– Topline Analysis from Phase 3 DeFi Trial Expected to be Triggered in the First Quarter of 2022; Topline Data Expected to be Reported During the First Half of 2022 –
– Expanded Collaboration with GlaxoSmithKline to Include Two New Sub-Studies Evaluating the Combination of Nirogacestat Plus BLENREP with Standard-of-Care Multiple Myeloma Therapies; Initial Clinical Data from Ongoing Study Expected Mid-Year –
– Further Advanced Broad, Non-Exclusive Strategy to Evaluate Nirogacestat as a Potential Cornerstone of BCMA Combination Therapy; Signed Seventh Clinical Collaboration and Currently Dosing Patients in Five Clinical Studies Across Modalities –
– Completed Enrollment in Phase 2b ReNeu Trial Evaluating Mirdametinib in Adult and Pediatric Patients with NF1-Associated Plexiform Neurofibromas –
– Expanded Targeted Oncology Pipeline with In-License of Portfolio of Next-Generation Mutation-Selective EGFR Inhibitors –
– Ended 2021 with $432.7 Million in Cash, Cash Equivalents and Marketable Securities –
STAMFORD, Conn., Feb. 24, 2022 (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 financial results for the fourth quarter and full-year periods ended December 31, 2021 and provided an update on recent company developments.
“2021 was another year of strong execution for SpringWorks as we advanced our targeted oncology portfolio and continued to build a fully-integrated biopharmaceutical company with capabilities spanning research, early and late-stage development, and commercial," said Saqib Islam, Chief Executive Officer of SpringWorks. “2022 is set up to be a meaningful year for us and the patients we are working to serve as we expect to share data across our pipeline, including topline data from the Phase 3 DeFi study and clinical data across our BCMA and biomarker-defined metastatic solid tumor programs. We believe we have a strong infrastructure that will allow us to continue to build upon the multiple opportunities we have created and drive our growth in 2022 and beyond.”
Recent Business Highlights and Upcoming Milestones
Rare Oncology
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 seven industry leaders.
Biomarker-Defined Metastatic Solid Tumors
Fourth Quarter and Full Year 2021 Financial Results
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 patients living with severe rare diseases and cancer. SpringWorks has a differentiated targeted oncology portfolio of small molecule product candidates and is advancing 17 development programs, including two potentially registrational clinical trials in rare tumor types as well as several 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 innovators in industry and academia to expand its portfolio and create more solutions for patients with cancer. 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, enrollment, 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 expected benefits of collaborations, 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) | |||||||||||
| Year Ended December 31, | ||||||||||
(in thousands, except share and per-share data) | 2021 | 2020 | 2019 | ||||||||
| | | | ||||||||
Licensing revenue | $ | — | $ | 35,000 | $ | — | |||||
Operating expenses: | |||||||||||
Research and development | 101,676 | 51,859 | 42,545 | ||||||||
General and administrative | 71,792 | 29,465 | 16,694 | ||||||||
Total operating expenses | 173,468 | 81,324 | 59,239 | ||||||||
Loss from operations | (173,468 | ) | (46,324 | ) | (59,239 | ) | |||||
Other income: | |||||||||||
Other income (expense) | (152 | ) | 25 | — | |||||||
Interest income, net | 698 | 1,330 | 3,547 | ||||||||
Total other income | 546 | 1,355 | 3,547 | ||||||||
Equity investment loss | (988 | ) | (605 | ) | (2,614 | ) | |||||
Net loss | $ | (173,910 | ) | $ | (45,574 | ) | $ | (58,306 | ) | ||
Reconciliation of net loss to net loss attributable to common stockholders and unit holders: | |||||||||||
Net loss | $ | (173,910 | ) | $ | (45,574 | ) | $ | (58,306 | ) | ||
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 | $ | (173,910 | ) | $ | (45,574 | ) | $ | (50,577 | ) | ||
Net loss per share, basic and diluted | $ | (3.59 | ) | $ | (1.05 | ) | $ | (3.81 | ) | ||
Weighted average common units outstanding, basic and diluted | — | — | — | ||||||||
Weighted average common shares outstanding, basic and diluted | 48,497,790 | 43,300,063 | 13,274,836 |
SpringWorks Therapeutics, Inc. | |||||||
Selected Balance Sheet Data (Unaudited) | |||||||
As of December 31, | |||||||
2021 | 2020 | ||||||
(in thousands) | |||||||
Cash, cash equivalents and marketable securities | $ | 432,731 | $ | 561,820 | |||
Working Capital (1) | 352,941 | 495,788 | |||||
Total assets | 452,494 | 576,191 | |||||
Total liabilities | 30,098 | 19,133 | |||||
Accumulated deficit | (292,513 | ) | (118,603 | ) | |||
Total stockholders’ equity | 422,396 | 557,058 |
(1) We define Working Capital as current assets less current liabilities.
Contacts:
Kim Diamond
Vice President, Communications and Investor Relations
Phone: 203-561-1646
Email: [email protected]
Samantha Hilson Sandler
Director, Investor Relations
Phone: 203-461-5501
Email: [email protected]
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