Curis Shares Show Recent Gains, Pipeline Review and FDA Decision

Curis, Inc. (NASDAQ: CRIS) is a biotechnology company, focused on the development and commercialization of drug candidates for the treatment of human cancers.


Recent Events

May 31, 2018. Curis announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of fimepinostat (formerly CUDC-907) in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Previously reported results from Phase 1 and Phase 2 clinical studies demonstrated that treatment with fimepinostat resulted in a complete or partial response in approximately one out of every four patients with R/R DLBCL with MYC alterations.


May 29, 2018. Curis announced that its previously disclosed 1-for-5 reverse stock split will be effective as of 5:00 p.m. Eastern Time today, May 29, 2018.  Curis’s common stock will begin trading on the Nasdaq Global Market on a split-adjusted basis when the market opens on Wednesday, May 30, 2018.  The new CUSIP number for Curis’s common stock following the reverse stock split is 231269 200.


May 24, 2018. Curis announced that Robert Martell, M.D., Ph.D., has been appointed Head of Research and Development. In this newly created role, Dr. Martell, a practicing oncologist and experienced drug developer, will directly manage the day-to-day operations of the Curis clinical development and research efforts. Dr. Martell is a member of the Board of Directors of Curis and will resign from his board duties simultaneous with his start date on June 1st.


Their clinical stage drug candidates are CUDC-907, which they are investigating in a Phase 2 clinical trial in patients with MYC-altered diffuse large B-cell lymphoma and solid tumors, CA-170, for which they are currently conducting a Phase 1 study in patients with advanced solid tumors and lymphomas, and CA-4948, for which, in January 2018 they initiated a Phase 1 trial in patients with advanced non-Hodgkin lymphomas, including those with the myeloid differentiation primary response 88, or MYD88 alterations.

Their pipeline also includes CA-327, which is a pre-IND stage oncology drug candidate. They expect to file an IND application with the United States Food and Drug Administration, or FDA, for clinical testing of CA-327 in 2018. In March 2018, they exercised their option to license a fourth program, which is an immuno-oncology program, from our collaboration partner Aurigene.

Further, they are party to a collaboration with F. Hoffmann-La Roche Ltd, or Roche, and Genentech Inc., or Genentech, a member of the Roche Group, under which Roche and Genentech are commercializing Erivedge, a first-in-class orally-administered small molecule Hedgehog signaling pathway inhibitor. Erivedge ® (vismodegib) is approved for the treatment of advanced basal cell carcinoma, or BCC.

They are party to a collaboration agreement focused on immuno-oncology and selected precision oncology targets with Aurigene Discovery Technologies Limited, or Aurigene, a specialized, discovery-stage biotechnology company and wholly-owned subsidiary of Dr. Reddy’s Laboratories. As of December 31, 2017, they have licensed three programs under the Aurigene collaboration, and they licensed the fourth program in March 2018.




Curis, Inc., a biotechnology company, focuses on the development and commercialization of drug candidates for the treatment of human cancers in the United States. Its clinical stage drug candidates include CUDC-907, an oral dual inhibitor of HDAC and PI3K enzymes, which is in Phase II clinical trial for the treatment of patients with MYC-altered diffuse large B-cell lymphoma and solid tumors; CA-170, an oral small molecule drug candidate that is in Phase I clinical trial for treating patients with advanced solid tumors and lymphomas; CA-4948, an oral small molecule drug candidate, which is in Phase I clinical trial for the treatment of non-hodgkin lymphomas; and CA-327, an oral small molecule drug candidate that is in preclinical stage for the treatment of cancers. The company has collaboration agreement with F. Hoffmann-La Roche Ltd. and Genentech Inc. for the development and commercialization of Erivedge, an orally-administered small molecule hedgehog signaling pathway inhibitor for the treatment of advanced basal cell carcinoma; and with Aurigene Discovery Technologies Limited for the discovery, development, and commercialization of small molecule compounds in the areas of immuno-oncology and precision oncology. Curis, Inc. was founded in 2000 and is headquartered in Lexington, Massachusetts.



Oct-24-17           Initiated              Guggenheim      Buy        $7


Financial review

For the first quarter of 2018, VAALCO reported income from continuing operations of $8.7 million, or $0.15 per diluted share.  In the same period in 2017, the Company reported income from continuing operations of $4.4 million, or $0.07 per diluted share, and in the fourth quarter of 2017 reported income from continuing operations of $3.5 million, or $0.06 per diluted share.  The average realized price for crude oil in the first quarter of 2018 was $68.69 per barrel, an increase of 32% from $51.99 per barrel in the first quarter of 2017.  In the fourth quarter of 2017, the average realized price for crude oil was $59.89 per barrel. Adjusted EBITDAX totaled $14.5 million in the first quarter of 2018 compared with $10.4 million in the same period of 2017, and $3.9 million in the fourth quarter of 2017.


Stock influences and risk factors

Incremental successes in Clinical Trials for their drug candidates could act as catalysts for the company’s shares;

They have incurred substantial losses, expect to continue to incur substantial losses for the foreseeable future and may never generate significant revenue or achieve profitability;

They will require substantial additional capital, which may be difficult to obtain, and if they are unable to raise capital when needed, they could be forced to delay, reduce, or eliminate drug development programs or commercialization efforts;

The therapeutic efficacy of their drug candidates is unproven in humans, and they may not be able to successfully develop and commercialize drug candidates pursuant to these programs.

Stock chart

On Thursday, May 31, 2018, CRIS shares were trading at $3.00 on traded volume of 3.6 million shares. The current RSI is 58.67

At $3.00 CRIS shares are trading above their 50 DMA of $2.85 and below their 200 DMA of $4.92.



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