BioShares Biotechnology Clinical Trials (BBC): $20.09, -$1.04, -30.8% YTD

BioShares Biotechnology Products (BBP): $30.54, -$1.04, -0.9% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures and the dollar weakened as investors took to sidelines ahead of a speech by Federal Reserve Chair Janet Yellen at a global central bankers’ meeting in Jackson Hole. July durable
goods and August Markit composite and services PMI data are scheduled to release later in the day. Autodesk and GameStop are due to report quarterly results after markets close. European markets were in the red, weighed down by losses among pharma and mining
sector stocks and Asian stocks closed lower. Oil prices steadied despite oversupply concerns and fading hopes of a production freeze. Gold edged lower.

 

 

MARKET HIGHLIGHTS

 

TxCell SA announced the appointment to its Scientific Advisory Board (SAB) of Olivier Danos, PhD, Senior Vice President of Cell and Gene Therapy at Biogen and a world-leading expert in the field
of Gene Therapy for hematological and neurological diseases.

 

Cellect Biotechnology announced that Dr. Shai Yarkoni, Chief Executive Officer, will present a corporate overview at the 18th Annual Rodman & Renshaw Global Investment Conference on Monday, September
12th.

 

Bioblast Pharma announced financial results for the second quarter ended June 30, 2016.  The Company reported a net loss of $3.685 million for the period, $.22 per share, as compared to $3.686
million, $.26 per share for the second quarter of 2015. Cash and cash equivalents (including short-term bank deposits) totaled $15.7 million at June 30, 2016, compared with $19.3 million at December 31, 2015.

 

Zealand Pharma A/S reported financial results for the half-year period 1 January – 30 June 2016.  Zealand reported revenue of DKK 14.7million/EURO2.0 million, and a net loss of DKK 175.7 million/EURO23.6
million.  The Company’s cash position amounted to DKK 423.2 million/EURO56.8 million at June 30, 2016.

 

Valneva SE announced the signing of an agreement with Seqirus, the second largest flu company in the world, for the marketing & distribution of Seqirus’ seasonal flu vaccines Sandovac® and Fluad®
in the Austrian market.  Seqirus is the global company created in July 2015 from the combined strength and expertise of bioCSL Inc. and the influenza vaccine business formerly owned by Novartis AG.  Under the terms of the agreement, Valneva will start distributing
the Sandovac and Fluad vaccines to the Austrian market at the beginning of the 2016-2017 flu season.

 

Mylan announced it is taking immediate action to further enhance access to EpiPen (epinephrine injection, USP) Auto-Injector by expanding already existing programs in recognition of those patients
who are facing the burden of higher out-of-pocket costs. The company is reducing the patient cost of EpiPen Auto-Injector through the use of a savings card which will cover up to $300 for their EpiPen 2-Pak. For patients who were previously paying the full
amount of the company’s list price for EpiPen, this effectively reduces their out-of-pocket cost exposure by 50%. Mylan also is doubling the eligibility for its patient assistance program, which will eliminate out-of-pocket costs for uninsured and under-insured
patients and families as well.

 

Nymox Pharmaceutical announced successful new study results from the long-term blinded placebo crossover group from the U.S. Phase III trials for fexapotide, the Company’s lead compound in late
stage development for enlarged prostate (BPH) and for localized prostate cancer. The aim of the study was to determine the clinical benefit fexapotide can provide to men who initially were double blind randomized to and received placebo, remained blinded as
to their placebo treatment, and who subsequently required additional medical and/or surgical treatment. In the new study long-term outcomes were determined in 391 patients who were given double blind placebo injections, which were followed by crossover to
other treatments at the patients’ discretion. The numbers of blinded placebo patients who subsequently received surgical treatment during the next 2-3 years for their BPH symptoms were then prospectively analyzed. Results have now shown that there was 82-95%
reduction in the number of these patients who required surgery after they received crossover fexapotide in the trial, as compared to patients who did not receive fexapotide but instead received crossover conventional approved BPH treatments (p<.0001).

 

Prima BioMed announced the granting of patent number 2142210 entitled “Cytotoxic anti-LAG-3 monoclonal antibody and its use in the treatment or prevention of organ transplant rejection and autoimmune
disease” by the European Patent Office.

 

BioLineRx announced that it has established a joint venture (JV) with
I-Bridge Capital, a Chinese venture capital fund focused on developing innovative therapies in China. The joint venture, named iPharma, will develop innovative clinical and pre-clinical therapeutic candidates originating primarily in Israel to serve
the Chinese and global healthcare markets. Under the terms of the JV agreement, each partner will provide seed capital of one million dollars to the venture. BioLineRx will screen and identify promising early-stage drug candidates originating primarily in
Israel with emphasis on therapeutic indications that are of special interest for the Chinese population. These therapeutic candidates will then be in-licensed by iPharma for further development and commercialization in China and possibly in other countries
as well. After a critical mass of in-licensed projects is reached, iPharma intends to raise additional funds from Chinese investors to accelerate further development activities. Each partner is protected from dilution for a five-year period and the first project
is expected to join iPharma’s pipeline within the next few months.

 

Arena Pharmaceuticals and
Eisai have received a “Paragraph IV certification” notification with respect to patents for BELVIQ (lorcaserin hydrochloride tablets, 10 mg) listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. The
certification was from an ANDA for a proposed generic version of BELVIQ. The notification is currently under investigation. In accordance with the Hatch-Waxman Act, the companies have 45 days from the receipt of the notification to file a patent infringement
suit against the ANDA filer which would result in the stay of FDA approval of the ANDA under statutory guidelines.

 

Mylan and Biocon announced that the EMA has accepted for review Mylan’s MAA for a proposed biosimilar Trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers.
This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe. Last month, Mylan’s MAA for the proposed biosimilar Pegfilgrastim was accepted for review by EMA.

 

Novartis announced the Phase III EXPAND study, evaluating the efficacy and safety of oral, once-daily, BAF312 (siponimod) in secondary progressive multiple sclerosis (SPMS), met its primary endpoint
of a reduction in the risk of disability progression, compared with placebo. The EXPAND study represents the largest randomized, controlled study in SPMS to date.

 

Amgen announced that the FDA has issued a CRL for the NDA for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease
(CKD) on hemodialysis. Amgen is reviewing the CRL, and anticipates a post-action meeting with the FDA later this year to discuss the Complete Response.  The Company mentioned that the Complete Response Letter does not impact its regulatory submissions in other
regions.

 

Lion Biotechnologies announced an amendment of its Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to extend the CRADA for an additional five-year
term until 2021. Under the extended CRADA, the Company will continue working with Steven A. Rosenberg, M.D., Ph.D., chief of NCI’s Surgery Branch, to develop TIL which have not been genetically altered as a stand-alone therapy or in combination with FDA-licensed
products routinely used for treatment of the indications covered under the CRADA. The CRADA includes the development of TIL therapy for the treatment of metastatic melanoma, bladder, lung, breast, and HPV-associated cancers. Under the CRADA, combination of
TIL with FDA-approved drugs, such as checkpoint inhibitors, will be explored. The financial terms of CRADA were not changed.

 

Teva Pharmaceutical confirmed the Patent Trial and Appeal Board (PTAB) decisions from an Inter Partes Review (IPR) to invalidate all claims of the ‘250 and ‘413 patents for 40 mg COPAXONE (glatiramer
acetate injection). Teva plans to appeal to the United States Court of Appeals for the Federal Circuit.

 

Sunesis Pharmaceuticals announced the publication of an article detailing the molecular and pharmacologic properties of vosaroxin as a new therapeutic for acute myeloid leukemia (AML) in the
journal Drugs. The article, titled “Molecular and Pharmacologic Properties of the Anticancer Quinolone Derivative Vosaroxin: A New Therapeutic for Acute Myeloid Leukemia,” is available online and will appear in the September 2016 print issue of Drugs.

 

Immunovaccine announced new data from its Phase I/Ib trial in ovarian cancer, which reinforced previously reported results showing that DPX-Survivac was well tolerated, with no unexpected treatment-related
serious adverse events (SAEs) and that it demonstrated the ability to generate a relevant, sustained immune response.

 

NeuroDerm announced that it has initiated enrollment of Parkinson’s disease (PD) patients in a Phase III efficacy trial (trial 007, named the “iNDiGO” trial) of ND0612L, the company’s low-dose
continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) liquid formulation.

 

Mallinckrodt announced the FDA has granted the company’s request for a Fast Track designation for its IND application for Synacthen Depot in the treatment of Duchenne muscular dystrophy (DMD).
Synacthen Depot is a depot formulation of Synacthen (tetracosactide), a synthetic 24 amino acid melanocortin receptor agonist. Synacthen Depot is approved and marketed outside of the U.S. for certain autoimmune and inflammatory conditions, but has never been
approved for use in patients in the U.S.

 

Regen BioPharma announced that significant interest is being expressed by potential strategic partners with regards to the Company’s proprietary assets. Previously, the Company had announced
that partnering strategies were to be explored with the goal to provide sources of non-dilutive funding.
Objective Capital Partners is serving as exclusive advisor to the Company and assisting in exploring strategic partnerships, co-development and licensing agreements to enhance shareholder value and provide sources of non-dilutive funding.

 

Teligent announced that its Estonian subsidiary,
Teligent OÜ, has received three Abbreviated New Drug Submission approvals from Health Canada’s Therapeutic Products Directorate for Baclofen Injection 0.05mg/mL, Baclofen Injection 0.5mg/mL and Baclofen Injection 2mg/mL.

 

Galectin Therapeutics announced interim results from an exploratory, open-label, Phase IIa clinical trial with GR-MD-02 in patients with moderate-to-severe plaque psoriasis.

 

Akorn announced that it has relaunched Ofloxacin Otic Solution 0.3%, a sterile aqueous anti-infective solution for otic use.

 

Boehringer Ingelheim Pharmaceuticals and the Duke Clinical Research Institute (DCRI) announced the expansion of the Idiopathic Pulmonary Fibrosis – PROspective Outcomes (IPF-PRO) Registry, a
patient registry developed to uncover insights into IPF, a rare and serious lung disease. The expansion will increase the study enrollment from 300 patients at 18 study sites to 1,500 patients at approximately 45 sites, creating the largest registry of newly
diagnosed IPF patients.

 

Viking Therapeutics announced it has entered into a $12.5 million common stock purchase agreement with
Aspire Capital Fund. Under the terms of the agreement, Aspire Capital has made an initial purchase of $500,000 of Viking common stock at $1.50 per share, which represents a 15% premium over the August 24 closing price of $1.31. In addition, after the
SEC declares the registration statement related to the transaction effective, Aspire Capital has committed to purchase up to an additional $12.0 million in shares of common stock over the next 30 months at prices based on the market price at the time of each
sale. No warrants, derivatives, or other share classes are associated with this agreement. Proceeds from the stock purchase agreement will be used for general corporate purposes, including advancing the company’s drug development pipeline.

 

Cesca Therapeutics announced that the Company has converted a senior secured three year convertible debenture of $12.5 million of principal and $8.25 million of interest to 6,102,941 shares of
its common stock. The conversion was effected in accordance with the previously announced purchase agreement entered into between Cesca Therapeutics and
Boyalife USA, dated February 2, 2016. It releases Cesca from all security interest and liens previously placed against the Company’s assets and eliminates Boyalife’s entitlement to certain participation rights in, or consent rights over, potential future
equity and debt financings.

 

Capstone Therapeutics and
LipimetiX Development, the Company’s drug development joint venture announced that the JV’s Series B-1 preferred stock offering totaling $1,012,000 closed on August 25, 2016. Individual accredited investors and management participated in the financing.
Evolution Venture Partners has been engaged to advise the JV on corporate finance matters.

 

MannKind announced that the United States District Court for the Central District of California has dismissed the class action that was pending against MannKind and two of its executives. The
Court granted the defendants’ motion to dismiss the plaintiffs’ amended class action complaint without leave to amend, thereby closing the case. The plaintiffs can appeal the decision within 30 days.

 

Provectus Biopharmaceuticals announced that it intends to offer and sell shares of its Series B Convertible Preferred Stock and warrants to purchase common stock, subject to market and other
conditions, in a “best efforts” public offering. Provectus intends to use the net proceeds of the offering for clinical development, working capital and general corporate purposes.
Maxim Group is acting as placement agent for the offering.

 

BeiGene announced the appointment of Amy C. Peterson, M.D. as Chief Medical Officer, Immuno-oncology. Dr. Peterson will lead the global clinical development of BGB-A317, BeiGene’s PD-1 inhibitor;
BGB-290, BeiGene’s PARP inhibitor; and the expanding pipeline of other immuno-oncology agents expected to enter clinical development. Dr. Eric Hedrick, currently serving as the Interim Chief Medical Officer, will continue to oversee global clinical hematology
development including the program for BGB-3111, BeiGene’s BTK inhibitor, and will remain serving as an advisor as BeiGene continues to expand its global clinical development capabilities.

 

TapImmune announced the appointment of Michael Loiacono as its Chief Financial Officer and Chief Accounting Officer. Michael will also act as Corporate Secretary. Michael has served an advisory
role to the Company as finance consultant to TapImmune since March 2016.

 

 

ANALYST RECOMMENDATIONS

 

Roth analyst Joseph Pantginis initiated
Actinium Pharmaceuticals with a “buy” rating and $5 price target, citing the late stage nature of the lead asset, addressing unmet medical needs for AML and pre-HSCT conditioning, clinical data in hand, and a broad set of upcoming catalysts.

 

Janney analyst Ken Trbovich initiated
Jazz Pharmaceuticals with a “neutral” rating and $145 price target, citing muted growth until Vyxeos is FDA-approved and launched in 2H17.