AEterna Zentaris Inc. (USA) (NASDAQ:AEZS)

AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) Explodes After Macrilen NDA Milestone

AEterna Zentaris Inc. (USA) (NASDAQ:AEZS)

Shares of AEterna Zentaris Inc. (USA)(NASDAQ:AEZS) more than doubled in value after the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for Macrilen. The stock ended the day at $2.34 a share after rallying by 129.41% on volumes exceeding 38.9 million shares.

AEterna Zentaris Inc. (USA) (NASDAQ:AEZS)
AEterna Zentaris Daily Candle Bar Graph July 20 2017

AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) is a specialty biopharmaceutical company focused on the development and commercialization of novel pharmaceutical therapies. Its principal product candidates are Zoptrex in oncology and Macrilen in endocrinology. Both drugs are currently in Phase III development.

AEterna Zentaris Inc. (USA)(NASDAQ:AEZS) made a NDA resubmission for Macrilen last month after receiving a Complete Response letter in November of 2014. The letter laid out the FDA’s request for the company to carry out additional clinical trials on the drug, pending its review as a novel treatment for growth hormone deficiency in adults.

“We are pleased that the FDA has formally accepted our resubmitted NDA and that it is under active review with an end-of-year PDUFA date. We remain confident that the FDA will approve our NDA and, therefore, we are moving forward with our preparations to launch the product in the first quarter of 2018,” said CEO, David A. Dodd.

Macrilen Approval Odds

The FDA review period for the drug is six months long which sets the stage for approval early next year or late this year. AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) remains confident on Macrilen achieving regulatory approval for assessing adult growth hormone deficiency. If approved, it will be the first and only FDA approved drug for assessing AGHD.

AEterna Zentaris Inc. (USA)(NASDAQ:AEZS) has already started to develop a commercialization infrastructure for Macrilen in anticipation of FDA approval. The company remains confident of launching Macrilen in the first quarter of 2018.

Macrilen is a ghrelin agonist oral active molecule designed to stimulate the secretion of growth hormone. The candidate drug has already achieved orphan drug designation for the diagnosis of AGHD. AEterna Zentaris Inc. (USA)(NASDAQ:AEZS) owns rights to the patented compound.

AGHD is a medical condition that affects 75,000 adults across the U.S, Canada and Europe. The condition is mostly caused by damage to the pituitary gland characterized by a reduction in bone mineral density, and lean body mass.

In the wake of the NDA milestone, Maxim analyst, Jason Kolbert has initiated coverage of AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) stock with a buy rating. The analyst currently has a $4 share price target on the stock.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $AEZS and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Marc has a degree in economics and a MSc. in Finance. Marc worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

Learning Tree International, Inc. (OTCMKTS:LTRE) Reports Q2 Financial Results

Learning Tree International, Inc. (OTCMKTS:LTRE)

Learning Tree International, Inc. (OTCMKTS:LTRE) was established in 1974. The company specializes in IT and management training, on a global scale, to businesses and governments. Learning Tree can count over 2.4 million professionals among its participants. Their more popular course offerings include data and security, computer networking, application operating systems, and development, and business management. Today the company released their Q2 2017 financial results.

For Q2 2017, Learning Tree International, Inc. (OTCMKTS:LTRE) posted reported revenues of $16.1 million – down from Q2 2016 when the company reported $18.7 million. Operational loss was (-$2.1) million compared to (-$5.2) million in Q2 2016. The company had a net loss of (-$2.3) million, or (-$0.18) per share compared to Q2 2016’s figures of (-$5.4) million or (-$0.41) per share.

The 14.0% decline in revenues for Learning Tree International, Inc. (OTCMKTS:LTRE) Q2 2017 was offset by a lower cost of revenues figure of 23.9% which resulted in an increase in gross profits of 6.8% from last quarter. Total operating expenses excluding the restructuring charge decreased 27.9% quarter over quarter, from $11.3 million to $8.1 million.

The liquidity and working capital needs for Learning Tree International, Inc. (OTCMKTS:LTRE were usually funded through their cash and cash equivalents. For Q2 2017, Learning Tree’s capital resources consisted of cash and cash equivalents of $5.3 million. They have the ability to access a financing and security agreement that has been put in place with Action Capital Corporation that provides the company with the ability to borrow a maximum aggregate amount of $3.0 million. However, the company notes, they have not had to avail themselves to the funds.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: James Marion is a University of Houston student studying Business with a concentration in Finance

Celsius Holdings, Inc. (OTCMKTS:CELH) Reports Q1 Financials

Celsius Holdings, Inc. (OTCMKTS:CELH)

Celsius Holdings, Inc. (OTCMKTS:CELH), headquartered in Boca Raton, FL, has developed and commercialized fitness drinks under the Celsius brand. Sweetened with Sucralose, the drink targets consumers who wish to limit their sugar intake. Today, Celsius Holdings, Inc. (OTCMKTS:CELH) filed their Q1 2017 financial report and released it to the public.

Revenues increased over 63%, to $6.0 million, overQ1 2016. Domestic revenues increased 81% and international revenues increased 18% from the same period one year ago. One year ago gross profit was reported at $1.5 million and that figure jumped to $2.4 million for this quarter. Non-GAPPP EBITDA was a loss of (-$322,000) which included HR considerations of $490,000 for the CEO’s retirement and transition expenses. Net loss to common shareholders was (-$2.0) million which was larger than the (-$1.3) million for the comparable quarter a year ago. Celsius Holdings, Inc. (OTCMKTS:CELH) shareholders lost (-$0.05) per share. Celsius Holdings, Inc. (OTCMKTS:CELH) reported cash on-hand of $20.9 million.

This week, Celsius Holdings, Inc. (OTCMKTS:CELH) announced the launch of a new brand – HEAT. The HEAT beverage line was developed for use by athletes undergoing intense physical training. Interestingly, the company claims that their proprietary formulas have been studied in six clinical trials and published in six peer-reviewed journals.

Celsius Holdings, Inc. (OTCMKTS:CELH) has some impressive investors behind the brand including Kimora Lee Simmons, Russel Simmons, and Horizons Ventures.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: James Marion is a University of Houston student studying Business with a concentration in Finance

Atossa Genetics Inc (NASDAQ:ATOS)

Market Crushing Celadon Group, Inc. (NYSE:CGI) on Alleged Financial Improprieties

Celadon Group, Inc. (NYSE:CGI)

Celadon Group, Inc. (NYSE:CGI) shares are plummeting after the company released a statement claiming that the company’s auditor, BKD LLP, withdrew its support on previously issued quarterly and year-end financial statements. CGI shares closed yesterday at $4.00 and gapped down to open today’s trading at $2.20 which also represents the stock’s highest trading level. Shares have dropped to as low as $1.30 as of 12:08 PM EST and are trading over 80% down from their 200-day simple moving average. Volumes have been large. The small-cap trucking company has a 30-day average daily volume of 627,000 but by noon over 10 million shares had traded.

The carnage visited upon shares of Celadon Group, Inc. (NYSE:CGI) reportedly began on April 5, 2017 when Prescience Point Research published allegations that Celadon had used off-balance sheet entities and manipulative accounting methods to hide its insolvency and shield it from possible adverse actions by creditors.

Short sellers are jumping on Celadon Group, Inc. (NYSE:CGI). The percent of the share float represented by short traders is, as of this writing, at 29%. Just 40 days ago CGI shares had been trading over $9.00 and had a 52-week high of $11.91. The Relative Strength Index (RSI) figure is 12.37. Traders use the RSI to gauge over sold/bought conditions. A figure below 20 is often thought of as over-sold. However, the errors in the financial releases may make many investors hesitant to take a chance.

Sales for Celadon Group, Inc. (NYSE:CGI) had been steadily increasing. In 2012, the company posted sales of $600 million. By 2016 that number had reached $1.07 Billion. In February Stifel analysts had upgraded the shares from a “sell” to a “Hold” and increased their target price from $5.50 to $10.

Securities law firms are out in force trying to sign up investors who owned shares of Celadon Group, Inc. (NYSE:CGI) during the period of the alleged financial misdeeds. It is alleged that Celadon violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (i) Celadon’s equity contribution to its joint venture with Element Financial Corp. was $68.2 million, not the $100 million that Celadon reported in public filings; (ii) Celadon was being investigated by the Securities and Exchange Commission; and (iii) as a result, Celadon’s financial statements were materially false and misleading.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading.

Aeterna Zentaris Inc. (NASDAQ:AEZS) Announces that ZoptEC Phase 3 Clinical Study of Zoptrex™ Did Not Achieve its Primary Endpoint

Aeterna Zentaris Inc. (NASDAQ:AEZS)

Aeterna Zentaris Inc. (NASDAQ:AEZS) has announced that its ZoptEC Phase 3 clinical trial of Zoptrex™ (zoptarelin doxorubicin), used in women with locally severe metastatic recurrent endometrial cancer, failed to attain its primary endpoint – a statistically significant raise in the average period of overall survival patients administered with Zoptrex™ compared to those on doxorubicin treatment.

Aeterna Zentaris Inc. (NASDAQ:AEZS) Chief Scientific Officer Dr. Richard Sachse in a statement said the product recorded an average overall period of 10.9 months as compared to doxorubicin’s 10.8 months. The figure does not meet the statistically significant clinical threshold required in the overall survival rates and hence the ZoptEC Phase 3 clinical trial failed. Additionally, Aeterna Zentaris Inc. (NASDAQ:AEZS) Zoptrex™ did not show any unique features or advantages compared to existing products in regards to the secondary endpoints of safety and efficacy.

According to Dr. Sachse, the product’s median period for patients’ progression-free survival on the Zoptrex™ trial was similar to that of patients in the doxorubicin study. Finally, the product did not exhibit any significant difference between itself and doxorubicin in regards to safety. Both studies had almost similar number of cardiac disorder patients with the Zoptrex™ having eight and the doxorubicin having nine. It is on these grounds that the results were deemed not strong enough to seek regulatory approval of the product.

The company’s President and Chief Executive Officer David A. Dodd expressed disappointment with the outcome of the study. He added that the company won’t undertake any Zoptrex™ trials in regards to any other indications. He thanked the company’s internal team at Aeterna Zentaris Inc. (NASDAQ:AEZS) as well as the company’s team of external investigators for their professionalism and dedication during the exercise.

In what could be the company’s next plan after the disappointing results, Mr. Dodd said they will be shifting focus towards Macrilen™, a new drug application being developed by the company. He expressed optimism that Macrilen™ will go through the final stage. The company is working to make sure that Macrilen™’s NDA is ready for submission in the third quarter of 2017. If the product if approved by the FDA, it will be launched for commercialization in the first quarter of 2018.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.