STAMFORD, Conn., Aug. 07, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today reported financial results for the second quarter of 2024 and provided an update on recent company developments.
"We are very pleased with the continued strong momentum of our U.S. launch of OGSIVEO for adults with desmoid tumors. In the second quarter, we also completed the submission of our NDA for mirdametinib in NF1-PN, which positions us to potentially have our second medicine available for patients in 2025," said Saqib Islam, Chief Executive Officer of SpringWorks. "Our focus for the second half of 2024 will be to drive broader adoption of OGSIVEO, to advance our commercial preparations for the launch of mirdametinib for children and adults with NF1-PN, to continue advancing OGSIVEO and mirdametinib through the European regulatory process, and to progress our emerging portfolio for patient populations with high unmet needs."
Recent Business Highlights and Upcoming Milestones
OGSIVEO® (Nirogacestat)
Mirdametinib
Emerging Pipeline
General Corporate
Second Quarter 2024 Financial Results
Conference Call Information
SpringWorks will host a conference call and webcast today, Wednesday, August 7, at 8:30 a.m. ET to review its second quarter 2024 financial results and discuss recent business updates. To join the live webcast and view the corresponding slides, please click here. To access the live call by phone, please pre-register for the call by clicking here. Once registration is complete, participants will be provided with a dial-in number and conference code to access the call. A replay of the webcast will be available for a limited time following the event on the Investors and Media section of the Company’s website at https://ir.springworkstx.com/.
About SpringWorks Therapeutics
SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer. OGSIVEO® (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment, is the Company’s first FDA-approved therapy. SpringWorks also has a diversified targeted therapy pipeline spanning solid tumors and hematological cancers, with programs ranging from preclinical development through advanced clinical trials. In addition to its wholly owned programs, SpringWorks has also entered into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients in need.
For more information, visit www.springworkstx.com and follow @SpringWorksTx on X (formerly Twitter), LinkedIn, and YouTube.
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 press release 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 and commercialization plans, our preclinical and clinical results, the market potential of OGSIVEO for adult patients with desmoid tumors, expectations regarding the adequacy of the data contained in the nirogacestat MAA to serve as the basis for marketing approval of nirogacestat for the treatment of desmoid tumors in the European Union, the potential for the results of the Phase 2b ReNeu clinical trial to support an approval of the mirdametinib NDA or an MAA submission for mirdametinib in the second half of 2024, our plans to report additional data from the Phase 2b ReNeu clinical trial at an upcoming medical conference and submit for publication data from such clinical trial in a peer-reviewed medical journal in 2024, our plans to present additional data from the Phase 3 DeFi trial of nirogacestat at upcoming conferences, the potential for mirdametinib to become an important new treatment for patients with NF1-PN, our plans for seeking regulatory approval for and making mirdametinib available for NF1-PN patients, if approved, expectations regarding the timing and initial data from the Phase 2 trial evaluating nirogacestat in patients with recurrent ovarian granulosa cell tumors, our expectations and the timing of the Phase 1a trial of SW-682, our plans to report additional clinical data of nirogacestat in combination with BCMA-directed therapies and initiate additional planned Phase 1 collaborator studies, our expectations and the timing of the Phase 1b dose expansion phase of brimarafenib, our expectations regarding the timing of enrollment in our combination therapy oncology programs, expectations about whether our patents for our lead assets will adequately protect SpringWorks against competition, 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 of our commercialization efforts with respect to OGSIVEO, (ii) our limited experience as a commercial company, (iii) our ability to obtain or maintain adequate coverage and reimbursement for OGSIVEO, (iv) the success and timing of our product development activities, including the initiation and completion of our clinical trials, (v) our expectations regarding the potential clinical benefit of OGSIVEO for adult patients with desmoid tumors who require systemic treatment, (vi) the potential for OGSIVEO to become the new standard of care for adult patients with desmoid tumors, (vii) estimates regarding the number of adult patients who are diagnosed with desmoid tumors annually per year in the U.S. and the potential market for OGSIVEO, (viii) the fact that topline or interim data from 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, (ix) the success and timing of our collaboration partners’ ongoing and planned clinical trials, (x) the timing of our planned regulatory submissions and interactions, including the timing and outcome of decisions made by the FDA, EMA, and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, (xi) whether FDA, EMA, or other regulatory authorities will require additional information or further studies, or may fail or refuse to approve or may delay approval of our product candidates, including nirogacestat and mirdametinib, (xii) our ability to obtain regulatory approval of any of our product candidates or maintain regulatory approvals granted for our products, (xiii) our plans to research, discover and develop additional product candidates, (xiv) our ability to enter into collaborations for the development of new product candidates and our ability to realize the benefits expected from such collaborations, (xv) our ability to maintain adequate patent protection and successfully enforce patent claims against third parties, (xvi) the adequacy of our cash position to fund our operations through any time period indicated herein, (xvii) our ability to establish manufacturing capabilities, and our and our collaboration partners’ abilities to manufacture our product candidates and scale production, and (xviii) our ability to meet any specific milestones set forth herein.
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 II of SpringWorks’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, 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 June 30, | Six Months Ended June 30, | |||||||||||||
(in thousands, except share and per-share data) | 2024 | 2023 | 2024 | 2023 | |||||||||||
Revenue: | |||||||||||||||
Product revenue, net | $ | 40,186 | $ | — | $ | 61,192 | $ | — | |||||||
Other revenue (1) | 19,547 | — | 19,547 | — | |||||||||||
Total revenue | 59,733 | — | 80,739 | — | |||||||||||
Operating costs and expenses: | |||||||||||||||
Cost of product revenue | 2,453 | — | 3,655 | — | |||||||||||
Selling, general and administrative | 57,839 | 46,994 | 117,952 | 91,169 | |||||||||||
Research and development | 44,362 | 35,858 | 97,984 | 69,382 | |||||||||||
Total operating costs and expenses | 104,654 | 82,852 | 219,591 | 160,551 | |||||||||||
| |||||||||||||||
Loss from operations | (44,921 | ) | (82,852 | ) | (138,852 | ) | (160,551 | ) | |||||||
Interest and other income: | |||||||||||||||
Interest and other income, net | 6,778 | 5,828 | 14,349 | 11,385 | |||||||||||
Total interest and other income | 6,778 | 5,828 | 14,349 | 11,385 | |||||||||||
Equity method investment loss | (1,776 | ) | (901 | ) | (2,801 | ) | (2,179 | ) | |||||||
Net loss | $ | (39,919 | ) | $ | (77,925 | ) | $ | (127,304 | ) | $ | (151,345 | ) | |||
| |||||||||||||||
Net loss per share, basic and diluted | $ | (0.54 | ) | $ | (1.25 | ) | $ | (1.72 | ) | $ | (2.43 | ) | |||
Weighted average common shares outstanding, basic and diluted | 74,121,014 | 62,464,081 | 73,944,809 | 62,360,651 |
(1) Related to recognition of all previously deferred revenue associated with the GSK License Agreement following notice of termination of the agreement received from GSK, as announced in June 2024.
SpringWorks Therapeutics, Inc. Selected Balance Sheet Data (Unaudited) |
June 30, 2024 | December 31, 2023 | ||||||
(in thousands) | |||||||
Cash, cash equivalents and marketable securities | $ | 521,933 | $ | 662,588 | |||
Working Capital (1) | 376,824 | 422,742 | |||||
Total assets | 617,331 | 725,788 | |||||
Total liabilities | 60,601 | 99,569 | |||||
Accumulated deficit | (1,022,338 | ) | (895,034 | ) | |||
Total stockholders’ equity | 556,730 | 626,219 |
(1) We define Working Capital as current assets less current liabilities.
Contacts:
Kim Diamond
Vice President, Communications and Investor Relations
Phone: 203-561-1646
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Samantha Hilson Sandler
Senior Director, Investor Relations
Phone: 203-461-5501
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Last Trade: | US$37.44 |
Daily Change: | -0.49 -1.29 |
Daily Volume: | 1,159,081 |
Market Cap: | US$2.780B |
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