[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

PART I – FINANCIAL INFORMATION This section provides the unaudited condensed consolidated financial statements and related management discussion for the period ended June 30, 2023 [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the period ended June 30, 2023, highlighting a decrease in total assets to **$517.3 million** and a net loss of **$151.3 million** [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This table presents the company's financial position, including assets, liabilities, and equity, as of June 30, 2023, and December 31, 2022 Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $115,001 | $67,490 | | Marketable securities | $361,706 | $524,722 | | **Total Assets** | **$517,329** | **$630,242** | | **Total Liabilities** | **$65,888** | **$72,050** | | **Total Stockholders' Equity** | **$451,441** | **$558,192** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This table summarizes the company's revenues, expenses, and net loss for the three and six months ended June 30, 2023 and 2022 Statement of Operations Summary (in thousands, except per-share data) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $35,858 | $38,024 | $69,382 | $72,127 | | General and administrative | $46,994 | $30,987 | $91,169 | $58,353 | | **Total operating expenses** | **$82,852** | **$69,011** | **$160,551** | **$130,480** | | **Net loss** | **$(77,925)** | **$(69,050)** | **$(151,345)** | **$(130,851)** | | Net loss per share | $(1.25) | $(1.41) | $(2.43) | $(2.67) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This table details the cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2023 and 2022 Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(109,629) | $(87,759) | | Net cash provided by investing activities | $159,360 | $53,181 | | Net cash (used in) provided by financing activities | $(2,190) | $173 | | **Net increase (decrease) in cash** | **$47,541** | **$(34,405)** | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides additional details and context for the financial statements, including business overview, significant accounting policies, and financial position - The company is a clinical-stage biopharmaceutical firm with two late-stage product candidates: nirogacestat and mirdametinib. An NDA for nirogacestat for desmoid tumors was submitted and accepted for **priority review** by the FDA[30](index=30&type=chunk) - The PDUFA target action date for the nirogacestat NDA was **extended by three months** to **November 27, 2023**, to allow the FDA more time to review additional data analyses[30](index=30&type=chunk) - The company has a history of losses, with an accumulated deficit of **$721.3 million** as of June 30, 2023. However, management believes its cash, cash equivalents, and marketable securities of **$476.7 million** are **sufficient to fund operations for at least the next twelve months**[31](index=31&type=chunk)[32](index=32&type=chunk) - Stock-based compensation expense for the six months ended June 30, 2023, was **$46.4 million**, an **increase** from **$35.5 million** in the same period of 2022[70](index=70&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's business overview, financial results, and liquidity, focusing on clinical progress, increased General & Administrative expenses, and sufficient capital for the next year [Overview](index=19&type=section&id=Overview) This section provides a strategic overview of the company's clinical development programs and commercialization plans for its lead product candidates - The company's most advanced product candidate, nirogacestat, is under **priority review** by the FDA for the treatment of desmoid tumors, with an updated PDUFA target action date of **November 27, 2023**[75](index=75&type=chunk) - The second lead product candidate, mirdametinib, is in a potentially registrational Phase 2b trial for NF1-PN. Topline data is expected in **Q4 2023**, with a planned NDA submission in the **first half of 2024** if data is positive[78](index=78&type=chunk) - The company is actively preparing for the **commercial launch** of nirogacestat in the U.S., if approved, and plans to file for marketing authorization in the European Union in **2024**[76](index=76&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) This section analyzes the company's operating expenses, highlighting changes in research and development and general and administrative costs Comparison of Operating Expenses (in thousands) | Expense Category | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $35,858 | $38,024 | $69,382 | $72,127 | | General and administrative | $46,994 | $30,987 | $91,169 | $58,353 | - General and administrative expenses **increased by 52%** for Q2 2023 and **56%** for H1 2023 compared to the same periods in 2022. This **increase** was primarily driven by commercial readiness activities for the potential U.S. launch of nirogacestat, including hiring for sales, marketing, and commercial functions[94](index=94&type=chunk)[95](index=95&type=chunk)[101](index=101&type=chunk) - Research and development expenses **decreased by 6%** for Q2 2023 and **4%** for H1 2023 compared to the prior year periods, mainly due to lower external costs for drug manufacturing and clinical trials[92](index=92&type=chunk)[93](index=93&type=chunk)[99](index=99&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's financial position, cash flows, and ability to fund future operations - The company had an accumulated deficit of **$721.3 million** as of June 30, 2023. Management estimates that its current cash, cash equivalents, and marketable securities are **sufficient to fund operating expenses for at least the next twelve months**[104](index=104&type=chunk) - Net cash used in operating activities **increased to $109.6 million** for the first six months of 2023, compared to **$87.8 million** for the same period in 2022, driven by a higher net loss and changes in operating assets and liabilities[105](index=105&type=chunk)[106](index=106&type=chunk) - Net cash provided by investing activities was **$159.4 million** for the first six months of 2023, primarily from the net sale and maturity of marketable securities[107](index=107&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) The company reports that there have been **no material changes** to its market risks from those disclosed in its Annual Report on Form 10-K for the year ended December 31, 2022 - There were **no material changes** to the company's market risks from those described in the 2022 Form 10-K[122](index=122&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2023, with **no changes** to internal control over financial reporting during the quarter - Management evaluated disclosure controls and procedures and found them to be **effective** as of the end of the reporting period[123](index=123&type=chunk)[124](index=124&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, these controls[125](index=125&type=chunk) PART II – OTHER INFORMATION This section covers legal proceedings, updated risk factors, and other standard disclosures [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) As of the report date, the company is **not currently involved in any material legal proceedings** - The company is **not currently involved in any material legal proceedings**[127](index=127&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) This section updates the company's risk factors, highlighting a **new risk factor** related to the financial services industry and its potential adverse impacts - A **new risk factor** has been added concerning adverse developments in the financial services industry, prompted by recent events like the failure of Silicon Valley Bank (SVB)[129](index=129&type=chunk) - Potential impacts from financial institution failures include **delayed or lost access** to deposits, **termination of cash management services**, and **impaired ability to secure financing**[131](index=131&type=chunk)[132](index=132&type=chunk) - The instability could also affect customers and suppliers, potentially leading to **payment defaults or disruptions** that would **materially harm** the company's business[133](index=133&type=chunk) [Other Items (Items 2-6)](index=29&type=section&id=Other%20Items%20(Items%202-6)) This section covers several standard disclosure items, reporting **no activity** for most, and listing the **index of exhibits** filed with the Form 10-Q - The company reported **no activity** under Item 2 (Unregistered Sales of Equity Securities), Item 3 (Defaults Upon Senior Securities), Item 4 (Mine Safety Disclosures), or Item 5 (Other Information)[134](index=134&type=chunk)[135](index=135&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk) - Item 6 provides an **index of exhibits** filed with the report, including **required certifications** from the CEO and CFO[139](index=139&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-Q ____________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2023 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _ TO _ COMMISSION FILE NUMBER 001-39044 _____ ...

Nirogacestat in Desmoid Tumors - The FDA accepted the NDA submission for Nirogacestat in desmoid tumors in Q1 2023 with Priority Review, with a PDUFA date of August 27, 2023 [61] - Desmoid tumor recurrence can be up to 77% following surgery [67] - In the Phase 3 DeFi trial, the objective response rate (ORR) for Nirogacestat was 41%, compared to 8% for placebo (p<0001) [90] - The Phase 3 DeFi trial demonstrated a 71% reduction in the risk of disease progression with Nirogacestat (hazard ratio: 029, p<0001) [140] - Among women of childbearing potential, ovarian dysfunction (OD) was observed in 75% receiving nirogacestat [119] Mirdametinib in NF1-PN - Topline data from the Phase 2b ReNeu trial in NF1-PN is expected in 2H 2023 [163] - NF1 patients have a ~30-50% lifetime risk of developing NF1-PN [151] - In the ReNeu trial, 50% of adult patients achieved an objective response by BICR [170] MAPK Portfolio - Approximately 25% of ER+ mBC patients progress on endocrine therapy [2] - Class 1 and 2 MEK mutants are sensitive to Mirdametinib in vitro [3] - BGB-3245 is active against resistance mutations that arise in BRAF V600 patients treated with approved BRAF inhibitors [270]

Clinical Trials and Regulatory Approvals - The company announced full enrollment in its registrational Phase 3 clinical trial of nirogacestat in July 2020 and initiated a potentially registrational Phase 2b clinical trial of mirdametinib in October 2019[294]. - Positive topline results from the Phase 3 clinical trial of nirogacestat were announced in May 2022, with additional data presented at the European Society for Medical Oncology Congress in September 2022[294]. - A New Drug Application (NDA) for nirogacestat was submitted to the FDA in December 2022, which was accepted in February 2023 and granted priority review with a PDUFA target action date of August 27, 2023[294]. - Positive topline data from the DeFi trial was reported in May 2022, supporting the NDA submission for nirogacestat in December 2022, which was accepted by the FDA in February 2023 with a PDUFA target action date of August 27, 2023[303]. - Successful completion of clinical trials is essential for submitting a New Drug Application (NDA) to the FDA and obtaining marketing approval for product candidates[386]. - The regulatory approval process for product candidates is lengthy and uncertain, with the company having submitted an NDA for nirogacestat in December 2022, which was accepted in February 2023[456]. - The FDA may require an Advisory Committee to evaluate safety and efficacy data, which could impact approval timelines[457]. - Clinical trials may face delays or termination due to various factors, including patient enrollment challenges and regulatory compliance issues[458]. - The FDA's ability to conduct inspections has been affected by the COVID-19 pandemic, potentially delaying approval processes[459]. - Data from clinical trials conducted outside the U.S. may not be accepted by the FDA, impacting the ability to support marketing applications[468]. Financial Performance and Capital Needs - The company has incurred significant net losses since inception and anticipates continuing to incur net losses in the future[292]. - The company has incurred significant net losses of $277.4 million, $173.9 million, and $45.6 million for the fiscal years ended December 31, 2022, 2021, and 2020, respectively, with an accumulated deficit of $569.9 million as of December 31, 2022[363]. - As of December 31, 2022, the company had $597.0 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into 2026[370]. - The company may need to raise additional capital to fund development or commercialization activities if suitable collaborations are not established[337]. - The company expects to continue incurring significant losses for the foreseeable future as it prepares for commercialization of its product candidates[363]. Dependence on Third Parties - The company relies on third parties for conducting certain aspects of preclinical studies and clinical trials, which could impact the ability to obtain regulatory approval for product candidates[288]. - The company has not yet manufactured on a commercial scale and relies on third parties for the production of its product candidates[289]. - The company relies on third-party manufacturers for all preclinical and clinical trial product supplies, which poses risks of limited supply or quality issues that could delay development efforts[321]. - The company relies heavily on third parties for operational support, which poses risks if these services are not available or if quality is compromised[352]. - The company’s reliance on third parties for clinical trials may limit control over compliance with protocols and regulatory requirements, impacting the reliability of clinical data[314]. - If any third-party relationships terminate, the company may struggle to establish new arrangements on commercially reasonable terms[319]. - The company relies on third parties for research and preclinical activities, and initial promise in preclinical studies may not translate to successful clinical outcomes[399]. Market and Competitive Landscape - The target patient populations for nirogacestat and mirdametinib are small, and if estimates of treatable patients are lower than expected, potential revenues could be compromised[288]. - The company faces significant competition in securing partnerships for its product candidates, which is a time-consuming and complex process[337]. - The company faces intense competition from larger biopharmaceutical firms with greater resources, which could impact its market position[408]. - Even with regulatory approval, market acceptance of product candidates may be limited by competition and physician reluctance to switch from existing treatments[411]. Intellectual Property and Legal Risks - Intellectual property protection is crucial for commercial success, and failure to secure adequate patent protection could adversely affect the company's competitive position[418]. - The U.S. patents covering polymorphic forms of nirogacestat will expire in 2039, and those for mirdametinib will expire in 2041, potentially allowing competition from generics post-expiration[419]. - The company intends to rely on orphan drug exclusivity to market lead products after patent expiration, which may not provide sufficient protection against competition[419]. - The patenting process is costly and time-consuming, and the company may not be able to file all necessary patent applications in a timely manner[420]. - There is uncertainty regarding the strength and enforceability of patents, which may be challenged by third parties, potentially leading to invalidation or narrowing of claims[421]. - The company may face substantial litigation expenses and resource diversion due to potential patent infringement claims, which could significantly harm its business[434]. - Changes in patent law and recent Supreme Court rulings may weaken the company's ability to protect its intellectual property and could diminish the value of its patents[450]. Operational Challenges - The ongoing COVID-19 pandemic may impact the company's research and development timelines and outcomes[283]. - The ongoing COVID-19 pandemic has significantly impacted the ability to meet development timelines due to disruptions with CROs, which may affect preclinical studies and clinical trials[320]. - The company may face challenges in expanding its organization and hiring new employees, which could hinder the development and commercialization of its product candidates[353]. - The company has a limited operating history, making it difficult to evaluate its prospects and likelihood of success[292]. - The company may face challenges in identifying, in-licensing, or acquiring product candidates, which could limit its growth strategy[357]. Compliance and Regulatory Obligations - The company is subject to various risks related to research and development in the biopharmaceutical industry, including the uncertainty of clinical trial outcomes[384]. - The company must comply with various state and foreign healthcare laws, which may impose broader requirements than federal laws, complicating compliance efforts[472]. - The company faces scrutiny from federal and state enforcement bodies regarding compliance with healthcare laws, which can lead to investigations and settlements[475]. - Ongoing regulatory obligations will result in significant expenses and potential penalties if the company fails to comply with requirements post-approval of product candidates[479].

Corporate Presentation November 2022 六 SpringW Forward-Looking Statements 2 Note: Unless otherwise indicated, the information presented herein is as of November 2022 and made publicly available on November 3, 2022. This presentation may contain "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 t ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-Q ____________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2022 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (203) 883-9490 FOR THE TRANSITION PERIOD FROM _ TO _ COMMISSION FILE NUM ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-Q ____________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2022 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _ TO _ COMMISSION FILE NUMBER 001-39044 ______ ...

Corporate Presentation May 2022 次 Spring\wੂ Forward-Looking Statements 2 Note: Unless otherwise indicated, the information presented herein is as of May 2022 and made publicly available on May 24, 2022. This presentation may contain "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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-Q ____________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2022 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 100 Washington Blvd Stamford, Connecticut 06902 (Address of principal execut ...