By Patrick Crutcher
We want to talk about several companies that are gaining some recent momentum. They all have upcoming catalysts that investors should be watching for.
With potential catalysts ahead that could easily transform their companies, money flow in these stocks should be relatively high. We feel that these all have potential for success over the coming months. (Relevant links for each stock can be found at the bottom.)
Amarin Corporation (NASDAQ: AMRN) has been on the move the last few days. Today, they announced Kristine Peterson to its board of directors. Peterson has an impressive track (20 years at Bristol-Myers Squibb (BMY)) and an expertise in cardiovascular and metabolic disease. For what it’s worth, it’s always a good sign to see a talent inflow at Amarin. This comes on top of announcing new CEO Joseph S. Zakrzewski. While CEO of Reliant Pharmaceutical, Mr. Zakrzewski led the successful development of Omacor®/Lovaza® for reducing very high triglyceride levels; Reliant was eventually purchased for $1.65 billion by GlaxoSmithKline (GSK).
During Leerink's conference call on AMR-101, they stated a belief in an 80% chance of success in the MARINE study and 60% in ANCHOR. Leerink rated them as Outperform, with a $6 target price. We also should note that the institutions have invested heavily in Amarin; in the past 3 months their institutional holdings are up 46% at 47M shares held.
Cyclacel Pharmaceuticals Inc. (NASDAQ: CYCC) has had some interesting movement recently. In their 3rd quarter update, investors learned that they would present Phase 2 1-year survival data of sapacitabine in patients with MDS at American Society of Hematology (ASH) in December 2010 (the 4th, to be specific). CYCC hopes that sapacitabine will eventually be used as a 2nd-line treatment in MDS. There needs to be >50% survival rate at 1-year for sapacitabine to be meaningful in this disorder. At ASCO 2010, they reported interim data on the overall response rate with 24 ‐ 35%. In mid-October they announced private placement to sell approximately $15.2M of its units to several institutional investors. We are still waiting on top line results from the APPRAISE NSCLC Phase 2b trial of seliciclib and interim Phase 2 data of sapacitabine in patients with NSCLC.
Inhibitex, Inc. (NASDAQ: INHX) shares were up 10+% today. Next month they are expected to announce results from their Phase 2 program in Shingles with FV-100. Investors should take note that this Phase 2 is evaluating FV-100 against an active control arm in Glaxo’s Valtrex. They also recently initiated a Phase 1b trial in Chronic Hepatitis C (HCV) and results should be expected sometime in early 2011. Both of these programs have substantial value if proven effective. INHX had around $25M in cash/cash eqiv. as of September 30th. Management has had some interest in both of these programs and potential partners could emerge sometime in 2011. Today, they filed a $20M shelf; they stated that they have no current plans to sell shares now, but may do so after top-line results from their trials.
Neoprobe Corporation (NEOP.OB) is another company to keep your eyes on. After the recent mention by Uri Landesman, President of Platinum Partners, about Neoprobe being an interesting acquisition by Covidien (COV) or Cardinal Health (CAH) sometime in 2011, assuming Lymphoseek Phase 3 trials are successful. They recently raised $6M in cash. Notably, insiders have been buying very recently. On 11/15, insiders collectively purchased 70K shares (about $120K) on the open market. Last week they gave several Lymphoseek presentations at the International Sentinel Node Society (ISNS) Bi-Annual Meeting 2010.
“Lymphoseek presentations at ISNS 2010 signal an important step in the international clinical community’s interest in the technology’s potential to improve lymph node mapping and patient treatment and care, and the growing importance of accurate intra-operative identification of sentinel lymph nodes in surgical oncology,” said Dr. Frederick O. Cope, Senior Vice President of Pharmaceutical Research and Clinical Development of Neoprobe. Neoprobe has plans to investigate Lymphoseek’s clinical potential to help improve diagnosis in melanoma, breast, head and neck cancer and other solid tumor cancers.
Repligen Corporation (NASDAQ: RGEN) is another attractive biotech that has revenues, cash and data coming in 2011. RGEN is the world’s biggest supplier of Protein A, necessary for the production of monoclonal antibodies, which are important therapies for cancer, autoimmune diseases and osteoporosis. In terms of catalysts, they have 2 big Q1 2011 clinical catalysts: Phase 3 data for RG1068 (pancreatic imaging agent) and Phase 2b data for their bipolar drug (RG2417). Phase 2a results demonstrated a statistically significant reduction in the symptoms of depression in patients receiving RG2417 (vs. placebo) on the MADRS and on the CGI-BP-C over the 6-week course of the study. RG2417 was safe and well tolerated. They have a great share structure (30M O/S), $55M in cash/cash equivalents and significant insider/institutional ownership.
CYCC 3Q 2010 resultsCompletes Enrollment in Phase II Clinical Trial of FV-100
INHX Initiates Phase 1b Trial of INX-189 in Patients with Chronic Hepatitis C
Disclosure: Long AMRN, CYCC, INHX