All amounts are in U.S. dollars
QUEBEC CITY, Aug. 14, 2012 /PRNewswire/ - Aeterna Zentaris Inc.
(NASDAQ: AEZS) (TSX: AEZ) (the "Company"), today reported financial and
operating results as at and for the second quarter ended June 30, 2012.
Perifosine (Oral Akt Inhibitor)
Phase 3 results for perifosine in refractory colorectal cancer presented
at ASCO in Chicago. Data showed no benefit in overall survival and in
progression-free survival when adding perifosine to capecitabine in the
refractory colorectal cancer setting. Data also showed no significant
difference in toxicity profiles between the two arms, confirming top
line results previously disclosed by the Company on April 2, 2012.
Termination of license agreement with Keryx Biopharmaceuticals, Inc.
("Keryx"), resulted in Aeterna Zentaris regaining full North American
rights to perifosine in all indications.
Company took over the ongoing Phase 3 trial in multiple myeloma from
Keryx, with a pre-planned interim analysis expected in Q1 2013.
Japanese partner, Yakult Honsha ("Yakult"), initiated a Phase 1 trial in
Japan with perifosine in multiple myeloma, which it is sponsoring.
Phase 1 data for perifosine in multiple myeloma published in June issue
of the British Journal of Haematology. The article outlined the safety profile and encouraging clinical
activity of perifosine when combined with lenalidomide and
dexamethasone in relapsed and relapsed/refractory multiple myeloma.
Article in May issue of PLoS ONE, outlined perifosine's potential as a novel approach for the treatment
of mesothelioma, an aggressive type of cancer associated with exposure
to asbestos. Data also described a novel mechanism of perifosine that
interferes, upstream of Akt, affecting EGFR and MET phosphorylation.
Phase 1 results for perifosine presented at the Advances in
Neuroblastoma Conference in Toronto, showed its single-agent activity
against neuroblastoma, a type of childhood cancer which usually begins
in the neural tissues.
Phase 2 data for perifosine as monotherapy in renal cell carcinoma
published in June Issue of Cancer. The article outlined perifosine's anticancer activity which was
comparable to current second-line agents, and authors concluded that
the compound may be worthy of further investigation in this indication
in combination with available therapies.
AEZS-130 (Oral Ghrelin Agonist)
Final Phase 3 results for AEZS-130 as diagnostic test for Adult Growth
Hormone Deficiency ("AGHD") presented at ENDO in Houston, showed the
compound to be safe and effective in diagnosing AGHD.
Subsequent to quarter-end, the Company filed a request with the FDA for
Fast Track designation and a rolling submission for AEZS-130 as a
diagnostic test for AGHD, as part of its New Drug Application ("NDA")
Subsequent to quarter-end, the U.S. Patent and Trademark Office granted
a patent for the use of AEZS-130 (EP1572) as a diagnostic test for
AGHD. Patent will expire on October 12, 2027.
AEZS-108 (LHRH agonist linked to doxorubicin)
Special Protocol Assessment ("SPA") for Phase 3 trial in endometrial
cancer expected to be filed during September 2012.
AEZS-136 (Oral PI3K/Akt Inhibitor)
Poster on AEZS-136 presented at AACR in Chicago, showed the compound's
unique inhibition and excellent preclinical activity against PI3K and
Erk signaling pathways, as well as being well tolerated.
Notification received from NASDAQ regarding the failure by the Company
to comply with the NASDAQ's minimum bid price requirements. Company has
been given until November 12, 2012 to regain compliance.
Share Consolidation (Reverse Stock Split)
Subsequent to quarter-end, Company convened a Special Meeting of
Shareholders for August 15, 2012, asking shareholders to consider and
authorize the Board of Directors to effect, in its discretion, a share
consolidation (or reverse stock split) of the outstanding common
At-The-Market Issuance Program (ATM Program)
During the three-month period ended June 30, 2012, pursuant to the
January 2012 ATM Program, the Company issued a total of 2.6 million
common shares for gross proceeds of approximately $1.9 million.
Appointment to Board of Directors
Subsequent to quarter-end, Carolyn Egbert, former Senior Executive Vice
President at Solvay North America, was appointed to the Board of
Directors. Her appointment is based on her expertise in pharmacology,
human resources and corporate governance with a focus on organizational
design and global restructuring. She was also a on the Board of
Directors of Solvay North America and its subsidiaries Peptisyntha and
Cash and cash equivalents totalled $39.8 million as at June 30, 2012, compared to $46.9 million as
at December 31, 2011.
Juergen Engel, PhD, Aeterna Zentaris President and Chief Executive
Officer, commented, "Unfortunately, the last quarter was marked by
unexpected disappointing results for the perifosine Phase 3 trial in
colorectal cancer. Nevertheless, we pushed forward with a strategic
plan aimed at refocusing the Company's activities and implementing
cost-cutting measures in order to control our burn-rate.
As for perifosine, we decided to continue the Phase 3 trial in multiple
myeloma as we believe this compound still has the potential to become a
novel oral anticancer treatment. Meanwhile, our partner, Yakult,
initiated a Phase 1 trial in the same indication in Japan, showing
their belief in perifosine's potential. Our NDA filing proceedings for
AEZS-130 as an oral diagnostic test for AGHD continued to make progress
with our request to the FDA for Fast Track designation in the hope of
accelerating the review process; and just last week, we announced that
AEZS-130 had been granted a patent for the U.S. in this same
indication, which will expire in 2027. Still with AEZS-130, the
Michael E. DeBakey VA Medical Center initiated a Phase 2 trial with
this compound as a treatment for cancer cachexia. Regarding AEZS-108,
we expect to file a SPA in September for our upcoming Phase 3 trial in
At the human resources level, we implemented an attrition policy whereby
approximately 16% of the workforce at our facility in Germany were
terminated or will terminate over the next year; we gained access to
governmental programs which refund salaries for another approximately
6% of our German workforce; and put some of our earlier-stage drug
development programs on hold to focus on our late-stage programs.
We believe that the strategic plan that we have put in place will enable
us to overcome our recent set back as we remain committed to moving our
late-stage drugs to market for the benefit of both patients and
Dennis Turpin, CPA, CA, Senior Vice President and Chief Financial
Officer at Aeterna Zentaris stated, "As of June 30, 2012, we had a cash
position of $39.8 million which allows us to be well poised to continue
to move our key product candidates through the pipeline."
CONSOLIDATED RESULTS AS AT AND FOR THE SECOND QUARTER ENDED JUNE 30,
Revenues were $7.5 million for the quarter ended June 30, 2012, compared to
$6.5 million for the same quarter in 2011. This increase is largely
attributable to comparative higher deliveries of Cetrotide® to certain customers and to higher research and development services
provided, partly offset by the relative weakening of the euro against
the US dollar.
R&D costs, net of refundable tax credits and grants were relatively stable at $5.2 million for the quarter ended June 30,
2012, compared to $5.6 million for the same quarter in 2011.
Finance income was $12.1 million for the quarter ended June 30, 2012, compared to
finance costs of $2.6 million for the same quarter in 2011. The
significant increase in net finance income is mainly due to the change
in fair value of our warrant liability, as well as to gains due to
changes in foreign currency exchange rates which are mainly related to
the period-over-period continued weakness of the Euro against the U.S.
Net income amounted to $4.5 million, or $0.04 per basic and diluted share, for the
quarter ended June 30, 2012, compared to a net loss of $10.6 million,
or $0.12 per basic and diluted share, for the same quarter in 2011.
This significant decrease in net loss is mainly attributable to higher
net finance income.
Management will be hosting a conference call for the investment
community beginning at 8:30 a.m. (Eastern Time) tomorrow, Wednesday,
August 15, 2012, to discuss the 2012 second quarter results.
Individuals interested in participating in the live conference call by
telephone may dial, in Canada, 514-807-9895 or 647-427-7450, outside
Canada, 888-231-8191. They may also listen through the Internet at www.aezsinc.com in the "newsroom" section. A replay will be available on the Company's
website for 30 days following the live event.
For reference, the Management's Discussion and Analysis ("MD&A") for the
second quarter 2012 with the associated Unaudited Interim Consolidated
Financial Statements can be found at www.aezsinc.com.
About Aeterna Zentaris Inc.
Aeterna Zentaris is an oncology and endocrinology drug development
company currently investigating treatments for various unmet medical
needs. The Company's pipeline encompasses compounds at all stages of
development, from drug discovery through to marketed products. For more
information please visit www.aezsinc.com.
This press release contains forward-looking statements made pursuant to
the safe harbour provisions of the U.S. Securities Litigation Reform
Act of 1995. 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, 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 take advantage of business opportunities in
the pharmaceutical industry, uncertainties related to the regulatory
process and general changes in economic conditions. Investors should
consult the Company's quarterly and annual filings with the Canadian
and U.S. securities commissions for additional information on risks and
uncertainties relating to forward-looking statements. Investors are
cautioned not to rely 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.