UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 9, 2015
Curis, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 000-30347 | 04-3505116 |
(State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
4 Maguire Road, Lexington, MA | 02421 |
(Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code: (617) 503-6500
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
[ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
[ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
[ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. Results of Operations and Financial Condition.
On November 9, 2015, Curis, Inc. announced its financial results for the three- and nine-month periods ended September 30, 2015. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K and the Exhibit attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(a) Director Resignation
On November 4, 2015, James R. Tobin resigned from the Company's Board of Directors. Mr. Tobin's resignation was not due to any disagreement with the Company or its management relating to the Company's operations, policies or practices.
Mr. Tobin had served as the Company's Chairman of its Compensation Committee. The Company's Board of Directors has appointed Marc Rubin, M.D., a current member of the Company's Board of Directors, to the Company's Compensation Committee and to serve as the Compensation Committee's Chairman.
Item 9.01. Financial Statements and Exhibits.
(d) The Exhibit to this Current Report on Form 8-K is listed in the Exhibit Index attached hereto.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Curis, Inc.
(Registrant) |
||
November 9, 2015
(Date) |
/s/ MICHAEL P. GRAY
Michael P. Gray Chief Financial and Business Officer |
EXHIBIT INDEX
Exhibit No. | Description | |
99.1 | Press release dated November 9, 2015 |
EXHIBIT 99.1
LEXINGTON, Mass., Nov. 9, 2015 (GLOBE NEWSWIRE) -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of cancers, today reported its financial results for the third quarter ended September 30, 2015.
"We are excited to have recently exercised two options under our collaboration with Aurigene to obtain exclusive licenses to the PD-L1/VISTA and IRAK4 programs," said Ali Fattaey, Ph.D., Curis' President and CEO. "Aurigene scientists presented compelling preclinical data for each program this weekend at the AACR-NCI-EORTC International Conference, and our internal team is working diligently with Aurigene to advance both programs into clinical development. During the first half of 2016, we expect to file an IND and initiate Phase 1 clinical testing of the PD-L1/VISTA inhibitor, CA-170, and also expect to file an IND for development of the IRAK4 inhibitor."
Dr. Fattaey continued, "We have also been working to advance CUDC-907 into the next stage of clinical development. We expect to provide additional data from the ongoing Phase 1 trial, as well as details of the planned Phase 2 study at the ASH annual meeting later this year."
Third Quarter and Nine Months ended September 30, 2015 Financial Results
Curis reported a net loss of $5.5 million, or ($0.04) per share on both a basic and fully diluted basis for the third 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 third quarter of 2014. Curis reported a net loss of $45.5 million, or ($0.37) per share on both a basic and fully diluted basis for the nine months ended September 30, 2015, as compared to a net loss of $13.0 million, or ($0.15) per share on both a basic and fully diluted basis for the nine months ended September 30, 2014. The net loss for the first nine months of 2015 includes an in-process research and development charge of $24.3 million related to Curis' collaboration agreement with Aurigene.
Revenues for the third quarter of 2015 were $2.0 million, as compared to $1.8 million for the same period in 2014. The increase in revenues was primarily due to an increase in royalty revenues recorded on Genentech/Roche's net sales of Erivedge, which increased to $2.3 million during the third quarter of 2015, as compared to $1.8 million during the same period in 2014.
Revenues for the nine months ended September 30, 2015, were $5.8 million, as compared to $7.9 million for the same period in 2014. The decrease was primarily related to a $3.0 million milestone payment that Curis received in 2014 related to its Genentech collaboration. Curis did not receive any such payments from Genentech during the nine months ended September 30, 2015. Offsetting this decrease, royalty revenues recognized from Genentech and Roche's net sales of Erivedge increased $1.1 million to $6.0 million during the nine months ended September 30, 2015 as compared to $4.9 million during the same period in 2014, a 23% increase over the prior year period.
Operating expenses for the third quarter of 2015 were $6.9 million, as compared to $6.5 million for the same period in 2014. Operating expenses for the nine months ended September 30, 2015 were $49.0 million, as compared to $18.9 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/Roche's Erivedge net sales, were $116,000 and $89,000 during the third quarters of 2015 and 2014, respectively. Costs of royalty revenues for the nine months ended September 30, 2015 were $303,000, as compared to $246,000 for the same period in 2014.
In-process research and development expenses. The Company recorded a one-time charge for in-process research and development expense of $24.3 million during the nine months ended September 30, 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 $4.0 million for the third quarter of 2015, as compared to $3.7 million for the same period in 2014. The increase in research and development expenses was primarily due to increased spending on CUDC-907 and preclinical programs under the Company's collaboration with Aurigene. The Company incurred expenses of $2.8 million and $2.1 million on CUDC-907 for the quarters ended September 30, 2015 and 2014, respectively, related to its ongoing Phase 1 studies of this molecule. The Company recorded costs of $700,000 on the Company's preclinical research programs under the Aurigene collaboration for the three months ended September 30, 2015. Offsetting these increases, spending on CUDC-427 and other programs decreased by $1 million during the three months ended September 30, 2015 as compared to the prior year period. Research and development expenses were $14.7 million for the nine months ended September 30, 2015 as compared to $10.2 million for the same period in 2014.
General and administrative expenses. General and administrative expenses were $2.8 million for the third quarter of 2015, as compared to $2.7 million for the same period in 2014. Increased spending on consulting and professional services and stock-based compensation were offset by decreases in legal spending. General and administrative expenses were $9.7 million for the nine months ended September 30, 2015 as compared to $8.5 million for the same period in 2014.
Other expense was $699,000 for the third quarter of 2015, as compared to $827,000 for the same period in 2014. Other expense primarily consisted of $827,000 and $934,000 in interest expense for the quarters ended September 30, 2015 and 2014, respectively, related to the loan made by BioPharma-II to Curis Royalty, a wholly-owned subsidiary of Curis. Other expense was $2.3 million and $2.0 million for the nine month periods ended September 30, 2015 and 2014, respectively.
As of September 30, 2015, Curis' cash, cash equivalents, marketable securities and investments totaled $93.5 million, and there were approximately 128.4 million shares of common stock outstanding.
Recent Operational Highlights
Aurigene Collaboration:
Erivedge:
A Phase 1b portion of the study will assess the safety of Erivedge plus ruxolitinib combined therapy. After getting confirmation about the safety and toxicity of this combination, a randomized, controlled portion of the study may begin. The primary endpoints relate to reduction in spleen volume and overall response rate. Details of the study have been posted on clinicaltrials.gov.
Upcoming Activities
Curis expects to present at the following conferences through February 2016:
Conference Call Information
Curis management will host a conference call today, November 9, 2015, at 8:30 a.m. EST, to discuss Curis' financial results for the quarter as well as provide a corporate update.
To access the live conference call, please dial (877) 868-1829 from the U.S. or (253) 237-1135 from other locations, shortly before 8:30 a.m. EST. The conference ID number is 66760275. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.
About Curis, Inc.
Curis is a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of cancers, including its lead development candidate, CUDC-907, an oral dual HDAC and PI3K inhibitor that is being investigated in two clinical studies in patients with lymphomas and solid tumors. Curis is also engaged in a broad collaboration with Aurigene in the areas of immuno-oncology and precision oncology. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are developing and commercializing Erivedge® for the treatment of advanced basal cell carcinoma. For more information, visit Curis' website at www.curis.com.
Cautionary Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding: the expected benefits of the Company's collaboration with Aurigene and the planned areas of development thereunder; the Company's plan to file an IND application for CA-170 and to initiate a Phase 1 study during the first half of 2016; the Company's plan to file an IND application for an IRAK4 inhibitor during the first half of 2016; the Company's plans to advance its PD-L1/VISTA and IRAK4 programs into clinical development; the Company's intent to advance CUDC-907 in clinical development; and its plans to provide additional data from the ongoing Phase 1 trial of CUDC-907, as well as details of the planned Phase 2 study at a medical meeting later this year. Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "seeks," "estimates," "assumes," "will," "may," "could" or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. For example, there can be no guarantee that the collaboration agreement with Aurigene will continue for its full term, that Curis or Aurigene will each maintain the financial and other resources necessary to continue financing its portion of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Curis faces a number of risks inherent in the research and development of novel drugs to treat cancer and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. Curis may experience adverse results, delays and/or failures in its drug development programs. Curis' drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Genentech and Roche may experience delays or failures in the manufacture of Erivedge. Erivedge's benefit/risk profile may not be widely accepted by the medical community or third-party payors for the treatment of advanced BCC, in which case revenues from sales of Erivedge could be adversely affected. Regulatory authorities may determine to delay or restrict Genentech's and/or Roche's ability to continue to develop or commercialize Erivedge. Competing drugs may be developed that are superior to Erivedge. Curis faces risks relating to its wholly-owned subsidiary's royalty-collateralized loan transaction, including the risk that it may not receive sufficient levels of royalty revenue from sales of Erivedge to satisfy the debt obligation or may otherwise lose its rights to royalties and royalty-related payments as a result of a foreclosure of the loan. Curis will require substantial additional capital to fund its business and such capital may not be available on reasonable terms, or at all. Curis faces substantial competition. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time consuming patent litigation and interference proceedings. Unstable market and economic conditions and unplanned expenses may adversely affect Curis' financial conditions and its ability to access capital to fund the growth of its business. Curis also faces other important risks relating to its business, operations, financial condition and future prospects that are discussed in its Quarterly Report on Form 10-Q for the period ended June 30, 2015 and other filings that it periodically makes with the Securities and Exchange Commission.
In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis' views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law.
CURIS, INC. | ||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
(UNAUDITED) | ||||
Three months ended September 30, |
Nine months ended September 30, |
|||
2015 | 2014 | 2015 | 2014 | |
Revenues: | ||||
Royalties | $2,292,608 | $1,783,271 | $5,997,514 | $4,895,454 |
License fees | — | — | — | 3,000,000 |
Research and development, net | (247,641) | (18,407) | (211,711) | (44,672) |
Total revenues: | 2,044,967 | 1,764,864 | 5,785,803 | 7,850,782 |
Operating expenses: | ||||
Costs of royalty revenues | 116,145 | 89,295 | 303,209 | 246,280 |
In-process research and development | — | — | 24,347,815 | — |
Research and development | 4,001,069 | 3,705,365 | 14,658,017 | 10,180,271 |
General and administrative | 2,771,496 | 2,723,235 | 9,711,470 | 8,475,392 |
Total operating expenses | 6,888,710 | 6,517,895 | 49,020,511 | 18,901,943 |
Net loss from operations | (4,843,743) | (4,753,031) | (43,234,708) | (11,051,161) |
Interest income | 127,329 | 38,881 | 251,692 | 129,120 |
Interest expense | (826,710) | (933,903) | (2,537,024) | (2,834,609) |
Change in fair value of warrant liability | — | 67,910 | — | 716,786 |
Other expense, net | (699,381) | (827,112) | (2,285,332) | (1,988,703) |
Net loss | $(5,543,124) | $(5,580,143) | $(45,520,040) | $(13,039,864) |
Basic and diluted net loss per common share | $(0.04) | $(0.06) | $(0.37) | $(0.15) |
Basic and diluted weighted average common shares outstanding | 128,392,413 | 86,004,857 | 121,634,415 | 85,962,415 |
CURIS, INC. | ||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
(UNAUDITED) | ||
September 30, 2015 |
December 31, 2014 |
|
ASSETS | ||
Cash, cash equivalents and investments | $93,470,393 | $50,538,961 |
Investments – restricted | 152,610 | 166,487 |
Accounts receivable | 2,318,202 | 1,960,995 |
Property and equipment, net | 315,470 | 407,738 |
Goodwill | 8,982,000 | 8,982,000 |
Other assets | 874,201 | 557,388 |
Total assets | $106,112,876 | $62,613,569 |
LIABILITIES AND STOCKHOLDERS' EQUITY | ||
Accounts payable, accrued expenses and other liabilities | 4,591,532 | 4,530,900 |
Debt obligations, net | 25,528,530 | 28,299,043 |
Total liabilities | 30,120,062 | 32,829,943 |
Total stockholders' equity | 75,992,814 | 29,783,626 |
Total liabilities and stockholders' equity | $106,112,876 | $62,613,569 |
CONTACT: For More Information: Mani Mohindru, Ph.D. Senior Vice President, Corporate Strategy and Investor Relations Curis, Inc. 617-503-6605 mmohindru@curis.com Michael P. Gray Chief Financial and Chief Business Officer Curis, Inc. 617-503-6632 mgray@curis.com