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Friday, April 29, 2016

How I Get To $21 Per Share For InVivo Therapeutics

Earlier this week, InVivo Therapeutics (NASDAQ: NVIV) announced that the sixth-implanted patient in the INSPIRE clinical study improved from complete AIS-A spinal cord injury to an incomplete AIS-B spinal cord injury. This is the fourth patient to show improvement from the INSPIRE trial, equating to two-thirds of the first six patients enrolled in the study. It is clearly fantastic news for InVivo, especially following news last week that the eight-implanted patient died just two days after the procedure.

Monday, April 25, 2016

BriaCell Identifies Biomarkers Consistent With Uber-Response to BriaVax

Company Obtains Funding For Initiation Of Phase I/II Clinical Trial

Last week, at the American Association for Cancer Research (AACR) annual meeting, scientists from BriaCell Therapeutics Corp. (TSXV: BCT) (OTC: BCTXF) presented research on the molecular profile of BriaVax™, the company's proprietary whole tumor cell vaccine. The findings (AACR #2369) are suggestive of the BriaVax™ mechanism of action and identify a gene signature potentially predictive of patient response to the vaccine. BriaCell is currently preparing to initiate a Phase I/II study with BriaVax™ in the third quarter of 2016. The company is also working on a companion diagnostic based on the identified biomarkers aimed at prospectively identifying patients likely to benefit from BriaVax™. Below is a review of the poster and the interesting biomarker data presented at AACR.

Thursday, April 21, 2016

Immune Presents Biomarker Data On Ceplene at AACR

A team of researchers from Gothenburg University in Sweden presented data from a Phase 4 study on Ceplene® earlier this week at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans, LA. These data could have a profound impact on future use of the drug in elderly patients with Acute Myeloid Leukemia (AML). Ceplene®, whose rights in the U.S. belong to Immune Pharmaceuticals (IMNP), is already approved in Europe and Israel. Immune plans to use these data to attract a development partner for Ceplene®, as the company prepares to advance the drug towards regulatory approval in the U.S.

Wednesday, April 20, 2016

RedHill Keeps Pipeline Moving Forward

On April 20, 2016, RedHill Biopharma Ltd. (RDHL) reported financial results for the first quarter ending March 2016. The first several months of 2016 have been rather successful for the company. The late-stage pipeline continues to move forward, with a focus on gastrointestinal and inflammatory-related assets. Management is pursuing a "multiple shots on goal" strategy; and, in this regard, progress has been demonstrated on a number of fronts. Additionally, the balance sheet remains solid, with $53.4 million in the bank and no debt as of March 31, 2016.

I believe RedHill continues to be well-positioned for the future. In my article below, I provide for investors a review of the recent financial results and an overview of some of the recent successes and upcoming catalysts for the company.

Phase 3 For Iomab-B Should Unlock Significant Value At Actinium Pharma

Next week, on April 26, 2016, Actinium Pharmaceuticals, Inc. (NYSEMKT: ATNM) will host a webinar to discuss the upcoming SIERRA Phase 3 clinical trial for Iomab-B. SIERRA - Study of Iomab-B in Elderly Relapsed or Refractory AML - is a randomized, controlled, multi-center trial expected to begin enrolling patients in the next few months. Target enrollment for SIERRA is 150 patients with refractory or relapsed Acute Myeloid Leukemia (AML) over the age of 55. Patients will be split equally between Iomab-B and (physician's choice) conventional care prior to allogeneic hematopoietic stem cell transplantation (HSCT). The primary endpoint of SIERRA is durable complete remission (dCR) at six months from HSCT. Secondary outcome measures include overall survival (OS) at one-year post treatment and safety. Additional data about SIERRA can is available on the ClinicalTrials.gov website (NCT02665065).

The initiation of SIERRA should begin the process of unlocking tremendous value at Actinium Pharma, as the company will officially be in Phase 3 trials with a potential breakthrough cancer medication targeting a high unmet medical need. There are currently no effective treatments approved in the U.S. for AML in this patient population, and the U.S. FDA has granted Orphan Drug designation to Iomab-B in this indication. Additionally, there is no defined standard of care, with physician's usually picking among a host of cytotoxic agents, including azacitidine, cladribine, clofarabine, cytarabine, daunorubicin, doxorubicin, fludarabine, idarubicin, and thioguanine.

I'm looking forward to hearing more about SIERRA next week, as I believe Actinium shares are vastly undervalued relative to peers due to some misconceptions around the company's strategy. Below is a quick review of Iomab-B and an attempt to clear up some of those misconceptions.

Thursday, April 14, 2016

Interview with 22nd Century CEO Highlights Catalysts for 2016

Earlier this week, I had a chance to speak with Henry Sicignano III, President & CEO of 22nd Century Group, Inc. (NYSEMKT: XXII). I wanted to get an update from the company on a key issue I believe may be holding back the shares, specifically the rollout and ramp-up of the company's MAGIC very low nicotine brand cigarettes in Europe. The success of MAGIC in Europe should serve as a proxy for the market opportunity with BRAND A in the U.S. BRAND A is a similar very low nicotine product currently under U.S. FDA review as a Modified Risk Tobacco Product (MRTP). While MAGIC does not have this "modified risk" claim in Europe, it still provides logistical experience to management and much-needed user feedback on the product ahead of the planned U.S. rollout for BRAND A.

I believe BRAND A will be the first tobacco cigarette approved in the U.S. with a modified risk claim later this year. Approximately 265 billion cigarettes were sold in the U.S. during 2015 (U.S. CDC). That equates to a retail market of roughly $75 billion. The U.S. CDC estimates that 70% of smokers attempt to quit each year, and according to research done by JP Morgan, 90% of smokers would be willing to try a new brand of cigarette if it were “safer” than their usual brand. I think BRAND A can be a tremendous product for 22nd Century Group, so let's get right into our conversation with Mr. Sicignano below!

Tuesday, April 12, 2016

BioSig A Name To Watch In Outperforming Med Tech Sector

The iShares Nasdaq Biotechnology (IBB) ETF performed fairly well last week, posting a gain of 3.2%. The best day was Wednesday, April 6, 2016 - the day Pfizer and Allergan called off their proposed $160 billion merger. "Pfizergan" was killed due to a new change in U.S. tax law designed to curve a flurry of recent of tax inversions, the process by which large U.S.-based corporations acquire smaller rivals and move offshore to reduce income taxes. In the case of Pfizer-Allergan, the plan was to re-incorporate in Ireland, a move that Pfizer CEO, Ian Read, estimated would save the combined company approximately $1 billion per year.

The breakout of the proposed merger created a wave of buying in the biotech sector as investors speculated where Pfizer and Allergan would turn their attention to now that the tax inversion strategy seems quashed (see Adam Feuerstein's article). And although the breakup fee to Allergan is only a measly $150 million, I think it will bring about a change in strategy for some of the world's largest players when it comes to future M&A.

  

Despite the impressive week for biotech stocks, the IBB is still down 20% year-to-date. The reasons are numerous, but political rhetoric stemming from the U.S. election and the potential for pricing pressure on expensive biopharma drugs seems at the center of investor angst in 2016. This issue will not be easily solved, but what I do find interesting is that it seems isolated to the pharmaceutical and biotechnology sectors. The iShares U.S. Medical Device (IHI) ETF is having a decent year, up 4% so far in 2016 and up 10% over the past six months. There are many biotech investors I know that would love to be up 10% since October 2015!

Thursday, April 7, 2016

Oasmia Looks To Duplicate Success With A Validated Model

Last month I wrote a detailed article introducing investors to Oasmia Pharmaceuticals (NASDAQ:OASM), a Swedish-based biopharmaceutical company developing next-generation novel formulations of well-established chemotherapeutic agents through its proprietary nanotechnology platform. Shares of Oasmia are up 50% since that article, and I think the upward momentum in the stock will continue based on some recent positive news.