Curis Reports First Quarter 2009 Financial Results -- Conference Call to be Held Today at 9:00 am EDT -- CAMBRIDGE, Mass.--(BUSINESS WIRE)

Reports First Quarter 2009 Financial Results

Conference Call to be Held Today at 9:00 am EDT --

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 5, 2009--Curis, Inc.

(NASDAQ:CRIS), a drug development company seeking to develop proprietary

targeted medicines for cancer treatment, today reported its financial

results for the quarter ended March 31, 2009.

"One of the highlights of the first quarter was the initiation by our

collaborator Genentech of a pivotal Phase II trial of a first-in-class

Hedgehog pathway inhibitor GDC-0449 in metastatic and locally advanced

basal cell carcinoma (BCC) in February. This is a key development

milestone for the treatment of this type of BCC as there is currently no

standard of care for patients with this type of BCC, and this trial is

designed so that its data, if positive, may serve as the basis for a New

Drug Application submission by Genentech," said Mike Gray, Curis' Chief

Financial Officer. "In addition, this trial initiation provided Curis

with $6 million in non-dilutive cash, bringing our cash equivalents and

marketable securities at the end of the quarter to $30 million, which we

expect should be sufficient to fund our planned operations into the

second half of 2010."

Dan Passeri, Curis' President and Chief Executive Officer added, "We

continue to pursue our strategic plan of progressing CUDC-101, our

first-in-class HDAC, EGFR and Her2 inhibitor, towards completion of its

ongoing Phase I clinical trial while concurrently working to secure a

collaboration or other licensing transaction for CUDC-305, our

orally-available, wholly-synthetic Hsp90 inhibitor, in 2009. We recently

completed IND-enabling toxicology studies for CUDC-305, and the data

suggest that CUDC-305 has a favorable safety profile, validating further

development of the compound, which we believe has the potential to be a

best-in-class asset."

For the first quarter of 2009, Curis reported net income of $1.1 million

or $0.02 per share, as compared to a net loss of $3.4 million or ($0.05)

per share for the same period in 2008.

Revenues for the first quarter of 2009 were $6.0 million as compared to

$2.1 million for the same period in 2008, an increase of 186%. Curis

recognized $6.0 million in license revenues during the first quarter of

2009 related to the receipt of a contractual payment from Genentech for

the initiation of a pivotal Phase II clinical trial of GDC-0449 in

metastatic and locally advanced BCC. During the same period in 2008,

Curis recognized $1.9 million in license revenues, $1.75 million of

which were related to the sale and assignment of Curis' remaining BMP

assets to Stryker Corporation.

Operating expenses for the first quarter of 2009 were $5.0 million as

compared to $5.9 million for the same period in 2008, a decrease of 15%.

Research and development spending was $2.9 million for the first

quarter of 2009 as compared to $3.5 million for the same period in

2008, a decrease of 17%. The decrease is attributable to lower

spending on our targeted cancer drug development platform programs as

well as the termination of our Hedgehog agonist program with Wyeth,

which ended in February 2008.

General and administrative spending was $2.1 million for the first

quarter of 2009 as compared to $2.4 million for the same period in

2008, a decrease of 13%. The decrease in general and administrative

expenses was primarily due to decreases in personnel and travel costs

as well as a decline in stock-based compensation expense. Offsetting

these decreases, legal expenses increased due to costs associated with

patent applications for Curis' targeted cancer programs.

As of March 31, 2009, Curis' cash, cash equivalents and marketable

securities totaled $30.0 million, and there were 63.7 million shares of

common stock outstanding.

First Quarter and Recent Highlights

-- Genentech's Initiation of GDC-0449 Pivotal Phase II Clinical Trial

In February 2009, Genentech initiated a pivotal Phase II clinical trial

of GDC-0449, an orally-administered small molecule Hedgehog Pathway

Inhibitor, as a single-agent therapy for patients with metastatic or

locally advanced BCC. Genentech has indicated that it expects to

evaluate GDC-0449 in approximately 100 patients with metastatic or

locally advanced BCC in a global, single-arm, two-cohort clinical trial.

One cohort includes all patients with histologically-confirmed,

RECIST-measurable metastatic BCC. The second cohort includes

histologically-confirmed, locally advanced BCC that is considered

inoperable by the treating physician. As a result of this trial

initiation, Curis received a $6 million cash payment from Genentech.

-- Collaborative Agreement between Genentech and National Cancer

Institute on GDC-0449

In February 2009, Curis announced that Genentech and the National Cancer

Institute's Division of Cancer Treatment and Diagnosis were planning to

enter into a Cooperative Research and Development Agreement, which will

allow the NCI to explore GDC-0449 in a number of cancer indications,

including clinical trials in patients with medulloblastoma, small cell

lung and pancreatic cancers, among others.

-- CUDC-305 presentations at AACR

In April 2009, Curis scientists made two presentations at the American

Association for Cancer Research 2009 Annual Meeting related to CUDC-305,

Curis' Hsp90 inhibitor. Rudi Bao, M.D., Ph.D. made a presentation

entitled, "Antitumor activity of CUDC-305, a novel oral Hsp90 inhibitor,

in solid and hematological tumor xenograft models," at a minisymposium

session, and Jing Wang, Ph.D, presented a poster entitled, "A novel

tumor-specific Hsp90 inhibitor with long lasting biological activity."

Both presentations are available on Curis' website.

-- CU-903 presentation at Keystone Symposia "PI3 Kinase Signaling in

In April 2009, a Curis scientist delivered an oral presentation at a

Keystone Symposia entitled "A single small molecule that inhibits

histone deacetylase and phosphatidylinositol-3-kinase." This

presentation was focused on CU-903, a potentially first-in-class

multi-targeted inhibitor of both HDAC and Phosphatidylinositol-3-Kinase,

or PI3K, signaling. Curis believes that CU-903 is an example of the

potential depth of its targeted cancer pipeline. This presentation is

available on Curis' website.

Conference Call Information

Daniel Passeri, President and Chief Executive Officer of Curis, will