SWTX SpringWorks Therapeutics Inc.

78
-8.95  -10%
Previous Close 86.95
Open 85.27
52 Week Low 19.5
52 Week High 96.48
Market Cap $3,820,137,594
Shares 48,976,123
Float 15,460,295
Enterprise Value $3,919,594,687
Volume 691,886
Av. Daily Volume 326,313
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Upcoming Catalysts

Drug Stage Catalyst Date
Mirdametinib
Neurofibromas
Phase 2b
Phase 2b
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Nirogacestat and Belantamab
Multiple Myeloma
Phase 1b
Phase 1b
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BGB-3245
Solid tumors
Phase 1/2
Phase 1/2
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Mirdametinib and lifirafenib
Solid tumors
Phase 1b
Phase 1b
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Nirogacestat (DeFi)
Desmoid tumors
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
ALLO-715 with nirogacestat
Multiple myeloma
Phase 1
Phase 1
Phase 1 enrollment has been initiated - February 25, 2021.
PBCAR269A
Multiple Myeloma
Phase 1/2
Phase 1/2
Phase 1/2a trial to commence 1H 2021.
Nirogacestat
Desmoid tumors - children
Phase 2
Phase 2
Phase 2 trial commenced recruitment in September 2020.

Latest News

  1. - 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 -

    Allogene- and Janssen-Sponsored Phase 1 Trials Evaluating Nirogacestat in Combination with BCMA Therapies Have Initiated -

    - Continued to Strengthen Nirogacestat Patent Portfolio -

    - Multiple Data Readouts Expected in 2021 Across Pipeline, Including Topline Data from Phase 3 DeFi Trial in Desmoid Tumors and Initial Nirogacestat BCMA Combination Data -

    - Ended 2020 with $561.8 Million in Cash, Cash Equivalents and Marketable Securities -

    STAMFORD, Conn., Feb. 25, 2021 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a clinical-stage biopharmaceutical…

    - 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 -



    Allogene- and Janssen-Sponsored Phase 1 Trials Evaluating Nirogacestat in Combination with BCMA Therapies Have Initiated -

    - Continued to Strengthen Nirogacestat Patent Portfolio -

    - Multiple Data Readouts Expected in 2021 Across Pipeline, Including Topline Data from Phase 3 DeFi Trial in Desmoid Tumors and Initial Nirogacestat BCMA Combination Data -

    - Ended 2020 with $561.8 Million in Cash, Cash Equivalents and Marketable Securities -

    STAMFORD, Conn., Feb. 25, 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 fourth quarter and full-year financial results for the period ended December 31, 2020 and provided an update on recent company developments.

    "2020 was a year characterized by strong performance for SpringWorks as we advanced our diversified targeted oncology portfolio, which currently spans 10 development programs across our three core focus areas: late-stage rare oncology, BCMA combinations in multiple myeloma and biomarker-defined metastatic solid tumors," said Saqib Islam, Chief Executive Officer of SpringWorks. "Our clinical execution has set the stage for multiple important data readouts in 2021, including the interim ReNeu data announced this morning and topline data from our Phase 3 DeFi trial later this year, and our business development efforts have allowed us to pursue additional combination therapy programs, continuing to grow our portfolio of opportunities across a broad range of potentially high-value and high-unmet need oncology patient settings. We look forward to reporting on our 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 AEs reported. SpringWorks reported that the ReNeu trial has reached approximately 70% of its final enrollment target of 100 patients and the Company expects to complete enrollment of the ReNeu 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.
    • 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 a Phase 1b trial sponsored by GSK evaluating nirogacestat in combination with BLENREP (belantamab mafodotin-blmf), GSK's anti-B-cell maturation antigen (BCMA) antibody-drug conjugate, in adult patients with relapsed or refractory multiple myeloma. Initial clinical data from this study are expected in 2021.
    • Two collaborator-sponsored Phase 1 studies were initiated evaluating nirogacestat in combination with BCMA therapies: nirogacestat + Allogene's ALLO-715 and nirogacestat + Janssen's teclistamab. SpringWorks also expects that two additional collaborator-sponsored trials will initiate in the first half of 2021, as previously disclosed: nirogacestat + Pfizer's elranatamab (PF‐06863135) and nirogacestat + Precision's PBCAR269A.

    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. BeiGene is sponsoring this trial and SpringWorks and BeiGene expect to report initial clinical data in 2021.
    • 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.
    • In December 2020, SpringWorks entered into a research collaboration agreement with Dr. Tatu Pantsar and Dr. Antti Poso at the University of Eastern Finland to conduct novel computational biology research to characterize the effector protein dynamics of different RAS mutations. The objective of the collaboration is to understand the biological consequences of KRAS-effector protein interactions and downstream oncogenic signaling with the goal of guiding patient selection strategies and exploring novel targets for future targeted therapy development.

    General Corporate

    • In February 2021, a Notice of Allowance was received from the United States Patent and Trademark Office for Patent Application No. 16/886,622 (the ‘622 application) with composition of matter claims covering several polymorphic forms of nirogacestat, including the polymorphic form that is currently in clinical development, which is also covered by U.S. Patent 10,590,087 (the ‘087 patent, issued in March 2020). Pursuant to an existing worldwide license agreement with Pfizer, SpringWorks has exclusive rights to the patent issuing from the ‘622 application. The patent granting from the ‘622 application, as well as the ‘087 patent, will both expire in August 2039.
    • In October 2020, SpringWorks completed a follow-on public offering that raised $269.5 million in net proceeds, which included the underwriters' full exercise of their option to purchase additional shares of common stock.
    • In October 2020, SpringWorks and Jazz Pharmaceuticals entered into an asset purchase and exclusive license agreement under which Jazz acquired SpringWorks' fatty acid amide hydrolase (FAAH) inhibitor program. Under the terms of the agreement, Jazz made an upfront payment of $35 million to SpringWorks, with potential future milestone payments of up to $375 million payable to SpringWorks based upon the achievement of certain clinical development, regulatory and commercial milestones. In addition, SpringWorks will receive incremental tiered royalties on future net sales of JZP-150 (formerly PF-04457845) in the mid- to high-single digit percentages.

    Fourth Quarter and Full Year 2020 Financial Results

    • Revenue: Revenue of $35.0 million for the fourth quarter and year ended December 31, 2020 was attributable to the nonrefundable upfront payment from Jazz in October 2020, related to the asset purchase and exclusive license agreement between SpringWorks and Jazz.
    • Research and Development (R&D) Expenses: R&D expenses were $15.3 million and $51.9 million for the fourth quarter and year-to-date periods, respectively, compared to $12.2 million and $42.5 million for the comparable periods of 2019. 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, including non-cash share-based compensation expenses, and increases in external costs related to drug manufacturing and clinical trial costs.
    • General and Administrative (G&A) Expenses: G&A expenses were $8.5 million and $29.5 million for the fourth quarter and year-to-date periods, respectively, compared to $5.2 million and $16.7 million for the comparable periods of 2019. 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, including 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 income of $11.3 million, or $0.24 per share, for the fourth quarter, and a net loss of $45.6 million, or $1.05 loss per share, for the year ended December 31, 2020. This compares to net losses of $16.2 million, or $0.39 loss per share, and $50.6 million, or $3.81 loss per share, for the comparable periods of 2019, respectively.
    • Cash Position: Cash, cash equivalents and marketable securities were $561.8 million as of December 31, 2020. This includes the net proceeds of $269.5 million from the Company's follow-on public offering completed in October 2020, and the $35.0 million upfront payment from Jazz Pharmaceuticals in October 2020, related to the asset purchase and exclusive license agreement between SpringWorks and Jazz.

    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 completion of SpringWorks' clinical trials or third-party clinical trials of its product candidates, 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.

    Consolidated Statements of Operations

    (Unaudited)

            
      Year Ended December 31, 
    (in thousands, except share, unit, per-unit and per-share data)    2020  2019     2018 
              
    Licensing revenue $35,000  $  $ 
    Operating expenses:         
    Research and development  51,859   42,545   9,898 
    General and administrative  29,465   16,694   8,593 
    Total operating expenses  81,324   59,239   18,491 
    Loss from operations  (46,324)  (59,239)  (18,491)
    Other income:         
    Other income  25       
    Interest income, net  1,330   3,547   678 
    Total other income  1,355   3,547   678 
    Equity investment loss  (605)  (2,614)   
    Net loss $(45,574) $(58,306) $(17,813)
    Reconciliation of net loss to net loss attributable to common stockholders and unit holders:         
    Net loss $(45,574) $(58,306) $(17,813)
    Net gain attributable to extinguishment of Series A convertible preferred and Junior Series A convertible preferred units     7,729    
    Net loss attributable to common stockholders and unit holders, basic and diluted $(45,574) $(50,577) $(17,813)
    Net loss per unit, basic and diluted $  $  $(52.24)
    Net loss per share, basic and diluted $(1.05) $(3.81) $ 
    Weighted average common units outstanding, basic and diluted        341,014 
    Weighted average common shares outstanding, basic and diluted  43,300,063   13,274,836    





    SpringWorks Therapeutics, Inc.


    Selected Balance Sheet Data

    (Unaudited)

      As of December 31,
    (in thousands)  2020    2019 
           
    Cash, cash equivalents and marketable securities $561,820  $ 327,652 
    Working Capital (1)  495,788    319,391 
    Total Assets  576,191    334,831 
    Total liabilities  19,133    12,759 
    Accumulated deficit  (118,603)   (73,029)
    Total stockholders' (deficit) equity  557,058    322,072 

    (1) We define working capital as current assets less current liabilities.

    Contact:

    Kim Diamond

    Vice President, Communications and Investor Relations

    Phone: 203-561-1646

    Email:



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  2. - Interim Data Reported from First 20 Adult Patients Enrolled with January 22, 2021 Data Cutoff -

    - 10/20 Patients (50%) Had Achieved an Objective Response by Blinded Independent Central Review (BICR) and 16/20 (80%) Remain on Study -

    - Mirdametinib Continues to Show a Potentially Differentiated Safety and Tolerability Profile -

    - Trial is Approximately 70% Enrolled and With Full Enrollment Expected in 2H2021 -

    - Conference Call and Webcast Scheduled for Today at 8:30 a.m. Eastern Time -

    STAMFORD, Conn., Feb. 25, 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…

    - Interim Data Reported from First 20 Adult Patients Enrolled with January 22, 2021 Data Cutoff -

    - 10/20 Patients (50%) Had Achieved an Objective Response by Blinded Independent Central Review (BICR) and 16/20 (80%) Remain on Study -

    - Mirdametinib Continues to Show a Potentially Differentiated Safety and Tolerability Profile -

    - Trial is Approximately 70% Enrolled and With Full Enrollment Expected in 2H2021 -

    - Conference Call and Webcast Scheduled for Today at 8:30 a.m. Eastern Time -

    STAMFORD, Conn., Feb. 25, 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 interim data from the first 20 adult patients enrolled in the ongoing Phase 2b ReNeu trial evaluating mirdametinib, an investigational MEK inhibitor, in adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN). As of the January 22nd data cutoff date, 10/20 (50%) of these patients had achieved an objective response, as assessed by blinded independent central review (BICR), 16/20 (80%) remained on study, and the median time on treatment was 10.1 cycles (approximately 10 months). Mirdametinib was also generally well tolerated, with the majority of treatment related adverse events (TRAE) being Grade 1 or 2 and only one Grade 3 TRAE; there have been no Grade 4 or 5 adverse events (AE). SpringWorks also provided an update on the enrollment status of ReNeu, highlighting that the trial has reached approximately 70% of its target enrollment of 100 patients and that full enrollment is expected in the second half of 2021.

    "We are very encouraged by these emerging data from our ongoing ReNeu trial, as they reaffirm our belief that mirdametinib has the potential to be a best-in-class treatment for patients with NF1-PN," said Saqib Islam, Chief Executive Officer of SpringWorks. "The robust response rate, which was assessed by blinded independent central review, and the very encouraging tolerability profile observed in these interim data are particularly compelling given the unmet need among NF1-PN patients for a therapy that can provide durable efficacy while maintaining a safety profile that is suitable for long-term dosing. We look forward to completing enrollment in the ReNeu trial in the second half of this year and sharing additional data from the study at a future medical conference in 2021."

    Interim Phase 2b Data from ReNeu Trial:

    The interim Phase 2b ReNeu data set for the first 20 adult patients enrolled utilized a January 22, 2021 data cutoff. Objective responses were defined as a ≥ 20% reduction in target tumor volume measured by MRI and were assessed by BICR. Patients received mirdametinib at a dose of 2 mg/m2 twice daily (maximum dose: 4 mg twice daily) without regard to food on a three weeks-on, one week-off intermittent schedule, with patients being allowed to stay on treatment for up to 24 cycles (approximately two years). The median time on treatment for the 20 adult patients evaluated for this analysis was 10.1 cycles (approximately 10 months), with an initial efficacy assessment performed following cycle five and then every four cycles thereafter.

    The preliminary efficacy and safety analysis showed:

    • 10/20 (50%) of patients had achieved an objective response by BICR.
    • For seven of the 10 patients who achieved an initial objective response, subsequent scheduled scans were available, and six of these seven patients had confirmed responses.
    • 16/20 (80%) of these patients remain on study and only one patient required a dose reduction due to an AE. Reasons for discontinuation included one each of progressive disease, participant decision, AE (Grade 1 diarrhea), and a patient being unable to undergo required MRI imaging due to a titanium rod implant from non-treatment-related worsening of scoliosis.
    • A generally well-tolerated safety profile. The majority of TRAEs were Grade 1 or 2 with only one Grade 3 TRAE reported. No Grade 4 or 5 AEs have been reported. The most common TRAEs were rash, nausea and diarrhea.

    Conference Call and Webcast:

    SpringWorks will host a conference call and webcast today, Thursday, February 25, 2021, at 8:30 a.m. Eastern Time to discuss the ReNeu trial data and program update. Participants can listen to the call by dialing +1 (800) 708-4539 (domestic) or +1 (847) 619-6396 (international) and providing the confirmation number 50110177. A live webcast presentation can be accessed through the "Investors & Media" section of the Company's website at https://ir.springworkstx.com/. A replay of the webcast will be available on the SpringWorks website for a limited time following the event.

    About the ReNeu Trial

    The ReNeu trial is a multi-center, open-label Phase 2b trial evaluating the efficacy, safety, and tolerability of mirdametinib in patients two years of age and older with an inoperable NF1-associated PN causing significant morbidity. The study will enroll approximately 100 patients in the United States. Patients receive mirdametinib at a dose of 2 mg/m2 twice daily (maximum dose of 4 mg twice daily, calculated based on body surface area) without regard to food. Mirdametinib is administered in a three-weeks on, one-week off dosing schedule.

    The primary endpoint is objective response rate, defined as ≥ 20% reduction in target tumor volume as measured by MRI and assessed by BICR. Secondary endpoints include safety and tolerability measures, duration of response, and changes from baseline in patient reported outcomes.

    More information about the ReNeu trial is available at www.clinicaltrials.gov under the identifier NCT03962543.

    About NF1-PN

    Neurofibromatosis type 1 (NF1) is a rare genetic disorder that arises from mutations in the NF1 gene, which encodes for neurofibromin, a key suppressor of the MAPK pathway.1,2 NF1 is the most common form of neurofibromatosis, with an estimated global birth incidence of approximately 1 in 3,000 individuals, and approximately 100,000 patients living with NF1 in the United States.3,4 The clinical course of NF1 is heterogeneous and manifests in a variety of symptoms across numerous organ systems, including abnormal pigmentation, skeletal deformities, tumor growth and neurological complications, such as cognitive impairment.5 Patients with NF1 have an eight to 15-year mean reduction in their life expectancy compared to the general population.2

    NF1 patients have approximately a 30-50% lifetime risk of developing plexiform neurofibromas, or PN, which are tumors that grow in an infiltrative pattern along the peripheral nerve sheath and that can cause severe disfigurement, pain and functional impairment; in rare cases, NF1-PN may be fatal.3,4,6 Patients with NF1 can also experience additional manifestations, including neurocognitive deficits and developmental delays.4 NF1-PNs are most often diagnosed in the first two decades of life.3 These tumors can be aggressive and are associated with clinically significant morbidities; typically, they grow more rapidly during childhood.7,8

    Surgical removal of these tumors is challenging due to the infiltrative tumor growth pattern along nerves and can lead to permanent nerve damage and disfigurement.9 MEK inhibitors have emerged as a validated class of treatment for NF1-PN.4

    About Mirdametinib

    Mirdametinib is an oral small molecule designed to inhibit MEK1 and MEK2. MEK proteins occupy a pivotal position in the MAPK pathway, a key signaling network that regulates cell growth and survival, and that plays a central role in multiple oncology and rare disease indications.

    Mirdametinib has been evaluated in several Phase 1 and Phase 2 clinical trials, with over 200 subjects having been exposed to treatment. A Phase 2 trial was conducted by the Neurofibromatosis Clinical Trial Consortium and evaluated mirdametinib in 19 adolescent and adult patients with inoperable and symptomatic or growing plexiform neurofibromas. Patients received an oral dose of 2 mg/m2 BID with a maximum dose of 4 mg BID on a four-week cycle of three weeks-on, one week-off. Eight patients (42%) achieved an objective response by cycle 12, prospectively defined as volumetric reduction in their target PN of at least 20%. Mirdametinib was generally well-tolerated in this trial. The most commonly reported treatment-emergent Grade 2 or higher AEs were acneiform rash, fatigue and nausea.  

    In addition to the Phase 2b monotherapy trial in NF1- PN, and given the critical role that the MAPK pathway plays in the growth and proliferation of a large number of tumor types, SpringWorks is also pursuing mirdametinib in combination with other rational anti-cancer agents across a range of solid tumors.

    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, please 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, the interim data of the ReNeu clinical trial, including its interim primary efficacy, safety and tolerability data, 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 presentation 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 presentation, including, without limitation, risks relating to: (i) the success and timing of our ongoing DeFi and ReNeu 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 product development activities and initiating clinical trials, (iv) the success and timing of our collaboration partners' ongoing and planned clinical trials, (v) our ability to obtain and maintain regulatory approval of any of our product candidates, (vi) our plans to research, discover and develop additional product candidates, (vii) our ability to enter into collaborations for the development of new product candidates, (viii) our ability to establish manufacturing capabilities, and our and our collaboration partners' abilities to manufacture our product candidates and scale production, (ix) our ability to meet any specific milestones set forth herein, and (x) 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" section(s) of our filings with the Securities and Exchange Commission.

    SpringWorks Media/Investor Contact:

    Kim Diamond

    Vice President, Communications and Investor Relations

    203-561-1646

    References

    1. Yap YS, McPherson JR, Ong CK, et al. The NF1 gene revisited - from bench to bedside. Oncotarget. 2014;5(15):5873-5892. doi:10.18632/oncotarget.2194.
    2. Rasmussen S, Friedman J. NF1 Gene and Neurofibromatosis 1. Am J Epidemiol. 2000;151(1):33-40. doi:10.1093/oxfordjournals.aje.a010118.
    3. Prada C, Rangwala F, Martin L et al. Pediatric Plexiform Neurofibromas: Impact on Morbidity and Mortality in Neurofibromatosis Type 1. J Pediatr. 2012;160(3):461-467. doi:10.1016/j.jpeds.2011.08.051.
    4. Ferner R. Neurofibromatosis 1 and neurofibromatosis 2: a twenty first century perspective. The Lancet Neurology. 2007;6(4):340-351. doi:10.1016/s1474-4422(07)70075-3.
    5. Weiss BD, Wolters PL, Plotkin SR, et al. NF106: A Neurofibromatosis Clinical Trials Consortium Phase II Trial of the MEK Inhibitor Mirdametinib (PD-0325901) in Adolescents and Adults With NF1-Related Plexiform Neurofibromas. Journal of Clinical Oncology. 2021;JCO.20.02220.doi.org/10. 1200/JCO.20.02220.
    6. Hirbe A, Gutmann D. Neurofibromatosis type 1: a multidisciplinary approach to care. The Lancet Neurology. 2014;13(8):834-843. doi:10.1016/s1474-4422(14)70063-8.
    7. Gross A, Singh G, Akshintala S et al. Association of plexiform neurofibroma volume changes and development of clinical morbidities in neurofibromatosis 1. Neuro Oncol. 2018;20(12):1643-1651. doi:10.1093/neuonc/noy067.
    8. Nguyen R, Dombi E, Widemann B et al. Growth dynamics of plexiform neurofibromas: a retrospective cohort study of 201 patients with neurofibromatosis 1. Orphanet J Rare Dis. 2012;7(1):75. doi:10.1186/1750-1172-7-75.
    9. Needle M, Cnaan A, Dattilo J et al. Prognostic signs in the surgical management of plexiform neurofibroma: The Children's Hospital of Philadelphia experience, 1974-1994. J Pediatr. 1997;131(5):678-682. doi:10.1016/s0022-3476(97)70092-1.


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  3. STAMFORD, Conn., Feb. 22, 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 the following upcoming investor conferences:

    • Cowen 41st Annual Health Care Conference on Wednesday, March 3 from 11:00-11:30 a.m. ET
    • H.C. Wainwright Global Life Sciences Conference on Tuesday, March 9 (presentation available on-demand)
    • Barclays Global Healthcare Conference on Wednesday, March 10 from 3:35-4:00 p.m. ET

    Webcasts of these events can be accessed by visiting the "Events & Presentations" page within the Investors & Media section of the SpringWorks…

    STAMFORD, Conn., Feb. 22, 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 the following upcoming investor conferences:

    • Cowen 41st Annual Health Care Conference on Wednesday, March 3 from 11:00-11:30 a.m. ET
    • H.C. Wainwright Global Life Sciences Conference on Tuesday, March 9 (presentation available on-demand)
    • Barclays Global Healthcare Conference on Wednesday, March 10 from 3:35-4:00 p.m. ET



    Webcasts of these events can be accessed by visiting the "Events & Presentations" page within the Investors & Media section of the SpringWorks website at https://ir.springworkstx.com. A replay of the webcasts will be available on the Company's website for a limited time following the conferences.

    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 Diamond

    Phone: 203-561-1646

    Email:





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  4. STAMFORD, Conn., Feb. 04, 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 Saqib Islam, Chief Executive Officer, will participate in a fireside chat at the Guggenheim Healthcare Talks 2021 Oncology Day on Friday, February 12, 2021 at 3:00 p.m. Eastern Standard Time.

    To access the live webcast of SpringWorks' presentation, 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…

    STAMFORD, Conn., Feb. 04, 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 Saqib Islam, Chief Executive Officer, will participate in a fireside chat at the Guggenheim Healthcare Talks 2021 Oncology Day on Friday, February 12, 2021 at 3:00 p.m. Eastern Standard Time.

    To access the live webcast of SpringWorks' presentation, 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 conference.

    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 Diamond

    Phone: 203-561-1646

    Email:



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  5. STAMFORD, Conn., Jan. 05, 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 Saqib Islam, Chief Executive Officer, will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 7:30 a.m. Eastern Standard Time.

    To access the live webcast of SpringWorks' presentation, 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 conference.

    About SpringWorks

    STAMFORD, Conn., Jan. 05, 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 Saqib Islam, Chief Executive Officer, will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 7:30 a.m. Eastern Standard Time.

    To access the live webcast of SpringWorks' presentation, 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 conference.

    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 Diamond

    Phone: 203-561-1646

    Email:



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