BioShares Biotechnology Clinical Trials (BBC): $23.53, +$0.20, +27.8% YTD

BioShares Biotechnology Products (BBP): $38.26, +$0.05, +16.8% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed on the first trading day of an event-packed week, with investors focusing on a potential Federal Reserve interest rate hike, Dutch elections and the G20 finance ministers’ meeting. European shares were mostly higher as gains among miners helped offset weaker energy stocks. Asian equities gained, with Japan’s Nikkei Index hitting a 15-month closing high. The greenback rose against a basket of currencies. Oil prices slipped to a three-month low as U.S. oil rig count increased, while gold edged up.

 

 

MARKET HIGHLIGHTS

 

Minerva Neurosciences reported financial results for the fourth quarter and fiscal year ended December 31, 2016.  Net loss was $9.4 million for the fourth quarter of 2016, or a loss per share of $0.27 (basic and diluted), compared to a net loss of $8.4 million for the fourth quarter of 2015, or a loss per share of $0.34 (basic and diluted).  Net loss was $31.0 million for the year ended December 31, 2016, or a loss per share of $0.99 (basic and diluted), compared to a net loss of $27.1 million, or a loss per share of $1.16 (basic and diluted), for the year ended December 31, 2015.  Cash, cash equivalents and marketable securities as of December 31, 2016 were approximately $83.0 million, compared to $32.2 million as of December 31, 2015.  During 2016, the Company received approximately $23.4 million in proceeds from the exercise of warrants granted in connection with a private placement in March 2015, approximately $1 million from a common stock purchase by a director of the Company, and net proceeds of approximately $53.7 million from a public offering of common stock.  Minerva presently expects that its existing cash and cash equivalents will be sufficient to meet its anticipated capital requirements for at least the next 12 months from today.

 

Bellerophon Therapeutics reported financial results for the fourth quarter and full year ended December 31, 2016.  For the full year ended December 31, 2016, the Company reduced its net loss to $23.8 million, from $46.5 million in the full year ended December 31, 2015. Net loss per share was reduced to $1.58 in the full year 2016 compared to $3.79 in the prior year.  At December 31, 2016, the Company had cash and cash equivalents, restricted cash and marketable securities of $20.5 million compared to cash and cash equivalents, restricted cash and marketable securities of $24.5 million at December 31, 2015.  

 

TiGenix NV announced top-line one-year results from the CAREMI clinical trial, an exploratory Phase I/II study of AlloCSCs in acute myocardial infarction (AMI).  CAREMI is the first-in-human clinical trial with the primary objective being safety and evaluating the feasibility of an intracoronary infusion of 35 million of AlloCSCs in patients with AMI and left ventricular dysfunction treated within the first week post-AMI.  The main findings of this study are: All safety objectives of the study have been met. No mortality or major cardiac adverse events (MACE) have been found at 30 days meeting the primary end-point of the study. Moreover no mortality and MACE have been found at 6 months or 12 months follow-up; Of particular relevance to this allogeneic approach, no immune-related adverse events have been recorded at one-year follow-up; and, A larger reduction in infarct size was found in one pre-specified subgroup associated with poor long-term prognosis and representing more than half of the patient population of the randomization phase of the study. This finding has revealed valuable insight, and provides a specific direction for potential studies in a targeted subset of high-risk patients.

 

Innate Pharma SA announced that its partner Bristol-Myers Squibb has amended the clinical trial protocol for its ongoing Phase I/II trial evaluating the safety and tolerability of lirilumab in combination with Opdivo in patients with advanced refractory solid tumors. Under the amended protocol, updated on clinicaltrials.gov, the study will expand in scope to include additional cohorts of Opdivo plus lirilumab in solid tumors, including a randomized cohort exploring Opdivo with or without lirilumab in platinum refractory recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), and initial testing of the triplet combination of Opdivo, Yervoy and lirilumab in solid tumors.

 

Advaxis will present a corporate overview at the 2017 Barclays Global Healthcare Conference on Tuesday, March 14 @ 8:30amET.

 

BioTime announced the expansion of its ongoing Phase I/IIa clinical trial for OpRegen® in the advanced dry form age-related macular degeneration (dry-AMD) by naming the first two sites that will treat patients in the U.S.

 

Gemphire Therapeutics will release fiscal year ended December 31, 2016 financial results on Wednesday, March 15 after the market close, and host a conference call at 4:30pm Eastern Time to review the company’s progress and answer questions. Gemphire is also announcing a poster presentation from a Phase 2 clinical trial with gemcabene in obese patients at the forthcoming American College of Cardiology 66th Annual Scientific Session (ACC), taking place in Washington, D.C., March 17-19.

 

Heat Biologics announced that the company achieved the efficacy endpoint for its Phase Ib trial evaluating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), for the treatment of non-small cell lung cancer (NSCLC) and that the trial met the expansion criteria to advance into a Phase II.  In reviewing the Phase Ib data, the Data Monitoring Committee (DMC) determined that the Phase Ib safety endpoint was met and that there do not appear to be additional toxicities seen in the HS-110/nivolumab combination compared to existing data on nivolumab alone.  Furthermore, 5 out of 15 patients treated with the HS-110/nivolumab combination had 20% or greater tumor reduction.  The DMC concluded that the positive safety profile, mechanistic evidence and encouraging signs of synergistic efficacy warranted expansion to a Phase II trial.

 

Fate Therapeutics announced that the FDA has cleared an investigational new drug application for FATE-NK100, the Company’s first-in-class adaptive memory natural killer (NK) cell product candidate. The Company expects a first-in-human clinical trial of FATE-NK100 for advanced acute myeloid leukemia (AML) to open enrollment at the Masonic Cancer Center, University of Minnesota following approval of the Center’s institutional review board.

 

Amgen announced positive top-line results from a Phase III study evaluating Repatha (evolocumab) in patients who were receiving apheresis to reduce low-density lipoprotein cholesterol (LDL-C). The study met its primary endpoint, demonstrating that treatment with Repatha significantly reduced the need for LDL-C apheresis in adult patients, as measured at the end of the randomized period. The study also met its secondary endpoints of percent change from baseline to week 4 in LDL-C, non-high-density lipoprotein cholesterol (non-HDL-C) and total cholesterol:HDL-C ratio.

 

Karyopharm Therapeutics announced that it has received written notice from the FDA that its clinical trials for selinexor (KPT-330) have been placed on partial clinical hold. While the partial clinical hold remains in effect, patients with stable disease or better may remain on selinexor therapy. No new patients may be enrolled until the partial clinical hold is lifted. The FDA has indicated that the partial clinical hold is due to incomplete information in the existing version of the investigator’s brochure (IB), including an incomplete list of serious adverse events (SAEs) associated with selinexor. At the FDA’s request, Karyopharm has amended the IB and updated the informed consent documents accordingly and has submitted such documents to the FDA as requested.  The partial clinical hold is not the result of any patient death or any new information regarding the safety profile of selinexor.

 

Agios Pharmaceuticals announced that Celgene has designated the development candidate focused on MTAP (methylthioadenosine phosphorylase) deleted cancers as a development candidate under the master research and collaboration agreement dated May 17, 2016. Under the terms of the Agreement, Celgene will pay Agios an $8 million designation fee for the MTAP pathway program. Exploratory research, drug discovery and early development on the MTAP pathway program is led by Agios, and Celgene will have an opt-in right on the program up through Phase I dose escalation for at least a $30 million fee. Upon opt-in, Celgene and Agios will have global co-development and co-commercialization rights with a worldwide 50/50 cost and profit share on the MTAP pathway program, and Agios will be eligible for up to $169 million in clinical and regulatory milestone payments.

 

Sunovion Pharmaceuticals announced that it has submitted a sNDA to the FDA to expand the indication for its antiepileptic drug (AED) APTIOM (eslicarbazepine acetate) to include use as monotherapy or adjunctive therapy for the treatment of partial-onset seizures (POS) in children four years of age and older.

 

Ipsen announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, in coordination with fourteen other European regulatory agencies, has approved a new indication for Decapeptyl as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine-responsive early-stage breast cancer in women at high-risk of recurrence who are confirmed as pre-menopausal after completion of chemotherapy.

 

Clovis Oncology announced new data from parts 1 and 2 of the ongoing ARIEL2 Phase II study being presented today at the 2017 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer in National Harbor, MD.

 

TESARO announced two niraparib presentations at the 2017 Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, March 12 to 15, 2017, in National Harbor, Maryland.

 

Valeant Pharmaceuticals announced that it has obtained the requisite lender approval for the previously announced amendment of the Company’s existing credit agreement to facilitate the borrowing of new Term B loans that mature in 2022 in order to repay other term loans outstanding under the Credit Agreement that mature prior to 2022, remove the maintenance covenants from the Term B loans, modify the maintenance covenants under the revolving facility and modify certain other provisions of the Credit Agreement.

 

Mylan announced that Mylan has agreed to the terms of a global settlement with Genentech, Inc. and F. Hoffmann-La Roche Ltd. in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licenses for its trastuzumab product.

 

Sosei Group reported that its subsidiaries, Heptares Therapeutics  has announced that it have entered into a drug discovery and licensing agreement with Daiichi Sankyo focused on a single G protein-coupled receptor (GPCR) nominated by Daiichi Sankyo that plays a crucial role in relieving pain.

 

Cempra announced that the company has retained Morgan Stanley as financial advisor to the company and to lead its recently announced process to review strategic business options.

 

Myriad Genetics announced that it has launched the EndoPredict test in the United States for patients with ER+ HER2- early-stage breast cancer. EndoPredict is a second-generation test for assessing the 10-year risk of disease recurrence following surgery and for determining which patients can safely forgo adjuvant chemotherapy.

 

Aethlon Medical announced that the company has concluded an FDA-approved feasibility study designed to assess the safety of the Aethlon Hemopurifier in health-compromised individuals. The single-site study was conducted at DaVita Med Center Dialysis in Houston, Texas.

 

Zynerba Pharmaceuticals announced that it has completed enrollment in the Phase II STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial evaluating ZYN002 cannabidiol (CBD) gel in adult epilepsy patients with refractory focal seizures. The Company also announced that enrollment has completed in the Phase II STOP (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain due to Osteoarthritis) clinical trial evaluating ZYN002 CBD gel for the treatment of osteoarthritis.

 

Alimera Sciences announced that Alimera Sciences Limited, its European subsidiary based in London, has signed an exclusive agreement with Brill Pharma for distribution of ILUVIEN in the Kingdom of Spain, Alimera’s sustained release intravitreal injection for the treatment of diabetic macular edema.

 

FORMA Therapeutics announced the achievement of a clinical development milestone in their alliance with Boehringer Ingelheim. The partnership focuses on the discovery and development of novel drug candidates against protein-protein interactions for the treatment of cancer. Financial milestones payable to FORMA for this achievement have not been disclosed.

 

Elite Pharmaceuticals announced that it has initiated pharmacokinetic testing of its reformulated SequestOx.  The reformulated product is expected to have a shorter Tmax under fed conditions. Elite is conducting a bioequivalence study which is a pivotal, open-label, randomized, single-dose, three-way, crossover study to evaluate the relative comparative bioavailability and bioequivalence of the modified formulation of SequestOx™ to the original formulation of SequestOx and to a comparator product under fed conditions. The study has enrolled forty-five healthy volunteers and the first subjects have been dosed.

 

 

ANALYST RECOMMENDATIONS

 

Jefferies analyst Brian Abrahams assumed coverage of Xenon with a “buy” rating and $13 price target, citing their acne and pain programs collectively could generate $1.5B cumulative future royalties/milestones if successful, and a valuation overly discounts the promise of their pipeline and platform.

 

Goldman analyst Terence Flynn downgraded Bioverativ to “neutral” from “buy,” citing valuation.

 

Goldman analyst Terence Flynn upgraded Blueprint Medicines to “buy” from “neutral” and increased his price target to $52 from $35, citing expectations for a steady flow of read outs at conferences from the extension phases of the trials this year and clarity on potential registration paths for the drugs.

 

Credit Suisse analyst Kennen MacKay increased his price target of Incyte to $174 from $136, citing an attractive cash flow positive M&A target.

 

Janney analyst Ken Trbovich upgraded Acorda Therapeutics to “buy” from “neutral” and increased his fair value estimate to $38 from $23, citing Acorda received a positive decision from the Patent Trial Appeal Board (PTAB) regarding the inter-partes review of four of its patents protecting Ampyra.

 

Goldman analyst Terence Flynn decreased his price target of Gilead to $68 from $70, citing lower than-expected 2017 guidance for its hepC franchise.