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43 companies, 1 interpreter! Insight, foresight
and recommendation 

Roll Call

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Adverum Biotechnologies (ADVM - Formerly Avalanche Biotech (AAVL) In May, 2015 AAVL acquired Annapurna Therapeutics and formed a new company – Adverum Biotechnologies – and is now trading under the symbol ADVM.  AAVL posted a net loss of $15.4 M or - $0.57 per share.  Recommendation:  HOLD

 

 

Hold

Aduro (ADRO) – On 5/16, ADRO announced its P2b ECLIPSE trial did not meet the primary endpoint of an improvement in overall survival for patients with pancreatic cancer who had failed at least two prior therapies in the metastatic setting.  For Q1/16, ADRO’s net loss was $28.8 M, or $0.45 per share, compared to a net loss of $16.6 M, or $39.97 per share for the same period in 2015.   Recommendation:  BUY

Buy

Applied Genetics Technology Corporations (AGTC) In Q1/16, AGTC recorded net income of $2.0 M, compared to a net loss of $6.3 M generated in the same period of 2015.  Cash, cash equivalents and investments amounted to $180.5 M.  In April, AGTC announced the publication of two toxicology studies that provide support for clinical investigation of its investigational gene therapy candidate for achromatopsia caused by mutations in the CNGB3 gene. Results, evaluating toxicology and biodistribution profiles in mouse and non-human primate models, and demonstrating efficacy in the mouse model, were published online in the peer-reviewed journal Human Gene Therapy Clinical Development and appear in the March print issue.  Recommendation:  BUY

 

Buy

Asterias Biotherapeutics (NYSE MKT: AST) -  In May, AST announced plans to expand its AST-OPC1 P1/2a trial in spinal cord injury patients following recent clearance for the expansion by the U.S. Food and Drug Administration (FDA) based on the favorable safety profile observed so far with AST-OPC1 in the current study.  In Q1/16, AST posted a net loss of $10.3 M or $0.27 per share compared to a net loss of -$2.9 M or -$0.09 per share for the same period in 2015. On May 13, it raised approximately $16.2 M in net proceeds from a public offering of shares of its common stock and warrants.  Recommendation:  Buy

Buy

Athersys, Inc. (ATHX) – During Q1/16, ATHX announced positive one-year follow-up results from the Phase 2 study of MultiStem® cell therapy to treat ischemic stroke - demonstrating progressive improvements and significantly higher rate of excellent outcomes at one year for MultiStem-treated patients - with greater benefits for patients receiving MultiStem treatment within 36 hours of the stroke.   It also formed a collaboration with HEALIOS K.K.  to develop MultiStem cell therapy for stroke in Japan, which included an upfront payment of $15 million, additional potential milestone payments aggregating up to $225 million, double-digit royalties on product sales and an option for Healios to expand the collaboration to include acute respiratory distress syndrome ("ARDS") and another indication with a $10 million expansion payment and additional associated milestone payments and royalties.  For Q1/16, ATHX posted net income of $4.8 M or $0.06 per share, compared with a net loss of -$12.9 M or -$0.16 per share.  Recommendation:  HOLD

Hold

AxoGen, Inc. (AXGN) – In Q1/16 AXGN commercially launched its AcroValTM Neurosensory & Motor Testing System (NSMTS) allowing physicians to electronically measure, map and monitor patient’s nerve function both prior to and following nerve repair.  The company posted a net loss for Q1/15 of- $3.6 M or -$0.12 per share compared to -$22.5 M or -$0.16 per share in Q1/15. Recommendation: BUY

Buy

Brainstorm Cell Therapeutics (BCLI) –In Q1/16 BCLI entered into a collaborative agreement with Hadassah Medical Center in Jerusalem, Israel, to conduct the planned multi dose Phase 2 trial with NurOwn in ALS.  Patients will receive three consecutive stem cell transplantations in order to explore the safety and efficacy of a multi dose treatment.  The multi dose study is designed to provide guidance for further clinical development of NurOwn therapy in ALS.  Approval for this trial has been received by the Hadassah's Helsinki Committee.  BCLI is now awaiting the approval of the Israeli Ministry of Health.  For Q1/15 BCLI posted a net of -$1.8 M, or -$0.10 per share, compared to a net loss of -$2.2 M or -$0.12 per share in Q1/15. Recommendation: HOLD

 

 

Hold

Bellicum Pharmaceuticals (BCLM) -  During Q1/16, BLCM reported new interim data from its BP-004 trial, showing disease-free outcomes in pediatric patients, including those with blood cancers who had undergone T-depleted, haploidentical hematopoietic stem cell transplantation (HSCT) followed by BPX-501 donor T-cell replacement.  Outcomes of 17 pediatric leukemia patients showed BPX-501 cells expand in vivo and persist over time, contributing to adaptive immunity. Additionally, the relapse rate compared favorably with that of historical controls, with 16 of 17 patients in the trial showing disease-free outcomes. BLCM also received orphan drug designation from FDA for the combination of BPX-501 genetically modified T cells and activator agent rimiducid as replacement T-cell therapy for the treatment of immunodeficiency and Graft versus Host Disease after allogeneic hematopoietic stem cell transplant. For Q1/16 BCLM reported a net loss of- $15.1 M or -$0.56 per share compared to a net loss of -$7.8 M or -$0.56 for the first quarter of 2015.  Recommendation: BUY

Buy

BioLife Solutions (BLFS) – In Q1/16, BSTG formed a relationship with MNX Global Logistics, a specialty courier offering door to door, same day and next flight out managed logistics in order to increase the attractiveness of its cold chain solutions by integrating value-added ancillary logistics services for time and temperature sensitive biologic materials directly into the biologistex SaaS. BSTG also introduced its, ALL SEASON™ Cold Packs and Payload Carriers for its  evo family of shippers.  Recommendation: BUY

Buy

Bluebird Bio (BLUE) – In Q1/16 BLUE treated its first patient in its P1 study of bb2121 in multiple myeloma.  The patient was infused in the CRB-401 study of anti-BCMA CAR T therapy bb2121 in relapsed/refractory multiple myeloma. Additionally, Celgene exercised its option to exclusively license bb2121. Under the terms of the collaboration, BLUE received a $10.0 M option exercise payment from and may now elect to co-develop and co-promote the product candidate in the U.S.   It is also eligible to receive specified development and regulatory milestone payments and royalty payments on net sales.  BLUE also reached fully enrolled status in its expanded NORTHSTAR study of LentiGlobin in patients with transfusion-dependent thalassemia, including three additional adolescent patients.  For Q1/16 BLUE posted a net loss of -$56.3 M or -$1.52 per share compared to a net loss of -$24.8 M or -$0.76 per share  for the first quarter of 2015.  Recommendation: BUY

Buy

Biostage (BSTG) -  In May, 2016, BSTG released  pre-clinical data, including the complete regeneration of a segment of the esophagus, from its collaborative large-animal study of its Cellspan™ organ implants with Mayo Clinic. The study demonstrated in a predictive large-animal model the ability of BSTG Cellspan organ implants to successfully stimulate the regeneration of sections of esophagus that had been surgically removed for the study. Cellspan esophageal implants, consisting of a proprietary biocompatible synthetic scaffold seeded with the recipient animal's own stem cells, were surgically implanted in place of the esophagus section that had been removed. The scaffolds, which are intended to be in place only temporarily, were later retrieved via the animal's mouth in a non-surgical endoscopic procedure. After 2.5 months, a complete epithelium and other specialized esophagus tissue layers were fully regenerated.  BSTG posted a net loss for Q1/16 was -$2.5 M, or -$0.18 per share, compared to -$2.6 M, or -$0.39 per share in Q1/15.A bottom could be recognized at $1.25 to $1.30 after the recent financing of $1.76.  Recommendation: HOLD

 

Hold

BioTime, Inc. (BTX) -- In Q1/16, the first cohort in BTX’s P1/2a clinical trial evaluating the safety and efficacy of OpRegen® for the treatment of the advanced form of dryage related macular degeneration (AMD) was successfully dosed.  BTX also expects to complete enrollment for its Renevia®  clinical trial in Europe in the second half of 2016 with top line data availability in early 2017. If the data are positive, BTX plans to submit an application for CE Mark approval in the first half of 2017.  BTX’s  subsidiary Asterias Biotherapeutics, Inc. completed the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for AST-VAC1, its lead clinical program targeting maintenance of relapse-free-survival in acute myeloid leukemia (AML) patients. Asterias is planning for the initiation of a single P3 trial that could support an accelerated development pathway towards a potential future biologic license application (BLA) filing.   BTX recorded a Q1/16 net loss of $17.1 M  or $0.19 per share compared to -$10.2 million or $0.13 per share  for Q1/15.  RECOMMENDATION - HOLD

Hold

Capricor (CAPR)  --  In Q1/16 Modified the enrollment goal of ALLSTAR to approximately 120 patients.  CAPR also resumed enrollment in its HOPE-Duchenne trial following a successful pre-specified DSMB review.  The company also received approval for a grant award of approximately $3.4 M from CIRM to support the HOPE-Duchenne trial .  During Q1. CAPR also completed an equity offering of approximately $4.1 M with new and existing investors.  For Q1/16, CAPR reported a net loss of approximately -$4.3 M, or -$0.26 per share  compared to a net loss of approximately- $3.5 M, or -$0.23 per share, for the first quarter of 2015 while CAPR’s cash, cash equivalents and marketable securities totaled approximately $14.3 M compared to $13.6 M at December 31, 2015.  Recommendation:  SELL

 

Sell

Caladrius (CLBS) --   During Q1/16 CLBS entered into a global collaboration and license agreement with Hitachi Chemical, selling a 19.9% equity stake in PCT for $19.4 M and licensing PCT’s cell therapy technology and know-how for certain Asian territories for $5.6 M and future royalties.  The company also enrolled the first patient in The Sanford Project: T-Rex Study, a P2 trial of CLBS03 (autologous expanded regulatory T cells, or Tregs) for the treatment of recent-onset type 1 diabetes (T1D) in adolescents.  It also received classification from the European Medicines Agency (EMA) of CLBS03 as an Advanced Therapeutic Medicinal Product (ATMP), and reached agreement with Japanese regulators on a P2 development plan that could qualify for early conditional approval for CD34 cell therapy as a treatment for critical limb ischemia.  CLBS reported a net loss of -$11.1 M or -$0.21 per share, compared to -$19.2 M or -$0.51 per share in Q1/15.  Recommendation: SELL

Sell

Cellectis (CLLS) –CLLS recently signed an agreement with CELLforCURE for the cGMP manufacturing of clinical batches of its lead product candidate UCART123, and for the implementation of cGMP manufacturing processes designed and developed by CLLS.  It also signed a supply and license agreement with Takara Bio Inc. (4974 TYO) for recombinant human fibronectin fragment RetroNectin® to support CLLS’s manufacturing processes and production capabilities.  CLLS also announced a research collaboration and license agreement with MabQuest SA for the development of a new class of anti PD-1 monoclonal antibodies.  CLLS recorded a net loss for Q1/16 of- €16.1 M or -€0.46 per share compared to net income €7.0 million or €0.22 per for Q1/15.  Recommendation:  BUY

 

Buy

Neuralstem (CUR) --  In May, CUR  announced a corporate reorganization to focus on advancing its NSI-189 neurogenic small molecule program, currently in a P2 clinical trial for the treatment of major depressive disorder, and to continue to pursue collaborations for the NSI-566 stem cell therapy program. This reorganization is necessary to efficiently allocate resources on the company's refocused strategy thereby creating value for all stakeholders.  CUR’s financial situation is on life support.  It is laying off staff and streamlining its activities because money is running out.  Cash and short-term investments decreased $4.6 M in Q1/16.  While net loss increased nearly 25% or $1.7 M during the same period.  CUR’s G&A costs rose 121% in Q1/16 for expenses related to severance accrual and increased stock based compensation resulting from the accelerated vesting of options, both related to the termination of its former CEO. Meanwhile R&D costs decreased approximately $117 K or 4% during from Q4/15 to Q1/16 due to decreased pre-clinical and clinical costs partially offset by increases in headcount and stock based compensation.  For Q1/16, CUR reported a net loss of $6.6 M or $0.07 per share, compared to a loss of approximately $5.1 M or $0.06 per share in Q1/15.  RECOMMENDATION - HOLD

 

Hold

Cytori (CYTX) – In Q1/16, CYTX’s SCLERADEC I therapy for scleroderma hand dysfunction received road orphan drug designation status by European Medicines Agency.  CYTX also launched a compassionate use program for scleroderma in Europe in partnership with Idis Managed Access, and announced STAR enrollment progress consistent with development timelines.  CYTX has a rights offering in the works, each right entitles the holder to purchase one unit at the subscription price of $2.90 per unit, composed of one share of common stock and 0.5 of a warrant, with each whole warrant exercisable to purchase one share of common stock at an exercise price of $3.48 per share for 30 months from the date of issuance. The runway is questionable.   Q1/16 net loss was - $5.3 M or -$0.03 per share ($0.41 per share after a 1:15 reverse split announced on 5/10/16), compared to a net loss of -$22 M or -$3.19 per share in Q1/15.  RECOMMENDATIONSELL

 

Sell

Fate Therapeutics (FATE) – In 1/16, FATE’s Investigational New Drug (IND) application for ProTmune (FT1050-FT4145 programmed mobilized peripheral blood (mPB) cells) was cleared by the U.S. Food and Drug Administration. FATE plans to begin subject enrollment in a multi-center, randomized, controlled study designed to evaluate safety and the potential of ProTmune to prevent acute graft-versus-host disease (GvHD) and cytomegalovirus (CMV) infection (HCT). There are currently no approved therapies for the prevention of GvHD or CMV infection in patients undergoing allogeneic HCT.   Q1/16 net loss was - $8.4 M or -$0.29 per share compared to a net loss of -$7.9 M or -$0.38 per share in Q1/15.  RECOMMENDATIONBUY

Buy

Fate Therapeutics (FATE) – In 1/16, FATE’s Investigational New Drug (IND) application for ProTmune (FT1050-FT4145 programmed mobilized peripheral blood (mPB) cells) was cleared by the U.S. Food and Drug Administration. FATE plans to begin subject enrollment in a multi-center, randomized, controlled study designed to evaluate safety and the potential of ProTmune to prevent acute graft-versus-host disease (GvHD) and cytomegalovirus (CMV) infection (HCT). There are currently no approved therapies for the prevention of GvHD or CMV infection in patients undergoing allogeneic HCT.   Q1/16 net loss was - $8.4 M or -$0.29 per share compared to a net loss of -$7.9 M or -$0.38 per share in Q1/15.  RECOMMENDATIONBUY

Hold

Histogenics (HSGX) --   HSGX continued to see positive enrollment trends in its NeoCart P3 clinical trial and remains on track to complete patient enrollment by the end Q2/17.  It also received approval from the FDA to begin using internally produced collagen in the ongoing trial. HSGX reported a Q1 net loss of $-8.0 M or -$0.60 per share, compared to -$8.0 M or -$0.60 per share in Q1/15.   Financing needed.  RECOMMENDATIONSELL

Sell

ImmunoCellular Therapeutics (IMUC) --   IMUC received approval from regulatory authorities in Canada, the United Kingdom and the Netherlands to initiate ICT-107 P3 registration trial in patients with newly diagnosed glioblastoma.  First clinical supplies could be manufactured for qualifying patients in Canada and Europe in Q3/16.  IMUC expects approval of clinical applications from six other European countries in 6/16, with patient screening to begin Q3/16.  IMUC reported a Q1/16 net loss of - $5.6 M or -$0.06 per share compared to a net loss of -$1.4 M or -$0.02 per share in Q1/15.  RECOMMENDATIONHOLD

Hold

Juno Therapeutics (JUNO) -- In Q1/16, JUNO’s investigational new drug (IND) amendment cleared the FDA, allowing it to begin clinical manufacturing of JCAR015 for its P2 ROCKET trial.  It also announced the initiation of enrollment for its trial combining JCAR014 and MedImmune’s anti-PDL-1 immune checkpoint inhibitor, durvalumab.   JUNO also announced that Celgene (CELG) exercised its option to develop and commercialize product candidates from Juno’s CD19 program outside North America and China. CELG paid JUNO a $50 M fee and the companies will now share global development expenses for product candidates in the CD19 program.  CELG has commercial rights outside of North America and China, and will pay Juno a royalty at a percentage in the mid-teens on any future net sales in CELG’s territories for therapeutic products developed through the CD19 program.   JUNO retains commercialization rights in North America and China.  JUNO posted a net loss for Q1/16 of - $71.1 M or- $0.72 per share compared to-$65 M or $0.79 per share, for Q1/15.  RECOMMENDATION:  HOLD

Hold

Kite Pharma (KITE) –  KITE announced that four presentations relating to its clinical programs will be delivered at the upcoming 2016 American Society of Clinical Oncology (ASCO) Annual Meeting. Data presented included results from Kite’s SCHOLAR-1 study, the first and largest meta-analysis of outcomes in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL), an aggressive non-Hodgkin lymphoma (NHL). Patients with chemorefractory DLBCL have not responded to prior treatment with chemotherapy or have relapsed within a year after autologous stem cell transplantation.  Data from a P1-2a study evaluating anti-CD19 CAR T cell therapy after low-dose chemotherapy in people with advanced lymphoma was presented in a Late-Breaking Abstract oral session by James N. Kochenderfer, M.D., an investigator in the Experimental Transplantation and Immunology Branch of the National Cancer Institute (NCI) Center for Cancer Research. This study is being conducted as part of a Cooperative Research and Development Agreement (CRADA) between KITE and the NCI. KITE also provided an update on patients with chemorefractory aggressive NHL from the P1 portion of the ZUMA-1 study and present a poster on the study design of ZUMA-4, an ongoing P1/2 study of KTE-C19 in children and young adults with previously treated acute lymphoblastic leukemia.   In Q1/16, KITE announced a partnership with Genentech (ROCHE -- ROCHG.VX)  to study its KTE-C19 in combination with the checkpoint inhibitor atezolizumab. KITE expects to initiate a P 1b/2 combination study in patients with chemorefractory diffuse large B cell lymphoma in the second half of 2016. KITE also entered into a new Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute’s Experimental Transplantation and Immunology Branch.  A P1 study of human anti-CD19 chimeric antigen receptor for treating B-cell malignancies is currently ongoing.  KITE reported a Q1/16 net loss of -$43.9 M, or -$0.90 per share, compared to a net loss of -$15.1 M or -$0.36 per share for Q1/15.  RECOMMENDATION:  BUY

Buy

Cesca Therapeutics (KOOL) – On 5/11/16, KOOL reported Favorable outcomes reported in Critical Limb Ischemia (CLI) study in New Delhi, India.  Follow-up data from a compassionate use initiative to treat six patients with late-stage CLI using KOOL’s SergWerks showed favorable outcomes in lifestyle and pain reduction.  The company received approval from the U.S. FDA for a pivotal trial for CLI using its SurgWerks System, and is preparing to submit an IDE supplement for review.  KOOL reported a Q3/16 net loss of -$10.9 M, or -$4.00 per share, compared to a net loss of -$4.8 M or -$2.38 per share for Q3/15.  RECOMMENDATION:  SELL

Sell

MiMedx Group (MDXG) – During 5/2016, MDXG launched legal proceedings against Osiris (OSIR) claiming OSIR deliberately used inadequate clinical study standards to produce a biased report comparing OSIR’s Grafix vs. MDXG’s Epifix effectiveness in treating acute and chronic wound. MDXG reported a Q1/16 net loss of -$10.9 M, or -$4.00 per share, compared to a net loss of -$4.8 M or -$2.38 per share for Q1/15.  RECOMMENDATIONBUY

Buy

Mesoblast (MESO) – During Q3/2016, MESO released Top-line P 2 results from its first cohort of rheumatoid arthritis patients who have previously failed one or more biologic agents showed a single intravenous infusion of the lower dose of MPC-300-IV resulted in early and sustained clinical responses, with no cell-related adverse events.  Also in Q3, MESO’s licensee in Japan, JCR Pharmaceuticals Co. Ltd. (JCR) launched the first fully-approved allogeneic regenerative medicine in Japan, TEMCELL® HS Inj. (TEMCELL) for acute Graft Versus Host Disease (aGVHD) in children and adults in Q3 FY2016.  MESO reported a Q3/16 net loss of -$16.9 M, or -$4.49 per share, compared to a net loss of -$22.2 M or -$7.00 per share for Q3/15.  Recommendation :  HOLD

Hold

Northwest Bio (NWBO) – On 5/2/16, NWBO reached conceptual agreement with three different sets of unnamed parties, in regard to three different combination treatments, for three different cancers in three different P II trials. NWBO and these parties are completing agreements and budgets and pursuing regulatory approval for the trials. At the end of 2/16, NWBO entered into definitive agreements with current institutional investors for a registered direct offering with gross proceeds of up to approximately $27.6 M.  As part of the transaction, NWBO sold 5.88 million shares of common stock at a purchase price of $1.70 per share resulting in gross proceeds of $10 million.  The investors also received warrants to purchase up to approximately 2.94 million shares of common stock with an exercise price of $2.25 per share.  For Q1/16 NWBO reported a net loss of -$6.1 M, or -$0.06 per share, compared to a net loss of -$46.4 M or -$0.67 per share for Q1/15.  RECOMMENDATION:  HOLD

Hold

Spark Therapeutics (ONCE) --   On 5/19/2016 ONCE and Pfizer (NYSE: PFE) announced data from initial subjects in hemophilia b trial demonstrating consistent therapeutic levels of factor ix expression.  The data demonstrate that the first three subjects enrolled in the study experienced AAV-mediated Factor IX activity levels following one administration of SPK-9001 at the initial dose level (5 x 1011 vg/kg) studied in the trial.  Factor IX activity levels in the first two subjects, without prior history of liver disease, rose consistently through the first four weeks post-administration.  The first subject stabilized at 28% of normal at eighteen weeks, and the second subject at 30% of normal at seven weeks post-administration. Factor IX activity level in the third subject, with a history of liver disease, also rose consistently and was at 16% of normal at three weeks post-administration. Data from a natural history of patients with hemophilia suggest that circulating factor activity levels sustained at a threshold of greater than or equal to 12% of normal generally are considered to be sufficient to reduce the risk of joint bleeds and the need for prophylactic clotting factor infusions.  ONCE was also granted Orphan Product Designation for its first preclinical product candidate targeting neurodegenerative for the treatment of CLN2 disease (neuronal ceroid lipofuscinosis (NCL)) caused by TPP1 deficiency. CLN2 is a form of Batten disease.  For Q1/16 ONCE reported a net loss of -$10.4 M, or -$0.58 per share, compared to a net loss of -$25.6 M or -$0.95 per share for Q1/15.  RECOMMENDATION:  BUY

Buy

Organovo Holdings (ONVO) – ONVO  opened on 3/1/16 at $2.30 and closed on 3/31 at $2.17.  This follows February’s open at $1.97 and January’s at $2.44.  For a year its “news” consists of management changes, announcements about conference presentations and financial data that are just not tickling the investors’ fancy.  Recommendation: HOLD

Hold

Opexa (OPXA) – OPXA’s  P2b clinical trial of Tcelna® (imilecleucel-T) in secondary progressive multiple sclerosis (SPMS) (Abili-T trial) is nearing completion. Top line data is expected in early Q4/16.  The final dose was administered to the last patient in 2/16 and approximately 98% of all patient visits have now been completed. The Abili-T clinical trial is being conducted at 35 clinical sites in the U.S. and Canada. Opexa has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for Tcelna in SPMS.  For Q1/16 OPXA reported a net loss of -$2.1 M, or -$0.31 per share, compared to a net loss of -$3.4 M or -$0.95 per share for Q1/15.  RECOMMENDATION:  BUY

 

 

Buy

Osiris Therapeutics (OSIR) – On 5/2, OSIR announced results from “A Retrospective, Single-Center,Non-Randomized, Cross-Sectional Comparative Effectiveness Study Evaluating Surface Area Reduction, Volume Reduction and Closure Rates in Acute and Chronic Wounds Managed with Grafix versus (MiMedx) EpiFix.”  In turn, MDXG launched legal proceedings against OSIR claiming OSIR deliberately used inadequate clinical study standards to produce a biased report.  OSIR continues to file Notifications of Late Filing to the SEC.  RECOMMENDATIONHOLD

 

Hold

Pluristem (PSTI) – During Q3/16, PSTI received clearance from the U.S. Food and Drug Administration (FDA) to initiate a P1 study in patients suffering from insufficient hematopoietic recovery following hematopoietic cell transplant. PSTI was also notified by The National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. National Institutes of Health (NIH), that it will initiate studies in large animals to evaluate the dosing of PLX-R18 for the treatment of ARS. The first NIAID study is expected to start in the second quarter of 2016.  PSTI also received two patents and licensed another patent from Tokyo University that covers the treatment of ischemic diseases with placental cell therapy in Japan.   Japan’s Pharmaceuticals and Medical Devices Agency cleared the protocol for the trial which could lead to conditional marketing approval of PLX-PAD in the treatment of critical limb ischemia.  For Q3/16 PSTI reported a net loss of -$17 M, or -$0.21 per share, compared to a net loss of -$19.4 M or -$0.28 per share for Q1/15.  RECOMMENDATIONHOLD

Hold

Stemline (STML) -- STML opened on 3/1/16 at $4.89 and closed on 3/31 at $4.66.  This follows February’s open at $5.01 and January’s at $6.23.  On 3/14, STML reported FY/15 earnings that showed its loss widened to $37.2 M, or $2.15 per share. Revenue was reported as $654 K.  Shares in STML have dropped 16% since the beginning of the FY16 and have dropped 67% in the last 12 months.  Recommendation:  HOLD

 

 

Hold

Vericel (VCEL) – During Q1/16, VCEL received U.S. Food and Drug Administration (FDA) approval of its Epicel Humanitarian Device Exemption (HDE) supplement, which revised the Epicel label to include pediatric patients and specify the probable benefit, mainly related to survival, for adult and pediatric patients.  It allows VCEL to sell Epicel for profit on up to 360,400 grafts per year.  During the quarter, VCEL also submitted a Biologics License Application for MACI for the treatment of cartilage defects of the knee, which was accepted for review by the FDA with a PDUFA goal date of January 3, 2017.  VCEL also entered into a $10 M credit facility and $5 M term loan agreement with Silicon Valley Bank to access low-cost, non-dilutive capital.  VCEL reported a Q1/16 net loss of -$2 M or -$0.08 per share, compared to a Q1/15 net loss of -$4.5 M, or -$0.19 per share.  RECOMMENDATIONBUY

Buy

Verastem (VSTM) --   In March 2016, VCEL announced a clinical trial collaboration agreement with Pfizer (NYSE: PFE) and Merck (NYSE: MRK) to evaluate the combination of VSTM’s focal adhesion kinase (FAK) inhibitor VS-6063 and PFE /MRK’s anti-PD-L1 immunotherapy avelumab. VSTM previously reported initial signs of clinical activity in patients with ovarian cancer when VS-6063 is used in combination with paclitaxel. Under the terms of the agreement, the parties will conduct a planned P1/1b clinical trial evaluating escalating doses of the combination of VS-6063 and avelumab as a potential treatment option for patients with advanced ovarian cancer.  VCEL reported a Q1/16 net loss of -$8.3 M or -$0.22 per share, compared to a Q1/15 net loss of -$15.2. M, or -$0.46 per share.  RECOMMENDATIONBUY

Buy

VistaGen (VTGN) – On 5/11/16, VTGN’s common stock began trading on NASDAQ under the symbol ‘‘VTGN”.  VTGN also announced pricing of its public offering of 2,352,942 shares of common stock and warrants to purchase up to 2,352,942 shares of common stock, at a combined price of $4.25 for aggregate gross proceeds of approximately $10.0 M. The warrants will have an exercise price of $5.30, are exercisable immediately, and will have a term of five years.   RECOMMENDATION:  BUY

Buy

Intrexon (NYSE: XON) – During Q1/16, XON’s subsidiary Oxitec announced receipt of a special temporary registration from the National Health Surveillance Agency of Brazil (Anvisa) to deploy its genetically engineered mosquito, OX513A, known as 'Friendly Aedes aegypti', throughout the country. The World Health Organization's Vector Control Advisory Group also issued a positive recommendation for planned pilot deployment of Oxitec's self-limiting mosquito (OX513A) under operational conditions.  Additionally the Pan American Health Organization offered to provide technical support for pilot studies of OX513A as part of its response to the Zika epidemic.  In the United States, the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine published a preliminary finding of no significant impact (FONSI) on Oxitec's self-limiting OX513A Ae. aegypti mosquito for an investigational trial in the Florida Keys.  Finally, the Cayman Islands Mosquito Research and Control Unit (MRCU) plans to utilize Oxitec's solution for suppression of wild populations of Ae. aegypti to help reclaim the island from this disease-carrying pest.  The program follows a successful trial of Oxitec's mosquito in the Cayman Islands that reduced Ae. aegypti by 96%.  XON reported a Q1/16 net loss of -$65.3 M or -$0.55 per share, compared to a Q1/15 profit of +$25.8 M or +$0.26 per share.  RECOMMENDATIONBUY

 

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