EXHIBIT 99.1
ARIAD Reports Second Quarter 2004 Results;
Update on Status of Clinical and Preclinical Programs
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 2, 2004--ARIAD
Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced results for the
second quarter of 2004 and updated the status of its clinical and
preclinical programs.
Financial Highlights
For the three months ended June 30, 2004, the Company reported a
net loss of $9.2 million, or $0.18 per share, compared to a net loss
of $4.3 million, or $0.12 per share, for the same period in 2003. The
Company ended the quarter with $94.8 million in cash, cash equivalents
and marketable securities. This compares to cash, cash equivalents and
marketable securities of $66.7 million at December 31, 2003. For the
six months ended June 30, 2004, the Company reported net cash used in
operations of $12.8 million.
"We are moving ahead aggressively with the global clinical
development of our lead oncology product, AP23573, and the further
development of our pipeline of preclinical programs. Our highest
priority is progressing AP23573 as quickly as possible to registration
trials in clinical indications in which there is great unmet medical
need," said Harvey J. Berger, M.D., chairman and chief executive
officer of ARIAD.
Update on AP23573 Clinical Program
In June, the Company announced details of its comprehensive global
clinical development plan for its lead oncology product candidate,
AP23573, and initiated enrollment of patients in a multicenter Phase 2
study of this product candidate as a single agent in hematologic
cancers (i.e., leukemias and lymphomas) in which current therapeutic
options are limited or only palliative. Concurrently, the Company
initiated enrollment of patients with glioblastoma multiforme in a
multicenter Phase 1b clinical trial to identify the optimal dosing of
AP23573 to achieve maximal activity within brain tumors.
The AP23573 development plan also calls for the initiation of
additional Phase 2 trials of the drug as a single agent in patients
with specific advanced, relapsed and/or metastatic solid tumors (e.g.,
brain, breast, endometrial and prostate cancers, as well as sarcomas)
in the United States and Europe. In parallel, additional Phase 1b
studies are planned in selected cancers aimed at further evaluating
the anti-tumor activity, safety and pharmacokinetics of AP23573, both
as a single agent and in combination with chemotherapeutic agents and
other molecularly targeted drugs.
A near-term objective of the AP23573 development plan is to obtain
sufficient clinical data to support expedited or "fast-track"
regulatory review of AP23573, both in the United States and Europe, in
specific clinical indications to be determined over the next year.
The initial Phase 1 clinical data presented at the recent American
Society of Clinical Oncology annual meeting supported the optimism
about the clinical potential of AP23573. Sustained anti-tumor activity
of AP23573 as a single agent was observed in 50% of the evaluable
patients in a broad spectrum of cancers in the daily dosing trial -
the dosing regimen that generally will be used in subsequent trials.
These Phase 1 results were especially striking since all patients had
untreatable advanced tumors, and many patients received very low doses
of drug (due to the dose-escalation design of the trials, which were
aimed primarily at evaluating the safety of the drug). Further follow
up of these patients is ongoing, as is enrollment of additional
patients at the higher doses.
The small-molecule drug, AP23573, starves cancer cells and shrinks
tumors by inhibiting the critical cell-signaling protein, mTOR, which
regulates the response of tumor cells to nutrients and growth factors,
and controls tumor blood supply and angiogenesis through effects on
Vascular Endothelial Grown Factor (VEGF).
Update on Preclinical Programs
In parallel with the Company's AP23573 clinical program, it is
also proceeding with both of its preclinical cancer programs - its
oncogenic kinase inhibitor program based on AP23464 and its
bone-targeted mTOR inhibitor program based on AP23841.
As part of the oncogenic kinase inhibitor program, extensive
preclinical studies have been conducted on AP23464 along with backup
compounds, providing insights into their biologic, metabolic and
pharmacologic profiles. Recently obtained results of animal studies in
this program have led the Company to focus its development efforts on
two classes of chemically related back-up compounds of AP23464 in
order to initiate clinical trials with a product candidate that has a
more optimal and competitive metabolic profile. Accordingly, the
Company is not currently providing updated guidance on the IND filing
date.
Dr. Berger added, "We remain strongly committed to our oncogenic
kinase inhibitor program which represents a compelling medical and
commercial opportunity. Our scientific team and network of academic
collaborators understand the cancer targets and inhibitors in this
program extremely well. We are actively pursuing a rapid path to
selection of the optimal compound for clinical development."
Upcoming Events
Updated clinical data on the Phase 1 trials of AP23573 will be
presented at EORTC-NCI-AACR Conference on Molecular Targets and Cancer
Therapeutics, Geneva, Switzerland (September 28 - October 1, 2004).
More information about this medical conference is available at the
meeting's website (http://www.aacr.org/4400m.asp).
In addition, ARIAD's chairman and chief executive officer will be
presenting updated overviews of the Company progress and plans at six
investor conferences - all to be webcast - during the next several
months:
-- Adams Harkness 24th Summer Seminar at the Marriot Long Wharf
in Boston, Massachusetts on August 3, 2004.
-- UBS 2004 Global Life Sciences Conference at the Grand Hyatt in
New York, New York on September 27-30, 2004.
-- JPMorgan Third Annual Small Cap Conference at the Four Seasons
in Boston, Massachusetts on October 25-26, 2004.
-- Rodman and Renshaw Sixth Annual Healthcare Conference at the
Waldorf-Astoria in New York, New York on October 26-28, 2004.
-- Lehman Brothers 2004 Small Cap Conference at the Phoenician in
Scottsdale, Arizona on November 17-19, 2004.
-- Lazard First Annual Life Sciences Conference at the Mandarin
Oriental in New York, New York on November 30 - December 1,
2004.
Details concerning audio webcasts of these presentations, together
with more specific dates and times, will be provided in separate press
releases for each conference.
ARIAD is engaged in the discovery and development of breakthrough
medicines to treat cancer by regulating cell signaling with small
molecules. The Company is developing a comprehensive approach to
patients with cancer that addresses the greatest medical need -
aggressive and advanced-stage cancers for which current treatments are
inadequate. ARIAD also has an exclusive license to pioneering
technology and patents related to certain NF-(kappa)B treatment
methods, and the discovery and development of drugs to regulate
NF-(kappa)B cell-signaling activity, which may be useful in treating
certain diseases.
Additional information about ARIAD can be found on the web at
http://www.ariad.com.
Some of the matters discussed herein are "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements are identified by the use of words
such as "anticipate," "estimate," "expect," "project," "intend,"
"plan," "believe," and other words and terms of similar meaning in
connection with any discussion of future operating or financial
performance. Such statements are based on management's current
expectations and are subject to certain factors, risks and
uncertainties that may cause actual results, outcome of events, timing
and performance to differ materially from those expressed or implied
by such forward-looking statements. These risks include, but are not
limited to, risks and uncertainties regarding the Company's ability to
accurately estimate the actual research and development expenses and
other costs associated with the preclinical and clinical development
of our product candidates, the adequacy of our capital resources and
the availability of additional funding, risks and uncertainties
regarding the Company's ability to successfully conduct preclinical
and clinical studies of its product candidates, risks and
uncertainties that clinical trial results at any phase of development
may be adverse or may not be predictive of future result or lead to
regulatory approval of any of the Company's product candidates, and
risks and uncertainties relating to regulatory oversight, intellectual
property claims, the timing, scope, cost and outcome of legal
proceedings, future capital needs, key employees, dependence on the
Company's collaborators and manufacturers, markets, economic
conditions, products, services, prices, reimbursement rates,
competition and other risks detailed in the Company's public filings
with the Securities and Exchange Commission, including ARIAD's Annual
Report on Form 10-K for the fiscal year ended December 31, 2003. The
information contained in this document is believed to be current as of
the date of original issue. The Company does not intend to update any
of the forward-looking statements after the date of this document to
conform these statements to actual results or to changes in the
Company's expectations, except as required by law.
ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
In thousands, Three Months Six Months
except share Ended Ended
and per share June 30, June 30,
data -------------------- --------------------
2004 2003 2004 2003
--------- --------- --------- ---------
(Unaudited) (Unaudited)
Total license
revenue $ 188 $ 153 $ 378 $ 279
----------- ----------- ----------- -----------
Operating
expenses:
Research and
development 7,102 3,206 11,435 7,747
General and
administrative 2,565 1,237 4,783 2,122
----------- ----------- ----------- -----------
Total operating
expenses 9,667 4,443 16,218 9,869
----------- ----------- ----------- -----------
Other income
(expense), net 234 (14) 360 (26)
----------- ----------- ----------- -----------
Net loss $ (9,245) $ (4,304) $ (15,480) $ (9,616)
----------- ----------- ----------- -----------
----------- ----------- ----------- -----------
Net loss per
common share
(basic and
diluted) $ (.18) $ (.12) $ (.31) $ (.27)
----------- ----------- ----------- -----------
----------- ----------- ----------- -----------
Weighted average
number of shares of
common stock
outstanding
(basic and
diluted) 52,416,929 36,769,778 49,978,892 35,814,896
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
June 30, Dec. 31,
In thousands 2004 2003
---------------------
(Unaudited)
Cash, cash equivalents and marketable securities $ 94,815 $66,740
Total assets $102,582 $74,284
Total liabilities $ 16,200 $14,958
Stockholders' equity $ 86,382 $59,326
CONTACT: ARIAD Pharmaceuticals, Inc.
Tom Pearson, 610-407-9260
or
Kathy Lawton, 617-621-2345