Curis Therapeutics, founded in 2000, is a clinical-stage biopharmaceutical company focused on developing therapies for cancer and tissue regeneration. The company's lead drug candidate, CUDC-907, is in Phase 2 trials for various hematologic cancers, while additional candidates like CA-170 and Erivedge target different cancer mechanisms. Financially, Curis has faced increasing operating losses, and success hinges on the approval of their drug pipeline amidst competition from larger pharmaceutical firms.

1. CURIS, SCREENSHOT – NOVEMBER 2016
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Curis

2. CURIS, SCREENSHOT – NOVEMBER 2016
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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

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(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)

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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

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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.

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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.

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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

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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.

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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.