Aeterna Zentaris (AEZS) Tops Q3 EPS by 12c

November 8, 2016 4:55 PM EST
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Aeterna Zentaris (NASDAQ: AEZS) reported Q3 EPS of ($0.61), $0.12 better than the analyst estimate of ($0.73). Revenue for the quarter came in at $289 thousand versus the consensus estimate of $160 thousand.

Cash and cash equivalents were approximately $21.1 million as at September 30, 2016, compared to approximately $26.2 million as at June 30, 2016.

Commenting on recent key developments, David A. Dodd, President and Chief Executive Officer of the Company, stated, “On September 30, 2016, we had unrestricted cash and cash equivalents of approximately $21.1 million. After the end of Q3, we concluded a financing transaction that secured our financial condition on the eve of our completion of two pivotal Phase 3 trials. We raised $7.56 million of gross proceeds from the sale of Common Shares, Pre-funded Warrants and Warrants in a registered direct offering on November 1, 2016. Also between September 14, 2016 and October 14, 2016, we raised approximately $2.3 million of gross proceeds from the sale of 580,912 Common Shares pursuant to our ATM program. Since October 14, 2016, our ATM program has not been utilized. Therefore, we believe we have the funds necessary to complete our two pivotal clinical trials, to report top-line results on both and to file a New Drug Application for Macrilen™ in the first half of 2017, if the results of the trial warrant doing so. While we will need to raise additional funds before we are able to bring a product to market, we expect that reporting favorable top-line results from one or both of our clinical trials will permit us to do so on favorable terms.”

Regarding developments with respect to Zoptrex™ (zoptarelin doxorubicin), the Company’s lead oncology compound, Mr. Dodd stated, “After quarter-end, we concluded the fourth out-license of Zoptrex™, our investigational compound that links a synthetic peptide carrier to doxorubicin as a New Chemical Entity (NCE). Specialised Therapeutics Asia Pty Ltd, a leading specialty pharmaceutical company based in Australia, licensed the product for commercialization in Australia and New Zealand. We received an up-front payment for the rights to Zoptrex™ and we will receive additional milestone payments and royalties if commercialization of the potential product proceeds. Furthermore, we obtained further validation of the market’s interest in Zoptrex™. We expect to release top-line results for our pivotal Phase 3 trial of Zoptrex™ in Q1 of 2017 and if the results of the trial warrant doing so, to file a new drug application for Zoptrex™ in 2017.”

Mr. Dodd continued his commentary with an update on the development of Macrilen™ (macimorelin), “We are pleased to announce that we recently completed recruitment in our confirmatory Phase 3 study of Macrilen™ for the evaluation of adult growth hormone deficiency. As a result, we are very confident that the study of Macrilen™ will be concluded and that we will report top-line results in early 2017. If our expectations for completion of the confirmatory Phase 3 study are realized and if the top-line results indicate that the product attained the primary endpoint of the Phase 3 study, we expect to file an NDA for Macrilen™ in the first half of 2017. Since the regulatory review period for the Macrilen™ confirmatory study is six months, we could begin commercializing the product late in 2017.”

For earnings history and earnings-related data on Aeterna Zentaris (AEZS) click here.

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