– Offered extra Part 3 DeFi knowledge at ASCO demonstrating clinically important reductions in ache and substantial reductions in tumor quantity and T2 hyperintensity with nirogacestat remedy –

– Accomplished enrollment of Part 2 trial evaluating nirogacestat in sufferers with ovarian granulosa cell tumors –

– Highlighted encouraging Part 1 and a pair of scientific knowledge from rising pipeline packages at AACR and EHA –

STAMFORD, Conn., Aug. 02, 2023 (GLOBE NEWSWIRE) — SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical firm targeted on growing life-changing medicines for sufferers with extreme uncommon ailments and most cancers, as we speak reported second quarter monetary outcomes for the interval ended June 30, 2023 and supplied an replace on latest firm developments.

“Our group continues to work with urgency and is able to serve sufferers with desmoid tumors following the anticipated FDA approval of nirogacestat later this yr,” stated Saqib Islam, Chief Govt Officer of SpringWorks. “We additionally imagine that mirdametinib has the potential to be a best-in-class remedy for sufferers with NF1-PN and sit up for reporting topline knowledge from our ReNeu trial within the fourth quarter whereas concurrently advancing our portfolio of alternatives throughout our uncommon oncology, BCMA mixtures in a number of myeloma, and biomarker-defined metastatic stable tumors packages.”

Current Enterprise Highlights and Upcoming Milestones

Uncommon Oncology

• In June 2023, SpringWorks introduced that the U.S. Meals and Drug Administration (FDA) has up to date the Prescription Drug Consumer Payment Act (PDUFA) motion date for the New Drug Software (NDA) for nirogacestat for the remedy of adults with desmoid tumors to permit extra time to overview extra analyses of beforehand submitted knowledge that had been supplied by SpringWorks in response to the FDA’s data requests. No extra knowledge or research have been requested by the FDA right now. The brand new PDUFA motion date is November 27, 2023.
• In June 2023, extra knowledge from the Part 3 DeFi trial assessing the impression of nirogacestat on ache, tumor quantity, and T2 hypersensitivity in adults with desmoid tumors had been introduced on the 2023 American Society of Scientific Oncology (ASCO) Annual Assembly. Statistically important and clinically significant reductions in ache had been noticed with nirogacestat in contrast with placebo at Cycle 10 throughout three prespecified ache evaluation instruments evaluated in DeFi. Reductions in ache had been speedy, turning into evident as early as Cycle 2 (the primary post-treatment timepoint evaluated), and these reductions had been sustained by to the tip of the double-blind section of the trial. As well as, researchers introduced knowledge from the DeFi trial demonstrating that remedy with nirogacestat led to considerably improved median greatest change from baseline in MRI-assessed tumor quantity of the biggest goal tumor in contrast with placebo. As well as, important enchancment within the median greatest p.c change in T2 hyperintensity sign ratio of the biggest goal tumor in contrast with placebo was additionally noticed with nirogacestat remedy.
• In Might 2023, SpringWorks introduced full enrollment of the Part 2 trial evaluating nirogacestat as a monotherapy in sufferers with recurrent ovarian granulosa cell tumors. SpringWorks expects to report preliminary knowledge from the trial in 2024.
• SpringWorks expects to current topline knowledge from the pediatric and grownup cohorts of the Part 2b ReNeu trial evaluating mirdametinib, an investigational MEK inhibitor, in NF1-associated plexiform neurofibromas (NF1-PN) within the fourth quarter of 2023. If these knowledge are optimistic, SpringWorks plans to submit an NDA to the FDA for mirdametinib for the remedy of NF1-PN within the first half of 2024.

B-cell Maturation Antigen (BCMA) Combos in A number of Myeloma

• SpringWorks continues to guage nirogacestat as a part of a number of BCMA mixture remedy regimens throughout remedy strains in collaboration with business leaders.
• In June 2023, up to date scientific knowledge from the Part 1/2 research sponsored by GSK plc evaluating nirogacestat together with low-dose belamaf (belantamab mafodotin-blmf, GSK’s antibody-drug conjugate) in sufferers with relapsed or refractory a number of myeloma (RRMM) had been introduced on the European Hematology Affiliation (EHA) 2023 Congress. These scientific knowledge proceed to assist that combining nirogacestat with a low dose of belamaf might end in comparable efficacy to a better monotherapy belamaf dose whereas concurrently considerably decreasing the frequency of high-grade ocular opposed occasions.
• In June 2023, new knowledge from the Part 1b scientific trial sponsored by Janssen Analysis & Improvement, LLC (Janssen) evaluating nirogacestat together with teclistamab, Janssen’s bispecific antibody concentrating on BCMA and CD3, had been introduced at EHA, representing the primary scientific knowledge set of nirogacestat together with a BCMA bispecific agent. The outcomes demonstrated that top and deep response charges had been noticed with the nirogacestat plus teclistamab mixture throughout all dose ranges assessed and the protection profile was optimized with delayed administration of lower-dose nirogacestat.
  

Biomarker-Outlined Metastatic Strong Tumors

• In April 2023, up to date scientific knowledge from the Part 1b trial evaluating mirdametinib together with BeiGene’s investigational RAF dimer inhibitor, lifirafenib, in sufferers with superior or refractory stable tumors with RAS mutations, RAF mutations and different MAPK pathway aberrations had been introduced on the American Affiliation for Most cancers Analysis (AACR) Annual Assembly 2023. The mix confirmed antitumor exercise in sufferers with varied mutations throughout a number of stable tumor varieties and assist the development of this mix into the dose-expansion portion of the research, which is able to consider the mix in sufferers with
  
  NRAS
  
  -mutated stable tumors. The growth is anticipated to start out within the second half of 2023.
• In April 2023, up to date scientific knowledge from the Part 1a/1b research of brimarafenib (BGB-3245), an investigational, selective RAF dimer inhibitor, in grownup sufferers with superior or refractory stable tumors harboring MAPK pathway aberrations had been introduced at AACR. Goal responders included sufferers with tumors harboring BRAF V600E that had progressed on prior BRAF/MEK inhibitors with or with out checkpoint inhibitor remedy, BRAF Class II mutation, BRAF fusion, NRAS and KRAS mutations. These knowledge supported the development of brimarafenib into the Part 1b dose growth portion of the research, which has been enrolling sufferers since October 2022 in outlined cohorts.
• Sufferers proceed to be enrolled within the SpringWorks-sponsored Part 1/2a mixture research of brimarafenib and mirdametinib.
• In April 2023, SpringWorks introduced new preclinical knowledge for SW-682, the Firm’s TEAD inhibitor growth candidate, at AACR. The info present promising proof of SW-682’s anti-tumor exercise, a positive pharmacokinetics profile and good tolerability in mice, and additional assist SpringWorks’ thesis that TEAD palmitoylation represents a rational level of intervention for Hippo-driven cancers. SpringWorks expects to file an Investigational New Drug Software for SW-682 within the fourth quarter of 2023.

Second Quarter 2023 Monetary Outcomes

• 
  Analysis and Improvement (R&D) Bills:
  
  R&D bills had been $35.9 million for the second quarter, in comparison with $38.0 million for the comparable interval of 2022. The lower in R&D bills was primarily attributable to a lower in exterior prices associated to drug manufacturing, scientific trials and different analysis, partially offset by a rise in inner prices pushed by the expansion in worker prices related to will increase within the variety of personnel, together with a rise in stock-based compensation expense.
• 
  Basic and Administrative (G&A) Bills
  
  : G&A bills had been $47.0 million for the second quarter, in comparison with $31.0 million for the comparable interval of 2022. The rise in G&A bills was largely attributable to industrial readiness actions to assist the U.S. launch of nirogacestat, if accepted, for the remedy of adults with desmoid tumors. The rise in inner prices was attributable to the expansion in worker prices related to will increase within the variety of personnel, together with a rise in stock-based compensation expense, pushed by the expansion of our industrial group, which included establishing sure gross sales, advertising and marketing, and commercialization capabilities. The rise in consulting {and professional} companies was additionally primarily attributable to industrial readiness actions as we broaden the capabilities of the group.
• 
  Web Loss Attributable to Frequent Stockholders:
  
  SpringWorks reported web lack of $77.9 million, or $1.25 per share, for the second quarter of 2023. This compares to a web lack of $69.1 million, or $1.41 per share, for the comparable interval of 2022.
• 
  Money Place:
  
  Money, money equivalents and marketable securities had been $476.7 million as of June 30, 2023.

About SpringWorks Therapeutics

SpringWorks is a clinical-stage biopharmaceutical firm making use of a precision medication method to buying, growing and commercializing life-changing medicines for sufferers dwelling with extreme uncommon ailments and most cancers. SpringWorks has a differentiated focused oncology pipeline spanning stable tumors and hematological cancers, together with two late-stage scientific trials in uncommon tumor varieties in addition to a number of packages addressing extremely prevalent, genetically outlined cancers. SpringWorks’ strategic method and operational excellence in scientific growth have enabled it to quickly advance its two lead product candidates into late-stage scientific trials whereas concurrently coming into into a number of shared-value partnerships with innovators in business and academia to unlock the complete potential for its portfolio and create extra options for sufferers with most cancers. For extra data, go to

www.springworkstx.com

and comply with @SpringWorksTx on

Twitter

and

LinkedIn

.

SpringWorks makes use of its web site as a way of revealing materials personal data and for complying with its disclosure obligations below Regulation FD. Such disclosures will likely be included on SpringWorks’ web site within the Traders & Media part. Accordingly, traders ought to monitor such parts of the SpringWorks web site, along with following press releases, SEC filings and public convention calls and webcasts.

Ahead-Wanting Statements

This presentation accommodates “forward-looking statements” throughout the which means of the Non-public Securities Litigation Reform Act of 1995, as amended, regarding our enterprise, operations, and monetary situations, together with, however not restricted to, present beliefs, expectations and assumptions concerning the way forward for our enterprise, future plans and techniques, our growth plans, our preclinical and scientific outcomes, the potential for nirogacestat to turn out to be an essential new remedy for grownup sufferers with desmoid tumors, the potential for Advertising Authorization Software for nirogacestat, expectations concerning the timing and outcomes of the FDA’s overview of the NDA for nirogacestat, together with the FDA’s PDUFA goal motion date for the NDA, and the adequacy of the info contained within the NDA to function the idea for an approval of nirogacestat for the remedy of adults with desmoid tumors, expectations concerning the timing of preliminary knowledge from the Part 2 trial evaluating nirogacestat in sufferers with recurrent ovarian granulosa cell tumors, expectations concerning the timing and outcomes of topline knowledge from the Part 2b ReNeu scientific trial

,

the potential for the outcomes of the Part 2b ReNeu scientific trial to assist an NDA submission for mirdametinib,


the potential for mirdametinib to turn out to be an essential new remedy for sufferers with NF1-PN, our plans for in search of regulatory approval for and making mirdametinib obtainable for NF1-PN sufferers, if accepted, expectations in regards to the timing of the graduation of the dose-expansion section of the Part 1b/2 trial evaluating mirdametinib with lifirafenib, our plans to file an Investigational New Drug Software for SW-682 within the fourth quarter of 2023, our plans to report extra scientific knowledge of nirogacestat together with BCMA-directed therapies and provoke extra deliberate Part 1 collaborator research, our expectations concerning the potential for the Part 1b dose growth section of brimarafenib, expectations about whether or not our patents for our lead property will adequately defend SpringWorks towards competitors, in addition to regarding different future situations. Phrases similar to, however not restricted to, “sit up for,” “imagine,” “count on,” “anticipate,” “estimate,” “intend,” “plan,” “would,” “ought to” and “might,” and comparable expressions or phrases, establish forward-looking statements. New dangers and uncertainties might emerge on occasion, and it isn’t doable to foretell all dangers and uncertainties. Any forward-looking statements on this press launch are based mostly on administration’s present expectations and beliefs and are topic to numerous dangers, uncertainties and essential components that will trigger precise occasions or outcomes to vary materially from these expressed or implied by any forward-looking statements contained on this press launch, together with, with out limitation, dangers regarding: (i) the success and timing of our product growth actions, together with the initiation and completion of SpringWorks’ scientific trials, (ii) the truth that topline knowledge or interim knowledge from our scientific research will not be predictive of the ultimate or extra detailed outcomes of such research, or the outcomes of different ongoing or future research, (iii) the success and timing of our collaboration companions’ ongoing and deliberate scientific trials, (iv) the timing of our deliberate regulatory submissions and interactions and the timing and consequence of selections made by the FDA and different regulatory authorities, investigational overview boards at scientific trial websites and publication overview our bodies; (v) whether or not FDA or different regulatory authorities would require extra data or additional research, or might fail or refuse to approve or might delay approval of our drug candidates, together with nirogacestat and mirdametinib, (vi) our means to acquire and keep regulatory approval of any of our product candidates, (vii) our plans to analysis, uncover and develop extra product candidates, (viii) our means to enter into collaborations for the event of latest product candidates and our means to understand the advantages anticipated from such collaborations, (ix) our means to take care of enough patent safety and efficiently implement patent claims towards third events, (x) the adequacy of our money place to fund our operations by any time interval indicated herein, (xi) our means to ascertain manufacturing capabilities, and our and our collaboration companions’ talents to fabricate our product candidates and scale manufacturing, and (xii) our means to fulfill any particular milestones set forth herein.

Besides as required by relevant legislation, we don’t plan to publicly replace or revise any forward-looking statements contained herein, whether or not because of any new data, future occasions, modified circumstances or in any other case. Though we imagine the expectations mirrored in such forward-looking statements are cheap, we can provide no assurance that such expectations will show to be appropriate. Accordingly, readers are cautioned to not place undue reliance on these forward-looking statements.

For additional data concerning the dangers, uncertainties and different components that will trigger variations between SpringWorks’ expectations and precise outcomes, it is best to overview the “Threat Elements” in Merchandise 1A of Half II of SpringWorks’ Quarterly Report on Kind 10-Q for the quarter ended June 30, 2023, in addition to discussions of potential dangers, uncertainties and different essential components in SpringWorks’ subsequent filings.

SpringWorks Therapeutics, Inc. Condensed Consolidated Statements of Operations (Unaudited)

​	Three Months Ended June 30,								Six Months Ended June 30,
(in hundreds, besides share and per-share knowledge)		2023				2022				2023				2022
Working bills:
Analysis and growth	$	35,858			$	38,024			$	69,382			$	72,127
Basic and administrative		46,994				30,987				91,169				58,353
Complete working bills		82,852				69,011				160,551				130,480
​
Loss from operations		(82,852	)			(69,011	)			(160,551	)			(130,480	)
Curiosity and different earnings (expense):
Different expense, web		(98	)			(24	)			(297	)			(217	)
Curiosity earnings, web		5,926				372				11,682				570
Complete curiosity and different earnings		5,828				348				11,385				353
Fairness funding loss		(901	)			(387	)			(2,179	)			(724	)
Web loss	$	(77,925	)		$	(69,050	)		$	(151,345	)		$	(130,851	)
​
Web loss per share, primary and diluted	$	(1.25	)		$	(1.41	)		$	(2.43	)		$	(2.67	)
Weighted common frequent shares excellent, primary and diluted		62,464,081				49,071,590				62,360,651				48,989,690

SpringWorks Therapeutics, Inc. Chosen Steadiness Sheet Information (Unaudited)

	June 30, 2023				December 31, 2022
(in hundreds)
Money, money equivalents and marketable securities	$	476,707			$	597,006
Working Capital (1)		441,991				548,711
Complete property		517,329				630,242
Complete liabilities		65,888				72,050
Collected deficit		(721,275	)			(569,930	)
Complete stockholders’ fairness		451,441				558,192

⁽¹⁾

We outline Working Capital as present property much less present liabilities.

Contacts:


Kim Diamond

Vice President, Communications and Investor Relations

Telephone: 203-561-1646

E mail:

[email protected]

Samantha Hilson Sandler

Senior Director, Investor Relations

Telephone: 203-461-5501

E mail:

[email protected]