QUÉBEC CITY--(BUSINESS WIRE)--Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”) today announced that on December 7, 2015, NASDAQ notified the Company that it has regained compliance with Rule 5450(a)(1), which requires a minimum bid price of $1.00 for continued listing on the NASDAQ Capital Market.
Commenting on the announcement, David A. Dodd, Chairman, President and Chief Executive Officer of the Company, stated: “We are pleased that we have been able to regain compliance with NASDAQ's minimum bid price rule, because our NASDAQ listing is important in maintaining liquidity in the trading of our common shares.”
The Company also disclosed that at its annual end-of-year meeting, its Board of Directors recently adopted the following objectives for the Company in 2016:
- Zoptrex™: Completion of the pivotal ZoptEC Phase 3 Clinical Trial – The objective is to complete the ZoptEC Phase 3 study of Zoptrex™ during the third quarter of 2016 and to report top-line results of the study shortly thereafter. In adopting this objective, the Board noted that the Company disclosed, on October 13, 2015, that the independent Data and Safety Monitoring Board recommended that the Company continue the ZoptEC Phase 3 clinical study to its conclusion following a comprehensive review of efficacy and safety data at 192 events. The Board viewed this as a very encouraging development.
- Macrilen™: Completion of the confirmatory Phase 3 Clinical Trial – The objective is to complete the confirmatory Phase 3 clinical trial of Macrilen™ during the fourth quarter of 2016 and to report top-line results within eight weeks of completion.
- Commercial Operations: Addition of another product to our commercial portfolio – The objective is to acquire or in-license at least one product during 2016 and to increase revenues from existing co-promotion arrangements.
- Financial Condition: Capital structuring and strengthening – The objective is to further strengthen the cash balance, while continuing to reduce burn rate. The Board noted that over the past two years, the Company has reduced its staff by over 50%, while significantly reducing its operating burn rate, successfully progressing its commercial focus and running two pivotal Phase 3 programs.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. We are engaged in drug development activities and in the promotion of products for others. The focus of our business development efforts is the acquisition of licenses to products that are relevant to our therapeutic areas of focus. We also intend to license out certain commercial rights of internally developed products to licensees in territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. For more information, visit www.aezsinc.com.
Zoptrex™ (zoptarelin doxorubicin), which was developed by Dr. Andrew V. Schally, a recipient of the Nobel Prize, represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, which could result in a more targeted treatment with less damage to healthy tissue. The Company is currently conducting a ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer, while zoptarelin doxorubicin is also in an investigator-initiated Phase 2 trial in prostate cancer. Aeterna Zentaris owns the worldwide rights to this compound except in China (including Hong Kong and Macau) where rights have been out-licensed to Sinopharm A-Think Pharmaceuticals, a subsidiary of Sinopharm, the largest medical and healthcare group in China and on Fortune's Global 500 list. On April 16, 2015, the Company announced the filing of a patent application intended to strengthen the exclusivity of zoptarelin doxorubicin through a unique, significantly lower cost in the manufacturing process.
Macrilen™ (macimorelin), a ghrelin agonist, is a novel small molecule that stimulates the secretion of growth hormone after the patient drinks a solution containing the compound. If approved by the FDA, Macrilen™ would be the first orally administered drug indicated for the evaluation of AGHD. In the United States, Macrilen™ is expected to be an alternative to the Insulin Tolerance Test (“ITT”), which is considered to be the “gold standard” for growth hormone secretion provocative tests but which requires constant patient monitoring by a physician while the test is administered intravenously and which is contra-indicated in patients with seizure disorders, with cardiovascular disease and in brain injured patients and elderly patients. MacrilenTM has been granted orphan drug designation by the FDA for diagnosis of AGHD. The Company owns the worldwide rights to this novel patented compound.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the US Securities Litigation Reform Act of 1995. Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words “expects,” “believes,” “intends,” “anticipates,” and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects and clinical trials, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process, the ability to protect our intellectual property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and US securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.