On May 3, 2023 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, 2023 and provided an update on recent company developments (Press release, SpringWorks Therapeutics, MAY 3, 2023, View Source [SID1234630940]).
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"In the first quarter of 2023 we continued to deliver strong results across our diversified oncology pipeline. We were very pleased that our New Drug Application for nirogacestat in desmoid tumors was accepted with Priority Review by the FDA, and that our Phase 3 DeFi trial was published in the New England Journal of Medicine. Our team is energized by the opportunity to deliver the first FDA-approved therapy for this devastating disease and continues to work expeditiously to serve the desmoid tumor patient and physician communities following potential FDA approval later this year," said Saqib Islam, Chief Executive Officer of SpringWorks. "In parallel, we are advancing our Phase 2b ReNeu trial and believe that mirdametinib has the opportunity to address a substantial unmet need that remains for patients with NF1-associated plexiform neurofibromas. We are on track to report topline data from the trial later this year, with the goal of submitting an NDA in the first half of 2024. We look forward to sharing our continued progress throughout the year."
Recent Business Highlights and Upcoming Milestones
Rare Oncology
In February 2023, the U.S. Food and Drug Administration (FDA) accepted SpringWorks’ New Drug Application (NDA) for nirogacestat, an investigational oral, small molecule gamma secretase inhibitor, in development as a monotherapy for the treatment of adults with desmoid tumors. The application has been granted Priority Review and given a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2023. SpringWorks also expects to file a Marketing Authorization Application for nirogacestat with the European Medicines Agency in 2024.
Data from the Phase 3 DeFi trial of nirogacestat in adult patients with progressing desmoid tumors were published in the March 9, 2023 edition of the New England Journal of Medicine.
SpringWorks expects to present topline data from the pediatric and adult cohorts of the Phase 2b ReNeu trial evaluating mirdametinib, an investigational MEK inhibitor, in NF1-PN in the second half of 2023. Pending these data, SpringWorks anticipates submitting an NDA to the FDA for mirdametinib as a treatment for NF1-PN in the first half of 2024.
Patients continue to be enrolled in a Phase 2 trial evaluating nirogacestat in ovarian granulosa cell tumors.
B-cell Maturation Antigen (BCMA) Combinations in Multiple Myeloma
SpringWorks continues to evaluate nirogacestat as part of several BCMA combination therapy regimens across treatment lines in collaboration with industry leaders. In 2023, SpringWorks expects that additional clinical data of nirogacestat in combination with BCMA-directed therapies will be presented and that additional planned Phase 1 collaborator studies will be initiated.
Biomarker-Defined Metastatic Solid Tumors
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 were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023. The combination showed antitumor activity in patients with various KRAS, NRAS, and BRAF mutations across several solid tumor types, including low-grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC), and endometrial cancer. These data support the advancement of this combination into the dose-expansion portion of the study, which will focus on a biomarker selected patient population with a tumor agnostic approach. The expansion is expected to start in the second half of 2023.
Updated clinical data from the Phase 1a/1b study of brimarafenib (BGB-3245), an investigational, selective RAF dimer inhibitor, in adult patients with advanced or refractory solid tumors harboring MAPK pathway aberrations were presented at AACR (Free AACR Whitepaper) in April 2023. Objective responders included patients with tumors harboring BRAF V600E that had progressed on prior BRAF/MEK inhibitors with or without checkpoint inhibitor treatment, BRAF Class II mutation, BRAF fusion, NRAS and KRAS mutations. These data supported the advancement of brimarafenib into the Phase 1b dose expansion portion of the study, which has been enrolling patients since October 2022 in defined cohorts.
Patients continue to be enrolled in the SpringWorks-sponsored Phase 1/2a combination study of brimarafenib and mirdametinib.
New preclinical data for SW-682, SpringWorks’ TEAD inhibitor, were presented at AACR (Free AACR Whitepaper) in April 2023. The data provide promising evidence of SW-682’s anti-tumor activity, a favorable pharmacokinetics profile and good tolerability in mice, and further support SpringWorks’ thesis that TEAD palmitoylation represents a rational point of intervention for Hippo-driven cancers. SpringWorks expects to file an Investigational New Drug Application for SW-682 in 2023.
General Corporate
SpringWorks continues to expand and strengthen its intellectual property portfolio. In March 2023, the United States Patent and Trademark Office issued U.S. Patent No. 11,612,588, which is directed to the treatment of desmoid tumors with pharmaceutical compositions of nirogacestat and expires in 2042. SpringWorks now has eight Orange Book-listable patents for nirogacestat.
First Quarter 2023 Financial Results
Research and Development (R&D) Expenses: R&D expenses were $33.5 million for the first quarter of 2023, compared to $34.1 million for the comparable period of 2022. The decrease in R&D expense was primarily attributable to a decrease in external costs related to drug manufacturing, clinical trial and other research, as well as facility-related costs, offset by 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.
General and Administrative (G&A) Expenses: G&A expenses were $44.2 million for the first quarter of 2023, compared to $27.4 million for the comparable period of 2022. The increase in G&A expense was largely attributable to commercial readiness activities to support the potential U.S. launch of nirogacestat for the treatment of adults with desmoid tumors. The increase in G&A included an increase in both internal costs and in consulting and professional services. The increase in internal costs was attributable to the growth in employee costs associated with increases in the number of personnel, including an increase in stock-based compensation expense, driven by the growth of our commercial organization, which included establishing certain sales, marketing, and commercialization functions. The increase in consulting and professional services was also primarily attributable to commercial readiness activities as we expand the capabilities of the organization.
Net Loss Attributable to Common Stockholders: SpringWorks reported a net loss of $73.4 million, or $1.18 per share, for the first quarter of 2023. This compares to a net loss of $61.8 million, or $1.26 per share, for the comparable period of 2022.
Cash Position: Cash, cash equivalents and marketable securities were $528.1 million as of March 31, 2023.