BioShares Biotechnology Clinical Trials (BBC): $21.18, -$0.51, +15.0% YTD

BioShares Biotechnology Products (BBP): $37.61, -$0.32, +14.8% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed, while the dollar rose ahead of minutes from the Federal Reserve’s latest meeting that may shed some light on the central bank’s interest rate strategy. Shares of Hewlett-Packard, Tesla Motors and Transocean will be in focus as they report quarterly results after the closing bell. Existing home sales data occupies the economic calendar. Solid corporate results helped the European shares hit a 14-month high and Asian stocks ended the day higher. Oil prices slipped, while gold steadied.

 

MARKET HIGHLIGHTS

 

Foamix Pharmaceuticals announced financial results for the year ended December 31, 2016.  Total revenues were $5.5 million, compared with $849,000 for the twelve months ended December 31, 2015.  Net loss for the year ended December 31, 2016 was $29.3 million, or 91 cents per basic and diluted share, compared to $16.5 million, or 58 cents per basic and diluted share for the year ended December 31, 2015.  Cash, cash equivalents, short and long-term investments as of December 31, 2016 totaled $131.0 million, compared to approximately $103.8 million as of December 31, 2015. The increase was mostly due to the $54.1 million dollars, net of commission and expenses, raised in the follow-on offering, which closed on September 30, 2016, offset by the operating expenses we incurred during the year.  The Company estimates that existing cash and investments provide sufficient financial flexibility to finance clinical and business operations into 2019.

 

OSE Immunotherapeutics SA has been invited to present its SIRP-α antagonist OSE-172 (Effi-DEM), and its main preclinical results at the 24th Molecular Med TRI-CON 2017 Meeting, session “Cancer Immunotherapy” in San Francisco (CA) on February 20-22, 2017.  OSE-172 (Effi-DEM) is a humanized monoclonal antibody targeting SIRP-α expressed on suppressive cells involved in the tumor micro-environment (Myeloid cells, named Myeloid Derived Suppressive Cells and Tumor Associated Macrophages).

 

TRACON Pharmaceuticals will report its fourth quarter and full year 2016 financial and operating results after the close of U.S. financial markets on Tuesday, February 28, 2017.

 

VBI Vaccines announced today that the Biologics and Genetic Therapies Directorate (BGTD) of Health Canada expressed its general support and acceptance of the company’s development path for its Sci-B-Vac™ vaccine, a prophylactic vaccine against hepatitis B, in a pre-Clinical Trial Application ("CTA") meeting. A complete CTA must be filed with and approved by BGTD, and all conditions of BGTD must be met, prior to the initiation of a clinical program in Canada.

 

Paratek Pharmaceuticals will host a conference call and live audio webcast on Thursday, March 2, 2017 at 8:30 AM ET to report fourth quarter and full year 2016 financial results and provide a corporate update.

 

TxCell announced the completion of its capital increase through the issue of new shares with share warrants attached with shareholders’ preferential subscription rights.  The offer has been subscribed at 100% and raised €11 million in gross proceeds. It led to the issuance of 5,549,300 New Shares with Warrants at a unit price of €2.00.

 

United Therapeutics reported 4Q16 GAAP EPS of $2.43, which compares to $2.10 for the same period a year ago. The company missed the GAAP EPS mean estimate of $3.68. Total revenue for 4Q16 was $409.0 million, which compares to $404.9 million for the same period a year ago. This compares to a mean estimate of $415.5 million.

 

After yesterday’s close, Ironwood reported 4Q16 GAAP EPS loss of $0.09, which compares to a $0.10 loss for the same period a year ago. The company beat the GAAP EPS mean estimate loss of $0.20. Total revenue for 4Q16 was $87.5 million, which compares to $53.3 million for the same period a year ago. This compares to a mean estimate of $76.9 million. Following Ironwood’s earnings, Goldman analyst Jami Rubin increased her price target to $17.50 from $16.50; Cowen analyst Boris Peaker increased his price target to $20 from $16; Barclays analyst Geoffrey Meacham increased his price target to $16 from $13.

 

Argos Therapeutics announced that the Independent Data Monitoring Committee (IDMC) for the company’s pivotal Phase III ADAPT clinical trial of rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of metastatic renal cell carcinoma (mRCC) has recommended that the study be discontinued for futility based on its planned interim data analysis. The IDMC concluded that the study was unlikely to demonstrate a statistically significant improvement in overall survival in the combination treatment arm, utilizing the intent-to-treat population, the primary endpoint of the study. The IDMC noted that rocapuldencel-T was generally well-tolerated in the trial. In conjunction with its clinical and scientific advisors, the company is analyzing the preliminary ADAPT trial data set and plans to discuss the data with the FDA. The company plans to leave the ADAPT trial open while the company conducts its ongoing data review and discussions with FDA. Based on these analyses and discussions, the company will make a determination as to the next steps for the rocapuldencel-T clinical program.

 

Amgen announced that the EC has adopted a decision to change the Repatha (evolocumab) marketing authorization, approving a new single-dose delivery option. The new automated mini-doser (AMD) with a pre-filled cartridge is a hands-free device that provides 420 mg of Repatha in a single injection per administration. Repatha is the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in Europe with the option of a single monthly injection. Repatha is a human monoclonal antibody that blocks a protein called PCSK9, which inhibits the body’s natural system for eliminating "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood.

 

Alimera Sciences and Knight Therapeutics announced that Knight’s NDS for ILUVIEN has been accepted for review by Health Canada. ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is Alimera’s sustained release intravitreal implant approved in the U.S. to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

 

Ocular Therapeutix announced that the company’s NDA resubmission for DEXTENZA (dexamethasone insert) 0.4 mg for intracanalicular use, for the treatment of ocular pain occurring after ophthalmic surgery has been accepted as a filing for review by the FDA. DEXTENZA is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days. The FDA determined that the NDA resubmission is a complete response and designated the resubmission as a Class 2 review, with a target action date under the PDUFA of July 19, 2017 for the potential approval of DEXTENZA.

 

Neuralstem announced that U.S. Patent No. 9572807 was issued by the USPTO for NSI-189, the lead compound in Neuralstem’s neurogenic small molecule program in development for the treatment of major depressive disorder. US 9,572,807 has claims to protocols for using NSI-189 and related compounds for treatment of major depressive disorder.  Counterparts have been filed in Australia, Canada, Europe, Japan, Singapore and South Korea.  These patents will expire in June 2035.

 

Delcath Systems announced that the American Journal of Clinical Oncology has published a single-center retrospective review, in which authors found that investigational PHP with Melphalan/HDS offers promising results with a doubling of overall survival and significantly longer progression-free survival (PFS) and hepatic progression-free survival (HPFS) than other targeted therapies. Percutaneous hepatic perfusion (PHP) is a minimally invasive procedure that isolates the liver from the body’s circulatory system, so that a high dose of chemotherapy (melphalan hydrochloride) may be infused directly into the liver. Blood from the liver is then filtered to remove the chemotherapeutic agent thereby minimizing systemic exposure.

 

Chimerix announced the presentation of final data from the AdVise trial of brincidofovir for the treatment of adenovirus (AdV) infection in allogeneic hematopoietic cell transplant (HCT) recipients at the BMT Tandem Meetings held February 22-26, 2017 in Orlando, FL.

 

Aldeyra Therapeutics announced that it has developed and launched the Aldeyra Registry for Sjögren-Larsson Syndrome (SLS), a rare inborn error of aldehyde metabolism that is characterized by severe skin and neurological disease. The Aldeyra Registry for SLS is designed to unite SLS patients worldwide, and to raise awareness of the significant physical challenges associated with the disease.

 

XBiotech announced that all subjects have been dosed in its pharmacokinetic (PK) study evaluating MABp1 half-life in healthy volunteers. This Phase I study will provide further PK data and will enable additional characterization of the PK of MABp1 at a 7.5mg/kg IV dose. Safety and tolerability will also be assessed. PK analyses at various time points ranging from pre-infusion to 336 hours post infusion will be collected. The study is on schedule to be completed as planned for the Company’s upcoming regulatory submission.

 

Immune Design announced that the FDA has granted Orphan Drug Designation for its investigational intratumoral therapy, G100, for the treatment of follicular non-Hodgkin’s lymphoma.

 

Global Blood Therapeutics announced the pricing of its upsized underwritten public offering of 5,102,041 shares of its common stock at a price to the public of $24.50 per share. The gross proceeds to GBT from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $125.0 million. The offering is expected to close on or about February 27, 2017, subject to customary closing conditions. In addition, GBT has granted the underwriter a 30-day option to purchase up to 765,306 additional shares of its common stock. Cantor Fitzgerald is the sole book-running manager for the offering.

 

Aytu BioScience announced the expansion of its U.S. sales team to up to 42 account managers from 35 currently, a 20% increase in the company’s commercial footprint.

 

NeuroVive Pharmaceutical AB announced two new research agreements and the appointment of Professor Philippe Gallay, PhD, and Professor Massimo Pinzani, MD, PhD, FRCP, as scientific advisors. The aim of the agreements is to further explore NeuroVive’s new drug compounds in development for the treatment of NASH and hepatocellular carcinoma (HCC).

 

Soligenix announced that its proprietary formulation of synthetic hypericin has been granted a European patent for the treatment of psoriasis.  The issued patent, EP 2571507, Formulations and methods of treatment of skin conditions, complements the method of treatment claims covered by the previously issued US patent 6001882, Photoactivated hypericin and the use thereof.

 

ChromaDex announced that University of Iowa researchers have published a study in the prestigious Journal of the International Association for the Study of Pain (PAIN) showing that NIAGEN Nicotinamide Riboside (NR) ameliorates chemotherapy-induced peripheral neuropathy (CIPN) in an animal model. Results from this study suggest that NR may be an effective therapy in relieving chemotherapy induced peripheral neuropathy (CIPN) in humans.

 

ProMetic Life Sciences announced positive results from its completed open label Phase II clinical trial in subjects suffering from idiopathic pulmonary fibrosis. In addition to demonstrating that PBI-4050 is safe and very well tolerated, an objective of this study was to seek early evidence of a clinical benefit with PBI-4050 treatment, whether administered alone or in addition to either of the drugs approved for the treatment of IPF, nintedanib or pirfenidone. These results confirm the preliminary results previously announced by Prometic on November 17, 2016, following the first 30 subjects’ completion of 12 weeks of treatment.

 

Lannett Company announced that it was notified by FDA late yesterday afternoon that FDA suspended indefinitely the deadline for the Company to submit materials in support of its request for a hearing to consider FDA’s proposal that Lannett withdraw its ANDA for Methylphenidate ER.

 

ImmusanT announced the completion of a Phase Ib clinical trial evaluating the safety and tolerability of Nexvax2 in celiac disease. The trial met its objectives and identified a Phase II dose regimen.

 

Cellectar Biosciences announced the successful completion of Cohort 3 and initiation of Cohort 4 in the company’s Phase I clinical study of CLR 131 in patients with relapsed and refractory multiple myeloma.

 

Inspyr Therapeutics announced the initiation of the second development program for Mipsagargin as part of a combination therapeutic approach. This new program is focused on the treatment of gastric cancer.

 

venBio Select Advisor sent a letter to Immunomedics stockholders in connection with venBio’s nomination of four highly-qualified candidates — Scott Canute, Peter Barton Hutt, Dr. Khalid Islam, and Dr. Behzad Aghazadeh — for election to the Company’s Board of Directors (the "Board") at the upcoming 2016 Annual Meeting of Stockholders, which is currently scheduled to be held on March 3, 2017.

 

Cancer Genetics announced that it has received approval for a $1.0 million gross tax credit from the New Jersey Technology Business Tax Certificate Transfer (NOL) Program. After expenses and fees, the company has received over $950,000 in net cash as a result of the tax credit transfer during the first quarter of 2017.

 

Auris Medical Holding announced the closing of its previously announced public offering of 10,000,000 common shares and 10,000,000 warrants, each warrant entitling its holder to purchase 0.70 of a common share. The warrants are exercisable for five years. The common shares and warrants were sold in units comprised of one common share and one warrant at a public offering price of $1.00 per unit. Net proceeds to the Company from the sale of the units were approximately $9.1 million. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. The Company also announced the closing of the sale of an additional 1,350,000 warrants pursuant to the underwriter’s partial exercise of its 30-day option to purchase up to 1,500,000 additional common shares and/or 1,500,000 additional warrants at the public offering price less underwriting discounts.  Roth Capital Partners acted as sole book-running manager in the offering. Maxim Group acted as a financial advisor in the offering.

 

Galena Biopharma announced that the Company’s Board of Directors appointed Stephen F. Ghiglieri as Interim Chief Executive Officer, effective immediately. Mr. Ghiglieri will also continue to serve as the Company’s Chief Financial Officer.

 

Acasti Pharma announced the concurrent closing of its previously announced public offering of units and its previously announced private placement of convertible debentures and warrants, for aggregate gross proceeds of approximately CAD$7,700,000. Acasti intends to use the net proceeds from the Offering and Private Placement to fund completion of its manufacturing scale-up and the clinical and regulatory planning and preparations necessary to be ready to enroll the first patient in the Phase III clinical trial for CaPre (omega-3 phospholipid), Acasti’s lead product candidate and for intellectual property expansion, business development activities, general and administration expenses, and working capital.

 

 

ANALYST RECOMMENDATIONS

 

LifeSci Capital analyst Jerry Isaacson initiated coverage on BioInvent, citing the company’s novel therapeutics for difficult-to-treat cancers with its antibody discovery platform.

 

Following Momenta’s earnings, Leerink analyst Jason Gerberry downgraded the stock to “market perform” from “outperform” and decreased his price target to $18 from $20; JP Morgan analyst Chris Schott decreased his price target to $19 from $20.

 

Wells Fargo analyst Jim Birchenough initiated coverage of the following CAR-T companies: Juno with an “overweight” rating and $34-$36 valuation range; Kite with a “market perform” rating and $52-$54 valuation range.

 

Oppenheimer analyst Leah Rush Cann increased her price target of Amgen to $189 from $175, citing recently reported label expansion filings and FDA approvals.

 

HC Wainwright analyst Ed Arce decreased his price target of Cidara Therapeutics to $18 from $25, citing Cidara has discontinued further development of topical CD101 for VVC.

 

Following Exact Sciences’ earnings, Roth analyst Chris Lewis upgraded the stock to “buy” from “neutral” and increased the price target to $26 from $15; Jefferies analyst Brandon Couillard increased his price target to $25 from $23; Baird analyst Catherine Ramsey increased her price target to $26 from $22; Canaccord analyst Mark Massaro increased to $27 from $24.

 

HC Wainwright analyst Carol Ann Werther downgraded Sage Therapeutics to “neutral” from “buy” and increased her price target to $76 from $56, citing an unfavorable risk/reward in shares ahead of upcoming STATUS trial results.

 

Wedbush analyst Robert Driscoll assumed coverage of Sierra Oncology with an “outperform” rating and increased his price target to $4 from $3, citing significant potential for SRRA’s newly licensed Chk1 inhibitor SRA737 across multiple cancer indications.

 

Aegis analyst Jason Wittes initiated coverage of TG Therapeutics with a “buy” rating and $26 price target, citing the company has two lead oncology drug candidates in Phase III trials: TG-1101 (a monoclonal antibody that targets a unique epitope on the B-lymphocyte CD20 antigen) and TGR-1202 (a PI3K delta inhibitor that has shown significantly better toxicity profile than competing PI3K inhibitors).

 

Canaccord analyst Dewey Steadman initiated coverage of the following companies: Pacira Pharmaceuticals with a “buy” rating and $55 price target; Perrigo with a “buy” rating and $100 price target; Endo International with a “hold” rating and $14 price target; Mallinckrodt with a “buy” rating and $91 price target.

 

Roth analyst Scott Henry downgraded ANI Pharmaceuticals to “neutral” from “buy,” citing concerns with the recent market share decline for the EEMT franchise.