.  As part of the Company’s strategic goal of building a diverse oncology pipeline, the Company is collaborating with The Scripps Research Institute on the discovery of novel, small-molecule, multi-targeted protein kinase inhibitors.  For additional information please visit www.poniard.com.




This release contains forward-looking statements, including statements regarding the Company’s business objectives and strategic goals, drug development plans, 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 Company’s anticipated operating losses, need for future capital and ability to obtain future funding; competition from third parties; market acceptance of the Company’s proposed products, 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, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2006, as amended. 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.

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

© 2007 Poniard Pharmaceuticals, Inc.  All Rights Reserved.

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

For Further Information:

Julie Rathbun
Poniard Pharmaceuticals
Corporate Communications
7000 Shoreline Court, Suite 270
South San Francisco, CA  94080
206-286-2517
jrathbun@poniard.com

# # #

2



EX-99.2 3 a07-12718_1ex99d2.htm EX-99.2

Exhibit 99.2

Poniard Pharmaceuticals Announces Treatment of First Patient with Picoplatin
in Pivotal Phase 3 Small Cell Lung Cancer Trial

South San Francisco, Calif. (May 1, 2007) – Poniard Pharmaceuticals, Inc. (NASDAQ: PARD), a biopharmaceutical company focused on oncology, today announced treatment of the first patient with picoplatin in its pivotal Phase 3 clinical trial in small cell lung cancer (SCLC).  Picoplatin, the Company’s lead product candidate, is a new generation platinum therapy with an improved safety profile designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors.  The Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), received a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA).

“With the initiation of our Phase 3 SPEAR trial, our goal is to obtain regulatory approvals to bring picoplatin to market to address the critical unmet medical need in small cell lung cancer.  Our SPA agreement with the FDA supports our plan to conduct a single pivotal Phase 3 trial that evaluates overall survival as the primary endpoint as a basis for filing for FDA approval to market picoplatin,” said Jerry McMahon, Ph.D., chairman, president and CEO of Poniard.  “We currently estimate that it will take approximately 20 months to complete enrollment and follow up in the SPEAR trial, potentially enabling us to file a New Drug Application in 2009.”

Phase 3 SCLC Study Design

The international, multi-center, randomized, controlled Phase 3 SPEAR trial is enrolling patients who are refractory to, or who have progressed within six months of completing, treatment with first-line platinum-containing chemotherapy (cisplatin or carboplatin).  The primary efficacy endpoint is overall survival.   Overall response rates, progression-free survival and disease control also will be evaluated.  The trial has a 2:1 randomization comparing the efficacy and safety of intravenous picoplatin plus best supportive care to best supportive care alone.  The Company expects to enroll approximately 400 patients in the trial, which is being conducted at clinical sites in Europe and India.

“Small cell lung cancer represents a critical unmet medical need as platinum-resistant or -refractory patients with small cell lung cancer often experience rapid disease progression and low overall survival despite treatment with available drugs, which have significant associated toxicities,” said Paul A. Bunn, Jr., M.D., a member of Poniard’s Clinical Advisory Board and the director of the University of Colorado Cancer Center in Aurora, Colo., where he holds the James Dudley Endowed Chair of Cancer Research and is professor of medicine at the University of Colorado Health Sciences Center.  “Moreover, no new drugs have been approved by the FDA for the treatment of platinum-resistant or - -refractory small cell lung cancer in nearly a decade.”

Interim Phase 2 SCLC Survival Results

In November 2006, Poniard announced positive interim median overall survival data from its Phase 2 open-label, multi-center clinical trial of picoplatin in SCLC.  The trial was designed to




confirm the clinical activity of picoplatin as second-line therapy in patients with platinum-refractory disease or disease that had progressed within six months following first-line treatment with a platinum-based chemotherapy, such as cisplatin or carboplatin.  The interim analysis showed a median overall survival of 26.7 weeks in the 72 evaluable patients treated with picoplatin.  According to the 2006 National Comprehensive Cancer Network practice guidelines, the median survival for patients who receive second-line chemotherapy is approximately 16 to 20 weeks, and patients who receive no chemotherapy have been shown in published studies to live only 13 to 14 weeks.

“The median overall survival observed to date in our Phase 2 trial suggests that picoplatin treatment may represent an improvement over best supportive care alone,” said David A. Karlin, M.D., senior vice president of clinical development and regulatory affairs of Poniard.

Final results of the Phase 2 trial are expected in mid-2007 and will be submitted for presentation at upcoming scientific conferences.

About Small Cell Lung Cancer

SCLC is the most aggressive and deadly form of lung cancer and accounts for approximately 20 percent of all lung cancer cases.  The current two-year survival rate for patients with extensive SCLC is less than 10 percent with current management options.  The estimated incidence of lung cancer in the United States in 2006 was 174,500, according to the National Cancer Institute.  The estimated incidence in Europe in 2006 was 386,300, according to the International Agency for Research on Cancer.  Poniard received orphan drug designation in November 2005 from the FDA for picoplatin for the treatment of SCLC.

SCLC is currently treated with platinum therapies, but many patients do not respond, and if they do respond, they typically relapse within a short time after treatment.  There is currently no FDA-approved therapy and no consistent and effective therapy for SCLC patients who have platinum-resistant or -refractory disease after treatment failure with first-line combination therapy with either cisplatin or carboplatin.

About Poniard Pharmaceuticals

Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative oncology products to impact the lives of people with cancer.  Picoplatin, the Company’s lead product candidate, is a new generation platinum therapy with an improved safety profile.  Picoplatin is designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors.  Picoplatin is currently being studied in clinical trials for the treatment of small cell lung, colorectal and hormone-refractory prostate cancers.  As part of the Company’s strategic goal of building a diverse oncology pipeline, the Company is collaborating with The Scripps Research Institute on the discovery of novel, small-molecule, multi-targeted protein kinase inhibitors.  For additional information please visit www.poniard.com.

This release contains forward-looking statements, including statements regarding the Company’s business objectives and strategic goals, drug development plans, 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

2




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, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2006, as amended.  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.

© 2007 Poniard Pharmaceuticals, Inc.  All Rights Reserved.

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

For Further Information:

Julie Rathbun
Poniard Pharmaceuticals
Corporate Communications
7000 Shoreline Court, Suite 270
South San Francisco, CA  94080
206-286-2517
jrathbun@poniard.com

# # #

3



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