Curis, Inc.~ Nasdaq Bio~ CRIS due diligence
CRIS Company Overview & Description
Curis, Inc is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new targeted small molecule drug candidates for cancer. Curis is building upon its previous experiences in targeting signaling pathways, including in the Hedgehog pathway, in its effort to develop proprietary targeted cancer programs. For more information, visit Curis' website at http://www.curis.com
CRIS Corporate Fact Sheet: http://www.curis.com/Corp_Fact_Sheet_2011.pdf
CRIS Corporate Overview Presentation: http://www.curis.com/Corporate_Overview.pdf
Daniel R. Passeri
President and Chief Executive Officer
Mr. Passeri has served as our President and Chief Executive Officer and as a director since September 2001. From November 2000 to September 2001, Mr. Passeri served as Senior Vice President, Corporate Development and Strategic Planning of the Company. From March 1997 to November 2000, Mr. Passeri was employed by GeneLogic Inc., a biotechnology company, most recently as Senior Vice President, Corporate Development and Strategic Planning. From February 1995 to March 1997, Mr. Passeri was employed by Boehringer Mannheim, a pharmaceutical, biotechnology and diagnostic company, as Director of Technology Management. Mr. Passeri is a graduate of the National Law Center at George Washington University, with a J.D., of the Imperial College of Science, Technology and Medicine at the University of London, with an M.Sc. in biotechnology, and of Northeastern University, with a B.S. in biology.
Maurizio Voi, M.D.
Chief Medical and Chief Development Officer
Dr. Voi has served as our Chief Medical and Chief Development Officer since November 2011. From October 2009 until November 2011, Dr. Voi was employed by Pfizer as Vice President of Clinical Development and Medical Affairs at the Oncology Business Unit of Pfizer’s Global Research and Development site in New York. Dr. Voi joined Pfizer as Thoracic Tumor Strategy Team Leader for Oncology. In this role, he was responsible for developing strategic plans for assets within the Pfizer portfolio for the treatment of thoracic cancers, with a special emphasis on identifying patient populations most likely to respond to targeted agents by concurrently developing compounds and diagnostics, including XALKORI® (crizotinib), an ALK inhibitor for the treatment of ALK+ advanced non-small cell lung cancer that was granted FDA approval in 2011. Prior to joining Pfizer, Dr. Voi served from 1998 to 2009 in several key positions at Bristol-Myers Squibb Company, most recently as the Executive Director, Global Clinical Development and Medical Affairs, Oncology, where he was instrumental in the development and regulatory submission and approval of Sprycel® in chronic myelogenous leukemia as well as in supplemental BLA’s of Erbitux® in colorectal, non-small cell lung and head and neck cancers. From 1987-1999, he served in several roles at Eli Lilly and Company, where he was involved in preparing the registration dossier for a regulatory approval filing in non-small cell lung cancer of Gemzar® in Europe as well as ultimately assuming responsibility for Gemzar® worldwide development and commercialization.
Dr. Voi received his medical degree from the University of Padua, School of Medicine Italy and practiced medicine at the General Hospital, Dolo in Venice, Italy.
Michael P. Gray
Chief Operating and Chief Financial Officer
Mr. Gray has served as our Chief Operating Officer and Chief Financial Officer since December 2006. From December 2003 until December 2006, Mr. Gray served as our Vice President of Finance and Chief Financial Officer and served as our Senior Director of Finance and Controller from August 2000 until December 2003. Mr. Gray held financial positions including Controller and de Facto Chief Financial Officer at Reprogenesis, a predecessor biotechnology company, from January 1998 until July 2000. Mr. Gray previously served as an audit professional for the accounting and consulting firm of Ernst & Young, LLP. Mr. Gray is a certified public accountant, holds an M.B.A. from the F.W. Olin Graduate School of Business at Babson College, and has a B.S. in accounting from Bryant College.
Changgeng Qian, Ph.D., M.D.
Senior Vice President, Discovery and Preclinical Development
Dr. Qian joined Curis in 2001. He has over 30 years of academic and industrial experience in drug discovery, including pharmacokinetics, drug metabolism, efficacy evaluation, experimental disease model development and drug safety assessment. Prior to Curis, he played a key role in the discovery of several anti-inflammation, anticancer and CNS drug candidates at CytoMed Inc., LeukoSite Inc., and Millennium Pharmaceuticals, Inc. He is an inventor on more than 10 issued U.S. patents and over 25 published PCT patents and has authored approximately 30 scientific publications. Dr. Qian earned a Ph.D. in Pharmacology and an M.D. from the Hunan Medical University and has served as a professor of the University since 1992.
Mark Noel
Vice President, Technology Management and Intellectual Property
Mr. Noel has served as our Vice President, Technology Management and Intellectual Property since September 2008. From March 2001 until September 2008, Mr. Noel served as our Vice President, Technology Management and Business Development. From March 2000 to February 2001, Mr. Noel was employed by GeneLogic, as Vice President of Customer Relations. From January 1998 to February 2000, Mr. Noel was employed by GeneLogic as Senior Director of Program Management. From December 1993 to January 1998, Mr. Noel was employed by the National Cancer Institute’s Office of Technology Development (now the Technology Transfer Branch of the NCI Office of Technology and Industrial Relations), where from July 1997 to January 1998, he served as Acting Deputy Director. From February 1989 to November 1993, Mr. Noel worked as a patent agent at Gist Brocades NV, a supplier of ingredients to the pharmaceutical and food sectors. Mr. Noel holds a B.S. from the University of Maryland.
Curis Inc. Corporate Headquarters
4 Maguire Road
Lexington, MA 02421
Tel: [617] 503-6500
Fax: [617] 503-6501
Website: http://www.curis.com
Email Alert Subscription: http://investors.curis.com/alerts.cfm?
Contact IR
Curis, Inc.
4 Maguire Road
Lexington, MA 02421
Phone: 617-503-6500
E-mail: info@curis.com
SEC Filings
http://finance.yahoo.com/q/sec?s=CRIS+SEC+Filings
Competitors
http://finance.yahoo.com/q/co?s=CRIS+Competitors
Industry
http://finance.yahoo.com/q/in?s=CRIS+Industry
Headlines
http://finance.yahoo.com/q/h?s=CRIS+Headlines
Collaborator Program Disease
Genentech (vismodegib) Hedgehog Pathway Inhibitor Cancer
Debiopharm SA (Debio 0932) Debio 0932 (Hsp90 inhibitor; formerly CUDC-305) Cancer
Curis is developing targeted small molecule drug candidates for cancer indications where there are substantial unmet therapeutic needs.
The Hedgehog pathway inhibitor program in collaboration with Genentech is our most advanced program. In September 2011, Genentech completed an NDA submission with the FDA for vismodegib (GDC-0449, RG3616) in advanced basal cell carcinoma and is also conducting a Phase II clinical trial of the molecule in less severe forms of basal cell carcinoma. In addition, there are several additional Phase I and II clinical trials ongoing under a collaboration between Genentech and independent investigators and the National Cancer Institute.
http://www.curis.com/collaborations_detail.php?collaborationid=1
Our second development candidate under collaboration is Debio 0932 (formerly CUDC-305), an Hsp90 inhibitor that we licensed to Debiopharm Group in August 2009 and that is currently in Phase I clinical testing.
http://www.curis.com/collaborations_detail.php?collaborationid=7
Over the past several years, targeted cancer drugs have been considered among the most promising cancer treatments for obtaining a therapeutic effect with less toxicity when compared with traditional chemotherapy, which, in addition to attacking cancerous cells, also tends to attack a broad range of healthy cells. A large body of published data shows cancers to have multiple, intersecting signaling pathways that support survival, growth, and invasion. Targeting only one or two of these pathways with single-targeted agents has generally only led to modest improvements to existing standards-of-care and most cancer patients with solid tumors do not respond in a clinically meaningful manner. Targeting the correct combination of critical signaling pathways within the network of cancer cell signaling pathways could provide a major improvement in outcomes for cancer patients and is an area of intense research and development.
Curis is utilizing medicinal chemistry and biological expertise to develop a series of proprietary targeted cancer drug programs. These programs focus on the development of single-agent drug candidates targeting one or more molecular components within the signaling pathways associated with certain cancers. These programs are primarily focused on developing a number of proprietary, small molecule, single-agent, multi-targeted inhibitor drug compounds. Each proprietary compound is being designed to inhibit biologically- or clinically-validated cancer targets, including, among others, EGFR, Her2, Bcr-Abl tyrosine kinase and phosphatidylinositol-3-kinase (PI3k), in combination with inhibition of HDAC, which is a validated non-kinase cancer target. Curis is also seeking to use this platform to develop proprietary, differentiated, single-agent, single-target drug candidates for cancer indications.
HDAC inhibition is a core component in each of Curis’ multi-targeted inhibitors. Curis believes that HDAC is a promising non-kinase target for cancer therapy, particularly when combined with simultaneous inhibition of certain other targets. There is substantial preclinical evidence of synergistic induction of cancer cell death when HDAC inhibitors are combined with a diverse range of other targeted therapies or standard chemotherapeutic agents, demonstrating that HDAC inhibition may be more broadly effective in the treatment of cancer when integrated with other inhibitory activities.
Currently, there are two Food and Drug Administration, or FDA, approved HDAC inhibitors and several other HDAC-targeted drug candidates in clinical trials for cancer.
In furtherance of the development of Curis’ targeted cancer programs, the Company outsources certain medicinal chemistry and other preclinical functions with contract research organizations in China. Curis has developed these relationships with Chinese providers to support its U.S. operations and Curis is currently engaging approximately 25 chemists in China. Curis’ drug discovery efforts utilize significant medicinal chemistry resources. The Company’s management believes that these relationships have been important to Curis’ efforts to create a broad portfolio of proprietary cancer drugs by generating several classes of compounds for further development in a cost-effective manner.
Curis filed a number of patents including a broad omnibus patent application that covers the drug design concept that is the basis for the multi-targeted cancer programs, as well as numerous species filings relating to specific classes of compounds which Curis believes will constitute novel compositions from a patentability standpoint. Curis expects that it will continue to file additional patent applications covering new compositions in the future.
CUDC-101, Curis’ first drug candidate from our targeted cancer programs, is being designed as a multi-target inhibitor of HDAC, EGFR and Her2 and is currently the subject of a phase Ib expansion clinical trial as well as a Phase I trial in head and neck cancer in combination with radiation and cisplatin. Curis is also developing CUDC-907, a PI3K/HDAC inhibitor and expects that it will submit an IND for this molecule in early 2012. In August, 2009 Curis licensed its first single-agent, single-target inhibitor drug candidate, CUDC-305 (now Debio 0932), an Hsp90 inhibitor to Debiopharm. Curis researchers are continuing to investigate other classes of compounds in an effort to advance additional compounds into clinical development.
Curis is developing targeted small molecule drug candidates for cancer indications where there are substantial unmet therapeutic needs.
The Hedgehog pathway inhibitor program in collaboration with Genentech is our most advanced program. In September 2011, Genentech submitted a New Drug Application (NDA) to the FDA for vismodegib (GDC-0449, RG3616) in advanced basal cell carcinoma and is also conducting a Phase II clinical trial of the molecule in less severe forms of basal cell carcinoma. In addition, there are several additional Phase I and II clinical trials ongoing under a collaboration between Genentech and independent investigators and the National Cancer Institute.
Our second development candidate under collaboration is Debio 0932 (formerly CUDC-305), an Hsp90 inhibitor that we licensed to Debiopharm Group in August 2009 and that is currently in Phase Ib clinical testing.
Curis also recently selected orally-available PI3K/HDAC inhibitor CUDC-907 as a development candidate and expects to begin Phase I clinical testing with this molecule in early 2012.
Curis has focused most of its internal resources on developing additional small molecule targeted cancer drug candidates. Curis completed a Phase I clinical trial of CUDC-101, a first-in-class inhibitor of EGFR, Her2 and HDAC, in the first half of 2010. The Company also initiated in August 2010 a Phase Ib expansion trial of this molecule in patients with breast, gastric, head and neck, liver and non-small cell lung cancers and in August 2011 initiated a Phase I clinical trial in HPV- locally advanced head and neck cancer in combination with standard-of-care treatment (cisplatin and radiation).
In addition, Curis has several programs that are in various stages of preclinical drug development. Because of the early stages of development of these programs, its ability and that of the Company's collaborators and licensors to successfully complete preclinical and clinical studies of these product candidates, and the timing of completion of such programs, is highly uncertain.
Shareholders tools: http://investors.curis.com/
CRIS follows under these quidelines on the Nasdaq market tier.
Investigate more @ http://www.otcmarkets.com/stock/CRIS/quote for more due diligence.
Share Structure
Market Cap. (Mil) $336.19
Shares Out (Mil)76.58
Float (Mil)56.84
Share Related information provided by MorningStar, Inc.
Data as of Jan 9, 2012.
Mil=Millions
watch updates here: http://investors.curis.com/financials.cfm
Par Value: .01
Shareholders
Shareholders of Record: 76
Transfer Agent(s)
BNY Mellon Shareowner Services
P.O. Box 358015
85 Challenger Road
Pittsburgh, PA 15252-8015
Phone: 877.810.2248
TA Corporate Website: http://www.bnymellon.com/shareowner/isd
Financial Reporting/Disclosure
Reporting Status: U.S. Registered & Reporting: SEC Filer
OTC Disclosure last 10Q reported Oct 31, 2011 period ending Sept 30, 2011
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=8212490
OTC Disclosure last 10K reported Mar 8, 2011 period ending Dec 31, 2011
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=7783210
CIK: 0001108205
Fiscal Year End: 12/31
OTC Market Tier: Nasdaq
Profile Data
SIC - Industry Classification: CURIS, INC. - SIC # 2836
Sector: HealthCare
Industry: Biotechnology
Incorporated In: DE, USA
Year of Inc:
Employees: 32
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Please note not all company websites are updated on a regular basis so you should use additional content sources to ensure accuracy.
Resources used in this post: otcmarket.com, www.bloomberg.com, www.finance.yahoo.com, CRIS website
(CRIS website contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Curis' future financial position, business strategy and plans and objectives of management for future operations. We may use such words as "believes," "expects," "anticipates," "plans," "estimates," and similar expressions to identify these forward-looking statements. There are a number of important factors that could cause Curis' actual results to differ materially from these indicated by such forward-looking statements, including those risk factors identified in the filings that Curis' makes from time to time with the SEC (click here to access SEC filings and risk factors contained herein). Curis disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date such statement was first made.)
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