SOUTH SAN FRANCISCO, Calif.,
March 18, 2021 /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 cancer and autoimmune therapeutics, today
reported its financial results for the year ended December 31, 2020, its recent business
highlights, and provided a preview of anticipated selected
milestones in 2021.
"2020 was a highly productive year for Sutro as we advanced the
clinical development of our programs and navigated through the
pandemic. Four product candidates that have now entered the
clinic, two of which are partnered programs, were discovered and
developed using our cell-free protein synthesis platform,
showcasing its strength and versatility," said Bill Newell, Sutro's Chief Executive Officer.
"We were particularly encouraged to see meaningful clinical benefit
for women with advanced platinum-resistant and refractory ovarian
cancer who were part of the Phase 1 dose-escalation study for
STRO-002, our FolRα-targeted ADC. We dosed the first patient in
dose-expansion in January 2021 and
are rapidly moving this program forward. Additionally, we are
progressing well on our partnerships – our Bristol Myers Squibb and
EMD Serono collaboration programs are enrolling patients in Phase 1
studies and we are continuing to work with Merck on the cytokine
derivatives collaboration to bring its first program to the clinic.
We look forward to continued progress on our clinical programs and
utilizing our industry leading cell-free platform to advance
additional product candidates to benefit patients with unmet
medical needs."
Recent Business Highlights and Expected 2021
Milestones
STRO-002: Continued progress in Phase 1 trial of
STRO-002, folate receptor-alpha (FolRα)-targeted
antibody-drug conjugate (ADC) for patients with recurrent
platinum resistant or refractory ovarian cancer.
- Dose-escalation portion of the Phase 1 trial completed
enrollment as of August 31,
2020 and interim data as of October 30,
2020 were presented by key opinion leaders (KOL) and
management at the KOL Discussion of STRO-002 Data Event in
December 2020.
- Additional data from dose-escalation, with extended follow-up
on patients remaining on study, is expected in the first half of
2021.
- Dose-expansion portion of the Phase 1 trial began enrolling
patients in January 2021 and initial
dose-expansion data is expected to be reported in the second half
of 2021.
- Dose-expansion data is expected to inform regulatory
interactions, potentially accelerate development of our
registration strategy, and enable identification of the broadest
population that may benefit from STRO-002.
STRO-001: Phase 1 dose-escalation
continues for STRO-001, a CD74-targeted ADC for
development in B-cell malignancies.
- Dose-escalation in the Phase 1 trial enrolling patients with
lymphoma and multiple myeloma is ongoing and the maximum tolerated
dose has not yet been reached.
- Interim data from the dose-escalation portion of the trial in
patients with non-Hodgkin lymphoma and preclinical data from our
collaboration with Fred Hutchinson Cancer Research Center were
presented at the 62nd American Society of Hematology (ASH) Annual
Meeting in December 2020.
- The dose-expansion portion of the Phase 1 trial is expected to
begin enrolling patients in the second half of 2021.
Merck collaboration: Working collaboratively with
Merck to advance two cytokine derivative programs towards the
clinic.
- Sutro is continuing to work with Merck to discover new
therapeutics for cancer and autoimmune diseases. The collaboration
is advancing two cytokine-derivative programs through the research
phase.
- In March 2020, Merck extended by
one year the research term of the collaboration's first program,
which included a $5.0 million payment
to Sutro.
- In August 2020, Sutro entered
into a supply agreement with Merck, giving Sutro responsibility for
manufacturing pre-clinical and clinical supply for products
emerging from the collaboration.
Bristol Myers Squibb (BMS)
collaboration: Phase 1 trial for CC-99712, a
BCMA-targeted ADC, is continuing to enroll multiple myeloma
patients.
- Since initiation of Phase 1 in the second half of 2019, BMS has
been enrolling patients in a dose-escalation/expansion trial to
assess treatment of relapsed and refractory multiple myeloma, with
the last reported dose level at 3.0 mg/kg.
- CC-99712 was granted Orphan Drug Designation by the FDA for
multiple myeloma.
- BMS is responsible for the worldwide clinical development and
commercialization of CC–99712. Sutro is responsible for clinical
supply manufacturing and certain development services for CC-99712
and is entitled to development and regulatory milestone or
contingent payments and tiered royalties on sales ranging from mid
to high single digit percentages.
Merck KGaA, EMD Serono (EMD Serono) collaboration:
Phase 1 trial for M1231, a first-in-class bispecific ADC
targeting MUC1–EGFR for development in solid tumors, was initiated
in the first quarter of 2021.
- EMD Serono is enrolling patients in the dose-escalation portion
of a Phase 1 trial of M1231 for treatment of metastatic solid
tumors including non-small cell lung cancer (NSCLC) and esophageal
squamous cell carcinoma.
- Sutro is responsible for manufacturing early clinical supply of
M1231 and is eligible for milestone or contingent payments and
tiered royalties.
Vaxcyte relationship: Potential vaccine
application demonstrates the power of Sutro's cell-free technology
in conjugated vaccines.
- Under a license from Sutro, Vaxcyte has the right to use the
XpressCF® and XpressCF+™ platforms to discover and
develop vaccine candidates for the treatment or prophylaxis of
infectious diseases.
- Vaxcyte is progressing their broader spectrum pneumococcal
conjugate vaccine (VAX–24) through preclinical development.
- Sutro is eligible to receive four percent (4%) royalties on
worldwide net sales of any licensed vaccine candidates. Sutro
retains the right to discover and develop vaccines for treatment or
prophylaxis of any disease not caused by an infectious pathogen,
including cancer.
- In June 2020, Vaxcyte completed
an initial public offering of its common stock. Sutro owns
approximately 1.6 million shares of Vaxcyte common stock as of
December 31, 2020.
Key 2020 financings
- In May 2020 and December 2020, Sutro closed public offerings of
its common stock, with gross proceeds of approximately $98.0 million and approximately $144.9 million, respectively.
- Sutro ended 2020 with cash, cash equivalents & marketable
securities of $326.5 million, with
projected runway into the second half of 2023, based on current
business plans and assumptions, and not including the value of its
holdings of Vaxcyte common stock.
Full Year 2020 Financial Highlights
Cash, Cash Equivalents and Marketable Securities
As of December 31, 2020, Sutro had cash, cash equivalents
and marketable securities of $326.5 million, as compared to
$133.5 million as of December 31, 2019, which represents a net cash
increase of $193.0 million during
2020. The cash, cash equivalents and marketable securities balance
noted above does not include the value associated with Sutro's
holdings of approximately 1.6 million shares of Vaxcyte common
stock. As of December 31, 2020, the
fair value of the Vaxcyte common stock held by Sutro was
$41.6 million.
Unrealized Gain from Increase in Value of Vaxcyte Common
Stock
The non-operating, unrealized gain of $41.5 million in 2020 consisted of $41.6 million due to the increase in the
estimated fair value of Sutro's holdings of approximately 1.6
million shares of Vaxcyte common stock, partially offset by
approximately $0.1 million in
adjustments related to revaluations of certain Vaxcyte equity
items. Vaxcyte common stock held by Sutro will be measured at fair
value based on the closing price of Vaxcyte's common stock on the
last trading day of each reporting period, with any non-operating,
unrealized gains and losses recorded in Sutro's statements of
operations.
Revenue
Revenue was $42.7 million in each of the year ended
December 31, 2020 and the year ended
December 31, 2019, related
principally to the Merck, BMS, and EMD Serono collaborations.
Future collaboration revenue from Merck, BMS, 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 year ended December 31, 2020 were $113.8 million, as compared to $98.2 million in 2019, including non-cash
stock-based compensation of $11.9
million and $10.3 million, and
depreciation and amortization expense of $4.3 million and $4.8
million, in 2020 and 2019, respectively. Total operating
expenses for 2020 were comprised of research and development
expenses of $77.0 million and general
and administrative expenses of $36.8
million, which are expected to increase in future periods 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
platform XpressCF® 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 a
CD74-targeting ADC currently being investigated in a Phase 1
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 (FolRα)-targeting ADC, currently being investigated
in a Phase 1 clinical trial of patients with ovarian and
endometrial cancers. A third product candidate, CC-99712
(BCMA-targeting ADC), which is part of Sutro's collaboration with
Bristol Myers Squibb (formerly Celgene Corporation), is enrolling
patients for its Phase 1 clinical trial of patients with multiple
myeloma and has received Orphan Drug Designation from the FDA for
multiple myeloma. A fourth product candidate, M1231, (MUC1-EGFR,
first-in-class bispecific ADC), which is part of Sutro's
collaboration with Merck KGaA, EMD Serono (EMD Serono) is enrolling
patients for its Phase 1 clinical trial of patients with metastatic
solid tumors, non-small cell lung cancer (NSCLC) and esophageal
squamous cell carcinoma. The four product candidates above
being evaluated in clinical trials resulted from Sutro's
XpressCF® and XpressCF+™ technology platforms. Bristol
Myers Squibb and EMD Serono have
worldwide development and commercialization rights for CC-99712 and
M1231, respectively, for which Sutro is entitled to milestone or
contingent payments and tiered royalties.
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's platform has led to cytokine-based
immuno-oncology therapies, ADCs, vaccines and bispecific antibodies
directed at precedented targets in clinical indications where the
current standard of care is suboptimal.
The 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 preclinical and clinical development
activities, timing of announcements of clinical results, potential
benefits of the company's product candidates and platform and
potential market opportunities for the company's product
candidates. 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 impact
of the COVID-19 pandemic on the Company's business, clinical trial
sites, supply chain and manufacturing facilities, 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, the value of the
Company's holdings of Vaxcyte common stock, 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 Contact
Annie J.
Chang
Sutro Biopharma
(650) 801-5728
ajchang@sutrobio.com
Media Contact
David
Schull
Russo Partners
(212) 845-4271
david.schull@russopartnersllc.com
Sutro Biopharma,
Inc.
Selected
Statements of Operations Financial Data
(Unaudited)
(In thousands,
except share and per share amounts)
|
|
|
|
Year Ended
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
|
2018
|
|
Revenue
|
|
|
42,722
|
|
|
|
42,736
|
|
|
|
38,419
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
76,961
|
|
|
|
65,612
|
|
|
|
54,262
|
|
General and
administrative
|
|
|
36,818
|
|
|
|
32,592
|
|
|
|
21,380
|
|
Total operating
expenses
|
|
|
113,779
|
|
|
|
98,204
|
|
|
|
75,642
|
|
Loss from
operations
|
|
|
(71,057)
|
|
|
|
(55,468)
|
|
|
|
(37,223)
|
|
Interest
income
|
|
|
1,508
|
|
|
|
4,074
|
|
|
|
1,616
|
|
Unrealized gain on
equity securities
|
|
|
41,498
|
|
|
|
—
|
|
|
|
—
|
|
Interest and other
expense, net
|
|
|
(4,077)
|
|
|
|
(4,350)
|
|
|
|
290
|
|
Net loss
|
|
$
|
(32,128)
|
|
|
$
|
(55,744)
|
|
|
$
|
(35,317)
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.99)
|
|
|
$
|
(2.43)
|
|
|
$
|
(6.13)
|
|
Weighted-average
shares used in computing
basic
and diluted net loss per share
|
|
|
32,573,469
|
|
|
|
22,958,577
|
|
|
|
5,758,875
|
|
Sutro Biopharma,
Inc.
Selected Balance
Sheet Financial Data
(Unaudited)
(In
thousands)
|
|
|
|
December
31,
|
|
|
|
2020
|
|
|
2019
|
|
|
|
(1)
|
|
|
(2)
|
|
Assets
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities
|
|
$
|
326,493
|
|
|
$
|
133,473
|
|
Accounts
receivable
|
|
|
5,559
|
|
|
|
6,298
|
|
Investment in equity
securities
|
|
|
41,644
|
|
|
|
—
|
|
Property and
equipment, net
|
|
|
12,935
|
|
|
|
9,633
|
|
Other
assets
|
|
|
7,480
|
|
|
|
6,966
|
|
Total
assets
|
|
$
|
394,111
|
|
|
$
|
156,370
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
|
|
Accounts payable and
other liabilities
|
|
$
|
16,815
|
|
|
$
|
13,045
|
|
Deferred
revenue
|
|
|
20,703
|
|
|
|
35,660
|
|
Debt
|
|
|
24,545
|
|
|
|
9,876
|
|
Total
liabilities
|
|
|
62,063
|
|
|
|
58,581
|
|
Total stockholders'
deficit
|
|
|
332,048
|
|
|
|
97,789
|
|
Total Liabilities
and Stockholders' Equity
|
|
$
|
394,111
|
|
|
$
|
156,370
|
|
|
|
(1)
|
The condensed balance
sheet as of December 31, 2020 was derived from the audited
financial statements included in the Company's Annual Report on
Form 10-K for the year ended December 31, 2020, filed with the
Securities and Exchange Commission on March 18, 2021
|
(2)
|
The condensed balance
sheet as of December 31, 2019 was derived from the audited
financial statements included in the Company's Annual Report on
Form 10-K for the year ended December 31, 2019, filed with the
Securities and Exchange Commission on March 16, 2020.
|
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SOURCE Sutro Biopharma