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

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Piper Jaffray on Insulet Corp - $PODD: "Growth Balanced by Near-Term Risk: Initiate at Neutral"

Insulet Corporation (NASDAQ: PODD) is an innovative medical device company based in Bedford, Massachusetts. It was founded in 2000 with the mission of improving the lives of people with diabetes. Specifically, through its revolutionary OmniPod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy. The OmniPod is a discreet and easy-to-use system that eliminates many of the issues associated with conventional pumps. Improvements include OmniPod's lack of tubing; automated, virtually pain-free insertion; and two straightforward parts that communicate wirelessly. By breaking down the barriers to insulin pump therapy, Insulet hopes to provide both a superior treatment option and life-long health benefits for people with diabetes. 

Our Daily Dose Thoughts: The Diabetes and Metabolic Disease area remains a vast and great unmet medical need. PODD is an exciting play in the Type 1 diabetes space. We are also watching other names in this area such as Islet Sciences (ONCE) which if successful in the cell therapy side of type 1 diabetes (this is encapsulated porcine cells) has potential to totally change the way we approach type 1 diabetes.

Piper Jaffray has issued a company note on Insulet. The report states: 

"As one of only a few pure plays in the diabetes device market, Insulet offers the only tubeless patch pump in the US, with roughly 10% overall market share. We see the opportunity for patch pumps as still in early stages of adoption, and view 2012 as a transition year for PODD. The potential Q2 launch of the company’s next generation OmniPod® should provide enhanced patient benefits and adoption of the device, as well as increased product margins. However, the oft delayed product does not yethave final FDA approval. Once approved, we believe high volume manufacturing and customer conversion activities add additional short term investor risk. Given uncertain timing of launch events we rate PODD Neutral with a $21 price target, pending better visibility on timing for the conversion to the next gen product."

Read the full report below. 

Piper Jaffray company note on insulet corp 3 22-12

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ThinkEquity LLC initiates coverage of Durect Corp: Buy Rating, $3 price target; $DRRX

Durect Corporation (DRRX) is a specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies to treat chronic debilitating diseases and enable biotechnology products. These platform technologies include the SABER™ Delivery System (a patented and versatile depot injectable useful for proteins, peptides and small molecule delivery), the ORADUR® sustained release oral gel-cap technology (an oral sustained release technology with several potential abuse deterrent properties), the TRANSDUR® transdermal patch technology, the DURIN™ Biodegradable Implant (drug-loaded implant system) and the MICRODUR™ Biodegradable Microparticulates (microspheres injectable system). 

 

DURECT also partners with pharmaceutical and biotechnology companies to develop and commercialize proprietary and enhanced pharmaceutical products based on its technologies. DURECT has seven disclosed on-going development programs of which six are in collaboration with pharmaceutical partners. 

 

Daily Dose Thoughts: Durect has been around forever but the company seems to be making great progress in perfecting their drug delivery technology.  With top line revenues and a solid balkance sheet and several catalysts that can play out ahead. This is a cheap biotech with a few shots on goal in potentially large indications.

 

ThinkEquity LLC has initiated coverage of Durect Corp, giving it a "Buy" rating and a $3 price target. 

The report states, 

 

"While DRRX has had a bumpy road over the past few years in our view, we continue to see a compelling combination of large-pharma collaborations with an under valued pipeline that could provide potential upside surprise. DRRX’s lead product is Remoxy, a less-abusable Oxycontin partnered with Pfizer (PFE), which we believe could be potentially re-filed with the FDA by late 2013E. In 2H12, DRRX could file an NDA for the post-surgical pain injection Posidur, partnered with Hospira (HSP) and targeting 10M-20M US surgeries. Additionally, in ourview, DRRX has a deep pipeline of earlier pain compounds." 

Read the full report below.

Think equity report on drrx

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Rodman & Renshaw initiate coverage of Affymax - $AFFY: Outperform rating, $20 target price

Affymax, Inc. (AFFY) is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. The company’s product candidate, peginesatide (formerly known as Hematide™), has been investigated in Phase 3 trials for the potential treatment of anemia associated with chronic kidney disease (CKD). A New Drug Application (NDA) for peginesatide for the treatment of anemia associated with CKD in adult patients on dialysis is currently being reviewed by the U.S. Food and Drug Administration (FDA).

Rodman & Renshaw has initiated coverage of Affymax, giving it an "Outperform" market rating and a price target of $20.

The report states: 

"AFFY is on the brink of FDA approval and launch of its non-EPO erythropoiesis stimulating agent (ESA), peginesatide (previously known as Hematide) for use in the treatment of severe anemia in patients with end-stage renal disease (ESRD) currently on dialysis. In our view, approval is likely by the product’s PDUFA date of March 27, 2012. Upon approval, AFFY will begin to chip away at Amgen’s (AMGN, Not Rated) 20-year monopoly over the dialysis space."

Daily Dose Comment: The market is so ready for an EPO alternative. This is worth watching.

Read the full report below. 

Rodman renshaw report on affy

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Biotech Stock Mailbag: Xoma's Big Backers, FDA Approvals Contest - $XOMA

XOMA Corporation (NASDAQ: XOMA) is a biotechnology company focused on the discover and development of monoclonal antibody-based therapeutics.  

 

XOMA’s world-class monoclonal antibody technologies have contributed to the development of marketed biologics with a total of more than $1 billion in annual sales and for which XOMA received substantial royalties. The company also has a strong track record of product discovery and development collaborations with pharmaceutical and biotechnology companies and the U.S. government, and has licensed certain of its fundamental technologies to numerous pharma and biotech companies. 

 

At TheStreet.com, senior columnist Adam Feuerstein wrote an article in answer to a reader's question: "Why is Xoma up 50% for the month?" 

 

Feuerstein explained that the stock rose because "Baker Bros., a well-respected and closely followed health-care hedge fund, bought half the Xoma deal" of $40 million financing that was announced on March 6. 

 

He continued,

"The question you're probably asking now is, "Wait a second -- Xoma? What the hell can Baker Bros. see in Xoma?" [I wondered the same thing.] Xoma is apparently getting a new lease on life, thanks to a top-to-bottom restructuring -- a new CEO and chief medical officer, cost cutting and a new business model. Xoma is still developing the same lead drug XOMA 052 (given a new name, gevokizumab) but money-wasting efforts in diabetes and cardiovascular indications have been shelved in favor of clinical trials for Behcets uveitis and non-infectious uveitis -- both diseases of the eye.

 

A phase III study of gevokizumab is expected to start this summer with data likely available by the end of 2013."

 

Daily Dose: We spoke with an analyst who covered Xoma for years. The analysts shared with us, that the indication "Behcets uveitus" has promising data.  Xoma has managed to stay alive since the dawn of biotech and sooner or later, this stock should work.

Read the full article at TheStreet.com.  

Emergent BioSolutions ($EBS) Receives NIAID Grant to Support Tuberculosis Vaccine Candidate

Emergent BioSolutions (NYSE: EBS) announced that it has received a multi-year grant from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to advance the development of MVA85A, a candidate vaccine against tuberculosis. The vaccine is being developed through a partnership between Aeras and the Oxford-Emergent Tuberculosis Consortium, a joint venture between Emergent and the University of Oxford, where the vaccine was originally developed and investigated.

See full press release @ EBS

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ImmunoCellular Therapeutics ($IMUC) licenses EphA2 from University of Pittsburgh

ImmunoCellular Therapeutics (OTCBB: IMUC) has entered into an agreement with University of Pittsburgh under where Pitt has licensed intellectual property to the company surrounding EphA2, a tyrosine kinase receptor that is highly expressed by ovarian cancer and other advanced and metastatic malignancies.

This agreement grants a world-wide exclusive license to the Pitt intellectual property for ovarian and pancreatic cancers, and a world-wide non-exclusive license to the Pitt intellectual property for brain cancer.

Financial terms of the agreement were not disclosed. The company will employ the Pitt intellectual property in the development and commercialization of ICT-140, a multivalent, dendritic cell-based vaccine for the treatment of ovarian cancer.

Please see our other post(s) on IMUC, PrimaBioMed and Merck KG (StimuVax).

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Lazard Capital Markets Releases Report on $VSTM: "Buy" Rating, $11 Price, $20 Price Target

Verastem, Inc. (NASDAQ:VSTM) is a biopharmaceutical company focused on discovering and developing novel drugs that selectively target cancer stem cells. Cancer stem cells are an underlying cause of tumor recurrence and metastasis. Verastem is translating discoveries in cancer stem cell research into new medicines for the treatment of major cancers such as breast cancer.

Lazard Capital Markets has released a report about Verastem and assigned it a BUY rating with an $11 price and a $20 price target: "We believe VSTM shares will appeal to investors by virtue of the company’s world-class scientific founders, highly experienced management team, and a research focus that may possess the potential to dramatically change the manner in which cancer is treated."

The Investment Summary is as follows:

 "Founded by world-class cancer biologists and experienced venture capitalists, Verastem is developing small-molecule drugs for the treatment of cancer with the specific focus of targeting cancer stem cells (CSCs). The underpinning theory behind Verastem’s approach is that, while typical cancer therapies may be effective in killing mature and differentiated cancer cells, ineffective killing of CSCs may provide the means for the tumors to re-grow. To facilitate development of CSC-targeting therapies, Verastem’s founders developed technologies to manipulate the epithelial-to-mesenchymal transition (EMT) to create CSCs. With them, standard high-throughput screening processes are applied to identify promising leads. Capital raised in the company’s IPO should support activities through to potential human proof of concept (POC). If Verastem is successful in the development of drugs that target CSCs, we believe there may be a high level of interest from other biopharma industry companies focused on developing cancer therapies."

Read the full report below.  

Vstm report by lazard capital markets 3 15-12

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