On May 5, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported first quarter financial results for the period ended March 31, 2022 and provided an update on recent company developments (Press release, SpringWorks Therapeutics, MAY 5, 2022, View Source [SID1234613665]).
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"In the first quarter of 2022 we continued to advance our diversified targeted oncology pipeline, which now includes 18 development programs across rare oncology, BCMA combinations in multiple myeloma, and biomarker-defined metastatic solid tumors," said Saqib Islam, Chief Executive Officer of SpringWorks. "The second quarter of 2022 will be a meaningful period for SpringWorks and the patients we are working to serve as we expect to announce topline data from our Phase 3 DeFi study, share initial clinical data from our collaboration with GSK evaluating nirogacestat in combination with low-dose BLENREP in patients with multiple myeloma at ASCO (Free ASCO Whitepaper), and host our first R&D Day, which will include initial clinical data from our biomarker-defined metastatic solid tumor programs with BeiGene, our preparations for serving patients with desmoid tumors, as well as broader developments across our pipeline."
Recent Business Highlights and Upcoming Milestones
Rare Oncology
SpringWorks is conducting the Phase 3 DeFi trial evaluating nirogacestat in adult patients with progressing desmoid tumors. DeFi is an event-driven trial with a primary endpoint of progression-free survival. The Company has commenced the activities to enable the topline analysis from the Phase 3 DeFi trial and expects to report topline data in the second quarter of 2022.
A poster entitled, "Extended progression free survival and long-term safety of nirogacestat in patients with desmoid tumors" will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The poster will include updated data from the NCI-sponsored Phase 2 study of nirogacestat in patients with progressing desmoid tumors.
Recruitment is ongoing in a Phase 2 study sponsored by the Children’s Oncology Group evaluating nirogacestat in pediatric patients with desmoid tumors.
The Phase 2b ReNeu trial evaluating mirdametinib in adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN) is fully enrolled.
Recruitment is ongoing in a Phase 1/2 clinical trial evaluating mirdametinib in children and young adults with low-grade glioma.
B-cell Maturation Antigen (BCMA) Combinations in Multiple Myeloma
SpringWorks continues to advance nirogacestat as a potential cornerstone of BCMA combination therapy across modalities in collaboration with eight industry leaders. Five studies are currently ongoing: nirogacestat + GSK’s BLENREP (belantamab mafodotin-blmf), nirogacestat + Allogene’s ALLO-715, nirogacestat + Janssen’s teclistamab, nirogacestat + Precision Biosciences’ PBCAR269A, and nirogacestat + Pfizer’s elrantamab; three additional studies are planned: nirogacestat + Seagen’s SEA-BCMA, nirogacestat + AbbVie’s ABBV-383, and nirogacestat + Regeneron’s REGN5458.
A poster entitled, "Synergistic effects of low-dose belantamab mafodotin in combination with a gamma-secretase inhibitor (nirogacestat) in patients with relapsed/refractory multiple myeloma (RRMM): DREAMM-5 study" will be presented in a poster discussion session at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting.
In April 2022, SpringWorks entered into a clinical trial collaboration and supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate nirogacestat in combination with Regeneron’s investigational bispecific antibody targeting BCMA and CD3, REGN5458, in patients with relapsed or refractory multiple myeloma.
Biomarker-Defined Metastatic Solid Tumors
Enrollment is ongoing in a Phase 1b/2 trial evaluating mirdametinib with BeiGene’s RAF dimer inhibitor, lifirafenib, in adult patients with RAS/RAF mutant and other MAPK pathway aberrant solid tumors. Initial clinical data from the BeiGene-sponsored trial are expected to be presented at an upcoming SpringWorks-sponsored R&D Day.
Enrollment is ongoing in a Phase 1 trial of BGB-3245 in adult patients with RAF mutant solid tumors. BGB-3245 is a selective RAF dimer inhibitor being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene. Initial clinical data from the MapKure-sponsored trial are expected to be presented at an upcoming SpringWorks-sponsored R&D Day.
Enrollment is ongoing in a Phase 1b/2a platform study sponsored by Memorial Sloan Kettering Cancer Center evaluating mirdametinib both as a monotherapy and as a combination therapy in advanced solid tumors harboring selected MAPK-activating mutations.
Preclinical data from the TEAD inhibitor program were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2022. SpringWorks expects to nominate a drug candidate from the TEAD inhibitor portfolio in the second half of 2022.
First Quarter 2022 Financial Results
Research and Development (R&D) Expenses: R&D expenses were $34.1 million for the first quarter of 2022, compared to $17.4 million for the comparable period of 2021. The increase in R&D expense was primarily attributable to an increase in internal costs driven by the growth in employee costs associated with increases in the number of personnel, including an increase in stock-based compensation expense, and an increase in external costs related to drug manufacturing and trial costs.
General and Administrative (G&A) Expenses: G&A expenses were $27.4 million for the first quarter of 2022, compared to $12.4 million for the comparable period of 2021. The increase in G&A expense was primarily attributable to an increase in internal costs driven by the growth in employee costs associated with increases in the number of personnel, including an increase in stock-based compensation expense as we continued to expand our operations to support the organization, and an increase in professional fees, as we continue to build new capabilities, including commercial.
Net Loss Attributable to Common Stockholders: SpringWorks reported net loss of $61.8 million, or $1.26 per share, for the first quarter of 2022. This compares to a net loss of $29.8 million, or $0.62 per share, for the comparable period of 2021.
Cash Position: Cash, cash equivalents and marketable securities were $380.7 million as of March 31, 2022.
COVID-19 Update
To date, the COVID-19 pandemic has had a relatively modest impact on SpringWorks’ business operations, in particular on SpringWorks’ clinical trial programs, and SpringWorks is undertaking considerable efforts to mitigate the various challenges presented by this crisis. For further details and descriptions of the risks associated with the COVID-19 pandemic, please see the Risk Factors in SpringWorks’ periodic filings with the Securities and Exchange Commission and refer to the Forward-Looking Statements section in this press release.