- MOMENTUM Phase 3 myelofibrosis clinical trial
anticipated to launch in Q4 2019 -
VANCOUVER, Nov. 4, 2019 /CNW/ - Sierra Oncology, Inc.
(SRRA), a late-stage drug development company focused on advancing
targeted therapeutics for the treatment of patients with
significant unmet needs in hematology and oncology, today reported
its financial and operational results for the third quarter ended
September 30, 2019.
"During the third quarter, we continued to prepare for the
launch of the MOMENTUM Phase 3 clinical trial, which is expected to
occur in the fourth quarter of 2019. Data that will be generated
from this trial, along with data from more than 800 myelofibrosis
patients previously treated with momelotinib, many of them durably
benefiting for several years of treatment, will form the basis of
our planned regulatory submissions for this drug," said Dr.
Nick Glover, President and CEO of
Sierra Oncology. "If ultimately approved, momelotinib could
represent a significant addition to the limited number of
therapeutics available to patients with myelofibrosis, and
potentially become the first therapeutic capable of improving
anemia in these patients rather than exacerbating it, while also
providing meaningful and long-lasting symptom and spleen
benefits."
Sierra's pipeline also includes a portfolio of DNA Damage
Response (DDR) assets, SRA737 (Chk1 inhibitor) and SRA141 (Cdc7
inhibitor). Sierra has previously announced plans to prioritize its
resources on the development of momelotinib and has launched a
campaign exploring non-dilutive strategic options to support the
future continued development of these other drug candidates.
About the MOMENTUM Phase 3 Clinical Trial for Patients with
Myelofibrosis:
Sierra plans to launch the MOMENTUM Phase 3 clinical trial in
the fourth quarter of 2019. The randomized double-blind trial is
designed to enroll 180 myelofibrosis patients who are symptomatic
and anemic, and who have been treated previously with a JAK
inhibitor. Patients will be randomized 2:1 to receive either
momelotinib or danazol. Danazol has been selected as an
appropriate treatment comparator given its use to ameliorate anemia
in myelofibrosis patients, as recommended by NCCN and ESMO
guidelines. After 24 weeks of treatment, patients on danazol will
be allowed to crossover to receive momelotinib.
The Primary Endpoint of the trial is the Total Symptom Score
(TSS) response rate of momelotinib compared to danazol at Week 24
(99% power; p-value < 0.05).
Secondary and exploratory endpoints include:
- Transfusion Independence (TI) rate at Week 24 (key secondary:
>90% powered; p-value < 0.05),
- Splenic response rate (SRR) at Week 24 (>90% powered;
p-value < 0.05),
- Duration of TSS response to Week 48,
- Other measures of anemia benefit, including Transfusion
Dependence response rate and various measures of cumulative
transfusion burden,
- Patient Reported Outcome measures of fatigue and physical
function.
Dr. Srdan Verstovsek, MD, PhD, Chief, Section for
Myeloproliferative Neoplasms, Department of Leukemia, Division of
Cancer Medicine, The University of
Texas MD Anderson Cancer Center, Houston, Texas, has been named Chief
Investigator of the MOMENTUM Phase 3 trial.
The FDA has granted Fast Track designation to momelotinib for
the treatment of patients with intermediate/high-risk myelofibrosis
who have previously received a JAK inhibitor.
Third Quarter 2019 Financial Results (all amounts reported in
U.S. currency)
Research and development expenses were $10.1 million for the three months ended
September 30, 2019, compared to
$12.9 million for the three months
ended September 30, 2018. The
decrease was due to a $3.0 million
upfront fee paid to Gilead to acquire momelotinib in the third
quarter of 2018 and decreases in SRA737 and SRA141 costs, including
a $2.4 million decrease in clinical
trial costs primarily related to SRA737, a $1.4 million decrease in third-party
manufacturing costs, and a $0.5
million decrease in research and preclinical costs. These
decreases were partially offset by costs pertaining to momelotinib
including an increase of $3.9 million
in clinical trial and development related costs and a $0.6 million increase in third-party
manufacturing costs. Research and development expenses included
non-cash stock-based compensation of $0.9
million and $1.2 million for
the three months ended September 30,
2019 and 2018, respectively.
Research and development expenses were $32.0 million for the nine months ended
September 30, 2019, compared to
$30.0 million for the nine months
ended September 30, 2018. The
increase was primarily due to costs related to momelotinib
including a $8.2 million increase in
clinical trial and development costs, a $1.9
million increase in third-party manufacturing costs and a
$2.1 million increase in
personnel-related and allocated overhead costs. These increases
were partially offset by a $3.0
million upfront fee paid to Gilead to acquire momelotinib in
the third quarter of 2018 and decreases in SRA737 and SRA141 costs,
including a $3.6 million decrease in
third-party manufacturing costs, a $2.4
million decrease in clinical trial costs primarily related
to SRA737, and a $1.3 million
decrease in research and preclinical costs. Research and
development expenses included non-cash stock-based compensation of
$3.3 million for the nine months
ended September 30, 2019 and
2018.
General and administrative expenses were $3.1 million for both the three months ended
September 30, 2019 and 2018. General
and administrative expenses included non-cash stock-based
compensation of $0.4 million and
$0.7 million for the three months
ended September 30, 2019 and 2018,
respectively.
General and administrative expenses were $10.0 million for the nine months ended
September 30, 2019, compared to
$10.7 million for the nine months
ended September 30, 2018. This
decrease was due to decreases in personnel-related and allocated
overhead costs of $0.3 million,
professional fees of $0.2 million and
business development related costs of $0.2
million. General and administrative expenses included
non-cash stock-based compensation of $1.5
million and $1.8 million for
the nine months ended September 30,
2019 and 2018, respectively.
For the three months ended September 30, 2019, Sierra
incurred a net loss of $12.9 million compared to a net loss of
$15.6 million for the three
months ended September 30, 2018. For the nine months ended
September 30, 2019, Sierra incurred a net loss of $40.8 million compared to a net loss of
$39.1 million for the nine
months ended September 30, 2018.
Cash and cash equivalents totaled $67.7
million as of September 30,
2019, compared to $106.0
million as of December 31,
2018. At September 30, 2019,
there were 74,688,283 shares of common stock issued and
outstanding, an additional 13,222,900 issuable upon exercise of
stock options and warrants, and a term loan of $5.0 million.
About Sierra Oncology
Sierra Oncology is a late stage drug development company focused
on advancing targeted therapeutics for the treatment of patients
with significant unmet medical needs in hematology and
oncology.
Momelotinib, Sierra's lead drug candidate, is a potent,
selective and orally-bioavailable JAK1, JAK2 & ACVR1 inhibitor
with a differentiated therapeutic profile in myelofibrosis
encompassing robust constitutional symptom improvements, a range of
meaningful anemia benefits, including eliminating or reducing the
need for frequent blood transfusions, and comparable spleen control
to ruxolitinib. More than 1,200 subjects have received momelotinib
since clinical studies began in 2009, including more than 800
subjects treated for myelofibrosis. Sierra plans to launch the
MOMENTUM Phase 3 clinical trial in the fourth quarter of 2019 to
support potential registration of momelotinib on a global basis.
Momelotinib is wholly owned by Sierra Oncology and is covered by
patent families anticipated to provide potential exclusivity to
2040 in the United States and
Europe (including Patent Term
Extension or Supplementary Protection Certificate).
Sierra is also developing a portfolio of DNA Damage Response
(DDR) assets, consisting of SRA737 and SRA141, and is conducting a
campaign intended to seek non-dilutive strategic options to support
their further advancement. SRA737 is a potent, highly selective,
orally bioavailable small molecule inhibitor of Checkpoint kinase 1
(Chk1), a key regulator of cell cycle progression and the DDR, and
has demonstrated preliminary clinical efficacy. SRA141 is a potent,
selective, orally bioavailable small molecule inhibitor of Cell
division cycle 7 kinase (Cdc7) with a potential novel mechanism of
cytotoxicity, and has successfully completed the IND process with
the FDA enabling the commencement of clinical trials.
Sierra Oncology retains the global commercialization rights to
momelotinib, SRA737 and SRA141. For more information, please visit
www.sierraoncology.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995, including, but not
limited to, statements regarding Sierra Oncology's expectations
from current data, anticipated clinical development activities,
timing of the initiation of MOMENTUM, expected timing of the
execution of, and expected results from, non-dilutive strategic
options, and potential benefits of Sierra Oncology's lead product
candidate and other product candidates. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. These statements are based on
management's 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. Such forward-looking statements are
subject to risks and uncertainties, including, among others, the
risk that Sierra Oncology's cash resources may be insufficient to
fund its current operating plans and it may be unable to raise
additional capital when needed, Sierra Oncology may be unable to
successfully develop and commercialize product candidates, product
candidates may not demonstrate safety and efficacy or otherwise
produce positive results, Sierra Oncology may experience delays in
the preclinical and anticipated clinical development of its product
candidates, Sierra Oncology may be unable to acquire additional
assets to build a pipeline of additional product candidates, Sierra
Oncology's third-party manufacturers may cause its supply of
materials to become limited or interrupted or fail to be of
satisfactory quantity or quality, Sierra Oncology may be unable to
obtain and enforce intellectual property protection for its
technologies and product candidates and the other factors described
under the heading "Risk Factors" set forth in Sierra Oncology's
filings with the Securities and Exchange Commission from time to
time. Sierra Oncology undertakes no obligation to update the
forward-looking statements contained herein or to reflect events or
circumstances occurring after the date hereof, other than as may be
required by applicable law.
SIERRA ONCOLOGY,
INC.
|
Condensed
Consolidated Balance Sheets
|
(unaudited)
|
(in
thousands)
|
|
September 30,
2019
|
|
December 31,
2018
|
ASSETS
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
Cash and cash
equivalents
|
$
|
67,694
|
|
$
|
106,046
|
Prepaid expenses and
other current assets
|
3,118
|
|
2,706
|
Total current
assets
|
70,812
|
|
108,752
|
Property and
equipment, net
|
137
|
|
168
|
Operating lease
right-of-use asset
|
630
|
|
-
|
Other
assets
|
738
|
|
549
|
TOTAL
ASSETS
|
$
|
72,317
|
|
$
|
109,469
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
Accrued and other
liabilities
|
$
|
6,738
|
|
$
|
8,812
|
Accounts
payable
|
1,304
|
|
1,287
|
Current portion of
term loan
|
1,171
|
|
-
|
Total current
liabilities
|
9,213
|
|
10,099
|
Term loan
|
3,841
|
|
4,891
|
Operating lease
liability
|
415
|
|
-
|
TOTAL
LIABILITIES
|
13,469
|
|
14,990
|
|
|
|
|
STOCKHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
Common
stock
|
74
|
|
74
|
Additional paid-in
capital
|
776,999
|
|
771,817
|
Accumulated
deficit
|
(718,225)
|
|
(677,412 )
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY
|
58,848
|
|
94,479
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
$
|
72,317
|
|
$
|
109,469
|
SIERRA ONCOLOGY,
INC.
|
Condensed
Consolidated Statements of Operations
|
(unaudited)
|
(in
thousands, except share and per share data)
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
$
|
10,113
|
|
$
|
12,913
|
|
$
|
31,978
|
|
$
|
30,032
|
General and
administrative
|
3,151
|
|
3,138
|
|
9,995
|
|
10,736
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
13,264
|
|
16,051
|
|
41,973
|
|
40,768
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(13,264)
|
|
(16,051)
|
|
(41,973)
|
|
(40,768)
|
Other income,
net
|
288
|
|
479
|
|
961
|
|
1,333
|
|
|
|
|
|
|
|
|
Loss before benefit
from income taxes, net
|
(12,976)
|
|
(15,572)
|
|
(41,012)
|
|
(39,435)
|
Benefit from income
taxes, net
|
(73)
|
|
(5)
|
|
(199)
|
|
(383)
|
|
|
|
|
|
|
|
|
Net loss
|
$
|
(12,903)
|
|
$
|
(15,567)
|
|
$
|
(40,813)
|
|
$
|
(39,052)
|
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
$
|
(0.17)
|
|
$
|
(0.21)
|
|
$
|
(0.55)
|
|
$
|
(0.56)
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net loss per common
|
|
|
|
|
|
|
|
share, basic and
diluted
|
74,688,283
|
|
74,347,489
|
|
74,621,364
|
|
69,517,119
|
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content:http://www.prnewswire.com/news-releases/sierra-oncology-reports-third-quarter-2019-results-300950928.html
SOURCE Sierra Oncology