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This filing consists of a transcript of a conference call held on May 28,
2008 in connection with the announcement of the proposed combination of Sonus
Pharmaceuticals, Inc. and OncoGenex Technologies Inc.
FINAL TRANSCRIPT
Conference
Call Transcript
SNUS
- Sonus Pharmaceuticals and
OncoGenex Technologies to Merge
Event
Date/Time: May. 28. 2008 / 11:00AM PT
2
CORPORATE PARTICIPANTS
Dahlia Bailey
Sonus
Pharmaceuticals Inc. - EVC Group
Mike Martino
Sonus Pharmaceuticals
Inc. - President - CEO
Scott Cormack
Sonus
Pharmaceuticals Inc. - President - CEO OncoGenex Technologies
Elaine Waller
Sonus
Pharmaceuticals Inc. - SVP of Regulatory and Clinical Development
Allen Fuhrman
Sonus
Pharmaceuticals Inc. - CFO
Cindy Jacobs
Sonus
Pharmaceuticals Inc. - CMO of OncoGenex
CONFERENCE CALL PARTICIPANTS
Mark Monane
Needham &
Company - Analyst
Matt Kaplan
Ladenburg
Thalmann - Analyst
Joseph Pantginis
Canaccord Adams
- Analyst
Philippa Flint
RBC Capital
Markets / Dain Rauscher - Analyst
David Miller
Biotech Stock
Research - Analyst
Jason Canter
RBC Capital
Markets - Analyst
PRESENTATION
Operator
Good
afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the
joint Sonus Pharmaceuticals and OncoGenex Technologies merger conference call.
During todays presentation, all parties will be in a listen-only mode.
Following the presentation, the conference will be open for questions.
(OPERATOR INSTRUCTIONS). This conference call is being recorded today, Wednesday,
May 28 of 2008. Now Id like to turn the conference over to Ms. Dahlia
Bailey. Please go ahead, maam.
Dahlia Bailey
-
Sonus Pharmaceuticals Inc. - EVC Group
Thank
you, operator. Good afternoon, everyone. Thank you for joining us today, Sonus
Pharmaceuticals, Inc. issued a news release before the market opened today
regarding hello? (inaudible - background noise). Thank you for joining us
today. Sonus Pharmaceuticals, Inc. issued a news release before the market
opened today regarding our proposed merger with OncoGenex Technologies, Inc.,
a privately held biopharmaceutical development company. If you need copies of
the press release please contact Sonus s Investor Relations firm, EVC Group at
(415)896-6820 or via e-mail to dabailey@evcgroup.com and a copy will be sent to
you. You can also access the news release on both companies website at
www.Sonuspharma.Com, or www.OncoGenex.ca.
3
Before
we begin, I would like to remind everyone that some of the statements made
today may include predictions regarding future events that may be considered
forward-looking. These statements are based on managements current expectations
and beliefs and are subject to a number of risks, uncertainties, and
assumptions that could cause actual results to differ materially from those
described in the forward-looking statements. These risks and uncertainties
include among others, the possibility that the merger does not close or that
the closing may be delayed, synergies and cost savings may not be achieved, or
the companies are unable to successfully execute their integration strategies,
the timing and cost of clinical trials, and regulatory approval, risks that
clinical trials will not be successful, risks associated with obtaining funding
from third parties or completing of financing necessary to support the costs
and expenses of clinical studies as well as research and development
activities, risks that the combined company will not be able to maintain
listing on NASDAQ, as well as other risks related to the development, safety
and efficacy of therapeutic drugs and potential applications for these drugs. A
complete discussion of risks and uncertainties that may affect forward-looking
statements are included in Sonus Pharmaceuticals filing with the Securities
and Exchange Commission. Now I will turn the call over to Mike Martino,
President and Chief Executive Officer of Sonus. Mike?
Mike Martino
-
Sonus Pharmaceuticals Inc. - President - CEO
Thank
you, Dahlia. Good afternoon, and thank you all for joining us. Here were me
today are members of the Sonus Senior Management Team, Alan Fuhrman, our Chief
Financial Officer, Dr. Elaine Waller, our Senior Vice President of
Regulatory Affairs and Clinical Development and Dean Kessler, our Vice
President of Pre-Clinical Development. In addition, Im really delighted to
welcome and introduce members of the OncoGenex Senior Management Team, Scott
Cormack, President and Chief Executive Officer, Stephen Anderson, Chief
Financial Officer, and Dr. Cindy Jacobs, Chief Medical Officer.
Seven
months ago, we at Sonus shared with you our strategy to rebuild shareholder
value. That strategy involved a number of initiatives designed to capitalize on
our strength as well as conserve our resources. One of our key initiatives was
to identify and evaluate strategic external alternatives and we engaged
Ferghana Partners to assist us in that endeavor. We applied a rigorous and
thorough process to this initiative. Over the past several months we have reviewed
approximately 100 opportunities. From those we selected the most compelling
opportunities for which we did in depth evaluations of available assets and
business fit. Our goal, from the beginning, was to identify quality assets that
would enhance, complement and leverage the strength of our existing clinical
pipeline, capabilities, infrastructure, cash, and public listing. Today were
very pleased to announce the result of that rigorous process and the proposed
merger of Sonus and OncoGenex. This combined Company will have a strong
portfolio of clinical and pre-clinical candidates focused on addressing unmet
needs in the treatment of cancer. It is important to note that each of the
drugs our candidates in the pipeline has a different mechanism of action and
thus, each represents a separate and distinct opportunity to provide new
treatment alternatives for a broad variety of cancers including some of the
most prevalent solid tumors. This merger results in a single more efficient
entity with the capabilities to drive these multiple shots on goal through
Clinical Development. It also gives us an opportunity to apply our cash against
a more diversified product portfolio. We believe this combination of a robust
product portfolio and our cash position should be more favorably reflected in
our market value.
In
addition to pipeline, we believe there are three areas in drug development that
require superb execution to achieve success in the biopharmaceutical industry.
These three areas are pre-clinical product development, clinical strategy and
operations and regulatory affairs. The combined company has proven execution in
all three areas and we believe is poised to achieve several potential
value-creating milestones in the relatively near-term. This proposed merger is
a significant step in the growth of our companies. The combined companies broad
pipeline encompasses a total of four drug candidates. OncoGenex brings the bulk
of these pipeline candidates to the merger. It is our belief that you cant
disconnect the knowledge of and passion for these assets, from the assets
themselves. There for, Scott Cormack will continue as President and CEO to lead
the combined company into the future. Following the closing, Scott will take
the company forward under the name OncoGenex Pharmaceuticals, Inc.
I
would now like to turn the call over to Scott who will provide you with an
overview of the OncoGenex product portfolio as well as his vision for the
combined company.
Scott Cormack
-
Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
Thank
you very much, Mike. We are very excited about this merger and its potential to
create both immediate and future value for the benefit of the Sonus and
OncoGenex shareholders. Though many institutional investors know OncoGenex and
have had the opportunity to observe our history of executing on our business
and clinical objectives, not all of the participants on this call may be
familiar with our story. Therefore, Id like to spend a bit of time introducing
you to OncoGenex, the product pipeline weve developed and why we believe youll
be as excited as we are by this transaction.
4
Id
like to first share with you the vision of the combined entity. The combined
company intends to develop cancer therapeutics that extends survival of
patients with cancer or improve their quality of life. This has been the
mission to both Sonus and OncoGenex before the merger and will continue to be
our mission after the merger. One of the many reasons this transaction makes
sense is that we do not need to realign the interest of our employees or
reinvent our product pipeline. Rather, we can focus on creating shareholder
value through the development of sound, clinical and regulatory strategies and
importantly, execution of these strategies. OncoGenex is committed to the
development and commercialization of new cancer therapies which focus on
mechanisms of treatment resistance in cancer patients. Our product candidates
address treatment resistance by blocking the production of specific proteins
which we believe promote survival of tumor cells. These survival proteins are
over produced in response to a variety of cancer treatments. Our aim in
targeting these particular proteins is to disable the tumor cells adaptive
defenses and thereby render the tumor cells more susceptible to attack with a
variety of cancer therapies. We believe this will increase survival time and
improve the quality of life for cancer patients.
We
bring to this merger three product candidates currently in our pipeline. They
are OGX-011, OGX-427, and OGX-225. OGX-011 is our lead product candidate. It
inhibits the production of clusterin, a protein that is associated with
treatment resistance in a number of solid tumors including prostate, breast,
non-small cell lung, ovarian and bladder cancer. OGX-011 has potential
applicability as a therapeutic in a broad number of cancers at different stages
and can potentially be used in combination with a variety of commonly used
cancer treatments including chemotherapy, radiation therapy, and hormone
ablation therapy. We have completed enrollment of five Phase 2 clinical trials
to evaluate the ability of OGX-011 to enhance the effects of therapy in
prostate, non-small cell lung and breast cancers. We continue collecting and
analyzing data from these trials and intend to provide data updates to augment
the interim data that have been presented over the past 12 months. We provided
an update two weeks ago on an ongoing Phase 2 Study of OGX-011 which further
justifies our registration pathway for this product candidate. From this study,
we reported encouraging outcomes when OGX-011 was administered in combination
with second-line chemotherapy to patients with hormone refractory prostate
cancer. Id like to highlight three key points from these data.
First,
50% of patients experienced a durable reduction in pain. Second, 27% of
patients experienced at least a 50% decline in their prostate specific antigen
value. Prostate specific antigen is also referred to as PSA and is used as an
indicator of prostate cancer progression. And third, 60% of patients are alive
at a median follow-up of 13.3 months. Each of these three outcomes is better
than expected compared to historical studies which evaluated current
second-line therapy. For example, the 50% survival rate we reported at a median
follow-up of 13.3 months is better than a median survival duration of
approximately ten months reported in historical studies.
Our
next clinical update will be a podium presentation at the American Society of
Clinical Oncology Annual Meeting, also known as ASCO, on June 1, 2008.
Based on data collected to date from our Phase 2 studies, we believe that a
randomized controlled clinical trials could be initiated in both prostate cancer
and in non-small cell lung cancer. In order to focus our resources, we intend
to perform a randomized clinical trial in hormone refractory prostate cancer
that will be used as a supportive registration file in the regulatory process.
We intend to initiate the supportive registration trial in the first half of
2009. In addition, we are pursuing a special protocol assessment or SPA from
the FDA for our primary registration trial.
Our
second product candidate, OGX-427, is designed to reduce production of Hsp27, a
protein that is also overproduced in response to many cancer treatments
including the hormone ablation therapy, chemotherapy, and radiation therapy. We
are progressing as planned in a Phase 1 clinical trial for the treatment of
solid tumors including prostate, non-small cell lung, breast, ovarian, and
bladder cancer. We anticipate that the single-agent aspect of this Phase 1
trial will be completed in the second half of 2008, and Phase 2 clinical
development will begin in 2009.
Our
third product candidate, OGX-225, aims to reduce the production of both
Insulin-Like Growth Factor Binding Protein-2 or IGFBP-2 an Insulin-Like Growth
Factor Binding Protein-5 or or IGFBP-5 with a single product to enhance
treatment sensitivity and delay tumor progression. IGFBP-2 and IGFBP-5 are both
hormones that make an alternate hormone known as IGF-1 available to the tumor
that facilitates continued tumor growth. We have completed pre-clinical
pharmacology and need to conduct INDA enabling pharmacokinetics and toxicology
studies before initiating a Phase 1 clinical trial. In combination with Sonus,
the resulting pipeline will have one Phase 2 product which is OGX-011, two
Phase 1 products, OGX-427 and SN2310 and one pre-clinical product OGX-225. To
provide you you with an update on the recent progress of SN2310, Id like to
now turn the call over to Dr. Elaine Waller, Senior Vice President of
Regulatory and Clinical Development for Sonus. Elaine?
Elaine Waller
-
Sonus Pharmaceuticals Inc. - SVP of Regulatory and Clinical
Development
Thank
you, Scott. As a reminder, SN2310 is a novel prodrug or SN-38 which is a potent
anti-cancer drug belonging to the class of topoisomerase I inhibitors. SN2310
is being developed to enhance the delivery and exposure of SN-38 to the tumor
by providing greater prodrug conversion and a longer half-life than achieved
with irinotecan. Additionally, the [put] for being moiety of irinotecan
associated with cholinergic effects including early diarrhea is absent from
SN2310. Our Phase 1 trial is ongoing and we continue to make progress in
determining the safety and
5
pharmacokinetic
profile, in addition to the maximum tolerated dose. While we have seen some
evidence of bone marrow toxicity, it has not yet been identified as a
consistent dose limiting toxicity and thus, we continue to escalate the dose.
We have seen no apparent early diarrhea. The preliminary pharmacokinetic
results suggest that 2310 provides for sustained release of SN-38 resulting in
a longer half-life and similar exposure to SN-38 at much lower doses than
irinotecan. This may result in improved anti-tumor activity. I will now turn
the call back to Scott.
Scott Cormack
-
Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
Thank
you, Elaine. As Mike stated at the beginning of the call, the key to success in
the pharmaceutical industry include having a robust pipeline of product
candidates, sound operations and exceptional clinical and regulatory
strategies. We have discussed the strength of the combined pipeline and
clinical strategy of those programs and now I want to briefly discuss the
people that will execute on the clinical and regulatory strategies. Since the
majority of the OncoGenex Clinical and Regulatory team have been located in
Seattle, Washington since 2005, and the Sonus personnel are located in nearby
Bothell, Washington, we expect to realize immediate synergies and we should be
able to combine our forces without any disruption. The combined teams of
OncoGenex and Sonus have tremendous experience in oncology product development.
This group has not only conducted successful early and late stage clinical
trials but has also been successful in registering oncology products with the
FDA and other regulatory agencies on several occasions. Dr. Cindy Jacobs,
our Chief Medical Officer who is with us on the call today leads our Clinical
Development programs and our Regulatory strategy for product approval with the
assistance of Dr. Monica Krieger, who is our VP of Regulatory Affairs.
Cindy and Monica with their experienced team have collectively been involved
with the clinical trials and/or regulatory approvals for Ambrel, CEPRATE,
Melacine and BEXXAR. Dr. Elaine Waller, the Head of Regulatory and
Clinical Development for Sonus has played a key role in the regulatory approval
of a diverse and successful list of drugs including a Allegra, Nicoderm,
[anasmep] and [rapredim]. The experience of this combined team is very
complimentary.
As a
result, we are confident that we have the clinical and regulatory team in place
to optimally develop our product pipeline and meet our key near-term
milestones, which include, one, the announcement of OGX-011 Phase 2 data in
second line hormone refractory prostate cancer on June 1, 2008, at the
ASCO meeting; number two, the completion of an SPA with the FDA which is
expected in the fourth quarter of 2008; number three, determination of the
recommended Phase 2 dose for OGX-427 in the fourth quarter of 2008; number
four, determination of the recommended Phase 2 dose for SN2310 in the fourth
quarter of 2008.
Now,
to provide you with an overview of the post transaction terms, as well as an
update on our NASDAQ listing, Id like to turn the call over to Allen Fuhrman,
Chief Financial Officer of Sonus Pharmaceuticals.
Allen Fuhrman
-
Sonus Pharmaceuticals Inc. - CFO
Thank
you, Scott. Under the terms of the proposed merger, Sonus will acquire all
outstanding shares and convertible debentures of OncoGenex through the issuance
of approximately 37 million shares of Sonus common stock. Following the close
of the proposed transaction, OncoGenex shareholders will hold 50% of Sonuss
common stock. An additional 25 million shares will be placed in escrow. The
escrow shares will be released to former OncoGenex shareholders upon
achievement of specific milestones that are intended to demonstrate continued
development of OncoGenex assets and execution of the combined companies
business plan. Over the past several months, Sonus evaluated a number of
prospective merger candidates and we believe that merging with OncoGenex
represents the best opportunity to build shareholder value. Throughout our
evaluation of strategic alternatives we analyzed numerous oncology companies
with product portfolios similar to that of OncoGenex. As part of our process we
also reviewed comparable companies with lead compounds with Phase 2 data and
additional clinical assets to establish an appropriate range of valuation for
perspective transaction.
As
Mike mentioned, Sonus has not received full value for its cash position. We
believe this may be due to a perception that we were not in a position to apply
our cash towards the development of a robust clinical pipeline, with the
combination of our product pipelines, development teams, and resulting clear
clinical pathways with near-term value drivers, we believe our valuation should
now reflect the technology value of comparable companies that have a lead
compound of Phase 2 data, similar market opportunities and our cash. The Board
of Directors of both companies has unanimously approved this transaction which
is expected to be completed in the third quarter of 2008 pending regulatory and
shareholders approvals. Voting agreements in favor of the transaction have
already been assigned by the directors and officers of OncoGenex as well as at
least 2/3 of each class and series of OncoGenex shareholders, which is
sufficient to approve the transaction. Additionally, OncoGenex is preparing an
information circular for approval by its shareholders. As is frequently the
case in cross boarder transactions of this nature, OncoGenex requires approval
by the Canadian Courts which is will be sought as soon as possible. We do not
anticipate any issues with obtaining this approval.
6
Sonuss
directors and officers have also signed voting agreements in favor of the
transaction. Sonuss preparing a proxy statement which it plans to file
promptly with the SEC, following the SECs approval we will file and mail a
copy to Sonuss shareholders who will be asked to approve the transaction at a
subsequent shareholder meeting.
Id
now like to provide brief update on our NASDAQ listing. We have requested a
hearing with a NASDAQ listing qualifications panel which we anticipate will
occur near the end of the second quarter. We expect Sonuss common stock will
continue to trade on the NASDAQ Global Market during this process. OncoGenex
will fully participate in our appeal process as the combined companies pipeline
and capabilities will figure prominently in our course of action. Now Ill turn
the call back to Mike to conclude our discussion.
Mike Martino
-
Sonus Pharmaceuticals Inc. - President - CEO
Thanks,
Allen. Today, weve announced a proposed merger that creates a combined company
with a broad and deep oncology drug pipeline, as well as the people and
development capabilities to drive those pipeline assets through pre-clinical
and clinical development. We are very excited about the potential for the combined
Company and believe this proposed transaction creates multiple potential value
inflection points for all shareholders through the achievement of near and
long-term milestones. This concludes our prepared remarks. We would now like to
open the call for questions. Operator?
7
QUESTION
AND ANSWER
Operator
Thank
you, sir. (OPERATOR INSTRUCTIONS). Our first question is from the line of Mark
Monane with Needham & Company. Please go ahead.
Mark Monane
-
Needham &
Company - Analyst
Good
afternoon, sunny day in New York City and sounds like a new start, a new bold
adventure for both companies, congratulations.
Mike Martino
-
Sonus Pharmaceuticals
Inc. - President - CEO
Hi,
Mark, well its actually sunny here in Seattle as well, believe it or not.
Scott Cormack
-
Sonus Pharmaceuticals
Inc. - President - CEO OncoGenex Technologies
Good
afternoon, Mark.
Mark Monane
-
Needham &
Company - Analyst
Thats
a good sign. A question for you. Lets start off with, please, with questions
with Allen. Whats the current cash position of the Company and do you have any
thoughts now about what the burn might be going forward developing these later
stage products which are now part of the portfolio?
Allen Fuhrman
- Sonus Pharmaceuticals Inc. - CFO
Yes,
Mark. So our last reported Q1 number was almost 29 million just shy and at that
point in time I believe that OncoGenex had approximately four, so on a pro
forma basis as of March 31, there was $33 million. I think in regard to
how we project going forward, Ill turn that question back to Scott.
Scott Cormack
-
Sonus Pharmaceuticals
Inc. - President - CEO OncoGenex Technologies
Thanks,
Allen. Hi, Mark. With respect to the go forward plan, clearly theres some
synergies that were going to be capturing as we move forward in the
post-merger time frame, and were expecting the burn rate on a monthly basis to
be somewhere around the range of 1.3 million. As Allen had just indicated, the
total cash for the two companies put together run into about 33 million gives
us a runway of about 25 months.
Mark Monane
-
Needham &
Company - Analyst
Terrific.
Okay, that was helpful. With regard to the clusterin product, prostate cancer
has been a challenging area of development right now in terms of acceptable
outcomes to the FDA versus acceptable outcomes to physicians and patients. Can
you talk to us about which outcomes are most relevant in your opinion and what
should we pay attention to perhaps at the ASCO presentation?
Scott Cormack
-
Sonus Pharmaceuticals
Inc. - President - CEO OncoGenex Technologies
Sure.
So I will take the first piece of that and then maybe turn that over to Dr. Cindy
Jacobs, our Chief Medical Officer. So with respect to prostate cancer and more
specifically hormone refractory prostate cancer theres two primary areas that
we look at for end points. The first is survival which is kind of the primary
that we should be looking at in many different indications of oncology. The
second that were evaluating is
8
in
respect to pain responses. As I had indicated in the prepared statements, we
have served in our treatment with OGX-011 with hormone refractory patients some
very very good data set with respect to the pain responses and that is similar
to what were seeing with respect to survival outcomes so those two metrics were
seeing, were basically following the biology and the data set that we see and
well be following those through to end points. Cindy, Ill turn it over to you
with respect to the ASCO conference or if you want to add anything else to that
statement.
Cindy Jacobs
-
Sonus Pharmaceuticals
Inc. - CMO of OncoGenex
Yes,
we have an expert advisory panel consisting of leading clinicians in the area
of hormone refractory prostate cancer and everyone is pretty much in agreement that
survival and pain palliation are the key end points for any of the trials.
These are also the end points that FDA is currently viewing as primary end
points for product approval, the docetaxel was approved on survival benefit,
mitoxantione which has been around has been approved on pain palliation, so
were at least in agreement in that regard.
Scott Cormack
-
Sonus Pharmaceuticals
Inc. - President - CEO OncoGenex Technologies
Okay,
thanks, Cindy.
Mark Monane
-
Needham &
Company - Analyst
That
was helpful and the last question, on the TOCOSOL platform it seems to provide
an engine for ongoing drug development, thus ways companies can get products to
move up the channel but TOCOSOL seems to provide a pathway. Can you update us
what your plans are going forward for developing this platform?
Mike Martino
-
Sonus Pharmaceuticals
Inc. - President - CEO
Well,
Mark, this is Mike. I think the one ongoing product candidate that utilizes at
least a version of TOCOSOL as a delivery vehicle is in fact SN2310, but as we
have previously discussed, what you really need to focus on with that product
is the fact that it is a unique prodrug of SN-38. TOCOSOL as the delivery
vehicle is really a secondary part of the story. Regarding intentions to
further develop TOCOSOL as a delivery vehicle going forward, Id bounce that
one over to Scott, although my bet is that its simply too early in the process
to make any conjectures on that, but Scott?
Scott Cormack
-
Sonus Pharmaceuticals
Inc. - President - CEO OncoGenex Technologies
Yes, thanks, Mike. I think that your last
conclusion is probably accurate. We clearly are interested the capabilities of
TOCOSOL and certainly look forward to evaluating the data particularly with
respect to SN2310, but it certainly will figure prominently as we look at other
potential opportunities in the field of oncology and using that potentially to
augmenting our approach.
Mark Monane
-
Needham &
Company - Analyst
Thanks
for the added information and best wishes going forward.
Mike Martino
-
Sonus Pharmaceuticals
Inc. - President - CEO
Thanks
a lot, Mark.
Scott Cormack
-
Sonus Pharmaceuticals
Inc. - President - CEO OncoGenex Technologies
Thank
you.
9
Operator
Our
next question is from the line of Matt Kaplan with Ladenburg Thalmann. Please
go ahead.
Matt Kaplan
-
Ladenburg Thalmann -
Analyst
Hi,
guys, thanks for taking my questions and congratulations, Mike and Allen.
Mike Martino
-
Sonus Pharmaceuticals
Inc. - President - CEO
Thank
you, Matt.
Scott Cormack
- Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
Thanks,
Matt.
Matt Kaplan
-
Ladenburg Thalmann -
Analyst
A
couple questions. Could you talk about clusterin and I guess why its a good
target and then talk a little bit also why about your (inaudible - background
noise) technology is the best way to address this technology.
Scott Cormack
- Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
Sure,
thanks, Matt. Its Scott Cormack speaking. So first with respect to clusterin
as a target, theres a very substantial body of data that exists in the
scientific peer review literature that associates clusterin with treatment
resistance in a very large number of different tumor types and I dont want to
get overly complicated in this particular call, but as we apply different
treatment strategies, whether its chemotherapy, radiation, hormone ablation,
etc, tumors try to adapt and survive, and in response to that, produce this
protein clusterin, and when clusterin is there, if you look again to the
literature youll find that the existence of clusterin makes these tumors
resistant to a very large and broad array of treatment strategies in creating
resistance. Thats been evidenced in a number of different human tumors,
certainly confirmed in pre-clinical model systems and clearly where were
moving in the clinical environment is to confirm that as a therapeutic approach
in larger randomized clinical trials.
With
respect to antisense, we are utilizing the Isis second-generation chemistry in
combination with the inhibitors for clusterin. We went through a very long
process early in our development history to evaluate different ways that we
could approach the knock down of this particular protein, and our best approach
because of the complexity of the molecular level of this protein is that we
needed to interrupt production of the protein at the RNA level and when we
looked at different opportunities for antisense and other strategies we
evaluated the number of different approaches whether it was formulation based
or whether it was chemistry based, and Isis second-generation chemistry known
as the two-prime mode chemistry performed extremely well for us in the
pre-clinical models, where we were able to give this drug on a once a week
basis and demonstrate superior knock down compared to the first-generation
chemistry so we felt we had a very good chemistry on our hand that we could
move forward, had all of the attributes of a drug we wanted to move forward into
the clinic and went forward on that basis.
Matt Kaplan
-
Ladenburg Thalmann -
Analyst
And
can you comment a little bit on in terms of are there other programs in
development from a competitive point of view targeting clusterin as well?
Scott Cormack
-
Sonus Pharmaceuticals
Inc. - President - CEO OncoGenex Technologies
Its
interesting. The biology of clusterin is actually fairly complicated and there
is one group that is trying to target a secreted form of the protein. That just
came out of one of the research centers not too long ago, but for the most
part, we dont believe thats going to be an effective strategy because we need
to influence a nuclear form of the protein as well as a secreted form of the
protein, and the only way that we can approach that is through disruption of
the production of the protein at the molecular level. We used a small molecule
approach, for example, we would only approach the secreted form of the protein
which in our hand simply is not going to yield the same power as we see with OG
X-011.
10
Matt Kaplan
-
Ladenburg Thalmann -
Analyst
And
could you also talk a little bit, you mentioned this in your answer to the
question, when you did your initial development, you saw a rapid reduction in
clusterin. How long does it typically take to see that reduction with your
compound?
Scott Cormack
-
Sonus Pharmaceuticals
Inc. - President - CEO OncoGenex Technologies
The
best way to look at that is probably in the context of a study that we
published in 2004, published in JNCI. This was a study that we wanted to answer
the key questions of antisense, which if I can categorize those questions are,
Can you deliver antisense systemically? Will these drugs go to tumor? Will they
actually be taken up by cells and ultimately is this a powerful enough tool to
regulate targets in various diseases and disorders? We did this in the context
of a prostate study in patients that were in high risk features, had high risk
features and candidates for radical prostatectomy or surgical removal of the
prostate. We treated those on a once a week basis with hormone ablation therapy
and removed the prostate on average four days after surgery and up to seven
days after surgery to evaluate, one, whether we got drug into the prostate and
lymph nodes and two, whether we saw target regulation sufficient in both
prostate and lymph nodes again, and that data set revealed that on a once a
week dosing we saw a 92% inhibition of clusterin in human prostate and 98% knock
down of clusterin in these patients lymph nodes. On average that says that the
range was, the radical prostatectomy was done as I said on the range of three
to four days and up to seven days, and we saw that kind of target knock down so
I think that supports a half-life in tissue that is similar to what we saw
pre-clinically in that range of about 10 days. That study has subsequently been
repeated in a Phase 2 environment where we look at trying to extend that and I
think we do see fall off if we try to push that out to a three week time frame,
but certainly were happy with having a once a week administration of this drug
in the oncology indications that were pursuing. Its a long winded answer for
you, Matt, but hopefully thats satisfactory.
Matt Kaplan
-
Ladenburg Thalmann -
Analyst
No,
great. I appreciate that and just in terms of how does the reduction that you
see in the prostate correlate with what you see in the serum in terms of
clusterin?
Scott Cormack
-
Sonus Pharmaceuticals
Inc. - President - CEO OncoGenex Technologies
Yes,
Cindy, do you want to touch base on that?
Cindy Jacobs
-
Sonus Pharmaceuticals
Inc. - CMO of OncoGenex
Sure.
We have been looking at the serum clusterin levels and what were initially
seeing is that the serum clusterin levels start to become lower, about the
second cycle of treatment so really after about four weeks of the weekly
administrations, and the serum clusterin is not quite as reduced as the tissue
levels but again we are seeing reduction in the serum of about 30%.
Mike Martino
-
Sonus Pharmaceuticals
Inc. - President - CEO
Its
important, Matt, I think to recognize that clusterin in is produced by a number
of different cells and tissues so what we see in serum may not necessarily and
doesnt obviously reflect precisely what we see at the sites of tumors and I
think the best evidence of that is that 2004 study where we looked at both
serum clusterin as well as target knock down in prostate and lymph nodes.
Cindy Jacobs
-
Sonus Pharmaceuticals
Inc. - CMO of OncoGenex
We
are; however, in our studies following serum clusterin levels and at the ASCO
Meeting some preliminary data will be presented on June 1 that you should
take a look at.
11
Matt Kaplan
-
Ladenburg Thalmann -
Analyst
Great.
And then just one more question. In terms of your deal with Isis?
Scott Cormack
-
Sonus Pharmaceuticals
Inc. - President - CEO OncoGenex Technologies
Yes.
Matt Kaplan
-
Ladenburg Thalmann -
Analyst
Can
you talk a little bit about that and I guess how that works from a business
point of view? Does Isis get a royalty or how that works in terms of the Isis
terms?
Mike Martino
-
Sonus Pharmaceuticals
Inc. - President - CEO
Sure
for OGX-011 there is a co-development relationship with Isis, thats been in
place since I believe it was 2001 where we basically are sharing costs for the
development of this program. Its a 65/35 co-development relationship where
OncoGenex has 65% of the cost and gets 65% of the resulting revenues and future
earnings. So its a true co-development relationship in respect to that
program.
Matt Kaplan
-
Ladenburg Thalmann -
Analyst
Great.
Thank you.
Mike Martino
-
Sonus Pharmaceuticals
Inc. - President - CEO
Youre
welcome.
Scott Cormack
- Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
Thanks,
Matt.
Matt Kaplan
-
Ladenburg Thalmann -
Analyst
Good
luck.
Operator
Thank
you. You our next question is from the line of Joseph Pantginis with Canaccord
Adams. Please go ahead.
Joseph
Pantginis
-
Canaccord Adams - Analyst
Hi,
guys, good afternoon and congratulations on the transaction as well. Two quick
questions on OGX-011 in prostate cancer as well. Can you just define again the
patient population that youre going after again and then also Scott, with your
comments regarding the Isis deal, co-development deal, can you define or help
to define your commercial strategy going forward for the drug and any potential
additional partnering efforts you might look towards? Thanks a lot.
Scott Cormack
-
Sonus Pharmaceuticals
Inc. - President - CEO OncoGenex Technologies
Ill have Cindy answer the first question and
Ill take your second one.
12
Cindy Jacobs
-
Sonus Pharmaceuticals Inc. - CMO of OncoGenex
The
patient population, we are looking at patients that have hormone refractive
prostate cancer that have failed first-line docetaxel chemotherapy that means
they have been treated with docetaxel and have now progressed after that
first-line chemotherapy. They are now then able to receive second-line
chemotherapy, that could be mitoxantione or retreatment with docetaxol as well.
Joseph
Pantginis
-
Canaccord Adams - Analyst
Okay.
Mike Martino
-
Sonus Pharmaceuticals Inc. - President - CEO
Now,
with respect, Joe, to your second question on commercial strategy or
commercialization strategy, as Im sure many people on the call will recognize,
neither OncoGenex nor Isis have established salesforce to be able to market
OGX-011 upon further development in clinical trials and ultimately regulatory
approval, so we have figured within the agreement if you were to look at those
agreements you would certainly see there was contemplation of doing partnering
and that still figures in our long-term vision for this program with a group
that has capacity to market a drug like this that has capacity across a broad
number of tumors in different stages of those diseases, so we look to see a
marketing partner that has that depth of sales force and penetration on a sort
of a worldwide geography.
Joseph
Pantginis
-
Canaccord Adams - Analyst
Great.
Thanks a lot.
Mike Martino
-
Sonus Pharmaceuticals Inc. - President - CEO
Thanks,
Joe.
Operator
Thank
you. Our next question is from the line of Philippa Flint with RBC Capital
Markets / Dain Rauscher. Please go ahead.
Philippa Flint
-
RBC Capital Markets / Dain Rauscher - Analyst
Great.
Thanks for taking my questions. Most of them have been answered. Just a couple
in regards to the OGX-011 Phase 3 or next steps. Could you remind me when you
expect to see data from the supportive registration trial that youre starting
at the beginning of 2009 and secondly your rationale for starting that study
first as opposed to completing the FDA and starting the pivotal trial with the
money that you have.
Mike Martino
-
Sonus Pharmaceuticals Inc. - President - CEO
Sure.
Elaine Waller
-
Sonus Pharmaceuticals Inc. - SVP of Regulatory and
Clinical Development
Okay,
let me just say the FDA, we have already been discussing with the FDA and we
are looking to our milestone to finalize the FDA for our registration or
primary registration study. In lieu of that we would also be looking at
starting a supportive registration trial the beginning of 2009. As far as the
timelines for completing that, we can look about 18 months or so, two years and
we dont have any specific timelines that have worked out and we would have to
give guidance on that at a later time.
13
Philippa Flint
-
RBC Capital Markets / Dain Rauscher - Analyst
And
so why start that first as opposed to the pivotal trial?
Scott Cormack
-
Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
Yes,
theres two reasons, Phillip. Its Scott again. At approach that we were
proceeding down before had us pursuing a Phase 3 registration trial with a
different combination approach, and as we were running our Phase 2 program that
we will be releasing the results of in the ASCO Meeting coming up in the next
couple weeks, that data set revealed a slightly different strategy, which was
demonstrating this ability to potentially reverse resistance in patients
treated with docetaxol. With that knowledge and biology behind us, there is a
logical argument to say we should bolster up the data set and have more
randomized control data to move forward with, and so this trial will allow us
to go down that pathway and also look at the pain response. In an ideal world
obviously youd want to run both of these for ultimate registration and the
timing is dependent on a number of factors which do include of course capital
availability.
Philippa Flint
-
RBC Capital Markets / Dain Rauscher - Analyst
Okay
and can you comment at all on when you would hope to find a marketing partner?
Scott Cormack
-
Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
Yes,
thats been an ongoing process for us particularly as we started to announce
Phase 2 data set. At this point we cant give specific guidance on timing other
than we will continue that effort as we move forward in the coming amount of
time.
Philippa Flint
-
RBC Capital Markets / Dain Rauscher - Analyst
Great.
Thanks very much.
Scott Cormack
-
Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
Thanks.
Operator
Thank
you. (OPERATOR INSTRUCTIONS). Our next question is from the line of David
Miller with Biotech Stock Research. Please go ahead.
David Miller
-
Biotech Stock Research - Analyst
Hi,
good morning and thanks for taking my questions.
Mike Martino
-
Sonus Pharmaceuticals Inc. - President - CEO
Hi,
David.
David Miller
-
Biotech Stock Research - Analyst
Where
will the companies headquarters be?
14
Mike Martino
-
Sonus Pharmaceuticals Inc. - President - CEO
So
currently we have offices in Vancouver, Canada, and Seattle, and we have been
operating, we, OncoGenex, sorry, have been operating on this front where our
Management team is somewhat split between those two facilities. Steve Anderson,
our CFO and myself are based in Vancouver and Cindy Jacobs and Monica Krieger
representing Chief Medical Office and Head of Regulatory respectively are based
in Seattle. We dont see that changing materially in this merger. We will
continue to be moving up and down the I-5 as we have been for the last three
years and thats worked out very effectively for us.
David Miller
-
Biotech Stock Research - Analyst
Okay.
Can you talk a little bit about the milestones that trigger the share amounts
and what share amounts those are, specifically are they sales milestones or
clinical milestones?
Mike Martino
-
Sonus Pharmaceuticals Inc. - President - CEO
Yes,
we can give you some general guidance. At this point, we will probably give
more detailed information, obviously in the proxy circular when that comes out
but suffice to say that these generally will be clinical and regulatory
milestones and be pretty much focused on initiation and completion of key clinical
trials.
David Miller
-
Biotech Stock Research - Analyst
Okay.
And completion, successful completion or just completion of enrollment?
Mike Martino
-
Sonus Pharmaceuticals Inc. - President - CEO
Its
more defined on enrollment actually.
David Miller
-
Biotech Stock Research - Analyst
Okay.
And you mentioned in the press release that theres likely going to be a
reverse split. Will the 25 million shares that are subject for these milestones
be part of that reverse split?
Mike Martino
-
Sonus Pharmaceuticals Inc. - President - CEO
Yes.
David Miller
-
Biotech Stock Research - Analyst
Okay.
Now, talk a little bit about the prostate cancer development program. Do you
expect to have data back from the randomized Phase 2 trial before you finalize
the SPA and launch the Phase 3 trial?
Scott Cormack
-
Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
So
for clarity, are you referring to the first-line prostate cancer trial?
David Miller
-
Biotech Stock Research - Analyst
Good
question, maybe you should go over that again for me.
15
Scott Cormack
-
Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
Okay.
Its a leading question.
David Miller
-
Biotech Stock Research - Analyst
Right.
Scott Cormack
-
Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
We
have two Phase 2 programs in prostate cancer, both of which are randomized. One
is in first-line Hormone Refractory Prostate Cancer so these are patients going
through chemotherapy for the first time.
David Miller
-
Biotech Stock Research - Analyst
Right,
yes.
Scott Cormack
-
Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
The
second is also a randomized trial but both arms were receiving OGX-011 and we
were actually evaluating the ability of OGX-011 to potentiate either
mitoxantione, after docetaxol or retreating these patients with docetaxol. The
second one is really sort of the guiding light to where were moving in the
registration path and we have evaluated initially looking at a registration
path that would pursue combination mitoxantione as I said through the prepared
statements were now reevaluating that strategy on the basis that we were
favorably impressed by the data set that we generated in retreat being these
patients with docetaxol. That has become our dominant strategy now and
principally I think because as many will recognize, Taxotere in prostate is the
only drug that has been registered and approved for survival benefit in this
patient population. If we can restore sensitivity to that drug after these
patients no longer respond, and we can get additional cycles of therapy into
these patients we think we would have a very robust therapeutic on our hands.
David Miller
-
Biotech Stock Research - Analyst
Okay,
so you have under way already two randomized programs or youre going to launch
those programs?
Scott Cormack
-
Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
The
first-line prostate is complete, interim data has been released and were now
following principally for survival outcome in that trial.
David Miller
-
Biotech Stock Research - Analyst
Okay.
Scott Cormack
-
Sonus Pharmaceuticals Inc. - President - CEO OncoGenex
Technologies
In
the second-line prostate, again interim data has been presented and an update
will be provided at June 1 at the ASCO Conference coming up.
David Miller
-
Biotech Stock Research - Analyst
Okay,
so the SPA in other words will be based upon those and so the Phase 3 trial
that youre looking at is second-line?
Scott Cormack
-
Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
Thats
correct.
16
David Miller
-
Biotech Stock Research - Analyst
Okay.
Scott Cormack
-
Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
And
the SPA would be in combination with docetaxol in second-line Hormone
Refractory Prostate Cancer.
David Miller
-
Biotech Stock Research - Analyst
All
right, and so the interim data that you have, you you were talking about that
the one trial showed there was 60% were alive at a median of 13.3 months versus
a 10 month historical. That particular trial have you compared those patients with
a nomogram to find out what their likely survival would have been? Like using
the Halabi Nomogram, or something like that to get a better idea than
traditional historic controls?
Cindy Jacobs
-
Sonus Pharmaceuticals Inc. - CMO of OncoGenex
No, we havent, the Halabi Nomogram was based
on first-line chemotherapy and this second-line chemotherapy she has done some
analysis with second-line but it is not quite as clear, so we have not formally
done that. We have as far as the trials that are out there looked at what the
median survival has been and even with the Tax-327 which was the main Phase 3
study that docetaxol first-line that was proved on we followed patients that
received second-line treatment whether it was with mitoxantione or docetaxol
and the median survival was 10 months in that study as well as other studies weve
seen so it was 10 months plus or minus a month but it looks pretty clear thats
a good target as far as what second-line chemotherapy can do.
David Miller
-
Biotech Stock Research - Analyst
Okay,
well good. I look forward to seeing data at ASCO in a couple of days.
Scott Cormack
-
Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
Great.
Thanks, David.
Operator
Our
next question is from the line of Jason Canter with RBC Capital Markets.
Jason Canter
-
RBC Capital Markets - Analyst
Yes,
Id like to extend my congratulations to both parties and just say that all my
questions have been asked, so congratulations.
Scott Cormack
-
Sonus Pharmaceuticals Inc. - President - CEO
OncoGenex Technologies
Great.
Thank you very much.
Operator
Thank
you, (OPERATOR INSTRUCTIONS). At this time there are no further questions. Id
like to turn it back to management for any closing remarks.
17
Mike Martino
-
Sonus Pharmaceuticals Inc. - President - CEO
Thank
you, Operator. This is Mike Martino. At this point, Id like to thank you all
again for joining us today. Reiterate that we are very very excited about the
potential for value creating milestones with this transaction, based on the
combined pipelines, people, and cash. As Allen indicated in his comments, we
will be filing a proxy promptly with SEC and following the filing of that
proxy, well look forward to getting out to individual shareholders and talking
with you more about this proposed transaction. That concludes our call.
Operator
Thank
you, sir. Ladies and Gentlemen, that does conclude our conference for today. If
youd like to listen to a replay of todays conference, please dial
1-800-405-2236, or 303-590-3000 using access code of 11114594 followed by the
pound key. ACT would like to thank you for your participation. You may now
disconnect.
END OF TRANSCRIPT
Proxy Solicitation
In connection with the proposed transaction, Sonus intends to file with
the SEC a Proxy Statement and related materials and to mail to its stockholders
the final Proxy Statement containing information about Sonus, OncoGenex and the
proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE
PROXY STATEMENT AND THE OTHER RELEVANT MATERIALS, CAREFULLY AND IN THEIR
ENTIRETY, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION ABOUT SONUS, ONCOGENEX AND THE PROPOSED TRANSACTION.
Sonus and OncoGenex, and certain of their directors, executive officers
and other members of management and employees may be deemed to be participants
in the solicitation of proxies in connection with the proposed
transaction. Information about the
directors and executive officers of Sonus, including their respective security
holdings, is set forth in Sonus Amendment No. 1 to Form 10-K for the
fiscal year ended December 31, 2007, filed with the Securities and
Exchange Commission on April 29, 2008.
As of May 27, 2008, OncoGenexs directors and executive officers
beneficially owned approximately 1,755,000 shares, or 14.5%, of OncoGenex
capital stock. Investors may obtain additional information regarding the
interests of OncoGenex, Sonus and their respective executive officers and
directors in the proposed transaction by reading the Proxy Statement for such
proposed transaction when it becomes available.
The Proxy Statement and other relevant materials, when they become
available, and any other documents filed by Sonus with the SEC, may be obtained
free of charge at the SECs web site at
www.sec.gov
. In addition, investors and security holders
may obtain free copies of the documents, when they are available, filed with
the SEC by Sonus by directing a request to: Sonus Pharmaceuticals, Inc.,
1522 217th Place SE, Suite 100, Bothell, WA 98021, Phone (425) 686-1500,
Fax (425) 686-1600, Attention: Investor Relations.
18
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