The NDA submission includes data from the pivotal Phase 2b ReNeu trial, which evaluated mirdametinib in patients ≥ 2 years of age with NF1-associated PN causing significant morbidity. Results were presented in an oral presentation at the 2024 American Society of Clinical Oncology Annual Meeting and demonstrated that mirdametinib treatment resulted in significant objective response rates confirmed by blinded independent central review, deep and durable responses, improvement in pain and health-related qualit ...

STAMFORD, Conn., June 05, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that management will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference, taking place in Miami, Florida on Tuesday, June 11, 2024 at 2:00 p.m. ET. To access the live webcast, please visit the Events & Presentations page within the Investors & Media section of the comp ...

– Results from pivotal Phase 2b ReNeu trial of mirdametinib in patients with NF1-PN to be presented in an oral presentation – – Additional data and analyses from Phase 3 DeFi trial of OGSIVEO® (nirogacestat) highlighting consistent safety and efficacy across subgroups of adults with desmoid tumors also being presented in oral and poster sessions – STAMFORD, Conn., May 23, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe ra ...

Start Time: 08:30 January 1, 0000 9:06 AM ET SpringWorks Therapeutics, Inc. (NASDAQ:SWTX) Q1 2024 Earnings Conference Call May 02, 2024, 08:30 AM ET Company Participants Saqib Islam - CEO Francis Perier - CFO Bhavesh Ashar - Chief Commercial Officer Jim Cassidy - CMO Samantha Sandler - Senior Director of IR Conference Call Participants Anupam Rama - JPMorgan Yaron Werber - TD Cowen Corinne Johnson - Goldman Sachs Peter Lawson - Barclays Alec Stranahan - Bank of America Michael Schmidt - Guggenheim Operator ...

Financial Performance - SpringWorks reported $21.0 million in net product revenue for OGSIVEO in the first full quarter on the market[22, 55] - The company's cash, cash equivalents, and marketable securities totaled $573.0 million as of March 31, 2024[4, 33] - Total operating expenses were $114.9 million for the quarter ended March 31, 2024[55] - Net loss for the quarter was $87.4 million[55] OGSIVEO Commercialization - There are approximately 5,500 to 7,000 U.S desmoid tumor patients actively managed annually[9] - 76% of surveyed oncologists are aware of OGSIVEO and have already used or plan to prescribe it[48] - 82% of oncologists who have used OGSIVEO prefer it to other systemic treatments[48] Mirdametinib Development - Mirdametinib rolling NDA submission for NF1-PN is underway, representing opportunity for a potential second approval by 2025[41] - The company completed a pre-NDA meeting and initiated the rolling NDA submission for mirdametinib[51] Pipeline Expansion - A Phase 1 trial of SW-682 in Hippo mutant solid tumors is planned for initiation in Q2 2024[2, 14] - Initial data from the Phase 2 OvGCT study of nirogacestat is expected in 2H 2024[54]

[PART I – FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited Q1 2024 financial statements detail $656.8 million in assets, an $87.4 million net loss, and $21.0 million in product revenue [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2024, total assets were $656.8 million, decreasing from $725.8 million, with liabilities at $89.4 million and stockholders' equity at $567.4 million Condensed Consolidated Balance Sheet Highlights (in thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Total current assets** | $471,798 | $500,912 | | **Total assets** | $656,832 | $725,788 | | **Total current liabilities** | $68,917 | $78,170 | | **Total liabilities** | $89,392 | $99,569 | | **Total stockholders' equity** | $567,440 | $626,219 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2024 saw first product revenue of $21.0 million, increased operating expenses to $114.9 million, and a net loss of $87.4 million Condensed Consolidated Statements of Operations (in thousands, except per-share data) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | **Product revenue, net** | $21,006 | $— | | **Total operating costs and expenses** | $114,937 | $77,699 | | **Loss from operations** | $(93,931) | $(77,699) | | **Net loss** | $(87,385) | $(73,420) | | **Net loss per share, basic and diluted** | $(1.18) | $(1.18) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2024 net cash used in operating activities increased to $78.9 million, while investing activities provided $21.5 million, resulting in a $58.0 million net decrease in cash Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(78,930) | $(61,818) | | **Net cash provided by investing activities** | $21,463 | $98,604 | | **Net cash used in financing activities** | $(552) | $(1,848) | | **Net (decrease) increase in cash and cash equivalents** | $(58,019) | $34,938 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's transition to commercial stage with OGSIVEO, $21.0 million Q1 revenue, and $573.0 million liquidity sufficient for twelve months - The company is a commercial-stage biopharmaceutical firm with its first product, **OGSIVEO**, approved in November 2023 for desmoid tumors. It generated **$21.0 million** in net revenue in Q1 2024[26](index=26&type=chunk) - As of March 31, 2024, the company had **$573.0 million** in cash, cash equivalents, and marketable securities, which management estimates will fund operations for at least the next **twelve months**[27](index=27&type=chunk) - In January 2024, the company made an additional investment of **$8.2 million** in MapKure for Series C preferred units, increasing its ownership interest to **39.7%**[44](index=44&type=chunk) Equity-Based Compensation Expense (in thousands) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $12,423 | $8,918 | | Selling, general and administrative | $18,039 | $14,477 | | **Total** | **$30,462** | **$23,395** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=17&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) MD&A discusses Q1 2024 financial performance, including $21.0 million OGSIVEO revenue, increased operating expenses, and sufficient liquidity for the next year [Overview](index=17&type=section&id=Overview) SpringWorks is a commercial-stage biopharma company with FDA-approved OGSIVEO, advancing mirdametinib, and developing other pipeline assets - **OGSIVEO (nirogacestat)** was approved by the FDA on November 27, 2023, for adult patients with progressing desmoid tumors and is the **first and only FDA-approved therapy** for this indication[65](index=65&type=chunk) - The company initiated a **rolling New Drug Application (NDA) submission** for mirdametinib for NF1-PN in March 2024, with completion expected in Q2 2024[70](index=70&type=chunk) - The company plans to initiate a Phase 1a trial of SW-682, a TEAD inhibitor development candidate, in Hippo mutant solid tumors in the second quarter of 2024[73](index=73&type=chunk) - In March 2024, the company **terminated its license agreement** with Dana-Farber for a portfolio of EGFR inhibitors, ceasing further investment in the program[74](index=74&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) Q1 2024 saw $21.0 million product revenue, a 48% increase in total operating expenses to $114.9 million, and an $87.4 million net loss Comparison of Results of Operations (in thousands) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Product revenue, net** | $21,006 | $— | $21,006 | —% | | **Selling, general and administrative** | $60,113 | $44,175 | $15,938 | 36% | | **Research and development** | $53,622 | $33,524 | $20,098 | 60% | | **Total operating costs and expenses** | $114,937 | $77,699 | $37,238 | 48% | | **Net loss** | $(87,385) | $(73,420) | $(13,965) | 19% | - SG&A expenses increased by **$15.9 million (36%)** in Q1 2024, primarily due to commercial activities supporting the U.S. launch of OGSIVEO, including growth of the commercial organization and sales force[87](index=87&type=chunk)[88](index=88&type=chunk) Research and Development Expenses by Program (in thousands) | Program | Q1 2024 | Q1 2023 | $ Change | | :--- | :--- | :--- | :--- | | Nirogacestat | $13,700 | $7,256 | $6,444 | | Mirdametinib | $16,155 | $6,499 | $9,656 | | Other | $9,583 | $1,987 | $7,596 | | **Total program specific costs** | **$39,438** | **$15,742** | **$23,696** | [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) The company had an accumulated deficit of $982.4 million, with $573.0 million in liquidity, estimated to fund operations for at least the next twelve months - The company had an accumulated deficit of **$982.4 million** as of March 31, 2024, and management estimates its current liquidity will fund operations for at least **twelve months** after the filing date of the report[94](index=94&type=chunk) Summary of Cash Flows (in thousands) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(78,930) | $(61,818) | | Net cash provided by investing activities | $21,463 | $98,604 | | Net cash used in financing activities | $(552) | $(1,848) | [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) No material changes to the company's market risks from those described in its 2023 Form 10-K - There were **no material changes** to the company's market risks from those disclosed in the Annual Report on Form 10-K for the year ended December 31, 2023[108](index=108&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective, with no material changes in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were **effective as of the end of the period** covered by the report[109](index=109&type=chunk) - **No changes in internal control over financial reporting occurred** during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control[110](index=110&type=chunk) [PART II. OTHER INFORMATION](index=26&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is **not currently a party to any material legal proceedings**[111](index=111&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) No material changes in the company's risk factors from those disclosed in the 2023 Form 10-K - There have been **no material changes** in the company's risk factors from those disclosed in the 2023 Form 10-K[112](index=112&type=chunk) [Item 5. Other Information](index=26&type=section&id=Item%205.%20Other%20Information) Several directors and executive officers adopted Rule 10b5-1 trading plans during Q1 2024 - Several directors and executive officers, including the **CEO (Saqib Islam)**, COO (Badreddin Edris), and CCO (Bhavesh Ashar), **adopted Rule 10b5-1 trading plans** during the quarter ended March 31, 2024[117](index=117&type=chunk) [Item 6. Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including required CEO and CFO certifications - The report includes an index of exhibits filed, such as **CEO and CFO certifications** pursuant to Section 302 and Section 906 of the Sarbanes-Oxley Act[119](index=119&type=chunk)

– Achieved $21.0 million in OGSIVEO (nirogacestat) net product revenue in the first quarter – ® – Received validation from the EMA for MAA of nirogacestat for the treatment of adults with desmoid tumors – Exhibit 99.1 SpringWorks Therapeutics Reports First Quarter 2024 Financial Results and Highlights Recent Business Updates – Initiated rolling submission of NDA to the FDA for mirdametinib for the treatment of children and adults with NF1-PN – – Phase 2b ReNeu trial results accepted for oral presentation at ...

PART I [Business Overview](index=4&type=section&id=Item%201.%20Business) SpringWorks Therapeutics is a commercial-stage biopharmaceutical company with OGSIVEO approved and a pipeline for rare diseases and cancer - SpringWorks Therapeutics is a commercial-stage biopharmaceutical company focused on developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer, applying a precision medicine approach[18](index=18&type=chunk) - OGSIVEO™ (nirogacestat) is the company's first commercial product, approved by the FDA on **November 27, 2023**, as the first and only therapy for adult patients with progressing desmoid tumors requiring systemic treatment[19](index=19&type=chunk)[31](index=31&type=chunk)[64](index=64&type=chunk) - Mirdametinib, an investigational oral MEK inhibitor, showed positive topline results from the Phase 2b ReNeu trial in adult and pediatric patients with NF1-PN, with an NDA submission planned for the **first half of 2024**[20](index=20&type=chunk)[45](index=45&type=chunk)[49](index=49&type=chunk) - The company's strategic priorities include successfully commercializing OGSIVEO in the U.S. and seeking global regulatory approval, advancing mirdametinib towards marketing approval, expanding nirogacestat and mirdametinib opportunities in rare oncology and genetically defined cancers, delivering new medicines through early-stage candidates, and maximizing portfolio potential via strategic partnerships[25](index=25&type=chunk)[32](index=32&type=chunk) - OGSIVEO's FDA approval was based on the Phase 3 DeFi trial, which demonstrated a **71% reduction in the risk of disease progression** (HR = 0.29; p<0.001) and an **objective response rate (ORR) of 41%** with OGSIVEO versus 8% with placebo[32](index=32&type=chunk) - Mirdametinib's Phase 2b ReNeu trial showed confirmed objective response rates of **52% in pediatric patients** and **41% in adult patients** with NF1-PN, with median best tumor volume reductions of **-42% and -41% respectively**, and generally well-tolerated safety profiles[47](index=47&type=chunk)[48](index=48&type=chunk) - The company relies on third parties for manufacturing all drug substance and product requirements, with commercial supply agreements in place for nirogacestat and plans for additional CMO arrangements[111](index=111&type=chunk) - Key intellectual property for nirogacestat includes U.S. patents covering composition of matter expiring in **2025**, drug substance/product in **2039**, pharmaceutical compositions in **2042**, and methods of treating desmoid tumors in **2043**, with Orphan Drug Exclusivity until **October 27, 2030**[106](index=106&type=chunk)[295](index=295&type=chunk) - Key intellectual property for mirdametinib includes U.S. patents covering polymorphic forms and pharmaceutical compositions expiring in **2041**, and methods of treatment expiring in **2041 and 2043**, with Orphan Drug Designation for NF1-PN[107](index=107&type=chunk)[295](index=295&type=chunk) - As of December 31, 2023, the company had **305 full-time employees**, with **142 in R&D**, **71 in commercial operations**, and **92 in strategic business development, finance, and general administration**[216](index=216&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks in commercialization, pipeline development, third-party reliance, and regulatory compliance - The business heavily depends on the successful commercialization of OGSIVEO in the U.S. and other jurisdictions, with no assurance of achieving expected revenue levels or profitability due to limited commercial experience and potential reimbursement challenges[234](index=234&type=chunk)[235](index=235&type=chunk)[237](index=237&type=chunk) - Successful development and regulatory approval of product candidates like mirdametinib are critical, and delays or failures in clinical trials due to safety, efficacy, or regulatory issues could materially harm the business[241](index=241&type=chunk)[242](index=242&type=chunk)[243](index=243&type=chunk) - Reliance on third-party contract manufacturers and suppliers for drug substance and product exposes the company to risks of supply limitations, interruptions, or quality issues, which could delay or impair development and commercialization efforts[269](index=269&type=chunk)[271](index=271&type=chunk)[274](index=274&type=chunk) - The company's intellectual property, including licensed patents for nirogacestat and mirdametinib, faces risks of expiration, invalidation, or unenforceability, which could diminish competitive advantage and impact financial performance[285](index=285&type=chunk)[295](index=295&type=chunk)[369](index=369&type=chunk) - Significant net losses have been incurred since inception (**$325.1 million in 2023**, **$277.4 million in 2022**, **$173.9 million in 2021**), and substantial additional capital will be required to fund ongoing R&D, commercialization, and operational expansion[307](index=307&type=chunk)[314](index=314&type=chunk)[553](index=553&type=chunk) - The company is subject to extensive government regulation, including anti-kickback, fraud and abuse, and data privacy laws (HIPAA, GDPR, CCPA), with non-compliance potentially leading to significant penalties, reputational harm, and operational restrictions[191](index=191&type=chunk)[195](index=195&type=chunk)[201](index=201&type=chunk)[207](index=207&type=chunk)[423](index=423&type=chunk)[464](index=464&type=chunk) - Cybersecurity threats, including information theft, data corruption, and operational disruption, pose a significant risk due to increasing reliance on IT systems and third-party providers, potentially leading to financial loss and reputational damage[479](index=479&type=chunk)[480](index=480&type=chunk)[481](index=481&type=chunk)[486](index=486&type=chunk) [Summary of company-specific material risk factors](index=39&type=section&id=Summary%20of%20company-specific%20material%20risk%20factors) The company's business depends on successful commercialization and pipeline development, facing risks in third-party reliance and intellectual property - The company's business is heavily dependent on the successful commercialization of OGSIVEO and the development of current product candidates like mirdametinib[231](index=231&type=chunk) - Key risks include limited commercial experience, reliance on third parties for preclinical studies, clinical trials, and manufacturing, and the ability to obtain and maintain intellectual property protection[231](index=231&type=chunk)[232](index=232&type=chunk)[233](index=233&type=chunk) - Other significant risks involve government regulation, managing organizational growth, the need for additional capital, and factors related to common stock performance[233](index=233&type=chunk) [Company-specific material risk factors](index=40&type=section&id=Company-specific%20material%20risk%20factors) This section details specific risks in R&D, commercialization, third-party reliance, IP, regulation, operations, finance, and common stock [Risks related to our research and development and commercialization](index=40&type=section&id=Risks%20related%20to%20our%20research%20and%20development%20and%20commercialization) Uncertainties in OGSIVEO commercialization and pipeline development pose risks of delays, regulatory issues, and market acceptance challenges - The company's ability to successfully commercialize OGSIVEO in the U.S. and other jurisdictions is uncertain, with no guarantee of achieving expected revenue levels due to limited commercial experience and potential reimbursement challenges[234](index=234&type=chunk)[235](index=235&type=chunk)[237](index=237&type=chunk) - Future success is highly dependent on the successful development, regulatory approval, and commercialization of product candidates, particularly mirdametinib, with potential for significant harm if safety, efficacy, or regulatory issues arise[241](index=241&type=chunk)[242](index=242&type=chunk)[243](index=243&type=chunk) - Interim or preliminary clinical trial data may not be predictive of final results and are subject to change, potentially harming business prospects and causing stock price fluctuations[247](index=247&type=chunk)[249](index=249&type=chunk) - Difficulties in patient enrollment for clinical trials, especially for rare diseases like NF1-PN, could delay or adversely affect clinical development activities and increase costs[255](index=255&type=chunk)[257](index=257&type=chunk)[258](index=258&type=chunk) - Even if approved, product candidates may fail to achieve market acceptance by physicians, patients, and third-party payers due to factors like efficacy, safety, cost, and competition[260](index=260&type=chunk)[261](index=261&type=chunk) [Risks related to our reliance on third parties](index=46&type=section&id=Risks%20related%20to%20our%20reliance%20on%20third%20parties) High dependence on third-party contractors for clinical trials, manufacturing, and supply creates risks of delays, quality issues, and disruptions - The company relies on third parties (CROs, investigators) to conduct preclinical studies and clinical trials, and their failure to meet contractual duties, deadlines, or regulatory requirements could delay or prevent regulatory approval and commercialization[263](index=263&type=chunk)[264](index=264&type=chunk)[266](index=266&type=chunk) - Dependence on third-party contract manufacturers for preclinical, clinical, and commercial product supplies exposes the company to risks of limited or interrupted supply,

Report Overview and Business Highlights [Executive Summary](index=1&type=section&id=Executive%20Summary) In 2023, SpringWorks Therapeutics achieved its first FDA approval for OGSIVEO™ for desmoid tumors, generating $5.4 million in its initial partial quarter, and reported positive Phase 2b data for mirdametinib in NF1-PN, planning an NDA submission in H1 2024 - OGSIVEO™ (nirogacestat) generated net product revenue of **$5.4 million** in its first partial quarter after FDA approval on November 27, 2023[1](index=1&type=chunk) - Submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for nirogacestat for the treatment of desmoid tumors[1](index=1&type=chunk) - Positive topline data from the Phase 2b ReNeu trial of mirdametinib in patients with NF1-PN was presented, with a New Drug Application (NDA) submission planned for the first half of 2024[1](index=1&type=chunk) - The company ended 2023 with **$662.6 million** in cash, cash equivalents, and marketable securities[2](index=2&type=chunk) - 2024 focus includes the U.S. launch of OGSIVEO, filing the NDA for mirdametinib, expanding OGSIVEO's geographic reach, and advancing the emerging portfolio[3](index=3&type=chunk) [Pipeline and Corporate Updates](index=1&type=section&id=Recent%20Business%20Highlights%20and%20Upcoming%20Milestones) The company achieved FDA approval for OGSIVEO™, submitted it for EMA approval, and reported positive Phase 2b results for mirdametinib, planning an NDA submission, while advancing its emerging pipeline and strengthening its balance sheet [OGSIVEO™ (Nirogacestat)](index=1&type=section&id=OGSIVEO%E2%84%A2%20(Nirogacestat)) OGSIVEO™ received FDA approval on November 27, 2023, for adult patients with progressing desmoid tumors, generating $5.4 million in its first partial quarter, with an MAA submitted to the EMA in February 2024 - Received U.S. FDA approval on November 27, 2023, for adult patients with progressing desmoid tumors[4](index=4&type=chunk) - Achieved **$5.4 million** in net product revenue in the first partial quarter of its U.S. launch, with payers representing over **98%** of commercial lives providing reimbursement[4](index=4&type=chunk) - Submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in February 2024[4](index=4&type=chunk) - Initial data from a Phase 2 trial in patients with recurrent ovarian granulosa cell tumors is expected in the second half of 2024[9](index=9&type=chunk) [Mirdametinib](index=2&type=section&id=Mirdametinib) The Phase 2b ReNeu trial of mirdametinib in patients with NF1-PN demonstrated positive results, with confirmed objective response rates of 52% in pediatric patients and 41% in adult patients, leading to an NDA submission planned for H1 2024 Phase 2b ReNeu Trial Topline Data | Patient Cohort | Confirmed Objective Response Rate (ORR) | | :--- | :--- | | Pediatric | 52% | | Adult | 41% | - Mirdametinib was generally well tolerated, with most adverse events being Grade 1 or 2, primarily rash, diarrhea, and nausea/vomiting[9](index=9&type=chunk) - An NDA submission to the FDA for the treatment of children and adults with NF1-PN is on track for the first half of 2024[9](index=9&type=chunk) [Emerging Pipeline & Corporate Updates](index=2&type=section&id=Emerging%20Pipeline) The company is advancing its emerging pipeline, with plans to present additional data for brimarafenib in H2 2024 and initiate a Phase 1a trial for SW-682 in H1 2024, supported by a public offering and new patent issuances - The FDA cleared the IND application for SW-682, a TEA Domain inhibitor, with a Phase 1a trial in Hippo mutant solid tumors planned for H1 2024[9](index=9&type=chunk) - Strengthened the balance sheet with a public offering in December 2023, raising gross proceeds of approximately **$316.2 million**[9](index=9&type=chunk) - New patents were issued for OGSIVEO and mirdametinib, extending intellectual property protection for both products into **2043**[9](index=9&type=chunk) Financial Performance [Fourth Quarter and Full Year 2023 Financial Results Summary](index=2&type=section&id=Financial%20Results%20Summary) For Q4 2023, SpringWorks reported its first product revenue of $5.4 million from OGSIVEO, with increased operating expenses leading to a net loss of $94.3 million, and a full-year net loss of $325.1 million, while maintaining a strong cash position of $662.6 million Q4 & Full Year 2023 Financial Highlights (in millions) | Metric | Q4 2023 | Q4 2022 | Full Year 2023 | Full Year 2022 | | :--- | :--- | :--- | :--- | :--- | | Net Product Revenues | $5.4M | $0 | $5.4M | $0 | | R&D Expenses | $43.7M | $37.9M | $150.5M | $146.1M | | SG&A Expenses | $59.8M | $40.5M | $197.6M | $134.6M | | Net Loss | $94.3M | $74.2M | $325.1M | $277.4M | | Net Loss Per Share | $1.44 | $1.19 | $5.15 | $5.21 | - The increase in SG&A expenses was largely attributable to commercial readiness activities to support the U.S. launch of OGSIVEO[14](index=14&type=chunk) - Cash, cash equivalents and marketable securities were **$662.6 million** as of December 31, 2023[14](index=14&type=chunk) [Condensed Consolidated Financial Statements](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated statements of operations for 2021-2023 and selected balance sheet data for 2022-2023, detailing revenue, operating expenses, net loss, and key financial positions Condensed Consolidated Statements of Operations (in thousands) | | Year Ended December 31, | | | | :--- | :--- | :--- | :--- | | | **2023** | **2022** | **2021** | | **Product revenue, net** | **$5,447** | **$—** | **$—** | | Total operating expenses | $348,460 | $280,674 | $173,468 | | Loss from operations | ($343,013) | ($280,674) | ($173,468) | | **Net loss** | **($325,104)** | **($277,417)** | **($173,910)** | | Net loss per share | ($5.15) | ($5.21) | ($3.59) | Selected Balance Sheet Data (in thousands) | | As of December 31, | | | :--- | :--- | :--- | | | **2023** | **2022** | | Cash, cash equivalents and marketable securities | $662,588 | $597,006 | | Total assets | $725,788 | $630,242 | | Total liabilities | $99,569 | $72,050 | | **Total stockholders' equity** | **$626,219** | **$558,192** | Company Information and Disclosures [About SpringWorks Therapeutics](index=3&type=section&id=About%20SpringWorks%20Therapeutics) SpringWorks Therapeutics is a commercial-stage biopharmaceutical company focused on precision medicine for severe rare diseases and cancer, with OGSIVEO™ as its first FDA-approved therapy - SpringWorks is a commercial-stage biopharmaceutical company focused on precision medicine for severe rare diseases and cancer[10](index=10&type=chunk) - The company's first FDA-approved therapy is OGSIVEO™ (nirogacestat), for adult patients with progressing desmoid tumors[10](index=10&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding the company's business, development, and commercialization plans, which are subject to risks and uncertainties, advising readers to consult SEC filings for detailed risk discussions - The press release includes forward-looking statements concerning business plans, clinical results, regulatory submissions (e.g., mirdametinib NDA), and commercialization efforts for OGSIVEO[13](index=13&type=chunk)[15](index=15&type=chunk) - Actual results may differ materially from expectations due to various risks and uncertainties[15](index=15&type=chunk) - For a detailed discussion of risks, investors should review the "Risk Factors" section in the company's Annual Report on Form 10-K for the year ended December 31, 2023[17](index=17&type=chunk)

[PART I – FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited Q3 2023 financial statements report a **$79.4 million** net loss, **$467.7 million** total assets, and **$422.4 million** liquidity [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$467.7 million** by September 30, 2023, driven by reduced marketable securities, with the accumulated deficit reaching **$800.7 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $98,895 | $67,490 | | Marketable securities | $323,524 | $529,516 | | Total current assets | $432,383 | $599,760 | | **Total assets** | **$467,654** | **$630,242** | | **Liabilities & Equity** | | | | Total current liabilities | $50,283 | $51,049 | | **Total liabilities** | **$72,755** | **$72,050** | | Accumulated deficit | ($800,712) | ($569,930) | | **Total stockholders' equity** | **$394,899** | **$558,192** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a Q3 2023 net loss of **$79.4 million** and a nine-month net loss of **$230.8 million**, primarily due to increased General and Administrative expenses Statement of Operations Summary (in thousands, except per-share data) | Metric | Q3 2023 | Q3 2022 | YTD 2023 | YTD 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $37,453 | $36,067 | $106,835 | $108,194 | | General and administrative | $46,546 | $35,673 | $137,715 | $94,026 | | **Total operating expenses** | **$83,999** | **$71,740** | **$244,550** | **$202,220** | | Loss from operations | ($83,999) | ($71,740) | ($244,550) | ($202,220) | | **Net loss** | **($79,437)** | **($72,388)** | **($230,782)** | **($203,239)** | | Net loss per share | ($1.27) | ($1.37) | ($3.70) | ($4.04) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$160.1 million** for the nine months ended September 30, 2023, offset by **$194.0 million** from investing activities Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($160,090) | ($107,363) | | Net cash provided by investing activities | $193,959 | $139,413 | | Net cash (used in) provided by financing activities | ($2,432) | $340,404 | | **Net increase in cash and cash equivalents** | **$31,437** | **$372,454** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail clinical-stage progress, including FDA acceptance of nirogacestat's NDA, confirmed liquidity of **$422.4 million**, and **$69.5 million** in YTD stock-based compensation - The FDA accepted the NDA for nirogacestat for desmoid tumors and granted priority review, with an updated PDUFA target action date of **November 27, 2023**[30](index=30&type=chunk) - Management estimates that its cash, cash equivalents, and marketable securities of **$422.4 million** as of September 30, 2023, are sufficient to fund operating expenses for at least the next twelve months[32](index=32&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Q3 2023 | Q3 2022 | YTD 2023 | YTD 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $8,502 | $7,101 | $25,976 | $22,217 | | General and administrative | $14,597 | $11,417 | $43,491 | $31,824 | | **Total** | **$23,099** | **$18,518** | **$69,467** | **$54,041** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical progress for nirogacestat and mirdametinib, increased net loss from G&A expenses, and a strong **$422.4 million** liquidity position [Overview](index=18&type=section&id=Overview) SpringWorks, a clinical-stage biopharmaceutical company, advances nirogacestat (FDA priority review, PDUFA **November 27, 2023**) and mirdametinib (Phase 2b data Q4 2023) - The FDA accepted the NDA for nirogacestat for adult desmoid tumors and set a PDUFA target action date of **November 27, 2023**[76](index=76&type=chunk) - The company expects to report topline data for the potentially registrational Phase 2b ReNeu trial of mirdametinib in NF1-PN in **Q4 2023** and plans to submit an NDA in the **first half of 2024** if data is positive[79](index=79&type=chunk) - The company nominated a TEAD inhibitor development candidate, **SW-682**, and plans to file an Investigational NDA in the **fourth quarter of 2023**[82](index=82&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) Q3 2023 R&D expenses rose **4%** to **$37.5 million**, while G&A expenses increased **30%** to **$46.5 million**, primarily due to commercial readiness activities for nirogacestat Comparison of Operating Expenses (in thousands) | Expense Category | Q3 2023 | Q3 2022 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $37,453 | $36,067 | $1,386 | 4% | | General and administrative | $46,546 | $35,673 | $10,873 | 30% | - The increase in G&A expense was largely attributable to commercial readiness activities for nirogacestat, including a **$8.0 million** increase in internal employee costs and a **$2.8 million** increase in consulting services for Q3 2023[97](index=97&type=chunk) YTD Comparison of Operating Expenses (in thousands) | Expense Category | YTD 2023 | YTD 2022 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $106,835 | $108,194 | ($1,359) | (1)% | | General and administrative | $137,715 | $94,026 | $43,689 | 46% | [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) The company's accumulated deficit reached **$800.7 million**, but management confirms sufficient liquidity to fund operations for at least the next twelve months, despite **$160.1 million** net cash used in operations YTD - As of September 30, 2023, the company had an accumulated deficit of **$800.7 million**[106](index=106&type=chunk) - Management estimates its current liquidity will enable it to meet operating expenses through at least **twelve months** after the filing date of this report[106](index=106&type=chunk) Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($160,090) | ($107,363) | | Net cash provided by investing activities | $193,959 | $139,413 | | Net cash (used in) provided by financing activities | ($2,432) | $340,404 | [Quantitative and Qualitative Disclosure About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) No material changes to market risks were reported compared to the 2022 Annual Report on Form 10-K - There were no material changes to the company's market risks from those described in the 2022 Form 10-K[126](index=126&type=chunk) [Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective** as of September 30, 2023[127](index=127&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal controls[128](index=128&type=chunk) [PART II. OTHER INFORMATION](index=28&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[130](index=130&type=chunk) [Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported from previous disclosures in the 2022 Form 10-K and Q2 2023 Form 10-Q - There have been no material changes in the company's risk factors from those previously disclosed in its 2022 Form 10-K and Q2 2023 Form 10-Q[131](index=131&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - None[132](index=132&type=chunk) [Other Information](index=28&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated Rule 10b5-1 trading plans during Q3 2023 - No directors or officers adopted, modified, or terminated any Rule 10b5-1 trading plans during the covered period[135](index=135&type=chunk) [Exhibits](index=28&type=section&id=Item%206.%20Exhibits) This section provides an index of exhibits filed with the Form 10-Q, including officer certifications