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Jason Napodano, CFA  

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  • Why You Should Own Brainstorm Cell Therapeutics
     • Yesterday, 8:34 AM BCLI 22 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 33 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 4 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 26 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 56 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 7 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 161 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 10 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.
  • Depomed Shares Offer 50% Upside Over The Next Six Months
       • Aug. 8, 2014 DEPO 11 Comments

    Summary

    • Depomed Q2 financial results exceed Street expectations based on strong product sales and royalties. The company raised guidance on their second quarter call. Business fundamentals looks strong.
    • We expect the company to win its ANDA patent litigation against Actavis, keeping a generic Gralise off the market until at least 2022.
    • Zipsor product sales are poised to increase meaningfully in 2015 based on loss of formulary coverage for chief competition and increase marketing effort by the company.
    • Depomed exited the second quarter with $224 million in cash, representing roughly 1/3rd of the current market capitalization.
    • Depomed currently trades at less than 3X 2014 revenues. The specialty pharma average is roughly 4.5X revenues. We see the stock as meaningfully under-valued. Our target is $17.50.
  • Why I'm Still Optimistic On LymPro And Amarantus Bio
    Editors' Pick • Aug. 6, 2014 AMBS 44 Comments

    Summary

    • Last month Amarantus presented data on LymPro, the company's Alzheimer's disease blood test, at two Alzheimer's conferences.
    • Amarantus shares ran up significantly in anticipation of this data, then corrected hard when the market was less than impressed with what was released.
    • We believe the market may have misinterpreted the initial data on LymPro. Additional data, specifically with a newer version of the test, is coming in September 2014.
    • Nothing we have seen over the past month changes our belief that the opportunity for Amarantus with LymPro, specifically under CLIA, remains meaningful.
  • Cipher's Business Continues To Hum Along
       • Jul. 31, 2014 CPHR Comment!

    Summary

    • Second quarter financial results exceeded our expectations on strong royalties from U.S. sales of Absorica and a surge in revenues on Lipofen.
    • We believe Cipher will become active in the in-licensing and M&A market over the next several months. Cipher exited the second quarter with nearly $40 million in the bank.
    • Cipher is trading at only 10x 2014 EPS, well below the specialty pharmaceutical industry average of 16x. Based on fair-value valuation, we see Cipher worth $12 per share.
  • Great Buying Opportunity In Pozen Shares
       • Jul. 30, 2014 POZN 16 Comments

    Summary

    • Pozen shares have sold off significantly over the past month on PDUFA delay and Horizon's loss of some formulary coverage for VIMOVO.
    • We believe PA will be approved in December 2014 and there will be a meaningful run in the shares ahead of approval.
    • Horizon losing formulary coverage for VIMOVO is unfortunate, but the impact to Pozen is minimized by minimum guaranteed payments and an increase in the Ex-U.S. sales royalty rate.
    • We believe Pozen is worth $11.50 per share based on DCF. Assuming PA gets approved in December 2014, Pozen should generate over $1.00 in EPS.
  • MYOS Corp. Tackles Muscles Health
       • Jul. 22, 2014 MYOS 18 Comments

    Summary

    • MYOS Corporation is a biotherapeutics and bionutrition company focused on improving muscle health and function to combat muscle related diseases.
    • We believe a solid scientific basis differentiates MYOS from other bionutrition companies.
    • Rapidly increasing revenues are helping to provide the necessary capital for research initiatives targeting muscle health.
    • The company just recently listed on the NASDAQ. MYOS has a clean capital structure and strong management.
    • We believe MYOS would make a good investment for those looking to get into the emerging area of muscle health. We see the shares fairly valued at $20.
  • For Avita, 'NICE' Decision In September Could Be Huge
       • Jul. 15, 2014 AVMXY 30 Comments

    Summary

    • The UK's MTAC is expected to meet on July 17th to review data on Avita Medical's ReCell for the treatment of burns and scalds.
    • A positive recommendation to MTAC to NICE would facilitate reimbursement of ReCell in the UK, opening up a huge market and setting a precedent for the rest of Europe.
    • ReCell is a simple to use and effective product for the treatment of a number of skin defects. Sales, however, are limited by lack of reimbursement.
    • A decision by NICE is expected in September 2014.