Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Historical Stock Chart
From Jul 2019 to Jul 2024
Allos Therapeutics Reports Third Quarter 2003 Financial Results
WESTMINSTER, Colo., Nov. 6 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc.
today reported financial results for the third quarter of 2003. For the three
months ended September 30, 2003, the company reported a net loss of $5.0
million, or $0.19 per share, compared to a net loss of $5.3 million, or $0.21
per share, for the same quarter in 2002.
For the nine months ended September 30, 2003, the company reported a net loss of
$23.9 million, or $0.92 per share, compared to a net loss of $18.6 million, or
$0.76 per share, for the same period in the previous year.
Cash, cash equivalents, short-term investments and long-term marketable
securities as of September 30, 2003 were $36.4 million. In addition, as
previously announced, on October 15, 2003, the company received approximately
$5.1 million from Durus Life Sciences Master Fund, Ltd., in complete
satisfaction of the company's claims against Durus and certain of its affiliates
under Section 16(b) of the Securities and Exchange Act of 1934.
Third quarter highlights:
* The company submitted to the U.S. Food and Drug Administration (FDA)
two of three required components of a rolling New Drug Application
(NDA) to market efaproxiral (RSR13) as an adjunct to radiation therapy
for the treatment of brain metastases from breast cancer. The first
component covers non-clinical information about the drug and was
submitted to the FDA in August 2003. The second component of the NDA
was submitted to the FDA in September 2003 and contains information
about the drug's chemistry, manufacture and controls (CMC). The
company plans to submit the third and final component of the NDA,
containing information about the company's clinical trials, in the
fourth quarter of 2003.
* The company announced the presentation of a retrospective case-match
analysis of survival results of a Phase 2 study of RSR13 in patients
with locally advanced non-small cell lung cancer (NSCLC) compared to
survival results of a Phase 3 randomized study, RTOG 94-10, in the
same patient population. Median survival of patients treated in the
RSR13 study was 20.6 months as compared to a median survival of
14.6 months for patients in the sequential chemoradiotherapy arm and
17.0 months for patients in the concurrent chemoradiotherapy arm of
study RTOG 94-10. These results were presented at the 10th World
Conference on Lung Cancer.
Upcoming fourth quarter events:
* Submission of the third component, the clinical section, of a rolling
NDA to the FDA to market RSR13 as an adjunct to radiation therapy for
the treatment of brain metastases from breast cancer
* Plenary presentation of Phase 3 study results of RSR13 in patients
with brain metastases at the Society of Neuro-Oncology (SNO),
November 13-16
* Poster presentation (Abstract #A182) of Phase I study of PDX plus
docetaxel or paclitaxel in patients with advanced cancer at the
AACR-NCI-EORTC, November 17-21
* Initiation of a Phase 1 NSCLC study of RSR13 and chemotherapy given
concurrently with radiation therapy
* Poster presentation (Abstract #175) of Phase 3 study results of RSR13
in patients with brain metastases from breast cancer at the 26th
Annual San Antonio Breast Cancer Symposium (SABCS), December 3-6
Conference Call
Allos Therapeutics will host a conference call to review the company's third
quarter 2003 results. The conference call will take place at 11:00 a.m. EST on
Thursday, November 6, 2003. The dial in number for U.S. residents to
participate is 800-915-4836. International callers should dial 1-973-317-5319.
Conference Call Replay
An audio replay of the conference call will be available from 6:00 p.m. EST,
November 6, 2003, until midnight November 13, 2003. To access the replay,
please dial 1-800-428-6051 (US/Canada); international +1-973-709-2089; the
conference ID number is 311459.
Webcast
Allos Therapeutics will hold a live webcast of the conference call. The webcast
will be available from the homepage and the investor relations' section of the
company's web site at http://www.allos.com/ and will be archived for 30 days.
About Allos Therapeutics, Inc.
Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing
and commercializing innovative drugs for improving cancer treatments. The
company's lead clinical candidate, efaproxiral (RSR13), is a synthetic small
molecule that has the potential to sensitize hypoxic (oxygen deprived) tumor
tissues and enhance the efficacy of standard radiation therapy. In addition,
Allos is developing PDX, a novel small molecule cytotoxic injectable antifolate
(DHFR inhibitor) being developed for non-small cell lung cancer, mesothelioma
and non-Hodgkin's lymphoma. For more information, please visit the company's
web site at: http://www.allos.com/ .
This announcement contains forward-looking statements that involve risks and
uncertainties. Future events may differ materially from those discussed herein
due to a number of factors, including, but not limited to, risks and
uncertainties related to Allos' ability to complete the submission of its NDA to
the FDA on schedule and in accordance with regulatory requirements, to
adequately demonstrate the safety and efficacy of RSR13 for use as a radiation
sensitizer in the treatment of metastatic breast cancer and any other type of
cancer, and its ability to obtain regulatory approval for RSR13, as well as
other risks and uncertainties detailed from time to time in the company's SEC
filings, including its Annual Report on Form 10-K for the year ended December
31, 2002. All forward-looking statements are based on information currently
available to the company on the date hereof, and the company assumes no
responsibility to update such statements.
ALLOS THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands ~ except share and per share information)
(unaudited)
Three-months ended Nine-months ended
September 30, September 30,
2003 2002 2003 2002
Operating expenses:
Research and
development $1,629 $1,937 $10,116 $10,166
Clinical manufacturing 707 1,243 6,653 2,414
Marketing, general and
administrative 2,797 2,657 7,339 7,882
Restructuring costs 60 -- 638 --
Total operating
expenses 5,193 5,837 24,746 20,462
Loss from operations (5,193) (5,837) (24,746) (20,462)
Interest and other
income, net 179 549 828 1,835
Net loss $(5,014) $(5,288) $(23,918) $(18,627)
Net loss per
common share:
basic and diluted $(0.19) $(0.21) $(0.92) $(0.76)
Weighted average
common shares:
basic and diluted 25,911,309 25,724,192 25,893,456 24,641,088
ALLOS THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
September 30, December 31,
2003 2002
ASSETS
Cash, cash equivalents and
short-term investments $24,053 $54,983
Other current assets 1,297 775
Long-term marketable securities 12,320 5,817
Equipment and leasehold improvements, net 1,592 1,826
Long-term investment -- 1,000
Total assets $39,262 $64,401
Liabilities and Stockholders' Equity
Liabilities $5,950 $7,079
Stockholders' equity 33,312 57,322
Total liabilities and
stockholders' equity $39,262 $64,401
DATASOURCE: Allos Therapeutics, Inc.
CONTACT: Monique M. Greer, Vice President, Corporate Communications and
Investor Relations of Allos Therapeutics, Inc., +1-303-426-6262,
Web site: http://www.allos.com/