On August 12, 2020 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 second quarter financial results for the period ended June 30, 2020 and provided an update on recent company developments (Press release, SpringWorks Therapeutics, AUG 12, 2020, View Source [SID1234563515]).
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"We continued to advance our six clinical programs during the second quarter of 2020, most notably completing enrollment in the Phase 3 DeFi trial of nirogacestat in patients with desmoid tumors and initiating, through our collaboration with GSK, the first Phase 1 trial evaluating nirogacestat in combination with a BCMA therapy for patients with multiple myeloma," said Saqib Islam, Chief Executive Officer of SpringWorks. "During the second half of the year, we will remain focused on executing against our objectives and believe we are well-positioned to progress our pipeline across our three distinct oncology focus areas of late-stage rare oncology, BCMA combinations in multiple myeloma and biomarker-defined metastatic solid tumors."
Recent Business Highlights
Achieved full enrollment in the Phase 3 DeFi trial evaluating nirogacestat in adult patients with progressing desmoid tumors.
Announced that the first patient was dosed in a Phase 1b trial evaluating nirogacestat in combination with BLENREP (belantamab mafodotin-blmf), GSK’s anti-B-cell maturation antigen (BCMA) antibody-drug conjugate, in patients with relapsed or refractory multiple myeloma.
Received a new patent (U.S. Patent No. 10,710,966 [the ‘966 patent]) with method of use claims covering the treatment of desmoid tumors with nirogacestat. Like the recently granted composition of matter patent covering the polymorphic form of nirogacestat that is currently in clinical development, this method of use patent expires in 2039 and further enhances the intellectual property position of nirogacestat. The ‘966 patent is assigned to Pfizer and SpringWorks has exclusive rights to it pursuant to an existing worldwide license with Pfizer.
Presented preclinical data from studies of mirdametinib in combination with BeiGene’s RAF dimer inhibitor, lifirafenib, at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II. Results demonstrated potent and synergistic activity in vitro and in vivo across a panel of cancer models harboring a variety of RAS mutations.
Expanded the ongoing Phase 1 trial of BGB-3245 to the United States and began dosing patients at Memorial Sloan Kettering Cancer Center. BGB-3245 is a selective RAF dimer inhibitor being developed by MapKure, LLC, a clinical-stage company that is jointly owned by SpringWorks and BeiGene, Ltd.
Continued to strengthen the Company’s Board of Directors with the appointment of Julie Hambleton, M.D., an experienced oncology drug developer and pharmaceutical executive.
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 the company 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’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 12, 2020 and refer to the Forward-Looking Statements section in this press release.
Second Quarter and Year to Date 2020 Financial Results
Research and Development (R&D) Expenses: R&D expenses were $12.9 million and $22.7 million for the second quarter and year-to-date periods, respectively, compared to $11.2 million and $19.6 million for the comparable periods of 2019, respectively. The increases in R&D expenses in 2020 were primarily attributable to growth in employee costs associated with increases in the number of R&D personnel, and an increase in non-cash share-based compensation expense.
General and Administrative (G&A) Expenses: G&A expenses were $6.9 million and $13.3 million for the second quarter and year-to-date periods, respectively, compared to $3.6 million and $6.9 million for the comparable periods of 2019, respectively. The increases in G&A expenses in 2020 were primarily attributable to growth in employee costs associated with increases in the number of G&A personnel supporting the growth of the organization, and an increase in non-cash share-based compensation expenses, as well as increases in expenses related to the expansion of business activities.
Net Loss Attributable to Common Stockholders: SpringWorks reported net losses of $19.9 million, or $0.47 loss per share, and $35.2 million, or $0.84 loss per share, for the second quarter and year-to-date periods ended June 30, 2020, respectively. This compares to net losses of $13.8 million, or $15.75 loss per share, and $17.5 million, or $22.47 loss per share, for the comparable periods of 2019, respectively.
Cash Position: Cash, cash equivalents and marketable securities were $291.2 million as of June 30, 2020.