- MOMENTUM Phase 3 clinical trial for momelotinib
underway, targeting enrolment of 180 patients with myelofibrosis
who are symptomatic and anemic -
- Publications highlighting durability, safety and efficacy data
for momelotinib planned throughout 2020 -
- Company to host analyst conference call at 8 am ET today -
VANCOUVER, March 3, 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 year ended December
31, 2019.
"Our focus is on achieving regulatory and commercial success
with our Phase 3 drug candidate, momelotinib, which may become the
first approved therapeutic capable of treating all three hallmarks
of myelofibrosis; anemia, constitutional symptoms and enlarged
spleen. Given its potentially unique profile, momelotinib could
command an important role in the poorly addressed anemic and
thrombocytopenic first-line and second-line myelofibrosis patient
populations," said Dr. Nick Glover, President and CEO of
Sierra Oncology. "During the fourth quarter of 2019, we launched
the MOMENTUM Phase 3 clinical trial, setting Sierra on course to
deliver top-line data in late 2021 and positioning momelotinib for
potential registration filing in 2022. Our focus now is on
activating global clinical trial sites over the coming months and
driving enrollment for MOMENTUM, and we look forward to providing
ongoing updates on our progress throughout this year."
"Myelofibrosis is characterized by progressive anemia and
thrombocytopenia, and current JAK inhibitor therapies can induce or
further exacerbate this myelosuppression, limiting their use in
first line treatment and resulting in a population of second line
patients who are no longer able to benefit from such therapies.
Conversely, we believe momelotinib's ability to address anemia,
while either sparing platelets or reversing thrombocytopenia, are
important potential drivers of its commercial opportunity. We plan
to further highlight momelotinib's differentiated durability,
safety and efficacy profile during 2020 with additional
dissemination of emerging data from the two previously completed
SIMPLIFY Phase 3 trials that compared momelotinib head-to-head with
ruxolitinib," added Dr. Glover. "Given momelotinib's distinct
clinical profile, we believe our drug candidate is also well
positioned amongst the JAK inhibitor class for emerging combination
approaches targeting myelofibrosis."
2019 Highlights for Momelotinib:
- During the second quarter, Sierra obtained regulatory clarity
with the FDA and announced the design of the MOMENTUM Phase 3
clinical trial intended to support the potential registration of
momelotinib. Sierra also announced that 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, had been named Chief Investigator of
the MOMENTUM trial.
- Sierra also reported during the second quarter 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.
- During the fourth quarter, Sierra launched the MOMENTUM
clinical trial for patients with myelofibrosis. The randomized
double-blind global Phase 3 trial is designed to confirm the
efficacy of momelotinib on myelofibrosis symptoms, transfusion
independence and splenomegaly, as compared to danazol. The trial is
targeting enrollment of 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). Data from MOMENTUM, along
with data from more than 820 myelofibrosis patients previously
treated with momelotinib in prior clinical studies, will form the
basis of the global registration strategy for momelotinib.
- During the fourth quarter, new analyses of RBC transfusion
data from SIMPLIFY-1, a double-blind Phase 3 trial of momelotinib
head-to-head versus ruxolitinib in JAK inhibitor naïve patients,
were presented in a poster by Dr. Ruben
Mesa, Director of the Mays Cancer Center, home to UT Health
San Antonio MD Anderson Cancer Center, at the 61st American Society
of Hematology (ASH) Annual Meeting in Orlando, Florida. These analyses
demonstrated that patients who received momelotinib had
significantly decreased transfusion requirements compared to those
treated with ruxolitinib, including an odds ratio of nearly 10 for
receiving no transfusions during the 24-week study period.
Transfusion dependency and moderate to severe anemia are critical
negative prognostic factors for overall survival in
myelofibrosis.
Year End 2019 Financial Results (all amounts reported in U.S.
currency)
Research and development expenses were $53.2 million for the year ended December 31, 2019, compared to $41.1 million for the year ended December 31, 2018. In addition to a non-cash
charge of $10.5 million pertaining to
the obligation to issue common stock and a warrant in consideration
for meaningfully reduced royalty rates and elimination of a near
term milestone payment in an amendment to our Asset Purchase
Agreement with Gilead Sciences, Inc. (Gilead), the increase was
primarily due to costs related to momelotinib, including a
$12.2 million increase in clinical
trial and development costs, a $2.5
million increase in third-party manufacturing costs and a
$1.4 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
2018 and decreases in SRA737 and SRA141 costs, including a
$5.0 million decrease in clinical
trial costs primarily related to SRA737, a $4.3 million decrease in third-party
manufacturing costs, and a $2.1
million decrease in research and preclinical costs. Research
and development expenses included non-cash stock-based compensation
of $3.9 million and $4.5 million for the year ended December 31, 2019 and 2018, respectively.
General and administrative expenses were $13.7 million for the year ended December 31, 2019, compared to $14.3 million for the year ended December 31, 2018. This decrease was primarily
due to decreases in personnel-related and allocated overhead costs.
General and administrative expenses included non-cash stock-based
compensation of $1.8 million and
$2.3 million for the year ended
December 31, 2019 and 2018,
respectively.
Other income (expense), net was $21.4
million of other expense, net for the year ended
December 31, 2019, compared to
$1.8 million of other income, net for
the year ended December 31, 2018. The
increase was primarily attributable to a non-cash charge of
$20.9 million related to the change
in fair value of warrant liabilities and offering expenses of
$1.3 million pertaining the issuance
of the warrants in the 2019 public offering and a $0.7 million increase in interest expense
incurred on the term loan that was repaid in December 2019.
For the year ended December 31,
2019, Sierra incurred a GAAP net loss of $88.3 million compared to a GAAP net loss of
$53.3 million for the year ended
December 31, 2018. The GAAP net loss
for the year ended December 31, 2019
includes a non-cash charge of $20.9
million, related to the change in fair value of warrant
liabilities included in other income (expense), net and a non-cash
charge of $10.5 million pertaining to
the obligation to issue securities to Gilead included in research
and development expenses as mentioned above. In January 2020, Sierra fulfilled this obligation,
issuing 725,283 shares of common stock to Gilead and a warrant to
purchase an equivalent amount of common stock.
Non-GAAP adjusted net loss was $51.2
million for the year ended December
31, 2019, compared to a non-GAAP adjusted net loss of
$46.5 million for the year ended
December 31, 2018. Non-GAAP adjusted
net loss excludes expenses related to the change in fair value of
warrant liabilities, the securities issuance obligation, and
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 $147.5
million as of December 31,
2019, compared to $106.0
million as of December 31,
2018. This increase was due to an underwritten public
offering in November 2019, pursuant
to which the company raised gross proceeds
of $103.0 million (net proceeds of $97.7 million). This increase was offset by cash
used in operating activities of $51.2
million and the full repayment of a term loan in
December 2019 in the amount of
$5.4 million, including prepayment
and final payment fees associated with terminating the debt
facility.
In January 2020, all of the Series
A convertible voting preferred stock converted into shares of
common stock. As of January 31, 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. At December 31, 2019 were 327,862 shares issuable
upon exercise of stock options and a warrant.
The company anticipates its current resources will be sufficient
to execute on its development strategy for momelotinib into the
second half of 2022. In addition, the Series B warrants issued
in the underwritten public offering in November 2019, may only be exercised by paying
the exercise price in cash, and will expire on the 75th day
anniversary following the announcement of top-line data from the
MOMENTUM Phase 3 trial. If these Series B warrants are fully
exercised, the company will receive approximately $34.0 million in proceeds.
Conference Call Information
Today at 8:00 am Eastern Time,
Sierra's management will host a conference call to discuss the
company's and operational results for 2019 and provide a business
update for 2020.
Date and Time: Tuesday, March 3 at
8:00 am ET
Domestic (Toll Free- US): 1-888-394-8218
International (Toll): 1-323-701-0225
Conference ID: 1052679
Webcast Link: www.sierraoncology.com
Direct Link: http://public.viavid.com/index.php?id=137946
Call registration is available through the Sierra Oncology
website at www.sierraoncology.com. An archive of the presentation
will be accessible after the event through the Sierra Oncology
website.
About Sierra Oncology
Sierra Oncology is a late stage drug development company focused
on achieving the successful registration and commercialization of
its lead product candidate, momelotinib. Momelotinib 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 820
patients treated for myelofibrosis.
Sierra recently launched the MOMENTUM Phase 3 clinical trial, a
randomized double-blind 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 for the treatment of patients with
intermediate/high-risk myelofibrosis who have previously received a
JAK inhibitor. Momelotinib is wholly owned by Sierra Oncology and
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).
Sierra also retains the global commercialization rights to 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.
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,
expected timing of announcement of top-line data and registration
of MOMENTUM, expected timing and success of enrollment of MOMENTUM,
expected timing of the execution of, expected results from,
non-dilutive strategic options, and potential benefits of Sierra
Oncology's lead product candidate and other product candidates 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,
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)
|
December 31,
2019
|
|
December 31,
2018
|
ASSETS
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
Cash and cash
equivalents
|
$
|
147,528
|
|
$
|
106,046
|
Prepaid expenses and
other current assets
|
2,369
|
|
2,706
|
Total current
assets
|
149,897
|
|
108,752
|
Property and
equipment, net
|
113
|
|
168
|
Operating lease
right-of-use asset
|
589
|
|
-
|
Other
assets
|
729
|
|
549
|
TOTAL
ASSETS
|
$
|
151,328
|
|
$
|
109,469
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
Accrued and other
liabilities
|
$
|
7,170
|
|
$
|
8,812
|
Accounts
payable
|
1,019
|
|
1,287
|
Warrant
liabilities
|
45,935
|
|
-
|
Securities issuance
obligation
|
10,485
|
|
-
|
Total current
liabilities
|
64,609
|
|
10,099
|
Operating lease
liability
|
374
|
|
-
|
Term loan
|
-
|
|
4,891
|
TOTAL
LIABILITIES
|
64,983
|
|
14,990
|
|
|
|
|
STOCKHOLDERS'
EQUITY:
|
|
|
|
Preferred
stock
|
1
|
|
-
|
Common
stock
|
74
|
|
74
|
Additional paid-in
capital
|
851,957
|
|
771,817
|
Accumulated
deficit
|
(765,687)
|
|
(677,412 )
|
TOTAL STOCKHOLDERS'
EQUITY
|
86,345
|
|
94,479
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
$
|
151,328
|
|
$
|
109,469
|
SIERRA ONCOLOGY, INC.
Condensed
Consolidated Statements of Operations
(unaudited)
(in thousands, except share and
per share data)
|
Three Months
Ended
December 31,
|
|
Year Ended
December 31,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
$
|
21,271
|
|
$
|
11,046
|
|
$
|
53,249
|
|
$
|
41,078
|
General and
administrative
|
3,748
|
|
3,603
|
|
13,743
|
|
14,339
|
Total operating
expenses
|
25,019
|
|
14,649
|
|
66,992
|
|
55,417
|
Loss from
operations
|
(25,019)
|
|
(14,649)
|
|
(66,992)
|
|
(55,417)
|
Other income
(expense), net
|
|
|
|
|
|
|
|
Changes in fair value
of warrant liabilities
|
(20,926)
|
|
-
|
|
(20,926)
|
|
-
|
Other income
(expense), net
|
(1,478)
|
|
447
|
|
(517)
|
|
1,780
|
Total other income
(expense)
|
(22,404)
|
|
447
|
|
(21,443)
|
|
1,780
|
Loss before provision
for (benefit from) income taxes, net
|
(47,423)
|
|
(14,202)
|
|
(88,435)
|
|
(53,637)
|
Provision for
(benefit from) income taxes, net
|
39
|
|
81
|
|
(160)
|
|
(302)
|
Net loss and
comprehensive loss
|
$
|
(47,462)
|
|
$
|
(14,283)
|
|
$
|
(88,275)
|
|
$
|
(53,335)
|
Net loss per common
share, basic and diluted
|
$
|
(7.88)
|
|
$
|
(7.68)
|
|
$
|
(30.30)
|
|
$
|
(30.16)
|
Weighted-average
shares used in computing net loss per common
|
|
|
|
|
|
|
|
share, basic and
diluted
|
6,023,267
|
|
1,859,141
|
|
2,913,487
|
|
1,768,480
|
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, 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 obligation to issue common stock and a
warrant to Gilead because it is a one-time initial charge and the
change in fair value of the obligation. 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
December 31,
|
|
Year Ended
December 31,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
GAAP net
loss
|
$
|
(47,462)
|
|
$
|
(14,283)
|
|
$
|
(88,275)
|
|
$
|
(53,335)
|
Adjustments:
|
|
|
|
|
|
|
|
Changes in fair value
of warrant liabilities (1)
|
20,926
|
|
-
|
|
20,926
|
|
-
|
Securities issuance
obligation (2)
|
10,485
|
|
-
|
|
10,485
|
|
-
|
Stock based
compensation (3)
|
958
|
|
1,694
|
|
5,695
|
|
6,796
|
Non-GAAP adjusted net
loss
|
$
|
(15,093)
|
|
$
|
(12,589)
|
|
$
|
(51,169)
|
|
$
|
(46,539)
|
GAAP net loss per
common share, basic and diluted
|
$
|
(7.88)
|
|
$
|
(7.68)
|
|
$
|
(30.30)
|
|
$
|
(30.16)
|
Adjustment to net
loss per common share
|
5.37
|
|
0.91
|
|
12.74
|
|
3.84
|
Non-GAAP adjusted net
loss per common share, basic and diluted
|
$
|
(2.51)
|
|
$
|
(6.77)
|
|
$
|
(17.56)
|
|
$
|
(26.32)
|
Weighted-average
shares used in computing net loss per common
|
|
|
|
|
|
|
|
share, basic and
diluted
|
6,023,267
|
|
1,859,141
|
|
2,913,487
|
|
1,768,480
|
|
|
(1)
|
To reflect a non-cash
charge to other income (expense), net for the change in fair value
of warrant liabilities.
|
(2)
|
To reflect a non-cash
charge to research and development expense 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.
|
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SOURCE Sierra Oncology