SpringWorks Therapeutics, Inc. (SWTX)
75.29 0.00 (0.00%)
After hours: 4:00PM EDT
Chart Events
Performance Outlook
| Previous Close | 72.84 |
| Open | 73.22 |
| Bid | 55.00 x 800 |
| Ask | 84.99 x 900 |
| Day's Range | 72.98 - 77.37 |
| 52 Week Range | 25.37 - 96.48 |
| Volume | 236,743 |
| Avg. Volume | 384,638 |
| Market Cap | 3.691B |
| Beta (5Y Monthly) | N/A |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -13.84 |
| Earnings Date | Feb 25, 2021 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 110.25 |
- GlobeNewswire
SpringWorks Therapeutics to Present at the Cowen 2nd Annual Oncology Innovation Summit
STAMFORD, Conn., May 14, 2021 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that management will participate in a Fireside Chat at the Cowen 2nd Annual Oncology Innovation Summit on Friday, May 21st at 10:00AM ET. To access the live webcast please visit the “Events & Presentations” page within the Investors & Media section of the company’s website at https://ir.springworkstx.com. A replay of the webcast will be available on SpringWorks’ website for a limited time following the summit. About SpringWorks Therapeutics SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have 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 leaders to expand its portfolio. For more information, visit www.springworkstx.com and follow @SpringWorksTx on Twitter and LinkedIn. Contact:Kim DiamondPhone: 203-561-1646Email: kdiamond@springworkstx.com
- GlobeNewswire
SpringWorks Therapeutics Appoints Dr. Mike Burgess as Head of Research and Development
STAMFORD, Conn., May 10, 2021 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, announced today that Mike Burgess, M.B.Ch.B., Ph.D. has been appointed Head of Research and Development (R&D). Dr. Burgess is a physician-scientist with clinical experience in pediatrics and pediatric oncology and over 20 years of pharmaceutical industry R&D leadership experience across several therapeutic areas, including oncology. Dr. Burgess will lead the R&D organization as the company continues to advance its diversified targeted oncology pipeline and to expand its portfolio with additional oncology programs. He succeeds Stephen Squinto, Ph.D., who served as Acting Head of R&D since the company’s launch in 2017. Dr. Squinto will continue to serve on the SpringWorks Board of Directors. “At SpringWorks, we are driven to execute on our ambitious plans to provide oncology patients with transformative new therapies, and our portfolio of programs is continuing to mature and expand in service of that goal,” said Saqib Islam, Chief Executive Officer. “Mike is a strong R&D leader with deep experience in oncology and a track record of excellence across all stages of preclinical and clinical development, culminating in multiple approvals of new cancer medicines under his leadership. I am delighted to welcome Mike to SpringWorks and look forward to the scientific, clinical and leadership excellence he will bring to our already strong team as we continue to build a world-class oncology company on behalf of a broad range of cancer patients.” “I am excited to be joining SpringWorks at such a seminal time as the company advances a diversified pipeline that is maturing across rare oncology indications, multiple myeloma and metastatic solid tumors,” said Dr. Burgess. “There is a significant opportunity ahead of us to accelerate and expand these efforts, including through the buildout of additional preclinical and clinical R&D capabilities within the organization. I look forward to working with the team to further our mission of developing life-changing medicines for people with cancer.” Dr. Burgess brings to SpringWorks over 20 years of experience building and leading R&D teams in oncology. He joins SpringWorks from Turnstone Biologics, where he was President of R&D and led the buildout of a leading cancer immunotherapy R&D organization. Prior to Turnstone, Dr. Burgess led the strategy and execution of translational medicine, early-stage clinical trials and clinical pharmacology across all therapeutic areas, including oncology, at Bristol-Myers Squibb. Before that, he held several different senior leadership positions at Hoffmann La-Roche, including Acting Global Head of Roche Pharma Research and Early Development (pRED) and Senior Vice President and Global Head of Oncology Research and Early Development. Prior to Roche, Dr. Burgess was with Eli Lilly and Company, where he worked on early-stage oncology trials. Dr. Burgess received his medical degree (M.B.Ch.B.) and Ph.D. in molecular biology from the University of Bristol, UK and spent 10 years as a practicing physician in pediatrics and pediatric oncology. About SpringWorks Therapeutics SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have 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 leaders to expand its portfolio. For more information, visit www.springworkstx.com and follow @SpringWorksTx on Twitter and LinkedIn. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations, and financial conditions, including but not limited to current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our development plans, our preclinical and clinical results, and other future conditions. 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 emerge from time to time, and it is not possible to predict all risks and uncertainties. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking 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 SpringWorks’ clinical trials, (ii) the fact that interim data from a clinical study may not be predictive of the final results of such study or the results of other ongoing or future studies, (iii) the success and timing of our collaboration partners’ ongoing and planned clinical trials, (iv) our ability to obtain and maintain regulatory approval of any of our product candidates, (v) our plans to research, discover and develop additional product candidates, (vi) our ability to enter into collaborations for the development of new product candidates, (vii) our ability to establish manufacturing capabilities, and our and our collaboration partners’ abilities to manufacture our product candidates and scale production, (viii) our ability to meet any specific milestones set forth herein, and (ix) uncertainties and assumptions regarding the impact of the COVID-19 pandemic on SpringWorks’ business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. For further information regarding the risks, uncertainties and other factors that may cause differences between SpringWorks’ expectations and actual results, you should review the “Risk Factors” in Item 1A of Part I of SpringWorks’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as well as discussions of potential risks, uncertainties and other important factors in SpringWorks’ subsequent filings. Contact Kim DiamondVice President Communications and Investor RelationsPhone: 203-561-1646Email: kdiamond@springworkstx.com
- GlobeNewswire
SpringWorks Therapeutics Reports First Quarter 2021 Financial Results and Recent Business Highlights
– Reported Interim Data from Phase 2b ReNeu Trial of Mirdametinib in NF1-PN Demonstrating Encouraging Clinical Activity and Tolerability in the First 20 Adult Patients Enrolled – – Announced Achievement of First Patient Dosed in Allogene and Janssen Phase 1 Trials Evaluating Nirogacestat in Combination with BCMA Therapies – – Expanded Targeted Oncology Pipeline with Exclusive Worldwide License to TEAD Inhibitor Portfolio – STAMFORD, Conn., May 06, 2021 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported first quarter financial results for the period ended March 31, 2021 and provided an update on recent company developments. “In the first quarter of 2021 we continued to execute on our 10 clinical programs and grew our portfolio of opportunities aimed at serving a broad group of patients across our three distinct oncology segments: late-stage rare oncology, hematological cancers and biomarker-defined metastatic solid tumors,” said Saqib Islam, Chief Executive Officer of SpringWorks. “We are poised for multiple important data readouts this year, including topline data from our Phase 3 DeFi trial, initial clinical data from our BCMA combination trial of nirogacestat with GSK’s BLENREP in multiple myeloma and initial clinical data from our metastatic solid tumor trials being conducted in collaboration with BeiGene. I look forward to reporting on our continued progress throughout 2021.” Recent Business Highlights and Upcoming Milestones Late-Stage Rare Oncology In February 2021, SpringWorks reported interim data from the adult stratum of the ongoing potentially registrational Phase 2b ReNeu trial evaluating mirdametinib in pediatric and adult patients with NF1-associated plexiform neurofibromas. Of the first 20 adult patients enrolled, 50% had achieved an objective response, the primary endpoint of the study, as assessed by blinded independent central review, and 16 of these 20 patients (80%) remained on study as of the January 22, 2021 data cutoff. In addition, mirdametinib was generally well tolerated, with the majority of treatment-related adverse events (TRAE) being Grade 1 or 2 and only one Grade 3 TRAE reported; there have been no Grade 4 or 5 TRAEs reported. The Company expects to report additional clinical data from the ReNeu trial at a medical conference this year and to complete enrollment of the trial in the second half of 2021.SpringWorks expects to report topline data from the Phase 3 DeFi trial in the second half of 2021, as previously disclosed.Recruitment is ongoing in a Phase 2 study sponsored by the Children’s Oncology Group evaluating nirogacestat in pediatric patients with desmoid tumors. B-cell Maturation Antigen (BCMA) Combinations in Multiple Myeloma Enrollment is ongoing in three Phase 1 studies evaluating nirogacestat in combination with anti-B-cell maturation antigen (BCMA) therapies in adult patients with relapsed or refractory multiple myeloma: a Phase 1b trial sponsored by GSK evaluating nirogacestat in combination with BLENREP (belantamab mafodotin-blmf), a Phase 1 study sponsored by Allogene evaluating nirogacestat in combination with ALLO-715, and a Phase 1 study sponsored by Janssen Research & Development, LLC (Janssen) evaluating nirogacestat in combination with teclistamab. Initial data from the GSK-sponsored study are expected in 2021. SpringWorks also expects that two additional collaborator-sponsored trials will initiate in the first half of 2021, as previously disclosed: nirogacestat + Pfizer’s elranatamab and nirogacestat + Precision Biosciences’ PBCAR269A.In March 2021, SpringWorks entered into a services agreement with ONCOtracker, Inc., a leading innovation center for novel cancer treatment and testing with a focus on the diagnosis and treatment of multiple myeloma, other B-cell malignancies, and related disorders, to explore the effect of nirogacestat on soluble BCMA release and membrane-bound BCMA receptor density in primary bone marrow samples collected from multiple myeloma patients. This research is intended to further confirm nirogacestat’s ability to potentiate BCMA by using ex vivo patient-derived models with associated longitudinal clinical characterization for each sample. Biomarker-Defined Metastatic Solid Tumors In May 2021, SpringWorks entered into an exclusive worldwide license agreement with Katholieke Universiteit Leuven (KU Leuven) and the Flanders Institute for Biotechnology (VIB) for the in-license of a portfolio of novel small molecule inhibitors of the TEA Domain (TEAD) family of transcription factors, designed for the potential treatment of biomarker-defined solid tumors driven by aberrant Hippo pathway signaling. The licensed portfolio includes advanced lead compounds and multiple backup compounds from diverse chemical series, which were discovered at KU Leuven’s Center for Drug Design and Discovery (CD3) in collaboration with Professor Georg Halder of the VIB-KU Leuven Center for Cancer Biology. SpringWorks expects to nominate a development candidate from this portfolio and move into IND-enabling studies in 2022.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. BeiGene is sponsoring this trial and SpringWorks and BeiGene expect to report initial clinical data in 2021, as previously disclosed.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 Phase 1 trial are expected in 2021, as previously disclosed.In March 2021, SpringWorks entered into a research collaboration agreement with Inserm Transfert, the private subsidiary of Inserm, acting as a delegatee of the French National Institute of Health and Medical Research (Inserm) to explore the ability of nirogacestat to delay the development of resistance to the EGFR inhibitor osimertinib in preclinical models of non-small cell lung cancer (NSCLC) driven by the EGFR C797S gatekeeper mutation. This research, which will be led by Antonio Maraver, Ph.D. at Montpellier Cancer Research Institute (IRCM U1194), is intended to build on previous in vivo work from Dr. Maraver’s lab demonstrating the potential for gamma secretase inhibition to enhance the activity of osimertinib in EGFR-driven models of NSCLC.1 General Corporate In March 2021, Bhavesh Ashar was appointed Chief Commercial Officer of SpringWorks. Mr. Ashar has more than 20 years of global pharmaceutical and biotechnology experience, most recently having served as Senior Vice President, General Manager of U.S. Oncology at Bayer Healthcare where he was responsible for a broad portfolio in prostate, liver, colorectal, GIST, hematologic and tumor-agnostic biomarker driven cancers. First Quarter 2021 Financial Results Research and Development (R&D) Expenses: R&D expenses were $17.4 million for the first quarter, compared to $9.7 million for the comparable period of 2020. The increases in R&D expenses were primarily attributable to an increase in external costs related to drug manufacturing and trial costs, and an increase in internal costs driven by the growth in employee costs associated with increases in the number of R&D personnel and an increase in stock-based compensation expense.General and Administrative (G&A) Expenses: G&A expenses were $12.4 million for the first quarter, compared to $6.4 million for the comparable period of 2020. The increases in G&A expenses were primarily attributable to the hiring of additional personnel in G&A functions supporting the growth of the organization, as well as an increase in stock-based compensation expense.Net Loss Attributable to Common Stockholders: SpringWorks reported net loss of $29.8 million, or $0.62 per share, for the first quarter of 2021. This compares to a net loss of $15.3 million, or $0.37 per share, for the comparable period of 2020.Cash Position: Cash, cash equivalents and marketable securities were $541.0 million as of March 31, 2021. 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. About SpringWorks Therapeutics SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have 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 leaders to expand its portfolio. For more information, visit www.springworkstx.com and follow @SpringWorksTx on Twitter and LinkedIn. SpringWorks uses its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the Company’s website in the ‘Investors & Media’ section. Accordingly, investors should monitor such portions of the SpringWorks website, in addition to following press releases, SEC filings and public conference calls and webcasts. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding SpringWorks’ clinical trials and its strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to SpringWorks’ financial results, the timing for initiation, progress and completion of SpringWorks’ clinical trials or third-party clinical trials of its product candidates, the timing for expected data readouts from partners and partners’ clinical trials, the fact that interim results from a clinical study may not be predictive of the final results of such study or the results of other ongoing or future studies, whether and when, if at all, SpringWorks’ product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, uncertainties and assumptions regarding the impact of the COVID-19 pandemic on SpringWorks’ business, operations, clinical trials involving its product candidates, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in SpringWorks’ SEC filings. SpringWorks cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. SpringWorks disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent SpringWorks’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. SpringWorks Therapeutics, Inc.Condensed Consolidated Statements of Operations(Unaudited) Three Months Ended March 31,(in thousands, except share and per-share data)2021 2020Operating expenses: Research and development$17,375 $9,727 General and administrative12,381 6,403 Total operating expenses29,756 16,130 Loss from operations(29,756) (16,130)Interest and other income: Other income3 — Interest income, net227 936 Total interest and other income230 936 Equity investment loss(261) (100)Net loss$(29,787) $(15,294) Net loss per share, basic and diluted$(0.62) $(0.37)Weighted average common shares outstanding, basic and diluted48,229,539 41,789,120 SpringWorks Therapeutics, Inc.Selected Balance Sheet Data(Unaudited) March 31, 2021 December 31, 2020(in thousands) Cash, cash equivalents and marketable securities$541,042 $561,820 Working Capital (1)462,785 495,788 Total assets554,588 576,191 Total liabilities19,891 19,133 Accumulated deficit(148,390) (118,603)Total stockholders’ equity534,697 557,058 (1)We define working capital as current assets less current liabilities. Contact:Kim DiamondVice President, Communications and Investor RelationsPhone: 203-561-1646Email: kdiamond@springworkstx.com References 1 Bousquet E, Quantin X, Pujol J, et al. Notch Inhibition Overcomes Resistance to Tyrosine Kinase Inhibitors Promoted by Gate-Keeper Mutations in EGFR-Driven Lung Adenocarcinoma. J Clin Invest. 2020;130(2):612-624. //doi.org/10.1172/JCI126896.
