Forward Looking Statement
This presentation contains forward-looking statements made pursuant to the safe harbor 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 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 U.S. 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.
Q3, 2015 -- Continued Progress
•
ZoptEC Final Interim Review by DSMB
•
Saizen® Commercial Launch
Capital Structure Update
•
Series B Warrants virtually eliminated
•
Share consolidation necessary
•
Maintain NASDAQ listing
•
Rebuild and move forward
Shareholder Value Growth Plan
•
Successfully rebuild capital structure and investor confidence
•
Achieve successful commercial presence and growth
•
Field promotion & development of EstroGel
®, Saizen
®& additional
in-licensed products
•
Leverage sales force
•
Focus on generating revenues and cash
•
Pursue successful development and commercialization of our
internal product portfolio
•
Zoptrex™ in oncology
ISS and Glass Lewis Recommend Shareholders of Aeterna Zentaris Vote
FOR Share Consolidation
“Stock consolidations, while not immediately adding to shareholder value, should enhance the long-term growth prospects of the company by broadening its financing alternatives. Continued low trading prices of the company's shares can put them below investment grade for many institutions, limiting the potential capital base for the company and its prospects for raising new capital as needed.”
Press Release
For immediate release
Leading Independent Advisory Firms ISS and Glass Lewis Recommend
Shareholders of Aeterna Zentaris Vote FOR Share Consolidation
AEZS EstroGel
®
Results
Measure (Units)
Q1 2015
Q2 2015
Q3 2015
AEZS % over 2014
8%
8%
8%
Saizen
®
Market Overview
•
Growth Hormones (GH) are used to treat Growth Hormone
Deficiency (GHD) in both adult and pediatric
patients
•
Annually, approximately 40,000 pediatric patients are treated with GH
•
$1.6 billion market that is growing 10% annually
•
Six companies are actively promoting a GH brand
•
No true generic competition in the market
•
All products utilize the same molecule,
somatropin
•
Products are differentiated by mode of delivery, reimbursement, and
patient support programs
AEZS Saizen
®
Goals and Strategies
•
24 sales representatives promoting Saizen
®
in specific US
territories
•
Increase market share and growth of Saizen
®
by
significantly increasing share-of-voice
•
Generate profitable commission revenue: AEZS
compensated for new patient starts, above an agreed-upon
baseline
Aeterna Zentaris Commercial Strategy
•
Achieve successful commercial presence and growth
•
Field promotion & development of EstroGel
®, Saizen
®& additional
in-licensed products
•
Leverage sales force
•
Focus on generating revenues and cash
•
Pursue successful development and commercialization of
our internal product portfolio
•
Zoptrex™ in oncology
•
Macrilen™ in endocrinology
•
Become a profitable, growth oriented specialty
biopharmaceutical company
Zoptrex
™
(zoptarelin doxorubicin)
A Potential Breakthrough in Cancer Therapy
Product
•
New Chemical Entity (NCE) composed of a targeted synthetic peptide carrier
linked to doxorubicin
Value proposition
Improved, targeted delivery of therapy with
improved benefit-risk profile
Zoptrex
™
Phase 2 Success in Prostate Cancer
Aeterna Zentaris’ Zoptarelin Doxorubicin Meets Phase 2 Primary Endpoint
in Men with Heavily Pretreated Castration and Taxane Resistant Prostate
Cancer
Quebec City, Canada, September 28, 2015 – Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the “Company”) today announced that its lead oncology compound, zoptarelin doxorubicin (formerly AEZS 108), met the primary end-point of the investigator-driven and sponsored Phase 2 clinical trial
in Castration and Taxane Resistant Prostate Cancer (CRPC) and demonstrated good tolerability. The primary endpoint was Clinical Benefit (CB) defined as remaining progression-free by RECIST and
Prostate Specific Antigen (PSA) after treatment for 12+ weeks.
Results were presented this morning by lead investigator, Jacek Pinski, MD, PhD, of the USC Norris Comprehensive Cancer Center, during a poster session at the 18th ECCO – 40th ESMO European
Cancer Congress in Vienna, Austria.
Press Release
Zoptrex™
–
Multiple Potential Applications
Tumor Site Estimated New US Cases 2015
Clinical Evaluation
Endometrium 54,870 Locally advanced, recurrent or metastatic,
failure after platinum-taxane
9,000 Phase 3; ZoptEC trial; NCT01767155 (n=500), zoptarelin dox vs doxorubicin
Ovary 21,290
Platinum refractory or resistant 14,180 Phase 2; NCT00569257 (n=42)
Prostate 220,800
Castration and taxane resistant 33,000 Phase 1/2; NCT01240629 (n=25)
Breast 234,190
Chemotherapy refractory triple negative breast cancer
39,800 Phase 2; NCT01698281 Terminated (n=8)
Zoptrex™ Advances to Completion of Pivotal, Phase 3 Program
Aeterna Zentaris: Data and Safety Monitoring Board Recommends
Continuation of ZoptEC Phase 3 Trial in Advanced Endometrial Cancer
DSMB's recommendation follows Final interim efficacy and safety analysis
Quebec City, Canada, October 13, 2015 – Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the “Company”) today announced that the independent Data and Safety Monitoring Board (“DSMB”) has recommended that the pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer)
study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer, continue as planned. The DSMB's decision follows completion of its pre-specified second interim analysis on efficacy and safety for the ZoptEC Phase 3 trial at approximately 192 events. In April 2015, the DSMB made the same recommendation following its first pre-specified analysis on
safety and futility at approximately 124 events. A final analysis of the data is expected at approximately 384 events.
Press Release
Zoptrex
™
Type of Cancer
Annual Market Potential
Endometrial Cancer
$300 million
$400 million
Other Cancers
(Ovarian; Prostate; etc.)
> $500 million
Estimated US Annual Market Potential
Treating Advanced, Recurrent Cancers
Zoptrex™ Commercial Opportunity
SUPERIOR EFFICACY EQUIVALENT EFFICACY INFERIOR EFFICACYWide utilization within indication (5,000 – 9,000 pts/yr)
Broadest utilization (15,000 – 30,000 pts/yr)
Wide Utilization within indication (5,000 – 9,000 pts/yr) INFERIOR SAFETY EQUIVALENT SAFETY SUPERIOR SAFETY
Zoptrex™ Brand Development
•
Core Scientific Explanation & Platform
•
Strong relationships with Gynecological
Oncology leaders
Macrilen
™
(macimorelin)
Product
Novel orally-active ghrelin agonist that induces a fasting
patient’s GH secretion
Status
Confirmatory Phase 3 trial initiated; completion expected
by year-end 2016
Macrilen
™… Strong Value Proposition
•
Novel
: potentially the
only FDA approved
product
for evaluation of AGHD
•
Accurate
: comparable to current standard procedures
•
Safe
: well tolerated
•
Convenient
vs ITT
•
If approved, anticipate rapid market penetration,
Erk Inhibitor Program Shows Progress and Promise
Aeterna Zentaris: Poster Presentation at AACR Meeting Provides Rationale
for New Therapeutic Opportunities in Oncology with Erk Inhibitors
Québec City, Canada, April 9, 2014 - Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company") today announced that a poster on AEZS-134, a highly potent and selective ATP competitive Erk inhibitor, provides rationale for new therapeutic opportunities in oncology with this
compound. The poster, titled, "Erk Inhibition as a Therapeutic Option for the Treatment of Raf- and Mek- Inhibitor Resistant Tumors", I. Seipelt, P. Schmidt, H. Märzhäuser, M. Gerlach, K. Jung, T.
Schuster and M. Teifel, was presented yesterday by Irene Seipelt, Ph. D., Director, Preclinical Development at Aeterna Zentaris, during a poster session at the American Association for Cancer
Research Annual Meeting in San Diego, California.
Press Release
AEZS Erk Inhibitors & Competitors
Erk2 inhibition IC50 [nM] tumor cell in vitro inhibition GI50 [ØnM] PK cmax [ng/ml @10mg/kg] Hct116 in vivo efficacy [%inhibition @60mg/kg] status of cpd AEZS-134 preclinical AEZS-140 preclinical AEZS-141 preclinical AEZS-139 preclinical GDC-0994 phase IKey results compared to AEZS-134
Selected financial information
Condensed interim consolidated statement of financial position information As of September 30, 2015(amounts in thousands of US dollars except share data)
Cash and cash equivalents $ 38,345 Shareholders' equity $ 12,824 Common shares outstanding 492,473,877
Condensed interim consolidated statements of comprehensive loss and cash flows information (amounts in thousands of US dollars except per share data)
Three months ended September 30, 2015 Nine months ended September 30, 2015
Loss from operations $ (7,501) $ (25,026) Net loss $ (15,290) $ (40,125)
Operating expense snapshot
R&D cost snapshot
(amounts in thousands of US dollars)
1,000 2,000 3,000 4,000 5,000 6,000 7,000
Third-party costs Employee compensation
and benefits
Other costs Total research and development
costs
Comparative quarter-to-quarter
Three months ended 9/30/14 Three months ended 9/30/15
2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000 18,000 20,000
Third-party costs Employee Other costs Total research
Third-party R&D cost snapshot
(amounts in thousands of US dollars, except percentages)
Three months ended 9/30/15 Zoptrex™ 1,985 Macrilen™ 408 Erk inhibitors 355 LHRH - Disorazol Z 50 Other 63
Total third-party costs 2,861 Three months ended 9/30/14 Zoptrex™ 2,122 Macrilen™ 68 Erk inhibitors 80 LHRH - Disorazol Z 47 Other 114
Total third-party costs 2,431 Nine months ended 9/30/15 Zoptrex™ 7,147 Macrilen™ 578 Erk inhibitors 1,010 LHRH - Disorazol Z 139 Other 118
Total third-party costs 8,992 Nine months ended 9/30/14 Zoptrex™ 6,059 Macrilen™ 212 Erk inhibitors 376 LHRH - Disorazol Z 202 Other 410 Total third-party costs 7,259