DARA BioSciences yesterday provided its 2010 annual report that was filed with the SEC on March 25, 2011 and provided a corporate overview. Highlights from the announcement included:
• DARA receiving approximately $8.4 million in cash and funding commitments to continue the clinical development of its two leading drug candidates for which the Company believes provides them with sufficient cash to achieve the next series of key milestones during 2011.
• Announcement of a Clinical Trial Collaboration Agreement with the Symptom Management & Drug Development, Community Oncology & Prevention Trials Group, Division of Cancer Prevention; National Cancer Institute (NCI) to advance the clinical study of KRN5500
• Completion of a successful Phase 1a clinical study for DB959 program
• Enhancement of patent portfolio to 88 granted patents and 60 pending applications (US and foreign)
• Receipt of equity investments in excess of $7.9 million, with CEO Richard A Franco Sr. personally investing approximately $350,000
• Receipt of approximately $500,000 in grant awards
With regards to 2011, DARA reported:
• Intentions for a Phase II clinical trial during H1 that will be funded in part through its partnership with the National Cancer Institute (NCI) to study the treatment and prevention of chemotherapy-induced peripheral neuropathy in cancer patients. NCI will fund the costs associated with conducting the Phase 2 study(s) of KRN5500, except for the costs associated with providing study drug.
• The completion of the first Phase 1 clinical study of DB959, the Company’s other promising oral drug candidate which is being developed for the treatment of type 2 diabetes. A new study is underway with a report on results slated for Q3.
Commenting on 2010 and looking ahead to 2011, CEO Richard Franco stated, “The Company achieved significant milestones both operationally and scientifically as we continued the advancement of our two key drug candidates and entered into a collaboration agreement with the National Cancer Institute.”
DARA has a pipeline of diverse drug candidates at various stages of development, with 88 US and foreign granted patents and 60 pending applications including CPT-1 inhibitors intended for topical application for patients with psoriasis, a library of DDPIV inhibitors and a diverse library of approximately 1800 PPAR agonists of various molecular modalities which may be useful in the treatment of Alzheimer’s disease, cystic fibrosis, liver disease, and a variety of autoimmune diseases. Presently, the Company has two drug candidates with cleared Investigational New Drug Applications from the United States FDA advancing through clinical development:
• KRN5500 for the treatment of neuropathic pain – successfully completed a Phase II study and plans in place to initiate a second Phase II study (Q2 2011) in conjunction with the National Cancer Institute focusing on the treatment of chemotherapy induced peripheral neuropathy (CIPN)
• DB959 for the treatment of type 2 diabetes – successfully completed a Phase Ia study and has initiated a Phase Ib study (Q1 2011)
Investors seem to like what they have seen with the progressions of the Company as the share price surged from the area of $2 to in excess of $4 at the end of 2010 and into the beginning of 2011. The price of a share of DARA has since stabilized at $3 as people are appearing to be patient in waiting for further developments in clinical trials. With only 4 million shares in the float and less than 5 million outstanding, DARA is sporting a market cap of under $15 million presently; a fact which typically has investors keen to any news that could send the stock price moving quickly.
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