Capital expected to be sufficient to complete two clinical trials, to report top-line results and to file a New Drug Application for Macrilen™ in first half of 2017
All $ amounts are in US Dollars
Key developments
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Product development programs remain on track towards FDA
submissions in 2017
- Zoptrex™ (zoptarelin doxorubicin) pivotal Phase 3 clinical program remains on track for release of top-line results in Q1 2017 and submission of New Drug Application to the U.S. FDA in 2017
- Macrilen™ (macimorelin) patient recruitment completed for confirmatory Phase 3 Trial after quarter-end; on track for release of top-line results in early 2017 and submission of New Drug Application to the U.S. FDA in H1 2017
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Zoptrex™ out-licensing activity successfully continues
- License and Supply Agreements were concluded with Specialised Therapeutics Asia Pty Ltd for Australia and New Zealand subsequent to quarter-end on October 12, 2016, following the out-licensing arrangements concluded during July 2016
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Financial condition and capital structure improved
- $21.1 million unrestricted cash and cash equivalents at quarter end; no third-party debt
- Approximately $9.8 million of combined gross proceeds raised from a successful registered direct offering of Units concluded on November 1 and sales of Common Shares pursuant to our ATM program during and subsequent to the third quarter
- Approximately 12.6 million Common Shares and Pre-Funded Warrants exercisable for Common Shares outstanding as of November 8, 2016
- Remaining Series B Share Purchase Warrants expired without being exercised on September 12, 2016
CHARLESTON, S.C.--(BUSINESS WIRE)--Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”), a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology and endocrinology, today reported financial and operating results for the third quarter ended September 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.”