Latest News by Industry
– Presented Positive Data from Phase 3 DeFi Trial Evaluating Nirogacestat in Adult Patients with Progressing Desmoid Tumors at the European Society for Medical Oncology (ESMO) Congress 2022 –
– Expanded Global, Non-Exclusive Collaboration with GSK to Continue Evaluating Nirogacestat in Combination with Belantamab Mafodotin (Belamaf) in Patients with Multiple Myeloma –
– Dosed First Patient in Phase 2 Trial Evaluating Nirogacestat in Patients with Ovarian Granulosa Cell Tumors –
– Strengthened Financial Position toOver $650Million in Cash, Cash Equivalents and Marketable Securities –
STAMFORD, Conn., Nov. 03, 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 third quarter financial results for the period ended September 30, 2022 and provided an update on recent company developments.
"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, 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
B-cell Maturation Antigen (BCMA) Combinations in Multiple Myeloma
Biomarker-Defined Metastatic Solid Tumors
General Corporate
Third Quarter 2022 Financial Results
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 pipeline spanning solid tumors and hematological cancers, including two late-stage 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 unlock the full potential for 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 SpringWorks' 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 presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, 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 ongoing and continued progression of our clinical trials, our plans to report additional data from the Phase 3 DeFi clinical trial at an upcoming medical conference, the potential for the results of the Phase 3 DeFi clinical trial to support an NDA submission, the timing of our planned NDA submission for nirogacestat, and our plans for seeking regulatory approval for and making nirogacestat available to desmoid tumor patients, if approved, our plans to report data from the Phase 1b/2 trial evaluating mirdametinib with lifirafenib at an upcoming medical conference, our plans to report additional data from the Phase 1 study evaluating BGB-3245 at an upcoming medical conference, our plans to begin dosing a Phase 1/2a combination study of BGB-3245 and mirdametinib as well as relating to 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 topline data or interim data from our clinical studies may not be predictive of the final or more detailed 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) the timing of our planned regulatory submissions and interactions, including the NDA for nirogacestat planned for the fourth quarter of 2022 and the timing and outcome of decisions made by the U.S. Food and Drug Administration (FDA) and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; (v) whether FDA or other regulatory authorities will require additional information or further studies, or may fail or refuse to approve or may delay approval of our drug candidates, including nirogacestat and mirdametinib, (vi) our ability to obtain and maintain regulatory approval of any of our product candidates, (vii) our plans to research, discover and develop additional product candidates, (viii) our ability to enter into collaborations for the development of new product candidates and our ability to realize the benefits expected from such collaborations, (ix) our ability to establish manufacturing capabilities, and our and our collaboration partners’ abilities to manufacture our product candidates and scale production, (x) our ability to meet any specific milestones set forth herein, and (xi) 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 September 30, 2022, as well as discussions of potential risks, uncertainties and other important factors in SpringWorks’ subsequent filings.
| SpringWorks Therapeutics, Inc. Condensed Consolidated Statements of Operations (Unaudited) |
| | Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||
| (in thousands, except share and per-share data) | 2022 | 2021 | 2022 | 2021 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 36,067 | 22,866 | 108,194 | 72,332 | |||||||||||
| General and administrative | 35,673 | 18,029 | 94,026 | 45,340 | |||||||||||
| Total operating expenses | 71,740 | 40,895 | 202,220 | 117,672 | |||||||||||
| | |||||||||||||||
| Loss from operations | (71,740 | ) | (40,895 | ) | (202,220 | ) | (117,672 | ) | |||||||
| Interest and other income (expense): | |||||||||||||||
| Other expense, net | (74 | ) | (58 | ) | (291 | ) | (96 | ) | |||||||
| Interest income, net | 912 | 179 | 1,482 | 617 | |||||||||||
| Total interest and other income | 838 | 121 | 1,191 | 521 | |||||||||||
| Equity investment loss | (1,486 | ) | (267 | ) | (2,210 | ) | (687 | ) | |||||||
| Net loss | $ | (72,388 | ) | $ | (41,041 | ) | $ | (203,239 | ) | $ | (117,838 | ) | |||
| | |||||||||||||||
| Net loss per share, basic and diluted | $ | (1.37 | ) | $ | (0.84 | ) | $ | (4.04 | ) | $ | (2.43 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 52,900,819 | 48,595,420 | 50,298,015 | 48,417,300 | |||||||||||
| SpringWorks Therapeutics, Inc. Selected Balance Sheet Data (Unaudited) |
| September 30, 2022 | December 31, 2021 | ||||||
| (in thousands) | |||||||
| Cash, cash equivalents and marketable securities | $ | 651,943 | $ | 432,731 | |||
| Working Capital (1) | 607,793 | 352,941 | |||||
| Total assets | 681,554 | 452,494 | |||||
| Total liabilities | 69,154 | 30,098 | |||||
| Accumulated deficit | (495,752 | ) | (292,513 | ) | |||
| Total stockholders’ equity | 612,400 | 422,396 | |||||
(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: kdiamond@springworkstx.com
Samantha Hilson Sandler
Director, Investor Relations
Phone: 203-461-5501
Email: samantha.sandler@springworkstx.com