SOUTH SAN FRANCISCO, Calif.,
May 7, 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 quarter ended March 31, 2021, its recent business highlights,
and provided a preview of anticipated selected milestones in
2021.
"We are enthusiastic about the meaningful clinical benefit of
STRO-002, our FolRα-targeting Antibody-Drug Conjugate (ADC), for
women with advanced ovarian cancer, as demonstrated by the Phase 1
dose-escalation data, and look forward to providing follow-up data
at ASCO," said Bill Newell, Sutro's
Chief Executive Officer. "We continue to enroll patients for the
dose-expansion portion of the Phase 1 study and we have activated
additional clinical sites. STRO-002 is one of the four product
candidates in the clinic that were discovered, developed, and are
manufactured using our proprietary and integrated cell-free protein
synthesis platform. We intend to continue creating value by
leveraging our platform to deliver on therapeutics that are
precise, rationally designed, and homogenous, for a broad set of
patients with unmet medical needs."
Recent Business Highlights and Expected 2021
Milestones
STRO-002, FolRα-targeting ADC:
Ongoing enrollment
in dose-expansion trial for patients with
advanced ovarian cancer
- The dose-escalation portion of the Phase 1 trial, in
patients with advanced ovarian cancer, completed enrollment as of
August 31, 2020. Follow-up data will
be presented as a poster at the American Society of Clinical
Oncology (ASCO) Virtual Annual Meeting being held in the second
quarter of 2021.
Abstract Number: 5550
Session: Gynecologic Cancer
Title: Phase 1 dose-escalation study of STRO-002, an
antifolate receptor alpha (FRα) antibody drug conjugate (ADC), in
patients with advanced, progressive platinum-resistant/refractory
epithelial ovarian cancer (EOC)
Presenter: R. Wendel Naumann,
M.D., Professor & Director of Gynecologic Oncology Research at
Levine Cancer Institute, Atrium Health
- The enrollment for the dose-expansion portion of the Phase 1
trial, in a less heavily pre-treated patient population, is ongoing
with additional sites activated in the US and a CTA approved by the
Spanish Agency for Medicine and Health Products to intiate the
study in Spain.
- The initial data for dose-expansion is expected to be reported
in the second half of 2021; the data is expected to inform
regulatory interactions and registration strategy and enable the
identification of the broadest patient population that may benefit
from STRO-002.
STRO-001, CD74-targeting
ADC: Continuing enrollment in Phase 1
dose-escalation for patients with B-cell
malignancies
- The dose-escalation trial is enrolling patients with lymphoma
and multiple myeloma 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.
STRO-003: Preclinical development underway and product
candidate expected to be unveiled in the second half of
2021
Merck collaboration on cytokine
derivatives: Moving towards the clinic on the first
cytokine derivatives program for cancer and autoimmune
disorders
- In April 2021, Merck initiated
IND-enabling toxicology studies for the first program under the
July 2018 cytokine derivatives
collaboration, for which Sutro earned a $15
million milestone payment.
- In August 2020, Sutro entered
into a supply agreement with Merck, providing Sutro with
responsibility for manufacturing pre-clinical and clinical supply
for products emerging from the collaboration.
- Merck has exclusive worldwide rights to therapeutic candidates
derived from the collaboration. Sutro is eligible to receive
contingent payments for each of the target programs selected by
Merck, assuming the development and sale of the therapeutic
candidate and all possible indications identified under the
collaboration. In addition, Sutro is eligible to receive tiered
royalties ranging from mid-single digit to low teen percentages on
worldwide sales of any commercial products that may result from the
collaboration.
BMS collaboration on CC-99712, BCMA-targeting
ADC: Ongoing enrollment for Phase 1 trial for patients
with multiple myeloma
- Since the Phase 1 trial initiation in the second half of 2019,
Bristol Myers Squibb (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, as reported in June
2020.
- 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 contingent payments
and tiered royalties ranging from mid to high single digit
percentages on worldwide sales of any commercial products that may
result from the collaboration.
EMD Serono collaboration on M1231, Bispecific ADC-targeting
MUC1-EGFR: Entered Phase 1 clinical trial in the first
quarter 2021
- Merck KGaA, EMD Serono (EMD Serono) began enrolling patients in
a Phase 1 dose-escalation trial in the first quarter of 2021 for
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 ranging from low to mid single digit percentages,
along with certain additional one-time royalties, on worldwide
sales of any commercial products that may result from the
collaboration.
Vaxcyte relationship on conjugated vaccines:
Utilization of Sutro's cell-free technology
- 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 broad 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
March 31, 2021.
First Quarter 2021 Financial Highlights
Cash, Cash Equivalents and Marketable Securities
As of March 31, 2021, Sutro had cash, cash equivalents and
marketable securities of $294.9 million, as compared to
$326.5 million as of December 31, 2020, with projected runway into the
second half of 2023, based on current business plans and
assumptions and not including the value associated with Sutro's
holdings of approximately 1.6 million shares of Vaxcyte common
stock. As of March 31, 2021, the fair
value of the Vaxcyte common stock held by Sutro was $31.0 million.
Unrealized Loss from Decrease in Value of Vaxcyte Common
Stock
The non-operating, unrealized loss of $10.7 million for the quarter ended March 31, 2021 was due to the decrease since
December 31, 2020 in the estimated
fair value of Sutro's holdings of approximately 1.6 million shares
of Vaxcyte common stock. Vaxcyte common stock held by Sutro will be
remeasured 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 $14.7 million for the quarter ended
March 31, 2021, compared to
$7.2 million in the corresponding
2020 quarter, 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 quarter ended March 31, 2021 were $33.7
million, compared to $26.3
million in the corresponding 2020 quarter, including
non-cash stock-based compensation of $4.0
million and $2.7 million, and
depreciation and amortization expense of $1.3 million and $1.1
million, in the 2021 and 2020 quarters, respectively. Total
operating expenses for the first quarter of 2021 were comprised of
research and development expenses of $22.6
million and general and administrative expenses of
$11.1 million, which are expected to
increase in 2021 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,
potential future milestone and royalty payments, 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
Maggie
Beller
Russo Partners
(646) 942-5631
Maggie.beller@russopartnersllc.com
Sutro Biopharma,
Inc.
Selected
Statements of Operations Financial Data
(Unaudited)
(In thousands,
except share and per share amounts)
|
|
|
|
Three Months
Ended
|
|
|
|
|
March
31,
|
|
|
|
|
2021
|
|
|
2020
|
|
|
Revenues
|
|
$
|
14,660
|
|
|
$
|
7,152
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
22,562
|
|
|
|
17,619
|
|
|
General and
administrative
|
|
|
11,107
|
|
|
|
8,713
|
|
|
Total operating
expenses
|
|
|
33,669
|
|
|
|
26,332
|
|
|
Loss from
operations
|
|
|
(19,009)
|
|
|
|
(19,180)
|
|
|
Interest
income
|
|
|
197
|
|
|
|
641
|
|
|
Unrealized loss on
equity securities
|
|
|
(10,689)
|
|
|
|
—
|
|
|
Interest and other
expense, net
|
|
|
(858)
|
|
|
|
(1,056)
|
|
|
Net loss
|
|
$
|
(30,359)
|
|
|
$
|
(19,595)
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.66)
|
|
|
$
|
(0.84)
|
|
|
|
|
|
|
|
|
|
|
|
|
Sutro Biopharma,
Inc.
Selected Balance
Sheet Financial Data
(Unaudited)
(In
thousands)
|
|
|
|
March
31,
|
|
|
December
31,
|
|
|
|
2021
(1)
|
|
|
2020
(2)
|
|
Assets
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities
|
|
$
|
294,888
|
|
|
$
|
326,493
|
|
Investment in equity
securities
|
|
|
30,955
|
|
|
|
41,644
|
|
Accounts
receivable
|
|
|
7,227
|
|
|
|
5,559
|
|
Property and
equipment, net
|
|
|
14,829
|
|
|
|
12,935
|
|
Other
assets
|
|
|
10,629
|
|
|
|
7,480
|
|
Total
Assets
|
|
$
|
358,528
|
|
|
$
|
394,111
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
|
|
Accounts payable and
other liabilities
|
|
$
|
13,600
|
|
|
$
|
16,815
|
|
Deferred
revenue
|
|
|
12,910
|
|
|
|
20,703
|
|
Debt
|
|
|
24,680
|
|
|
|
24,545
|
|
Total
liabilities
|
|
|
51,190
|
|
|
|
62,063
|
|
Total stockholders'
equity
|
|
|
307,338
|
|
|
|
332,048
|
|
Total Liabilities
and Stockholders' Equity
|
|
$
|
358,528
|
|
|
$
|
394,111
|
|
|
|
(1)
|
The condensed balance
sheet as of March 31, 2021 was derived from the unaudited financial
statements included in the Company's Quarterly Report on Form 10-Q
for the quarter ended March 31, 2021, filed with the Securities and
Exchange Commission on May 7, 2021.
|
|
|
(2)
|
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.
|
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SOURCE Sutro Biopharma