SpringWorks Therapeutics Announces Q1 2024 Financial Results and Business Updates

SpringWorks Therapeutics, a biopharmaceutical company, has reported its first-quarter financial results for 2024 along with key business updates. The company, which focuses on rare diseases and cancer, has shown promising progress in several areas.

The company's net product revenue for OGSIVEO® (nirogacestat) reached $21.0 million in the first quarter. This marked a strong initial performance for the drug, which is targeted at adults with desmoid tumors. SpringWorks CEO Saqib Islam expressed optimism about the momentum of OGSIVEO, emphasizing efforts to establish the drug as the standard treatment for desmoid tumors. Additionally, the company has initiated a rolling submission of a New Drug Application (NDA) to the FDA for mirdametinib, aimed at treating children and adults with NF1-PN.

In recent business milestones, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for nirogacestat to treat adults with desmoid tumors in February 2024. Furthermore, the FDA approved a Supplemental New Drug Application (NDA) for OGSIVEO tablets in new blister packaging, which will enhance patient convenience. These packs are expected to be available by mid-May 2024.

Additional data from the Phase 3 DeFi trial of nirogacestat for desmoid tumors will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Initial data from the Phase 2 trial of nirogacestat as a monotherapy for recurrent ovarian granulosa cell tumors is expected in the second half of 2024. Moreover, SpringWorks continues to support several studies evaluating nirogacestat as part of combination therapies for multiple myeloma.

For mirdametinib, the rolling NDA submission to the FDA began in March 2024, with completion expected in the second quarter. The company also plans to submit an MAA to the EMA for mirdametinib in the latter half of the year. Data from the Phase 2b ReNeu trial, covering pediatric and adult cohorts, have been accepted for oral presentation at the 2024 ASCO Annual Meeting. SpringWorks also aims to publish these results in a peer-reviewed journal within the year.

In its emerging pipeline, the company plans to present further data from a Phase 1b trial evaluating brimarafenib (BGB-3245) in patients with RAF mutant solid tumors in the latter part of 2024. Brimarafenib is being developed by MapKure, a joint venture between SpringWorks and BeiGene. Additionally, patients are being enrolled in a dose escalation study combining brimarafenib with mirdametinib. MapKure has also initiated a Phase 1b trial combining brimarafenib with panitumumab for colorectal and pancreatic cancers. A Phase 1a trial of SW-682, a pan-TEAD inhibitor for Hippo-mutant solid tumors, is on track to commence in the second quarter of 2024.

On the corporate front, the U.S. Patent and Trademark Office has issued five new patents for OGSIVEO, bringing the total to 21 patents with protection extending into 2043.

Financially, SpringWorks reported $21.0 million in net product revenue for OGSIVEO in the first quarter of 2024. Selling, general, and administrative expenses rose to $60.1 million, compared to $44.2 million in the previous year, primarily due to commercial activities supporting the U.S. launch of OGSIVEO. Research and development expenses also increased to $53.6 million, attributed to higher costs related to drug manufacturing, clinical trials, and personnel growth. The net loss for the quarter was $87.4 million, or $1.18 per share, compared to a net loss of $73.4 million in the same period last year. The company had cash and equivalents totaling $573.0 million as of March 31, 2024.

SpringWorks remains committed to advancing its commercial, development, and corporate objectives, with plans to provide continuous updates throughout the year.