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Daily Dose Newsroom is a Daily Dose of Wall Street research and news in the Healthcare, Biotech, and Biomedical sectors.

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Entries in cowan (2)

Monday
Mar262012

Cowan updates their report on Immunocellular Therapeutics ($IMUC)

Immunocellular Therapeutics ($IMUC) is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. The Company recently commenced a Phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma.

Cowan and Company updated their research report to "Neutral (2)":

"Earnings reported; valuation has gotten rich, we remain on sidelines.

Cowan Summary: Through its 10K filing, IMUC reported 2011 financials and provided a pipeline update. We reiterate our Neutral rating and recommend that investors avoid IMUC shares given:

  • Lack of significant newsflow (the only meaningful expected milestone in the next year is the interim Phase II data from the ICT-107 study in GBM, which is expected 1Q13), and especially
  • Valuation, which at an EV around $175M seems very rich for a stock whose main asset has produced very limited clinical evidence of its efficacy and safety (single-site, single-trial, single-arm, open-label, non-randomized, uncontrolled, 16-19 patients, etc).

Clinical update: The Phase II trial of ICT-107 in GBM has enrolled 156 patients at 24 U.S. centers. IMUC plans to add more U.S. sites and expects to complete enrollment of ~200 patients in 2Q12. IMUC also plans to submit an IND with the FDA for ICT-121 in 1H12 and to initiate a physician-sponsored, Phase I trial, that will be conducted at Cedars-Sinai and is expected to enroll approximately 20 recurrent GBM patients following resection of tumor and standard of care treatment.

What's next?

  • Complete enrollment in Phase II trial of ICT-107 in GBM in 2Q12, 2) initiate a physician-sponsored Phase I trial of ICT-121 in GBM in 1H12, 3) initiate Phase I/II trial of ICT-140 in ovarian cancer in 1H12, 4) report interim data from Phase II trial of ICT-107 in 1Q13, and 5) report final data from Phase II trial of ICT-107 in 3Q13/4Q13.
  • Earnings reported. IMUC spent $2.9M ($2M in R&D, $0.7M in SG&A, and $0.2M in stock-based compensation) in 4Q and $8.6M ($5M in R&D, $2.4M in SG&A, and $1.2M in stock-based compensation) in 2011. IMUC ended 2011 with $6.7M in cash and raised $9.3M in net proceeds in a January secondary offering of 9.5M shares at $1.10/share, bringing its pro-forma cash position to approximately $16M or $0.26/share in cash. According to the company, current cash is sufficient to fund operations through the end of 2013.

Cowan Contacts:

Simos Simeonidis, Ph.D.

(646) 562-1386 simos.simeonidis@cowen.com

Yatin Suneja

(646) 562-1388 yatin.suneja@cowen.com

Thursday
Mar152012

PolyMedix ($PYMX) - Cowen Research Report is released

PolyMedix (PYMX) -- Outperform (1)

PYMX files 10K; focus remains on antibiotic & heptagonist data expected 1H12

Summary: PolyMedix filed its 2011 10K last night, reporting 4Q11/FY11 numbers. There were no significant updates in the 10K, other than the financials, and investors' attention remains focused on the PMX-30063 (antibiotic) and PMX-60056 (heptagonist) Phase II data expected in 1H12.

  • Antibiotic data, expected in a few weeks, represent the moment of truth for PYMX. We believe that the full data from PMX-30063's trial in ABSSSI, which will include data from MRSA patients, will be a very significant milestone for PYMX shares, since it will represent the first time that one of the company's compounds will have been tested in 1) a relatively large 2) patient population. If the full Phase II data replicate what we saw in the first ~80 patients, especially if the drug continues to demonstrate 1) very high clinical response rates, averaging 92% among the four groups, and 2) a clean safety profile, we expect the market to start paying much closer attention to PYMX. Given the compound's first-in-class status, coupled with its mechanism of action, that carries the theoretical potential to overcome resistance, we believe that if the full Phase II data corroborate what we saw in the interim look, investors will start viewing PMX-30063 as a compound with significant commercial potential.
  • Data from two PMX-60056 trials expected in 1H12. In addition to PMX-30063, investors will be watching for data from: 1) the 40-patient Phase II trial of PMX-60056 in PCI (Percutaneous Coronary Intervention), and 2) the Phase Ib/II dose-ranging trial of PMX-60056 in the reversal of Lovenox.
  • 4Q11/FY11 numbers reported. PYMX spent $6.7M ($4.9M in R&D, $1.9M in SG&A) in 4Q11 and $21M ($13.8M in R&D, $7.2M in SG&A) in FY11, and ended 2011 with $14.6M in net cash ($21.4M in cash, minus $6.8M in debt).


Simos Simeonidis, Ph.D.
(646) 562-1386
simos.simeonidis@cowen.com

Yatin Suneja
(646) 562-1388
yatin.suneja@cowen.com