SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage
biopharmaceutical company focused on developing life-changing
medicines for patients with severe rare diseases and cancer,
announced that the Company will host a virtual R&D Day today,
Friday, June 10th from 10:00 a.m. to 1:00 p.m. ET.
SpringWorks’ R&D Day will feature presentations by Saqib
Islam, Chief Executive Officer; Badreddin Edris, PhD., Chief
Operating Officer; L. Mary Smith, PhD, Chief Development Officer;
Bhavesh Ashar, Chief Commercial Officer; Mike Burgess, MBChB, PhD,
Head of R&D; and Jim Cassidy, MD, PhD, Chief Medical Officer.
The event will also include presentations from two external key
opinion leaders: Breelyn Wilky, MD, Director of Sarcoma Medical
Oncology at the University of Colorado, Denver (CU Denver) and Neal
Rosen, MD, PhD, Director of the Center for Mechanism-Based Therapy
and the Enid A. Haupt Chair in Medical Oncology at Memorial Sloan
Kettering Cancer Center (MSKCC).
“SpringWorks is at an exciting juncture in terms of data
generation, regulatory discussions, and launch preparations. Our
goal is to provide the first approved therapy for patients with
desmoid tumors in 2023, and we expect to have two approved products
with the potential to serve patients across four distinct oncology
indications by 2025,” said Saqib Islam, Chief Executive Officer of
SpringWorks. “We are confident that our strong execution across our
R&D programs, our disciplined, rigorous approach to business
development, and our focused commercial buildout will drive our
success in 2022 and beyond.”
Agenda
- Introduction and Business Overview (Saqib Islam, Badreddin
Edris, PhD)
- KOL Presentation: Unmet Need in Desmoid Tumors (Bree Wilky, MD,
CU Denver)
- Nirogacestat
- Clinical Experience in Desmoid Tumors (L. Mary Smith, PhD)
- Desmoid Tumor Commercial Opportunity (Bhavesh Ashar)
- Additional Expansion Opportunity (Badreddin Edris, PhD)
- BCMA Therapy Combination Development (Mike Burgess, MBChB,
PhD)
- Mirdametinib
- NF1-PN (L. Mary Smith, PhD)
- Additional Expansion Opportunities (Jim Cassidy, MD, PhD)
- Mirdametinib + Lifirafenib: Combination Development (Jim
Cassidy, MD, PhD)
- KOL Presentation: Introduction to BGB-3245 (Neal Rosen, MD,
PhD, MSKCC)
- BGB-3245
- Initial Clinical Data and Program Update (Jim Cassidy, MD,
PhD)
- Preclinical
- TEAD and EGFR Inhibitor Program Overview (Mike Burgess, MBChB,
PhD)
- Closing Remarks and Q&A (Saqib Islam)
Webcast and Conference Call Information:The
Company’s R&D Day will be held today, Friday, June 10th, from
10:00 a.m. to 1:00 p.m. ET. The webcast can be accessed here.
Participants can also listen to the event by dialing + 1 (844)
946-0285 (domestic) or +1 (602) 585-9676 (international) and
providing the conference ID 4453188. A replay will be available on
the SpringWorks website for a limited period of time following the
event.
About SpringWorks TherapeuticsSpringWorks is a
clinical-stage biopharmaceutical company applying a precision
medicine approach to acquiring, developing and commercializing
life-changing medicines for patients living with severe rare
diseases and cancer. SpringWorks has a differentiated targeted
oncology portfolio of small molecule product candidates and is
advancing 19 development programs, including two potentially
registrational clinical trials in rare tumor types as well as
several programs addressing highly prevalent, genetically defined
cancers. SpringWorks’ strategic approach and operational excellence
in clinical development have enabled it to rapidly advance its two
lead product candidates into late-stage clinical trials while
simultaneously entering into multiple shared-value partnerships
with innovators in industry and academia to expand its portfolio
and create more solutions for patients with cancer. For more
information, visit www.springworkstx.com and follow
@SpringWorksTx on Twitter and LinkedIn.
SpringWorks Forward-Looking StatementsThis
presentation 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 plans, our preclinical
and clinical results, our plans to report additional data from the
Phase 3 DeFi clinical trial at an upcoming medical conference, the
potential for the results of the Phase 3 DeFi clinical trial to
support an NDA submission, the timing of our planned NDA submission
for nirogacestat, and our plans for seeking regulatory approval for
and making nirogacestat available to desmoid tumor patients, if
approved, 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 press release
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 press release, including, without limitation,
risks relating to: (i) the success and timing of our product
development activities, including the initiation and completion of
SpringWorks’ clinical trials, (ii) the fact that topline or interim
data from the Phase 3 DeFi trial or other 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, (iii) the
success and timing of our collaboration partners’ ongoing and
planned clinical trials, (iv) the timing of our planned regulatory
submissions and interactions, including the NDA for nirogacestat
planned for the second half of 2022 and the timing and outcome of
decisions made by the U.S. Food and Drug Administration (FDA) and
other regulatory authorities, investigational review boards at
clinical trial sites and publication review bodies; (v) whether FDA
or other regulatory authorities will require additional information
or further studies, or may fail or refuse to approve or may delay
approval of our drug candidates, including nirogacestat and
mirdametinib, (vi) our ability to obtain and maintain regulatory
approval of any of our product candidates, (vii) our plans to
research, discover and develop additional product candidates,
(viii) our ability to enter into collaborations for the development
of new product candidates, (ix) our ability to establish
manufacturing capabilities, and our and our collaboration partners’
abilities to manufacture our product candidates and scale
production, (x) our ability to meet any specific milestones set
forth herein, and (xi) uncertainties and assumptions regarding the
impact of the COVID-19 pandemic on SpringWorks’ business,
operations, clinical trials, supply chain, strategy, goals and
anticipated timelines.
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 I of SpringWorks’ Quarterly Report on
Form 10-Q for the quarter ended March 31, 2022, as well as
discussions of potential risks, uncertainties and other important
factors in SpringWorks’ subsequent filings.
Contacts:Kim DiamondVice President,
Communications and Investor RelationsPhone: 203-561-1646 Email:
kdiamond@springworkstx.com
Samantha Hilson SandlerDirector, Investor RelationsPhone:
203-461-5501Email: samantha.sandler@springworkstx.com
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