SpringWorks Therapeutics at Pr – GuruFocus.com


— NDA filing for Nirogacestat in desmoid tumors, which will be reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, scheduled for the second half of 2022 —

— Announcement of a new phase 2 study to evaluate nirogacestat in patients with ovarian granulosa tumors —

— Eight clinical collaborations evaluating nirogacestat as a cornerstone of BCMA combination therapy Ongoing; Nirogacestat in Combination with GSK’s Low-Dose BLENREP Being Evaluated in a Phase 2 Trial and Advanced in Additional Substudies with Reference Agents —

— Mirdametinib Being Evaluated in Monotherapy and Combination Studies in Rare Oncology Indications and Biomarker-Defined Solid Tumors —

— BGB-3245 Monotherapy to Advance in Cohort Expansion Studies —

— Well capitalized to execute current R&D programs and preparations to serve patients with desmoid tumors from 2023 –

STAMFORD, Conn., June 10, 2022 (GLOBE NEWSWIRE) — SpringWorks Therapeutics, Inc. (SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing drugs for patients with serious rare diseases and cancer, has announced that the company will host a virtual R&D day today, Friday, June 10, from 10:00 a.m. to 1:00 p.m. ET.

SpringWorks R&D Day will include presentations by Saqib Islam, President and CEO; Badreddin Edris, PhD., Chief Operating Officer; L. Mary Smith, PhD, Director of Development; Bhavesh Ashar, Commercial Director; Mike Burgess, MBChB, PhD, R&D Manager; and Jim Cassidy, MD, PhD, chief medical officer. The event will also include presentations from two outside thought leaders: Breelyn Wilky, MD, Director of Sarcoma Medical Oncology at the University of Colorado, Denver (CU Denver) and Neal Rosen, MD, PhD, Director of 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 time in terms of data generation, regulatory discussions and launch preparations. Our goal is to provide the first approved treatment for patients with desmoid tumors in 2023, and we expect to have two products approved with the potential to serve patients in four distinct oncology indications by 2025,” Saqib Islam said. , CEO of SpringWorks. “We are confident that our strong execution across all of our R&D programs, our disciplined and rigorous approach to business development, and our focused business development will drive our success in 2022 and beyond.”


  • Business Introduction and 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 Business Opportunity (Bhavesh Ashar)
    • Opportunity for further expansion (Badreddin Edris, PhD)
    • Development of BCMA therapeutic combinations (Mike Burgess, MBChB, PhD)
  • Mirdametinib
    • NF1-PN (L. Mary Smith, PhD)
    • Additional expansion opportunities (Jim Cassidy, MD, PhD)
    • Mirdametinib + Lifirafenib: developing a combination (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
    • Overview of the TEAD and EGFR Inhibitor Program (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 10e, from 10 a.m. to 1 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 conference ID 4453188. A replay will be available on the SpringWorks website for a limited period of time following the event.

About SpringWorks Therapeutics
SpringWorks is a clinical-stage biopharmaceutical company that applies a precision medicine approach to acquire, develop and commercialize life-changing medicines for patients with serious rare diseases and cancer. SpringWorks has a differentiated targeted oncology product 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 in highly genetically defined cancers. prevalent. SpringWorks’ strategic approach and operational excellence in clinical development has enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry innovators. industry and academia to expand its portfolio and create more solutions. for cancer patients. For more information, visit www.springworkstx.com and follow @SpringWorksTx on Twitter and LinkedIn.

SpringWorks Forward-Looking Statements
This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding our business, operations and financial conditions, including, but not limited to, beliefs, expectations and current assumptions regarding the future of our business, our future plans and strategies, our development plans, our preclinical and clinical results, our plans to report additional data from the DeFi Phase 3 clinical trial at an upcoming conference clinical trial, the potential for the results of the DeFi Phase 3 clinical trial to support an NDA submission, the timing of our planned NDA submission for nirogacestat, and our plans to seek regulatory approval and make nirogacestat available for patients with desmoid tumor, if approved, as well as other future terms. 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 arise from time to time and it is not possible to foresee all risks and uncertainties. All forward-looking statements contained in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and factors that may cause actual events or results to differ. differ materially from those expressed or implied by any forward-looking statement. 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 clinical trials of SpringWorks, (ii) the fact that primary 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 this study, or the results of other studies in ongoing or future, (iii) the success and timing of our ongoing and planned collaborative clinical trials, (iv) the timing of our planned regulatory submissions and interactions, including the NDA for nirogacestat scheduled for the second half of 2022 and d the timing and outcome of decisions made by the U.S. Food and Drug Administration (FDA) and other regulatory authorities, clinical trial site research review boards, and regulatory bodies. publication review systems; (v) whether the FDA or other regulatory authorities will require additional information or further studies, or may fail or refuse to approve or delay approval of our drug candidates, including nirogacestat and mirdametinib, ( (vi) our ability to obtain and maintain regulatory approval for any of our product candidates, (vii) our plans to research, discover and develop additional product candidates, (viii) our ability to enter into collaborations to 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 up production, (x) our ability to meet specific milestones set forth herein, and (xi) uncertainties and assumptions regarding the impact of the COVID-19 pandemic on SpringWorks’ business, operations, clinical trials, ch supply chain, strategy, objectives and expected timelines.

Except as required by applicable law, we do not intend to publicly update or revise any forward-looking statements contained herein, whether as a result of new information, future events, changed circumstances or otherwise. . Although we believe that the expectations reflected in these forward-looking statements are reasonable, we cannot guarantee that these expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements.

For additional information regarding the risks, uncertainties and other factors that could cause SpringWorks’ expectations to differ from actual results, you should review “Risk Factors” in Part I, Item 1A of the Report. SpringWorks quarterly 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.

Kim Diamond
Vice President, Communications and Investor Relations
Phone: 203-561-1646
E-mail: [email protected]

Samantha Hilson Sandler
Director, Investor Relations
Phone: 203-461-5501
E-mail: [email protected]



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