- Reported that a randomized Phase 2 trial of CRLX101 in combination with Avastin ® (bevacizumab) in 3 rd and 4 th line metastatic renal cell carcinoma did not meet its endpoint.
- Announced reduction in force of approximately 48% percent, which the Company expects to be substantially completed by end of 2016.
- Received Food and Drug Administration Fast Track Designation for CRLX101 in combination with paclitaxel, for the treatment of platinum-resistant ovarian carcinoma, fallopian tube or primary peritoneal cancer.
- Announced a five-target collaboration with Novartis to combine Cerulean's proprietary NDC technology with Novartis-selected compounds. Cerulean received an upfront payment of $5 million plus funding for five full-time equivalents. Cerulean also is eligible to receive preclinical, clinical, regulatory, and sales milestones for each of the five targets of up to $233 million per target. In addition, Cerulean can earn single-digit to low double-digit tiered royalties on net sales for each NDC product commercialized by Novartis.
- Announced a firm commitment at-the-market equity facility for up to $20 million with Aspire. In connection with entry into the facility, Aspire made an initial $1,000,000 investment.
R&D Expenses - Research and development expenses were $7.1 million for the third quarters of each of 2016 and 2015.G&A Expenses - General and administrative expenses for the third quarter were $2.4 million, compared to $3.0 million for the same period in 2015. Net Loss Attributable to Common Stockholders - Net loss attributable to common stockholders for the third quarter was $10.0 million, compared to $10.6 million for the same period in 2015. More detailed financial information and analysis may be found in our Quarterly Report on Form 10-Q, which was filed with the Securities and Exchange Commission on November 3, 2016. Anticipated Upcoming Milestones During 2017, Cerulean expects to:
- Report further results from the ongoing Phase 1b/2 clinical trial of CRLX101 in combination with weekly paclitaxel, in patients with platinum-resistant ovarian cancer
- Report initial results from the ongoing Phase 1/2 clinical trial of CRLX101 in combination with AstraZeneca's PARP inhibitor, LYNPARZA, in patients with advanced solid tumors
- Report initial results from the ongoing Phase 1/2a clinical trial of CRLX301 using a weekly dosing schedule in patients with advanced solid tumors
About CRLX301CRLX301 is a dynamically tumor-targeted NDC designed to concentrate in tumors and slowly release its anti-cancer payload, docetaxel, inside tumor cells. In preclinical studies, CRLX301 delivers up to 10 times more docetaxel into tumors, compared to an equivalent milligram dose of commercially available docetaxel and was similar to or better than docetaxel in seven of seven animal models, with a statistically significant survival benefit seen in five of those seven models. In addition, preclinical data show that CRLX301 had lower toxicity than has been reported with docetaxel in similar preclinical studies. CRLX301 is in a Phase 1/2a clinical trial. About Cerulean's Dynamic Tumor Targeting™ Platform Cerulean's Dynamic Tumor Targeting Platform creates NDCs that are designed to provide safer and more effective cancer treatments. We believe our NDCs concentrate their anti-cancer payloads inside tumors while sparing normal tissue because they are small enough to pass through the "leaky" vasculature present in tumors but are too large to pass through the wall of healthy blood vessels. Once inside tumors, our NDCs enter tumor cells where they slowly release anti-cancer payloads from within the tumor cells. Cautionary Note on Forward Looking Statements Any statements in this press release about our future expectations, plans and prospects, including statements about the clinical development of our product candidates, statements about the sufficiency of our cash and cash equivalents to fund our operations, debt service and other scheduled expenditures and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "hypothesize," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and completion of clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 3, 2016, and in other filings that we make with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.
Avastin is a registered trademark of Genentech, Inc.LYNPARZA is a trademark of the AstraZeneca group of companies.