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
- 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
- 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
- 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
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.”
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.”
Third Quarter 2016 Financial Highlights
R&D costs were $4.5 million and $11.9 million for the
three and nine months ended September 30, 2016, respectively,
compared to $4.1 million and $13.0 million for the same periods in
2015. The increase in R&D costs for the three months ended
September 30, 2016, as compared to the same periods in 2015, is
mainly attributable to higher comparative third-party costs. During
2015, we initiated the new confirmatory Phase 3 clinical trial of
Macrilen™. The first patient recruitment was achieved in the fourth
quarter of 2015 and we completed the patient recruitment in the
fourth quarter of 2016. The decrease in R&D costs for the nine
months ended September 30, 2016, as compared to the same periods in
2015, is mainly attributable to lower comparative third-party
costs. Third-party costs attributable to Zoptrex™ decreased
considerably during the nine months ended September 30, 2016, as
compared to the same period in 2015, mainly due to the fact that
dosing of patients in the ZoptEC trial was completed in February
2016. This is consistent with our expectations as we are
approaching the end of the clinical trials. The overall decrease
for the nine-month period is also explained by lower employee
compensation and benefits costs as well as lower other costs. A
substantial portion of this decrease is due to the realization of
cost savings in connection with our ongoing efforts to streamline
our R&D activities and to increase our commercial operations
and flexibility by reducing our R&D staff, which was started in
2014.
General and administrative (“G&A”) expenses were $1.6
million and $5.4 million for the three and nine months ended
September 30, 2016, respectively, as compared to $1.9 million and
$7.4 million for the same periods in 2015. The decrease in our
G&A costs for the three months ended September 30, 2016, as
compared to the same period in 2015, is mainly due to the
realization of cost savings in connection with our corporate
restructuring, which was announced in the fourth quarter of 2015.
The comparative decrease for the nine-month period is also
partially explained by the realization of costs saving in
connection with our corporate restructuring although mainly
attributable to the recording, in the prior year period, of certain
transaction costs allocated to warrants in connection with the
completion of an offering in March 2015.
Selling expenses were $1.8 million and $5.2 million for
the three and nine months ended September 30, 2016, respectively,
as compared to $1.7 million and $5.1 million for the same periods
in 2015. The selling expenses for the three and nine months ended
September 30, 2016, and 2015 represent mainly the costs of our
contracted sales force related to the co-promotion activities as
well as our internal sales management team.
Net loss for the three and nine months ended September
30, 2016, was $6.1 million and $16.7 million, or $0.61 and $1.68
per basic and diluted share, as compared to a net loss of $15.3
million and $40.1 million, or $6.66 and $29.12 per basic and
diluted share, for the same periods in 2015. The decrease in net
loss for the three months ended September 30, 2016, as compared to
the same period in 2015, is due largely to higher comparative net
finance income. The decrease in net loss for the nine months ended
September 30, 2016, as compared to the same period in 2015, is due
largely to lower operating expenses and higher comparative net
finance income. The movements in net finance income (costs)
primarily relate to the change in fair value of warrant
liability.
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.
Conference Call & Webcast
The Company will host a conference call and live webcast to
discuss these results on Wednesday, November 9, 2016, at 8:30 a.m.,
Eastern Time. Participants may access the live webcast via the
Company's website at www.aezsinc.com, or by telephone using the
following number: 201-689-8029, Confirmation #13646681. A
replay of the webcast will also be available on the Company’s
website for a period of 30 days.
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.
We are now conducting Phase 3 studies of two internally developed
compounds. The focus of our business development efforts is the
acquisition or in-license of 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.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provisions of the US Securities
Litigation Reform Act of 1995, which reflect our current
expectations regarding future events. 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 risks and uncertainties, many of which are discussed
in the Company's MD&A, while others are discussed under the
caption "Key Information - Risk Factors" in our most recent Annual
Report on Form 20-F filed with the relevant Canadian securities
regulatory authorities in lieu of an annual information form and
with the US Securities and Exchange Commission ("SEC"). Such
statements include, but are not limited to, statements about the
progress of our research, development and clinical trials and the
timing of, and prospects for, regulatory approval and
commercialization of our product candidates, the timing of expected
results of our studies, anticipated results of these studies,
statements about the status of our efforts to establish a
commercial operation and to obtain the right to promote or sell
products that we did not develop and estimates regarding our
capital requirements and our needs for, and our ability to obtain,
additional financing. Known and unknown risks and uncertainties
could cause our 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 our research and development 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 rejection or non-acceptance
of any new drug application by one or more regulatory authorities
and, more generally, uncertainties related to the regulatory
process, the ability of the Company to efficiently commercialize
one or more of its products or product candidates, the degree of
market acceptance once our products are approved for
commercialization, our ability to take advantage of business
opportunities in the pharmaceutical industry, our 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 U.S. securities commissions
for additional information on risks and uncertainties. Given these
uncertainties and risk factors, readers are cautioned not to place
undue reliance on these forward-looking statements. We disclaim any
obligation to update any such factors or to publicly announce 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.
Condensed Interim Consolidated
Statements of Comprehensive Loss Information
(in thousands, except share and per share
data)
Three months ended September 30,
Nine months ended September 30, (Unaudited)
2016
2015 2016 2015 $
$ $
$ Revenues Sales commission and other
105 111
319 256 License fees
164 62
288
187
269 173
607
443
Operating expenses Research and development costs
4,512 4,050
11,876 12,991 General and administrative
expenses
1,631 1,910
5,390 7,355 Selling expenses
1,829 1,714
5,219 5,123
7,972 7,674
22,485 25,469
Loss from operations (7,703 ) (7,501 )
(21,878 ) (25,026 ) (Loss) gain due to changes in
foreign currency exchange rates
(64 ) (367 )
326 (1,452 ) Change in fair value of warrant liability
1,687 (7,573 )
4,682 (13,986 ) Other finance income
25 40
131 279
Net
finance income (costs) 1,648 (7,900 )
5,139 (15,159 ) Net loss from continuing operations
(6,055 ) (15,401 )
(16,739 ) (40,185 )
Net income from discontinued operations
— 111
— 60
Net loss (6,055 )
(15,290 )
(16,739 ) (40,125 )
Other comprehensive
loss: Items that may be reclassified subsequently to profit or
loss: Foreign currency translation adjustments
(62 )
(21 )
(301 ) 1,260 Items that will not be
reclassified to profit or loss: Actuarial (loss) gain on defined
benefit plans
(400 ) —
(2,622 )
960
Comprehensive loss (6,517 ) (15,311
)
(19,662 ) (37,905 )
Net loss per share (basic
and diluted) from continuing operations (0.61 )
(6.71 )
(1.68 ) (29.16 )
Net income per share
(basic and diluted) from discontinued operations —
0.05
— 0.04
Net loss per
share (basic and diluted) (0.61 ) (6.66 )
(1.68 ) (29.12 )
Weighted average number of shares
outstanding: Basic
9,951,573 2,294,504
9,938,980 1,378,260 Diluted
9,951,573
2,294,504
9,938,980 1,378,260
Condensed Interim Consolidated
Statement of Financial Position Information
(in thousands)
As at September 30, As at December
31, (Unaudited)
2016 2015 $ $ Cash
and cash equivalents1
21,052 41,450 Trade and other
receivables and other current assets
904 944 Restricted cash
equivalents
512 255 Property, plant and equipment
224
256 Other non-current assets
9,047 8,593
Total assets
31,739 51,498 Payables and other current liabilities2
5,066 4,770 Current portion of deferred revenues
453
244 Warrant liability (current and non-current portions)
6,209 10,891 Non-financial non-current liabilities3
16,729 13,978
Total liabilities 28,457 29,883
Shareholders' equity 3,282 21,615
Total
liabilities and shareholders' equity 31,739 51,498
_________________________
1 Approximately $1.0 and $1.5 million were denominated in EUR as
of September 30, 2016 and December 31, 2015, respectively and
approximately$4.5 and $4.4 million were denominated in Canadian
dollars as of September 30, 2016 and December 31, 2015,
respectively.
2 Approximately $0.1 and $0.6 million related to our provision
for restructuring as at September 30, 2016 and December 31, 2015,
respectively.
3 Comprised mainly of employee future benefits, provisions for
onerous contracts and non-current portion of deferred revenues.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161108006227/en/
Aeterna Zentaris Inc.Philip A. Theodore, 843-900-3211Senior Vice
PresidentIR@aezsinc.com
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