Full Press Release Details
Cerulean Reports Fourth Quarter 2014 Corporate Highlights and Financial Results
Phase 1b/2 trial of CRLX101 in renal cell carcinoma achieves primary endpoint
Closed debt facility for up to $26.0 million with Hercules Technology Growth Capital in first quarter
CAMBRIDGE, Mass., March 19, 2015 Cerulean Pharma Inc. (Nasdaq: CERU), a leader in Dynamic Tumor Targeting , today provided an
update on corporate activities during the quarter ended December 31, 2014, and reported progress with its clinical development programs.
Today, Cerulean made the important announcement that the Phase 1b/2 trial of CRLX101 in combination with Avastin in relapsed renal cell carcinoma, or RCC, that completed enrollment in the fourth quarter met its primary endpoint, said Paul Friedman, M.D., Executive Chairman of Cerulean.
Additionally, patients in the trial receiving CRLX101 plus Avastin experienced median progression free survival, or PFS, of 9.9 months. Standard of care in the 3rd and 4th line RCC setting is roughly 3.5 months PFS. These results support the rationale for our ongoing randomized Phase 2 trial of CRLX101 plus Avastin in
3rd and 4th line RCC. We expect to report top-line primary endpoint data from this randomized trial in the second quarter of 2016.
Friedman continued, In addition to completing enrollment of the Phase 1b/2 RCC trial in the fourth quarter, Cerulean achieved another significant
clinical milestone- our second platform-generated candidate, CRLX301, moved into clinical development when the first patient was treated in a Phase 1/2a trial in solid tumor malignancies in December 2014.
Fourth Quarter 2014 Corporate Highlights
Key Subsequent Events
During the remainder of 2015, Cerulean expects:
In 2016, Cerulean expects:
As of December 31, 2014, Cerulean had cash and cash equivalents of $51.2 million. In January 2015, the Company entered into a loan and
security agreement with Hercules for a term loan of up to $26.0 million and sold $1.0 million of Cerulean common stock to Hercules in a private placement.
Cerulean estimates that its current cash and cash equivalents will fund operations into the third quarter of 2016 and allow it to fund:
More detailed financial information and analysis may be found in the Company s Annual Report on Form 10-K, which was filed with the Securities and
Exchange Commission on March 19, 2015.
Conference Call Information
Paul Friedman, M.D., Executive Chairman, and Chris Guiffre, Chief Operating Officer, will conduct a conference call at 4:30 p.m. (ET) today to provide a
business update and review the Company s fourth-quarter financial results. The call can be accessed by dialing (844) 831-3031 or (443) 637-1284 prior to the start of the call and referencing conference ID: 94512863. The conference
call will also be webcast live over the Internet and can be accessed on the Investors section of the Cerulean website, www.ceruleanrx.com. The webcast will be archived on the Company s website for two weeks.
CRLX101 is a dynamically tumor-targeted
nanoparticle-drug conjugate (NDC) designed to concentrate in tumors and slowly release its anti-cancer payload, camptothecin, inside tumor cells. CRLX101 inhibits topoisomerase 1 (topo 1), which is involved in cellular replication, and
hypoxia-inducible factor-1 (HIF-1 ), which research suggests is a master regulator of cancer
cell survival mechanisms thought to promote drug and radiation resistance. CRLX101 has shown activity in four different tumor types, both as monotherapy and in combination with other cancer
treatments. CRLX101 is currently in Phase 2 clinical development and has been dosed in more than 250 patients.
CRLX301 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 superior to 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 currently in Phase 1 clinical
About Cerulean Pharma
team is committed to improving treatment for people living with cancer. We apply our Dynamic Tumor Targeting Platform to create a portfolio of NDCs designed to selectively attack tumor cells, reduce toxicity by sparing the body s normal cells,
and enable therapeutic combinations. Our first platform-generated candidate, CRLX101, is in multiple clinical trials in combination with other cancer treatments, all of which aim to unlock the power of combination therapy. Our second
platform-generated candidate, CRLX301, is in a Phase 1/2a clinical trial. For more information, please visit www.ceruleanrx.com.
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
statements in this press release about our future expectations, plans and prospects, including statements about the clinical development of our product candidates, statements about our estimated research and development expenses and sufficiency of
cash to fund specified use of cash 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 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 19, 2015 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 trademark of Genentech,
Cerulean Pharma Inc.
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