- Sierra preparing to launch the MOMENTUM Phase 3
myelofibrosis clinical trial expected in Q4 2019 -
- Exploring non-dilutive options to support future continued
development of DDR portfolio -
VANCOUVER, Aug 8, 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 second quarter ended June 30, 2019.
"During the second quarter, we achieved major milestones in the
development programs for our drug candidates. We reported Phase 3
regulatory clarity and the granting of Fast Track designation by
the U.S. Food and Drug Administration (FDA) for our lead asset,
momelotinib, and we reported proof-of-concept clinical data for our
Chk1 inhibitor, SRA737, at the 2019 ASCO Annual Meeting, suggesting
that this drug candidate has a defined clinical path forward toward
potential initial registration," said Dr. Nick Glover, President and CEO of Sierra
Oncology. "Our current focus is on preparing for the launch of the
MOMENTUM Phase 3 clinical trial, expected in the fourth quarter of
2019, designed to support potential registration of momelotinib on
a global basis. We also continue to develop the assets in our DDR
portfolio, SRA737 and SRA141, and have previously announced we are
conducting a campaign intended to seek non-dilutive strategic
options to support their further advancement."
Second Quarter 2019 Highlights:
Momelotinib (targeting JAK1/JAK2/ACVR1):
- During the second quarter, Sierra obtained regulatory clarity
with the FDA concerning the design of a Phase 3 clinical trial for
momelotinib intended to support its potential registration.
- Sierra also announced the design of the MOMENTUM Phase 3
clinical trial, planned for launch in the fourth quarter of 2019.
The randomized double-blind trial is designed to enroll 180
myelofibrosis patients who are symptomatic, anemic and have been
treated previously with a JAK inhibitor. 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). 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 trial.
- Sierra also reported that 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.
DNA Damage Response (DDR) portfolio (SRA737 and SRA141):
- At the 2019 ASCO Annual meeting, Sierra reported preliminary
efficacy and safety data from two ongoing clinical trials
evaluating SRA737 across multiple indications, as monotherapy and
when potentiated by non-cytotoxic low-dose gemcitabine (LDG).
SRA737 demonstrated notable anti-cancer activity in multiple
indications including a 30% Overall Response Rate in evaluable
patients with anogenital cancer treated with SRA737+LDG, an
indication for which the second line metastatic setting represents
a significant unmet medical need with no approved therapies and
very poor life expectancy. Additionally, evaluable RAS wild-type
subjects whose tumors harbored FA/BRCA gene network mutations
displayed favorable outcomes across multiple indications, with an
Overall Response Rate of 25%.
- During the second quarter, Sierra announced plans to prioritize
its resources on the development of momelotinib and that it has
launched a campaign exploring non-dilutive strategic options to
support the future continued development of its portfolio of DDR
assets.
Second Quarter 2019 Financial Results (all amounts reported
in U.S. currency)
Research and development expenses were $11.7 million for the three months ended
June 30, 2019, compared to
$8.8 million for the three months
ended June 30, 2018. The increase was
primarily due to momelotinib related costs, including a
$3.1 million increase in clinical
trial and development related costs and a $1.2 million increase in third-party
manufacturing costs, and a $1.1
million increase in personnel-related and allocated overhead
costs. These increases were partially offset by decreases in SRA737
and SRA141 costs, including a $1.3
million decrease in third-party manufacturing costs, a
$0.7 million decrease in clinical
trial costs primarily related to SRA737, and a $0.5 million decrease in research and preclinical
costs. Research and development expenses included non-cash
stock-based compensation of $1.2
million for the three months ended June 30, 2019 and 2018.
Research and development expenses were $21.9 million for the six months ended
June 30, 2019, compared to
$17.1 million for the six months
ended June 30, 2018. The increase was
primarily due to momelotinib related costs, including a
$4.4 million increase in clinical
trial and development costs and a $1.3
million increase in third-party manufacturing costs, and a
$2.4 million increase in
personnel-related and allocated overhead costs. These increases
were partially offset by decreases in SRA737 and SRA141 costs,
including a $2.2 million decrease in
third-party manufacturing costs and a $1.2
million decrease in research and preclinical costs. Research
and development expenses included non-cash stock-based compensation
of $2.4 million and $2.2 million for the six months ended
June 30, 2019 and 2018,
respectively.
General and administrative expenses were $3.5 million for the three months ended
June 30, 2019, compared to
$4.2 million for the three months
ended June 30, 2018. This decrease
was primarily due to decreases in professional fees of $0.4 million and personnel-related and allocated
overhead costs of $0.3 million.
General and administrative expenses included non-cash stock-based
compensation of $0.5 million and
$0.6 million for the three months
ended June 30, 2019 and 2018,
respectively.
General and administrative expenses were $6.8 million for the six months ended
June 30, 2019, compared to
$7.6 million for the six months ended
June 30, 2018. This decrease was
primarily due to decreases in professional fees of $0.5 million and personnel-related and allocated
overhead costs of $0.3 million.
General and administrative expenses included non-cash stock-based
compensation of $1.0 million and
$1.1 million for the six months ended
June 30, 2019 and 2018.
For the three months ended June 30, 2019, Sierra incurred a
net loss of $14.9 million
compared to a net loss of $12.0 million for the three months ended
June 30, 2018. For the six months ended June 30, 2019,
Sierra incurred a net loss of $27.9 million compared to a net loss of
$23.5 million for the six months
ended June 30, 2018.
Cash and cash equivalents totaled $78.8
million as of June 30, 2019,
compared to $106.0 million as of
December 31, 2018. At June 30, 2019, there were 74,688,283 shares of
common stock issued and outstanding, an additional 13,335,583
issuable upon exercise of stock options and warrants, and a term
loan of $5.0 million.
Equity Inducement Plan
On August 5, 2019, the
Compensation Committee of Sierra Oncology's Board of Directors
granted non-qualified stock options to purchase an aggregate of
112,000 shares of its common stock to two new employees under
Sierra Oncology's 2018 Equity Inducement Plan.
The 2018 Equity Inducement Plan is used exclusively for the
grant of equity award to individuals who were not previously an
employee or non-employee director of Sierra (or following a bona
fide period of non-employment), as an inducement material to such
individual's entering into employment with Sierra, pursuant to Rule
5635(c)(4) of the NASDAQ Listing Rules.
The options have an exercise price of $0.49 per share, which is equal to the closing
price of Sierra's common stock on the date of grant. Each option
will vest and become exercisable as to 25% of the shares on the
first anniversary of the recipient's start date, and then will vest
and become exercisable as to the remaining 75% of the shares in 36
equal monthly installments following the first anniversary, in each
case, subject to each such employee's continued employment with
Sierra on such vesting dates. The options are subject to the terms
and conditions of Sierra's 2018 Equity Inducement Plan, and the
terms and conditions of the stock option agreement covering the
grant.
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
patents anticipated to provide potential exclusivity to 2040 in
the United States.
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.
Tumors with high levels of replication stress become reliant on
Chk1 to mitigate the potentially catastrophic consequences of
excess genomic instability. SRA737+LDG, a novel drug combination
where non-cytotoxic low dose gemcitabine (LDG) acts as a potent
extrinsic inducer of replication stress, 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. Sierra has successfully
completed the IND process with the FDA enabling the commencement of
clinical trials for SRA141 and has designed a potential Phase 1/2
trial with this drug candidate.
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 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'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 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)
|
|
|
|
|
|
|
|
|
June 30,
2019
|
|
|
December 31,
2018
|
ASSETS
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
78,831
|
|
$
|
106,046
|
Prepaid expenses and
other current assets
|
|
3,761
|
|
|
2,706
|
Total current
assets
|
|
82,592
|
|
|
108,752
|
Property and
equipment, net
|
|
134
|
|
|
168
|
Operating lease
right-of-use asset
|
|
671
|
|
|
-
|
Other
assets
|
|
778
|
|
|
549
|
TOTAL
ASSETS
|
$
|
84,175
|
|
$
|
109,469
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
Accrued and other
liabilities
|
$
|
7,064
|
|
$
|
8,812
|
Accounts
payable
|
|
1,203
|
|
|
1,287
|
Current portion of
term loan
|
|
668
|
|
|
-
|
Total current
liabilities
|
|
8,935
|
|
|
10,099
|
Term loan
|
|
4,303
|
|
|
4,891
|
Operating lease
liability
|
|
466
|
|
|
-
|
TOTAL
LIABILITIES
|
|
13,704
|
|
|
14,990
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY:
|
|
|
|
|
|
Common
stock
|
|
74
|
|
|
74
|
Additional paid-in
capital
|
|
775,719
|
|
|
771,817
|
Accumulated
deficit
|
|
(705,322)
|
|
|
(677,412 )
|
TOTAL STOCKHOLDERS'
EQUITY
|
|
70,471
|
|
|
94,479
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
$
|
84,175
|
|
$
|
109,469
|
SIERRA ONCOLOGY,
INC. Condensed Consolidated Statements of
Operations (unaudited) (in
thousands, except share and per share data)
|
|
|
|
Three Months
Ended
June 30,
|
|
|
Six Months
Ended
June 30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
11,728
|
|
$
|
8,785
|
|
$
|
21,865
|
|
$
|
17,119
|
General and
administrative
|
|
3,479
|
|
|
4,178
|
|
|
6,844
|
|
|
7,598
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
15,207
|
|
|
12,963
|
|
|
28,709
|
|
|
24,717
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(15,207)
|
|
|
(12,963)
|
|
|
(28,709)
|
|
|
(24,717)
|
Other income,
net
|
|
348
|
|
|
582
|
|
|
673
|
|
|
854
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision
for (benefit from) income taxes, net
|
|
(14,859)
|
|
|
(12,381)
|
|
|
(28,036)
|
|
|
( 23,863)
|
Provision for
(benefit from) income taxes, net
|
|
19
|
|
|
(421)
|
|
|
(126)
|
|
|
(378)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
|
(14,878)
|
|
$
|
(11,960)
|
|
$
|
(27,910)
|
|
$
|
(23,485)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
$
|
(0.20)
|
|
$
|
(0.16)
|
|
$
|
(0.37)
|
|
$
|
(0.35)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net loss per common
share, basic and
diluted
|
|
74,688,283
|
|
|
74,320,415
|
|
|
74,587,350
|
|
|
67,061,904
|
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content:http://www.prnewswire.com/news-releases/sierra-oncology-reports-second-quarter-2019-results-300898143.html
SOURCE Sierra Oncology