BioShares Biotechnology Clinical Trials (BBC): $22.15, -$0.08, +20.3% YTD

BioShares Biotechnology Products (BBP): $37.48, -$0.40, +14.4% YTD

 

 

MARKET COMMENTARY

 

A day after the Federal Reserve held interest rates unchanged, U.S. stock index futures rose as focus shifted towards the non-farm payrolls report due on Friday. CBS, Marathon Oil and Activision Blizzard are some of the major companies scheduled to report quarterly results later in the day. On the economic front, investors will look forward to trade balance figures, claims for unemployment benefits, and the Labor Department’s productivity data. European shares rose following a flurry of well-received quarterly results and Asian shares closed mixed. Gold fell as the dollar rose to a two-week high. Oil fell after data showed a lower-than-expected decline in U.S. inventories.

 

 

MARKET HIGHLIGHTS

 

BIOPHYTIS announced it presented at the ICFSR the full results of Sarconeos (BIO101), the Company’s lead drug candidate for the treatment of sarcopenia, in the SARA-PK clinical study. The analysis of pharmacodynamics data showed that some biomarkers of muscle metabolism or key hormones of the Renin Angiotensin System (RAS) were modulated in accordance with the mechanism of action of Sarconeos. Three other scientific studies were also presented, BIOPHYTIS being the most active biotech company at the 7th International Conference on Frailty & Sarcopenia Research, held April 27-29th 2017 in Barcelona, Spain.

 

Arrowhead Pharmaceuticals announced financial results for its fiscal 2017 second quarter ended March 31, 2017.  The company reported a second quarter 2017 net loss of $6.0 million, or ($0.08) per diluted share, on $9.0 million in revenue, compared to a second quarter 2016 net loss of $20.8 million, or ($0.35) per diluted share, on $43k in revenue.  The company had approximately $61.7 million in cash and cash equivalents as of March 31, 2017, compared to approximately $85.4 million at September 30, 2017.

 

Neovacs announced that Thérèse Croughs, M.D., Chief Medical Officer of Neovacs, will present an update on the clinical development of the Company’s IFN? Kinoid in dermatomyositis at the 2nd World Conference on Myositis, to be held May 5-8, 2017, in Potomac, Maryland.

 

TiGenix announced that the positive 52-week results from its Cx601 ADMIRE-CD Phase III clinical trial for the treatment of complex perianal fistulas in patients with Crohn’s disease will be presented at the 2017 Digestive Disease Week annual meeting taking place from May 6-9 in Chicago, IL.

 

Rockwell Medical today mailed a letter to its shareholders in connection with the Company’s upcoming 2017 Annual Meeting of Shareholders (“Annual Meeting”) to be held on June 1, 2017.

 

Minerva Neurosciences reported financial results for the quarter ended March 31, 2017.  Net loss was $10.6 million for the first quarter of 2017, or a loss per share of $0.30 (basic and diluted), compared to a net loss of $8.0 million, or a loss per share of $0.29 (basic and diluted) for the first quarter of 2016.  Cash, cash equivalents and marketable securities as of March 31, 2017 were approximately $85.4 million.  The Company believes that its existing cash, cash equivalents and marketable securities will be sufficient to meet its cash commitments for at least the next 12 months.

 

Eiger BioPharmaceuticals will host a key opinion leader lunch to address the need for novel mechanisms in the treatment of pulmonary arterial hypertension (PAH), promising preclinical research identifying the potential for disease modification in PAH, and new classes of investigational therapies now in the clinic.  The event will be held at the Lotte New York Palace Hotel in New York City on Wednesday, May 10th from 12:00pm to 1:30pm Eastern Time.

 

Neovacs announced that Thérèse Croughs, M.D., Chief Medical Officer of Neovacs, will present an update on the clinical development of the Company’s IFN? Kinoid in dermatomyositis at the 2nd World Conference on Myositis, to be held May 5-8, 2017, in Potomac, Maryland, USA.

 

Evogene has filed its annual report on Form 20-F for the fiscal year ended December 31, 2016 with the U.S. Securities and Exchange Commission.  The annual report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC website at www.sec.gov/ as well as via the Company’s investor relations website at investors.evogene.com/sec-filings.

 

Paratek Pharmaceuticals reported financial results for the quarter ended March 31, 2017.  Paratek reported a net loss of $27.7 million, or $1.14 per share, for the quarter ended March 31, 2017 compared to a net loss of $31.3 million, or $1.78 per share, for the same period in 2016.  As of March 31, 2017, Paratek had cash, cash equivalents, and marketable securities of $139.6 million. Based upon Paratek’s current operating plan, the Company anticipates that its existing cash, cash equivalents and marketable securities, the remaining $10.0 million it may borrow under existing debt arrangements, proceeds to be received under its existing controlled equity offering agreements, and anticipated upfront and regulatory milestone payments from its collaborations with Allergan and Zai will enable the Company to fund its operating expenses and capital expenditure requirements into the second quarter of 2019.

 

Ignyta announced the pricing of an underwritten public offering of 12.5 million shares of its common stock at a price to the public of $6.15 per share. The gross proceeds from this offering are expected to be approximately $76.9 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Ignyta. The offering is expected to close on or about May 9, 2017, subject to customary closing conditions. In addition, Ignyta has granted the underwriters a 30-day option to purchase up to an additional 1.875 million shares of its common stock at the public offering price, less the underwriting discounts and commissions, in connection with the offering.

 

Addex Therapeutics announced that the results of a preclinical study evaluating ADX71441 in animal models of alcohol use disorder were published in the Journal of Psychopharmacology.  The study was led by Prof. Markus Heilig of Linköping University, Sweden, and was conducted in collaboration with the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a division of National Institutes of Health. 

 

Onconova Therapeutics will release its first quarter 2017 financial results on May 15, 2017 before the market opens.

 

CymaBay Therapeutics will host a conference call and live audio webcast on Thursday, May 11th at 4:30 p.m. Eastern Time to discuss financial results for the first quarter ended March 31, 2017 and provide a business update.

 

BioLife Solutions announced that the Company’s first quarter 2017 financial results will be released after market close on Thursday, May 11, 2017, and that the Company will host a conference call and live webcast at 1:30 p.m. PT that afternoon.

 

SciClone Pharmaceuticals will report financial results for the first quarter 2017 on Wednesday, May 10, 2017. SciClone will host a conference call and webcast to provide a business update at 4:30 pm ET (1:30 pm PT) that day.

 

TRACON Pharmaceuticals will report its first quarter financial and operating results after the close of U.S. financial markets on Wednesday, May 10, 2017.

 

Ocera Therapeutics will report its first quarter 2017 financial results and provide a clinical update on May 9, 2017.

 

Immune Pharmaceuticals announced that it has entered into definitive agreements with several institutional investors for a private placement of up to $3.4 million of convertible debentures. The debentures are convertible at any time into up to 1,245,675 shares of the Company’s common stock at a conversion price of $2.89 per share, subject to adjustment.  In addition, the investors will receive up to 680,000 shares of the Company’s common stock. The sale of the debentures will be implemented in multiple closings. The Company will sell $1.5 million of convertible debentures to the investors at the initial closing of the transaction and the remaining $1.9 million to the investors in subsequent closings linked to the achievement of certain milestones. The initial closing of the transaction is expected to take place on or about May 9, 2017, subject to the satisfaction of customary closing conditions. Maxim Group is acting as the sole placement agent for the offering.

 

China Biologic reported 1Q17 GAAP EPS of $1.06, which compares to $0.94 for the same period a year ago. The company beat the GAAP EPS mean estimate of $0.99. Total revenue for 1Q17 was $91.5 million, which compares to $85.6 million for the same period a year ago. This compares to a mean estimate of $85.1 million.

 

Regeneron reported 1Q17 non-GAAP EPS of $2.92, which compares to $2.40 for the same period a year ago. The company missed the non-GAAP EPS mean estimate of $3.06. Total revenue for 1Q17 was $1.32 billion, which compares to $1.20 billion for the same period a year ago. This compares to a mean estimate of $1.30 billion.

 

Incyte reported 1Q17 GAAP EPS loss of $0.96, which compares to $0.12 for the same period a year ago. The company beat the GAAP EPS mean estimate loss of $1.01. Total revenue for 1Q17 was $384.1 million, which compares to $263.5 million for the same period a year ago. This compares to a mean estimate of $360.8 million.

 

Agios Pharmaceuticals reported 1Q17 GAAP EPS loss of $1.56, which compares to a loss of $0.61 for the same period a year ago. The company beat the GAAP EPS mean estimate loss of $1.78. Total revenue for 1Q17 was $10.5 million, which compares to $31.3 million for the same period a year ago. This compares to a mean estimate of $8.1 million.

 

Intercept Pharmaceuticals reported 1Q17 GAAP EPS loss of $3.61, which compares to a loss of $5.17 for the same period a year ago. The company beat the GAAP EPS mean estimate loss of $4.20. Total revenue for 1Q17 was $21.0 million, which compares to $0.4 million for the same period a year ago. This compares to a mean estimate of $15.8 million.

 

After yesterday’s close, Clovis Oncology reported 1Q17 non-GAAP EPS loss of $1.33 which compares to a loss of $2.17 for the same period a year ago. The company beat the non-GAAP EPS mean estimate loss of $1.48. Total revenue for 1Q17 was $7.0 million, which compares to no revenue reported for the same period a year ago. This compares to a mean estimate of $4.9 million. Following Clovis’ earnings, Bank of America Merrill Lynch Tazeen Ahmad decreased her price target to $75 from $76;Goldman analyst Terence Flynn decreased his price target to $67 from $75; SunTrust analyst Peter Lawson increased his price target to $85 from $80.

 

Conatus Pharmaceuticals announced that Novartis has exercised its option to an exclusive license for the global development and commercialization of emricasan, the company’s first-in-class, orally-active pan-caspase inhibitor, under terms of the Option, Collaboration and License Agreement signed in December 2016. Subject to usual and customary conditions, including required anti-trust approvals, the license will become effective upon Conatus’ receipt of a $7 million option exercise payment, expected in mid-2017. The option exercise by Novartis followed notification by Conatus of the initiation of the Phase IIb ENCORE-LF (for Liver Function) randomized, double-blind, placebo-controlled clinical trial evaluating emricasan in patients with decompensated liver cirrhosis caused by nonalcoholic steatohepatitis (NASH). With the $50 million upfront payment received in December 2016, the $15 million received in exchange for a convertible promissory note issued to Novartis in February 2017, the anticipated $7 million option exercise payment, and Novartis sharing 50% of the costs of Conatus’ four ongoing Phase IIb emricasan clinical trials after the license becomes effective, the company believes that current financial resources are sufficient to maintain operations and ongoing clinical development activities through the end of 2019. In addition, with the Novartis commitment to fund Phase III single agent emricasan development and all combination drug development activities, the company believes the resources are in place to complete emricasan development both as a single agent for NASH cirrhosis, and as a single agent or part of a combination drug therapy for NASH fibrosis. Conatus is eligible to receive significant payments if certain clinical development, regulatory and commercial milestones are met, as well as tiered double digit royalties on emricasan single agent sales and tiered single to double digit royalties on sales of combination drug products containing emricasan. Conatus has the option to co-commercialize emricasan in the U.S, including combination drug therapies, on a cost-sharing and revenue-sharing basis in lieu of U.S. royalties and with reduced ex-U.S. royalties.

 

Celsion announced updated additional clinical and translational research data from its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company’s IL-12 gene-mediated immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with Stage III and IV ovarian cancer who will undergo neoadjuvant chemotherapy (NACT) followed by interval debulking surgery.  Of the five evaluable patients in the first two cohorts who have been on the study for over one year, only one patient’s cancer has progressed after 11.7 months. This compares quite favorably to the historical median progression free survival (PFS) of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer who undergo neoadjuvant chemotherapy (NACT) followed by interval debulking surgery.  Of the remaining four patients in the first two cohorts, their average PFS is 15.1 months with the longest progression-free patient at 19.1 months.  None of the patients in the third or fourth dosing cohorts have progressed to date.

 

Sangamo Therapeutics announced that the company has received notice from the FDA of special regulatory designations for three of the Company’s clinical programs.

 

ContraVir Pharmaceuticals announced it is developing a second-generation formulation of TXL, the Company’s proprietary liver-targeting prodrug of the antiviral agent tenofovir for treating chronic HBV.

 

BioPharmX announced that it achieved the primary endpoint in its Phase IIb clinical trial evaluating BPX-01(1), the first completely solubilized topical minocycline gel product candidate for the treatment of moderate-to-severe acne.

 

Fortress Biotech announced that study sponsor Columbia University has dosed the final patient in the Phase Ib clinical trial of CAEL-101, in development by Fortress subsidiaryCaelum Biosciences for the treatment of amyloid light chain (“AL”) amyloidosis. Caelum expects to readout preliminary Phase Ib data mid-2017, and full data by the end of the year.

 

OncoMed Pharmaceuticals announced that the first patient has been dosed in the company’s Phase Ia clinical trial of anti-TIGIT (OMP-313M32).  Anti-TIGIT is an investigational immuno-oncology therapeutic candidate intended to block suppression of the immune system in tumors and enable immune system anti-tumor activity, similar to marketed checkpoint inhibitors that target the PD-L1-PD-1 axis.

 

Karyopharm Therapeutics and Anivive Lifesciences announced their entry into a licensing agreement whereby Anivive licensed from Karyopharm exclusive worldwide rights to research, develop and commercialize verdinexor (KPT-335) for the treatment of cancer in companion animals. Under the terms of the agreement, Anivive will make a one-time upfront payment of $1 million to Karyopharm. Karyopharm is eligible to receive up to $43.5 million dollar payments from future regulatory, clinical and commercial milestones, assuming approval in both the U.S and the EU.  In addition, Anivive agreed to pay Karyopharm up to low double-digit royalty payments based on future net sales of verdinexor.

 

Pfizer announced that detailed results from the Phase III Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) clinical program were published in The New England Journal of Medicine (NEJM). Data from all three pivotal Phase III studies – OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain – met their respective primary endpoints, demonstrating that tofacitinib citrate was more effective than placebo in inducing and maintaining remission in patients with moderate to severe ulcerative colitis (UC). Remission was defined as a Mayo score* of 2 points or lower, with no individual subscore exceeding 1 point, and a rectal bleeding subscore of 0.

 

Aratana Therapeutics announced that it has entered into a securities purchase agreement with several institutional investors providing for the issuance and sale of an aggregate of 5,000,000 shares of its common stock at a price of $5.25 per share in a registered direct offering. Barclays is acting as exclusive placement agent for the offering.

 

POXEL SA announced positive top line Phase IIb data results for Imeglimin for the treatment of type 2 diabetes in Japan. The randomized, double-blind, placebo-controlled study of Imeglimin administered twice-daily for 24 weeks, demonstrated dose-dependent efficacy on two key measures of diabetes control in 299 Japanese patients. The trial achieved statistical significance (p <0.0001) for its primary endpoint of glycated hemoglobin A1c reduction versus placebo in all treatment groups at 24 weeks. In the study, hemoglobin A1c reduction was 0.52%, 0.94% and 1.00% for the 500 mg, 1000 mg and 1500 mg dose twice-daily, respectively. The level of reduction of hemoglobin A1c for Imeglimin was even more pronounced in the Japanese Phase IIb data than what has previously been shown in the U.S. and EU Phase IIb data.

 

Epizyme announced it has earned a $10 million milestone payment fromGlaxoSmithKline. The milestone payment follows GSK’s initiation of GLP toxicology studies for a first-in-class methyltransferase inhibitor discovered by Epizyme and licensed to GSK.

 

Novocure announced two pilot trials are open and actively recruiting pediatric patients with high grade gliomas to evaluate the safety and feasibility of Tumor Treating Fields (TTFields) in this population. The trials are sponsored by the Pediatric Brain Tumor Consortium and Hackensack University Medical Center.

 

OncoCyte announced that a Medical Advisory Committee of lung cancer specialists has been established to provide guidance to OncoCyte’s senior management team on issues relating to lung cancer diagnosis.  The Committee is expected to provide advice in a number of areas, including unmet clinical needs, the profiles of patients that will benefit from diagnostic tests, and the role of molecular diagnostics in clinical practice. The Committee will also help to shape OncoCyte’s future pipeline products.

 

Apricus Biosciences reported that the Vitaros drug-device combination human factor testing study required by the FDA is underway.

 

Alere announced certain modifications to the previously announced consent solicitations relating to the Company’s 6.500% Senior Subordinated Notes due 2020, 6.375% Senior Subordinated Notes due 2023 and 7.250% Senior Notes due 2018 (collectively, the "Notes").

 

Imprimis Pharmaceuticals announced the launch of its new patent-pending Simple Drops preservative-free glaucoma drops at the American Society of Cataract and Refractive Surgery (ASCRS) 2017 meeting being held at the Los Angeles Convention Center on May 5-9, 2017.  

 

Biohaven Pharmaceutical announced the pricing of its initial public offering of 9,900,000 of its common shares at an initial public offering price of $17.00 per share.  In addition, Biohaven has granted the underwriters a 30-day option to purchase up to an additional 1,485,000 common shares at the initial public offering price, less underwriting discounts and commissions. The shares are expected to begin trading on the New York Stock Exchange on May 4, 2017 under the ticker symbol "BHVN." The offering is expected to close on May 9, 2017, subject to customary closing conditions.Morgan StanleyPiper Jaffray & Co. and Barclays Capital are acting as joint book-running managers for the proposed offering. William Blair & Company, L.L.C. is acting as lead manager.  Needham & Company, LLC is acting as co-manager.

 

Swedish Orphan Biovitrum announced that Guido Oelkers has been appointed President and Chief Executive Officer effective as of 22 May 2017, succeeding Geoffrey McDonough.

 

CRISPR Therapeutics promoted Dr. Samarth Kulkarni, Ph.D. to the role of President and Chief Business Officer of CRISPR Therapeutics.

 

 

ANALYST RECOMMENDATIONS

 

Chardan analyst Madhu Kumar increased his price target of Lion Biotechnologies to $20 from $17.50 based upon model updates post-1Q17 earnings.

 

Following BluePrint Medicines’ earnings, Goldman analyst Terence Flynn increased his price target to $56 from $52.

 

Following Insmed’s earnings, Leerink analyst Joseph Schwartz increased his price target to $27 from $21.