Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a
clinical-stage oncology company pioneering site-specific and
novel-format antibody drug conjugates (ADCs), today reported its
financial results for the first quarter of 2023, its recent
business highlights, and a preview of select anticipated
milestones.
“We’ve had a strong start to the year with the continued
advancement of our pipeline,” said Bill Newell, Sutro’s Chief
Executive Officer. “As we look toward the rest of the year, we are
excited for the imminent initiation of REFRaME, our
registration-directed trial for luveltamab tazevibulin, or luvelta,
in the second quarter of 2023, in addition to the data readout from
our ongoing dose expansion Cohort C in ovarian cancer anticipated
in the second half of 2023. We will seek to build on the positive
momentum from this quarter to deliver on our goal to provide
transformational therapies to cancer patients.”
Recent Business
Highlights and
Select Anticipated
Milestones
STRO-002, International Nonproprietary Name, “luveltamab
tazevibulin,” abbreviated as “luvelta”, FolRα-Targeting
ADC: Luveltamab tazevibulin (luvelta) is being studied in
the clinic, in the U.S. and Europe, for patients with ovarian and
endometrial cancers.
- Data from the Phase 1 dose expansion
study will be featured as an oral presentation at the 2023 American
Society of Clinical Oncology (ASCO 2023) Annual Meeting in Chicago,
IL in June 2023.
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Presentation Title: |
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Luveltamab Tazevibulin (STRO-002), an anti-Folate Receptor alpha
(FolRα) Antibody Drug Conjugate (ADC), Safety and Efficacy in a
Broad Distribution of FOLRα Expression in Patients with Recurrent
Epithelial Ovarian Cancer (OC): Update of STRO-002-GM1 Phase 1 Dose
Expansion Cohort |
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Session
Type/Title: |
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Oral Abstract Session -
Gynecologic Cancer |
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Session
Time: |
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Saturday, June 3, 2023, 3:00 p.m.
– 6:00 p.m. CDT |
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Presentation
Time: |
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5:24 p.m. CDT |
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Abstract
Number: |
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#5508 |
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- Sutro plans to initiate REFRaME, a
Phase 2/3 registration-directed study for patients with
platinum-resistant ovarian cancer, in the second quarter of 2023,
as discussed with the U.S. Food and Drug Administration (FDA). Once
results are collected on approximately 110 patients in the selected
dose of the luvelta arm, Sutro plans to apply for accelerated
approval based on overall response rate (ORR) as the primary
endpoint. At the end of the trial, full approval can be sought
based on progression-free survival (PFS) as the primary endpoint,
comparing results from the luvelta arm and the standard of care
arm.
- In January 2023, the company announced
results from the luvelta Phase 1 dose-expansion study demonstrating
that FolRα-selected patients, defined as patients with TPS >25%,
experienced meaningful clinical benefit, with 43.8% ORR, median
duration of response (DOR) of 5.4 months, and median PFS of 6.6
months for those receiving the higher starting dose of 5.2 mg/kg.
The safety profile is generally consistent with previously released
data; asymptomatic, transient neutropenia was the primary adverse
event and no new safety signals were observed. Interim data from an
exploratory cohort (Cohort C), with 5.2 mg/kg doses of luvelta
together with prophylactic pegfilgrastim, appear to demonstrate
reduced dose delays and lower incidences of Grade 3+ neutropenia.
Sutro plans to announce updated data from Cohort C in the second
half of 2023.
- Patients with CBFA2T3::GLIS2 (CBF/GLIS)
AML, a highly refractory and uniformly fatal subtype of acute
myeloid leukemia found exclusively in infants and young children,
were treated with luvelta under compassionate use. During the 64th
American Society of Hematology Annual Meeting and Exposition (ASH
2022), an oral presentation was given by Soheil Meshinchi, M.D.,
Ph.D. summarizing preliminary results from compassionate use of
luvelta in this rare indication, suggesting that luvelta was well
tolerated as a monotherapy agent and in combination with standard
cancer therapies.
- Additional ongoing clinical studies for
luvelta include a combination study with bevacizumab for patients
with advanced ovarian cancer and a dose-expansion study for
patients with endometrial cancer. Sutro expects to announce data
from both the combination study and endometrial study in the second
half of 2023.
- Translational work is ongoing to
support an Investigational New Drug (IND) application for the
initiation of a non-small cell lung cancer (NSCLC) study, for which
submission is planned in 2023.
STRO-001, CD74-Targeting ADC: The Phase 1 study
for patients with B-cell malignancies has been completed in global
sites ex-Greater China and clinical studies in Greater China have
been initiated.
- Sutro has completed the Phase 1
dose-escalation study in patients with non-Hodgkin’s lymphoma (NHL)
and multiple myeloma (MM), after reaching a maximum tolerated dose
(MTD). Sutro plans to leverage the clinical data produced by its
partner BioNova Pharma (BioNova) in Greater China to make future
prioritization decisions regarding further clinical
development.
- BioNova is advancing clinical
development of BN301 (STRO-001) for patients with hematological
malignancies in Greater China. In February 2023, BioNova announced
that the first patient had been dosed in the Phase 1 clinical study
of BN301 for the treatment of advanced non-Hodgkin’s lymphoma
(NHL).
STRO-003, ROR1-Targeting ADC: IND-enabling
studies and manufacturing development are underway for STRO-003
with an IND planned for Q1 2024.
- STRO-003, a novel, next-generation ADC
that has been designed to target ROR1, features eight precisely
placed β-Glucuronidase-cleavable linkers attached to
next-generation exatecan warheads, which, when released, inhibit
topoisomerase-1 (TOPO-1) and cause DNA disruption.
- Expanded preclinical data for STRO-003
was presented at the American Association for Cancer Research
(AACR) Annual Meeting in April 2023, demonstrating potent
anti-tumor activity and immune-modulating properties, suggesting
that STRO-003 may have the potential to augment checkpoint blockade
therapy.
- STRO-003 has demonstrated, in NSCLC and
breast cancer patient-derived xenograft models, strong cell-killing
activity in low and heterogeneous ROR1-expressing tumors. STRO-003
has also exhibited promising tolerability in preclinical studies
involving rodents and non-human primates, with potentially reduced
lung toxicity relative to other TOPO-1 inhibiting ADCs.
Collaboration Updates: Sutro continues to seek
to maximize the value of its proprietary cell-free platform by
working with partners on programs in multiple disease spaces and
geographies and has generated from collaborators an aggregate of
approximately $626 million in payments through March 31, 2023,
including equity investments.
- In December 2022, Sutro and Vaxcyte
expanded upon a nearly decade-long relationship through a new
agreement, under which Vaxcyte acquired an option to access
expanded rights to develop and manufacture cell-free extract, among
other rights, and includes a $22.5 million upfront payment and,
upon exercise of the option, up to an additional $135 million in
option exercise and contingent payments. Under an existing license
agreement with Vaxcyte, Sutro is eligible to receive four percent
(4%) royalties on worldwide net sales of any licensed vaccine
candidates for human health use.
- Sutro’s collaboration with Astellas on
the discovery of immunostimulatory antibody-drug conjugates (iADCs)
for three targets is ongoing, for which Sutro receives additional
financial support for its research efforts, potential milestone
payments and royalties, and has an option to co-develop and
co-commercialize product candidates in the U.S.
- Sutro is manufacturing initial drug
supply for the clinical development of Merck’s MK-1484, currently
in Phase 1; and clinical trial materials for Bristol Myers Squibb’s
(BMS) CC-99712, a BCMA-targeting ADC for treatment of multiple
myeloma, also currently in Phase 1.
- Sutro is providing clinical drug supply
to BioNova for clinical studies for BN301 (STRO-001) in Greater
China. Sutro is currently supporting Tasly Biopharmaceuticals
(Tasly) for their IND filing and the initiation of clinical
development activities in Greater China for STRO-002 and will
provide initial clinical drug supply.
Corporate Updates: Sutro strengthened and
continues to build upon a world-class leadership team.
- Venkatesh Srinivasan, Ph.D., has been
promoted to Chief Technical Operations Officer from SVP, Process
and Analytical Development, and will be responsible for Chemistry,
Manufacturing, and Controls (CMC) and Process and Analytical
Development (P&AD) for Sutro’s cell-free manufacturing
technology and platform.
- Shabbir T. Anik, Ph.D., who has served
as Sutro’s Chief Technical Operations Officer since March 2016,
will transition to the role of Strategic Advisor.
- As previously announced, Trevor Hallam,
Ph.D., will be stepping down from his role as President of Research
& Chief Scientific Officer, effective May 31, 2023. Dr. Hallam
will become a member of Sutro’s Scientific Advisory Board. Nicki
Vasquez, Ph.D., Chief Portfolio Strategy & Alliance Officer,
will assume interim responsibility for leading the research
organization. An executive search is ongoing for a Chief Scientific
Officer.
First Quarter 2023 Financial
Highlights
Cash, Cash Equivalents and Marketable SecuritiesAs of March 31,
2023, Sutro had cash, cash equivalents and marketable securities of
$251.5 million, as compared to $302.3 million as of December 31,
2022, and approximately 0.7 million shares of Vaxcyte common stock
with a fair value of $25.0 million, which together provide a
projected cash runway into the second half of 2024, based on
current business plans and assumptions.
Unrealized Loss from Decrease in Value of Vaxcyte Common
StockThe non-operating, unrealized loss of $7.0 million in the
quarter ended March 31, 2023 was due to the decrease since December
31, 2022 in the estimated fair value of Sutro’s holdings 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.
RevenueRevenue was $12.7 million for the quarter ended March 31,
2023, as compared to $5.9 million for the same period in 2022, with
the 2023 amount related principally to the Astellas, Merck and BMS
collaborations. Future collaboration and license revenue under
existing agreements, and from any additional collaboration and
license partners, will fluctuate as a result of the amount and
timing of revenue recognition of upfront, milestones, and other
agreement payments.
Operating ExpensesTotal operating expenses for the quarter ended
March 31, 2023 were $54.9 million, as compared to $45.0 million for
the same period in 2022. The first quarter 2023 amount includes
non-cash expenses for stock-based compensation of $6.0 million and
depreciation and amortization of $1.6 million, as compared to $7.0
million and $1.3 million, respectively, in the comparable 2022
period. Total operating expenses for the quarter ended March 31,
2023 were comprised of research and development expenses of $39.4
million and general and administrative expenses of $15.5 million,
which are expected to increase in the remainder of 2023 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., headquartered in South San Francisco, is
a clinical-stage oncology company pioneering site-specific and
novel-format antibody drug conjugates (ADCs). Sutro has two wholly
owned ADCs in the clinic—luveltamab tazevibulin (STRO-002 or
luvelta), a folate receptor alpha (FolRα)-targeting ADC, in
clinical studies for ovarian and endometrial cancers; and STRO-001,
a CD74-targeting ADC, in clinical studies for B-cell malignancies.
Additionally, Sutro is collaborating with Bristol Myers Squibb
(BMS) on CC-99712, a BCMA-targeting ADC in the clinic for patients
with multiple myeloma; with Merck, known as MSD outside of the
United States and Canada, on MK-1484, a selective IL-2 agonist in
clinical studies as a monotherapy and in combination with
pembrolizumab for the treatment of solid tumors; and with Astellas
Pharma (Astellas) on novel modality, immunostimulatory
antibody-drug conjugates (iADCs). Sutro’s platform technology also
enabled the spin out of Vaxcyte and the creation of VAX-24, a
24-valent pneumococcal conjugate vaccine in clinical studies for
the prevention of invasive pneumococcal disease. Sutro’s rational
design and precise protein engineering has enabled six product
candidates in the clinic. 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, trial
initiation, and regulatory filings, potential benefits of luvelta
and the Company’s other product candidates and platform, potential
future milestone and royalty payments, and potential market
opportunities for luvelta and the Company’s other 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 and the
Company’s ability to successfully leverage Fast Track designation,
the market size for the Company’s product candidates to be smaller
than anticipated, 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 ContactAnnie J. Chang Sutro Biopharma
(650) 801-5728ajchang@sutrobio.com
Media ContactAmy BonannoSolebury Strategic
Communications(914) 450-0349abonanno@soleburystrat.com
Sutro Biopharma, Inc. |
Selected Statements of Operations Financial
Data |
(Unaudited) |
(In thousands, except share and per share
amounts) |
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2023 |
|
|
2022 |
|
Revenues |
$ |
12,674 |
|
|
$ |
5,897 |
|
Operating expenses |
|
|
|
|
|
|
|
Research and development |
|
39,399 |
|
|
|
29,990 |
|
General and administrative |
|
15,512 |
|
|
|
15,039 |
|
Total operating expenses |
|
54,911 |
|
|
|
45,029 |
|
Loss from operations |
|
(42,237 |
) |
|
|
(39,132 |
) |
Interest income |
|
2,560 |
|
|
|
116 |
|
Unrealized (loss) gain on
equity securities |
|
(6,992 |
) |
|
|
563 |
|
Interest and other income
(expense), net |
|
(2,986 |
) |
|
|
(657 |
) |
Loss before provision for
income taxes |
|
(49,655 |
) |
|
|
(39,110 |
) |
Provision for income
taxes |
|
395 |
|
|
|
- |
|
Net loss |
$ |
(50,050 |
) |
|
$ |
(39,110 |
) |
Net loss per share, basic and
diluted |
$ |
(0.85 |
) |
|
$ |
(0.84 |
) |
Weighted-average shares used
in computing basic and diluted loss per share |
|
58,723,432 |
|
|
|
46,499,602 |
|
|
Sutro Biopharma, Inc. |
Selected Balance Sheets Financial Data |
(Unaudited) |
(In thousands) |
|
|
March
31,2023(1) |
|
December
31,2022(2) |
Assets |
|
|
|
|
|
Cash, cash equivalents and marketable securities |
$ |
251,466 |
|
$ |
302,344 |
Investment in equity securities |
|
25,028 |
|
|
32,020 |
Accounts receivable |
|
9,873 |
|
|
7,122 |
Property and equipment, net |
|
24,029 |
|
|
24,621 |
Operating lease right-of-use assets |
|
25,802 |
|
|
26,443 |
Other assets |
|
21,818 |
|
|
14,394 |
Total
Assets |
$ |
358,016 |
|
$ |
406,944 |
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
Accounts payable, accrued expenses and other liabilities |
$ |
23,807 |
|
$ |
32,822 |
Deferred revenue |
|
102,232 |
|
|
106,644 |
Operating lease liability |
|
33,322 |
|
|
34,159 |
Debt |
|
13,242 |
|
|
16,271 |
Total liabilities |
|
172,603 |
|
|
189,896 |
Total stockholders’
equity |
|
185,413 |
|
|
217,048 |
Total Liabilities and
Stockholders’ Equity |
$ |
358,016 |
|
$ |
406,944 |
(1) |
The condensed
balance sheet as of March 31, 2023 was derived from the unaudited
financial statements included in the Company's Quarterly Report on
Form 10-Q for the quarter ended March 31, 2023, filed with the
Securities and Exchange Commission on May 15, 2023. |
(2) |
The condensed balance sheet as of December 31, 2022 was derived
from the audited financial statements included in the Company's
Annual Report on Form 10-K for the year ended December 31, 2022,
filed with the Securities and Exchange Commission on March 30,
2023. |
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