Press Release
Cerulean Reports Second Quarter 2015 Corporate Highlights and Financial Results
Strengthened Balance Sheet with Underwritten Public Offering of Common Stock
Conference Call Today at
"Cerulean strengthened its balance sheet and team during the second
quarter," commented
"We are in a strong financial position to support our multiple clinical
development programs with CRLX101 and CRLX301 and to leverage our
platform technology to expand our development portfolio of
nanoparticle-drug conjugates, or NDCs," said Guiffre. "Cerulean is
rapidly maturing as a platform-based, product-driven company, and we
strengthened our team by adding
Second Quarter 2015 Corporate Highlights
-
Generated approximately
$40.3 million in gross proceeds from an underwritten public offering of common stock, including full exercise of the underwriters' overallotment option -
Granted Fast Track designation by the
US Food and Drug Administration , orFDA , for CRLX101 in combination with Avastin in metastatic RCC in patients who have progressed through two or three prior lines of therapy -
Granted Orphan designation for CRLX101 by the
FDA for the treatment of ovarian cancer -
Principal Investigator,
Stephen Keefe , M.D., presented full data for Phase 1b/2 investigator-sponsored trial, or IST, of CRLX101 in combination with Avastin in metastatic RCC, or the RCC IST, at 2015American Society for Clinical Oncology , or ASCO, Annual Meeting -
Appointed
Gregg Beloff , JD, MBA, as Chief Financial Officer -
Appointed
Stuart Arbuckle , Executive Vice President and Chief Commercial Officer at Vertex Pharmaceuticals Incorporated, to Board of Directors
Key Subsequent Event
-
Dosed first patient in Phase 1b trial with
GOG Foundation, Inc. of CRLX101 in combination with weekly paclitaxel in relapsed ovarian cancer
Anticipated Upcoming Milestones
During the remainder of 2015, Cerulean expects to:
- Report updated results from ongoing Phase 2 IST of CRLX101 in combination with Avastin in relapsed ovarian cancer
- Report updated results from ongoing Phase 1b/2 IST of CRLX101 in combination with chemoradiotherapy in non-metastatic rectal cancer
- Report initial clinical results from ongoing Phase 1 trial of CRLX301
In 2016, Cerulean expects to:
-
Report clinical results from ongoing Phase 1b trial with
GOG Foundation of CRLX101 in combination with weekly paclitaxel in relapsed ovarian cancer in the first half - Report primary (PFS) and secondary (ORR) endpoint data from the ongoing randomized Phase 2 RCC trial during the first half
- Initiate Phase 2a trial of CRLX301 in patients with selected solid tumors in the first half
- Initiate Phase 3 trial of CRLX101 in combination with Avastin in patients with 3rd and 4th line RCC during the second half
Brief Financial Summary
As of
More detailed financial information and analysis may be found in our
Quarterly Report on Form
10-Q, which was filed with the
Conference Call Information
Management will conduct a conference call at
About CRLX101
CRLX101 is a 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 also inhibits hypoxia-inducible
factor-1α (HIF-1α), which research suggests is a master regulator of
cancer cell survival mechanisms. CRLX101 has shown activity in four
different tumor types, both as monotherapy and in combination with other
cancer treatments. CRLX101 is in Phase 2 clinical development and has
been dosed in more than 300 patients. The U.S.
About CRLX301
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 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 currently in Phase 1/2a clinical development.
About
The Cerulean 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.
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.
About
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 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 Quarterly Report
on Form 10-Q filed with the
Avastin® is a trademark of
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Director,
Investor Relations and
Corporate Communications
njones@ceruleanrx.com
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