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Stock Movers: Hasbro, TetraLogic Pharmaceuticals

TetraLogic Pharmaceuticals (TLOG) shares are up more than 19% in early trading Monday after the clinical-stage biopharmaceutical company, said it has partnered with Merck (MRK) to study combination therapy to treat solid tumors.

The stock recently changed hands at $4.87, slightly below a session high of $5.29. The 52-week range is $3.51 – $6.86. Merck is up 1.6% at $57.83 and has a spread of $52.49 – $63.62. The Phase 1 study will evaluate the safety and efficacy of birinapant, TetraLogic’s SMAC-mimetic, in combination with KEYTRUDA, MRK’s anti-PD-1 therapy, in patients with relapsed or refractory solid tumors.

The study is expected to begin in late 2015. Under the terms of the agreement, TLOG will sponsor and fund the study and MRK will provide KEYTRUDA. The companies have formed a Joint Development Committee to collaboratively oversee the conduct of the study. Results from the study will be used to determine the path for further clinical development of the combination.

“Both molecules are designed to help the body’s immune system better attack cancer cells, and we think the combination could be very promising,” said Kevin Buchi, President and Chief Executive Officer of TLOG.

Hasbro (HAS) shares jumped to a fresh lifetime high Monday morning after the toy and board-game maker reported Q1 financial results that handily beat analysts’ expectations. Shares were up 7.5% in recent trading at $70.85, after earlier climbing to their new high of $71.62. The stock’s previous 52-week high was $66.32.

The company posted Q1 net income of $26.7 million, or $0.21 per diluted share, compared with the prior-year period’s $32.1 million, or $0.24 per diluted share. The prior-year period included $0.10 per share in favorable tax adjustments. Analysts polled by Capital IQ were expecting EPS of $0.08 for the latest quarter.

Revenue was $713.5 million, up from $679.5 million in the same quarter last year and surpassing analysts’ mean estimate for revenue of $660.3 million. The company said the continued growth momentum in the quarter was led by its Entertainment and Licensing Segment, with net revenue rising 74% to $60.6 million. Segment growth was driven by Franchise Brands, particularly the increase in license revenue from My Little Pony and Transformers during the 2014 holiday period. Hasbro also cited underlying strength in demand across international markets, including the emerging markets.

Stocks

Inovio Pharmaceuticals Shares Jump Amid Narrower Q4 Loss

Inovio Pharmaceuticals shares gained more than 17% in trading Monday after reporting a narrower Q4 loss from the same period a year ago and as it announced receiving a $16 million grant.

INO is trading in the lower half of the 52-week range between $6.33 and $15.56, on heavy volume of 1.6 million shares. Average daily volume is 636,392 shares.

The net loss attributable to common stockholders for the quarter was $7.4 million, or $0.12 per share, compared to $15.5 million or $0.30 per share in the same period a year ago. The loss was wider than the loss of $0.10 predicted by analysts.

Total revenue was $2.5 million, up from $1.7 million in Q4 2013 but short of analyst projections of $5.2 million.

“In 2015 we look forward to our first cancer data, our complete phase II data being published in a peer-reviewed medical journal, advancing the many steps toward our phase III launch, initiating clinical studies for additional diseases, and new corporate development steps,” said Dr. J. Joseph Kim, President and CEO.

Separately, the company said that it and academic collaborators, including the University of Pennsylvania, were awarded a $16 million Integrated Preclinical/Clinical AIDS Vaccine Development Program grant from the National Institute of Allergy and Infectious Diseases.

“The grant will fund research to expand PENNVAX coverage of HIV strains as well as to further enhance antibody responses generated by the vaccine,” Inovio said in a statement.

Stocks

Pfenex Posts Narrower Q4 Loss Vs. Estimates

Shares of Pfenex Inc. were slightly lower Monday morning after the clinical-stage biotechnology firm reported a narrower-than-expected loss in Q4 but lower revenues that just missed the consensus of analysts polled by Capital IQ. PFNX is trading near the higher end of the 52-week range of $5.28 to $15.19.

Net loss widened to $3.6 million from $469,000 a year earlier. On a share basis, net loss totaled $0.18 per share compared to a net loss of $0.59 per share in the prior-year period as the number of outstanding shares rose to 20,388 from 1,542 shares. Analysts were expecting a loss of $0.20 per share.

Revenues fell 52.2% year-on-year to $2.0 million, just missing the consensus of $2.1 million. The decrease was due to the expected decrease in BARDA program activity in Q4.

Looking ahead, CEO Bertrand Liang said “2015 is off to an exciting start,” as the company entered into a previously-announced exclusive collaboration with injectable drugs and infusion technologies provider Hospira (HSP) to develop and commercialize PF582, PFNX’s generic version of Genentech’s LUCENTIS.

Under the terms of the collaboration, PFNX will receive an upfront payment of $51 million and, over the next five years and beyond, will be eligible to receive a combination of development and sales-based milestone payments up to an additional $291 million, and tiered double-digit royalty on net sales of the product.

Science, Stocks

Apricus Biosciences Q4 Loss Widens, But Adjusted Loss Is Narrower Than Expected

Apricus Biosciences, a biopharmaceutical company focused on urology and rheumatology, on Monday reported a wider Q4 loss on a large in-licensing charge, but shares edged higher in the pre-market session as its loss excluding that charge was narrower than two analysts had expected. Shares of APRI were up 1.5% recently at $2.10, within a 52-week range of $0.92 to $2.75.

The company reported a Q4 net loss of $17.3 million, or $0.40 per share, compared with a net loss of $1.3 million, or $0.04 per share for Q4 2013. The company noted the widening in the quarterly net loss was primarily due to the in-licensing of fispemifene, a selective estrogen receptor modulator.

Excluding a $13.6 million charge related to the in-licensing, the company’s loss for the latest quarter was $0.09 per share. Two analysts polled by Capital IQ had predicted a loss of $0.12 for the quarter, on average.

Total revenue surged to $1.9 million from $362,000 in Q4 2013, topping one analyst’s prediction of $850,000.

In 2015, APRI expects to generate cash from milestone payments and royalty revenue from partner sales of Vitaros, its product for the treatment of erectile dysfunction. The company also said it will continue to pursue out-license opportunities for Vitaros in Asia Pacific and Latin America.

APRI plans to advance the pipeline with clinical trial progress of RayVa and fispemifene in 2015. The company expects to complete the enrollment of the RayVa Phase 2a clinical trial in Raynaud’s phenomenon in Q2 2015 with the goal of establishing proof-of-concept and the optimal dose required to advance the program into to late-stage clinical trials. APRI plans to begin a Phase 2b clinical trial for fispemifene in Q2 2015, with results expected in Q12016. The company believes its current cash will support its operating plan through 2015.

Science, Stocks

MacroGenics Begins Phase 1 Study of MGD010 for Treatment of Autoimmune Disorders

MacroGenics, a clinical-stage biopharmaceutical company, said Monday it has begun its Phase 1 study with MGD010, the company’s first Dual-Affinity Re-Targeting molecule being developed for patients with autoimmune disorders.

This Phase 1 clinical trial is a first-in-human, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of MGD010 in healthy subjects.

MGD010 is a bi-specific molecule that simultaneously targets CD32B and CD79B, two B-cell surface proteins, for the treatment of autoimmune disorders. MGD010 is designed to inhibit B-cell activation by exploiting the inhibitory function of CD32B, a checkpoint molecule expressed by B cells.

As a result of the study initiation, MGNX will receive a $3 million milestone payment from its partner, Takeda Pharmaceutical. The two companies entered into an option agreement for the development and commercialization of MGD010 in May 2014. Shares closed Friday at $34.77, with a 52-week range of $17.31 to $39.90, and was inactive pre-market.

Science, Stocks

AdLarge Media Signs Exclusive National Advertising Sales Agreement To Represent “The National Marijuana News” Radio Program

AdLarge Media has announced an agreement for exclusive, national advertising sales representation of The National Marijuana News (TNMNews), the unbiased news/talk program focused on the political, economic, medical, and social implications of the rapidly evolving marijuana industry.

“How marijuana fits into our culture is a conversation that is taking place across America, and the public wants the kind of balanced information that TNMNews delivers,” observed Jessica Sherman, Senior Director, Affiliate Marketing, AdLarge Media. “TNMNews is engaging listeners with guests who are experts in the legal and medical professions, and helping audiences find their position on marijuana by presenting the facts.”

Developed by seasoned news producers and media industry professionals, TNMNews takes a deep dive beyond the headlines to explore breaking cannabis news, including field segments, interviews, and roundtable discussions.

The driving force behind TNMNews has been Executive Producer Martin Wagmaister, whose background includes producer of Rick Dees In the Morning and On Air with Ryan Seacrest.

“It’s no longer a debate ‘for or against’,” Wagmaister stated. “Americans are looking for answers that will help them with their personal decisions.  Our goal at TNMNews is to present all the accurate information available, and to explore every viewpoint out there.”

About AdLarge Media (www.adlarge.com)
AdLarge Media is the fastest-growing independent audio advertising sales company in the U.S., representing radio, digital, and mobile content providers.  The company is at the forefront of advertising innovation, driving revenue at the intersection of content and technology with customized solutions that deliver a demonstrated return on investment in an ever-changing media landscape.  AdLarge serves a large portfolio of agencies and brands, and is widely recognized for its collaborative partnerships.  Founded in 2010 by industry leaders Gary Schonfeld and Cathy Csukas, AdLarge Media has offices in New York, Los Angeles, Chicago, and Detroit.

About The National Marijuana News
TNMNews examines the medicinal, political, scientific, professional, and social aspects of the controversial cannabis industry, which is legal in 23 states and the District of Columbia. The radio program goes deep and personal, exploring how cannabis has changed lives, and looks to the future with its potential to reshape the economy. TNMNews seeks to report and explore the subject of medical and recreational cannabis from diverse perspectives, with an open-minded, fact-based approach. For more information, go to www.tnmnews.com.  The National Marijuana News Corp., is a wholly owned subsidiary of DigiPath, Inc. (OTCBB and OTCQB: DIGP).

Information about Forward-Looking Statements
This press release contains “forward-looking statements” that include information relating to future events, and future financial and operating performance. Forward-looking statements should not be read as a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which that performance or those results will be achieved. Forward-looking statements are based on information available at the time they are made and/or management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in, or suggested by, the forward-looking statements. Important factors that could cause these differences include, but are not limited to: the in-demand for the Company’s products, the introduction of new products, the Company’s ability to maintain customer and strategic business relationships, the impact of competitive products and pricing, growth in targeted markets, the adequacy of the Company’s liquidity and financial strength to support its growth, and other information that may be detailed from time-to-time in the Company’s filings with the United States Securities and Exchange Commission. An example of such forward-looking statements in this press release includes statements regarding the Company expanding into the botanical, nutraceutical, and cannabis industries. For a more detailed description of the risk factors and uncertainties affecting DigiPath, please refer to the Company’s recent Securities and Exchange Commission filings, which are available at www.sec.gov. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.