– MOMENTUM Phase 3 Trial on Track to Complete
Enrollment in mid-2021 with Top-line Data Anticipated in H1 2022
–
– Data Presented Throughout the Year Included Long-Term
Overall Survival, Efficacy in Various
Patient Subsets
and Dosing Durability –
– Key Appointments Made to
Executive Team in Preparation for Commercial Execution –
SAN MATEO, Calif., March 11, 2021 /CNW/ - Sierra Oncology, Inc.
(SRRA), a late-stage biopharmaceutical company on a quest to
deliver targeted therapies that treat rare forms of cancer, today
reported its financial and operational results for the fourth
quarter and fiscal year ended December 31, 2020.
"We are excited to enter the final phase of patient
recruitment for MOMENTUM. Trial enrollment remains on track, and we
anticipate closing screening in the first half of the
year," said Stephen Dilly,
MBBS, PhD, President and CEO of Sierra Oncology. "Two important
retrospective analyses from the SIMPLIFY studies were presented in
December 2020 at the American Society
of Hematology. Long-term survival in both JAK inhibitor-naïve and
JAK inhibitor-exposed patients highlighted momelotinib's disease
modifying potential, and, efficacy in patients with reduced
platelets added to the totality of evidence supporting
momelotinib's unique and differentiated profile.
"We are now looking forward to completing enrollment of our
pivotal Phase 3 MOMENTUM study, analyzing and presenting topline
data, and preparing internally for commercialization. Results of
the MOMENTUM study, combined with the SIMPLIFY data sets, will
support future regulatory filings and the potential approval of
momelotinib for the treatment of myelofibrosis."
Recent and Upcoming Business Highlights
- Pivotal Phase 3 MOMENTUM study is on track to complete
enrollment by mid-2021. Top-line data are anticipated in H1
2022
- Following top-line data availability, Sierra anticipates filing
for regulatory approval of momelotinib in H2 2022
- Robust overall survival and sustained efficacy outcome data
from the previously completed SIMPLIFY studies presented at
American Society of Hematology annual meeting in December 2020
- Long-term safety and dose intensity data presented at European
Hematology Association annual meeting in June 2020
- Significant executive appointments made in preparation for
commercial execution: Chief Executive Officer, Stephen Dilly, Chief Business Officer,
Kevin Norrett, General Counsel,
Christina Thomson and Chief
Regulatory & Technical Operations Officer, William Turner
- Amendment to CRT Pioneer Fund agreement for SRA737 allowing for
potential future development of the compound
Year End 2020 Financial Results (all amounts reported in U.S.
currency)
Research and development expenses were
$45.1 million for the year ended
December 31, 2020 compared to $53.2
million for the year ended December 31, 2019. The
decrease was primarily due to a non-cash charge of $10.5 million that was recognized during the year
ended December 31, 2019 pertaining to
an obligation to issue common stock and a warrant to Gilead
Sciences, Inc. (Gilead) in consideration for meaningfully reduced
royalty rates and the elimination of a milestone payment, partially
offset by a $1.5 million non-cash
charge during the year ended December 31,
2020 to recognize the change in fair value of the securities
until their issuance in January of 2020. Also contributing to the
decrease was a reduction of $7.6
million in clinical trial, third-party manufacturing, and
research and preclinical costs for SRA737 and a $0.9 million decrease in personnel-related and
allocated overhead costs for the year ended December 31, 2020. These decreased costs were
offset by a $9.4 million increase in
clinical trial and development costs related to momelotinib for the
year ended December 31, 2020.
Research and development expenses included non-cash stock-based
compensation of $4.3 million and
$3.9 million for the year ended
December 31, 2020 and 2019, respectively.
General and administrative expenses were $20.1 million for year ended December 31,
2020, compared to $13.7 million for
the year ended December 31, 2019. The increase was due to a
$4.9 million increase in
personnel-related and allocated overhead costs, including a
$3.4 million increase in non-cash
stock-based compensation and $1.0
million of severance charges that were primarily related to
the resignation of an executive, and an increase of $1.5 million in professional fees primarily
relating to pre-commercial planning costs for momelotinib. General
and administrative expenses included non-cash stock-based
compensation of $5.2 million and
$1.8 million for the year ended
December 31, 2020 and 2019, respectively.
Total other income (expense), net was $15.8 million of other expense, net for the year
ended December 31, 2020, compared to
$21.4 million of other expense, net
for the year ended December 31, 2019.
The difference was primarily attributable to
a non-cash charge of $20.9 million recognized during the year
ended December 31, 2019, related to
the change in fair value of warrant liabilities and $1.3 million of offering expenses pertaining to
the issuance of the warrants in the 2019 public offering, offset by
a non-cash charge of $16.2 million recognized during the year
ended December 31, 2020, related to
the change in fair value of warrant liabilities which were
reclassified to equity in January
2020.
For the year ended December 31, 2020, Sierra incurred a
Generally Accepted Accounting Principles (GAAP) net loss of
$80.9 million compared to a GAAP net
loss of $88.3 million for the year
ended December 31, 2019. The GAAP net loss includes a non-cash
charge of $16.2 million and
$20.9 million, related to the change
in fair value of warrant liabilities, for the year ended
December 31, 2020 and December 31,
2019, respectively, and a non-cash charge of $1.5 million and $10.5 million pertaining to the obligation to
issue securities to Gilead for the year ended December 31,
2020 and 2019, respectively.
Non-GAAP adjusted net loss was $53.7
million for the year ended December 31, 2020, compared
with a non-GAAP adjusted net loss of $51.2 million for the
year ended December 31, 2019. 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 $104.1
million as of December 31, 2020, compared to
$147.5 million as of
December 31, 2019.
As of December 31, 2020, there were 11,128,484 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 4,146,928 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
biopharmaceutical company on a quest to deliver targeted therapies
that treat rare forms of cancer. We harness our deep scientific
expertise to identify compounds that target the root cause of
disease to advance targeted therapies with assets on the leading
edge of cancer biology. Our team takes an evidence-based approach
to understand the limitations of current treatments and explore new
ways to change the cancer treatment paradigm. Together, we are
transforming promise into patient impact.
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
data and analysis, expected timing and success of enrollment of
MOMENTUM, potential benefits of momelotinib, the ability of Sierra
Oncology to obtain regulatory approval of momelotinib and the
timing of such regulatory approvals, the development of SRA737 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 may not
be able to successfully develop, obtain regulatory approval for and
commercialize momelotinib or experience significant delays in doing
so, Sierra Oncology may not be able to demonstrate acceptable
safety and efficacy of momelotinib, the risk that disruptions and
impacts of COVID-19 will be significant and lengthy, 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 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)
|
|
December 31, 2020
|
|
|
December 31, 2019
|
ASSETS
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
104,055
|
|
|
$
|
147,528
|
Prepaid expenses and
other current assets
|
|
|
2,415
|
|
|
|
2,369
|
Total current
assets
|
|
|
106,470
|
|
|
|
149,897
|
Property and
equipment, net
|
|
|
52
|
|
|
|
113
|
Operating lease
right-of-use asset
|
|
|
318
|
|
|
|
589
|
Other
assets
|
|
|
647
|
|
|
|
729
|
TOTAL
ASSETS
|
|
$
|
107,487
|
|
|
$
|
151,328
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
Accrued and other
liabilities
|
|
$
|
7,148
|
|
|
$
|
7,170
|
Accounts
payable
|
|
|
2,205
|
|
|
|
1,019
|
Deferred
revenue
|
|
|
—
|
|
|
|
—
|
Warrant
liabilities
|
|
|
—
|
|
|
|
45,935
|
Securities issuance
obligation
|
|
|
—
|
|
|
|
10,485
|
Total current
liabilities
|
|
|
9,353
|
|
|
|
64,609
|
Operating lease
liability
|
|
|
175
|
|
|
|
374
|
TOTAL
LIABILITIES
|
|
|
9,528
|
|
|
|
64,983
|
STOCKHOLDERS' EQUITY:
|
|
|
|
|
|
|
|
Preferred
stock
|
|
|
—
|
|
|
|
1
|
Common
stock
|
|
|
11
|
|
|
|
74
|
Additional paid-in
capital
|
|
|
944,537
|
|
|
|
851,957
|
Accumulated
deficit
|
|
|
(846,589)
|
|
|
|
(765,687)
|
TOTAL
STOCKHOLDERS' EQUITY
|
|
|
97,959
|
|
|
|
86,345
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
$
|
107,487
|
|
|
$
|
151,328
|
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,
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
Collaboration
revenue
|
|
$
|
200
|
|
|
$
|
—
|
|
|
$
|
300
|
|
|
$
|
—
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
12,906
|
|
|
|
21,271
|
|
|
|
45,118
|
|
|
|
53,249
|
General and
administrative
|
|
|
5,207
|
|
|
|
3,748
|
|
|
|
20,123
|
|
|
|
13,743
|
Total operating
expenses
|
|
|
18,113
|
|
|
|
25,019
|
|
|
|
65,241
|
|
|
|
66,992
|
Loss from
operations
|
|
|
(17,913)
|
|
|
|
(25,019)
|
|
|
|
(64,941)
|
|
|
|
(66,992)
|
Other income
(expense), net:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in fair value
of warrant liabilities
|
|
|
—
|
|
|
|
(20,926)
|
|
|
|
(16,240)
|
|
|
|
(20,926)
|
Other income
(expense), net
|
|
|
(74)
|
|
|
|
(1,478)
|
|
|
|
421
|
|
|
|
(517)
|
Total other income
(expense), net
|
|
|
(74)
|
|
|
|
(22,404)
|
|
|
|
(15,819)
|
|
|
|
(21,443)
|
Loss before provision
for (benefit from) income taxes, net
|
|
|
(17,987)
|
|
|
|
(47,423)
|
|
|
|
(80,760)
|
|
|
|
(88,435)
|
Provision for
(benefit from) income taxes, net
|
|
|
36
|
|
|
|
39
|
|
|
|
142
|
|
|
|
(160)
|
Net loss
|
|
$
|
(18,023)
|
|
|
$
|
(47,462)
|
|
|
$
|
(80,902)
|
|
|
$
|
(88,275)
|
Net loss per common
share, basic and diluted
|
|
$
|
(1.63)
|
|
|
$
|
(7.88)
|
|
|
$
|
(7.70)
|
|
|
$
|
(30.30)
|
Weighted-average
shares used in computing net loss per common
|
|
|
11,028,200
|
|
|
|
6,023,267
|
|
|
|
10,506,739
|
|
|
|
2,913,487
|
share, basic and
diluted
|
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 non-cash charges pertaining to the 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 December 31,
|
|
|
Year
Ended December 31,
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
GAAP net
loss
|
|
$
|
(18,023)
|
|
|
$
|
(47,462)
|
|
|
$
|
(80,902)
|
|
|
$
|
(88,275)
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in fair value
of warrant liabilities (1)
|
|
|
—
|
|
|
|
20,926
|
|
|
|
16,240
|
|
|
|
20,926
|
Changes in fair value
to securities issuance obligation (2)
|
|
|
—
|
|
|
|
10,485
|
|
|
|
1,485
|
|
|
|
10,485
|
Stock-based
compensation (3)
|
|
|
2,861
|
|
|
|
958
|
|
|
|
9,470
|
|
|
|
5,695
|
Non-GAAP adjusted net
loss
|
|
$
|
(15,162)
|
|
|
$
|
(15,093)
|
|
|
$
|
(53,707)
|
|
|
$
|
(51,169)
|
GAAP net loss per
common share, basic and diluted
|
|
$
|
(1.63)
|
|
|
$
|
(7.88)
|
|
|
$
|
(7.70)
|
|
|
$
|
(30.30)
|
Adjustment to net
loss per common share
|
|
|
0.26
|
|
|
|
5.37
|
|
|
|
2.59
|
|
|
|
12.74
|
Non-GAAP adjusted net
loss per common share, basic and diluted
|
|
$
|
(1.37)
|
|
|
$
|
(2.51)
|
|
|
$
|
(5.12)
|
|
|
$
|
(17.56)
|
Weighted-average
shares used in computing net loss per common
|
|
|
11,028,200
|
|
|
|
6,023,267
|
|
|
|
10,506,739
|
|
|
|
2,913,487
|
share, basic and
diluted
|
|
|
(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 pertaining to the
obligation and subsequent changes in fair value 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
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SOURCE Sierra Oncology