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Jason Napodano, CFA  

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  • Matinas' Pipeline Is Ready To Shine
    Thu, Apr. 16 MTNB 2 Comments

    Summary

    • Matinas just completed a private placement raising net proceeds of $8.5 million.
    • Earlier in the year, the company acquired Aquarius Bio, and with it the cochleate drug-delivery technology formerly owned by BioDelivery Sciences.
    • The lead candidate acquired with Aquarius is CAmB, an oral amphotericin B currently in Phase 2 studies funded by the NIH.
    • Matinas is also preparing to initiate a Phase 3 study with MAT9001, a next-generation Omega-3 fatty acid by the end of the year.
  • Brainstorm Rallies On Endorsement Of Competitor's Drug
    Mon, Apr. 13 BCLI 9 Comments

    Summary

    • The Mayo Clinic (and Dr. Sanjay Gupta) think cell therapy for ALS shows potential.
    • We believe Brainstorm's cell, called Nur-Own, has superior characteristics to traditional MSC's being used by competitors in similar programs.
    • Full data from Brainstorm's Phase 2a study is coming next week at AAN.
    • We think the shares are worth $10.
  • Pieris' Anticalin Platform Could Revolutionize Drug Development
     • Fri, Apr. 10 PIRS 10 Comments

    Summary

    • Pieris has a novel Anticalin platform we believe could revolutionize drug development.
    • PRS-080 in Phase 1 for anemia. PRS-060 is preclinical for asthma. PRS-300 / PRS-110 are preclinical immune-oncology candidates.
    • Partnerships already in place with big players like Allergan and Sanofi. Ultimately, I believe PIRS gets acquired by a larger company.
    • The company is well-capitalized, has a clean capital structure, and management looks to be very credible.
    • Near-term target is $6.00 per share, almost 100% upside from today.
  • Protalex To Start Phase 1/2 Trial With PRTX-100 In Patients With ITP
     • Tue, Apr. 7 PRTX 3 Comments

    Summary

    • Protalex recently received FDA clearance to begin a Phase 1/2 study with PRTX-100 in Immune Thrombocytopenia (ITP).
    • Previous data with PRTX-100 in patients with Rheumatoid Arthritis (RA) demonstrated the drug to be both safe and highly efficacious.
    • We remains big fans of PRTX at this price. We think the shares could double by year end.
  • RES-529 Offers Two Shots On Goal For RestorGenex
    Tue, Apr. 7 RESX 2 Comments

    Summary

    • RES-529 targets the PI3K/AKT/mTOR signaling pathway that is implicated in a number of cellular processes, including cell growth, proliferation, differentiation, motility, angiogenesis, and survival.
    • RestorGenex is developing RES-529 in wet Age-Related Macular Degeneration (AMD) and Glioblastoma Multiforme (GBM).
    • We believe the shares are worth $6.50.
  • Nuo Hit By Perfect Storm In 2014, But We See Blue Sky Ahead
     • Thu, Apr. 2 NUOT 11 Comments

    Summary

    • In the second half of 2014, Nuo was hit by the perfect storm. Financial results in the fourth quarter were pretty bad. No reason to sugar-coat it.
    • However, we believe the storm has passed the fundamentals have bottomed. In fact, we believe the tide has already turned in the company's favor, despite the stock price.
    • Cash is a concern, but valuation is too attractive to ignore.
  • Why You Should Own Brainstorm Cell Therapeutics
     • Sat, Mar. 28 BCLI 77 Comments

    Summary

    • Top-line data from a Phase 2a ALS study with NurOwn gave highly encouraging results earlier in the year. Full data is coming in April at AAN.
    • The data is suggestive of a beneficial effect for NurOwn on terms of slowing the rate of decline in ALS patients as measured by ALSFRS-r and FVC.
    • We believe Brainstorm shares are very attractive given the company's market leading position in developing a cell therapy for the treatment of ALS.
  • InVivo Revolutionizing Spinal Cord Injury
    Fri, Mar. 27 NVIV 59 Comments

    Summary

    • InVivo's pilot study of the company's neuro-spinal scaffolding is going exceptionally well. The company is "2 for 2" in terms of returning previously completely paralyzed patients to some motor function.
    • Over the next several months, InVivo will enroll another three patients in the IDE pilot study. We expect steady news flow over the summer months on all five patients.
    • InVivo running the pilot study under a humanitarian use device pathway. We believe a registration study will begin next year.
    • Despite a meaningful run in the shares over the past six months, we see tremendous upside left in the stock; this is a revolutionary breakthrough device for spinal cord injury.
  • Raising Price Target On Epirus Biopharma - The Biosimilar Revolution Has Started
    Wed, Mar. 25 EPRS 6 Comments

    Summary

    • Epirus Should begin recording meaningful revenues from sales of its biosimilar Remicade product, Infimab, in India in the coming quarters.
    • We believe the U.S. approval of Novartis' Zarxio is a significant positive for biosimilar players such as Epirus.
    • Epirus is focused on the development of biosimilars for RA. We believe the company's strategy is sound and the shares are worth $12.
  • An Introduction To Can-Fite Ahead Of Phase II Psoriasis Data Next Week
       • Tue, Mar. 17 CANF 27 Comments

    Summary

    • Can-Fite BioPharma Ltd. (CANF) is a clinical-stage biopharmaceutical company developing small molecule therapeutics for the treatment of autoimmune-inflammatory, oncological, and ophthalmic diseases.
    • The lead compound, CF101, is in a Phase 2/3 clinical trial for psoriasis with top-line results expected by the end of March 2015.
    • CF101 is also being developed for the treatment of rheumatoid arthritis, with a Phase 3 trial set to get underway later in 2015.
    • CF102 is an additional clinical candidate that is in a Phase 2 trial for hepatocellular carcinoma.
    • With multiple “shots on goal”, Can-Fite is an intriguing play in the small cap biotech space with the potential for significant returns.
  • DURECT's Endogenous Epigenomic Regulator DUR-928 - What You Need To Know
       • Thu, Mar. 5 DRRX 5 Comments

    Summary

    • On March 2, 2015, DURECT held a conference call and introduced a new pipeline candidate, DUR-928, an endogenous epigenomic regulator protein.
    • Management thinks DUR-928 has potential in a number of metabolic indications such as acute organ injury, NAFLD/NASH, and lipid homeostasis.
    • DURECT shares are looking attractive based on improved visibility for POSIDUR, a path forward with REMOXY, and the new Phase 1 asset in DUR-928.
  • Why You Should Own Cipher Pharmaceuticals
    Thu, Feb. 26 CPHR 16 Comments

    Summary

    • Newly NASDAQ listed Cipher Pharmaceuticals posted solid financial results in 2014. The company generated $27.3 million in cash from operations.
    • Cipher is now laser-focused on building a specialty dermatology pharmaceutical company. Over the past two months they company in-licensed five clinical stage candidates.
    • The NDS for a sixth potential new product, Beteflam Patch, is now under review in Canada.
    • With a growing revenue base, a deep pipeline of derm products, and cash-flow positive commercial operations, Cipher offers investors an attractive specialty pharma play.
    • We see $16 per share as fair-value today, with significant upside as the pipeline rolls forward.
  • Corbus Plans Multiple Clinical Trials With Resunab In Orphan Indications
       • Wed, Feb. 11 CRBP 4 Comments

    Summary

    • Newly public Corbus Pharmaceuticals plans to begin two Phase 2 clinical trials with Resunab, a novel anti-inflammatory candidate, in the next few months.
    • Resunab's novel mechanism of action could prove important in treating inflammatory diseases such as cystic fibrosis and scleroderma.
    • Besides initiating clinical trials, we believe the company will actively pursue Orphan Drug filings for Resunab, leading to potential partnering interest in the candidate.
    • We believe potential non-dilutive funds are available to Corbus through collaboration with the Cystic Fibrosis Foundation.
  • Why Vericel Shares Will Double In 2015
    Fri, Feb. 6 VCEL 46 Comments

    Summary

    • Vericel's commercial business should generate close to $50 million in sales in 2015. Based on the current market cap, the shares are trading at only 1.5x forward revenues.
    • The company's ixCELL-DCM study recently completed enrollment and will offer data in the first quarter of 2016. We expect the shares will run-up ahead of the data later this year.
    • Management has laid out an aggressive yet astute strategy to drive Vericel to profitability in the coming years. We believe valuation is extremely attractive and upside is significant.
  • Matinas Biopharma Acquires Aquarius Biotechnologies
       • Wed, Feb. 4 MTNB 1 Comment

    Summary

    • Matinas Biopharma Inc. announced the establishment of a lipid-based, anti-infective platform with the acquisition of Aquarius BioTechnologies, Inc.
    • Aquarius lead pipeline candidate is a encochleated nano-particle formulation of Amphotericin B, with plans to enter a Phase 2a study this spring.
    • CAmB (now MAT2203) is designed to offer oral administration of and lower toxicity to current IV Amphotericin B products, the market leader which is Gilead's Ambisome.
    • Our initial assessment is that this is a relatively low-risk deal for Matinas, with funding already in place for MAT2203 from the NIH, with nice upside potential.
  • Tonix Shares Looking Attractive As Clinical Programs Advance Forward
       • Wed, Jan. 28 TNXP 66 Comments

    Summary

    • A Phase 3 For TNX-102SL in fibromyalgia is expected to begin in May or June 2015.
    • Tonix also just recently started a Phase 2 study with TNX-102SL in military-related PTSD.
    • A third program with a second candidate, TNX-201, in tension headache will also begin in the next several months.
    • Once all three of these programs are underway we believe institutional investor attention in the Tonix story will soar.
    • Our NPV modeling calculates fair-value for Tonix shares at $10, offering significant upside for investors with low-risk over the next 12 months.
  • Next Steps For Protalex With PRTX-100 Expected To Unlock Significant Value
    Wed, Jan. 21 PRTX 4 Comments

    Summary

    • Final analysis of the Phase 1b study continues. Management is in discussion with the FDA on the design of a Phase 2 study in RA.
    • Beyond RA, we expect the company to finalize an agreement with the U.S. FDA to move into a Phase 1 study in ITP by the middle of the year.
    • ITP is an Orphan Drug indication and would provide additional upside to the company on both pricing and exclusivity.
    • Protalex balance sheet may look low on cash but the company is backed by management and insiders who collectively just made $5 million available to move PRTX-100 forward in development.
  • Depomed Acquires Nucynta Franchise From J&J
       • Tue, Jan. 20 DEPO 8 Comments

    Summary

    • On January 15, 2015, Depomed announced it had agreed to acquire the U.S. rights to Nucynta from Janssen Pharmaceuticals.
    • The deal is an excellent strategic fit for Depomed.
    • It is, however, rather expensive, and financing will be required to close the transaction.
    • The stock remains attractive for long-term holders, although we suspect near-term upside is capped by the pending financing and execution risk.
    • We see $21 as fair value, based on our early estimates (no financial guidance given).
  • Auspex Firing On All Cylinders
       • Wed, Jan. 14 ASPX 6 Comments

    Summary

    • Auspex has further differentiated Austedo by showing virtually no impact on QT vs. Xenazine.
    • The company also licensed rights to a deuterium-containing levodopa product we believe has enormous potential.
    • We continue to be very optimistic on the Auspex story.
  • Brainstorm Takes Major Leap Forward In Battle Vs. ALS
    Tue, Jan. 6 BCLI 8 Comments

    Summary

    • Brainstorm Phase 2a data showed a slowing of disease progression on two commonly used scales to assess ALS patients.
    • We believe these data are demonstrative of proof-of-concept for NurOwn for the treatment of ALS.
    • A U.S. Phase 2 study is ongoing with data expected in 2016.
    • Full data from the Phase 2a study is expected at a major medical meeting later this year.
  • 15 Biotech Names For 2015
    Mon, Jan. 5 AMBS, ASPX, BCLI 167 Comments

    Summary

    • The biotech sector had a fantastic 2014; the broader index climbing 35%. The index was up 60% in 2013.
    • Below we provide quick analysis on 15 biotech names (within our coverage universe) where investors can look for positive returns in 2015.
    • We are big fans of Neuralstem, Cynapsus, Nuo Therapeutics, Amarantus, Lipocine, Neurocrine Bio, Auspex, and Protalex, among several others listed below.
  • Auspex Hits Home Run With Phase 3 Data In Huntington's Chorea
    Editors' Pick • Dec. 17, 2014 ASPX 7 Comments
  • Buy Auspex Ahead Of Pivotal Phase 3 Data In December 2014
       • Nov. 13, 2014 ASPX 13 Comments

    Summary

    • Auspex is developing SD-809, an improved formulation of tetrabenazine for the treatment of movement and neurological disorders.
    • The lead indication for SD-809 is Huntington's disease, an indication for which the US FDA just granted Orphan Drug status.
    • Important Phase 3 data on SD-809 is expected in December 2014.
    • We believe the data will be positive, and that Auspex stock is worth $36 per share.
  • Neurotrope Tackles Alzheimer's Disease With Novel Mechanism
       • Oct. 21, 2014 NTRP 12 Comments

    Summary

    • Neurotrope, Inc. is developing therapeutics for neurodegenerative diseases such as Alzheimer’s Disease (AD).
    • The company’s lead compound, bryostatin-1, is a natural compound isolated from a tiny, ocean dwelling organism.
    • Bryostatin-1 activates protein kinase C (PKC) and represents a novel treatment option for AD that is supported by extensive preclinical data.
    • The company is also developing an AD diagnostic test with early results showing sensitivity (correctly diagnosing AD) ≥ 97% and specificity (correctly identifying individuals without AD) ≥ 96%.
    • Neurotrope has a basic market capitalization of only $14 million, with $10+ million in cash in the bank and data from a Phase 2a study coming in early 2015.
  • InVivo, Neuralstem Treat Spinal Cord Injury Patients
       • Oct. 16, 2014 CUR 59 Comments

    Summary

    • Two small biotechnology companies are pioneering efforts into treating patients with spinal-cord injury.
    • Neuralstem’s approach is to use human spinal cord stem cells injected directly around the site of injury in chronic patients.
    • InVivo’s approach involves using a biocompatible scaffolding has been designed to stabilize the spinal cord immediately following injury, as well as protect the existing tissue from further injury.
    • We believe both companies have tremendous upside pending the results of their respective Phase 1 trials.
    • Below we provide a quick background on SCI and touch briefly on each company and their technology.
  • Strong Enrollment In Phase 3 Trial Means Good News For Titan Pharma
       • Sep. 24, 2014 TTNP 10 Comments

    Summary

    • Titan's confirmatory Phase 3 trial is enrolling well - slightly ahead of schedule. We believe this is a good sign and shows strong potential demand for the drug.
    • Data from the Phase 3 trial is expected around the middle of 2015, with a NDA re-filing expected before the end of 2015.
    • We see Probuphine as a $250 to $300 million drug, making Titan shares highly attractive at today's depressed price of only $0.56 per share.
  • FDA Advisory Committee Comments Create Buying Opportunity In Lipocine
       • Sep. 23, 2014 LPCN 4 Comments

    Summary

    • Lipocine’s (LPCN) stock price was down 32% on September 18th after consecutive FDA advisory committee meetings held in regards to testosterone replacement therapy (TRT).
    • Regarding TRT, the committee overwhelmingly voted to alter labeling language to narrow the indication for TRT products.
    • The committee did not believe there was an overwhelming concern regarding TRT and CV risk; however, most members thought clinical trials examining the connection are warranted.
    • We believe that the market has overreacted and is undervaluing Lipocine based on what we see as only minimal changes to the overall size of the TRT market.
    • At the current valuation Lipocine is a good acquisition target upon positive Phase 3 clinical trial results, which are due during the current quarter.
  • Does TapImmune Have What It Takes To Succeed?
    Sep. 18, 2014 TPIV 2 Comments

    Summary

    • Below we provide a quick overview and analysis of TapImmune, an OTC micro-cap biotech company focused on the treatment of cancer and infectious diseases.
    • Leading pipeline candidates include TPIV100 for HER2/neu breast cancer and TPIV200 for both ovarian and breast cancers.
    • We believe TapImmune faces signficant systemic and company specific challenges, but the technology is fairly interesting and the upside potential is enormous.
    • Due to the early-stage nature of the pipeline, investment in TapImmune seems high risk / high reward.
  • What Will Depomed Do With Half A Billion In Cash?
       • Sep. 11, 2014 DEPO 11 Comments

    Summary

    • Thanks to a recent $300+ million convertible debt offering, Depomed now holds over $500 million in cash on hand.
    • Based on our analysis of previous transaction, we believe Depomed's model is working. We have identified a few potential targets for the company.
    • Based on the current market capitalization and the potential to acquire new products that plug into the model, we believe Depomed's stock has tremendous near-term upside potential.
  • Newly Nasdaq-Listed Immune Pharma Offers Big Upside
       • Aug. 26, 2014 IMNP 9 Comments

    Summary

    • Immune Pharma shares listed on the Nasdaq last week.
    • Two Phase 2 trials with Bertilimumab - one in orphan disease Bullous Pemphigoid and another in ulcerative colitis - should start in September 2014.
    • Immune is currently engaging partners for a Phase 3 study with AmiKet in PHN, with a goal of securing a deal by the end of the year.
    • We see a number of catalysts coming in the next few months. We believe IMNP shares are under-valued. Our target is $9 per share.
  • Second Quarter Results Confirm Why We Like Aastrom
       • Aug. 19, 2014 VCEL 7 Comments

    Summary

    • Second quarter results confirm a turnaround is underway at Aastrom Biosciences, lead by the recent acquisition of the CTRM business from Sanofi.
    • We believe Aastrom will generate roughly $50 million in revenues in 2015 and $5 million in positive cash flow from the CTRM business.
    • The Phase 2b ixCELL-DCM study continues on plan.
    • We believe Aastrom shares are worth $6.50 based on the revenues and projected cash flow from CTRM and the NPV of the Phase 2 ixmyelocel-T asset in DCM.
  • DARA Q2 Shows Good Progress, Signs Of Upside
       • Aug. 14, 2014 DARA 10 Comments

    Summary

    • Revenues for the Q2-2014 were $0.41 million, up 432% from last year and exceeding expectations for the first time.
    • DARA's revamped and enhanced commercial sales efforts seem to be working. We believe revenues in 2015 can approach $5.0 million.
    • DARA will meet with the U.S. FDA to discuss KRN5500 in the coming months. KRN5500 has been awarded two Orphan Drug designations and Fast Track development status.
    • Securing a development partnership for the initiation of a Phase 2b study with KRN5500 is top-priority after the FDA meeting. The company reports being in-talks with potential partners right now.
    • As of June 30, 2014, DARA held cash of $15.9 million. We believe this is enough to fund operations into 2016 based on a declining burn rate.