Curis Reports Fourth Quarter and Year-End 2012 Financial Results

Curis Reports Fourth Quarter and Year-End 2012 Financial Results

Conference Call to Discuss Results and Provide 2013 Outlook Today at 9:00 a.m.
EST

LEXINGTON, Mass., Feb. 20, 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
fourth quarter and year ended December 31, 2012.

"During the last few months, we have taken key steps to strengthen Curis'
position as an innovative targeted cancer drug company. This period was marked
by several important achievements, including in-licensing the exclusive
worldwide rights from Genentech to CUDC-427, bringing CUDC-907 into Phase I
clinical testing, securing $30 million of important capital in an Erivedge®
royalty-secured debt transaction to further advance our pipeline and enhancing
our scientific depth and capacity by hiring Dr. Ali Fattaey as our President
and Chief Operating Officer," said Dan Passeri, Chief Executive Officer.

"We believe the combination of our 2012 revenues and the completion of the $30
million Erivedge royalty-secured debt transaction have put Curis in a strong
capital position to advance our lead assets further in clinical development,"
said Mike Gray, Curis' Chief Financial Officer. "We ended 2012 with
approximately $59 million in cash, cash equivalents and investments, and we
anticipate that we may earn additional revenues in 2013 related to the
successful achievement of development and commercialization milestones under
our partnered programs, including potential Erivedge® approvals in Europe and
Australia in the first half of 2013 under our collaboration agreement with
Genentech, a member of the Roche Group."

Full Year and Fourth Quarter 2012 Financial Results

For the year ended December 31, 2012, Curis reported a net loss of $16.4
million, or ($0.21) per basic and fully diluted share, as compared to a net
loss of $9.9 million or ($0.13) per basic and fully diluted share for the year
ended December 31, 2011. The 2012 net loss included a one-time expense of $9.5
million pursuant to the Company's November 2012 CUDC-427 license agreement
with Genentech. For the fourth quarter of 2012, Curis reported a net loss of
$12.4 million, or ($0.15) per share on both a basic and fully diluted basis,
as compared to net income of $6.1 million or $0.08 per basic share and $0.07
per fully diluted share for the same period in 2011.

Revenues for the year ended December 31, 2012 were $17.0 million as compared
to $14.8 million for the year ended December 31, 2011. Revenues for the fourth
quarter of 2012 were $1.7 million, as compared to $14.1 million for the same
period in 2011. Curis earned $14 million in milestone payments under its
collaboration with Genentech in each of the years ended December 31, 2012 and
2011 related to the achievement of regulatory objectives for Erivedge®, which
was approved for sale in the U.S. in January 2012. The increase in revenues in
2012 as compared to 2011 was primarily the result of $1.5 million in royalty
revenues resulting from Genentech's net sales of Erivedge® and $1 million in
milestone payments received under the Company's agreement with LLS.

Research and development expenses were $15.5 million for the year ended
December 31, 2012, as compared to $13.7 million for the year ended December
31, 2011 and $2.7 million for the fourth quarter of 2012 as compared to $4.4
million for the same period in 2011. During the year ended December 31, 2012,
the Company incurred $2.1 million in sublicense expenses related to its
obligations to university licensors as compared to $700,000 for the prior
year. In addition, stock-based compensation increased $350,000 over the prior
year primarily related to the expense recognized on unvested non-employee
stock options.

In-process research and development expense of $9.5 million was recorded for
the year ended December 31, 2012 and the fourth quarter of 2012 as a result of
up-front payments related to the Company's in-license of CUDC-427 from
Genentech. The Company did not record in-process research and development
expense in 2011.

General and administrative expenses were $10.4 million for the year ended
December 31, 2012, as compared to $8.3 million for the year ended December 31,
2011 and $2.9 million for the fourth quarter of 2012 as compared to $2.1
million for the same period in 2011. The increase was primarily due to
increases in stock-based compensation expense of $1.5 million and legal and
consulting fees of $500,000.

Other income was $2.2 million for the year ended December 31, 2012, as
compared to other expense of $2.7 million for the year ended December 31,
2011. Other income was $1.1 million for the fourth quarter of 2012 compared to
other expense of $1.5 million for the same period in 2011. These increases are
primarily the result of decreases in the fair value of a warrant liability,
largely caused by a decline in the market value of the Company's common stock
during the full year and fourth quarter of 2012.

As of December 31, 2012, Curis' cash, cash equivalents, marketable securities
and investments totaled $58.7 million and there were approximately 80.0
million shares of common stock outstanding.

2013 Financial Expectations

Curis expects to end 2013 with cash, cash equivalents and investments of $31
to $36 million, excluding potential future milestone payments from existing or
new collaborators. This also excludes any royalty revenues in 2013 related to
net sales of Erivedge®.Curis is required to pay BioPharma II up to $1 million
per quarter of the royalty revenues that it receives from Genentech in 2013
per the terms of the Erivedge royalty-secured debt transaction, but would
retain royalty revenues that exceed this amount, if any, for use in funding
its operations.

Curis expects that 2013 research and development expenses will be $16 to $20
million and that general and administrative expenses will be $10 to $12
million. These expense expectations include approximately $800,000 and $1.9
million of stock-based compensation expense in research and development and
general and administrative expense, respectively.

Potential 2013 Milestones

In 2013, Curis expects to advance its proprietary pipeline of targeted cancer
therapeutics and also expects that its partners will advance their programs
under development, including the potential for Genentech and Roche to
successfully broaden the commercial opportunity for Erivedge.

CUDC-427:

  *Principal investigators and Genentech to present full study results from
    its completed Phase I study in solid tumors or lymphoma at a medical
    meeting in mid-2013
    
  *Curis to initiate clinical studies of CUDC-427 administered in combination
    with other anti-cancer agents and explore the therapeutic potential of
    single-agent CUDC-427 in selected population of cancer patients

CUDC-907:

  *Curis to continue enrollment and provide updates on ongoing Phase I study
    in patients with advanced or refractory lymphomas or multiple myeloma
    
  *Curis to evaluate CUDC-907 administered in combination with other
    anti-cancer agents in solid tumor clinical study

Erivedge:

  *Regulatory approval decisions in advanced BCC in Europe and Australia in
    the first half of 2013 and decisions in other territories later in 2013
    
  *Results of Phase II study in operable nodular BCC expected in first half
    of 2013
    
  *Results from ongoing National Cancer Institute and investigator sponsored
    clinical studies

Debio 0932:

  *Debiopharm intends to plan the initiation of a Phase I/II clinical trial
    with Debio 0932 in combination with everolimus in renal cell carcinoma
    patients
    
  *Debiopharm to present Phase Ib clinical study results at a medical meeting
    in 2013
    
  *Debiopharm to continue enrollment in Phase I/II study of Debio 0932 in
    advanced non-small cell lung cancer

CUDC-101:

  *Curis to continue enrollment in Phase I study in locally advanced head and
    neck cancer patients
    
  *Curis to pursue development of alternate oral formulations

Recent Operational Highlights

  *In February 2013, Curis hired Ali Fattaey, Ph.D. as its President and
    Chief Operating Officer.
    
  *In January 2013, Curis treated the first patient in a Phase I clinical
    study of CUDC-907 in relapsed or refractory lymphoma or multiple myeloma
    cancer patients.During the fourth quarter of 2012 and early 2013, Curis
    received an aggregate of $1.1 million under its agreement with LLS.
    
  *In December 2012, Curis closed a $30 million Erivedge royalty-secured debt
    transaction.The debt is secured with certain future royalties and other
    royalty-related payments from net sales of Erivedge.
    
  *In December 2012, the U.S. Patent and Trademark Office issued a patent
    covering a genus of compounds that includes Debio 0932, an
    orally-administered Heat Shock Protein 90 (HSP90) inhibitor, which is
    being developed by Curis' licensee Debiopharm.
    
  *In November 2012, Curis secured the exclusive global development and
    commercialization rights from Genentech to antagonist of IAP proteins,
    CUDC-427.
    
  *In October 2012, Curis initiated a Phase I clinical study of an oral
    formulation of CUDC-101. This study was subsequently terminated as
    sufficient drug exposure was not achieved after dosing the first cohort of
    patients. Curis is currently pursuing the development of alternative
    formulations as well as backup candidates, which may be more amenable to
    oral dosing.

Upcoming Activities

Curis expects to present at the following investor conferences through April
2013:

  *Citi 2013 Global Healthcare Conference on February 25-27, 2013 in New York
    City
    
  *2013 RBC Capital Markets' Healthcare Conference on February 26-27, 2013 in
    New York City
    
  *Cowen and Company 33rd Annual Health Care Conference on March 4-6, 2013 in
    Boston, Massachusetts
    
  *Roth Capital Partners 25th Annual ROTH Growth Conference on March 18-20,
    2013 in Dana Point, California
    
  *BioCentury Future Leaders in the Biotech Industry on April 5, 2013 in New
    York City
    
  *12th Annual Needham Healthcare Conference on April 30 – May 1, 2013 in New
    York City

Conference Call Information

Daniel Passeri, Chief Executive Officer of Curis, will host a conference call
today, February 20, 2013, at 9:00 a.m. EST, to discuss Curis' financial
results for the quarter and year ended December 31, 2012, as well as corporate
developments, plans and strategies.

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. EST. The
conference ID number is 98576283. The conference call can also be accessed on
the Curis website at www.curis.com in the Investors section. A replay will be
available approximately two hours after the completion of the call through
12:00 p.m. EST, Tuesday, February 26, 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 98576283.

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-427, a small molecule antagonist of IAP
proteins; CUDC-907, a dual PI3K and HDAC inhibitor; and CUDC-101, an EGFR/HER2
and HDAC inhibitor. For more information, visit Curis' website at
www.curis.com.

The Curis, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=11347

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 expected benefits of the Company's recent financial,
clinical and operational developments; the Company's potential positioning
among oncology drug development companies; expectations regarding Erivedge
sales; the Company's financial positioning for 2013 and beyond; the Company's
expectations regarding potential milestone achievement in 2013 under both its
internal and partnered drug development and commercialization programs; and
the Company's 2013 financial guidance.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, if Genentech's
sales of Erivedge are lower than anticipated, the time period for repayment of
the royalty-secured loan will be extended. There are also certain events of
default in which the loan repayment could be accelerated, including actions by
Curis' that could lead to Genentech's termination of the collaboration
agreement between Curis and Genentech. 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 sales and 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 Quarterly Report on
Form 10-Q for the quarter ended September 30, 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.



CURIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)

                                               
                  Three months ended            Year ended
                  December 31,                  December 31,
                  2012            2011          2012            2011
Revenues           $1,686,406    $14,089,053 $16,971,991   $14,762,580
                                                             
Operating                                                     
expenses:
Cost of revenues   27,993         —             176,482        —
Research and       2,707,400      4,447,859     15,492,302     13,692,659
development
In-Process
research and       9,500,000      —             9,500,000      —
development
General and        2,883,498      2,076,087     10,423,014      8,272,424
administrative
Total operating    15,118,891      6,523,946     35,591,798     21,965,083
expenses
                                                             
Net loss from      (13,432,485)    7,565,107     (18,619,807)   (7,202,503)
operations
                                                             
Other income       1,061,297       (1,503,232)  2,202,900      (2,656,392)
(expense), net
Net income (loss)  $(12,371,188) $6,061,875   $(16,416,907) $(9,858,895)
income
                                                             
Basic net
(loss)/income per  $(0.15)       $0.08       $(0.21)       $(0.13)
common share
Diluted net                                     
(loss)/income per  (0.15)          0.07          (0.21)         (0.13)
common share
Basic weighted                                   
average common     79,971,888      76,649,034    79,059,153      76,351,856
shares outstanding
                                              
Diluted weighted                                              
average common     79,971,888      81,354,223    79,059,153     76,351,856
shares outstanding



CURIS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)

                                                   December 31, December 31,
                                                    2012         2011
ASSETS                                                          
                                                               
Cash, cash equivalents and investments              $58,701,423 $37,717,575
Investments – restricted                            194,282      235,914
Accounts receivable                                 908,064      42,067
Property and equipment, net                         434,168      455,730
Goodwill                                            8,982,000    8,982,000
Other assets                                        760,471      746,779
Total assets                                                    
                                                    $69,980,408 $48,180,065
                                                               
LIABILITIES AND STOCKHOLDERS' EQUITY                            
Accounts payable, accrued expenses and other        $ 4,224,731  $3,942,940
liabilities
Debt                                                30,000,000 —
Warrant liability                                   1,488,179   4,361,168
Total liabilities                                   35,712,910  8,304,108
                                                               
Total stockholders' equity                          34,267,498   39,875,957
                                                               
Total liabilities and stockholders' equity         $69,980,408 $48,180,065

CONTACT: Michael P. Gray
         Chief Financial Officer
         Curis, Inc.
         617-503-6632
         mgray@curis.com

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