BioShares Biotechnology Clinical Trials (BBC): $22.10, -$0.04, -23.9% YTD

BioShares Biotechnology Products (BBP): $35.99, -$0.42, +16.8% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures traded lower ahead of a flurry of economic data, including producer prices, industrial and manufacturing output, capital flow data and NAHB housing market index. Markets will also watch for shares of Cisco Systems and NetApp as they report quarterly earnings later in the day. European shares surrendered gains, after rising earlier in the day. The yen’s slide helped lift Japan’s Nikkei index. The dollar edged higher against a basket of currencies, while gold eased. Oil prices slid on oversupply concerns.

 

 

MARKET HIGHLIGHTS

 

Foamix Pharmaceuticals announced financial results for the three and nine months ended September 30, 2016.  Net loss for the quarter ended September 30, 2016 was $5.8 million or $0.19 per share, basic and diluted share, compared with a loss of $3.4 million or $0.11 per share, basic and diluted, for the three months ended September 30, 2015.  Cash, cash equivalents, short and long-term investments as of September 30, 2016 totaled $140.1 million, compared with approximately $103.8 million as of December 31, 2015.

 

Achaogen announced the addition of Mr. Gary Loeb as General Counsel.  Mr. Loeb will serve as Achaogen’s general counsel and will report to Kenneth Hillan, Chief Executive Officer and President.

 

Selexis SA and OSE Immunotherapeutics SA announced the signing of two service agreements that provide OSE Immunotherapeutics with access to high performance research cell banks (RCBs) from the Selexis SUREtechnology Platform™.  The agreements are designed to help OSE Immunotherapeutics advance two of its preclinical products based on immune activation and regulation.

 

Aurinia Pharmaceuticals highlighted additional findings from its global Phase IIb AURA study of voclosporin in the treatment of lupus nephritis (LN). The abstract was presented at the American College of Rheumatology and Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Washington, D.C. during the Late-Breaking News session on November 15, 2016.

 

Evogene announced positive field trial results conducted in Israel from its Ag-biologicals program, which is currently focused on the development of Bio-stimulant products. In these tests, candidate microbial strains identified and predicted by Evogene for their ability to improve corn resistance to drought conditions, yielded positive efficacy and stability results in the first year of field testing.

 

On November 11, 2016, StemCells, together with two of its wholly-owned subsidiaries, Stem Cell Sciences Holdings Limited and StemCells California, Inc., entered into an Asset Purchase Agreement with BOCO Silicon Valley, a California corporation and wholly-owned subsidiary of Bright Oceans Corporation. Pursuant to the terms and subject to the conditions set forth in the Asset Purchase Agreement, the Sellers will sell to BOCO US certain stem and progenitor cell lines that have been researched, studied or manufactured by the Company since 2007 (the "Cell Lines") and certain other tangible and intangible assets, including intellectual property and books and records, related to the foregoing (together with the Cell Lines, the "Assets") in exchange for $4,000,000 in cash, subject to a return of $100,000 to BOCO US if the sale of the Assets (the "Asset Sale") is not completed by December 1, 2016 (the "Asset Consideration"). $300,000 of the Asset Consideration was provided to the Company prior to November 11, 2016 in exchange for the Sellers’ agreement not to solicit or reach any agreement with any third party pertaining to the sale of the Assets. It is anticipated that sixteen former employees of the Company will receive, in aggregate, 15% of the Asset Consideration in accordance with their June 2016 agreements with the Company under which each accepted a more than 50% reduction in his or her severance award otherwise payable. It is also anticipated that, following the completion of the Asset Sale, $400,000 of the Asset Consideration will remain in a twelve-month escrow for the benefit of BOCO US to satisfy certain indemnification obligations of the Sellers which may arise.

 

Cellectis announced that a series of production runs of UCART123, a Company’s wholly-owned TALEN(®) gene edited product candidate, was successfully performed in large scale, according to cGMP standards, for the purpose of conducting two Phase I clinical trials in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN). The cGMP manufacturing of UCART123 clinical batches has been operated with CELLforCURE, a LFB group company and the largest industrial    facility for clinical and commercial production of innovative cell and gene therapies in Europe. CELLforCURE is in charge of    implementing cGMP manufacturing processes that are designed and developed by Cellectis.

 

Amgen and Allergan announced the submission of a BLA to the FDA for ABP 215, a biosimilar candidate to Avastin (bevacizumab). ABP 215 is the most advanced of the four oncology biosimilar medicines that Amgen and Allergan are collaborating on. The companies believe this submission is the first bevacizumab biosimilar application submitted to the FDA.

 

Aclaris Therapeutics announced that two pivotal Phase III trials of its lead product candidate A-101 40% Topical Solution (A-101), a novel treatment for seborrheic keratosis (SK) met all primary and secondary endpoints of each trial, achieving clinically and statistically significant clearance of SK lesions. Following the news, William Blair analyst Tim Lugo increased his price target to $40 from $37; JMP analyst Donald Ellis increased his price target to $39 from $34; Jefferies analyst David Steinberg increased his price target to $32 from $29.

 

GTx announced the achievement of the Stage 1 milestone for the 18 mg cohort of its Phase II clinical trial of enobosarm (GTx-024) to treat women with advanced, estrogen receptor positive (ER+), androgen receptor positive (AR+) breast cancer. A pre-defined number of patients demonstrated clinical benefit per protocol to allow the clinical trial to advance to the second and final stage of the trial (Stage 2) for the 18 mg cohort. In September, GTx announced that it had achieved the Stage 1 milestone for the 9 mg cohort of the clinical trial, and that it was enrolling patients in the second and final stage for that dose group. The Company anticipates reporting Stage 1 data from the 9 mg dose group in December 2016.

 

Summit Therapeutics announced that it has enrolled its first patients at trial sites in the US into PhaseOut DMD, a Phase II proof of concept clinical trial of ezutromid in patients with DMD. Ezutromid dosing is expected to follow within a screening period of up to 28 days. Enrolment and dosing of patients into PhaseOut DMD in the UK is ongoing. Ezutromid is a utrophin modulator and represents a potential disease modifying treatment for all patients with DMD.

 

Can-Fite BioPharma announced that the United States Adopted Names Council (USAN) of the American Medical Association and the World Health Organization’s International Nonproprietary Name (INN) group have accepted the proposed generic name "Namodenoson" for its drug candidate, CF102.

 

Shire announced the launch of CUVITRU [Immune Globulin Subcutaneous (Human), 20% ution], the first and only Subcutaneous 20% treatment option without proline available in the U.S. to treat adult and pediatric patients (two years of age and older) with primary immunodeficiency (PI).

 

Cumberland Pharmaceuticals has entered into an Agreement to acquire the exclusive U.S. rights to Nordic Group B.V.‘s innovative injectable methotrexate product line. The products are designed for the treatment of active rheumatoid arthritis, juvenile idiopathic arthritis, severe psoriatic arthritis, and severe disabling psoriasis. The product line is approved for patient use in various European countries. Cumberland will register and commercialize the methotrexate products in the United States. Under the terms of the Agreement, Cumberland will be responsible for the products’ FDA submission and registration. The regulatory submission, expected to occur during the first half of 2017, will be based on the dossier provided by Nordic. Following registration, Cumberland will be responsible for product launch and commercialization, including all marketing, promotion, and distribution of the products in the U.S. Cumberland projects building to $40 million in annual sales over time for the product line. As consideration for the license, Cumberland will provide Nordic a series of payments tied to the products’ FDA approval and achievement of certain sales milestones. Nordic will be responsible for manufacture and will receive a transfer price on supplies of the products.

 

Genexine announced that it has entered into a clinical research collaboration with Merck for the assessment of Genexine’s GX-188E, HPV therapeutic DNA vaccine, in combination with MSD’s anti-PD-1 therapy, Keytruda (pembrolizumab), for the treatment of patients with HPV-induced cancers. Under the terms of the agreement between Genexine and MSD, through a subsidiary of Merck, Genexine will conduct a Phase Ib/IIa clinical trial to access safety and efficacy of the combination therapy, and MSD will provide clinical supplies of Keytruda and offer support to the study. The agreement also includes provision for potential expansion to include Phase III registration studies in the same indication. Additional details were not disclosed.

 

Regeneron Pharmaceuticals and Sanofi will present results of SARIL-RA-MONARCH, a Phase III study, which demonstrated the superiority of investigational sarilumab monotherapy versus adalimumab (marketed by AbbVie as HUMIRA) monotherapy in improving the clinical signs and symptoms in adults with active rheumatoid arthritis (RA). The results are being presented at an oral session during the American College of Rheumatology (ACR) Annual Meeting in Washington, DC. The SARIL-RA-MONARCH study enrolled 369 adults with active RA who were inadequate responders to, intolerant of, or inappropriate candidates for methotrexate (MTX). Patients were randomized to receive either subcutaneous sarilumab monotherapy (200 mg every 2 weeks) or adalimumab monotherapy (40 mg every 2 weeks); patients who did not respond adequately to adalimumab could increase to weekly dosing. Top-line results were previously announced in March 2016. The primary endpoint was change from baseline in DAS28-ESR at 24 weeks, which demonstrated a statistically significant difference in favor of sarilumab (-3.28 for sarilumab compared to -2.20 for adalimumab, p less than 0.0001).i DAS28-ESR is a measure of disease activity in RA, which includes the evaluation of 28 joints in the body for tenderness and swelling, a general health assessment by the patient, and ESR, a laboratory measure for inflammation.

 

Bristol-Myers Squibb and Enterome announced that they have entered into an Immuno-Oncology focused collaboration agreement for the discovery and development of microbiome-derived biomarkers, drug targets and bioactive molecules to be developed as potential companion diagnostics and therapeutics for cancer. Additionally, the collaboration will seek to identify novel microbiome-derived biomarkers in an effort to improve clinical outcomes for patients treated with Bristol-Myers Squibb’s Immuno-Oncology portfolio.

 

Orexo AB announced that the United States District Court for the District of Delaware ruled in Orexo’s favor in one of the patent infringement litigations against Actavis regarding Zubsolv in the US. The other litigations regarding infringement by Actavis on Orexo’s IP for Zubsolv continues. Orexo commenced this patent infringement litigation in June 2014 in response to Actavis’s ANDA seeking approval to market and sell generic versions of Orexo’s patented Zubsolv 1.4/0.36 mg and 5.7/1.4 mg buprenorphine/naloxone products. The Orexo patents in the litigation were US Patent No. 8,454,996 (expiring in September 2019) and US Patent No. 8,940,330 (expiring in September 2032).

 

Boehringer Ingelheim announced updated results from data for 494 patients participating in the ongoing phase III RE-VERSE AD study, which showed that administration of 5g of idarucizumab immediately reversed the anticoagulant effect of dabigatran, the active ingredient in Pradaxa (dabigatran etexilate). Idarucizumab, marketed as Praxbind, is the first and only approved specific reversal agent for a non vitamin K antagonist oral anticoagulant (NOAC) and RE-VERSE AD is the largest patient study investigating a reversal agent for a NOAC. The updated results were presented at the American Heart Association (AHA) Scientific Sessions 2016 in New Orleans, Louisiana.

 

Tiziana Life Sciences announced new data from animal studies demonstrating the potential of its novel oral therapy with foralumab (NI-0401) for NASH, diabetes and other life-threatening inflammatory diseases. Tiziana’s foralumab is the only fully human engineered anti-CD3 monoclonal antibody (mAb) in clinical development to date.

 

ImmunoCellular Therapeutics announced that at the Special Meeting of Stockholders held on November 14, 2016, ImmunoCellular’s stockholders voted to approve a reverse stock split of the Company’s issued and outstanding common stock. Upon effectiveness of the reverse stock split, every forty (40) shares of ImmunoCellular common stock will be converted into one (1) share of common stock. Concurrently, the authorized number of shares of the Company’s common stock will be reduced from 249 million to 25 million.

 

Amgen Canada announced new detailed results from GLAGOV (GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound), a Phase III coronary intravascular ultrasound imaging trial. The study showed that adding Repatha (evolocumab) to optimized statin therapy resulted in statistically significant regression of atherosclerosis in patients with coronary artery disease (CAD). These data were presented at a Late-Breaking Clinical Trials Session of the American Heart Association (AHA) Scientific Sessions 2016 and simultaneously published in the Journal of the American Medical Association.

 

Glycomine announced that it has raised $12 million in a Series A financing led by Sanderling Ventures and supported by Chiesi Ventures as well as existing high net worth individuals and patients. Glycomine will use the proceeds from this financing to complete IND enabling pre-clinical studies and initiate clinical studies of its substrate replacement therapy in patients with Congenital Disorder of Glycosylation Type Ia (CDG-Ia), and to accelerate discovery efforts towards an enzyme replacement therapy for N-glycanase deficiency (Ngly1).

 

ProMetic Life Sciences reported that it has received clearance by Health Canada to commence a placebo-controlled phase II clinical trial with its PBI-4050, the company’s orally active, lead small molecule anti-fibrosis drug candidate, in patients with metabolic syndrome and type 2 diabetes. The objectives of this 12 week randomized, double-blind, placebo-controlled, multi-center, 4 arm with 67 patients per arm (1 placebo, 3 escalating doses) phase II clinical trial includes the evaluation of the effects of PBI-4050 on metabolic syndrome parameters and on pro-inflammatory/fibrotic and diabetic biomarkers in the blood and urine. The phase II clinical trial is expected to commence in Q4 2016.

 

Flexion Therapeutics announced the pricing of an underwritten public offering of 3,600,000 shares of its common stock at a price to the public of $18.00 per share. The gross proceeds from this offering are expected to be approximately $64.8 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Flexion. The offering is expected to close on or about November 21, 2016, subject to customary closing conditions. Flexion has also granted the underwriters a 30-day option to purchase up to 540,000 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. Wells Fargo Securities, RBC Capital Markets and BMO Capital Markets are acting as joint book-running managers.

 

ANALYST RECOMMENDATIONS

 

Piper Jaffray analyst Charles Duncan increased his price target of Aimmune to $40 from $38, citing perception of reduced clinical risk and despite dilution from the Nestle stake.

 

Following Teva’s earnings, Morgan Stanley analyst David Risinger downgraded the stock to “equal-weight” from “overweight” and decreased his price target to $42 from $63; BTIG analyst Timothy Chiang downgraded the stock to “neutral” from “buy;” Susquehanna analyst Andrew Finkelstein decreased his price target to $50 from $60; Leerink analyst Jason Gerberry decreased his price target to $43 from $57; UBS analyst Marc Goodman decreased his price target to $42 from $60; Jefferies analyst David Steinberg downgraded the stock to “hold”  from “buy” and  decreased his price target to $40 from $69; Credit Suisse analyst Vamil Divan decreased his price target to $52 from $47; Piper Jaffray analyst David Amsellem decreased his price target to $43 from $57; Deutsche Bank analyst Gregg Gilbert decreased his price target to $54 from $68.

 

Piper Jaffray analyst Joshua Schimmer downgraded uniQure to “neutral” from “overweight” and decreased his price target to $8 from $16, citing the company’s pipeline will continue to face substantial competitive headwinds.

 

Mizuho analyst Irina Koffler downgraded Eagle Pharmaceuticals to “neutral” from “buy,” citing weaker Treanda/Bendeka revenues reported by partner Teva, and fully loaded pipeline valuation.

 

Ladenburg Thalman analyst Matt Kaplan upgraded Repros Therapeutics to “buy” from “neutral,” citing positive Proellex phase II b results.

 

Roth analyst Mark Breidenbach resumed coverage of Macrogenics with a “buy” rating and $40 price target, citing a broad therapeutic pipeline of biologics that could improve the standard of care in various cancers and other diseases, while continuing to attract an influx of non-dilutive funding from big biopharma.