The intention of the strategic review is to evaluate potential alternatives such as the sale of the company, a merger, a business combination, a strategic investment into the company, or a sale, license or disposition of assets of the company. This process may not result in any transaction.
In its strategic review, the Board is considering, among other things, Cerulean's clinical assets, NDC platform, and cash reserves as outlined below:
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: whether the company's
cash resources will be sufficient to fund its continuing operations for
the period anticipated; 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; and other factors discussed in
the "Risk Factors" section of our Quarterly Report on Form 10-Q filed
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