Aeterna Zentaris Inc. (NASDAQ: AEZS) is a biopharmaceutical company, engaged in developing and commercializing novel treatments in oncology, endocrinology, and women’s health. The company’s product pipeline includes MACRILEN, which completed Phase III trial for use in the diagnosis of adult growth hormone deficiency. It is also developing an LHRH-disorazol Z conjugate, which is in pre-clinical development in oncology. Aeterna Zentaris Inc. was founded in 1991, is headquartered in Summerville, South Carolina, and registered in Montreal, Canada.

 

Recent Catalyst:

The company reported on July 18, 2017, it was notified by the FDA, that the Company’s New Drug Application (“NDA”) seeking approval of Macrilen™ (macimorelin) for the evaluation of growth hormone deficiency in adults (“AGHD”) has been accepted as a complete response to the FDA’s November 5, 2014 Complete Response Letter and granted a PDUFA date of December 30, 2017.

David A. Dodd, President and Chief Executive Officer of the Company stated, “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.”

 

Aeterna Zentaris Product Pipeline:

MacrilenTM (macimorelin)

Evaluation of Adult Growth Hormone Deficiency (AGHD)

AGHD affects approximately 75,000 adults across the U.S., Canada, and Europe.  Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status.  AGHD mostly results from damage to the pituitary gland.  It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life as well as an increase of cardiovascular risks.

Clinical Trial Results

Following a comprehensive analysis of the data from the confirmatory trial, the Company concluded as follows:

• Macrilen™ stimulates the pituitary gland to produce growth hormone more effectively than the ITT; in approximately 80% of all patients, measured growth hormone levels following the administration of Macrilen™ were equal to or higher than the growth hormone levels produced by the ITT;
• The Macrilen™ test performed well in the study:
• Sensitivity (87%) and specificity (96%) of the Macrilen™ test were satisfactory;
• Data of the previous study (82% sensitivity, 92% specificity) could be reproduced;
• The co-primary endpoint “negative agreement” with the ITT, which is considered as the more relevant endpoint, was met, demonstrating that the Macrilen™ test provides medical benefit;
• The co-primary endpoint “positive agreement” with the ITT was not met;
• In the repeatability part of the study, conducted upon request of the European Medicines Agency, Macrilen™ results proved to be highly reproducible:
• 94% reproducibility (32 out of 34 cases at the cut-off point defined in the study protocol);
• Reproducibility of the ITT, which was not investigated in this study, appears worse than the Macrilen™ test as demonstrated by a high number of non-evaluable ITTs in the study;
• Study results can be further optimized by modulation of the pre-defined cut-off point of 2.8 ng/mL:
• Any cut-off point for Macrilen™ between 4.6 ng/mL and 8.6 ng/mL would have resulted in a positive study outcome in that both protocol-defined co-primary endpoints would have been met; and
• The dose of Macrilen™ used in the study was adequate and appropriate.

Macrilen™ has been granted orphan drug designation by the FDA for diagnosis of AGHD.  The Company owns the worldwide rights to this patented compound and has significant patent protection left.  The Company’s U.S. composition of matter patent expires in 2022 and its U.S. utility patent runs through 2027.  The Company proposes, subject to FDA approval, to market macimorelin under the tradename Macrilen™.

The Company currently co-promotes two products: Saizen® [somatropin (rDNA origin) for injection], a recombinant human growth hormone supplement, on behalf of EMD Serono; and, APIFINY®, the first non-PSA blood test for use in evaluating and managing the risk of prostate cancer, on behalf of Armune Bioscience.

APIFINY®

The only cancer specific, non-PSA blood test that may aid clinicians in the assessment of risk for the presence of prostate cancer.

• Apifiny® is a simple blood test that measures specific biological markers known to be associated with an immune system response to prostate cancer. Such autoantibodies are detectable in patient’s serum, providing the basis for this diagnostic blood test.
• Now available for commercial use, Apifiny® is an AEZS proprietary, patented technology that may aid clinicians in the assessment of risk for the presence of prostate cancer.
• Apifiny® measures eight autoantibodies released by the immune system in response to the presence of prostate cancer.

Saizen®

Aeterna Zentaris has signed a promotional services agreement with EMD Serono, Inc. Under the terms of the agreement, Aeterna Zentaris details Saizen® to designated medical professionals in specified territories in the United States.

• Saizen® [somatropin (rDNA origin) for injection] is a prescription medicine indicated for the treatment of growth hormone deficiency (GHD) in children and adults:
• to increase growth rate in children with growth failure and who produce low amounts of growth hormone.
• to replace growth hormone in adults because of either a deficiency that started as a child or started as an adult due to pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma

 

First Quarter Financial Highlights:

Revenues were $261,000 for the three months ended March 31, 2017, as compared to $242,000 for the same period in 2016. The increase is mainly explained by the amortization of the up-front payment received in connection with one of the out-licensing agreements that were entered into in 2016 for ZoptrexTM.

R&D costs were $2.5 million for the three months ended March 31, 2017, compared to $3.7 million for the same period in 2016. The decrease is mainly attributable to lower third-party costs attributable to Zoptrex™. Third-party costs attributable to Macrilen™ remained stable during the three months ended March 31, 2017, as compared to the same period in 2016.

G&A expenses were $1.9 million for both three-month periods ended March 31, 2017 and 2016.

Selling expenses were $1.5 million for the three months ended March 31, 2017, as compared to $1.7 million for the same period in 2016. The decrease in selling expenses is explained by the reduction in the number of sales representatives from 20 to 13 in February 2017.

Net finance income was $1.5 million for the three months ended March 31, 2017, as compared to $3.3 million, for the same period in 2016.

Net loss for the three months ended March 31, 2017 was $(4.1) million, or $(0.31) per basic and diluted share, as compared to a net loss of $(3.7) million, or $(0.37) per basic and diluted share, for the same period in 2016. The basic and diluted loss per share decreased because the number of shares outstanding increased following an offering completed in November 2016 as well as issuances under various ATM programs.

Cash and cash equivalents were $17.8 million as at March 31, 2017, as compared to $22.0 million as at December 31, 2016. The decrease in cash and cash equivalents as at March 31, 2017, as compared to December 31, 2016, is due to the net cash used in operating activities and variations in components of working capital.

 

Stock Influences and Risk Factors:

Recent FDA actions have been a catalyst for AEZS shares, however;

The FDA PDUFA date is forthcoming (December 2017) and there is no guaranteed outcome.

If approved, Macrilen™ will be the only FDA-approved drug for assessing AGHD, granted orphan drug status, Patented through 2027

The company may need to generate significant cash in the future to effectively produce and market Macrilen™.

The prospects for companies operating in the biopharmaceutical industry are uncertain.

 

Stock Performance:

On July 19, 2017 AEZS shares closed at $2.37 up 132% on traded volume of 58.9 million shares. The shares hit an intra-day high of $2.80 per share. While the shares have crossed their 50-day MA of $1.01 in a bullish manner, they are still below their 200-day MA of $ $2.65.

 

Summary:

In May 2017, shares of AEZS plummeted after the Phase 3 trial of Zoptrex, a treatment for women with metastatic endometrial cancer, did not meet its primary endpoint of an increase in survival and the company abandoned its clinical trials for the drug. The recent FDA catalyst for Macrilen™ may have put AEZS shares back on track. In May 2017, analysts at both H.C. Wainwright and Maxim Group reiterated their “buy” rating for Aeterna Zentaris shares with high side targets of $11 and $7.50 respectively.

 

 

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