BioShares Biotechnology Clinical Trials (BBC): $22.04, -$0.11, +19.7% YTD

BioShares Biotechnology Products (BBP): $37.48, +$0.00, +14.4% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures pointed to a mixed open on Friday as traders digested the release of a stronger-than-expected jobs report. The U.S. economy added 211,000 jobs last month. Economists polled by Reuters expect the U.S. economy to have added 185,000 jobs last month versus 98,000 in March. Average hourly earnings rose 0.3 percent and the unemployment rate fell to 4.4 percent.

 

 

MARKET HIGHLIGHTS

 

Mirati Therapeutics reported financial results for the first quarter 2017.  Net loss for the first quarter of 2017 was $17.8 million, or $0.73 per share basic and diluted, compared to net loss of $21.9 million, or $1.13 per share basic and diluted for the same period in 2016.  In January 2017, the Company completed a public offering of common stock and pre-funded common stock warrants that generated net proceeds of $66.8 million.  Cash, cash equivalents, and short-term investments were $105.5 million at March 31, 2017, compared to $56.7 million at December 31, 2016.  The Company expects that its currently available cash, cash equivalents and short-term investments are sufficient to fund operations into late 2018.

 

Zogenix announced financial results for the first quarter ended March 31, 2017.  Total net loss for the first quarter ended March 31, 2017 was $21.3 million, or $0.86 per share, compared with a net loss of $10.4 million, or $0.42 per share, in the first quarter ended March 31, 2016.  At March 31, 2017, the Company had cash and cash equivalents of $80.1 million.  The Company believes that it has sufficient funds to support operations into the first half of 2018.

 

Rockwell Medical will hold a conference call to discuss first quarter 2017 financial results on Tuesday, May 9th at 4:30pm Eastern Time.

 

iCAD announced researchers will present new clinical data supporting use of the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® for the treatment of endometrial and cervical cancer at the 36th Congress of the European Society for Radiotherapy & Oncology (ESTRO) in Vienna, Austria, from May 5-9, 2017. The Company will also showcase the multi-platform Xoft System and its suite of products at its booth (#4330) throughout the meeting.

 

Achaogen announced that it has signed an agreement with the Bill & Melinda Gates Foundation (the Gates Foundation) to partner in efforts to prevent neonatal sepsis in developing countries through the generation of monoclonal antibodies against gram-negative bacteria. Neonatal sepsis, a bacterial bloodstream infection (BSI) in newborn babies, causes approximately 345,000 deaths per year worldwide.

 

Rexahn Pharmaceuticals announced that the Company’s previously announced 1-for-10 reverse split (the “Reverse Stock Split”) of its common stock (the “Common Stock”) became effective today prior to the opening of trading on the NYSE MKT, and that the Common Stock will begin trading on a split-adjusted basis at the opening of trading today.

 

Gemphire Therapeutics will host a key opinion leader lunch to discuss the evolving nonalcoholic steatohepatitis (NASH) landscape in New York City on Tuesday, May 9 from 12:00pm – 1:30pm Eastern Time.

 

Altimmune announced the completion of its merger with PharmAthene, effective May 4, 2017. Upon the completion of the merger, the combined company was renamedAltimmune, and will commence trading on The NASDAQ Capital Market under the ticker symbol “ALT” on May 5, 2017. The combined company is a fully integrated and diversified immunotherapeutics company with one preclinical-stage and four clinical-stage drug-development programs.

 

Alnylam Pharmaceuticals reported 1Q17 GAAP EPS loss of $1.25, which compares to a loss $1.21 for the same period a year ago. The company beat the GAAP EPS mean estimate loss of $1.26. Total revenue for 1Q17 was $19.0 million, which compares to $7.3 million for the same period a year ago. This compares to a mean estimate of $23.6 million.

 

After yesterday’s close, BioMarin Pharmaceuticals reported 1Q17 GAAP EPS loss of $0.09, which compares to a loss of $0.51 for the same period a year ago. The company beat the First Call GAAP EPS mean estimate loss of $0.29. Total revenue for 1Q17 was $303.7 million, which compares to $236.7 million for the same period a year ago. This compares to a mean estimate of $288.9 million

 

After yesterday’s close, Juno Therapeutics reported 1Q17 GAAP EPS loss of $0.79, which compares to a $0.72 loss for the same period a year ago. The company missed the GAAP EPS mean estimate loss of $0.65. Total revenue for 1Q17 was $19.3 million, which compares to $9.8 million for the same period a year ago. This compares to a mean estimate of $13.5 million. Following Juno’s earnings, BTIG analyst Dane Leone decreased his price target to $11.20 from $23; FBR analyst Ed White decreased his price target to $29 from $30. 

 

After yesterday’s close, Ultragenyx Pharmaceuticals reported 1Q17 GAAP EPS loss of $1.63 which compares to a loss of $1.35 for the same period a year ago. The company beat the GAAP EPS mean estimate loss of $1.70. There was no revenue reported for 1Q17 compared to no revenue for the same period last year. Following Ultragenyx’searnings, Leerink analyst Joseph Schwartz decreased his price target to $89 from $93; Piper Jaffray analyst Joshua Schimmer decreased his price target to $67 from $70; JP Morgan analyst Cory Kasimov decreased his price target to $92 from $106.

 

Zafgen announced positive topline data from its Phase I clinical trial of ZGN-1061, the Company’s second generation MetAP2 inhibitor. ZGN-1061 demonstrated rapid drug absorption and clearance in line with pre-specified criteria established for the molecule, and was well-tolerated and safe, with no evidence of prothrombotic effects. Patients in the clinical trial experienced mean weight loss of up to approximately one pound per week.

 

Seattle Genetics announced that it has agreed to terminate its license agreement withImmunomedics for sacituzumab govitecan (IMMU-132) and settle the related litigation. The license agreement had not yet closed due to legal action brought by an Immunomedics stockholder challenging the transaction. The termination and settlement remain subject to court approval.

 

On April 28, 2017, Dr. Robert Charnas, Senior Vice President, Regulatory Affairs and Project Management, notified Puma Biotechnology that he will be resigning for health reasons effective May 15, 2017.

 

Syros announced new data generated using its gene control platform, including the discovery of 14 new drug targets in triple negative breast cancer. These discoveries demonstrate the power of Syros’ pioneering approach for systematically analyzing regulatory regions of the genome to identify novel targets for defined subsets of patients with diseases that have eluded other genomics-based approaches. These data were presented at the IMPAKT 2017 Breast Cancer Conference in Brussels, Belgium.

 

Mallinckrodt confirmed enrollment of the first patient in the company’s Phase II study assessing the safety, tolerability and efficacy of Stratagraft regenerative skin tissue as an alternative to autografting full-thickness complex skin defects.

 

Ovid Therapeutics announced that it has priced its initial public offering of 5,000,000 shares of its common stock at a public offering price of $15.00 per share, for an aggregate offering of $75 million, before underwriting discounts, commissions and expenses. In addition, Ovid Therapeutics has granted the underwriters a 30-day option to purchase up to 750,000 additional shares of common stock at the initial offering price to cover over-allotments, if any. The common stock will begin trading on The NASDAQ Global Select Market on May 5, 2017 under the trading symbol "OVID." The offering is expected to close on May 10, 2017, subject to customary closing conditions. Citigroup and Cowen are acting as joint book-running managers for the offering, andWilliam Blair and JMP Securities are acting as co-managers for the offering.

 

Acerus Pharmaceuticals announced that it has appointed Mr. Ken Yoon to the position of Chief Financial Officer. Mr. Yoon will officially join Acerus on June 1, 2017.

 

Merck announced that the EC has approved KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV. The approval allows marketing of KEYTRUDA in all 28 EU member states plus Iceland, Lichtenstein and Norway, at the approved dose of 200 mg every three weeks until disease progression or unacceptable toxicity.

 

GlaxoSmithKline and Innoviva announced positive results from the innovative Salford Lung Study (SLS) in asthma, carried out amongst 4,233 patients treated by their own General Practitioner in everyday clinical practice. This open-label, randomized study showed that significantly more asthma patients initiated on treatment with Relvar Ellipta 100/25mcg or 200/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) achieved an improvement in their asthma control compared with patients who continued to take their usual care medicines. Usual care treatment included inhaled corticosteroids (ICS) administered as monotherapy or as ICS/LABA (Long Acting Beta Agonist) combinations.

 

Teva Pharmaceutical Industries announced that data suggests that women with relapsing forms of multiple sclerosis (RMS) who were exposed to COPAXONE 20 mg/mL daily during pregnancy are not at higher risk for congenital anomalies compared to reference rates for abnormal pregnancy outcomes reported in two large databases representing the general population.

 

Aclaris Therapeutics announced it has completed a Phase I clinical trial of ATI-50001, an investigational oral Janus Kinase (JAK) 1/3 inhibitor. Aclaris is developing ATI-50001 as a treatment for patients with alopecia areata (AA), including the more severe forms of AA that result in total scalp hair loss, known as alopecia totalis, and total hair loss on the scalp and body, known as alopecia universalis. This Phase I cross-over trial was conducted in 12 healthy volunteers at one investigational center in the United States to assess the safety, bioavailability, and pharmacodynamics of ATI-50001. In the trial, treatment with ATI-50001 capsules was well tolerated, with a safety profile similar to placebo. No clinically significant laboratory abnormalities were observed. These data are consistent with results from an earlier Phase I clinical trial in 44 healthy volunteers conducted by Rigel Pharmaceuticals in which the study drug was well tolerated at all doses, with a safety profile similar to placebo.

 

Immunomedics delivered several business and leadership updates and outlined a new strategic plan to drive long-term value for stockholders. These updates include the termination of the previously announced Exclusive Global Licensing Agreement withSeattle Genetics, returning full rights of Sacituzumab Govitecan (“IMMU-132”), the Company’s breakthrough therapy candidate to treat metastatic triple-negative breast cancer (mTNBC), to Immunomedics. Immunomedics also announced that it has raised $125 million in gross proceeds in a private placement of its Series A-1 Convertible Preferred Stock with institutional investors, and has taken a series of steps to drive positive organizational and operational changes.

 

Aptevo Therapeutics announced that it presented information on the Company’s ADAPTIR protein therapeutic platform at the 13(th) Annual Protein Engineering (PEGS Summit) in Boston, May 1-4, 2017. Dr. Peter Pavlik, Principal Scientist at Aptevo, presented a detailed overview of the unique features of the ADAPTIR platform and portfolio of candidates differentiating Aptevo’s ADAPTIR technology from other bispecific approaches.

 

AmpliPhi Biosciences announced the pricing of an underwritten public offering of 6,956,522 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof), and common warrants to purchase up to an aggregate of 6,956,522 shares of common stock. Each share of common stock and, as applicable, pre-funded warrant is being sold together with a common warrant to purchase one share of common stock at a combined effective price to the public of $1.50 per share and accompanying common warrant. For each pre-funded warrant AmpliPhi sells, the number of shares of common stock AmpliPhi is offering will be decreased on a one-for-one basis. The common warrants will be immediately exercisable at a price of $1.50 per share of common stock and will expire five years from the date of issuance. The shares of common stock or the pre-funded warrants, and the accompanying common warrants, can only be purchased together in the offering but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about May 10, 2017, subject to customary closing conditions. Rodman & Renshaw, a unit of H.C. Wainwright & Co., is acting as the sole book-running manager for the offering.

 

 

ANALYST RECOMMENDATIONS

 

Raymond James analyst Reni Benjamin increased his price target of Keryx Biopharmaceuticals to $9 from $7, citing the recent strong growth of Auryxia scripts as well as the addition of Auryxia to the formularies of the nation’s two large Medicare Part D providers.

 

Cantor analyst Elemer Piros initiated coverage of Versartis with an “overweight” rating and $34 price target, citing somavaratan, Versartis’ long-acting growth hormone (GH) therapy, is well positioned to achieve a successful Phase 3 readout in pediatric growth hormone deficiency, based on the totality of data generated from Versartis’ clinical programs and historical registries of daily GH therapies.

 

BMO analyst Ian Somaiya initiated coverage of Coherus Biosciences with an “outperform” rating and $54 price target, citing Coherus’ lead asset, CHS-1701, a biosimilar to Neulasta, can achieve blockbuster sales of $1.6bn in febrile neutropenia based on the potential of a first-to-market advantage.

 

UBS analyst Ami Fadia initiated coverage of Alder Biopharmaceuticals with a “sell” rating and $13 price target, citing the stock already reflects an expectation for positive Phase 3 data for eptinezumab (first Phase 3 reports in 2Q17) and a timely launch in 2H19 with consensus sales >$1B in 2025, well above our est. of $400M.

 

Following Regeneron’s earnings, Canaccord analyst John Newman upgraded the stock to “buy” from “hold” and increased his price target to $484 from $375; Bank of America analyst Ying Huang increased his price target to $512 from $502; Barclays analyst Geoff Meacham increased his price target to $400 from $375; Goldman analyst Terence Flynn increased his price target to $455 from $417.

 

William Blair analyst John Kreeger upgraded Catalent to “outperform” from “market perform,” citing an encouraging fiscal third-quarter earnings release on Thursday afternoon, May 4.

 

Bank of America analyst Tazeen Ahmad initiated coverage of Neurocrine with a “buy” rating and $70 price target. 

 

Following Juno’s earnings, BTIG analyst Dane Leone decreased his price target to $11.20 from $23; FBR analyst Ed White decreased his price target to $29 from $30.

 

Raymond James analyst Reni Benjamin decreased his price target of InVivo to $6 from $10, citing the company revealed that two patients who originally improved from an AIS A spinal cord injury to an AIS B SCI have recently reverted back to AIS A.