SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage
biopharmaceutical company focused on severe rare diseases and
cancer, today reported first quarter financial results for the
period ended March 31, 2024 and provided an update on recent
company developments.
"We are very encouraged by the strong start to the OGSIVEO
launch and are focused on continuing our momentum towards
establishing OGSIVEO as the standard of care treatment for adults
with desmoid tumors," said Saqib Islam, Chief Executive Officer of
SpringWorks. "We are also pleased to have initiated the rolling NDA
submission for mirdametinib in children and adults with NF1-PN,
which would be our second marketed product serving another group of
patients who are currently suffering with a high unmet need, if
approved. We are making significant progress across our commercial,
development and corporate objectives and look forward to providing
updates throughout the year."
Recent Business Highlights and Upcoming
Milestones
OGSIVEO®
(Nirogacestat)
- Strong execution in the first full quarter of launch, with net
product revenue of $21.0 million in the first quarter of 2024.
- Received U.S. Food and Drug Administration (FDA) approval of a
Supplemental New Drug Application (NDA) for OGSIVEO 150 mg and 100
mg tablets in new blister packaging, which have been developed to
enhance patient convenience with OGSIVEO. The blister packs are
expected to be on the market in mid-May 2024.
- Received validation from the European Medicines Agency (EMA) on
a Marketing Authorization Application (MAA) for nirogacestat for
the treatment of adult patients with desmoid tumors in February
2024.
- Additional data from the Phase 3 DeFi trial of nirogacestat in
adults with desmoid tumors were accepted for presentation at the
2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
An abstract describing the onset and resolution of ovarian toxicity
for desmoid tumor patients treated with nirogacestat was selected
as an oral presentation to be delivered on May 31, 2024. Two
additional sub-group analyses evaluating nirogacestat in desmoid
tumor patients with poor prognostic factors and in those with
adenomatous polyposis (APC) mutations will also be presented on
June 1, 2024.
- On track to report initial data from the Phase 2 trial
evaluating nirogacestat as a monotherapy in patients with recurrent
ovarian granulosa cell tumors in the second half of 2024.
- Continuing to support several industry and academic
collaborator studies evaluating nirogacestat as part of B-cell
maturation antigen (BCMA) combination therapy regimens across
treatment lines in patients with multiple myeloma.
Mirdametinib
- Initiated rolling submission of an NDA to the FDA for
mirdametinib for the treatment of children and adults with NF1-PN
in March 2024. SpringWorks expects to complete the NDA submission
in the second quarter of 2024 and expects to file an MAA with the
EMA for mirdametinib for the treatment of children and adults with
NF1-PN in the European Union the second half of 2024.
- Data from the pediatric and adult cohorts of the Phase 2b ReNeu
trial were accepted for oral presentation as a rapid oral abstract
at the 2024 ASCO Annual Meeting on June 3, 2024. SpringWorks also
expects to publish the ReNeu trial results in a peer-reviewed
journal in 2024.
Emerging Pipeline
- On track to present additional data from the dose expansion
portion of the Phase 1b trial evaluating brimarafenib (BGB-3245) in
adult patients with RAF mutant solid tumors in the second half of
2024. Brimarafenib is an investigational, selective RAF dimer
inhibitor being developed by MapKure, LLC, a joint venture between
SpringWorks and BeiGene, Ltd.
- Patients continue to be enrolled in the dose escalation phase
of the SpringWorks-sponsored Phase 1/2a combination study of
brimarafenib and mirdametinib.
- MapKure initiated a Phase 1b combination trial of brimarafenib
with panitumumab, a monoclonal antibody targeting Epidermal Growth
Factor Receptor in colorectal and pancreatic cancer patients with
known MAPK pathway mutations; patient dosing is currently
underway.
- Dose expansion in adult patients with NRAS mutant solid tumors
is ongoing in the BeiGene-sponsored Phase 1b trial evaluating
mirdametinib in combination with BeiGene’s RAF dimer inhibitor,
lifirafenib.
- On track to initiate a Phase 1a trial of SW-682, an
investigational novel, oral, potent, and selective pan-TEAD
inhibitor, in Hippo-mutant solid tumors in the second quarter of
2024.
General Corporate
- The U.S. Patent and Trademark Office has recently issued five
new patents for OGSIVEO. The U.S. patent portfolio for OGSIVEO now
includes 21 Orange Book listed patents, providing protection into
2043.
First Quarter 2024
Financial Results
- Revenues: OGSIVEO net product revenues were
$21.0 million in the first quarter of 2024, the first full quarter
of the U.S. launch.
- Selling, General and Administrative (SG&A)
Expenses: SG&A expenses were $60.1 million for the
first quarter of 2024, compared to $44.2 million for the comparable
period of 2023. The increase in SG&A expense was primarily
attributable to commercial activities supporting the U.S. launch of
OGSIVEO.
- Research and Development (R&D) Expenses:
R&D expenses were $53.6 million for the first quarter of 2024,
compared to $33.5 million for the comparable period of 2023. The
increase in R&D expenses was primarily attributable to an
increase in costs related to drug manufacturing, clinical trials,
other research, consulting and professional services, and an
increase in employee costs associated with headcount growth.
- Net Loss Attributable to Common Stockholders:
SpringWorks reported a net loss of $87.4 million, or $1.18 per
share, for the first quarter of 2024. This compares to a net loss
of $73.4 million, or $1.18 per share, for the comparable period of
2023.
- Cash, Cash Equivalents, and Marketable
Securities: Cash, cash equivalents and marketable
securities were $573.0 million as of March 31, 2024.
Conference Call Information
SpringWorks will host a conference call and webcast today,
Thursday, May 2, at 8:30 a.m. ET to review its first quarter 2024
financial results and discuss recent business updates. To join the
live webcast and view the corresponding slides, please click here.
To access the live call by phone, please pre-register for the call
by clicking here. Once registration is complete, participants will
be provided with a dial-in number and conference code to access the
call. A replay of the webcast will be available for a limited time
following the event on the Investors and Media section of the
Company’s website at https://ir.springworkstx.com.
About SpringWorks Therapeutics
SpringWorks is a commercial-stage biopharmaceutical company
applying a precision medicine approach to developing and delivering
life-changing medicines for people with severe rare diseases and
cancer. OGSIVEO® (nirogacestat), approved in the
United States for the treatment of adult patients with progressing
desmoid tumors who require systemic treatment, is the Company’s
first FDA-approved therapy. SpringWorks also has a diversified
targeted therapy pipeline spanning solid tumors and hematological
cancers, with programs ranging from preclinical development through
advanced clinical trials. In addition to its wholly owned programs,
SpringWorks has also entered into multiple collaborations with
innovators in industry and academia to unlock the full potential
for its portfolio and create more solutions for patients in
need.
For more information, visit www.springworkstx.com and follow
@SpringWorksTx on X (formerly Twitter), LinkedIn, and YouTube.
SpringWorks uses its website as a means of disclosing material
non-public information and for complying with its disclosure
obligations under Regulation FD. Such disclosures will be included
on SpringWorks' website in the Investors & Media section.
Accordingly, investors should monitor such portions of the
SpringWorks website, in addition to following press releases, SEC
filings and public conference calls and webcasts.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, relating to our business, operations, and
financial conditions, including but not limited to current beliefs,
expectations and assumptions regarding the future of our business,
future plans and strategies, our development and commercialization
plans, our preclinical and clinical results, the market potential
of OGSIVEO for adult patients with desmoid tumors, expectations
regarding the adequacy of the data contained in the MAA to serve as
the basis for marketing approval of nirogacestat for the treatment
of desmoid tumors in the European Union, the potential for the
results of the Phase 2b ReNeu clinical trial to support an NDA
submission for mirdametinib in the second quarter of 2024 or an MAA
submission in the second half of 2024, our plans to report
additional data from the Phase 2b ReNeu clinical trial at an
upcoming medical conference and submit for publication data from
such clinical trial in a peer-reviewed medical journal in 2024, our
plans to present additional data from the Phase 3 DeFi trial of
nirogacestat at upcoming conferences, the potential for
mirdametinib to become an important new treatment for patients with
NF1-PN, our plans for seeking regulatory approval for and making
mirdametinib available for NF1-PN patients, if approved,
expectations regarding the timing and initial data from the Phase 2
trial evaluating nirogacestat in patients with recurrent ovarian
granulosa cell tumors, our plans to initiate a Phase 1a trial of
SW-682 in Hippo mutant solid tumors in the second quarter of 2024,
our plans to report additional clinical data of nirogacestat in
combination with BCMA-directed therapies and initiate additional
planned Phase 1 collaborator studies, our expectations regarding
the potential for and the timing of the Phase 1b dose expansion
phase of brimarafenib, our plans to present additional data for
brimarafenib monotherapy in MAPK-mutant solid tumors in second half
of 2024, expectations about whether our patents for our lead assets
will adequately protect SpringWorks against competition, as well as
relating to other future conditions. Words such as, but not limited
to, “look forward to,” “believe,” “expect,” “anticipate,”
“estimate,” “intend,” “plan,” “would,” “should” and “could,” and
similar expressions or words, identify forward-looking statements.
New risks and uncertainties may emerge from time to time, and it is
not possible to predict all risks and uncertainties. Any
forward-looking statements in this presentation are based on
management’s current expectations and beliefs and are subject to a
number of risks, uncertainties and important factors that may cause
actual events or results to differ materially from those expressed
or implied by any forward-looking statements contained in this
presentation, including, without limitation, risks relating to: (i)
the success of our commercialization efforts with respect to
OGSIVEO, (ii) our limited experience as a commercial company, (iii)
our ability to obtain or maintain adequate coverage and
reimbursement for OGSIVEO, (iv) the success and timing of our
product development activities, including the initiation and
completion of our clinical trials, (v) our expectations regarding
the potential clinical benefit of OGSIVEO for adult patients with
desmoid tumors who require systemic treatment, (vi) the potential
for OGSIVEO to become the new standard of care for adult patients
with desmoid tumors, (vii) estimates regarding the number of adult
patients who are diagnosed with desmoid tumors annually per year in
the U.S. and the potential market for OGSIVEO, (viii) the fact that
topline or interim data from clinical studies may not be predictive
of the final or more detailed results of such study or the results
of other ongoing or future studies, (ix) the success and timing of
our collaboration partners’ ongoing and planned clinical trials,
(x) the timing of our planned regulatory submissions and
interactions, including the timing and outcome of decisions made by
the FDA, EMA, and other regulatory authorities, investigational
review boards at clinical trial sites and publication review
bodies, (xi) whether FDA, EMA, or other regulatory authorities will
require additional information or further studies, or may fail or
refuse to approve or may delay approval of our product candidates,
including nirogacestat and mirdametinib, (xii) our ability to
obtain regulatory approval of any of our product candidates or
maintain regulatory approvals granted for our products, (xiii) our
plans to research, discover and develop additional product
candidates, (xiv) our ability to enter into collaborations for the
development of new product candidates and our ability to realize
the benefits expected from such collaborations, (xv) our ability to
maintain adequate patent protection and successfully enforce patent
claims against third parties, (xvi) the adequacy of our cash
position to fund our operations through any time period indicated
herein, (xvii) our ability to establish manufacturing capabilities,
and our and our collaboration partners’ abilities to manufacture
our product candidates and scale production, and (xviii) our
ability to meet any specific milestones set forth herein.
Except as required by applicable law, we do not plan to publicly
update or revise any forward-looking statements contained herein,
whether as a result of any new information, future events, changed
circumstances or otherwise. Although we believe the expectations
reflected in such forward-looking statements are reasonable, we can
give no assurance that such expectations will prove to be correct.
Accordingly, readers are cautioned not to place undue reliance on
these forward-looking statements.
For further information regarding the risks, uncertainties and
other factors that may cause differences between SpringWorks’
expectations and actual results, you should review the “Risk
Factors” in Item 1A of Part II of SpringWorks’ Quarterly Report on
Form 10-Q for the quarter ended March 31, 2024, as well as
discussions of potential risks, uncertainties and other important
factors in SpringWorks’ subsequent filings.
SpringWorks Therapeutics, Inc.Condensed Consolidated
Statements of Operations(Unaudited) |
|
Three Months Ended March 31, |
(in thousands, except share and per-share
data) |
|
2024 |
|
|
|
2023 |
|
Revenue: |
|
|
|
Product revenue, net |
$ |
21,006 |
|
|
$ |
— |
|
Total revenue |
|
21,006 |
|
|
|
— |
|
Operating costs and
expenses: |
|
|
|
Cost of product revenue |
|
1,202 |
|
|
|
— |
|
Selling, general and administrative |
|
60,113 |
|
|
|
44,175 |
|
Research and development |
|
53,622 |
|
|
|
33,524 |
|
Total operating costs and expenses |
|
114,937 |
|
|
|
77,699 |
|
|
|
|
|
Loss from operations |
|
(93,931 |
) |
|
|
(77,699 |
) |
Interest and other
income: |
|
|
|
Interest and other income, net |
|
7,571 |
|
|
|
5,557 |
|
Total interest and other income |
|
7,571 |
|
|
|
5,557 |
|
Equity method investment
loss |
|
(1,025 |
) |
|
|
(1,278 |
) |
Net loss |
$ |
(87,385 |
) |
|
$ |
(73,420 |
) |
|
|
|
|
Net
loss per share, basic and diluted |
$ |
(1.18 |
) |
|
$ |
(1.18 |
) |
Weighted average common shares outstanding, basic and diluted |
|
73,768,603 |
|
|
|
62,326,992 |
|
SpringWorks Therapeutics, Inc.Selected Balance Sheet
Data(Unaudited) |
|
March 31, 2024 |
|
December 31, 2023 |
(in
thousands) |
|
|
|
Cash, cash equivalents and marketable securities |
$ |
572,987 |
|
|
$ |
662,588 |
|
Working Capital (1) |
|
402,881 |
|
|
|
422,742 |
|
Total
assets |
|
656,832 |
|
|
|
725,788 |
|
Total
liabilities |
|
89,392 |
|
|
|
99,569 |
|
Accumulated deficit |
|
(982,419 |
) |
|
|
(895,034 |
) |
Total
stockholders’ equity |
|
567,440 |
|
|
|
626,219 |
|
(1) We define working capital as current assets
less current liabilities.Contacts:Kim DiamondVice
President, Communications and Investor RelationsPhone:
203-561-1646Email: kdiamond@springworkstx.com
Samantha Hilson SandlerSenior Director, Investor RelationsPhone:
203-461-5501Email: samantha.sandler@springworkstx.com
SpringWorks Therapeutics (NASDAQ:SWTX)
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SpringWorks Therapeutics (NASDAQ:SWTX)
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