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 2024, its recent
business highlights, and a preview of select anticipated
milestones.
“The Sutro team executed on multiple fronts in the first quarter
of 2024, advancing luvelta through the clinic in multiple
indications of high unmet need, continuing to progress our pipeline
and collaboration programs, and establishing a new licensing
relationship with Ipsen. The upfront funding from the Ipsen deal
and our recent financing also augmented our strong cash position,”
said Bill Newell, Sutro’s Chief Executive Officer. “We plan to
deliver on important catalysts throughout 2024, reporting on
expanded patient data with luvelta in combination with bevacizumab,
the initiation of a registrational trial for pediatric patients
with a rare form of acute myeloid leukemia (AML), and a Phase 2
trial in non-small cell lung cancer (NSCLC). We continue to build
upon our momentum and are well positioned on our goal to rapidly
deliver precisely designed ADCs to patients in need.”
Recent Business
Highlights and
Select Anticipated
Milestones
Luveltamab Tazevibulin (luvelta), FolRα-Targeting ADC
Franchise:
- Part 1 (dose-optimization) of the
registration-directed trial, REFRαME-O1, for treatment of
platinum-resistant ovarian cancer (PROC), has completed enrollment.
Part 2 (randomized portion) is now enrolling, with an anticipated
~140 sites in ~20 countries planned to be opened by the end of
2024.
- Enrollment of REFRαME-P1, a
registration-enabling trial for pediatric patients with
CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) AML, is expected to be
initiated in the second half of 2024.
- An Investigational New Drug (IND)
application for the treatment of NSCLC has been cleared by U.S.
Food and Drug Administration (FDA). The Phase 2 trial is expected
to begin enrolling patients in the second half of 2024. Initial
data is expected in the first half of 2025.
- A Phase 2 expansion study in
combination with bevacizumab is well underway. Enrollment is
expected to be complete in the first half of 2024.
Additional Pipeline Development and Collaboration
Updates:
- In April 2024, Sutro announced a global
licensing agreement for STRO-003, a ROR1-targeting ADC, with Ipsen.
Sutro is eligible to receive up to $899 million in upfront and
potential milestone payments, including up to $92 million in
near-term payments, of which $75 million, including an equity
investment, have been received in April. Sutro is also eligible to
receive tiered royalties ranging from low double-digit to mid-teen
digit percentages on annual global sales of STRO-003.
- Sutro plans to submit an IND for
STRO-004, a tissue factor-targeting ADC, in 2025.
- 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 $864
million in payments through March 31, 2024, including equity
investments.
Corporate Updates:
- Additionally, Sutro strengthened its
cash position with an underwritten offering of 14,478,764 shares of
its common stock at a price of $5.18 per share, resulting in gross
proceeds of $75.0 million. The offering was led by a high-quality
group of new and existing healthcare-focused institutional
investors.
Upcoming Events: Sutro will participate in two
upcoming investor conferences. Webcasts of the presentations will
be accessible through the News & Events page of the Investor
Relations section of the Company’s website at www.sutrobio.com.
Archived replays will be available for at least 30 days after the
events.
- The Citizens JMP Life Sciences
Conference in New York, May 13-14, 2024
- Jefferies Healthcare Conference in New
York, June 5-6, 2024
First Quarter 2024 Financial
Highlights
Cash, Cash Equivalents and Marketable SecuritiesAs of March 31,
2024, Sutro had cash, cash equivalents and marketable securities of
$267.6 million, and approximately 0.7 million shares of Vaxcyte
common stock with a fair value of $45.6 million.
Unrealized Gain from Increase in Value of Vaxcyte Common
Stock
The non-operating, unrealized gain of $3.7 million for the
quarter ended March 31, 2024 was due to the increase since December
31, 2023 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.
Revenue
Revenue was $13.0 million for the quarter ended March 31, 2024,
as compared to $12.7 million for the same period in 2023, with the
2024 amount related principally to the Astellas collaboration, and
the Tasly and Vaxcyte agreements. 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 Expenses
Total operating expenses for the quarter ended March 31, 2024
were $69.6 million, as compared to $54.9 million for the same
period in 2023. The 2024 quarter includes non-cash expenses for
stock-based compensation of $6.1 million and depreciation and
amortization of $1.8 million, as compared to $6.0 million and $1.6
million, respectively, in the comparable 2023 period. Total
operating expenses for the quarter ended March 31, 2024 were
comprised of research and development expenses of $56.9 million and
general and administrative expenses of $12.7 million.
About Sutro Biopharma Sutro Biopharma,
Inc., is a clinical-stage company relentlessly focused on the
discovery and development of precisely designed cancer
therapeutics, to transform what science can do for patients.
Sutro’s fit-for-purpose technology, including cell-free XpressCF®,
provides the opportunity for broader patient benefit and an
improved patient experience. Sutro has multiple clinical stage
candidates, including luveltamab tazevibulin, or luvelta, a
registrational-stage folate receptor alpha (FolRα)-targeting ADC in
clinical studies. A robust pipeline, coupled with high-value
collaborations and industry partnerships, validates Sutro’s
continuous product innovation. Sutro is headquartered in South San
Francisco. For more information, follow Sutro on social
media @Sutrobio, or visit www.sutrobio.com.
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, including enrollment and site
activation; timing of announcements of clinical results, trial
initiation, and regulatory filings; outcome of regulatory
decisions; potential benefits of luvelta and the Company’s other
product candidates and platform; timing of payments under our
collaboration agreements; potential expansion into other
indications and combinations, including the timing and development
activities related to such expansion; potential market
opportunities for luvelta and the Company’s other product
candidates; and the Company’s expected cash runway. 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, 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.
ContactEmily WhiteSutro Biopharma (650)
823-7681
ewhite@sutrobio.com
Sutro Biopharma, Inc.Selected Statements of
Operations Financial Data(Unaudited)(In
thousands, except share and per share amounts) |
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
|
|
|
2024 |
|
|
2023 |
|
Revenue |
|
|
|
|
|
|
|
|
|
$ |
13,008 |
|
|
$ |
12,674 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
|
|
|
|
|
|
|
56,878 |
|
|
|
39,399 |
|
General and administrative |
|
|
|
|
|
|
|
|
|
|
12,721 |
|
|
|
15,512 |
|
Total operating expenses |
|
|
|
|
|
|
|
|
|
|
69,599 |
|
|
|
54,911 |
|
Loss from operations |
|
|
|
|
|
|
|
|
|
|
(56,591 |
) |
|
|
(42,237 |
) |
Interest income |
|
|
|
|
|
|
|
|
|
|
4,096 |
|
|
|
2,560 |
|
Unrealized gain (loss) on equity
securities |
|
|
|
|
|
|
|
|
|
|
3,679 |
|
|
|
(6,992 |
) |
Non-cash interest expense related
to the sale of future royalties |
|
|
|
|
|
|
|
|
|
|
(7,184 |
) |
|
|
- |
|
Interest and other income
(expense), net |
|
|
|
|
|
|
|
|
|
|
(2,213 |
) |
|
|
(2,986 |
) |
Loss before provision for income
taxes |
|
|
|
|
|
|
|
|
|
|
(58,213 |
) |
|
|
(49,655 |
) |
Provision for income taxes |
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
395 |
|
Net loss |
|
|
|
|
|
|
|
|
|
$ |
(58,213 |
) |
|
$ |
(50,050 |
) |
Net loss per share, basic and
diluted |
|
|
|
|
|
|
|
|
|
$ |
(0.95 |
) |
|
$ |
(0.85 |
) |
Weighted-average shares used in
computing basic and diluted loss per share |
|
|
|
|
|
|
|
|
|
|
61,457,793 |
|
|
|
58,723,432 |
|
Sutro Biopharma, Inc.Selected Balance Sheets
Financial Data(Unaudited)(In
thousands) |
|
|
March
31,2024(1) |
|
|
December 31, 2023(2) |
|
Assets |
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
267,602 |
|
|
$ |
333,681 |
|
Investment in equity securities |
|
|
45,616 |
|
|
|
41,937 |
|
Accounts receivable |
|
|
31,300 |
|
|
|
36,078 |
|
Property and equipment, net |
|
|
20,630 |
|
|
|
21,940 |
|
Operating lease right-of-use assets |
|
|
21,594 |
|
|
|
22,815 |
|
Other assets |
|
|
16,660 |
|
|
|
14,285 |
|
Total
Assets |
|
$ |
403,402 |
|
|
$ |
470,736 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Accounts payable, accrued expenses and other liabilities |
|
$ |
54,028 |
|
|
$ |
64,293 |
|
Deferred revenue |
|
|
66,815 |
|
|
|
74,045 |
|
Operating lease liability |
|
|
28,070 |
|
|
|
29,574 |
|
Debt |
|
|
- |
|
|
|
4,061 |
|
Deferred royalty obligation related to the sale of future
royalties |
|
|
156,465 |
|
|
|
149,114 |
|
Total liabilities |
|
|
305,378 |
|
|
|
321,087 |
|
Total stockholders’
equity |
|
|
98,024 |
|
|
|
149,649 |
|
Total Liabilities and
Stockholders’ Equity |
|
$ |
403,402 |
|
|
$ |
470,736 |
|
(1) The condensed balance sheet as of March 31,
2024 was derived from the unaudited financial statements included
in the Company's Quarterly Report on Form 10-Q for the quarter
ended March 31, 2024, filed with the Securities and Exchange
Commission on May 13, 2024.
(2) The condensed balance sheet as of December 31,
2023 was derived from the unaudited financial statements included
in the Company's Annual Report on Form 10-K for the year ended
December 31, 2023, filed with the Securities and Exchange
Commission on March 25,
2024.
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