SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage
biopharmaceutical company focused on severe rare diseases and
cancer, will present today at the 42nd Annual J.P. Morgan
Healthcare Conference at 7:30 a.m. PT (10:30 a.m. ET), and a live
webcast will be available at ir.springworkstx.com. Ahead of the
presentation, the Company highlighted its 2023 accomplishments and
announced its anticipated key milestones for 2024.
2023 Accomplishments
Nirogacestat
- Received approval from the United States Food and Drug
Administration (FDA) for OGSIVEO™ (nirogacestat), an oral gamma
secretase inhibitor, for the treatment of adult patients with
progressing desmoid tumors who require systemic treatment.
- Published data from the Phase 3 DeFi trial of nirogacestat in
adult patients with progressing desmoid tumors in the New England
Journal of Medicine.
- Presented additional data from the Phase 3 DeFi trial at
several leading medical conferences. These presentations
demonstrated rapid, sustained and consistent improvements in pain
and functional status in patients receiving OGSIVEO using multiple
assessment tools.
- Completed enrollment in the Phase 2 trial evaluating
nirogacestat as a monotherapy in patients with recurrent ovarian
granulosa cell tumors (OvGCT).
- Continued to evaluate nirogacestat in patients with multiple
myeloma as part of several B-cell maturation antigen (BCMA)
combination therapy regimens across treatment lines in
collaboration with industry leaders. Clinical data from two BCMA
combination studies were presented at the European Hematology
Association congress and provided further validation of the
mechanistic approach supporting nirogacestat’s ability to enhance
the activity of BCMA-directed therapies across modalities. In
addition, a Regeneron-sponsored study was initiated to evaluate
nirogacestat in combination with linvoseltamab, Regeneron’s
bispecific antibody targeting BCMA and CD3.
Mirdametinib (NF1-PN)
- Presented positive topline data from the pivotal Phase 2b ReNeu
trial evaluating mirdametinib, an investigational oral MEK
inhibitor, in pediatric and adult patients with neurofibromatosis
type 1-associated plexiform neurofibromas (NF1-PN). Data
demonstrated a confirmed objective response rate of 52% in
pediatric patients and 41% in adult patients, as assessed by
Blinded Independent Central Review. Mirdametinib treatment resulted
in deep and durable responses and led to significant improvements
in key secondary patient-reported outcome measures. Mirdametinib
was generally well tolerated in the ReNeu trial, with the majority
of adverse events being Grade 1 or Grade 2.
Emerging Pipeline
- Presented updated data from the Phase 1a/1b study of
brimarafenib (BGB-3245), an investigational, selective RAF dimer
inhibitor being developed by MapKure, LLC, a joint venture between
SpringWorks and BeiGene, Ltd., in adult patients with advanced or
refractory solid tumors harboring MAPK pathway aberrations at the
American Association for Cancer Research (AACR) annual meeting.
These data supported the advancement of brimarafenib into the Phase
1b cohort expansion portion of the study.
- Shared updated clinical data from the Phase 1b trial evaluating
mirdametinib in combination with BeiGene’s investigational RAF
dimer inhibitor, lifirafenib, in patients with advanced or
refractory solid tumors with RAS mutations, RAF mutations and other
MAPK pathway aberrations at AACR. The combination showed antitumor
activity in patients with various mutations across several solid
tumor types and support the advancement of this combination into
the dose-expansion portion of the study, which is evaluating the
combination in patients with NRAS-mutated solid tumors.
- Dosed the first patient in a Phase 1/2a combination study of
brimarafenib and mirdametinib.
- The FDA cleared the Investigational New Drug (IND) application
submitted through MapKure for a combination study of brimarafenib
with panitumumab, a monoclonal antibody targeting EGFR, in
colorectal and pancreatic cancer patients with known MAPK pathway
mutations. Amgen Inc. is supplying panitumumab pursuant to a
clinical trial collaboration agreement with MapKure.
- Submitted an IND application for SW-682, a novel, potent, and
selective TEAD inhibitor development candidate targeting tumors
driven by Hippo pathway mutations.
General Corporate
- Continued to expand and strengthen the intellectual property
portfolios for nirogacestat and mirdametinib, with Orange Book
listable patents providing protection past 2040 for both
nirogacestat and mirdametinib.
- Strengthened balance sheet with upsized public offering; gross
proceeds from the offering, before deducting underwriting discounts
and commissions and estimated offering expenses, were approximately
$316.25 million. SpringWorks estimates that its cash, cash
equivalents and marketable securities as of September 30, 2023
exceeded $700 million on a pro forma basis.
Anticipated 2024 Key Milestones
Nirogacestat
- Continue to advance U.S. launch of OGSIVEO (nirogacestat) as
the first and only approved therapy for adult patients with desmoid
tumors and establish as standard of care.
- Submit Marketing Authorisation Application (MAA) for
nirogacestat for the treatment of adult patients with desmoid
tumors to the European Medicines Agency (EMA) in the first half of
2024.
- Report initial data from the Phase 2 trial evaluating
nirogacestat as a monotherapy in patients with OvGCT in the second
half of 2024.
- Expand data set with additional clinical data of nirogacestat
in combination with BCMA-directed therapies.
Mirdametinib (NF1-PN)
- Submit a New Drug Application (NDA) to the FDA for mirdametinib
for the treatment of children and adults with NF1-PN in the first
half of 2024.
- Present data from the pediatric and adult cohorts of the Phase
2b ReNeu trial of mirdametinib in NF1-PN at a medical congress in
the first half of 2024 and submit for publication in a
peer-reviewed journal in 2024.
Emerging Pipeline
- Present additional data for brimarafenib as a monotherapy in
MAPK-mutant solid tumors in the second half of 2024.
- Support initiation of Phase 1b trial of brimarafenib in
combination with panitumumab, a monoclonal antibody targeting EGFR,
in colorectal and pancreatic cancer patients with known MAPK
pathway mutations in the first quarter of 2024.
- Initiate Phase 1 trial of SW-682, SpringWorks’ TEAD inhibitor,
in Hippo mutant solid tumors in the first half of 2024.
“Our focus in 2024 is to deliver a successful U.S. launch of
OGSIVEO as the first and only FDA-approved therapy for adults with
desmoid tumors and to prepare for our second potential FDA approval
by filing our NDA for mirdametinib as a treatment for patients with
NF1-PN in the first half of the year,” said Saqib Islam, Chief
Executive Officer of SpringWorks. "We are very pleased with our
progress towards our goal of having two marketed products by 2025
given the highly positive topline data from our Phase 2b ReNeu
trial and will simultaneously advance our broader pipeline of
targeted oncology programs. Our achievements in 2023, our strong
financial position and the durable IP protections for our lead
assets position us for continued, long-term success as we execute
on our mission to improve the lives of patients with devastating
diseases.”
Presentation at the 42nd Annual J.P. Morgan
Healthcare Conference
SpringWorks will webcast its presentation from the 42nd Annual
J.P. Morgan Healthcare Conference today, Monday, January 8, 2024 at
7:30 a.m. PT (10:30 a.m. ET). To access the live webcast, please
visit the Events & Presentations page within the Investors
& Media section of the company’s website at
https://ir.springworkstx.com. A replay of the webcast will be
available on SpringWorks’ website for a limited time following the
conference.
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.
Founded in 2017, SpringWorks has a diversified targeted oncology
pipeline spanning solid tumors and hematological cancers, including
clinical trials in rare tumor types and highly prevalent,
genetically defined cancers. OGSIVEO™, approved in the United
States for the treatment of adult patients with progressing desmoid
tumors who require systemic treatment, is SpringWorks’ first
FDA-approved therapy. SpringWorks’ strategic approach and
operational excellence in clinical development have enabled it to
rapidly advance its lead product candidates into late-stage trials
and enter into multiple collaborations with innovators in industry
and academia to unlock the full potential for its portfolio and
create more solutions for patients with cancer.
For more information, visit www.springworkstx.com and
follow @SpringWorksTx on X (formerly Twitter), LinkedIn,
and YouTube.
SpringWorks 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, the potential
for a Marketing Authorisation Application for nirogacestat with the
European Medicines Agency, the potential for the results of the
Phase 2b ReNeu clinical trial to support an NDA submission for
mirdametinib, 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, expectations
regarding the timing and results of topline data from the Phase 2b
ReNeu clinical trial, our plans to initiate a Phase 1 trial of
SW-682 in the first half 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 the Phase 1b
dose expansion phase of brimarafenib, 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 SpringWorks’ clinical trials, (v)
our expectations regarding the potential clinical benefit of
OGSIVEO for patients with desmoid tumors, (vi) the potential for
OGSIVEO to become the new standard of care for 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) our
expectations regarding the potential clinical benefit of
mirdametinib for NF1-PN patients, (ix) 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, (x) the success and timing of our
collaboration partners’ ongoing and planned clinical trials, (xi)
the timing of our planned regulatory submissions and interactions,
including the timing and outcome of decisions made by the U.S. Food
and Drug Administration (FDA), European Medicines Agency (EMA), and
other regulatory authorities, investigational review boards at
clinical trial sites and publication review bodies, (xii) 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, (xiii) our ability to obtain
regulatory approval of any of our product candidates or maintain
regulatory approvals granted for our products, (xiv) our plans to
research, discover and develop additional product candidates, (xv)
our ability to enter into collaborations for the development of new
product candidates and our ability to realize the benefits expected
from such collaborations, (xvi) our ability to maintain adequate
patent protection and successfully enforce patent claims against
third parties, (xvii) the adequacy of our cash position to fund our
operations through any time period indicated herein, (xviii) our
ability to establish manufacturing capabilities, and our and our
collaboration partners’ abilities to manufacture our product
candidates and scale production, and (xix) 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 September 30, 2023, as well as
discussions of potential risks, uncertainties and other important
factors in SpringWorks’ other filings with the Securities and
Exchange Commission.
Contacts
Kim DiamondVice President, Communications and Investor
RelationsPhone: 203-561-1646 Email: kdiamond@springworkstx.com
Samantha Hilson SandlerSenior Director, Investor RelationsPhone:
203-461-5501Email: samantha.sandler@springworkstx.com
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