SlideShare a Scribd company logo
1 of 10
Download to read offline
CURIS, SCREENSHOT – NOVEMBER 2016
Page 1 of 10
		
Curis
CURIS, SCREENSHOT – NOVEMBER 2016
Page 2 of 10
		
DISCLAIMER
This report (Report) has been produced independently by QStat Consulting. The intent of this Report
is to provide a structured example of QStat Consulting’s service and to provide information for the
public. The views expressed in this Report are not necessarily the views of QStat Consulting. The
information, statements, statistics and commentary (together the ‘Information’) contained in this
Report have been prepared by QStat Consulting from publicly available material and from discussions
held with stakeholders. QStat Consulting does not express an opinion as to the accuracy or
completeness of the information provided, the assumptions made by the parties that provided the
information or any conclusions reached by those parties. QStat Consulting has based this Report on
information received or obtained, on the basis that such information is accurate and, where it is
represented to QStat Consulting as such, complete. The information contained in this Report has not
been subject to an audit. All expressions of opinion are subject to change without notice, and the
Authors do not undertake to update this Report or any information contained herein. This Report
remains the property of QStat Consulting and any effort to use this Report as an actual and factual
appraisal Report is not permitted.
CURIS, SCREENSHOT – NOVEMBER 2016
Page 3 of 10
		
CASE ABSTRACT
	
Curis Therapeutics (Company) was incorporated on February 14, 2000 and trades on the NASDAQ Global Market
(NASDAQ:CRIS). Headquartered in Lexington, Massachusetts, it is a clinical-stage biopharmaceutical company
engaged in developing and commercializing therapeutics for the regeneration and restoration of human tissues and
organs. The Company is engaged in the development and commercialization of drug candidates for the treatment of
human cancers.
The Company's drug candidate, CUDC-907, is an orally available, small molecule inhibitor of histone deacetylase
(HDAC) and phosphatidylinositol-3-kinase (PI3K) enzymes. Specifically, CUDC-907 is designed to inhibit HDACs 1, 2,
3, 6 and 10 and PI3K-alpha, delta and beta isoforms. CUDC-907 can be indicated for antitumor activity in various
hematologic tumor models, such as non-Hodgkin's lymphoma and multiple myeloma.
CA-170 is an oral small molecule drug candidate designed to selectively target programmed death ligand 1 (PD-L1)
and VISTA checkpoint proteins, both of which independently function as negative regulators of immune activation.
CA-4948 is an oral small molecule drug candidate that is designed to inhibit the interleukin-1 receptor-associated
kinase 4 (IRAK4) kinase, which is a transducer of toll-like receptor or certain interleukin receptor signaling pathways.
These signaling pathways are shown to be involved in certain human cancers and inflammatory diseases.
Erivedge is an orally bioavailable small molecule, and is designed to selectively inhibit the Hedgehog signaling pathway.
The Hedgehog signaling pathway is active during embryonic development and unregulated activation of the pathway
and plays a role in allowing the proliferation and survival of cancer cells and leading to formation and maintenance of
certain cancers. Erivedge is indicated for adults with advanced forms of basal-cell carcinoma (BCC).
CUDC-427 is an oral, small molecule Smac mimetic that is designed to promote cancer cell death by antagonizing
inhibitor of apoptosis (IAP) proteins.
CUDC-305 is an oral HSP90 inhibitor for the development in advanced lung cancer.
Number of patents as owner: 247
Number of patents as third party: 5
CURIS, SCREENSHOT – NOVEMBER 2016
Page 4 of 10
		
(2015, 10K Annual report)
Drug Candidate Primary Disease Collaborator/Licensee Current Status
CUDC-907 Relapsed,
refractory DLBCL
with MYC
alterations
Internal development Phase 2 –ONGOING Ph2 IN 2016-
(12/31/2017
Phase 2 data due 2017)
Solid tumors
including NUT
midline carcinoma
Internal development Phase 1 –RECRUITING Ph1 IN 2016-
01 Oct 2016 Phase-I clinical trials in Lymphoma (In
adolescents, In children, In infants, Second-line therapy
or greater, In adults) in USA (PO) (NCT02909777)
01 Oct 2016 Phase-I clinical trials in Solid tumours
(Second-line therapy or greater, In adolescents, In
adults, In children, In infants) in USA (PO)
(NCT02909777)
13 Sep 2016 Curis plans a phase I trial for Solid
tumors and Lymphoma (Second-line therapy, In infants,
In children, In adolescents, In adults) in USA
(NCT02909777)
CA-170 Cancers Aurigene Pre-IND –RECRUITING Ph1 IN 2016-
01 Jun 2016 Phase-I clinical trials in Lymphoma (Late-
stage disease) in USA (PO) (NCT02812875)
01 Jun 2016 Phase-I clinical trials in Solid tumors
(Late-stage disease) in USA (PO) (NCT02812875)
01 Jun 2016 US FDA approves IND application for CA
170 in Cancer
CA-4948 Hematologic
cancers
Aurigene Pre-IND –ON-HOLD-
29 Feb 2016 Curis plans a phase I trial for
Haematological malignancies in USA (Curis, Form 10-K,
February 2016)
07 Oct 2015 Curis exercises its option to exclusively
license small molecule antagonists of Interleukin-1
receptor-associated kinase 4 (IRAK4)
CURIS, SCREENSHOT – NOVEMBER 2016
Page 5 of 10
		
Erivedge Advanced BCC Genentech (Roche) Approved in US, Australia and other countries and
conditional approval in the EU
Preceding
excision and
multiple BCC
Roche Phase 2 –RECRUITING Ph2 IN 2016-
Idiopathic
Pulmonary
Fibrosis
Roche Phase 1b –RECRUITING Ph1 IN 2016-
Myelofibrosis Roche Phase 1b –RECRUITING Ph1 IN 2016-
CUDC-427 Advanced solid
tumor &
lymphomas
Internal development;
Seeking collaborator
Completed Phase 1 –ON-HOLD-
01 Apr 2016 Curis completes a phase I trial in Solid
tumors and lymphomas (second-line therapy or
greater; late stage disease) in USA
06 Oct 2015 Phase-I development is ongoing for Solid
tumors and Lymphomas in USA
06 Oct 2015 CUDC 427 is available for licensing -
http://www.curis.com/pipeline/cudc-427
CUDC-305 Cancers Internal development;
Seeking collaborator
Completed Phase 1 –ON-HOLD-
19 Jun 2015 CUDC 305 is available for licensing as of
19 Jun 2015. http://www.curis.com/
11 May 2015 Phase-I clinical trials in Cancer in USA
(PO)
01 Feb 2015 Curis re-acquires CUDC 305 from
Debiopharm
CURIS, SCREENSHOT – NOVEMBER 2016
Page 6 of 10
		
INTERNAL DEVELOPMENT
One pre-clinical and two drugs following successful Phase 1 are available for licensing (on-hold).
There are currently six active recruiting clinical trials (Lymphoma - CUDC-427; Advanced Solid Tumors or Lymphomas
– CA170; Relapsed and/or Refractory Diffuse Large B-cell Lymphoma – CUDC-907; NUT Midline Carcinoma; Breast
Cancer; Solid Tumors – CUDC-907; Multiple Myeloma; Lymphoma – CUDC-907; Lymphoma; Neuroblastoma; Brain
Tumor; Solid Tumor – CUDC-907).
One trial has been terminated for adverse effects: CUDC-101 in Cancer.
Since its inception in 2000, substantially all the revenues derived from collaborations and other agreements with third
parties.
CURIS, SCREENSHOT – NOVEMBER 2016
Page 7 of 10
		
LATEST FINANCIAL NEWS
In September 2016, Aurigene received 10.2 million shares of Curis' common stock, priced at $2.40 per share,
representing a 39% premium to the closing price on September 02, 2016, in lieu of receiving up to $24.5 millions
of milestone and other payments from Curis.
In February 2015, the company commenced an underwritten public offering of shares of its common stock. At that
time, the company expected to grant the underwriters a 30-day option to buy an additional 15% of the shares of its
common stock. Later that month, the company priced the underwritten public offering of 21,818,181 shares at
$2.75 each and granted the underwriters a 30-day option to purchase up to an additional 3,272,727 shares. The
aggregate proceeds from the offering was expected to be $60.0 million and the offering was expected to close on or
about March 02, 2015. In March 2015, the offering was closed. The company received net proceeds of about $64.7
million from the offering.
CURIS, SCREENSHOT – NOVEMBER 2016
Page 8 of 10
		
LATEST PRESS RELEASES
(11-Oct-2016) Curis Expands Oncology Pipeline with an Oral Small Molecule PD-L1/TIM-3 Immune Checkpoint
Antagonist
(11-Oct-2016) Curis Reports Inducement Grants Under NASDAQ Listing Rule 5635(4)
(11-Oct-2016) Aurigene Announces the Exercise of Curis' Option for CA-327 (PD-L1/TIM-3 Small Molecule
Antagonist), The Third Program Under Its Collaboration, License and Option Agreement of January, 2015 (October
11, 2016, New Jersey, NJ, USA)
(16-Sep-2016) Curis Reports Inducement Grants Under NASDAQ Listing Rule 5635(4)
(07-Sep-2016) Aurigene to Invest in Curis at Premium Through Waiver of Certain Milestone Payments Under
Collaboration Agreement
CURIS, SCREENSHOT – NOVEMBER 2016
Page 9 of 10
		
DISCUSSION
The company is engaging a conservative strategy through product development of its leading compound CUDC-907
and divestiture of early drugs (on hold seeking outlicensing opportunities). EBITDA fell from $(8M) in 2013 to $(15M)
in 2014 and $(55M) in 2015 due to increasing operating expenses (R&D). ROA, Operating/Net margin and ROE are
far below the industry average.
If approved, CUDC-907 would contribute to almost 90% of Company’s income starting as early as 2018 (worldwide
market).
In February 2016, an open label, single group assigned, randomized phase II trial (NCT02674750;CUDC-907-201 )
was initiated with and without rituximab in patients (n=120) with relapsed/refractory MYC-altered diffuse large B-cell
lymphoma in the US. At that time, the trial was expected to complete in January 2018.
CURIS, SCREENSHOT – NOVEMBER 2016
Page 10 of 10
	
The success rate for small molecule to advance from Phase 2 to 3 is 24%, then 65% from Phase 3 to registration;
the likelihood of approval is narrowed to 8.1% in Oncology. Within Oncology, the solid tumor (B-cell lymphoma) as
an average success rate of 40%.
The list of competitors for CUDC-907 is quite long and fierce, though the novelty for CUDC-907 is targeting both HDAC
and PI3K. However, product and price will make the difference to differentiate CUDC-907 from the market for its activity
(if any) and price fights (or licensing) with other larger companies.
CONCLUSION
The market is led by large pharmaceutical companies with marketed and clinical compounds targeting B-cell lymphoma.
If approved (15%, risk adjusted rate) CUDC-207, Curis would struggle to launch its compound by relying on its assets
only. Curis could become a target for M&A activity confirmed also by the large interest of Roche/Genentech and financial
share of Aurigene. If not approved (85%, risk adjusted rate), Curis’s pipeline would be still in the run for two more
drugs, CA-170 and Erivedge in Pulmonary Fibrosis.

More Related Content

Similar to Curis, snapshot November 2016

Access Pharmaceuticals (ACCP)
Access Pharmaceuticals (ACCP)Access Pharmaceuticals (ACCP)
Access Pharmaceuticals (ACCP)Brett_Johnson
 
A project report on financial analysis of novartis india (1)
A project report on financial analysis of novartis india (1)A project report on financial analysis of novartis india (1)
A project report on financial analysis of novartis india (1)yashicaj9
 
Glaukos investor presentation updated as of 11282016 for website possting
Glaukos investor presentation updated as of 11282016 for website posstingGlaukos investor presentation updated as of 11282016 for website possting
Glaukos investor presentation updated as of 11282016 for website posstingglaukos
 
Cardinal Health 2016 Annual Shareholder Meeting Presentation
Cardinal Health 2016 Annual Shareholder Meeting PresentationCardinal Health 2016 Annual Shareholder Meeting Presentation
Cardinal Health 2016 Annual Shareholder Meeting PresentationCardinal_Health
 
20160126 smb m dx health jan groen
20160126 smb m dx health jan groen20160126 smb m dx health jan groen
20160126 smb m dx health jan groenSMBBV
 
Corporate Presentation: February 2016
Corporate Presentation: February 2016Corporate Presentation: February 2016
Corporate Presentation: February 2016Exact Sciences
 
2018/01 – JP Morgan Healthcare Conference
2018/01 – JP Morgan Healthcare Conference2018/01 – JP Morgan Healthcare Conference
2018/01 – JP Morgan Healthcare ConferenceSanofi
 
Glaukos investor presentation-q1-2016-for-website-06022016
Glaukos investor presentation-q1-2016-for-website-06022016Glaukos investor presentation-q1-2016-for-website-06022016
Glaukos investor presentation-q1-2016-for-website-06022016glaukos
 
Glaukos investor presentation for q2 2017 for website and 8_k
Glaukos investor presentation for q2 2017 for website and 8_kGlaukos investor presentation for q2 2017 for website and 8_k
Glaukos investor presentation for q2 2017 for website and 8_kglaukos
 
Exact Sciences Corporate Presentation: August 2016
Exact Sciences Corporate Presentation: August 2016Exact Sciences Corporate Presentation: August 2016
Exact Sciences Corporate Presentation: August 2016Exact Sciences
 
Brain cancer pipeline review, h1 2015
Brain cancer   pipeline review, h1 2015Brain cancer   pipeline review, h1 2015
Brain cancer pipeline review, h1 2015Ambikabasa
 
Prescient Therapeutics Investor Presentation
Prescient Therapeutics Investor PresentationPrescient Therapeutics Investor Presentation
Prescient Therapeutics Investor PresentationCorey Hulls
 
Sustaining innovation day 2017 presentation
Sustaining innovation day 2017 presentationSustaining innovation day 2017 presentation
Sustaining innovation day 2017 presentationSanofi
 
Critical Outcome Technologies - Investor Presentation - June 2013
Critical Outcome Technologies - Investor Presentation - June 2013Critical Outcome Technologies - Investor Presentation - June 2013
Critical Outcome Technologies - Investor Presentation - June 2013Critical Outcome Technologies Inc.
 
Oncologyintelligence 2013
Oncologyintelligence 2013Oncologyintelligence 2013
Oncologyintelligence 2013Akanksha Sharma
 
Corporate Presentation: August 2016
Corporate Presentation: August 2016Corporate Presentation: August 2016
Corporate Presentation: August 2016Exact Sciences
 

Similar to Curis, snapshot November 2016 (20)

Access Pharmaceuticals (ACCP)
Access Pharmaceuticals (ACCP)Access Pharmaceuticals (ACCP)
Access Pharmaceuticals (ACCP)
 
A project report on financial analysis of novartis india (1)
A project report on financial analysis of novartis india (1)A project report on financial analysis of novartis india (1)
A project report on financial analysis of novartis india (1)
 
Glaukos investor presentation updated as of 11282016 for website possting
Glaukos investor presentation updated as of 11282016 for website posstingGlaukos investor presentation updated as of 11282016 for website possting
Glaukos investor presentation updated as of 11282016 for website possting
 
Cardinal Health 2016 Annual Shareholder Meeting Presentation
Cardinal Health 2016 Annual Shareholder Meeting PresentationCardinal Health 2016 Annual Shareholder Meeting Presentation
Cardinal Health 2016 Annual Shareholder Meeting Presentation
 
20160126 smb m dx health jan groen
20160126 smb m dx health jan groen20160126 smb m dx health jan groen
20160126 smb m dx health jan groen
 
Critical Outcome Technologies - May 2014
Critical Outcome Technologies - May 2014Critical Outcome Technologies - May 2014
Critical Outcome Technologies - May 2014
 
Corporate Presentation: February 2016
Corporate Presentation: February 2016Corporate Presentation: February 2016
Corporate Presentation: February 2016
 
2018/01 – JP Morgan Healthcare Conference
2018/01 – JP Morgan Healthcare Conference2018/01 – JP Morgan Healthcare Conference
2018/01 – JP Morgan Healthcare Conference
 
Glaukos investor presentation-q1-2016-for-website-06022016
Glaukos investor presentation-q1-2016-for-website-06022016Glaukos investor presentation-q1-2016-for-website-06022016
Glaukos investor presentation-q1-2016-for-website-06022016
 
Critical Outcome Investor Presentation - March 2014
Critical Outcome Investor Presentation - March 2014Critical Outcome Investor Presentation - March 2014
Critical Outcome Investor Presentation - March 2014
 
Glaukos investor presentation for q2 2017 for website and 8_k
Glaukos investor presentation for q2 2017 for website and 8_kGlaukos investor presentation for q2 2017 for website and 8_k
Glaukos investor presentation for q2 2017 for website and 8_k
 
Critical Outcome - September 2014
Critical Outcome - September 2014Critical Outcome - September 2014
Critical Outcome - September 2014
 
Exact Sciences Corporate Presentation: August 2016
Exact Sciences Corporate Presentation: August 2016Exact Sciences Corporate Presentation: August 2016
Exact Sciences Corporate Presentation: August 2016
 
Brain cancer pipeline review, h1 2015
Brain cancer   pipeline review, h1 2015Brain cancer   pipeline review, h1 2015
Brain cancer pipeline review, h1 2015
 
Prescient Therapeutics Investor Presentation
Prescient Therapeutics Investor PresentationPrescient Therapeutics Investor Presentation
Prescient Therapeutics Investor Presentation
 
Sustaining innovation day 2017 presentation
Sustaining innovation day 2017 presentationSustaining innovation day 2017 presentation
Sustaining innovation day 2017 presentation
 
Critical Outcome Technologies - Investor Presentation - June 2013
Critical Outcome Technologies - Investor Presentation - June 2013Critical Outcome Technologies - Investor Presentation - June 2013
Critical Outcome Technologies - Investor Presentation - June 2013
 
Critical Outcome BIO Investor Forum
Critical Outcome BIO Investor ForumCritical Outcome BIO Investor Forum
Critical Outcome BIO Investor Forum
 
Oncologyintelligence 2013
Oncologyintelligence 2013Oncologyintelligence 2013
Oncologyintelligence 2013
 
Corporate Presentation: August 2016
Corporate Presentation: August 2016Corporate Presentation: August 2016
Corporate Presentation: August 2016
 

Recently uploaded

obat aborsi Sragen wa 082223595321 jual obat aborsi cytotec asli di Sragen
obat aborsi Sragen wa 082223595321 jual obat aborsi cytotec asli di Sragenobat aborsi Sragen wa 082223595321 jual obat aborsi cytotec asli di Sragen
obat aborsi Sragen wa 082223595321 jual obat aborsi cytotec asli di Sragensiskavia171
 
Personnel and Equipment - Code and Rapid Response Workshop
Personnel and Equipment - Code and Rapid Response WorkshopPersonnel and Equipment - Code and Rapid Response Workshop
Personnel and Equipment - Code and Rapid Response WorkshopBrian Locke
 
Understanding Metabolic Syndrome in PCOS: Symptoms, Risks, and Management
Understanding Metabolic Syndrome in PCOS: Symptoms, Risks, and ManagementUnderstanding Metabolic Syndrome in PCOS: Symptoms, Risks, and Management
Understanding Metabolic Syndrome in PCOS: Symptoms, Risks, and ManagementDr.Laxmi Agrawal Shrikhande
 
INTERNATIONAL HEALTH AGENCIES BY ANUSHRI SRIVASTAV.pptx
INTERNATIONAL HEALTH AGENCIES BY ANUSHRI SRIVASTAV.pptxINTERNATIONAL HEALTH AGENCIES BY ANUSHRI SRIVASTAV.pptx
INTERNATIONAL HEALTH AGENCIES BY ANUSHRI SRIVASTAV.pptxAnushriSrivastav
 
Technology transfer documentation and strategies
Technology transfer documentation and strategiesTechnology transfer documentation and strategies
Technology transfer documentation and strategiesNidhi Joshi
 
Healthcare Market Overview, May 2024: Funding, Financing and M&A, from Oppenh...
Healthcare Market Overview, May 2024: Funding, Financing and M&A, from Oppenh...Healthcare Market Overview, May 2024: Funding, Financing and M&A, from Oppenh...
Healthcare Market Overview, May 2024: Funding, Financing and M&A, from Oppenh...Levi Shapiro
 
The 2024 Outlook for Older Adults: Healthcare Consumer Survey
The 2024 Outlook for Older Adults: Healthcare Consumer SurveyThe 2024 Outlook for Older Adults: Healthcare Consumer Survey
The 2024 Outlook for Older Adults: Healthcare Consumer SurveyMedia Logic
 
Session-1-MBFHI-A-part-of-the-Global-Strategy.ppt
Session-1-MBFHI-A-part-of-the-Global-Strategy.pptSession-1-MBFHI-A-part-of-the-Global-Strategy.ppt
Session-1-MBFHI-A-part-of-the-Global-Strategy.pptMedidas Medical Center INC
 
clostridiumbotulinum- BY Muzammil Ahmed Siddiqui.pptx
clostridiumbotulinum- BY Muzammil Ahmed Siddiqui.pptxclostridiumbotulinum- BY Muzammil Ahmed Siddiqui.pptx
clostridiumbotulinum- BY Muzammil Ahmed Siddiqui.pptxMuzammil Ahmed Siddiqui
 
Famous Indian Vedic Astrologer | Best Astrological Solutions UK
Famous Indian Vedic Astrologer | Best Astrological Solutions UKFamous Indian Vedic Astrologer | Best Astrological Solutions UK
Famous Indian Vedic Astrologer | Best Astrological Solutions UKdarmandersingh4580
 
Antiepileptic-Drugs-and-Congenital-Anomalies copy.pptx
Antiepileptic-Drugs-and-Congenital-Anomalies copy.pptxAntiepileptic-Drugs-and-Congenital-Anomalies copy.pptx
Antiepileptic-Drugs-and-Congenital-Anomalies copy.pptxdrdeepikaj
 
Pulse Check Decisions - RRT and Code Blue Workshop
Pulse Check Decisions - RRT and Code Blue WorkshopPulse Check Decisions - RRT and Code Blue Workshop
Pulse Check Decisions - RRT and Code Blue WorkshopBrian Locke
 
Session-3-Promoting-Breastfeeding-During-Pregnancy.ppt
Session-3-Promoting-Breastfeeding-During-Pregnancy.pptSession-3-Promoting-Breastfeeding-During-Pregnancy.ppt
Session-3-Promoting-Breastfeeding-During-Pregnancy.pptMedidas Medical Center INC
 
Leadership Style - Code and Rapid Response Workshop
Leadership Style - Code and Rapid Response WorkshopLeadership Style - Code and Rapid Response Workshop
Leadership Style - Code and Rapid Response WorkshopBrian Locke
 
ITM HOSPITAL The hospital has also been recognised as the best emerging hosp...
ITM  HOSPITAL The hospital has also been recognised as the best emerging hosp...ITM  HOSPITAL The hospital has also been recognised as the best emerging hosp...
ITM HOSPITAL The hospital has also been recognised as the best emerging hosp...jvomprakash
 
Cytotec 200mcg tab in Riyadh (+919101817206// Get Abortion Pills in Saudi Arabia
Cytotec 200mcg tab in Riyadh (+919101817206// Get Abortion Pills in Saudi ArabiaCytotec 200mcg tab in Riyadh (+919101817206// Get Abortion Pills in Saudi Arabia
Cytotec 200mcg tab in Riyadh (+919101817206// Get Abortion Pills in Saudi Arabiajaanualu31
 
Making change happen: learning from "positive deviancts"
Making change happen: learning from "positive deviancts"Making change happen: learning from "positive deviancts"
Making change happen: learning from "positive deviancts"HelenBevan4
 
Top^Clinic ^%[+27785538335__Safe*Abortion Pills For Sale In Soweto
Top^Clinic ^%[+27785538335__Safe*Abortion Pills For Sale In SowetoTop^Clinic ^%[+27785538335__Safe*Abortion Pills For Sale In Soweto
Top^Clinic ^%[+27785538335__Safe*Abortion Pills For Sale In Sowetodoctorjoe1984
 

Recently uploaded (20)

obat aborsi Sragen wa 082223595321 jual obat aborsi cytotec asli di Sragen
obat aborsi Sragen wa 082223595321 jual obat aborsi cytotec asli di Sragenobat aborsi Sragen wa 082223595321 jual obat aborsi cytotec asli di Sragen
obat aborsi Sragen wa 082223595321 jual obat aborsi cytotec asli di Sragen
 
Personnel and Equipment - Code and Rapid Response Workshop
Personnel and Equipment - Code and Rapid Response WorkshopPersonnel and Equipment - Code and Rapid Response Workshop
Personnel and Equipment - Code and Rapid Response Workshop
 
Understanding Metabolic Syndrome in PCOS: Symptoms, Risks, and Management
Understanding Metabolic Syndrome in PCOS: Symptoms, Risks, and ManagementUnderstanding Metabolic Syndrome in PCOS: Symptoms, Risks, and Management
Understanding Metabolic Syndrome in PCOS: Symptoms, Risks, and Management
 
INTERNATIONAL HEALTH AGENCIES BY ANUSHRI SRIVASTAV.pptx
INTERNATIONAL HEALTH AGENCIES BY ANUSHRI SRIVASTAV.pptxINTERNATIONAL HEALTH AGENCIES BY ANUSHRI SRIVASTAV.pptx
INTERNATIONAL HEALTH AGENCIES BY ANUSHRI SRIVASTAV.pptx
 
Technology transfer documentation and strategies
Technology transfer documentation and strategiesTechnology transfer documentation and strategies
Technology transfer documentation and strategies
 
Healthcare Market Overview, May 2024: Funding, Financing and M&A, from Oppenh...
Healthcare Market Overview, May 2024: Funding, Financing and M&A, from Oppenh...Healthcare Market Overview, May 2024: Funding, Financing and M&A, from Oppenh...
Healthcare Market Overview, May 2024: Funding, Financing and M&A, from Oppenh...
 
The 2024 Outlook for Older Adults: Healthcare Consumer Survey
The 2024 Outlook for Older Adults: Healthcare Consumer SurveyThe 2024 Outlook for Older Adults: Healthcare Consumer Survey
The 2024 Outlook for Older Adults: Healthcare Consumer Survey
 
Session-10-Infants-with-Special-meeds.ppt
Session-10-Infants-with-Special-meeds.pptSession-10-Infants-with-Special-meeds.ppt
Session-10-Infants-with-Special-meeds.ppt
 
Session-1-MBFHI-A-part-of-the-Global-Strategy.ppt
Session-1-MBFHI-A-part-of-the-Global-Strategy.pptSession-1-MBFHI-A-part-of-the-Global-Strategy.ppt
Session-1-MBFHI-A-part-of-the-Global-Strategy.ppt
 
clostridiumbotulinum- BY Muzammil Ahmed Siddiqui.pptx
clostridiumbotulinum- BY Muzammil Ahmed Siddiqui.pptxclostridiumbotulinum- BY Muzammil Ahmed Siddiqui.pptx
clostridiumbotulinum- BY Muzammil Ahmed Siddiqui.pptx
 
Famous Indian Vedic Astrologer | Best Astrological Solutions UK
Famous Indian Vedic Astrologer | Best Astrological Solutions UKFamous Indian Vedic Astrologer | Best Astrological Solutions UK
Famous Indian Vedic Astrologer | Best Astrological Solutions UK
 
Antiepileptic-Drugs-and-Congenital-Anomalies copy.pptx
Antiepileptic-Drugs-and-Congenital-Anomalies copy.pptxAntiepileptic-Drugs-and-Congenital-Anomalies copy.pptx
Antiepileptic-Drugs-and-Congenital-Anomalies copy.pptx
 
Pulse Check Decisions - RRT and Code Blue Workshop
Pulse Check Decisions - RRT and Code Blue WorkshopPulse Check Decisions - RRT and Code Blue Workshop
Pulse Check Decisions - RRT and Code Blue Workshop
 
Session-3-Promoting-Breastfeeding-During-Pregnancy.ppt
Session-3-Promoting-Breastfeeding-During-Pregnancy.pptSession-3-Promoting-Breastfeeding-During-Pregnancy.ppt
Session-3-Promoting-Breastfeeding-During-Pregnancy.ppt
 
LTM Session-8-Practices-that-assist-BF..ppt
LTM Session-8-Practices-that-assist-BF..pptLTM Session-8-Practices-that-assist-BF..ppt
LTM Session-8-Practices-that-assist-BF..ppt
 
Leadership Style - Code and Rapid Response Workshop
Leadership Style - Code and Rapid Response WorkshopLeadership Style - Code and Rapid Response Workshop
Leadership Style - Code and Rapid Response Workshop
 
ITM HOSPITAL The hospital has also been recognised as the best emerging hosp...
ITM  HOSPITAL The hospital has also been recognised as the best emerging hosp...ITM  HOSPITAL The hospital has also been recognised as the best emerging hosp...
ITM HOSPITAL The hospital has also been recognised as the best emerging hosp...
 
Cytotec 200mcg tab in Riyadh (+919101817206// Get Abortion Pills in Saudi Arabia
Cytotec 200mcg tab in Riyadh (+919101817206// Get Abortion Pills in Saudi ArabiaCytotec 200mcg tab in Riyadh (+919101817206// Get Abortion Pills in Saudi Arabia
Cytotec 200mcg tab in Riyadh (+919101817206// Get Abortion Pills in Saudi Arabia
 
Making change happen: learning from "positive deviancts"
Making change happen: learning from "positive deviancts"Making change happen: learning from "positive deviancts"
Making change happen: learning from "positive deviancts"
 
Top^Clinic ^%[+27785538335__Safe*Abortion Pills For Sale In Soweto
Top^Clinic ^%[+27785538335__Safe*Abortion Pills For Sale In SowetoTop^Clinic ^%[+27785538335__Safe*Abortion Pills For Sale In Soweto
Top^Clinic ^%[+27785538335__Safe*Abortion Pills For Sale In Soweto
 

Curis, snapshot November 2016

  • 1. CURIS, SCREENSHOT – NOVEMBER 2016 Page 1 of 10 Curis
  • 2. CURIS, SCREENSHOT – NOVEMBER 2016 Page 2 of 10 DISCLAIMER This report (Report) has been produced independently by QStat Consulting. The intent of this Report is to provide a structured example of QStat Consulting’s service and to provide information for the public. The views expressed in this Report are not necessarily the views of QStat Consulting. The information, statements, statistics and commentary (together the ‘Information’) contained in this Report have been prepared by QStat Consulting from publicly available material and from discussions held with stakeholders. QStat Consulting does not express an opinion as to the accuracy or completeness of the information provided, the assumptions made by the parties that provided the information or any conclusions reached by those parties. QStat Consulting has based this Report on information received or obtained, on the basis that such information is accurate and, where it is represented to QStat Consulting as such, complete. The information contained in this Report has not been subject to an audit. All expressions of opinion are subject to change without notice, and the Authors do not undertake to update this Report or any information contained herein. This Report remains the property of QStat Consulting and any effort to use this Report as an actual and factual appraisal Report is not permitted.
  • 3. CURIS, SCREENSHOT – NOVEMBER 2016 Page 3 of 10 CASE ABSTRACT Curis Therapeutics (Company) was incorporated on February 14, 2000 and trades on the NASDAQ Global Market (NASDAQ:CRIS). Headquartered in Lexington, Massachusetts, it is a clinical-stage biopharmaceutical company engaged in developing and commercializing therapeutics for the regeneration and restoration of human tissues and organs. The Company is engaged in the development and commercialization of drug candidates for the treatment of human cancers. The Company's drug candidate, CUDC-907, is an orally available, small molecule inhibitor of histone deacetylase (HDAC) and phosphatidylinositol-3-kinase (PI3K) enzymes. Specifically, CUDC-907 is designed to inhibit HDACs 1, 2, 3, 6 and 10 and PI3K-alpha, delta and beta isoforms. CUDC-907 can be indicated for antitumor activity in various hematologic tumor models, such as non-Hodgkin's lymphoma and multiple myeloma. CA-170 is an oral small molecule drug candidate designed to selectively target programmed death ligand 1 (PD-L1) and VISTA checkpoint proteins, both of which independently function as negative regulators of immune activation. CA-4948 is an oral small molecule drug candidate that is designed to inhibit the interleukin-1 receptor-associated kinase 4 (IRAK4) kinase, which is a transducer of toll-like receptor or certain interleukin receptor signaling pathways. These signaling pathways are shown to be involved in certain human cancers and inflammatory diseases. Erivedge is an orally bioavailable small molecule, and is designed to selectively inhibit the Hedgehog signaling pathway. The Hedgehog signaling pathway is active during embryonic development and unregulated activation of the pathway and plays a role in allowing the proliferation and survival of cancer cells and leading to formation and maintenance of certain cancers. Erivedge is indicated for adults with advanced forms of basal-cell carcinoma (BCC). CUDC-427 is an oral, small molecule Smac mimetic that is designed to promote cancer cell death by antagonizing inhibitor of apoptosis (IAP) proteins. CUDC-305 is an oral HSP90 inhibitor for the development in advanced lung cancer. Number of patents as owner: 247 Number of patents as third party: 5
  • 4. CURIS, SCREENSHOT – NOVEMBER 2016 Page 4 of 10 (2015, 10K Annual report) Drug Candidate Primary Disease Collaborator/Licensee Current Status CUDC-907 Relapsed, refractory DLBCL with MYC alterations Internal development Phase 2 –ONGOING Ph2 IN 2016- (12/31/2017 Phase 2 data due 2017) Solid tumors including NUT midline carcinoma Internal development Phase 1 –RECRUITING Ph1 IN 2016- 01 Oct 2016 Phase-I clinical trials in Lymphoma (In adolescents, In children, In infants, Second-line therapy or greater, In adults) in USA (PO) (NCT02909777) 01 Oct 2016 Phase-I clinical trials in Solid tumours (Second-line therapy or greater, In adolescents, In adults, In children, In infants) in USA (PO) (NCT02909777) 13 Sep 2016 Curis plans a phase I trial for Solid tumors and Lymphoma (Second-line therapy, In infants, In children, In adolescents, In adults) in USA (NCT02909777) CA-170 Cancers Aurigene Pre-IND –RECRUITING Ph1 IN 2016- 01 Jun 2016 Phase-I clinical trials in Lymphoma (Late- stage disease) in USA (PO) (NCT02812875) 01 Jun 2016 Phase-I clinical trials in Solid tumors (Late-stage disease) in USA (PO) (NCT02812875) 01 Jun 2016 US FDA approves IND application for CA 170 in Cancer CA-4948 Hematologic cancers Aurigene Pre-IND –ON-HOLD- 29 Feb 2016 Curis plans a phase I trial for Haematological malignancies in USA (Curis, Form 10-K, February 2016) 07 Oct 2015 Curis exercises its option to exclusively license small molecule antagonists of Interleukin-1 receptor-associated kinase 4 (IRAK4)
  • 5. CURIS, SCREENSHOT – NOVEMBER 2016 Page 5 of 10 Erivedge Advanced BCC Genentech (Roche) Approved in US, Australia and other countries and conditional approval in the EU Preceding excision and multiple BCC Roche Phase 2 –RECRUITING Ph2 IN 2016- Idiopathic Pulmonary Fibrosis Roche Phase 1b –RECRUITING Ph1 IN 2016- Myelofibrosis Roche Phase 1b –RECRUITING Ph1 IN 2016- CUDC-427 Advanced solid tumor & lymphomas Internal development; Seeking collaborator Completed Phase 1 –ON-HOLD- 01 Apr 2016 Curis completes a phase I trial in Solid tumors and lymphomas (second-line therapy or greater; late stage disease) in USA 06 Oct 2015 Phase-I development is ongoing for Solid tumors and Lymphomas in USA 06 Oct 2015 CUDC 427 is available for licensing - http://www.curis.com/pipeline/cudc-427 CUDC-305 Cancers Internal development; Seeking collaborator Completed Phase 1 –ON-HOLD- 19 Jun 2015 CUDC 305 is available for licensing as of 19 Jun 2015. http://www.curis.com/ 11 May 2015 Phase-I clinical trials in Cancer in USA (PO) 01 Feb 2015 Curis re-acquires CUDC 305 from Debiopharm
  • 6. CURIS, SCREENSHOT – NOVEMBER 2016 Page 6 of 10 INTERNAL DEVELOPMENT One pre-clinical and two drugs following successful Phase 1 are available for licensing (on-hold). There are currently six active recruiting clinical trials (Lymphoma - CUDC-427; Advanced Solid Tumors or Lymphomas – CA170; Relapsed and/or Refractory Diffuse Large B-cell Lymphoma – CUDC-907; NUT Midline Carcinoma; Breast Cancer; Solid Tumors – CUDC-907; Multiple Myeloma; Lymphoma – CUDC-907; Lymphoma; Neuroblastoma; Brain Tumor; Solid Tumor – CUDC-907). One trial has been terminated for adverse effects: CUDC-101 in Cancer. Since its inception in 2000, substantially all the revenues derived from collaborations and other agreements with third parties.
  • 7. CURIS, SCREENSHOT – NOVEMBER 2016 Page 7 of 10 LATEST FINANCIAL NEWS In September 2016, Aurigene received 10.2 million shares of Curis' common stock, priced at $2.40 per share, representing a 39% premium to the closing price on September 02, 2016, in lieu of receiving up to $24.5 millions of milestone and other payments from Curis. In February 2015, the company commenced an underwritten public offering of shares of its common stock. At that time, the company expected to grant the underwriters a 30-day option to buy an additional 15% of the shares of its common stock. Later that month, the company priced the underwritten public offering of 21,818,181 shares at $2.75 each and granted the underwriters a 30-day option to purchase up to an additional 3,272,727 shares. The aggregate proceeds from the offering was expected to be $60.0 million and the offering was expected to close on or about March 02, 2015. In March 2015, the offering was closed. The company received net proceeds of about $64.7 million from the offering.
  • 8. CURIS, SCREENSHOT – NOVEMBER 2016 Page 8 of 10 LATEST PRESS RELEASES (11-Oct-2016) Curis Expands Oncology Pipeline with an Oral Small Molecule PD-L1/TIM-3 Immune Checkpoint Antagonist (11-Oct-2016) Curis Reports Inducement Grants Under NASDAQ Listing Rule 5635(4) (11-Oct-2016) Aurigene Announces the Exercise of Curis' Option for CA-327 (PD-L1/TIM-3 Small Molecule Antagonist), The Third Program Under Its Collaboration, License and Option Agreement of January, 2015 (October 11, 2016, New Jersey, NJ, USA) (16-Sep-2016) Curis Reports Inducement Grants Under NASDAQ Listing Rule 5635(4) (07-Sep-2016) Aurigene to Invest in Curis at Premium Through Waiver of Certain Milestone Payments Under Collaboration Agreement
  • 9. CURIS, SCREENSHOT – NOVEMBER 2016 Page 9 of 10 DISCUSSION The company is engaging a conservative strategy through product development of its leading compound CUDC-907 and divestiture of early drugs (on hold seeking outlicensing opportunities). EBITDA fell from $(8M) in 2013 to $(15M) in 2014 and $(55M) in 2015 due to increasing operating expenses (R&D). ROA, Operating/Net margin and ROE are far below the industry average. If approved, CUDC-907 would contribute to almost 90% of Company’s income starting as early as 2018 (worldwide market). In February 2016, an open label, single group assigned, randomized phase II trial (NCT02674750;CUDC-907-201 ) was initiated with and without rituximab in patients (n=120) with relapsed/refractory MYC-altered diffuse large B-cell lymphoma in the US. At that time, the trial was expected to complete in January 2018.
  • 10. CURIS, SCREENSHOT – NOVEMBER 2016 Page 10 of 10 The success rate for small molecule to advance from Phase 2 to 3 is 24%, then 65% from Phase 3 to registration; the likelihood of approval is narrowed to 8.1% in Oncology. Within Oncology, the solid tumor (B-cell lymphoma) as an average success rate of 40%. The list of competitors for CUDC-907 is quite long and fierce, though the novelty for CUDC-907 is targeting both HDAC and PI3K. However, product and price will make the difference to differentiate CUDC-907 from the market for its activity (if any) and price fights (or licensing) with other larger companies. CONCLUSION The market is led by large pharmaceutical companies with marketed and clinical compounds targeting B-cell lymphoma. If approved (15%, risk adjusted rate) CUDC-207, Curis would struggle to launch its compound by relying on its assets only. Curis could become a target for M&A activity confirmed also by the large interest of Roche/Genentech and financial share of Aurigene. If not approved (85%, risk adjusted rate), Curis’s pipeline would be still in the run for two more drugs, CA-170 and Erivedge in Pulmonary Fibrosis.