Cerulean Reports Third Quarter 2016 Financial Results and Provides Corporate Update
Conference Call Today at
"Cerulean experienced a clinical setback in the third quarter, but in
October we demonstrated the promise of our NDC platform when we
announced a collaboration with
Third Quarter 2016 Corporate Developments
- Reported that a randomized Phase 2 trial of CRLX101 in combination with Avastin® (bevacizumab) in 3rd and 4th 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.
Key Developments Subsequent to the End of the Third Quarter
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 millionplus 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 millionper 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 millionwith Aspire. In connection with entry into the facility, Aspire made an initial $1,000,000investment.
Third Quarter 2016 Financial Summary
Cash Position - As of
R&D Expenses - Research and development expenses were
G&A Expenses - General and administrative expenses for the third quarter
Net Loss Attributable to Common Stockholders - Net loss attributable to
common stockholders for the third quarter was
More detailed financial information and analysis may be found in our
Quarterly Report on Form 10-Q, which was filed with the
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
Conference Call Information
Management will conduct a conference call at
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 nanoparticle-drug conjugates (NDCs) designed to selectively attack tumor cells, reduce toxicity by sparing the body's normal cells, and enable therapeutic combinations. Our first platform-generated NDC clinical candidate, CRLX101, is in clinical trials in combination with other cancer treatments, all of which aim to unlock the power of combination therapy. Our second platform-generated NDC clinical candidate, CRLX301, is in a Phase 1/2a clinical trial. For more information, please visit http://www.ceruleanrx.com/.
CRLX101 is an 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. CRLX101 has shown activity in multiple 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 400
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 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
Avastin is a registered trademark of
LYNPARZA is a trademark of the AstraZeneca group of companies.
Director, Investor Relations and Corporate Communications
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