BioShares Biotechnology Clinical Trials (BBC): $21.64, -$0.03, +17.5% YTD

BioShares Biotechnology Products (BBP): $36.85, -$0.14, +12.5% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures pointed to a lower start for Wall Street ahead of a bunch of economic indicators including Consumer Price Index, retail sales, and the University of Michigan’s consumer sentiment survey. The dollar rose on bets the Federal Reserve will raise U.S. interest rates in June. European shares inched up, underpinned by gains among drugmakers, while Asian markets recorded a mixed trading day. Oil prices fell on concerns over global oversupply and gold was set to end the week slightly higher.

 

 

MARKET HIGHLIGHTS

 

TRACON Pharmaceuticals announced that preclinical data indicating the potential clinical utility of targeting endoglin in acute myeloid leukemia (AML) and B-cell acute lymphoblastic leukemia (B-cell ALL), was published in the May 4, 2017 issue of Blood (Volume 129, Number 19, pages 2526-2536), a weekly medical journal of the American Society of Hematology.

 

BioLife Solutions reported financial results for the first quarter of 2017.  Net loss for the first quarter was $0.9 million, compared to a net loss of $1.5 million in the same period in 2016.  The Company had cash & cash equivalents of $2.3 million at March 31, 2017, compared to $1.4 million at December 31, 2016.

 

CymaBay Therapeutics announced financial results for the quarter ended March 31, 2017.  Net loss was $5.4 million, or ($0.20) per diluted share in the first quarter of 2017, as compared to $6.8 million, or ($0.29) per diluted share in the first quarter of 2016.  Cash, cash equivalents and marketable securities totaled $23.4 million at the end of the first quarter of 2017. Management believes it has funds sufficient to fund operations through at least the next 12 months.

 

STRATA Skin Sciences reported financial results for the quarter ended March 31, 2017. Revenues for the first quarter of 2017 were $7.3 million compared with revenues for the first quarter of 2016 of $7.6 million.  Net loss for the first quarter of 2017 was $2.2 million or ($1.03) per diluted share, compared with a net loss for the first quarter of 2016 of $1.4 million or ($1.30) per diluted share.  As of March 31, 2017, the Company had cash and cash equivalents of $3.8 million, compared with $3.9 million as of December 31, 2016.

 

Capnia announced financial results for the three months ended March 31, 2017.  Net loss for the first quarter of 2017 was $2.9 million, or a loss of $0.11 per share, compared to a net loss of $3.2 million, or a loss of $0.22 per share, for the first quarter of 2016.  Cash and cash equivalents at March 31, 2017, totaled $10.5 million, compared to $2.7 million at December 31, 2016.

 

Ohr Pharmaceutical reported results for its second quarter ended March 31, 2017.  For the quarter ended March 31, 2017, the Company reported a net loss of approximately $7.7 million, or ($0.21) per share, compared to a net loss of approximately $5.3 million, or ($0.17) per share in the same period of 2016.  At March 31, 2017, the Company had cash and cash equivalents of approximately $9.5 million, compared to cash and equivalents of approximately $12.5 million at September 30, 2017.  This does not include the approximately $12.7 million in net proceeds from the public offering completed in April 2017.

 

Ohr Pharmaceutical announced the appointment of the Honorable Mike Ferguson as a director and Chairman of the Board following the resignation of Ira Greenstein from the Company’s Board of Directors.  The Honorable Mike Ferguson is Senior Advisor and Leader of the Federal Policy Team at Baker Hostetler, one of the nation’s largest law firms, and is a member of the Board of Directors of NanoVibronix Inc.  He served for nearly a decade in the House of Representatives and was a leader on a number of key healthcare and financial services policy initiatives to remove regulatory roadblocks to innovation.  As Vice Chairman of the House health subcommittee, he led policy reforms including the creation of the Medicare Part D prescription drug benefit and pharmaceutical and medical device user fee reauthorizations.  He also authored and shepherded passage of the Lifespan Respite Care Act of 2006, which champions pioneering healthcare policies that improve treatment options for patients.

 

Eiger BioPharmaceuticals announced financial results for the three months ended March 31, 2017.  Net loss for the first quarter of 2017 was $11.2 million, or $1.34 per share basic and diluted, compared to a net loss of $9.7 million, or $10.42 per share basic and diluted for the first quarter of 2016.  As of March 31, 2017, Eiger had cash, cash equivalents and short term marketable securities of $49.0 million, compared to $59.9 million at December 31, 2016.

 

Capricor Therapeutics announced that a pre-specified administrative interim analysis performed on six-month follow-up data from the ALLSTAR Trial, an ongoing randomized, double-blind, placebo-controlled, 142-patient Phase II clinical trial of CAP-1002 (allogeneic cardiosphere-derived cells) in adults who have experienced a large heart attack with residual cardiac dysfunction, has demonstrated a low probability (futility) of achieving a statistically-significant difference in the 12-month primary efficacy endpoint of percent change from baseline infarct size as a percent of left ventricular mass, measured by cardiac magnetic resonance imaging (MRI). Capricor will continue to perform analyses of the cumulative ALLSTAR data to better understand the basis for this outcome. At six months, a near-statistically-significant (p=0.05) reduction of mean end-diastolic volume, as well as a trend of reduction of mean end-systolic volume, were seen in the CAP-1002 treatment group. There was no notable difference between treatment groups with respect to the change in ejection fraction. There were no safety signals in the CAP-1002 treatment cohort.

 

Ardelyx reported positive, topline results from the T3MPO-1 trial, the first of two Phase III trials evaluating tenapanor for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). Tenapanor is Ardelyx’s investigational, minimally systemic, small-molecule NHE3 inhibitor.

 

Abeona Therapeutics announced updated data from the ongoing gene therapy clinical trial for Sanfilippo syndrome Type A (MPS IIIA) at the American Society Gene and Cell Therapy (ASGCT) 20(th) Annual Meeting. The ongoing Phase I/II trial for ABO-102 (AAV-SGSH) is a first-in-man clinical trial utilizing a single intravenous injection of AAV gene therapy for subjects with Sanfilippo syndrome (MPS IIIA), a rare autosomal-recessive lysosomal storage disease.

 

AstraZeneca and MedImmune, its global biologics research and development arm, announced positive results for the Phase III PACIFIC trial, a randomised, double-blinded, placebo-controlled multi-centre trial of Imfinzi (durvalumab) as sequential treatment in patients with locally-advanced, unresectable (Stage III) non-small cell lung cancer (NSCLC) who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy.

 

Eli Lilly announced that galcanezumab, an investigational treatment for the prevention of episodic and chronic migraine, met its primary endpoint in three Phase III studies (EVOLVE-1, EVOLVE-2 and REGAIN) demonstrating statistically significant reductions in the number of monthly migraine headache days compared to placebo at both studied doses.

 

Antibe Therapeutics provided an update on the clinical development program for ATB-346, its lead drug candidate targeting the global need for a safer remedy for chronic pain and inflammation.

 

Loxo Oncology announced that the FDA has granted orphan drug designation to larotrectinib for the “treatment of solid tumors with NTRK-fusion proteins.” NTRK fusions are genetic abnormalities that occur rarely in various adult and pediatric solid tumors.

 

Newron Pharmaceuticals announced the receipt of milestone payments linked to the approval of its lead compound Xadago (safinamide) for the treatment of Parkinson’s disease by the FDA. The payments were made by Newron’s partner Zambon, who holds the rights to develop and commercialize Xadago globally, excluding Japan and other key territories where Meiji Seika has the rights to develop and commercialize the compound, and relate to the 2012 “strategic collaboration and license agreement for safinamide” between Newron and Zambon. Payments totaled EUR11.3 million which under the applicable IFRS rules will be recognized as immediate revenue. Newron is also eligible to receive royalty payments on sales as part of the 2012 agreement.

 

Selecta Biosciences announced that patient dosing has commenced in a Phase I clinical trial to assess the safety, tolerability and pharmacodynamic profile of SELA-070, a nicotine vaccine candidate in development for smoking cessation and relapse prevention. The project is being funded primarily by an $8 million grant (#U01DA037592) from the National Institute on Drug Abuse (NIDA), part of NIH.

 

Biohaven Pharmaceutical announced the closing of its previously announced initial public offering of 9,900,000 common shares at a price to the public of $17.00 per share. In connection with the initial public offering, the underwriters exercised in full their option to purchase an additional 1,485,000 common shares from Biohaven. As a result, the total initial public offering size was 11,385,000 common shares. The aggregate gross proceeds to Biohaven from the offering, before deducting the underwriting discounts and commissions and offering expenses, were approximately $193.5 million.  Morgan StanleyPiper Jaffray & Co. and Barclays Capital acted as joint book-running managers for the offering. William Blair acted as lead manager. Needham & Company acted as co-manager.

 

 

ANALYST RECOMMENDATIONS

 

Following NantHealth’s earnings, Cowen analyst Charles Rhyee decreased his price target to $8 from $11.

 

William Blair analyst Tim Lugo downgraded Akari Therapeutics to “market perform” from “outperform,” citing the company’s board of directors had established an ad hoc special committee to review the involvement of company personnel with a materially inaccurate research report, titled “Akari’s Coversin matches Soliris in Phase II,” published by Edison Investment Research Ltd. on April 26

 

Oppenheimer analyst Jay Olson initiated coverage of Incyte with a “perform” rating and $125 price target, citing a market premium driven by takeover speculation that we have no insight into over the near term.

 

Bank of America analyst Tazeen Ahmad initiated coverage of Sage Therapeutics with a “buy” rating and $85 price target.

 

Following Avexis’ earnings, Goldman analyst Salveen Richter decreased her price target to $106 from $108.

 

Craig Hallum analyst Matt Hewitt increased his price target of MiMedx to $19 from $15, citing the company’s prospects and given the diminishing risk factors, MDXG’s stock deserves a higher multiple.

 

Jefferies analyst Jeffery Holford revised his price target of the following companies:Abbott increased to $51 from $50; AstraZeneca decreased to 4,700p from 4,900p;Johnson & Johnson decreased to $135 from $140; Novartis increased to CHF100 from CHF95; Novo Nordisk increased to DKK260 from DKK250; Roche increased to CHF305 from CHF295; Sanofi increased to €92 from €87.

 

Piper Jaffray analyst Brett Wong decreased his price target of Arcadia Biosciences to $1 from $4, citing the commercialization timeline for Arcadia’s core HB4 trait in soybeans will be extended as it has taken more time than previously expected to get to market.