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under which Genentech and Roche are commercializing Erivedge® for the treatment of advanced basal c

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By: Curis, Inc. via PR Newswire

November 01, 2018 at 07:00 AM EDT

Curis Reports Third Quarter 2018 Financial Results

LEXINGTON, Mass., Nov. 1, 2018 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today reported financial results for the third quarter ended September 30, 2018.

"Following Curis's recent leadership change, we are increasing our focus on the clinical execution of our three first-in-class therapeutics that have the potential to be significant and innovative cancer treatments. We expect all three drug candidates to progress rapidly in the clinic and have data readouts in 2019," said James Dentzer, President & Chief Executive Officer of Curis. "To achieve this goal, we are re-allocating resources to prioritize clinical operations and have implemented a reduction in headcount and expenditure on pre-clinical science, pipeline expansion, and general and administrative expenses. We expect these reductions will offset an increase in headcount and costs associated with clinical operations and result in net savings for the Company, reducing cash burn from approximately $11 million to $8 million per quarter. This renewed focus on clinical execution will benefit patients in need of life-changing medications and shareholders alike," Mr. Dentzer concluded.

Third Quarter 2018 Financial Results

Curis reported a net loss of $7.2 million, or $0.22 per share on a basic and diluted basis for the third quarter of 2018, as compared to a net loss of $15.5 million, or $0.53 per share respectively for the same period in 2017.

Revenues for the third quarter of 2018 were $2.8 million, as compared to $2.4 million for the same period in 2017. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche's net sales of Erivedge®.

Operating expenses were $9.3 million for the third quarter of 2018, as compared to $16.9 million for the same period in 2017, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, resulting from payments to third-party university patent licensors associated with Genentech and Roche's Erivedge net sales, were $0.2 million as compared to $0.1 million for the same period in 2017.

Research and Development Expenses. Research and development expenses were $5.0 million, as compared to $13.4 million for the same period in 2017. The decrease was primarily driven by decreased costs related to clinical activities and manufacturing for fimepinostat, CA-170 and CA-4948 and a payment to Aurigene of $3.8 million for an exclusivity option in September 2017.

General and Administrative Expenses. General and administrative expenses were $4.1 million as compared to $3.4 million for the same period in 2017. The increase in general and administrative expenses was primarily driven by higher personnel costs and professional and consulting services partially offset by lower stock-based compensation for the period.

Other Expenses. Net other expenses totaled $0.8 million as compared to $1.0 million for the same period in 2017. Net other expense primarily consisted of interest expense related to Curis Royalty's (a wholly owned subsidiary of Curis) debt obligations.

As of September 30, 2018, Curis's cash, cash equivalents and investments totaled $30.8 million and there were approximately 33.1 million shares of common stock outstanding.

Recent Operational Highlights

Precision oncology, fimepinostat (formerly CUDC-907):

Having received Fast Track designation for fimepinostat, Curis is working with the FDA and select clinical sites to initiate a combination study of fimepinostat (a MYC inhibitor) with venetoclax (a BCL-2 inhibitor) in DLBCL, including patients with DH/DE Lymphoma.

DLBCL with alterations in both the MYC gene and the BCL2 gene is defined as Double-Hit Lymphoma. In preclinical studies, the combination of fimepinostat with venetoclax has demonstrated highly synergistic effect, resulting in significant tumor size reduction.

Precision oncology, CA-4948 (IRAK4 Kinase Inhibitor; Aurigene collaboration):

Curis continues to enroll patients with relapsed or refractory non-Hodgkin lymphoma in a dose escalation study evaluating CA-4948, a first-in-class oral, small molecule IRAK4 kinase inhibitor. CA-4948 is designed to target cancers with MYD88 mutations in DLBCL and Waldenström's macroglobulinemia.

Immuno-oncology, CA-170 (VISTA / PDL1 antagonist; Aurigene collaboration):

Patient treatment continues in the dose escalation study evaluating CA-170 in patients with advanced solid tumors or lymphomas.

Curis is working with select clinical sites to initiate a study of CA-170 in patients with mesothelioma, following evidence of mesothelioma tumor samples expressing high levels of VISTA. Recent publications have identified VISTA as a possible resistance mechanism to treatment with anti-PD1 antibodies in several cancer indications.

Curis collaborator Aurigene continues to enroll immunotherapy treatment-naïve patients in a clinical study of CA-170 at select trial sites in India.

Recent Corporate Highlights

In September, Curis announced change in leadership with the appointment of James Dentzer to the position of President and Chief Executive Officer.

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