BioShares Biotechnology Clinical Trials (BBC): $22.74, +$0.21, +23.5% YTD

BioShares Biotechnology Products (BBP): $37.06, +$0.28, +13.2% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed ahead of U.S. President Donald Trump’s first significant policy test, as he looks to get a healthcare bill passed in U.S. congress. New home sales, jobless claims and Kansas City Fed manufacturing data are slated for release. European shares pared earlier losses as markets took the latest terror attack in London largely in their stride, while Asian stocks closed higher. Gold futures fell, while the dollar edged higher. Oil prices rebounded, after touching their lowest level since November overnight, on data that showed U.S. crude inventories grew more than expected.

 

 

MARKET HIGHLIGHTS

 

Advaxis today announced the European Medicines Agency (EMA) issued an advanced therapy medicinal product certificate for manufacturing quality and non-clinical data.  The certification procedure involved a thorough scientific evaluation over several months of the quality (CMC) data and non-clinical data by the EMA’s Committee for Advanced Therapies (CAT).  After a positive opinion from CAT, EMA issued a certificate confirming that the CMC and non-clinical data comply with the standards that apply for evaluating the Marketing Authorization Application (MAA) of axalimogene filolisbac for the treatment of metastatic cervical cancer.  Advaxis is now positioned to file the complete MAA in the second half of 2017.

 

Aeglea BioTherapeutics announced topline data from a Phase 1 open-label study evaluating the safety and tolerability of its lead product candidate, AEB1102, for patients with Arginase I deficiency. The poster, entitled “Initial Results of a Phase I Open-Label Study of AEB1102 Enzyme Replacement Therapy in Adult Patients with Arginase I Deficiency” (Abstract #809), will be presented today at the 2017 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting being held in Phoenix, Arizona.

 

Eiger BioPharmaceuticals announced financial results for the three months and full year ended December 31, 2016.  Net loss for the fourth quarter of 2016 was $12.8 million, or $1.53 per share basic and diluted, compared to a net loss of $7.1 million, or $25.78 per share basic and diluted for the fourth quarter of 2015. Net loss for the year ended December 31, 2016 was $47.1 million, or $7.84 per share basic and diluted, compared to a net loss of $13.3 million, or $62.19 per share basic and diluted for the year ended December 31, 2015.  As of December 31, 2016, Eiger had cash, cash equivalents and short term marketable securities of $59.9 million, compared to $4.8 million at December 31, 2015. The increase was primarily attributable to cash received from investors and Celladon in connection with our merger with Celladon which closed March 22, 2016. Also during 2016 were the $20.0 million in gross proceeds from a common stock offering that was completed in August and in December gross proceeds of $15.0 million from the first tranche of our debt agreement with Oxford.

 

La Jolla Pharmaceutical announced the pricing of an underwritten public offering of approximately 3.7 million shares of common stock, offered at a price of $33.50 per share, for gross proceeds of $125 million. In addition, La Jolla has granted the underwriters a 30-day option to purchase up to an additional 559,700 shares of common stock. The offering is expected to close on or about March 28, 2017, subject to customary closing conditions. La Jolla intends to use the net proceeds from the offering for general corporate purposes, including funding its ongoing and future clinical trials of its drug candidates, expenses relating to the potential regulatory approval of LJPC-501, potential future acquisitions, and general and administrative expenses. J.P. Morgan Securities LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering. SunTrust Robinson Humphrey, Chardan, and LifeSci Capital LLC are acting as lead managers for the offering.

 

Cellect Biotechnology announced financial results for the fourth quarter and full year ended December 31, 2016.  Net loss for the fourth quarter and for the full year of 2016 was $0.75 million and $3.98 million respectively, or $0.007 per share for the fourth quarter and $0.044 per share for the year of 2016 respectively, compared to $0.96 million, or $0.012 per share, in the fourth quarter and $2.65 million, or $0.035 per share for the full year of 2015.  Cash and cash equivalents (including marketable securities and short terms deposits) totaled $8.0 million as of December 31, 2016, compared to $9.4 million on September 30, 2016, and $3.1 million on December 31, 2015. The change compared to December 31, 2015 was primarily due to net proceeds of $7.6 million (after deducting underwriters’ fees) raised through the IPO in the U.S., priced on July 29, 2016, and additional net proceeds of approximately $2.0 million raised through a private placement completed in March 2016, offset by cash used in operations during the year.

 

Valneva SE reported today its fourth quarter and full year financial results ending December 31, 2016.  Valneva’s aggregate revenues and grants in the full year 2016 increased to €97.9 million from €83.3 million in 2015. This increase was mainly a result of strong growth of IXIARO®/JESPECT® product sales.  Valneva’s net loss for the year 2016 was €49.2 million. Excluding the one-time impairment charges related to the Pseudomonas project, Valneva’s net loss amounted to €15.1 million compared to a net loss of €20.6 million for the year 2015.  Liquid funds on December 31, 2016 stood at €42.2 million compared to €42.6 million on December 31, 2015 and consisted of €35.3 million in cash and cash equivalents and €6.9 million in restricted cash.

 

CTD Holdings has begun recruiting patients at Children’s Hospital & Research Center Oakland for the Company’s Phase I clinical study in the U.S. that will evaluate the intravenous administration of Trappsol® Cyclo™ in patients with Niemann-Pick Disease Type C (NPC), a rare and fatal genetic disease that impacts the brain, lung, liver, spleen, and other organs. Dr. Caroline Hastings, Pediatric Hematologist Oncologist at UCSF Benioff Children’s Hospital Oakland, is the Principal Investigator for the U.S. study. The U.S. clinical study will require 12 patients to be fully enrolled.

 

Insys Therapeutics announced that the DEA has issued an interim final rule that would result in Syndros (dronabinol oral solution) being placed in Schedule II of the Controlled Substances Act.

 

Egalet announced the issuance of new U.S. and international patents for Egalet’s proprietary Guardian Technology.

 

Ultragenyx Pharmaceutical announced topline data from the Phase II study of UX007 in glucose transporter type-1 deficiency syndrome (Glut1 DS) patients with seizures. The study did not meet the primary endpoint of reducing the frequency of total number of observable and absence seizures among patients treated from baseline to Week 8 with UX007 compared to placebo. When evaluating each seizure type independently, treatment with UX007 did show a reduction in absence seizures captured on EEG, but not observable seizures captured by diary. Following the news, Citi analyst Yigal Nochomovitz decreased his price target to $56 from $67; Canaccord analyst Arlinda Lee decreased her price target to $100 from $103; HC Wainwright analyst Carol Ann Werther decreased her price target to $88 from $105; Wedbush analyst David Nierengarten decreased his price target to $80 from $88; Credit Suisse analyst Kennen MacKay decreased his price target to $86 from $90; Piper Jaffray analyst Steven Breazzano downgraded the stock to “neutral” from “overweight” and decreased his price target $70 from $96.

 

Alexion Pharmaceuticals announced that it has submitted an application to Japan’s Ministry of Labour and Welfare (MHLW) to extend the indication for Soliris (eculizumab) as a potential treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. The submission is supported by comprehensive data from the Phase III REGAIN study.

 

Regeneron Pharmaceuticals announced a major research initiative among the Regeneron Genetics Center (RGC), U.K. Biobank and GSK to generate genetic sequence data from the 500,000 volunteer participants in the U.K. Biobank resource. The initiative will enable researchers to gain valuable insights to support advances in the development of new medicines for a wide range of serious and life threatening diseases.

 

Reuters reported that U.S. lawmakers sent a letter to PTC Therapeutics, seeking information about the drugmaker’s pricing strategy for its recently acquired muscle-wasting disorder drug. PTC said last week that it would buy Marathon Pharmaceuticals’s recently approved Duchenne muscular dystrophy drug (DMD), Emflaza, and promised to re-examine the hefty U.S. price tag for the treatment, known generically as deflazacort. Marathon did not invent deflazacort and patients in the U.S had been able to import it for as little as $1,000, but lost that option after Emflaza’s controversial U.S. approval in February.

 

InVivo Therapeutics Holdings announced that Health Canada has approved the company’s Investigational Testing Authorization application to commence a clinical study of the Neuro-Spinal Scaffold in patients with acute, complete (AIS A) cervical (C5-T1) spinal cord injuries (SCIs). InVivo currently is in late stage conversation with several site Research Ethics Boards and expects to announce its first Canadian site in the coming weeks.

 

Regen BioPharma provided an update on the status of its medicinal chemistry program being conducted by ChemDiv for the optimization of its lead compounds, RG-NA01, RG-NA02, RG-NI01 and RG-NI02. These compounds are small molecules and consist of activators (RG-NA01 and RG-NA02) and inhibitors (RG-NI01 and RG-NI02) of NR2F6. They were identified using Regen’s patented screening methodology and unique chemical libraries.

 

Galectin Therapeutics announced that trading will be halted in GALTW and GALTU at close of business on March 23, 2017 due to the expiration, on March 28, 2017, of certain publicly traded warrants that were issued in March 2012. The Company’s common stock, GALT, will not be affected and will continue to trade on the Nasdaq market. GALTU are units that were sold in March 2012 that consist of two shares of GALT common stock and one warrant. Unit holders had the right at any time to separate each GALTU unit into two shares of GALT common stock and one publicly traded warrant, and most unit holders exercised that right.  GALTW are the free-standing warrants that were separated from the units. Unit holders who did not previously separate their units may now exchange each unit for two shares of GALT common stock.

 

ImmunoCellular Therapeutics and Memgen announced the signing of a non-binding letter of intent to exclusively negotiate the terms  to possibly establish an immuno-oncology strategic collaboration focused on conducting clinical trials combining the companies’ respective cancer immunotherapy product candidates. The discussions pertain to ImmunoCellular’s dendritic cell (DC)-based immunotherapy product candidates, ICT-107 and ICT-140, and Memgen’s ISF35, a viral cancer immunotherapy encoding an optimized version of CD40 ligand. Combining DC-based and viral oncology immunotherapeutic approaches could provide a novel way to stimulate CD40 to possibly induce a potent, specific and effective anti-tumor response. Insights from these combination trials, if successful, could also lead to later combination trials with other immune-oncology technologies, including checkpoint inhibitors.

 

Stemline Therapeutics announced that enrollment of Stage III in the SL-401 pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN) has been completed. The company also reviewed key milestones for the SL-401 program over the coming year.

 

Citius Pharmaceuticals announced that it has recently concluded negotiations to add South America to its worldwide license for Mino-Lok.  South America was the only territory that was not included in the original sub-license between Novel Anti-Infective Technologies, an affiliate of MD Anderson Cancer Center ("MDACC"), and Leonard-Meron Biosciences, a wholly owned subsidiary of Citius Pharmaceuticals, Inc.

 

Merrimack Pharmaceuticals announced the enrollment of its first patient in a Phase I study of MM-310 in solid tumors. MM-310 is an antibody-directed nanotherapeutic (ADN) that encapsulates a novel taxane and targets the EphA2 receptor, a protein which surveys suggest is overexpressed in 50-100% of many major tumor types, including prostate, ovarian, bladder, gastric, pancreatic and lung cancers.

 

BioLineRx announced that it has acquired Agalimmune, a private UK-based company with an innovative, anti-cancer immunotherapy platform. Acquisition consideration consisted of a $6 million upfront payment, of which $3 million is in cash and the remainder in BioLineRx shares. Additional future payments may be made based on development and commercial milestones.

 

Arrowhead Pharmaceuticals announced that on March 21, 2017 it entered into a stockholder rights agreement in accordance with an authorization and declaration from its board of directors of a dividend distribution of one preferred share purchase right on each outstanding share of the company’s common stock. The rights agreement is intended to ensure that all of the company’s stockholders receive fair and equal treatment and realize the long-term value of their investment in the company in the event of any proposed takeover of the company and to guard against abusive tactics to gain control of the company without paying all stockholders a premium for that control. The rights plan was not adopted in response to any specific attempt to acquire the company.

 

Origent Data Sciences and Cytokinetics announced the advancement of their research collaboration to prospectively validate Origent’s computer model to predict the course of ALS (amyotrophic lateral sclerosis) disease progression using data from VITALITY-ALS, Cytokinetics’ ongoing Phase III clinical trial of tirasemtiv. Funded by a grant from The ALS Association to Origent, this joint research program is designed to enable the first prospective validation of the predictive model in a clinical trial. Previously, the Origent models predicting both function and survival of ALS patients have been validated using the placebo arms of retrospective clinical trial datasets.

 

HEAT BIOLOGICS announced the pricing of an underwritten public offering of 5,000,000 shares of its common stock at a public offering price of $0.80 per share. The gross proceeds to Heat from this offering are expected to be $4,000,000 before deducting underwriting discounts and commissions and other estimated offering expenses payable by Heat. Heat intends to use the proceeds from this offering to continue to fund its and its subsidiaries’ preclinical and clinical programs, for working capital and general corporate purposes, as well as to acquire, license or invest in complementary businesses, technologies, product candidates or other intellectual property.  Heat has granted the underwriters a 45-day option to purchase up to 750,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about March 28, 2017, subject to customary closing conditions. Aegis Capital Corp. is acting as the sole book-running manager for the offering.

 

Zosano Pharma announced the closing of the previously announced public offering of 19,550,000 shares of its common stock at a price of $1.50 per share, which includes the exercise in full by the underwriters of their over-allotment option to purchase up to 2,550,000 additional shares of common stock. The gross proceeds to Zosano from this offering are approximately $29.3 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Zosano. Zosano intends to use the net proceeds of the proposed offering to fund the manufacture of its lead product candidate, M207, in sufficient quantities to support its long term safety study and associated regulatory activities necessary to file for product approval, and to fund a portion of the long term safety study itself. Piper Jaffray & Co. and Guggenheim Securities acted as joint book-running managers for the offering.

 

Bellicum Pharmaceuticals announced that it has commenced an underwritten public offering of 5,000,000 shares of its common stock. Bellicum expects to grant the underwriters of the offering a 30-day option to purchase up to an additional 750,000 shares of its common stock at the public offering price, less the underwriting discounts and commissions. Citigroup and Jefferies are acting as lead book-running managers for the offering.

 

Tyme Technologies announced that Ben Taylor has been appointed President and CFO, effective April 3, 2017.

 

 

ANALYST RECOMMENDATIONS

 

Societe Generale analyst Florent Cespedes made revisions to the following companies: upgraded AbbVie to “hold” from “sell” and increased his price target to $65 from $49; Bristol-Myers Squibb to $40 from $44.20; Eli Lilly to $86 from $71; GlaxoSmithKline to 1,300p from 1,320p; Johnson & Johnson to $126 from $116; Merck & Co. to $90 from $85; Novo Nordisk to DKK200 from DKK220; Pfizer to $36 from $34; Roche to CHF330 from CHF315; Sanofi to €100 from €96.

 

Leerink analyst Paul Matteis increased his price target of the following companies, citing due diligence in conjunction with a CNS whitepaper: Alkermes to $68 from $64 and Sage to $90 from $82.

 

Mizuho analyst Irina Koffler decreased her price target of Paicra to $54 from $59, citing dilution associated with the recent convertible debt offering.