BioShares Biotechnology Clinical Trials (BBC): $16.33, -$1.24, -43.8% YTD

BioShares Biotechnology Products (BBP): $28.09, -$0.96, -8.9% YTD

 

 

MARKET COMMENTARY

 

Wall Street looked set to open little changed on Friday as uncertainty about the outcome of the U.S. presidential election continued to weigh on investors’ minds. Data showing a strong pace of hiring in October had little impact on stock index futures ahead of the opening. Nonfarm payrolls increased by 161,000 jobs last month, below the 175,000 additions expected by economists polled by Reuters. Unemployment rate fell to 4.9 percent from 5.0 percent and average hourly earnings increased 0.4 percent in October after advancing 0.3 percent in September.

 

 

MARKET HIGHLIGHTS

 

TxCell SA announced the issue of a second tranche of notes convertible into shares for an amount of €2 million in nominal value, as part of the financing through the issuance of warrants giving access to Notes with share subscription warrants attached announced in TxCell’s press release dated June 17, 2016.

 

Aimmune Therapeutics announced that Nestlé Health Science will make a $145.0 million equity investment in Aimmune. Aimmune and Nestlé Health Science also entered into a strategic collaboration agreement designed to enable the successful development and commercialization of innovative food allergy therapies. Aimmune will retain all current and future pipeline assets developed with the CODIT approach, including AR101, the company’s investigational oral biologic desensitization therapy for peanut allergy, which is currently in Phase 3 clinical development.

 

Onconova Therapeutics announced that three abstracts relating to the Company’s lead product candidate, rigosertib were accepted for presentation at the 58th American Society of Hematology (ASH) Annual Meeting in San Diego, California, which takes place December 3-6, 2016.

 

Windtree Therapeutics announced that recently presented preclinical data at the 62nd Radiation Research Society Annual Meeting suggest that KL4 surfactant could potentially be an effective medical countermeasure to mitigate acute and chronic/late-phase radiation-induced lung injury (pneumonopathy) due to exposure from a nuclear accident or act of terrorism. The Company believes that, as a possible additional application, KL4 surfactant may also mitigate radiation pneumonopathy associated with cancer radiation therapy.

 

La Jolla Pharmaceutical Company reported financial results for the three and nine months ended September 30, 2016 and recent corporate progress.  La Jolla’s net loss for the three and nine months ended September 30, 2016 was $21.3 million and $53.3 million, or $1.23 per share and $3.10 per share, respectively, compared to a net loss of $10.5 million and $30.1 million, or $0.70 per share and $1.99 per share, respectively, for the same periods in 2015. As of September 30, 2016, La Jolla had $85.0 million in cash and cash equivalents, compared to $126.5 million as of December 31, 2015.  Based on current operating plans and projections, La Jolla believes that its current cash and cash equivalents are sufficient to fund operations into 2018.

 

TRACON Pharmaceuticals announced the following presentation at the upcoming Connective Tissue Oncology Society (CTOS) 2016 Annual Meeting in Lisbon, Portugal: TRC105 (Endoglin Antibody) in Combination with Pazopanib in Patients with Advanced Angiosarcoma.

 

BioTime reported financial results for the third quarter ended September 30, 2016, and recent therapeutic program progress.  For the third quarter of 2015, net loss attributable to BioTime was $14.0 million, or ($0.18) per share.  Cash and cash equivalents totaled $30.5 million as of September 30, 2016, compared to $42.2 million as of December 31, 2015.

 

Albireo Pharma announced the completion of the share exchange transaction between Biodel Inc. and Albireo Limited and its shareholders and noteholders, effective as of November 3, 2016.  The combined organization will be called Albireo Pharma, Inc. and will commence trading on The NASDAQ Capital Market on November 4, 2016 under the symbol “ALBO.”

 

Reuters reported that four patients have suffered serious adverse events in a clinical trial of an experimental hemophilia medicine from Roche, the Swiss group said, clouding prospects for its potential blockbuster product.  The problems relate to thrombosis, or blood clots, with two thromboembolic events and two cases of thrombotic microangiopathy in patients who were being treated for breakthrough bleeding in the trial of Roche’s ACE910.  Roche said additional monitoring had now been instigated in the study.

 

Reuters reported that two prominent U.S. lawmakers called on federal antitrust regulators on Thursday to probe whether Sanofi, Eli Lilly, Merck, and Novo Nordisk may have colluded to set the prices for insulin and other diabetes drugs. In a letter to the Justice Department and Federal Trade Commission, Vermont Independent Senator Bernie Sanders and Democratic Congressman Elijah Cummings of Maryland raised questions about the skyrocketing prices of insulin, and included a chart showing that many of the price spikes appeared to occur in tandem. "We believe this egregious behavior warrants a thorough investigation," they wrote.

 

Regeneron reported 3Q16 non-GAAP EPS of $3.13, which compares to $2.38 for the same period a year ago. The company beat the First Call non-GAAP EPS mean estimate of $2.71. Total revenue for 3Q16 was $1.22 billion, which compares to $1.14 billion for the same period a year ago. This compares to a mean estimate of $1.29 billion.

 

After yesterday’s close, Nektar Therapeutics reported 3Q16 GAAP EPS loss of $0.32, which compares to a loss of $0.06 for the same period a year ago. The company beat the First Call GAAP EPS mean estimate loss of $0.33. Total revenue for 3Q16 was $36.3 million, which compares to $60.0 million for the same period a year ago. This compares to a mean estimate of $32.9 million. Following earnings, JP Morgan analyst Jessica Fye decreased her price target to $18 from $19.

 

After yesterday’s close, Ligand Pharmaceuticals reported 3Q16 non-GAAP EPS of $0.62, which compares to $0.57 for the same period a year ago. The company beat the First Call non-GAAP EPS mean estimate of $0.59. Total revenue for 3Q16 was $21.6 million, which compares to $17.7 million for the same period a year ago. This compares to a mean estimate of $23.1 million.

 

After yesterday’s close, Tesaro reported 3Q16 GAAP EPS loss of $1.98, which compares to a loss of $1.66 for the same period a year ago. The company missed the First Call GAAP EPS mean estimate loss of $1.91. Total revenue for 3Q16 was $3.7 million, which compares to no revenue for the same period a year ago. This compares to a mean estimate of $4.4 million. Following earnings, Baird analyst Michael Ulz increased his price target to $127 from $120; SunTrust analyst Peter Lawson increased his price target to $145 from $130; FBR analyst Ed White increased his price target to $133 from $115; Raymond James analyst Christopher James downgraded the stock to “hold” from “strong buy.”

 

After yesterday’s close, Ironwood reported 3Q16 GAAP EPS loss of $0.23, which compares to a $0.33 loss for the same period a year ago. The company beat the First Call GAAP EPS mean estimate loss of $0.26. Total revenue for 3Q16 was $66.1 million, which compares to $39.6 million for the same period a year ago. This compares to a mean estimate of $68.6 million. Following earnings, Mizuho analyst Irina Koffler increased her price target to $20 from $19; Leerink analyst Jason Gerberry increased his price target to $15 from $14; Barclays analyst Geoffrey Meacham increased his price target to $13 from $12.

 

After yesterday’s close, Exelixis reported 3Q16 GAAP EPS loss of $0.04, which compares to a loss of $0.21 for the same period a year ago. The company beat the First Call GAAP EPS mean estimate loss of $0.12. Total revenue for 3Q16 was $62.2 million, which compares to $9.9 million for the same period a year ago. This compares to an estimate of $45.5 million.

 

After yesterday’s close, Spectrum Pharmaceuticals reported Q3 revenues were $33.4 million, including $30.3 million in product sales, with recently launched drug EVOMELA (melphalan) for injection contributing $5.9 million. The Company ended the quarter with Cash and Cash Equivalents of $171.9 million.

 

Cempra announced that NASDAQ has halted trading of the company’s common stock. The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) is meeting to discuss the safety and efficacy of solithromycin to treat community-acquired bacterial pneumonia (CABP).

 

Kura Oncology presented preclinical findings and data from the company’s ongoing Phase II trial in HRAS mutant solid tumors at the 9th European Scientific Oncology Conference (ESOC-9) in Marbella, Spain. Antonio Gualberto, M.D., Ph.D., chief medical officer, delivered a presentation titled, "Targeting the RAS-ERK Pathway."

 

Sanofi Genzyme announced that the first patient has been enrolled and received an infusion in a pivotal Phase III clinical trial named COMET for the investigational therapy neoGAA. NeoGAA is a second-generation enzyme replacement therapy being studied for the treatment of Pompe disease.

 

Depomed announced the introduction of a new formulation of CAMBIA (diclofenac potassium) for oral solution, that contains the sweetener sucralose, replacing the sweeteners saccharin sodium and aspartame. The new formulation, which was approved by the FDA, addresses some patient sensitivities towards certain sweeteners and is not as a result of any product safety concerns nor does it alter the efficacy profile of the product. CAMBIA with sucralose will be available following the dispensing of current inventories containing aspartame.

 

Nordic Nanovector ASA announced that the independent Safety Review Committee (SRC) for the ongoing Lymrit 37-01 clinical trial of Betalutin in relapsed/refractory NHL, has recommended escalating the dose of Betalutin in Arm 4 from 15 MBq/kg to 20 MBq/kg following pre-dosing with 100 mg/m2 lilotomab. Recruitment of 3 patients into Arm 4 to receive this new higher dosing regimen is now underway. The SRC also concluded that Arm 3 should be discontinued.

 

Omeros announced that it has completed the initial funding under its senior secured credit facility with affiliates of CRG LP consisting of an $80 million term loan. The company used approximately $76 million of the loan proceeds to repay its obligations under its previous credit facility and the remaining net proceeds will be used for general corporate purposes and working capital. With more favorable overall financial terms than the company’s previous credit facility, the CRG secured credit facility has a six-year term with at least four years of interest-only payments, which can be extended to maturity by meeting one of two pre-specified milestones. The restricted cash covenants of the new credit facility are significantly reduced from those of the previous facility, with Omeros now required to maintain no more than $5 million in cash and cash equivalents during the full term of the facility. With its initial draw of the CRG loan, together with funds on hand and current annualized OMIDRIA revenues and expenses, Omeros anticipates that it has at least 12 months of operating capital. By satisfying either revenue or market capitalization milestones, Omeros also has the option of drawing up to an additional $25 million through September 19, 2017 and up to an additional $20 million through March 21, 2018.

 

Spotlight Innovation announced that the USPTO issued to the Company’s subsidiary Celtic Biotech Iowa U.S. Patent No. 9,345,751, entitled "Crotalus Durissus Terrificus Venom Administration for Cancer Treatment." The patented invention relates to compositions isolated from rattlesnake venom ("Crotoxin") and methods for intravenous administration of Crotoxin to cancer patients.

 

TherapeuticsMD announced two new strategic hires: Dawn Halkuff as Chief Commercial Officer and Yulii Bogatyrenko as Senior Vice President of Business Development. Both executives bring women’s health experience and relevant skills to the company in advance of the potential launch of its first bio-identical hormone therapy drug candidate in the second half of 2017.

 

Innocoll Holdings announced that based on top-line data from its COACT-1 and COACT-2 Phase III clinical trials of COGENZIA (gentamicin collagen topical matrix) in patients  with moderate to severe diabetic foot infections administered in conjunction with systemic antibiotics and wound therapy, the standard of care (SOC), did not meet their primary endpoint of clinical cure of infection after 28 days versus either placebo plus SOC or SOC alone.

 

 

ANALYST RECOMMENDATIONS

 

Following Intercept’s earnings, Wedbush analyst Liana Moussatos decreased her price target to $224 from $239.  

 

Following Akorn’s earnings, RBC analyst Randall Stanicky downgraded the stock to “sector perform” from “outperform” and decreased his price target to $24 from $37.

 

Following Agios Pharmaceuticals’ earnings, Leerink analyst Michael Schmidt assumed coverage of the stock with a “market perform” rating and $56 price target; Janney analyst Debjit Chattopadhyay increased his fair value to $51 from $49; Goldman analyst Terence Flynn increased his price target to $48 from $46.

 

Chardan analyst Gbola Amusa upgraded Achillion to “neutral” from “sell,” citing 1H17 clinical catalysts in the multiple ascending dose (MAD) study of ACH-4471.

 

HSBC analyst Steve McGarry downgraded Teva Pharmaceuticals to “hold” from “buy” and decreased his price target to $44 from $66, citing US DOJ investigation into alleged US generic drug price collusion creates significant uncertainty.

 

Cowen analyst Chris Shibutani initiated coverage of Array Biopharma with an “outperform” rating and $10 price target, citing the strongly positive COLUMBUS trial data positions ARRY’s wholly-owned BRAF/MEK combination as potentially bestinclass for BRAF-mutant melanoma.

 

Cowen analyst Ken Cacciatore decreased his price target of AMAG Pharmaceuticals to $35 from $80, citing Feraheme and CBR continue to be flat.

 

BTIG analyst Dane Leone upgraded Juno to “neutral” from “sell,” citing the ASH abstract release showed similar response rates for JCAR017 versus Kite’s KTE-C19 in the treatment of patients with Diffuse Large B-Cell Lymphoma.