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 second quarter of 2024, its recent
business highlights, and a preview of select anticipated
milestones.
“We continue to make meaningful progress with the development of
luvelta across multiple indications, including enrollment of a
patient expansion cohort in combination with bevacizumab, nearing
initiation of our second registration-enabling trial, REFRaME-P1,
for pediatric patients with a rare form of acute myeloid leukemia
(AML) and approaching site activation of a Phase 2 trial in
non-small cell lung cancer (NSCLC),” said Bill Newell, Sutro’s
Chief Executive Officer. “We plan to share supplemental data from
our Phase 1b trial of luvelta in combination with bevacizumab at
the ESMO meeting in September.”
Mr. Newell added, “We are off to strong start in our new
partnership with Ipsen for STRO-003 and continue to advance our
preclinical pipeline of next-generation ADCs, including our
tissue-factor targeting exatecan ADC, STRO-004. In parallel, we are
exploring new partnership opportunities to maximize the potential
of our platform and pipeline, led by our new Chief Business
Development Officer Barbara Leyman. Additionally, we are delighted
to welcome Sukhi Jagpal to our Board, as he brings a wealth of
invaluable financial and strategic expertise.”
Recent Business
Highlights and
Select Anticipated
Milestones
Luveltamab Tazevibulin (luvelta), FRα-Targeting ADC
Franchise:
- Sutro will present updated data from
the Phase 1b study of luvelta in combination with bevacizumab for
patients with ovarian cancer in a poster presentation at the
European Society for Medical Oncology (ESMO) Congress 2024 to be
held September 13-17 in Barcelona, Spain.
- Title: Luveltamab tazevibulin, an
antifolate receptor alpha (FRα) antibody-drug conjugate (ADC), in
combination with bevacizumab (bev) in patients with recurrent
high-grade epithelial ovarian cancer (EOC): STRO-002-GM2 phase 1
study
- Date: Saturday, September 14, 2024
- Part 2 (randomized portion) of the
Phase 3 trial, REFRαME-O1, for treatment of platinum-resistant
ovarian cancer (PROC), is underway.
- 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.
- A Phase 2 expansion study in
combination with bevacizumab is ongoing, with data expected in the
first half of 2025.
- A Phase 2 trial for the treatment of
NSCLC is expected to initiate in the second half of 2024, with
initial data expected in the first half of 2025.
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 plans to submit an IND for
STRO-004 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 $970
million in payments through June 30, 2024, including equity
investments.
Corporate Updates:
- In August, Sutro strengthened its Board
of Directors with the appointment of Sukhi Jagpal, MBA, CPA, CBV.
Mr. Jagpal brings 20 years of experience in the life sciences
industry, with expertise in financial management, communication,
and organizational effectiveness, including financial analysis,
mergers and acquisitions, and cost optimization.
- In July, Sutro appointed Barbara
Leyman, Ph.D., as Chief Business Development Officer, with a focus
on building value and executing the Company’s business development
strategy, in addition to serving on Sutro’s senior management
team.
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.
- Wedbush PacGrow Healthcare Conference
in New York, August 13-14, 2024
- Wells Fargo Healthcare Conference in
Boston, September 4-6, 2024
Second Quarter 2024 Financial
Highlights
Cash, Cash Equivalents and Marketable Securities and Vaxcyte
Common StockAs of June 30, 2024, Sutro had $426.0 million, composed
of cash, cash equivalents and marketable securities of $375.6
million and approximately 0.7 million shares of Vaxcyte common
stock with a fair value of $50.4 million.
Unrealized Gain from Increase in Value of Vaxcyte Common
StockThe non-operating, unrealized gain of $4.8 million for the
quarter ended June 30, 2024 was due to the increase since March 31,
2024 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 $25.7 million for the quarter ended June 30,
2024, as compared to $10.4 million for the same period in 2023,
with the 2024 amount related principally to the Astellas
collaboration and the Vaxcyte agreement. 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
June 30, 2024 were $74.4 million, as compared to $56.6 million for
the same period in 2023. The 2024 quarter includes non-cash
expenses for stock-based compensation of $6.2 million and
depreciation and amortization of $1.8 million, as compared to $6.7
million and $1.7 million, respectively, in the comparable 2023
period. Total operating expenses for the quarter ended June 30,
2024 were comprised of research and development expenses of $62.0
million and general and administrative expenses of $12.4
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.
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, |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Revenues |
$ |
25,706 |
|
|
$ |
10,412 |
|
|
$ |
38,714 |
|
|
$ |
23,086 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
62,020 |
|
|
|
41,592 |
|
|
|
118,898 |
|
|
|
80,991 |
|
General and administrative |
|
12,371 |
|
|
|
14,999 |
|
|
|
25,092 |
|
|
|
30,511 |
|
Total operating expenses |
|
74,391 |
|
|
|
56,591 |
|
|
|
143,990 |
|
|
|
111,502 |
|
Loss from operations |
|
(48,685 |
) |
|
|
(46,179 |
) |
|
|
(105,276 |
) |
|
|
(88,416 |
) |
Interest income |
|
4,911 |
|
|
|
2,842 |
|
|
|
9,007 |
|
|
|
5,402 |
|
Unrealized gain on equity
securities |
|
4,808 |
|
|
|
8,321 |
|
|
|
8,487 |
|
|
|
1,329 |
|
Non-cash interest expense
related to the sale of future royalties |
|
(7,286 |
) |
|
|
(442 |
) |
|
|
(14,470 |
) |
|
|
(442 |
) |
Interest and other income
(expense), net |
|
(1,758 |
) |
|
|
(2,915 |
) |
|
|
(3,971 |
) |
|
|
(5,901 |
) |
Loss before provision for
income taxes |
|
(48,010 |
) |
|
|
(38,373 |
) |
|
|
(106,223 |
) |
|
|
(88,028 |
) |
Provision for income
taxes |
|
8 |
|
|
|
151 |
|
|
|
8 |
|
|
|
546 |
|
Net loss |
$ |
(48,018 |
) |
|
$ |
(38,524 |
) |
|
$ |
(106,231 |
) |
|
$ |
(88,574 |
) |
Net loss per share, basic and
diluted |
$ |
(0.59 |
) |
|
$ |
(0.64 |
) |
|
$ |
(1.49 |
) |
|
$ |
(1.49 |
) |
Weighted-average shares used
in computing basic and diluted loss per share |
|
81,224,628 |
|
|
|
60,339,475 |
|
|
|
71,341,211 |
|
|
|
59,535,918 |
|
Sutro Biopharma, Inc.Selected Balance
Sheets Financial
Data(Unaudited)(In
thousands) |
|
June 30,
2024(1) |
|
|
December 31,
2023(2) |
|
Assets |
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
$ |
375,568 |
|
|
$ |
333,681 |
|
Investment in equity securities |
|
50,424 |
|
|
|
41,937 |
|
Accounts receivable |
|
6,950 |
|
|
|
36,078 |
|
Property and equipment, net |
|
19,414 |
|
|
|
21,940 |
|
Operating lease right-of-use assets |
|
20,333 |
|
|
|
22,815 |
|
Other assets |
|
16,354 |
|
|
|
14,285 |
|
Total
Assets |
$ |
489,043 |
|
|
$ |
470,736 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
Accounts payable, accrued expenses and other liabilities |
$ |
50,782 |
|
|
$ |
64,293 |
|
Deferred revenue |
|
95,654 |
|
|
|
74,045 |
|
Operating lease liability |
|
26,526 |
|
|
|
29,574 |
|
Debt |
|
- |
|
|
|
4,061 |
|
Deferred royalty obligation
related to the sale of future royalties |
|
163,905 |
|
|
|
149,114 |
|
Total liabilities |
|
336,867 |
|
|
|
321,087 |
|
Total stockholders’
equity |
|
152,176 |
|
|
|
149,649 |
|
Total Liabilities and
Stockholders’ Equity |
$ |
489,043 |
|
|
$ |
470,736 |
|
(1) |
|
The condensed balance sheet as of June 30, 2024 was derived from
the unaudited financial statements included in the Company's
Quarterly Report on Form 10-Q for the quarter ended June 30, 2024,
filed with the Securities and Exchange Commission on August 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. |
|
|
|
Contact
Emily White
Sutro Biopharma
(650) 823-7681
ewhite@sutrobio.com
Sutro Biopharma (NASDAQ:STRO)
過去 株価チャート
から 7 2024 まで 8 2024
Sutro Biopharma (NASDAQ:STRO)
過去 株価チャート
から 8 2023 まで 8 2024