CBLI Back On Track, HTBX Joins Hands With OncoSec, PRAH In Good Health

(RTTNews) - Cleveland BioLabs Inc. (CBLI) has regained compliance with the minimum bid price requirement under NASDAQ rules.

On March 10, 2014, the company was notified that it was not in compliance with the minimum bid price requirement of $1.00 per share, and was given time until September 8, 2014, to regain compliance. On September 9, 2014, the company was afforded an additional 180 calendar day period to regain compliance with the minimum bid price requirement of $1.00 per share.

In order to increase the per share trading price of its common stock to satisfy the $1.00 minimum bid price requirement for continued listing on the NASDAQ Capital Market, Cleveland BioLabs effected a 1-for-20 reverse stock split on January 28, 2015.

CBLI closed Wednesday's trading at $3.55, up 7.90%.

Coronado Biosciences Inc. (CNDO) has in-licensed an intravenous formulation of Tramadol, a phase III ready asset, from Revogenex Ireland Ltd., a privately held company in Dublin, Ireland.

Coronado has formed a wholly owned subsidiary, Avenue Therapeutics Inc., to acquire, in-license, develop and commercialize products principally for use in the U.S. hospital market. Coronado will transfer the Revogenex license to Avenue Therapeutics, Inc. In addition to IV tramadol, Avenue Therapeutics plans to seek additional products.

Tramadol is available as immediate release or extended-release tablets in the U.S., and its sales were roughly $1.2 billion in the U.S. in 2014.

CNDO closed Wednesday's trading down 3.72% at $2.33.

Heat Biologics Inc. (HTBX) and OncoSec Medical Inc. (ONCS.OB) have entered into an agreement to evaluate the combination of the immunotherapy approaches developed by each company.

Under the agreement, Heat and OncoSec will jointly evaluate the preclinical efficacy of Heat's proprietary gp-96-Ig based ImPACT immunotherapy platform using OncoSec's core technology, ImmunoPulse, an investigational stage intratumoral DNA delivery platform.

Heat has two clinical stage programs based on the ImPACT platform - Viagenpumatucel-L (HS-110) in a Phase 2 clinical trial in patients with non-small cell lung cancer and Vesigenurtacel-L (HS-410) in a Phase 2 clinical trial in patients with non-muscle invasive bladder cancer. OncoSec's core platform, ImmunoPulse, which is based on the intratumoral delivery of DNA IL-12, is currently in Phase 2 clinical trials, investigating the approach for treatment of metastatic melanoma, head and neck cancer, triple negative breast cancer, and cutaneous T-cell lymphoma.

HTBX closed Wednesday's trading 12.42% higher at $6.97.

Oncolytics Biotech Inc. (ONC.TO) (ONCY) has completed enrollment in a randomized phase II study of REOLYSIN in advanced or metastatic colorectal cancer, with 103 patients.

The trial is being sponsored and conducted by the NCIC Clinical Trials Group at Queen's University in Kingston, Ontario. Patients were randomized to receive either FOLFOX-6 and Bevacizumab alone (control arm) or FOLFOX-6 and Bevacizumab plus REOLYSIN (test arm).

The primary objective of the trial is to evaluate the effect of REOLYSIN in combination with standard FOLFOX-6 and Bevacizumab therapy on the progression-free survival of patients with advanced or metastatic colorectal cancer.

ONCY closed Wednesday's trading at $0.75, up 4.15%.

PRA Health Sciences Inc. (PRAH), which went public as recently as last November, has delivered strong revenue growth and bottom line results for the fourth quarter ended December 31, 2014.

The company's adjusted net income was $18.6 million or $0.35 per share on total revenue of $369.9 million for the three months ended December 31, 2014. This compares with an adjusted net income of $10.4 million or $0.26 per share and total revenue of $349.6 million in the year-ago quarter.

Service revenue, which accounts for a major chunk of the company's total revenue, was $323.8 million in Q4-2014, up 8% from Q4-2013.

Looking ahead to 2015, PRA Health expects to achieve service revenues between $1.35 billion and $1.4 billion, GAAP earnings per share between $0.60 and $0.65, and Adjusted Net Income per share of $1.35 to $1.45.

PRAH went public on November 13, 2014, pricing its shares at $18 each. The stock closed Wednesday's trading at $27.84, up 1.35%.

Seattle Genetics Inc. (SGEN) has submitted a supplemental Biologics License Application for ADCETRIS to the FDA as consolidation therapy immediately following an autologous stem cell transplant in Hodgkin lymphoma patients at high risk of relapse.

ADCETRIS is already approved in relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma.

Net sales of ADCETRIS in 2014 increased to $178.2 million from $144.7 million in 2013. For 2015, the company anticipates revenues from ADCETRIS net product sales to be in the range of $200 million to $210 million.

SGEN closed Wednesday's trading 5.01% higher at $34.14.