SOUTH SAN FRANCISCO, Calif.,
Aug. 14, 2019 /PRNewswire/ -- Sutro
Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug
discovery, development and manufacturing company focused on the
application of precise protein engineering and rational design to
create next-generation oncology therapeutics, today reported its
financial results for the three and six months ended June 30, 2019.
"During the second quarter of 2019, we presented encouraging
interim safety data from our Phase 1 trial for STRO-001 at the EHA
Congress and continued to advance our pipeline of product
candidates and programs," said Bill
Newell, Sutro's Chief Executive Officer. "We believe our
proprietary technology allows us to rapidly and
precisely create optimally designed, next-generation protein
therapeutics candidates for cancer and autoimmune disorders. At
Sutro, we hold ourselves to the highest standards and set ambitious
goals for ourselves which we have been meeting and exceeding."
Recent Business Highlights and Developments
STRO-001 Clinical Program
- Potential first-in-class and best-in-class Antibody Drug
Conjugate ("ADC") directed against CD74, which is highly expressed
in many B cell malignancies
- Phase 1 dose-escalation, with dose expansion, clinical trial
enrolling patients with multiple myeloma and non-Hodgkin lymphoma,
with initial safety data presented at the EHA Congress on
June 15, 2019 and initial efficacy
data expected by year end 2019
STRO-002 Clinical Program
- Potential best-in-class ADC directed against folate
receptor-alpha, which is highly expressed in ovarian cancer
- Phase 1 dose-escalation, with dose expansion, clinical
trial enrolling women with advanced ovarian and endometrial
cancers, with initial safety data expected by year end 2019
BCMA ADC Clinical Program and Celgene
Collaboration
- Celgene received FDA clearance on its IND application for an
ADC targeting B-cell maturation antigen ("BCMA") for the treatment
of multiple myeloma. This is the third product candidate to
originate from Sutro's proprietary discovery and manufacturing
platform to enter clinical development since early 2018, and for
which Celgene has worldwide development and commercialization
rights. Sutro is entitled to development and regulatory milestone
payments and tiered royalties ranging from mid to high single digit
percentages from Celgene for this BCMA ADC.
- Existing pipeline was bolstered as Sutro gained back rights to
three bispecific assets from the collaboration with Celgene. Sutro
holds U.S. development and commercialization rights targeting
BCMA-CD3, PD1-LAG3 and PD1-TIM3. For any products resulting
from these three programs, Celgene will own ex-U.S. development and
commercialization rights and will be obligated to pay Sutro
development and regulatory milestone payments and tiered
royalties.
Second Quarter 2019 Financial Highlights
Cash, Cash Equivalents and Marketable Securities
As of June 30, 2019, Sutro had cash, cash equivalents and
marketable securities of $168.2 million, as compared to
$204.5 million as of December 31, 2018, which represents net cash
usage of $36.3 million during the six
months ended June 30,
2019.
Revenue
Revenue was $10.5 million and $19.2 million for the three and six months ended
June 30, 2019, respectively, compared
to $5.7 million and $11.5 million for the same periods in
2018. The 2019 periods included collaboration revenue
from Celgene, Merck and EMD Serono. On January 1, 2019, Sutro adopted Accounting
Standards Update No. 2014-09 Revenue from Contracts with
Customers (Accounting Standards Codification Topic 606). For
more information on the impact of the adoption of the new revenue
standard, see "Notes to Unaudited Interim Condensed Financial
Statements" contained in Part I, Item 1 of Sutro's Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission
on August 14, 2019. Future collaboration revenue from Celgene,
Merck and EMD Serono, and from any future collaboration partners,
will fluctuate as a result of the amount and timing of revenue
recognition of upfront, milestones and other collaboration
agreement payments.
Operating Expenses
Total operating expenses for the three and six months ended
June 30, 2019, were $24.2 million and $47.1
million, respectively, compared to $17.8 million and $35.3
million for the same periods in 2018, including non-cash
stock-based compensation of $2.5
million and $0.2 million, and
depreciation and amortization expense of $1.2 million and $1.1
million, in the 2019 and 2018 second quarters,
respectively. Total operating expenses for second quarter
2019 were comprised of research and development expenses of
$16.1 million and general and
administrative expenses of $8.1
million, with both expense types expected to increase in
2019 as Sutro's internal product candidates advance in clinical
development and additional general and administrative expenses are
incurred as a public company.
About Sutro Biopharma
Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug
discovery, development and manufacturing company. Using precise
protein engineering and rational design, Sutro is advancing
next-generation oncology therapeutics.
Sutro's proprietary and integrated cell-free protein
synthesis and site-specific conjugation platform, XpressCF+™, led
to the discovery of STRO-001 and STRO-002, Sutro's first two
internally-developed ADCs. STRO-001 is an CD-74 ADC currently being
investigated in a Phase I clinical trial of patients with advanced
B-cell malignancies, including multiple myeloma and non-Hodgkin
lymphoma. STRO-001 was granted Orphan Drug Designation by the FDA
for multiple myeloma in October 2018. STRO-002 is a folate
receptor alpha (FoIRα) ADC, currently being investigated in a Phase
I clinical trial of patients with ovarian and endometrial cancers.
This is the second product candidate to be evaluated in clinical
trials resulting from Sutro's XpressCF+™ technology platform. A
third program, BCMA ADC, which is part of Sutro's collaboration
with Celgene, recently received FDA clearance for its IND. Sutro's
proprietary technology was responsible for the discovery and
manufacturing of the BCMA ADC, for which Celgene has worldwide
development and commercialization rights. Sutro is entitled to
development and regulatory milestone payments and tiered royalties
from Celgene for this BCMA ADC.
Sutro is dedicated to transforming the lives of cancer patients
by creating medicines with improved therapeutic profiles for areas
of unmet need.
To date, Sutro has designed cytokine-based immuno-oncology
therapies, ADCs, vaccines and bispecific antibodies primarily
directed at clinically-validated targets for which the current
standard of care is suboptimal.
Sutro's platform allows it to accelerate discovery and
development of potential first-in-class and best-in-class molecules
through rapid and systematic evaluation of protein
structure-activity relationships to create optimized homogeneous
product candidates.
In addition to developing its own oncology pipeline, Sutro is
collaborating with select pharmaceutical and biotech companies to
discover and develop novel, next-generation therapeutics. As the
pace of clinical development accelerates, Sutro and its partners
are developing therapeutics designed to more efficiently kill
tumors without harming healthy cells.
Follow Sutro on Twitter, @Sutrobio, and at www.sutrobio.com to
learn more about our passion for changing the future of
oncology.
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, anticipated clinical development activities, potential
benefits of the company's product candidates and platform and
anticipated financial trends. All statements other than statements
of historical fact are statements that could be deemed
forward-looking statements. Although the company believes that the
expectations reflected in such forward-looking statements are
reasonable, the company cannot guarantee future events, results,
actions, levels of activity, performance or achievements, and the
timing and results of biotechnology development and potential
regulatory approval is inherently uncertain. Forward-looking
statements are subject to risks and uncertainties that may cause
the company's actual activities or results to differ significantly
from those expressed in any forward-looking statement, including
risks and uncertainties related to the company's ability to advance
its product candidates, the receipt and timing of potential
regulatory designations, approvals and commercialization of product
candidates, the Company's ability to maintain and recognize the
benefits of certain designations received by product candidates,
the timing and results of preclinical and clinical trials, the
company's ability to fund development activities and achieve
development goals, the company's ability to protect intellectual
property, and the Company's commercial collaborations with third
parties and other risks and uncertainties described under the
heading "Risk Factors" in documents the company files from time to
time with the Securities and Exchange Commission. These
forward-looking statements speak only as of the date of this press
release, and the company undertakes no obligation to revise or
update any forward-looking statements to reflect events or
circumstances after the date hereof.
Investor Contacts
John Graziano
Solebury Trout
+1 646-378-2942
jgraziano@soleburytrout.com
Xuan Yang
Solebury Trout
+1 646-378-2975
xyang@soleburytrout.com
Media Contacts
David Schull
Russo Partners
(212) 845-4271
david.schull@russopartnersllc.com
Scott Stachowiak
Russo Partners
(646) 942-563
(646) 300-3590 mobile
scott.stachowiak@russopartnersllc.com
Sutro Biopharma,
Inc.
|
Selected
Statements of Operations Financial Data
|
(Unaudited)
|
(In thousands,
except share and per share amounts)
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
|
June
30,
|
|
June
30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues
|
|
$
|
10,525
|
|
$
|
5,704
|
|
$
|
19,154
|
|
$
|
11,497
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
16,143
|
|
|
13,751
|
|
|
31,323
|
|
|
26,833
|
General and
administrative
|
|
|
8,067
|
|
|
4,041
|
|
|
15,782
|
|
|
8,455
|
Total operating
expenses
|
|
|
24,210
|
|
|
17,792
|
|
|
47,105
|
|
|
35,288
|
Loss from
operations
|
|
|
(13,685)
|
|
|
(12,088)
|
|
|
(27,951)
|
|
|
(23,791)
|
Interest
income
|
|
|
1,124
|
|
|
40
|
|
|
2,300
|
|
|
80
|
Interest and other
expense, net
|
|
|
(1,232)
|
|
|
507
|
|
|
(2,392)
|
|
|
124
|
Net loss
|
|
$
|
(13,793)
|
|
$
|
(11,541)
|
|
$
|
(28,043)
|
|
$
|
(23,587)
|
Net loss per share,
attributable to common
stockholders, basic and diluted
|
|
$
|
(0.60)
|
|
$
|
(24.17)
|
|
$
|
(1.22)
|
|
$
|
(49.90)
|
Weighted-average
shares used in computing net loss per
share
attributable to common stockholders
|
|
|
22,926,390
|
|
|
477,521
|
|
|
22,895,902
|
|
|
472,647
|
Sutro Biopharma,
Inc.
|
Selected Balance
Sheet Financial Data
|
(Unaudited)
|
(In
thousands)
|
|
|
|
June
30,
|
|
December
31,
|
|
|
2019
(1)
|
|
2018
(2)
|
Assets
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
$
|
168,226
|
|
$
|
204,492
|
Accounts receivable,
net
|
|
|
6,500
|
|
|
2,489
|
Property and
equipment, net
|
|
|
9,273
|
|
|
10,934
|
Other
assets
|
|
|
4,813
|
|
|
5,224
|
Total
assets
|
|
$
|
188,812
|
|
$
|
223,139
|
Liabilities and
Stockholders'
Equity
|
|
|
|
|
|
|
Accounts payable and
other liabilities
|
|
$
|
9,494
|
|
$
|
10,703
|
Deferred
revenue
|
|
|
46,957
|
|
|
66,173
|
Debt
|
|
|
12,806
|
|
|
14,724
|
Total
liabilities
|
|
|
69,257
|
|
|
91,600
|
Total stockholders'
equity
|
|
|
119,555
|
|
|
131,539
|
Total liabilities
and stockholders' equity
|
|
$
|
188,812
|
|
$
|
223,139
|
|
|
|
|
|
|
|
(1)
|
The condensed balance
sheet as of June 30, 2019 was derived from the unaudited financial
statements included in the Company's Quarterly Report on Form 10-Q
for the quarter ended June 30, 2019, filed with the Securities and
Exchange Commission on August 14, 2019.
|
(2)
|
The condensed balance
sheet as of December 31, 2018 was derived from the audited
financial statements included in the Company's Annual Report on
Form 10-K for the year ended December 31, 2018, filed with the
Securities and Exchange Commission on March 29, 2019.
|
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SOURCE Sutro Biopharma, Inc.