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Poniard Pharmaceuticals Reports Fourth Quarter and Year End 2009 Financial Results; - Conference Call Today at 8:30 a.m. Eastern Time -.

SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif., March 8 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD pard  
n.
A leopard or other large cat.



[Middle English parde, from Old French, from Latin pardus, from Greek pardos, probably of Iranian origin; akin to Sogdian purdhank.]
), a biopharmaceutical company focused on innovative oncology therapies, today reported financial results for the fourth quarter and year ended December 31, 2009.

"Picoplatin's value proposition rests on establishing it as the preferred platinum," said Ronald A. Martell, chief executive officer of Poniard. "With nearly 1,100 patients treated in clinical trials to date, picoplatin has already demonstrated clinically meaningful safety and efficacy in a variety of solid tumor indications as a single agent or in combination. We look forward to finalizing registration strategies in a number of these settings with our clinical advisors and the Food and Drug Administration, while simultaneously evaluating strategic opportunities, including potential partnerships, which we believe will enable us to unlock the full value of picoplatin."

Recent Clinical and Corporate Developments

Picoplatin Clinical Update

* Prostate Cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. : On Friday, March 5, 2010, Poniard presented final data from the Company's Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study.  of picoplatin in 32 men with metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.

Mentioned in: Coagulation Disorders


metastatic

pertaining to or of the nature of a metastasis.
 castration-resistant (hormone-refractory) prostate cancer (CRPC) during the American Society of Clinical Oncology (ASCO ASCO American Society of Clinical Oncology
ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland)
ASCO Australian Standard Classification of Occupations
ASCO Automatic Switch Company
) 2010 Genitourinary genitourinary /gen·i·to·uri·nary/ (jen?i-to-u´ri-nar-e) pertaining to the genital and urinary organs.

gen·i·to·u·ri·nar·y
adj. Abbr.
 Cancers Symposium. These data indicated that picoplatin, when added to the recommended first-line therapy of docetaxel and prednisone prednisone (prĕd`nĭsōn): see corticosteroid drug.  for CRPC, is active, as demonstrated by overall survival (21.4 months) in 29 evaluable patients, progression-free survival (PFS PFS,
n post facilitation stretch; therapeutic approach utilized during proprioceptive neuromuscular facilitation in which the patient begins the stretch midway between the fully relaxed and fully stretched position and uses maximum level of effort to
) (7.4 months), and prostate specific antigen PSA (Prostate specific antigen)
A tumor marker associated with prostate cancer.

Mentioned in: Tumor Markers
 (PSA (Professional Services Automation) An information system designed to organize, track and manage all opportunities, work, resources, costs, revenues and invoices to improve the productivity and efficiency of the workforce. ) response rate (78 percent). In contrast, data from published literature demonstrate an overall survival benefit of 18.9 months and a PSA response of 45 percent for patients who received recommended doses of docetaxel and prednisone alone.(1) The Phase 2 trial evaluated the efficacy and safety of intravenous picoplatin (120 mg/meter squared) administered every three weeks in combination with full doses of docetaxel (75 mg/meter squared) with daily prednisone (5 mg) as a first-line treatment in chemotherapy naive patients with metastatic CRPC. These results also showed that picoplatin can be safely administered with full doses of docetaxel and prednisone, without neurotoxicity neurotoxicity /neu·ro·tox·ic·i·ty/ (noor?o-tok-sis´it-e) the quality of exerting a destructive or poisonous effect upon nerve tissue.  being observed in these patients.

* Colorectal Cancer colorectal cancer

Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat.
 (CRC (Cyclical Redundancy Checking) An error checking technique used to ensure the accuracy of transmitting digital data. The transmitted messages are divided into predetermined lengths which, used as dividends, are divided by a fixed divisor. ): During the ASCO 2010 Gastrointestinal Cancers Symposium in January, Poniard presented final results from a randomized, controlled Phase 2 trial evaluating picoplatin as a neuropathy-sparing alternative to oxaliplatin for the first-line treatment of metastatic CRC. The 101 patient study met its primary objective, as picoplatin in combination with 5-fluorouracil and leucovorin in the FOLPI FOLPI Forestry-Oriented Linear Programming Interpreter  regimen produced a statistically significant reduction in neurotoxicity, p <0.004, compared to oxaliplatin given in combination with 5-fluorouracil and leucovorin in the FOLFOX FOLFOX 5-Fluorouracil, Leucovorin and Oxaliplatin (chemo treatment)  regimen. Neuropathy was 2.5 times more frequent for FOLFOX- treated patients compared to FOLPI-treated patients, and no Grade 3/4 neuropathy occurred in the FOLPI treated patients. Results suggest that FOLPI had anti-tumor activity comparable to FOLFOX, as measured by disease control, PFS and overall survival. Hematologic hematological, hematologic

pertaining to or emanating from blood cells.


hematological tests
total and differential white cell counts, hematocrit estimation, erythrocyte count.
 toxicity was the most frequent adverse event in the FOLPI regimen, but was manageable.

* Small Cell Lung Cancer Lung Cancer, Small Cell Definition

Small cell lung cancer is a disease in which the cells of the lung tissues grow uncontrollably and form tumors.
Description

Lung cancer is divided into two main types: small cell and non-small cell.
 (SCLC SCLC
abbr.
Southern Christian Leadership Conference
): In November 2009, the Company reported results from the Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial, which enrolled 401 patients and evaluated intravenous picoplatin in patients who were refractory to or who progressed within six months following initial treatment with a platinum-based therapy. While the data analysis showed that the study did not meet its primary endpoint of overall survival the data suggest a potential trend toward a survival advantage in SCLC patients treated with picoplatin and best supportive care supportive care,
n medical and other interventions that attempt to support and make comfortable rather than to cure.
 compared to best supportive care alone. An imbalance in the use of post-study chemotherapy was observed in favor of patients who received best supportive care alone compared to patients who received picoplatin plus best supportive care, and we believe that this may have been a significant factor contributing to the trial outcome. The intent-to-treat analysis was based on 321 patient deaths and showed a hazard ratio of 0.82 and a p value of 0.089.

Corporate Update

* In February 2010, the Company secured a committed equity financing Equity Financing

The act of raising money for company activities by selling common or preferred stock to individual or institutional investors. In return for the money paid, shareholders receive ownership interests in the corporation.
 facility with Commerce Court Small Cap Value Fund Ltd, pursuant to which it may, subject to certain limitations, sell up to $20 million of its registered common stock to Commerce Court over an approximately 18-month period. The Company believes that this facility offers a competitive cost of capital and a flexible structure to help finance its regulatory and partnering strategies to support the continued development of picoplatin.

* In February 2010, Poniard announced management changes and a realignment of the Company's workforce. Ronald A. Martell was appointed chief executive officer, succeeding Jerry McMahon, Ph.D., who remains as non-executive chairman of the Board of Directors. In addition, Michael S. Perry, DVM DVM Doctor of Veterinary Medicine.

DVM
abbr.
Doctor of Veterinary Medicine



DVM

Doctor of Veterinary Medicine.
, Ph.D., has been named president and chief medical officer. The Company also reduced its workforce by approximately 57 percent in order to focus its resources on the ongoing development of picoplatin in solid tumors.

* In the fourth quarter of 2009, Poniard raised net proceeds of $13.8 million from the sale of common stock under the Company's committed equity financing facility with Azimuth azimuth (ăz`əməth), in astronomy, one coordinate in the altazimuth coordinate system. It is the angular distance of a body measured westward along the celestial horizon from the observer's south point.  Opportunity Ltd. That facility terminated by its terms on December 22, 2009.

2010 Goals and Objectives

The Company will focus on the following goals and objectives in 2010:

* Pursue strategic opportunities, including a partnership to help advance the clinical development of picoplatin in multiple indications and two formulations;

* Pursue a process with the Food and Drug Administration to identify a regulatory path forward for picoplatin in small cell lung cancer; and

* Leverage insights gained from Phase 2 colorectal, prostate and ovarian cancer trials to develop registration strategies for these indications in collaboration with key opinion leaders and the FDA.

Fourth Quarter 2009 Financial Results

The Company reported a net loss of $13.2 million ($0.36 diluted loss per share on a loss applicable to common shares of $13.3 million) for the quarter ended December 31, 2009, compared with a net loss of $13.9 million ($0.41 diluted loss per share on a loss applicable to common shares of $14.1 million) for the quarter ended December 31, 2008. The Company reported a net loss of $45.7 million ($1.31 diluted loss per share on a loss applicable to common shares of $46.2 million) for the year ended December 31, 2009, compared with a net loss of $48.6 million ($1.41 diluted loss per share on a loss applicable to common shares of $49.1 million) for the same period in 2008.

Total operating expenses for the quarter ended December 31, 2009, were $12.4 million compared with $13.4 million for the quarter ended December 31, 2008, and were $43.0 million for the year ended December 31, 2009, compared with $49.2 million for the same period in 2008. Total operating expenses for the quarter and year ended December 31, 2009 include charges of $1.5 million and $2.5 million, respectively, for the $1.5 million asset impairment loss on dedicated manufacturing equipment effective December 31, 2009, and for the $1.0 million restructuring and related asset impairment resulting from the Company's implementation of a strategic restructuring plan to discontinue its in-house preclinical research operations and reduce its workforce by approximately 12 percent effective March 31, 2009.

Research and development expenses were $7.2 million for the quarter ended December 31, 2009, compared with $10.0 million for the quarter ended December 31, 2008. Research and development expenses were $25.7 million for the year ended December 31, 2009, compared with $33.7 million for the same period in 2008.

General and administrative expenses were $3.8 million for the quarter ended December 31, 2009, compared with $3.3 million for the quarter ended December 31, 2008. General and administrative expenses were $14.7 million for the year ended December 31, 2009, compared with $15.4 million for the same period in 2008.

Cash and investment securities as of December 31, 2009, were $43.4 million, compared with $72.8 million at December 31, 2008. The Company believes that its existing cash and investment securities, together with its projected operating and financing results, will provide adequate resources to fund the Company's operations at least through the end of 2010.

Conference Call Details

Poniard's management team will host a conference call and Webcast today at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time. To participate in the call by telephone, please dial 866-543-6403 (United States) or 617-213-8896 (International). The passcode for the conference call is 50673823. In addition, the call is being Webcast and can be accessed on the "Events" page of the "News & Events" section of the Company's Web site at http://www.poniard.com. A replay of the Webcast will be available on the Company's Web site for 10 days.

About Poniard Pharmaceuticals

Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative oncology products. For additional information please visit http://www.poniard.com.

Forward-Looking Statements

This release contains forward-looking statements describing the Company's results of operations and financial condition, the Company's 2010 goals and objectives, including its regulatory and partnering strategies focused on optimizing the potential value of picoplatin, and the adequacy of the Company's resources to successfully implement and pursue these strategies. Actual results and events may differ materially from those indicated in these forward-looking statements based on a number of factors, including risks and uncertainties inherent in the Company's business, including, but not limited to, the results and timing of the Company's discussions with the FDA; the potential safety, efficacy and commercial viability of picoplatin; the risk that the Company's additional analyses of data from clinical trials of picoplatin may produce negative or inconclusive results, or may be inconsistent with previously announced results or previously conducted trials; the Company's anticipated future operating losses, need for future capital and ability to obtain future funding; the Company's ability to retain key personnel and enter into strategic partnerships or other relationships to support the continued development of picoplatin on favorable terms, or at all; competition from third parties; the Company's ability to preserve and protect its intellectual property rights; the Company's dependence on third-party manufacturers, suppliers and other contractors; changes in technology, government regulation and general market conditions; the receipt and timing of any FDA and other required regulatory approvals, if any; 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, 2008, and its Quarterly Report on Form 10-Q for the period ended September 30, 2009. 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.

(1) Tannock et al, NEJM NEJM New England Journal of Medicine  2004;351:1502-12.
 Poniard Pharmaceuticals, Inc.
                  Condensed Consolidated Statements of Operations
                      (In thousands, except per share data)
                                   (Unaudited)
                                           Three Months       Twelve
Months
                                              Ended               Ended
                                           December 31,        December
31,
                                          --------------
--------------
                                          2009      2008      2009
2008
                                          ----      ----      ----
----
    Operating expenses:
        Research and development
         (Note 1)                        7,194    10,011    25,739
33,732
        General and administrative
         (Note 1)                        3,769     3,346    14,698
15,425
        Restructuring & asset
         impairment                      1,485         -     2,541
-
                                         -----     -----     -----
-----
      Total operating expenses          12,448    13,357    42,978
49,157
                                        ------    ------    ------
------
    Loss from operations               (12,448)  (13,357)  (42,978)
(49,157)
                                       -------   -------   -------
-------
    Other income (expense), net           (720)     (585)   (2,737)
592
                                          ----      ----    ------
---
      Net loss                         (13,168)  (13,942)  (45,715)
(48,565)
    Preferred stock dividends             (125)     (125)     (500)
(500)
                                          ----      ----      ----
----
    Loss applicable to common
     shares                           $(13,293) $(14,067) $(46,215)
$(49,065)
                                      ========  ========  ========
========
    Loss per share:
      Basic and diluted                 $(0.36)   $(0.41)   $(1.31)
$(1.41)
                                        ======    ======    ======
======
    Shares used in calculation of
     loss per share:
      Basic and diluted                 36,899    34,688    35,272
34,686
                                        ======    ======    ======
======
                     Condensed Consolidated Balance Sheets
                                 (In thousands)
                                                  December 31,
December 31,
                                                      2009
2008
                                                  ------------
------------
                                                   (Unaudited)     (Note
2)
    ASSETS:
    Cash and investment securities                   $43,389
$72,755
    Cash - restricted                                    281
281
    Facilities and equipment, net                        219
1,123
    Licensed products, net                             7,592
8,807
    Other assets                                         961
1,266
                                                        ----
-----
      Total assets                                   $52,442
$84,232
                                                     =======
=======
    LIABILITIES AND SHAREHOLDERS' EQUITY:
    Current liabilities                              $17,127
$19,140
    Long term liabilities                             11,671
17,445
    Shareholders' equity                              23,644
47,647
                                                      ------
------
      Total liabilities and shareholders'
       equity                                        $52,442
$84,232
                                                     =======
=======
    Note 1: Patent related legal expenses are included in G&A
expenses
    beginning in 2009.  These expenses, which have been reclassified for
2008
    to conform to the 2009 presentation, are $1.0 million for each of
2009 and
    2008.
    Note 2: Derived from audited financial statements included in the
    Company's Annual Report on Form 10-K for the year ended
December 31, 2008. 


SOURCE Poniard Pharmaceuticals, Inc.
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