On November 3, 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 third quarter financial results for the period ended September 30, 2022 and provided an update on recent company developments (Press release, SpringWorks Therapeutics, NOV 3, 2022, View Source [SID1234622989]).
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"In the third quarter of 2022, we were very pleased to present positive data from our Phase 3 DeFi trial of nirogacestat in patients with desmoid tumors during a Presidential Symposium at ESMO (Free ESMO Whitepaper), expand our collaboration with GSK to enable further development of nirogacestat in combination with belamaf in patients with multiple myeloma across lines of therapy, and initiate a new Phase 2 trial of nirogacestat in patients with ovarian granulosa cell tumors," said Saqib Islam, Chief Executive Officer of SpringWorks. "In addition, we significantly strengthened our financial position, providing us with sufficient runway into 2026 to continue executing on our mission to make a profound impact on the lives of patients with devastating cancers. We look forward to completing our NDA filing package for nirogacestat in desmoid tumors to potentially enable our first product launch in 2023 and to further advancing our diversified targeted oncology pipeline."
Recent Business Highlights and Upcoming Milestones
Rare Oncology
In September 2022, SpringWorks presented positive data from the Phase 3 DeFi trial of nirogacestat in adult patients with progressing desmoid tumors in a late-breaking oral presentation during a Presidential Symposium at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022; the data were presented by Bernd Kasper, M.D., Ph.D., University of Heidelberg, Mannheim Cancer Center, Mannheim, Germany. The DeFi trial met its primary endpoint of improving progression-free survival (PFS), as assessed by blinded independent central review, demonstrating a statistically significant improvement for nirogacestat over placebo, with a 71% reduction in the risk of disease progression (hazard ratio (HR) = 0.29 (95% CI: 0.15, 0.55); p< 0.001). In addition, all key secondary endpoints achieved statistical significance, including objective response rate and improvements in six different patient-reported outcomes; notably, a significant reduction in pain severity compared with placebo (p<0.001) was observed. Nirogacestat also exhibited a manageable safety profile in the DeFi trial. These data will be highlighted by Mrinal Gounder, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center in an encore presentation at the Connective Tissue Oncology Society (CTOS) 2022 Annual Meeting in Vancouver, BC, Canada on Saturday, November 19, at 1:30pm PT (4:30pm ET). In this oral session, Dr. Gounder will also present an assessment of the GODDESS© (GOunder/Desmoid Tumor Research Foundation DEsmoid Symptom/Impact Scale) tool for evaluating changes in disease-specific symptom severity and impact in desmoid tumors as assessed in the DeFi trial. SpringWorks plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2022 for review under the FDA’s Real-Time Oncology Review (RTOR) program.
In September 2022, the first patient was dosed in a Phase 2 trial evaluating nirogacestat as a monotherapy in patients with recurrent ovarian granulosa cell tumors.
Dosing is ongoing in the Phase 2b ReNeu trial evaluating mirdametinib in adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN). As previously announced, this trial is fully enrolled. SpringWorks expects to provide an update on the ReNeu trial in the first half of 2023.
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 industry leaders.
In September 2022, SpringWorks announced that it entered into an expanded global, non-exclusive license and collaboration agreement with GSK plc (GSK) for nirogacestat in combination with belantamab mafodotin (belamaf) in patients with multiple myeloma. The expanded agreement includes the potential for continued development and commercialization of the combination of belamaf and nirogacestat in earlier lines of treatment, including in newly diagnosed multiple myeloma patients. In connection with the expanded agreement, SpringWorks received a $75 million equity investment from GSK and is also eligible to receive up to $550 million in development and commercial milestones. SpringWorks continues to retain full commercial rights to nirogacestat. Additionally, SpringWorks will supply nirogacestat for future belamaf clinical trials and will seek to make nirogacestat commercially available in markets where approval has been sought by GSK for a combination with belamaf. GSK continues to fund all development costs, except for those related to the supply of nirogacestat and certain expenses related to intellectual property rights.
A Phase 2 randomized DREAMM-5 study is ongoing evaluating low-dose belamaf in combination with nirogacestat in patients with relapsed or refractory multiple myeloma. In addition, two new sub-studies evaluating belamaf plus nirogacestat in combination with standard of care agents in patients with relapsed or refractory multiple myeloma have been initiated and are dosing patients: sub-study 6 (belamaf plus nirogacestat plus lenalidomide plus dexamethasone) and sub-study 7 (belamaf plus nirogacestat plus pomalidomide plus dexamethasone).
In September 2022, SpringWorks entered into a collaborative study agreement with GSK and Memorial Sloan Kettering Cancer Center (MSKCC) to conduct a Phase 1b study to evaluate the combination of belamaf and nirogacestat in patients with relapsed/refractory multiple myeloma. Malin Hultcrantz, M.D., Ph.D. will serve as the principal investigator of the study.
Biomarker-Defined Metastatic Solid Tumors
The BeiGene-sponsored 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 is ongoing. SpringWorks expects data from this trial to be presented at a medical conference in the first half of 2023.
The Phase 1 trial evaluating BGB-3245, a selective RAF dimer inhibitor being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene, in adult patients with RAF mutant solid tumors is ongoing. SpringWorks expects data from this trial to be presented at a medical conference in the first half of 2023. BGB-3245 monotherapy is advancing into cohort expansion studies and SpringWorks expects to begin dosing a Phase 1/2a combination study of BGB-3245 and mirdametinib in the first half of 2023.
General Corporate
In July 2022, SpringWorks appointed Carlos Albán to its Board of Directors. Mr. Albán previously served as Vice Chairman and Chief Commercial Officer at AbbVie until his retirement last year and brings over 30 years of experience in global commercial strategy and operations.
In August 2022, SpringWorks sold approximately 2.25 million shares of its common stock as pursuant to its at-the-market (ATM) offering program, raising approximately $67.8 million in net proceeds. In September 2022, SpringWorks sold approximately 8.65 million shares of its common stock to a select group of institutional investors in a private placement transaction, raising approximately $216.8 million in net proceeds.
Third Quarter 2022 Financial Results
Research and Development (R&D) Expenses: R&D expenses were $36.1 million for the third quarter, compared to $22.9 million for the comparable period of 2021. The increase in R&D expense was primarily attributable to an increase in external costs related to drug manufacturing, clinical trial and other research, and 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 $35.7 million for the third quarter, compared to $18.0 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 continue to expand our operations to support the organization, and an increase in information technology costs and consulting and professional services, including legal, regulatory and compliance, as we continue to build new capabilities, including commercial.
Net Loss Attributable to Common Stockholders: SpringWorks reported a net loss of $72.4 million, or $1.37 per share, for the third quarter of 2022. This compares to a net loss of $41.0 million, or $0.84 per share, for the comparable period of 2021.
Cash Position: Cash, cash equivalents and marketable securities were $651.9 million as of September 30, 2022. This includes net proceeds of approximately $67.8 million received pursuant to sales under the Company’s ATM program, net proceeds of approximately $216.8 million from a private placement in September 2022, and proceeds from an equity investment of $75.0 million from GSK in September 2022 related to the expanded global, non-exclusive license and collaboration agreement between SpringWorks and GSK.