Curis Reports First Quarter 2013 Financial Results

Curis Reports First Quarter 2013 Financial Results

-- Management to Host Conference Call Today at 9:00 a.m. EDT --

LEXINGTON, Mass., April 30, 2013 (GLOBE NEWSWIRE) -- Curis, Inc.
(Nasdaq:CRIS), an oncology-focused company seeking to develop next generation
targeted drug candidates for cancer treatment, today reported its financial
results for the first quarter ended March 31, 2013.

"This quarter was marked by the continued progress of our proprietary drug
candidates, including the enrollment of the first dosing cohort for our Phase
I clinical trial in advanced lymphomas and multiple myeloma patients of
CUDC-907, a dual targeted PI3K and HDAC inhibitor, as well as our advancement
of IAP inhibitor CUDC-427 towards initiation of a Phase II development
campaign," said Ali Fattaey, President and Chief Operating Officer of Curis.

"Our collaborator Genentech/Roche has continued to successfully expand the U.S
commercialization of Erivedge®, with an approximately 20% sequential sales
growth in this quarter when compared to the fourth quarter of 2012. Genentech
and Roche have demonstrated their commitment to make Erivedge available to
patients globally, having recently secured marketing approvals in Israel,
Mexico and South Korea and having received a positive opinion for the
conditional marketing approval of Erivedge from the Committee for Medicinal
Products for Human Use (CHMP) in Europe. We expect Erivedge marketing
approvals in Europe and Australia in the coming months, and Genentech and
Roche are actively pursuing approvals in several other territories," said Dan
Passeri, Chief Executive Officer of Curis.

First Quarter 2013 Financial Results

Curis reported a net loss of $5.0 million, or ($0.06) per share on both a
basic and fully diluted basis for the first quarter of 2013, as compared to
net income of $2.2 million or $0.03 per share on both a basic and fully
diluted basis for the same period in 2012.

Revenues for the first quarter of 2013 were $900,000, as compared to $10.4
million for the same period in 2012. This decrease in revenues is primarily
the result of $10 million in license fee revenues received from Genentech upon
FDA approval of Erivedge in the first quarter of 2012. Genentech/Roche's net
sales of Erivedge during the first quarter of 2013 were $13.3 million
resulting in an increase in royalty revenues recorded on net sales of
Erivedge, which increased to $660,000 for the first quarter of 2013 from
$270,000 during the same period in 2012.

Costs of royalty revenues, which are comprised of amounts due to third-party
university patent licensors in connection with Genentech and Roche's Erivedge
net sales, were $30,000 and $110,000 during the first quarters of 2013 and
2012, respectively. The first quarter of 2012 included in a one-time charge of
$100,000 on the first commercial sale of Erivedge.

Operating expenses for the first quarter of 2013 were $5.2 million, as
compared to $8.2 million for the same period in 2012. Research and development
expenses were $2.6 million for the first quarter of 2013 as compared to $5.2
million for the same period in 2012. The decrease in research and development
expense was primarily due to expenses of $1.5 million that the Company
incurred related to amounts due to various university licensors in connection
with the FDA approval of Erivedge during the first quarter of 2012. Curis also
decreased its spending on CUDC-101 and discovery research to $700,000 during
the first quarter of 2013 from $2.4 million during the first quarter of 2012.
The Company increased its spending on CUDC-427 by $700,000. CUDC-427 was
licensed from Genentech by Curis in November 2012.

General and administrative expenses were $2.6 million for the first quarter of
2013 as compared to $2.8 million for the same period in 2012. The decrease was
primarily due to decreased expenses for legal services and stock-based
compensation, offset in part by an increase in other professional services and
personnel costs.

Other expense was $600,000 for the first quarter of 2013 compared to other
income of $30,000 for the same period in 2012. The increase in other expense
is primarily the result of $900,000 in interest expense related to the
Company's December 2012 $30 million royalty-secured debt transaction,
partially offset by $300,000 in other income recorded based on a decrease in
the fair value of a warrant liability during the first quarter of 2013.

As of March 31, 2013, Curis' cash, cash equivalents, marketable securities and
investments totaled $54.2 million and there were approximately 80.2 million
shares of common stock outstanding.

Recent Operational Highlights

  *The CHMP of the European Medicines Agency (EMA) issued a positive
    recommendation for the conditional marketing approval of Erivedge for the
    treatment of advanced basal cell carcinoma in Europe. The European
    Commission, which has the authority to approve medicines for use in the
    European Union, generally delivers its final decision within three months
    of the CHMP recommendation. Curis would earn a $6 million milestone
    payment from Genentech/Roche upon the conditional approval of Erivedge.
  *Curis appointed Kenneth Pienta, M.D. to its Board of Directors.
  *Curis appointed Ali Fattaey, Ph.D. as its President and Chief Operating
  *Curis treated the first patient in a Phase I clinical study of CUDC-907 in
    relapsed or refractory lymphoma or multiple myeloma cancer patients. To
    date Curis has received an aggregate of $1.1 million in funding under its
    agreement with The Leukemia and Lymphoma Society related to the continued
    development of CUDC-907.

Upcoming Activities

Curis expects to present at the following investor conferences through July

  *Needham & Co. 12th Annual Healthcare Conference, April 30 – May 1, 2013,
    in New York City
  *Deutsche Bank 38th Annual dbAccess Health Care Conference, May 29-30,
    2013, in Boston, Massachusetts
  *Jefferies 2013 Global Healthcare Conference, June 3-6, 2013, in New York
  *Wells Fargo Securities 2013 Health Care Conference, June 18-19, 2013, in
    Boston, Massachusetts
  *BMO Capital Markets Biotech Corporate Access Day, July 30, 2013, in
    Boston, Massachusetts

Conference Call Information

Daniel Passeri, Chief Executive Officer of Curis, will host a conference call
today, April 30, 2013, at 9:00 a.m. ET, to discuss Curis' financial results
for the quarter as well as provide a corporate update.

To access the live conference call, please dial (877) 868-1829 from the U.S.
or (253) 237-1135 from other locations, shortly before 9:00 a.m. ET. The
conference ID number is 35916940. The conference call can also be accessed on
the Curis website at in the Investors section. A replay will be
available approximately two hours after the completion of the call through
12:00 p.m. ET, Tuesday, May 7, 2013. To access the replay, please dial (855)
859-2056 from the United States or (404) 537-3406 from other locations and
reference conference ID number 35916940.

About Curis, Inc.

Curis is an oncology-focused company seeking to develop and commercialize next
generation targeted drug candidates for cancer treatment. Erivedge^® is the
first and only FDA-approved medicine for the treatment of advanced basal cell
carcinoma and is being commercialized and developed by Roche and Genentech, a
member of the Roche Group, under a collaboration agreement between Curis and
Genentech. Curis is also developing its pipeline of proprietary targeted
cancer drug candidates, including CUDC-907, a dual PI3K and HDAC inhibitor;
CUDC-427, a small molecule antagonist of IAP proteins; and CUDC-101, an
EGFR/HER2 and HDAC inhibitor. For more information, visit Curis' website at

Cautionary Note Regarding Forward-Looking Statements: This press release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including without limitation
statements regarding the Company's potential positioning among oncology drug
development companies; expectations regarding the Company's clinical
development plans and expectations regarding Erivedge® sales and regulatory
approvals. Forward-looking statements used in this press release may contain
the words "believes," "expects," "anticipates," "plans," "seeks," "estimates,"
"assumes," "will", "may," "could" or similar expressions. These
forward-looking statements are not guarantees of future performance and
involve risks, uncertainties, assumptions and other important factors that may
cause actual results to be materially different from those indicated by such
forward-looking statements. For example, Genentech and Roche may not
ultimately demonstrate to the satisfaction of regulatory authorities outside
the U.S. the safety and efficacy profile of Erivedge in the treatment of
advanced BCC, in which case Erivedge may not be approved for marketing for the
treatment of such indication in the respective territory. Genentech and Roche
may experience delays or failures in the manufacture of Erivedge. Erivedge's
benefit/risk profile may not be widely accepted by the medical community or
third-party payors for the treatment of advanced BCC. Regulatory and
administrative governmental authorities may determine to delay or restrict
Genentech's and/or Roche's ability to continue to develop or commercialize
Erivedge. Competing drugs may be developed that are superior to Erivedge.
Curis may not achieve meaningful amounts of royalty revenue from sales of
Erivedge and may not receive contingent payments from existing or new
collaborators. Curis and its collaborators may experience adverse results,
delays and/or failures in their drug development programs. Curis' drug
candidates may cause unexpected toxicities and/or fail to demonstrate
sufficient safety and efficacy in clinical trials and may never achieve the
requisite regulatory approval needed for commercialization.Curis will require
substantial additional capital to fund the research and development of its
drug development programs. The proceeds of Curis' royalty-secured loan may not
be sufficient to fund its near-term capital requirements for advancing
programs.Curis may not obtain or maintain necessary patent protection for its
programs and could become involved in expensive and time consuming patent
litigation and interference proceedings.Curis faces substantial competition
from other companies developing cancer therapeutics.Unstable market and
economic conditions may adversely affect Curis' financial conditions and its
ability to access capital to fund the growth of its business. Curis also faces
other important risks relating to its business, operations, financial
condition and future prospects that are discussed in its Annual Report on Form
10-K for the year ended December 31, 2012 and other filings that it
periodically makes with the Securities and Exchange Commission.

In addition, any forward-looking statements represent the views of Curis only
as of today and should not be relied upon as representing Curis' views as of
any subsequent date. Curis disclaims any intention or obligation to update any
of the forward-looking statements after the date of this press release whether
as a result of new information, future events or otherwise.

                                                  Three months ended
                                                  March 31,
                                                  2013           2012
Operating expenses:                                              
Royalties                                          $664,400     $270,622
License Fees                                      --             10,000,000
Research and development                          207,035        85,630
Operating expenses:                                871,435        10,356,252
Operating expenses:                                              
Cost of royalty revenues                           33,220         113,531
Research and development                          2,628,457      5,241,949
General and administrative                        2,567,122      2,801,077
Total operating expenses                           5,228,799      8,156,557
Net loss from operations                           (4,357,364)    2,199,695
Other (expense) income, net                        (604,930)      26,042
Net (loss) income                                 $(4,962,294) $2,225,737
Basic and diluted net (loss)/income per common     $(0.06)      $0.03
Basic weighted average common shares outstanding   80,096,650     77,556,366
Diluted weighted average common shares             80,096,650     83,336,695

CURIS, INC.                                                      
                                                     March 31,   December 31,
                                                     2013        2012
Cash, cash equivalents and investments                $54,189,529 $58,701,423
Investments – restricted                              180,364     194,282
Accounts receivable                                   764,429     908,064
Property and equipment, net                           434,967     434,168
Goodwill                                              8,982,000   8,982,000
Other assets                                          541,154     548,412
Total assets                                          $65,092,443 $69,768,349
LIABILITIES AND STOCKHOLDERS' EQUITY                             
Accounts payable, accrued expenses and other          3,520,348   4,173,747
Debt obligations, net                                30,137,128  29,838,925
Warrant liability                                     1,186,919   1,488,179
Total liabilities                                     34,844,395  35,500,851
Total stockholders' equity                            30,248,048  34,267,498
Total liabilities and stockholders' equity           $65,092,443 $69,768,349

CONTACT: For More Information:
         Michael P. Gray
         Chief Financial Officer
         Curis, Inc.

Curis, Inc. Logo
Press spacebar to pause and continue. Press esc to stop.