- Company to Host Conference Call at 4:30 p.m. EDT Today -
SUNNYVALE, Calif., April 24 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today reported financial results for its third fiscal quarter ended March 31, 2008. The net loss for the third quarter of fiscal 2008 was $7.0 million, or $0.27 per share, compared to a net loss of $6.8 million, or $0.26 per share, in the third quarter of fiscal 2007.
Total operating expenses were $7.2 million in the third quarter of fiscal 2008 compared to $7.4 million for the third quarter of fiscal 2007, a decrease of $0.2 million. Share-based compensation expense was $0.5 million in the third quarter of fiscal 2008 compared to $0.9 in the third quarter of fiscal 2007. The decrease in total operating expenses in the third quarter of fiscal 2008 was primarily related to reduced personnel expenses due to lower headcount and lower share-based compensation expense, partially offset by increased outside pre-clinical and drug manufacturing expenses associated with the Company's HDAC, Btk and Factor VIIa inhibitor programs.
Pharmacyclics also reported its financial results for the nine months ended March 31, 2008. The net loss for the nine months ended March 31, 2008 was $19.7 million, or $0.76 per share, compared to a net loss of $19.2 million, or $0.82 per share, for the nine months ended March 31, 2007.
As of March 31, 2008 the company's cash, cash equivalents and marketable securities totaled $21.3 million compared to $38.8 million at June 30, 2007. The company expects cash used in operations over the next four quarters to be approximately $16 million.
"In the remainder of 2008, we anticipate expanding our clinical
programs with our oral HDAC inhibitor, PCI-24781, by initiating a Phase 1/2
trial evaluating it in hematologic malignancies, and filing investigational
new drug applications for our Factor VIIa inhibitor and our Btk inhibitor,"
said Richard A. Miller, M.D., president and chief executive officer of
Pharmacyclics. "We own worldwide rights to these novel compounds, which
have the potential to address unmet needs in large patient populations."
Recent Events and Upcoming Milestones
-- Data was published in the February 7 issue of Leukemia characterizing
the company's novel highly-selective histone deacetylase (HDAC)
inhibitor showing that the drug candidate, PCI-34501, inhibits HDAC-8
with 200-1000 fold selectivity over other HDAC enzymes.
-- Six presentations relating to the company's HDAC, Factor VIIa and Btk
programs were made at the American Association for Cancer Research
(AACR) 2008 Annual Meeting held in April 2008:
- Reseachers from the University of Texas M.D. Anderson Cancer
Center conducted laboratory studies with the company's HDAC
inhibitor, PCI-24781, demonstrating inhibition of NFkB, a
transcription factor known to drive tumor growth;
- Other researchers at M.D. Anderson found that treatment of animals
with resistant tumors that overexpress the protein ErbB2, or
Her2, with PCI-24781 led to control of tumors in 80 percent of the
animals, with most achieving partial response;
- The company's Factor VIIa inhibitor, PCI-27483, led to inhibition
of tumor growth in animal models of human pancreatic tumors; and
- PCI-32765, the company's orally available, selective inhibitor of
Bruton's tyrosine kinase, or Btk, was shown to block B-cell
receptor mediated signaling in vitro in the treatment of B-cell
lymphomas. Treatment with PCI-32765 in lymphoma-bearing animal
models resulted in inhibition of tumor growth and significant
activity in animal models of arthritis.
-- Plan to initiate Phase 1/2 trial evaluating HDAC inhibitor, PCI-24781,
given orally in hematologic malignancies in second quarter of 2008.
-- Plan to file investigational new drug (IND) application for the
company's Factor VIIa inhibitor in the second half of 2008.
-- Plan to file IND application for the company's small molecule Btk
inhibitor in the second half of 2008.
Conference Call and Webcast Details
The Company will hold a conference call today at 4:30 p.m. EDT to discuss third quarter 2008 financial results and achievements. To participate in the conference call, please dial 800-497-0451 for domestic callers and 706-758-3306 for international callers and reference conference passcode, 43624853. To access the live audio broadcast or the subsequent archived recording, log on to http://ir.pharmacyclics.com. The archived version of the webcast will be available on the company's website for one month.
Pharmacyclics is a pharmaceutical company developing innovative products to treat cancer and other serious diseases. The company is leveraging its small-molecule drug development expertise to build a pipeline in oncology and other diseases based on a wide range of targets, pathways and mechanisms. More information about the company, its technology, and products can be found at http://www.pharmacyclics.com. Pharmacyclics(R), and the "pentadentate" logo(R) are registered trademarks of Pharmacyclics, Inc.
NOTE: Other than statements of historical fact, the statements made in
this press release about our expected cash used in operations over the next
four quarters, the initiation of and enrollment and future plans for our
clinical trials, progress of and reports of results from preclinical and
clinical studies, clinical development plans and product development and
corporate partnering activities are forward-looking statements, as defined
in the Private Securities Litigation Reform Act of 1995. The words
"believe," "will," "may," "continue," "plan," "expect," "intend,"
"anticipate," variations of such words, and similar expressions also
identify forward-looking statements, but their absence does not mean that
the statement is not forward-looking. The forward-looking statements are
not guarantees of future performance and are subject to risks and
uncertainties that may cause actual results to differ materially from those
in the forward-looking statements. Factors that could affect actual results
include risks associated with our ability to accurately predict our future
cash needs; unexpected delays in clinical trials and preclinical studies
and the timing for making related regulatory filings; the fact that data
from preclinical studies and Phase 1 or Phase 2 clinical trials may not
necessarily be indicative of future clinical trial results; our ability to
obtain future financing and fund the product development of our pipeline;
the initiation, timing, design, enrollment and cost of clinical trials and
preclinical studies; our ability to establish successful partnerships and
collaborations with third parties; the regulatory approval process in the
United States and other countries; and our future capital requirements. For
further information about these risks and other factors that may affect the
actual results achieved by Pharmacyclics, please see the company's reports
as filed with the U.S. Securities and Exchange Commission from time to
time, including but not limited to its annual report on Form 10-K for the
period ended June 30, 2007 and its subsequently filed quarterly reports on
Form 10-Q. Forward-looking statements contained in this announcement are
made as of this date, and we undertake no obligation to publicly update any
forward-looking statement, whether as a result of new information, future
events or otherwise.
-- FINANCIALS ATTACHED --
(a development stage enterprise)
Condensed Statements of Operations
(unaudited) (in thousands, except per share data)
Three Months Nine Months
Ended March 31, Ended March 31,
2008 2007 2008 2007
Grant revenue $ -- $ -- $ -- $19
Research and development 5,120 5,669 14,822 15,557
General and administrative 2,100 1,705 5,923 5,315
Total operating expenses 7,220 7,374 20,745 20,872
Loss from operations (7,220) (7,374) (20,745) (20,853)
Interest and other, net 240 615 1,075 1,626
Net loss $(6,980) $(6,759) $(19,670) $(19,227)
Basic and diluted net loss per share $(0.27) $(0.26) $(0.76) $(0.82)
Shares used to compute basic and
diluted net loss per share 25,994 25,938 25,983 23,581
Condensed Balance Sheets
(unaudited, in thousands)
March 31, June 30,
Cash, cash equivalents and marketable securities $21,272 $38,762
Other current assets 611 961
Total current assets 21,883 39,723
Property and equipment, net 633 849
Other noncurrent assets 523 523
Liabilities and stockholders' equity
Current liabilities $2,348 $2,615
Long-term obligations 74 79
Stockholder's equity 20,617 38,401
|SOURCE Pharmacyclics, Inc.|
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