BioShares Biotechnology Clinical Trials (BBC): $18.25, +$0.32, -37.2% YTD

BioShares Biotechnology Products (BBP): $30.40, +$0.32, -1.4% YTD

 

 

MARKET COMMENTARY

 

A surprise victory of U.S. Republican Donald Trump over Democrat Hillary Clinton in the race for the White House augmented uncertainty in the markets, pushing U.S. stock index futures lower. European shares dropped too, following a major selloff in Asian stocks. The dollar fell and the Mexican peso slumped versus the greenback to a historic low. Gold rose on risk aversion and oil paired losses.

 

 

MARKET HIGHLIGHTS

 

TxCell SA reported its revenues for the third quarter of 2016 and its cash position as of September 30, 2016.  As of September 30, 2016, TxCell’s cash and cash equivalents amounted to €4.6 million, vs. €3.2 million as of June 30, 2016.

 

TRACON Pharmaceuticals announced financial results for the third quarter ended September 30, 2016.  The net loss for the third quarter of 2016 was $5.9 million, compared to a loss of $6.4 million for the third quarter of 2015.  Cash and cash equivalents were $35.1 million at September 30, 2016, compared to $36.2 million and $52.2 million at June 30, 2016 and December 31, 2015, respectively.

 

Aradigm Corporation announced financial results for the third quarter and nine months ended September 30, 2016.  The Company recorded $50,000 in revenue in the third quarter of 2016 compared with $4.7 million in revenue in the third quarter of 2015.  Net loss for the third quarter of 2016 was $8.2 million or $0.55 per share, compared with a net loss of $5.5 million or $0.38 per share in the third quarter of 2015.  As of September 30, 2016, the Company reported cash and cash equivalents of $28.5 million.

 

BioDelivery Sciences International reported financial results for the third quarter ended September 30, 2016.  BDSI’s total net revenue for the three-months ended September 30, 2016 was $3.6 million compared to $1.2 million for the same period last year and $5.0 million for the quarter ended June 30, 2016.  Net loss for the third quarter ended September 30, 2016, was $16.0 million, or ($0.30) per diluted share, compared to a net loss of $20.4 million, or ($0.39) per diluted share in the same period of 2015.  BDSI had cash and cash equivalents of approximately $44.7 million at September 30, 2016.

 

Zealand Pharma A/S reported financial results for the nine-month period ended September 30, 2016.  The net loss for the nine months was DKK 206.7 million , a 13% increase vs. the same period of 2015.  The cash position amounted to DKK 381.9 million at September 30, 2016, compared DKK 453.9 million at September 30, 2015. This excludes DKK 135.5 million in net proceeds raised in new share capital paid on October 4, 2016.

 

CymaBay Therapeutics announced that the United States Patent and Trademark Office has issued U.S. Patent No. 9,486,428. This patent provides coverage to at least 2035 and claims a method for the treatment of PBC with MBX-8025.

 

CoLucid Pharmaceuticals reported financial and operating results for the quarter ended September 30, 2016.  Net loss attributable to common stockholders for the third quarter of 2016 was $12.7 million, or $0.79 per share, compared to $8.9 million, or $0.59 per share, for the third quarter of 2015.  The Company ended the third quarter of 2016 with cash, cash equivalents, and investments of $100.2 million compared to $64.5 million at year-end 2015.   The increase was due to the follow-on public offering of 3.7 million shares of CoLucid common stock which was completed in the third quarter of 2016 and generated approximately $69.9 million in net proceeds to the Company.  The Company believes it has sufficient cash, cash equivalents and available for sale securities to enable it to fund the remainder of SPARTAN, a substantial portion of GLADIATOR, and the submission of an NDA to the FDA for lasmiditan.  The Company also estimates that such funds will support its operating expenses and capital expenditure requirements through at least the second quarter of 2018.

 

Aeglea BioTherapeutics reported financial results for the quarter ended September 30, 2016.  Net loss totaled $6.2 million and $3.4 million for the third quarter of 2016 and 2015, respectively.  At September 30, 2016, Aeglea had available cash, cash equivalents and marketable securities of $68.0 million, with net cash burn of $5.8 million. Management believes that Aeglea has sufficient capital resources to fund anticipated operations through the second quarter of 2018.

 

Valneva reported financial results for the nine months ended September 30, 2016.  Total revenues and grants grew to €70.7 million in the first nine months of 2016, compared to €60.7 million in the same period of 2015.  Valneva’s net loss in the first nine months of 2016 was €46.5 million.  Liquid funds on September 30, 2016 stood at €40.3 million, compared to €37.3 million on September 30, 2015 and consisted of €39.7 million in cash and cash equivalents and €0.6 million in restricted cash.

 

Windtree Therapeutics will present a corporate overview at the Stifel 2016 Healthcare Conference on Tuesday, November 15th.

 

Ionis reported 3Q16 GAAP EPS of $0.06, which compares to a loss of $0.30 for the same period a year ago. The company missed the First Call GAAP EPS mean estimate of $0.08. Total revenue for 3Q16 was $110.9 million, which compares to $49.1 million for the same period a year ago. This compares to a mean estimate of $113.1 million.

 

Kite Pharma reported 3Q16 GAAP EPS loss of $1.49, which compares to a loss of $0.63 for the same period a year ago. The company beat the First Call GAAP EPS mean estimate loss of $1.62. Total revenue for 3Q16 was $7.3 million, which compares to $5.1 million reported for the same period a year ago. This compares to a mean estimate of $4.9 million. 

 

After yesterday’s close, Jazz Pharmaceuticals reported 3Q16 non-GAAP EPS of $2.57, which compares to $2.52 for the same period a year ago. The company missed the First Call non-GAAP EPS mean estimate of $2.61. Total revenue for 3Q16 was $374.2 million, which compares to $340.9 million for the same period a year ago. This compares to a mean estimate of $389.2 million.

 

Arrowhead Pharmaceuticals provided an update on its Heparc-2004 clinical study of ARC-520, its therapeutic candidate under clinical investigation for the treatment of chronic hepatitis B virus (HBV) infection. Heparc-2004 is a multicenter, randomized, double-blind, placebo-controlled, multi-dose study of ARC-520, which is currently being performed in up to 12 patients in the United States under an IND. Arrowhead was notified verbally by the FDA of its decision to place a clinical hold on Heparc-2004. The study is on hold while the company provides responses to questions arising from a nonclinical toxicology study in non-human primates using EX1, the company’s liver-targeted, intravenously administered delivery vehicle.

 

Bristol-Myers Squibb and Infinity Pharmaceuticals announced a clinical trial collaboration to evaluate Bristol-Myers Squibb’s Opdivo in combination with Infinity’s IPI-549 in patients with advanced solid tumors. The dose-escalation portion exploring IPI-549 as a monotherapy in Infinity’s Phase I study is continuing, and the first dose-escalation cohort studying IPI-549 in combination with Opdivo, a PD-1 immune checkpoint inhibitor, is expected to begin this fall. IPI-549 is an oral immuno-oncology development candidate that is designed to selectively inhibit phosphoinositide-3-kinase (PI3K)-gamma and is the only investigational PI3K-gamma inhibitor in clinical development.

 

ARIAD Pharmaceuticals announced clinical data on its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, were published in The Lancet Oncology (Gettinger, S.; ed al. The Lancet Onc. 2016, DOI: 10.1016/S1470-2045(16)30392-8 Published 8 November 2016). ARIAD has submitted a NDA for brigatinib to the FDA, seeking U.S. marketing approval for patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who are resistant or intolerant to crizotinib.

 

Can-Fite BioPharma announced it has received a Notice of Allowance from the USPTO for its patent application covering A3 adenosine receptor ligands for use in the treatment of erectile dysfunction. The patent addresses methods for treating erectile dysfunction with different A3 adenosine receptor (A3AR) ligands including Can-Fite’s erectile dysfunction drug candidate, CF602. This marks Can-Fite’s second notice of allowance in the U.S. for ligands which bind to the A3AR target. The prior patent, issued in February, addresses composition of matter for allosteric compounds. Can-Fite’s CF602, an allosteric compound at the A3AR demonstrated effects on erection superior to that demonstrated by sildenafil (Viagra(R)) in diabetic animal studies. CF602 has a mechanism of action similar to sildenafil.

 

Merus N.V. announced that it has been awarded a EUR1.5 million EUREKA Eurostars grant ("iMOD-ReACT") with Aquila BioMedical to jointly develop novel immunological assays supporting the selection of potent bispecific antibodies that positively modulate tumor immunity with superior potency and lower toxicity compared to existing drugs.

 

Assembly Biosciences announced initiation of a Phase Ia/Ib clinical trial of ABI-H0731, its initial Core protein Allosteric Modifier (CpAM) for the treatment of chronic HBV.

 

InVivo Therapeutics Holdings announced that University of Iowa Hospitals and Clinics in Iowa City, IA, has been added as a clinical site for The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury. UI Hospitals and Clinics is a 732-bed hospital which, in fiscal year 2015, received more than 57,000 emergency room visits.

 

RegeneRx Biopharmaceuticals announced that the first patients have been enrolled in a Phase III clinical trial (ARISE-2 trial) with RGN-259 (Thymosin beta 4), its sterile, preservative-free eye drop formulation developed for patients with dry eye syndrome, neurotrophic keratopathy (NK), and other corneal disorders.

 

Vitality Biopharma announced the filing of an international PCT patent application, a milestone in its development of a platform of cannabinoid pharmaceuticals.

 

 

ANALYST RECOMMENDATIONS

 

Citi analyst Yigal Nochomovitz increased his price target of Ardelyx to $17 from $13, citing the introduction of Hyperkalemia into the thesis.

 

Aegis analyst Difei Yang initiated coverage of Vanda Pharmaceuticals with a “buy” rating and $24 price target, citing potential material upside lies in the Smith-Magenis Syndrome indication.

 

Mizuho analyst Irina Koffler upgraded Depomed to “buy” from “neutral” and decreased her price target to $24 from $27, citing lower Nucynta and lower sales multiples in a potential deal.

 

HC Wainwright analyst Ed Arce decreased his price target of Conatus to $9 from $15, citing projected U.S. net sales of emricasan for the treatment of POLT and projected U.S. net sales of emricasan for the treatment of NASH-driven cirrhosis.

 

Following Applied Genetic Technology’s earnings, Wedbush analyst David Nierengarten decreased his price target to $17 from $20; Roth analyst Joseph Pantginis upgraded the stock to “buy” from “neutral” and increased his price target to $15 from $12; Stifel analyst Stephen Willey decreased his price target to $22 from $24.

 

Following Endo International’s earnings, William Blair analyst Tim Lugo decreased his price target to $15 from $20; JMP analyst Donald Ellis decreased his price target to $34 from $44; RBC analyst Randall Stanicky decreased his price target to $21 from $26; UBS analyst Marc Goodman decreased his price target to $28 from $30; Leerink analyst Jason Gerberry decreased his price target to $15 from $22; Deutsche Bank analyst Gregg Gilbert decreased his price target to $25 from $31; JP Morgan analyst Chris Schott decreased his price target to $30 from $38; Goldman analyst Stephan Stewart decreased his price target to $19 from $22.

 

Following Valeant’s earnings, RBC analyst Douglas Miehm decreased his price target to $29 from $35; Susquehanna analyst Andrew Finkelstein decreased his price target to $16 from $25; Jefferies analyst David Steinberg decreased his price target to $22 from $40; ScotiaBank analyst Alan Ridgeway decreased his price target to $17 from $32; JP Morgan analyst Christopher Schott decreased his price target to $22 from $35; CIBC analyst Prakash Gowd decreased his price target to $9 from $16; Canaccord analyst Neil Maruoka decreased his price target to $17 from $33; Piper Jaffray analyst David Amsellem decreased her price target to $16 from $22.