- MOMENTUM Phase 3 clinical trial enrollment on
track; top-line data anticipated in H1 2022 -
- Updated analyses comparing symptomatic benefits of momelotinib to
ruxolitinib from the SIMPLIFY-1 Phase 3 trial anticipated in late
2020 -
VANCOUVER, BC, Aug. 6, 2020 /CNW/ - Sierra Oncology, Inc.
(SRRA), a late-stage drug development company focused on the
registration and commercialization of momelotinib, a JAK1, JAK2
& ACVR1 inhibitor with a potentially differentiated therapeutic
profile for the treatment of myelofibrosis, today reported its
financial and operational results for the second quarter
ended June 30, 2020.
"We believe momelotinib, if approved, may provide an important
treatment option for underserved myelofibrosis patients, in
particular those with anemia and thrombocytopenia, and as such is
well-positioned to generate significant value," said
Dr. Stephen Dilly, President and CEO of Sierra Oncology.
"During the second quarter, we continued to advance the MOMENTUM
Phase 3 trial and are on track to deliver top-line results in the
first half of 2022. In anticipation of these pivotal data, we are
preparing for the regulatory submission process and the potential
commercialization of momelotinib, and subsequent to the end of the
quarter, we substantially strengthened our senior management team
to support these activities."
"We made significant progress during the first half of
2020 operationalizing the global MOMENTUM Phase 3 trial and,
while the potential impact of the COVID-19 pandemic continues to be
uncertain, we are pleased with the current pace of enrollment,"
said Dr. Barbara Klencke, Chief Development
Officer, Sierra Oncology. "During the EHA virtual conference,
two world-leading physicians in the treatment of myelofibrosis
reported long-term data that continue to reinforce
momelotinib's differentiated durability, safety and efficacy
profile. We plan to report updated analyses in late 2020 comparing
the symptomatic benefits of momelotinib to ruxolitinib from the
SIMPLIFY-1 Phase 3 trial that will further emphasize momelotinib's
differentiated and competitive profile."
"As the MOMENTUM trial ramps up, we've managed our resources
prudently and continue to anticipate our current cash runway will
extend beyond top-line data and into the second half of 2022,
subject to the potential impact of COVID-19," said Mr. Sukhi Jagpal, Chief Financial Officer of Sierra
Oncology. "In addition, our Series B warrants will expire on the
75th day following the announcement of top-line data and may only
be exercised by paying the exercise price in cash, which would
amount to approximately $34.0 million
in proceeds to the Company if fully exercised. We are also
starting to explore non-dilutive options that could provide
additional capital to support our North American commercialization
strategy."
Second Quarter Highlights:
- Hosted an Analyst & Investor Call featuring a presentation
by renowned myelofibrosis expert Dr. Ruben Mesa, Director of
the Mays Cancer Center, home to UT Health San Antonio MD Anderson
Cancer Center, who discussed momelotinib's ability to address
anemia and transfusion dependency, two critical unmet medical needs
in treating patients with myelofibrosis.
- Reported favorable Long-Term Safety and Dose Intensity data for
momelotinib from more than 550 patients across the two previously
conducted SIMPLIFY Phase 3 studies and their subsequent ongoing
extended treatment periods, at the 25th EHA Virtual
Congress.
-
- Professor Claire Harrison, Guy's
and St. Thomas' NHS Foundation
Trust, London, United Kingdom
presented a poster on the long-term safety profile of momelotinib,
which demonstrated a lack of emergent or cumulative toxicity with
extended daily administration. More than 90 SIMPLIFY-1 and
SIMPLIFY-2 patients continued to receive momelotinib for 3.5 years
or longer. Patients treated with momelotinib experienced rapid and
sustained increases in hemoglobin, in contrast to the significant
decrease in hemoglobin for patients receiving ruxolitinib. Patients
treated with momelotinib also experienced significantly higher mean
platelet counts compared to those receiving ruxolitinib.
Importantly, patients who switched from ruxolitinib to momelotinib
also achieved a sustained improvement in hemoglobin in both
studies, and platelets in SIMPLIFY-1.
- Dr. Vikas Gupta, Princess
Margaret Cancer Centre, Toronto,
Canada, presented a poster highlighting the sustained dose
intensity and prolonged clinical activity of momelotinib across the
continuum of JAK inhibitor naïve and previously JAK inhibitor
treated myelofibrosis patients. While the starting doses for
ruxolitinib were often attenuated due to low platelets, further
reductions in dose intensity were also commonly required for
ruxolitinib. In contrast, momelotinib was initiated at full dose
for all patients enrolled to the SIMPLIFY studies and high dose
intensity was maintained in the majority over extended dosing
durations. Patients who switched from ruxolitinib to momelotinib
saw an immediate and sustained improvement in dose intensity.
- The data from the two interrelated presentations suggest that
the favorable effect on hemoglobin and platelets allows momelotinib
to be initiated at high dose intensity and maintained at high dose
intensity over extended durations while retaining a favorable
long-term safety profile. Notably, some patients continue to
receive momelotinib 10 years after enrolling in the initial
momelotinib Phase 2 trials, while 90 Phase 3 SIMPLIFY patients who
enrolled into those trials 4 to 6 years ago continue to receive
momelotinib, suggesting that the dosing and safety profile
contributes to momelotinib's potential ability to provide sustained
benefits over extended durations.
Second Quarter 2020 Financial Results (all amounts reported
in U.S. currency)
Research and development expenses were
$10.2 million for the three months
ended June 30, 2020 compared to
$11.7 million for the three months
ended June 30, 2019. The
decrease was primarily due to a $2.1
million decrease in clinical trial, third-party
manufacturing, research and preclinical costs for SRA737, a
$1.1 million decrease in
personnel-related and allocated overhead costs, and a $0.9 million decrease in third-party
manufacturing costs for momelotinib. These decreases were partially
offset by a $2.6 million
increase in clinical trial and development costs for momelotinib.
Research and development expenses included non-cash stock-based
compensation of $0.9 million and
$1.2 million for the three months
ended June 30, 2020 and 2019,
respectively.
Research and development expenses were $21.8 million for the six months ended
June 30, 2020, compared with
$21.9 million for the six months
ended June 30, 2019. The decrease was
primarily due to a $5.2 million
decrease in clinical trial, third-party manufacturing, research and
preclinical costs for SRA737, a $2.1 million decrease in personnel-related
and allocated overhead costs, and a $0.6
million decrease in third-party manufacturing costs for
momelotinib. These decreases were offset by a $6.3 million increase in clinical trial and
development costs for momelotinib, and a non-cash charge of
$1.5 million pertaining to the change
in fair value of an obligation to issue common stock and a warrant
to Gilead Sciences, Inc. (Gilead), which were issued during the
first quarter of 2020. Research and development expenses included
non-cash stock-based compensation of $1.5
million and $2.4 million for
the six months ended June 30, 2020
and 2019, respectively.
General and administrative expenses were $6.3 million for the three months ended
June 30, 2020, compared to
$3.5 million for the three months
ended June 30, 2019. The increase was
primarily due to a non-cash $2.2
million stock-based compensation charge and a $0.6 million severance charge pertaining to an
executive resignation. General and administrative expenses included
non-cash stock-based compensation of $2.7
million and $0.5 million for
the three months ended June 30, 2020
and 2019, respectively.
General and administrative expenses were $10.8 million for the six months ended
June 30, 2020, compared to
$6.8 million for the six months ended
June 30, 2019. The increase was
primarily due to a $3.0 million
increase in personnel-related and allocated overhead costs,
including a non-cash $2.2 million
stock-based compensation charge noted above and $1.0 million of severance charges, offset by a
decrease of $0.2 million in other
personnel-related and allocated overhead costs. There was also an
increase of $1.0 million in
professional fees, including pre-commercial planning costs for
momelotinib. General and administrative expenses included non-cash
stock-based compensation of $3.1
million and $1.0 million for
the six months ended June 30, 2020
and 2019, respectively.
Other income (expense), net was $24,000 of other expense, net for the three
months ended June 30, 2020, compared
to $0.3 million of other income, net
for the three months ended June 30,
2019. The difference was primarily attributable to a
decrease in interest income due to lower interest rates. Other
income (expense), net was $15.7
million of other expense, net for the six months ended
June 30, 2020, compared to
$0.7 million of other income, net for
the six months ended June 30, 2019.
The difference was primarily attributable to a non-cash charge of
$16.2 million related to the change
in fair value of warrant liabilities which were reclassified to
equity in January 2020.
For the three months ended June 30,
2020, Sierra incurred a GAAP net loss of $16.5 million compared to a GAAP net loss of
$14.9 million for the months ended
June 30, 2019. For the six months
ended June 30, 2020, Sierra incurred
a GAAP net loss of $48.4 million
compared to a GAAP net loss of $27.9
million for the six months ended June
30, 2019. The GAAP net loss for the six months ended
June 30, 2020 includes a non-cash
charge of $16.2 million related to
the change in fair value of warrant liabilities included in other
income (expense), net and a $1.5
million non-cash charge pertaining to the obligation to
issue securities to Gilead included in research and development
expenses as mentioned above.
Non-GAAP adjusted net loss was $12.8
million for the three months ended June 30, 2020, compared with a non-GAAP adjusted
net loss of $13.1 million for the
three months ended June 30, 2019.
Non-GAAP adjusted net loss for the three months ended June 30, 2020 and 2019 excludes expenses related
to stock-based compensation. For the six months ended June 30, 2020, Sierra incurred a non-GAAP
adjusted net loss of $26.1 million
compared to a non-GAAP adjusted net loss of $24.5 million for the six months ended
June 30, 2019. Non-GAAP adjusted net
loss for the six months ended June 30,
2020 excludes expenses related to the change in fair value
of warrant liabilities, the change in fair value of the securities
issuance obligation, and stock-based compensation. Non-GAAP
adjusted net loss for the six months ended June 30, 2019 excludes expenses related to
stock-based compensation. See "Non-GAAP Financial Measures" and
"Reconciliation of GAAP to Non-GAAP Financial Measures" below for a
reconciliation of this GAAP and non-GAAP financial measure.
Cash and cash equivalents totaled $123.2
million as of June 30, 2020,
compared to $147.5 million as of
December 31, 2019.
As of June 30, 2020, there were
10,395,732 total shares of common stock outstanding and warrants to
purchase 11,102,251 shares of common stock, with an exercise price
equal to $13.20 per share. There were 2,351,055 shares
issuable upon exercise of stock options and an additional warrant
to purchase 1,839 shares.
About Sierra Oncology
Sierra Oncology is a late stage
drug development company focused on achieving the successful
registration and commercialization of momelotinib, a potent,
selective and orally-bioavailable JAK1, JAK2 & ACVR1 inhibitor
with a differentiated mechanism of action that enables it to
potentially address all three key drivers of myelofibrosis: anemia,
constitutional symptoms and enlarged spleen. Momelotinib's
therapeutic profile targets the underserved myelofibrosis
patient population, in particular those with anemia and
thrombocytopenia. More than 1,200 subjects have received
momelotinib since clinical studies began in 2009, including more
than 820 patients treated for myelofibrosis.
Sierra has launched MOMENTUM, a randomized double-blind Phase 3
clinical trial designed to enroll 180 myelofibrosis patients who
are symptomatic and anemic, and who have been treated previously
with a JAK inhibitor. The U.S. Food and Drug Administration has
granted Fast Track designation to momelotinib. Momelotinib is
protected by patents anticipated to provide potential exclusivity
to 2040 in the United States and
Europe (inclusive of potential
Patent Term Extension or Supplementary Protection Certificate).
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, impact of the
COVID-19 pandemic on clinical trial plans, including enrollment and
site initiations, expected timing of release of further momelotinib
analysis, expected timing and success of enrollment of MOMENTUM,
potential benefits of momelotinib, and Sierra Oncology's
capitalization and sufficiency of its capital resources. 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, the risk that
disruptions and impacts of COVID-19 will be significant and
lengthy, Sierra Oncology may be unable to successfully develop and
commercialize momelotinib, momelotinib may not demonstrate
safety and efficacy or otherwise produce positive results, Sierra
Oncology may experience delays in the clinical development of
momelotinib, 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 momelotinib 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,
2020
|
|
|
December 31,
2019
|
ASSETS
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
123,233
|
|
$
|
147,528
|
Prepaid expenses and
other current assets
|
|
1,392
|
|
|
2,369
|
Total current
assets
|
|
124,625
|
|
|
149,897
|
Property and
equipment, net
|
|
97
|
|
|
113
|
Operating lease
right-of-use asset
|
|
504
|
|
|
589
|
Other
assets
|
|
667
|
|
|
729
|
TOTAL
ASSETS
|
$
|
125,893
|
|
$
|
151,328
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
Accrued and other
liabilities
|
$
|
6,698
|
|
$
|
7,170
|
Accounts
payable
|
|
1,983
|
|
|
1,019
|
Deferred
revenue
|
|
300
|
|
|
-
|
Warrant
liabilities
|
|
-
|
|
|
45,935
|
Securities issuance
obligation
|
|
-
|
|
|
10,485
|
Total current
liabilities
|
|
8,981
|
|
|
64,609
|
Operating lease
liability
|
|
261
|
|
|
374
|
TOTAL
LIABILITIES
|
|
9,242
|
|
|
64,983
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
stock
|
|
-
|
|
|
1
|
Common
stock
|
|
10
|
|
|
74
|
Additional paid-in
capital
|
|
930,702
|
|
|
851,957
|
Accumulated
deficit
|
|
(814,061)
|
|
|
(765,687 )
|
TOTAL STOCKHOLDERS'
EQUITY
|
|
116,651
|
|
|
86,345
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
$
|
125,893
|
|
$
|
151,328
|
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,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
10,189
|
|
$
|
11,728
|
|
$
|
21,780
|
|
$
|
21,865
|
General and
administrative
|
|
6,260
|
|
|
3,479
|
|
|
10,804
|
|
|
6,844
|
Total operating
expenses
|
|
16,449
|
|
|
15,207
|
|
|
32,584
|
|
|
28,709
|
Loss from
operations
|
|
(16,449)
|
|
|
(15,207)
|
|
|
(32,584)
|
|
|
(28,709)
|
Other income
(expense), net
|
|
|
|
|
|
|
|
|
|
|
|
Changes in fair value
of warrant liabilities
|
|
-
|
|
|
-
|
|
|
(16,240)
|
|
|
-
|
Other income
(expense), net
|
|
(24)
|
|
|
348
|
|
|
517
|
|
|
673
|
Total other income
(expense), net
|
|
(24)
|
|
|
348
|
|
|
(15,723)
|
|
|
673
|
Loss before provision
for (benefit from) income taxes, net
|
|
(16,473)
|
|
|
(14,859)
|
|
|
(48,307)
|
|
|
(28,036)
|
Provision for
(benefit from) income taxes, net
|
|
(11)
|
|
|
19
|
|
|
67
|
|
|
(126)
|
Net loss
|
$
|
(16,462)
|
|
$
|
(14,878)
|
|
$
|
(48,374)
|
|
$
|
(27,910)
|
Net loss per common
share, basic and diluted
|
$
|
(1.58)
|
|
$
|
(7.97)
|
|
$
|
(4.71)
|
|
$
|
(14.97)
|
Weighted-average
shares used in computing net loss per common
share, basic and diluted
|
|
10,395,732
|
|
|
1,867,207
|
|
|
10,276,180
|
|
|
1,864,684
|
Non-GAAP Financial Measures
In addition to operating
results as calculated in accordance with GAAP, Sierra Oncology uses
certain non-GAAP financial measures when evaluating operational
performance. The following table presents the company's net loss
and net loss per common share calculated in accordance with GAAP
and as adjusted to remove the impact of certain non-cash charges.
Sierra Oncology's management believes that these non-GAAP financial
measures are useful to enhance understanding of the company's
financial performance, and are more indicative of its operational
performance and facilitate a better comparison among fiscal
periods.
These non-GAAP financial measures are not, and should not be
viewed as, substitutes for GAAP reporting measures. These non-GAAP
financial measures are not based on any comprehensive set of
accounting rules or principles, differ from GAAP measures with the
same names, and may differ from non-GAAP financial measures with
the same or similar names that are used by other companies. Sierra
Oncology believes that non-GAAP financial measures should only be
used to evaluate its results of operations in conjunction with the
corresponding GAAP financial measures. Sierra Oncology encourages
investors to carefully consider its results under GAAP, as well as
the reconciliations between these presentations, to more fully
understand our business.
Non-GAAP adjusted net loss and non-GAAP adjusted net loss per
share exclude changes in fair value for warrant liabilities,
changes in fair value for a securities issuance obligation and
stock-based compensation. Sierra Oncology excludes changes in fair
value of warrant liabilities because it is a non-cash expense and
has no direct correlation to the operation of its business. Sierra
Oncology excludes a non-cash charge pertaining to the changes in
fair value of an obligation to issue common stock and a warrant to
Gilead because it is a non-cash expense. Sierra Oncology excludes
non-cash stock-based compensation expense from its non-GAAP
financial measures because it believes that excluding this item
provides meaningful supplemental information regarding operational
performance. In particular, companies calculate stock-based
compensation expense using a variety of valuation methodologies and
subjective assumptions.
SIERRA ONCOLOGY, INC.
Reconciliation of GAAP to Non-GAAP Financial
Measures
(unaudited)
(in thousands,
except share and per share data)
A reconciliation between GAAP net loss to non-GAAP adjusted net
loss and GAAP net loss per common share to non-GAAP adjusted net
loss per common share:
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
GAAP net
loss
|
$
|
(16,462)
|
|
$
|
(14,878)
|
|
$
|
(48,374)
|
|
$
|
(27,910)
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
Changes in fair value
of warrant liabilities (1)
|
-
|
|
|
-
|
|
|
16,240
|
|
|
-
|
Changes in fair value
to securities issuance obligation (2)
|
|
-
|
|
|
-
|
|
|
1,485
|
|
|
-
|
Stock-based
compensation (3)
|
|
3,617
|
|
|
1,758
|
|
|
4,535
|
|
|
3,457
|
Non-GAAP adjusted net
loss
|
$
|
(12,845)
|
|
$
|
(13,120)
|
|
$
|
(26,114)
|
|
$
|
(24,453)
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per
common share, basic and diluted
|
$
|
(1.58)
|
|
$
|
(7.97)
|
|
$
|
(4.71)
|
|
$
|
(14.97)
|
Adjustment to net
loss per common share
|
|
0.34
|
|
|
0.94
|
|
|
2.17
|
|
|
1.86
|
Non-GAAP adjusted net
loss per common share, basic and diluted
|
$
|
(1.24)
|
|
$
|
(7.03)
|
|
$
|
(2.54)
|
|
$
|
(13.11)
|
Weighted-average
shares used in computing net loss per common
share, basic and diluted
|
|
10,395,732
|
|
|
1,867,207
|
|
|
10,276,180
|
|
|
1,864,684
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
To reflect a non-cash
charge to other income (expense), net for the changes in fair value
of warrant liabilities.
|
(2)
|
To reflect a non-cash
charge to research and development expense for the changes in fair
value pertaining to the obligation to issue common stock and a
warrant to Gilead.
|
(3)
|
To reflect a non-cash
stock-based compensation charge to research and development expense
and general and administrative expense.
|
View original
content:http://www.prnewswire.com/news-releases/sierra-oncology-reports-second-quarter-2020-results-301107154.html
SOURCE Sierra Oncology