BioShares Biotechnology Clinical Trials (BBC): $23.15, -$0.30, +25.7% YTD

BioShares Biotechnology Products (BBP): $37.99, -$0.41, +16.0% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures fell as investors booked profits on the last trading day of the month and quarter. Consumer spending and University of Michigan’s sentiment data are on the radar. European shares traded lower, as losses among miners and a slump in insurer Old Mutual weighed in. Asian stocks dipped. The dollar rose, benefitting from a weaker euro, while gold slipped. Oil prices fell as growing U.S. crude stockpiles posed a threat to OPEC-led production cuts.

 

 

MARKET HIGHLIGHTS

 

Transgene will present a poster entitled “Local and abscopal effects in oncolytic virotherapy are boosted by immune checkpoint blockade, immunogenic chemotherapy, or IFNAR blockade” with new and encouraging preclinical data of a next generation armed engineered oncolytic virus at the American Association for Cancer Research annual meeting in Washington, DC.

 

Catalyst Biosciences announced receipt of notice from the European Patent Office that the opposition period for a patent granted to Catalyst has expired and no opposition has been filed.

 

NEOVACS announced its full-year 2016 financial results.  The Company’s net loss amounted to €13.9 million in 2016, compared with €4.7 million recorded in the previous year.  At December 31, 2016, Neovacs had €3.9 million in cash. 

 

Windtree Therapeutics today reported financial results for the fourth quarter ended December 31, 2016.  The Company reported a net loss of $6.6 million ($0.77 per basic share) on 8.5 million weighted-average common shares outstanding for the quarter ended December 31, 2016, compared to a net loss of $10.1 million ($1.26 per basic share) on 8.1 million weighted average common shares outstanding for the comparable period in 2015.  As of December 31, 2016, the Company had cash and cash equivalents of $5.6 million.

 

BioDelivery Sciences International announced that two important new patents were granted extending patent protection around all three of its FDA approved products, BELBUCA® (buprenorphine) buccal film, BUNAVAIL® (buprenorphine and naloxone) buccal film, and ONSOLIS® (fentanyl buccal soluble film), further strengthening BDSI’s overall intellectual property position.

 

Kiadis Pharma N.V. announces its audited annual results for the year ended December 31, 2016.  The net loss for the year decreased to €14.8 million in 2016 from €16.5 million in 2015.  The cash position decreased to €14.6 million at year-end 2016 compared to €28.7 million at the end of 2015. This is mainly due to the cash used in operating activities in 2016.

 

Mateon Therapeutics announced that updates on several of its preclinical programs are being presented at the American Association for Cancer Research (AACR) annual meeting in Washington, D.C.

 

Valneva Chief Executive Thomas Lingelbach was featured in an article in New Scientist entitled Lyme Disease is Set to Explode and We Still Don’t Have a Vaccine.

 

The Medicrea Group published its 2016 IFRS annual results.  The Company reported a net loss of €7.6M for the year ended December 31, 2016, compared to a net loss of €1.5M in prior year period.  Available cash amounted to €8 million at December 31,2016.

 

Akari Therapeutics announced that the FDA has granted Fast Track designation for Coversin for treatment of paroxysmal nocturnal hemoglobinuria (PNH) in patients who have polymorphisms conferring eculizumab resistance. Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing the release of C5a and the formation of C5b–9 (also known as the membrane attack complex or MAC), and independently also inhibits LTB4 activity.

 

Incyte and Merck announced additional details of their clinical development program investigating the combination of epacadostat, Incyte’s investigational oral selective IDO1 enzyme inhibitor, with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients across five tumor types: metastatic melanoma, non-small cell lung cancer (NSCLC), bladder cancer, renal cell carcinoma (RCC), and squamous cell carcinoma of the head and neck (SCCHN).

 

Mesoblast announced that the Independent Data Monitoring Committee (IDMC) for the ongoing Phase III trial in chronic heart failure (CHF) has initiated the process for the pre-specified interim futility analysis of the trial’s efficacy endpoint. The interim analysis dataset has been locked and will be analyzed and reviewed by the trial’s independent statisticians. Throughout this review process, Mesoblast will remain blinded to individual treatment allocation as well as grouped safety and efficacy data.

 

Novocure announced that the last patient has been enrolled in the STELLAR trial, a Phase II pilot trial testing Tumor Treating Fields (TTFields) in combination with either pemetrexed and cisplatin or carboplatin in patients with newly diagnosed, unresectable malignant mesothelioma. The final data collection date will be 12 months after the last patient in.

 

AstraZeneca announced that the FDA has granted full approval for TAGRISSO (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy. TAGRISSO is the first and only approved medicine in the US indicated for NSCLC patients who have tested positive for the EGFR T790M mutation, and efficacy data suggest it may be a new standard of care for these patients.

 

China Cord Blood Corporation announced that Ms. Yue Deng, Chief Executive Officer of the Company’s Beijing subsidiary, has resigned from the Company, effective April 1, 2017. Ms. Deng’s departure is for personal reasons and does not reflect any disagreements between Ms. Deng and the Company. The Board of Directors has named Ms. Ting Zheng, Chief Executive Officer of CCBC, to serve as interim Chief Executive Officer of the Beijing subsidiary upon Ms. Deng’s departure.

 

miRagen Therapeutics announced that the FDA has granted orphan-drug designation to miRagen’s product candidate, MRG-106, for the treatment of mycosis fungoides. Mycosis fungoides is the most common form of a type of blood cancer called cutaneous T-cell lymphoma (“CTCL”). CTCL occurs when certain types of T-cells become cancerous and cause debilitating tumors in the skin and in other parts of the body.

 

Emergent BioSolutions announced that it has signed a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) to manufacture and store bulk drug substance for its botulism antitoxin, BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)], valued at approximately $53 million with a five-year period of performance. This modification to the contract will enable future filling and deliveries of final drug product to the Strategic National Stockpile (SNS). BAT is indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients.

 

FibroGen announced the approval by the CFDA of the Company’s clinical trial application (CTA) in China for a Phase II/III pivotal trial of roxadustat in anemia associated with lower risk myelodysplastic syndromes (MDS). FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat in China, the U.S., and other major markets. FibroGen is conducting all clinical trials and regulatory submissions in both the U.S. and China, and will retain all regulatory licenses and manufacturing permits in China.

 

Impax Laboratories announced that Judge Richard G. Andrews of the U.S. District Court, District of Delaware, has found that the U.S. patents 6,750,237 and 7,220,767 protecting Zomig (zolmitriptan) Nasal Spray are not invalid and are infringed by the Lannett Holdings and Lannett Company ANDA . 

 

Johnson & Johnson announced that its Swiss subsidiary, Janssen Holding GmbH, published the provisional notice of the interim result of its all-cash public tender offer in Switzerland to acquire all publicly held shares of Actelion for $280 per share, payable in U.S. dollars, per the offer prospectus of February 16, 2017.

 

argenx announced the dosing of the first patient in a Phase II proof-of-concept study of ARGX-113 in patients with primary immune thrombocytopenia (ITP).

 

Cara Therapeutics announced the pricing of its underwritten public offering of 4,450,000 shares of its common stock at a public offering price of $18.00 per share. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by Cara Therapeutics, are expected to be approximately $80 million. In addition, Cara Therapeutics granted the underwriters a 30-day option to purchase up to 667,500 additional shares of its common stock on the same terms and conditions. The proceeds of the offering are expected to be used to fund the company’s clinical and research development activities, including the completion of the Phase III program for I.V. CR845 in uremic pruritus, two Phase III trials of I.V. CR845 in acute pain and a Phase IIb trial of oral CR845 in osteoarthritis pain, as well as for working capital and general corporate purposes.  Piper Jaffray & Co. and Stifel are acting as joint book-running managers for the offering. Canaccord GenuityNeedham & CompanyJanney Montgomery Scott and H.C. Wainwright & Co. are acting as co-managers.

 

BioLineRx announced that it has priced an underwritten public offering of approximately 29.4 million American Depositary Shares ("ADSs"), each representing one (1) of its ordinary shares, at a public offering price of $0.85 per ADS for gross proceeds of $25 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by BioLineRx. All of the ADSs in the offering are to be sold by BioLineRx.  Delivery of the ADSs is expected to occur on April 5, 2017, subject to customary closing conditions.  BioLineRx has granted the underwriters a 30-day option to purchase up to an additional approximately 4.4 million ADSs at the public offering price. BioLineRx anticipates using the net proceeds from the offering to fund a number of clinical trials, including for BL-8040 and AGI-134, and for working capital and general corporate purposes. JMP Securities acted as sole book-running manager for the offering. H.C. Wainwright & Co., LLC acted as lead manager. Maxim Group acted as co-manager.

 

CytoSorbents announced the pricing of an underwritten public offering of 2,222,222 shares of its common stock at a public offering price of $4.50 per share, representing gross proceeds of approximately $10.0 million. In addition, CytoSorbents has granted the underwriters a 30-day over-allotment option to purchase up to 333,333 additional shares of common stock at the public offering price.  The offering is expected to close on or about April 5, 2017, subject to customary closing conditions. The company intends to use the net proceeds from this offering for general corporate and working capital purposes, including advancing its U.S. pivotal trial for treatment of inflammation in conjunction with cardiac surgery. Cowen and Company is acting as the sole book-running manager and representative of the underwriters for the offering.  Aegis CapitalH.C. Wainwright & Co.B. Riley & Co.Maxim Group LLC and Northland Capital Markets are acting as co-managers for the offering.

 

Dicerna Pharmaceuticals announced that it has signed a stock purchase agreement with a syndicate of current and new investors, led by Bain Capital Life Sciences, for the sale of redeemable convertible preferred stock for gross proceeds of $70.0 million. Other participants in the financing include EcoR1 Capital, Cormorant Asset Management, RA Capital, Domain Associates and Skyline Ventures, among others. Under the terms of the stock purchase agreement, upon closing of the Preferred Stock transaction, Adam M. Koppel, M.D., Ph.D., a managing director of Bain Capital Life Sciences, will be named to the Company’s Board of Directors, increasing the membership to nine. The Company intends to use the proceeds from the offering to further develop its GalXC pipeline programs, including both pre-clinical and clinical work, as well as for general corporate purposes. The transaction is expected to close on or before April 11, 2017, subject to the satisfaction of customary closing conditions.

 

 

ANALYST RECOMMENDATIONS

 

Maxim analyst Jason Kolbert increased his price target on BrainStorm Cell Therapeutics to $8 from $6, citing the company has taken strategic steps to begin Phase 3 clinical trials of NurOwn in ALS.

 

Raymond James analyst Reni Benjamin initiated coverage of the following companies:BioTime with an “outperform” rating and $6 price target; MacroGenics with an “outperform” rating and $26 price target.

 

Needham analyst Chad Messer initiated coverage of Exelixis with a “buy” rating and $28 price target, citing with two approvals now under its belt, and several more to come, Exelixis looks poised to turn profitable.

 

Credit Suisse analyst Erin Wilson Wright initiated coverage of Quintiles with an “outperform” rating and $89 price target, citing Q is the world’s largest contract research organization (CRO) and healthcare information & technology services company with solutions that uniquely span the clinical development and commercial drug lifecycle.

 

Mizuho analyst Irina Koffler initiated coverage of Dermira with a “buy” rating and $42 price target, citing an innovative dermatology "biotech" that may serve as a 2018 takeout target in a sector that has recently become more exciting with the entry of multiple large-cap pharma companies.

 

Maxim analyst Jason McCarthy upgraded Vertex to “buy” from “hold” and established a $143 price target, citing positive data from two pivotal studies of tezacaftor/ ivacaftor (tez/iva) in F508del homozygotes (EVOLVE) and in the first of two studies in heterozygotes (EXPAND, F508del/residual CFTR).

 

Credit Suisse analyst Vamil Divan increased his price target of Alkermes to $78 from $72, citing higher Vivitrol forecasts following meetings with management.

 

Chardan analyst Gbola Amusa initiated coverage of GenSight Biologics with a “buy” rating and €35 price target based on the opportunity likely addressed by GS010, a Phase III AAV-based gene therapy (GT) for a rapidly-progressing form of blindness, LHON.

 

Chardan analyst Gbola Amusa decreased his price target of Adverum Biotechnologies to $3.50 from $5, citing an updated model. 

 

Jefferies analyst Anthony Petrone increased his price target of Antares Pharma to $6 from $3, citing expectations of positive catalysts over next 24 months.