LEXINGTON, Mass., May 7, 2015 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers, today reported its financial results for the first quarter ended March 31, 2015.
“The first quarter of 2015 was a potentially transformative period for Curis, highlighted by our entry into a broad, exclusive collaboration with Aurigene for the discovery, development and commercialization of small molecule drug candidates in the areas of immuno- and precision oncology,” said Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. “This collaboration has the potential to generate a steady pipeline of novel drug candidates in the coming years. Our partner Aurigene reports that it has made significant progress in advancing the lead immuno-oncology program with molecules designed to antagonize the PD-1/ PD-L1 pathway and that it has a growing number of small molecules under investigation addressing other immune checkpoint pathways. Aurigene is also advancing compounds that are designed to inhibit the IRAK4 kinase, and we expect to exercise options to exclusively license these first two programs in the near future.”
Dr. Fattaey continued, “We are pleased that the U.S. FDA recently granted Orphan Drug Designation to CUDC-907 for the treatment of diffuse-large B-cell lymphoma (DLBCL), which represents an area of significant unmet need, especially in the relapsed/refractory setting. Clinical development of CUDC-907 continues in the ongoing expansion stage of the Phase 1 hematology trial, with a focus on DLBCL. We look forward to presenting completed dose escalation and available expansion stage data from this trial at the ASCO 2015 Annual Meeting later this month. We are also planning for a registration-directed Phase 2 study in DLBCL, which could initiate later this year. This would represent an important step in our continued evolution in clinical development and towards commercialization of an increasingly robust pipeline of innovative therapeutics.”
“During the first quarter of 2015, Curis successfully raised $64.6 million from a public offering of shares of common stock, significantly strengthening our capital position and providing the company with cash that is expected to fund planned operations into 2017,” said Michael Gray, Chief Financial and Chief Business Officer of Curis. “Importantly, this estimated cash runway should provide us with the resources that we need as we seek to generate significant milestones across many of our programs, including advancement of CUDC-907 into a registration-directed Phase 2 study and securing early proof-of-concept clinical data with the lead PD-L1 antagonist and IRAK4 inhibitor under our collaboration with Aurigene.”
First Quarter 2015 Financial Results
Curis reported a net loss of $31.8 million, or ($0.30) per share, on both a basic and fully diluted basis for the first quarter of 2015, as compared to a net loss of $5.6 million, or ($0.06) per share, on both a basic and fully diluted basis for the same period in 2014. The net loss for the current period includes an in-process research and development charge of $24.3 million related to Curis’ license agreement with Aurigene.
Revenues for the first quarter of 2015 were $1.7 million, as compared to $1.3 million for the same period in 2014. Revenues for both periods are comprised solely of royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.
Operating expenses were $32.7 million for the first quarter of 2015, as compared to $6.0 million for the same period in 2014, and were comprised of the following:
Costs of Royalty Revenues. Costs of royalty revenues, which are comprised of amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $84,000 for the first quarter of 2015, up from $65,000 during the first quarter of 2014.
In-Process Research and Development Expense. The Company recorded one-time in-process research and development expense of $24.3 million during the first quarter of 2015 associated with the issuance of 17,120,131 shares of Curis common stock to Aurigene as partial consideration for the rights granted under the terms of the parties’ January 2015 collaboration agreement.
Research and Development Expenses. Research and development expenses were $4.7 million for the first quarter of 2015, as compared to $3.1 million for the same period in 2014. The increase in research and development expense was primarily due to increased spending on CUDC-907 of $1.3 million related to outside services supporting the ongoing Phase 1 clinical trials. During the quarter ended March 31, 2015, Curis also paid Debiopharm $750,000 in connection with the termination and transition agreement entered into between the parties related to CUDC-305 (formerly Debio 0932). These increases were partially offset by decreased spending on CUDC-427.
General and Administrative Expenses. General and administrative expenses were $3.5 million for the first quarter of 2015, as compared to $2.8 million for the same period in 2014. The increase was primarily due to an increase in legal, professional and consulting costs related to the Aurigene transaction. Costs associated with the Company’s intellectual property and stock-based compensation also increased as compared to the prior year period.
Other expense was $827,000 for the first quarter of 2015, as compared to $811,000 for the same period in 2014. Other expense primarily consisted of $867,000 and $951,000 in interest expense for the quarters ended March 31, 2015 and 2014, respectively, related to the loan made by BioPharma II to Curis Royalty, a wholly-owned subsidiary of Curis. The Company also recorded other income of $91,000 associated with the change in fair value of a warrant liability during the first quarter of 2014.
As of March 31, 2015, Curis’ cash, cash equivalents and investments totaled $107.2 million and there were approximately 128.3 million shares of common stock outstanding.
2015 Financial Expectations
Curis expects to end 2015 with cash, cash equivalents and investments of $65 to $70 million, excluding any potential future payments from existing or new collaborators.
Curis expects that 2015 research and development expenses will be $37 to $42 million and that general and administrative expenses will be $12 to $14 million. These expense expectations include approximately $800,000 and $2.4 million of estimated 2015 stock-based compensation expense in research and development and general and administrative expense, respectively, based on stock awards that are currently outstanding.
Recent Operational Highlights
CUDC-907:
- In April 2015, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to Curis’ lead proprietary drug candidate, CUDC-907, for the treatment of DLBCL. The FDA’s Orphan Drug Designation program grants orphan status to drugs and biologics that are intended for use in rare diseases or disorders, defined as those that affect fewer than 200,000 people in the U.S. or that affect more than 200,000 people in the U.S. where there is no reasonable expectation that the developmental cost for the specific disease or condition will be recovered from sales in the U.S. within 7 years following approval. Orphan drug designation may qualify the sponsor for certain incentives. For example, the first product to receive FDA approval for an indication for which it has orphan designation may result in orphan drug exclusivity. This means that the FDA may not approve a market competitor for that indication for a period of 7 years, except in limited circumstances, such as demonstration of therapeutic superiority as compared to the drug granted orphan exclusivity.
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