Company expects to complete enrollment in pivotal trial of
brentuximab vedotin (SGN-35) during the third quarter of 2009
Conference call today at 5:00 p.m. ET
Seattle Genetics, Inc. (Nasdaq: SGEN) today reported financial results
for the second quarter and six months ended June 30, 2009. The company
also highlighted recent product development progress.
“The second quarter featured strong clinical data presentations with
SGN-35, now named brentuximab vedotin, that continue to demonstrate a
compelling objective response rate and tolerability profile in patients
with Hodgkin lymphoma or systemic anaplastic large cell lymphoma
(ALCL),” said Clay B. Siegall, Ph.D., President and Chief Executive
Officer of Seattle Genetics. “In both of our phase I clinical trials,
brentuximab vedotin achieved complete or partial responses in greater
than 50 percent of patients treated at the higher dose levels. These
data reinforce the potential of brentuximab vedotin and are supportive
of our aggressive development plans. We expect to complete accrual to
the ongoing pivotal trial for Hodgkin lymphoma in the third quarter of
2009, and we also recently initiated a phase II trial in systemic ALCL.
We ended the second quarter financially strong, with $190 million in
cash and investments, including a $4 million upfront payment received
under our new antibody-drug conjugate (ADC) collaboration with
Millennium: The Takeda Oncology Company. We anticipate continued
milestone momentum across our product pipeline and by our ADC
collaborators over the remainder of 2009.”
Recent and Planned Pipeline and ADC Collaborator Highlights
Brentuximab vedotin (SGN-35)
-
Given robust enrollment to the Hodgkin lymphoma pivotal trial, expect
to complete accrual in the third quarter of 2009
-
Reported a median duration of response of at least 7.3 months from an
every three week dosing phase I trial (European Hematology Association
(EHA) 14th Congress)
-
Reported that the objective response rate for patients treated at
doses of 1.2 milligrams per kilogram (mg/kg) and higher every three
weeks was 54 percent based on investigator assessment, compared to 57
percent based on independent review, demonstrating high concordance
between the two assessments (EHA 14th Congress)
-
Presented data from an ongoing phase I weekly-dosing clinical trial
demonstrating that, among 20 evaluable patients treated at doses of
0.8 mg/kg and higher, 60 percent achieved an objective response,
including 50 percent with complete responses (American Society of
Clinical Oncology (ASCO) 2009 Annual Meeting)
-
In both phase I clinical trials, brentuximab vedotin has been
generally well tolerated. The majority of adverse events have been
Grade 1 and 2, with the most common being fatigue, fever, peripheral
neuropathy, neutropenia, diarrhea and nausea
-
Initiated a phase II clinical trial for patients with relapsed or
refractory systemic ALCL
-
Obtained brentuximab vedotin as the SGN-35 U.S. Adopted Name (USAN), a
nonproprietary designation for the product candidate
-
Preparing to initiate a clinical trial to assess retreatment of
patients who previously received brentuximab vedotin therapy
-
Planning to present additional phase I data in the second half of 2009
-
Evaluating and planning multiple trials of brentuximab vedotin both as
a single agent and in combination with chemotherapy for additional
relapsed and refractory therapeutic settings, front-line therapy and
other CD30-positive malignancies
Dacetuzumab (SGN-40)
-
Presented data showing a correlation between a diagnostic gene
signature and sensitivity to treatment with dacetuzumab in patients
with diffuse large B-cell lymphoma (ASCO 2009 Annual Meeting)
-
Expect to report clinical data from multiple ongoing clinical trials
of dacetuzumab for non-Hodgkin lymphoma and multiple myeloma later in
2009
Lintuzumab (SGN-33)
-
Reported data from a single-agent dose-escalation phase I clinical
trial demonstrating multiple objective responses at well-tolerated
doses in patients with acute myeloid leukemia (AML) and that 47
percent of AML patients treated across all dose levels experienced
reductions in tumor blasts compared to baseline (EHA 14th
Congress)
-
Continued patient treatment in a randomized phase IIb trial of
lintuzumab plus low-dose chemotherapy for patients 60 years and older
with AML to determine if the combination extends overall survival. The
trial, which is event driven, is expected to yield data in the first
half of 2010.
SGN-70
-
Initiated treatment of patients with autoimmune disease in a phase I
trial, following completion of the healthy volunteer portion of the
study
SGN-75
-
Advanced investigational new drug (IND)-enabling activities towards a
planned IND submission in the second half of 2009 for CD70-positive
hematologic malignancies and solid tumors
ASG-5ME (formerly AGS-5 ADC)
-
In collaboration with Agensys, a wholly-owned subsidiary of Astellas
Pharma, advanced a novel ADC for solid tumors towards a planned IND
submission in the first half of 2010
ADC Collaborations
-
Entered into a new ADC collaboration with Millennium: The Takeda
Oncology Company, under which Seattle Genetics received a $4 million
upfront payment and is entitled to receive progress-dependent
milestone payments and mid-single digit royalties on any resulting ADC
products
Second Quarter and Six Month 2009 Financial Results
Revenues in the second quarter of 2009 were $9.4 million, compared to
$10.0 million in the second quarter of 2008. For the first six months of
2009, revenues were $18.6 million, up from $17.1 million in the first
six months of 2008. Revenues are primarily driven by the earned portion
of the upfront fee, reimbursements and milestone payments received under
the company’s dacetuzumab collaboration with Genentech. Revenues also
reflect amounts earned under the company’s ADC collaborations.
Total operating expenses for the second quarter of 2009 were $32.7
million, compared to $27.6 million for the second quarter of 2008. For
the first six months of 2009, total operating expenses were $70.1
million, compared to $53.7 million in the first six months of 2008. The
planned increases in 2009 were primarily driven by clinical development
and manufacturing activities for brentuximab vedotin. Non-cash,
share-based compensation expense for the first six months of 2009 was
$5.4 million, compared to $5.0 million for the same period in 2008.
Net loss for the second quarter of 2009 was $22.5 million, or $0.26 per
share, compared to $16.0 million, or $0.20 per share, for the second
quarter of 2008. For the six months ended June 30, 2009, net loss was
$49.7 million, or $0.59 per share, compared to $33.1 million, or $0.43
per share, for the same period in 2008.
As of June 30, 2009, Seattle Genetics had $189.9 million in cash and
investments, compared to $192.4 million as of March 31, 2009. Cash and
investments as of June 30, 2009 reflect net proceeds of approximately
$11.5 million from the company’s sale of 1,178,163 shares of common
stock in a private placement to Baker Brothers Life Sciences, L.P.,
which was approved at the company’s annual stockholders meeting on May
15, 2009.
Conference Call Details
Seattle Genetics’ management will host a conference call and webcast to
discuss the financial results and provide an update on business
activities. The event will be held today at 2:00 p.m. Pacific Time (PT);
5:00 p.m. Eastern Time (ET). The live event will be available from
Seattle Genetics’ website at www.seattlegenetics.com,
under the News and Investor Information section, or by calling (877)
941-8610 (domestic) or (480) 629-9818 (international). The access code
is 4114066. A replay of the discussion will be available beginning at
approximately 4:00 p.m. PT today from Seattle Genetics’ website or by
calling (800) 406-7325 (domestic) or (303) 590-3030 (international),
using access code 4114066. The telephone replay will be available until
4:00 p.m. PT on July 27, 2009.
About Seattle Genetics
Seattle Genetics is a clinical stage biotechnology company focused on
the development and commercialization of monoclonal antibody-based
therapies for the treatment of cancer and autoimmune disease. The
company’s lead product candidate, brentuximab vedotin (SGN-35), is in a
pivotal trial under a special protocol assessment with the FDA.
Brentuximab vedotin is empowered by Seattle Genetics’ proprietary ADC
technology comprising highly potent synthetic drugs and stable linkers
for attaching the drugs to monoclonal antibodies. In addition, Seattle
Genetics has three other product candidates in ongoing clinical trials:
dacetuzumab (SGN-40), lintuzumab (SGN-33) and SGN-70. Dacetuzumab is
being developed under a worldwide collaboration with Genentech (a
wholly-owned member of the Roche Group). Seattle Genetics has
collaborations for its ADC technology with a number of leading
biotechnology and pharmaceutical companies, including Genentech, Bayer,
CuraGen, Progenics, Daiichi Sankyo, MedImmune, a subsidiary of
AstraZeneca, and Millennium: The Takeda Oncology Company, as well as an
ADC co-development agreement with Agensys, a subsidiary of Astellas
Pharma. More information can be found at www.seattlegenetics.com.
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the company’s
expectations for regulatory approval and commercial launch of its
product candidates, including brentuximab vedotin, initiation of future
clinical trials, and data availability from ongoing clinical trials.
Actual results or developments may differ materially from those
projected or implied in these forward-looking statements. Factors that
may cause such a difference include risks that the company may
experience delays in the completion of its clinical trials, whether
caused by competition, adverse events, patient enrollment rates,
regulatory issues or other factors; that data from our phase I clinical
trials of brentuximab vedotin may not necessarily be indicative of the
subsequent clinical trial results, including our pivotal clinical trial
results; and that the safety and/or efficacy results of these trials,
including the brentuximab vedotin pivotal clinical trial for relapsed or
refractory Hodgkin lymphoma, will not support continued development or,
in the case of our pivotal trial, an application for marketing approval
in the United States or any other country. We may also fail to achieve
milestones under our collaborations and experience unforeseen increased
expenses or unexpected reductions in revenues. More information about
the risks and uncertainties faced by Seattle Genetics is contained in
the company’s 10-K for the year ended December 31, 2008 filed with the
Securities and Exchange Commission. Seattle Genetics disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise.
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Seattle Genetics, Inc.
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Condensed Consolidated Balance Sheets
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(Unaudited)
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(In thousands)
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|
|
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June 30,
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December 31,
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2009
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2008
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Assets
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|
|
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|
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Cash, cash equivalents, short and long term investments
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$
|
189,937
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$
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160,708
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|
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Other assets
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|
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22,884
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|
|
27,009
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|
|
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Total assets
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$
|
212,821
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|
$
|
187,717
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|
|
|
|
|
|
|
|
|
|
|
|
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Liabilities and Stockholders' Equity
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|
|
|
|
|
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Accounts payable and accrued liabilities
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|
$
|
19,159
|
|
$
|
15,879
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|
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Deferred revenue and long-term liabilities
|
|
|
93,572
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|
|
92,820
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|
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Stockholders' equity
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|
|
100,090
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|
|
79,018
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|
|
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Total liabilities and stockholders' equity
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$
|
212,821
|
|
$
|
187,717
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Seattle Genetics, Inc.
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Condensed Consolidated Statements of Operations
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(Unaudited)
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(In thousands except per share amounts)
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|
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Three months ended
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Six months ended
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June 30,
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June 30,
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2009
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2008
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2009
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2008
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Revenues
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$
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9,408
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|
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$
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10,004
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$
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18,550
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$
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17,089
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Expenses
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Research and development
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28,712
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23,499
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61,958
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45,651
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General and administrative
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|
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4,019
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4,094
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8,175
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|
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8,029
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Total operating expenses
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|
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32,731
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27,593
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70,133
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53,680
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Loss from operations
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(23,323
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)
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(17,589
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)
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(51,583
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)
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(36,591
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)
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Investment income, net
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852
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1,561
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1,844
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3,451
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Net loss
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|
|
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$
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(22,471
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)
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$
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(16,028
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)
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$
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(49,739
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)
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|
$
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(33,140
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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Basic and diluted net loss per share
|
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$
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(0.26
|
)
|
|
$
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(0.20
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)
|
|
$
|
(0.59
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)
|
|
$
|
(0.43
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)
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Weighted-average shares used in computing
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basic and diluted net loss per share
|
|
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86,200
|
|
|
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79,277
|
|
|
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84,880
|
|
|
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77,768
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Seattle Genetics, Inc.
Peggy Pinkston, 425-527-4160
ppinkston@seagen.com