UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 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: 001-38978 FULCRUM THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Emerging growth company ☒ If an emerging ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 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 001-38978 FULCRUM THERAPEUTICS, INC. (Exact name of registrant as specified in its Charter) Delaware 47-4839948 (State or other jurisdict ...

For the transition period from to UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-38978 FULCRUM THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 47-4839948 (State or other j ...

Company Overview - Fulcrum is a clinical-stage biopharmaceutical company focused on rebalancing gene expression to treat genetically defined diseases[4] - The company utilizes a systematic approach and its FulcrumSeek platform to identify small molecules that can modulate gene expression[4, 5] Pipeline Highlights - **COVID-19 (Losmapimod):** A Phase 3 trial (LOSVID) was initiated in Q3 2020[7, 8, 9] with topline data expected in Q1 2021[8, 17] The trial involves approximately 400 subjects randomized 1:1 to receive either 15mg of losmapimod or a placebo twice daily for 14 days[17] - **FSHD (Losmapimod):** Phase 2b ReDUX4 trial data is expected, with topline data in Q1 2021 and full data in Q2 2021[7, 8, 47] An interim analysis (IA) of the first 29 randomized subjects was conducted in Q3 2020[29] - **Sickle Cell Disease (FTX-6058) & β-Thalassemia:** An IND filing is planned for Q3 2020, with Phase 1 initiation in SCD expected in Q4 2020[7, 8] FTX-6058 has shown potent activity with less than 1 nM concentration and a clean off-target profile[50] Losmapimod for FSHD - The estimated US FSHD population is between 16,000 and 38,000, while the global population is estimated between 300,000 and 780,000[20] - Interim analysis of the ReDUX4 trial showed a 38-fold reduction in DUX4-driven gene expression in the losmapimod arm compared to a 5.4-fold reduction in the placebo arm in highest expressing muscle biopsies[35, 37] FTX-6058 for Hemoglobinopathies - FTX-6058 has demonstrated an absolute 8-18% increase in fetal hemoglobin (HbF) upon treatment, which could reduce mortality risk and recurring events in SCD patients[52] - The company's data indicates that small increases in HbF (1-5%) have the potential to provide clinical benefits to all SCD patients[52] Research and Discovery Collaborations - Fulcrum has research and discovery collaborations with Acceleron and MyoKardia, with potential milestone payments exceeding $800 million, plus upfront payments and R&D reimbursement[55, 56] - Fulcrum received a $10 million upfront payment from Acceleron and a $12.5 million payment at the close of the transaction with MyoKardia, along with reimbursement for relevant research expenses[55]

Fulcrum | --- | --- | --- | --- | --- | --- | |---------------------------------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Fulcrum Q2 2020 Conference Call | | | | | | | August 11, 2020 | | | | | | | | | | | | | | | | | | | | Disclaimer and Notice This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regard ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 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: 001-38978 FULCRUM THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 47-4839948 (State or other jurisd ...

Financial Data and Key Metrics Changes - The company entered Q1 2020 with $81.2 million in cash, cash equivalents, and marketable securities, which is expected to support operations into Q3 2021 [29] - Research and development expenses for Q1 2020 were $14.5 million, a decrease from $34.6 million in Q1 2019, primarily due to a one-time cost in the previous year [30] - General and administrative expenses increased to $5.1 million in Q1 2020 from $2.6 million in Q1 2019, attributed to increased personnel costs and public company operating expenses [31] Business Line Data and Key Metrics Changes - The FSHD program received orphan drug designation from both the U.S. FDA and the European Commission, supporting the advancement of losmapimod [9] - The ReDUX4 trial was amended to extend the treatment period from 24 to 48 weeks, allowing for a more robust data set [16][20] - The sickle-cell program, FTX-6058, is progressing towards IND filing, with plans to submit in the second half of 2020 and initiate a Phase 1 trial by year-end [28] Market Data and Key Metrics Changes - The estimated patient population for FSHD in the U.S. is between 16,000 to 38,000, with no approved drugs currently available [12] - The company continues to advance its proprietary product engine, FulcrumSeek, to identify drug targets in genetically defined diseases [23] Company Strategy and Development Direction - The company aims to discover and develop therapeutics for genetically defined diseases, focusing on addressing root causes [6] - The strategy includes increasing fetal hemoglobin levels to develop therapies for sickle-cell disease and beta thalassemia [26] - The company is committed to maintaining high standards in patient safety and data integrity during clinical trials, especially in light of COVID-19 [14][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to adapt to challenges posed by COVID-19, emphasizing the commitment to patient safety and data collection [15][20] - The company anticipates reporting interim analysis data from the ReDUX4 trial in Q3 2020 and expects to report top-line data in Q1 2021 [18][32] Other Important Information - The company has made significant progress in its clinical candidate FTX-6058, with robust preclinical data supporting its efficacy [28] - The management highlighted the importance of flexibility in trial protocols to accommodate potential disruptions due to the pandemic [43][54] Q&A Session Summary Question: Concerns about power loss with interim analysis - Management believes the sample size of 80 subjects provides appropriate power for the trial, and the interim analysis will offer initial insights for Phase III planning [35][36] Question: Recruitment status for subjects - Recruitment has been completed, and management is confident they have all necessary subjects [37] Question: Biopsy completion amid pandemic concerns - Management has built flexibility into the protocol to ensure data collection at either 16 or 36 weeks, mitigating risks associated with potential patient dropouts [39] Question: Doubling duration of ReDUX protocol - The extension was made to provide flexibility for data collection over a longer period, accommodating the ongoing pandemic [42][43] Question: Insights from the open-label trial - The open-label trial has been impacted more significantly due to being a single-site study, but valuable learnings have been gained [46] Question: Powering assumptions and study length - Management clarified that the amendment does not impact power assumptions, and patient compliance has been high [50][52] Question: Integrity of biopsy readings at different time points - Studies indicate stability in the DUX4 gene signature, supporting the integrity of readings at both 16 and 36 weeks [53][54]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (I.R.S. Employer Identification No.) (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (617) 651-8851 Securities registered pursuant to S ...

```markdown [PART I](index=5&type=section&id=PART%20I) [Business](index=5&type=section&id=Item%201.%20Business) Fulcrum Therapeutics is a clinical-stage biopharmaceutical company utilizing a proprietary product engine to develop small molecule therapies for genetically defined rare diseases [Overview and Pipeline](index=5&type=section&id=Overview%20and%20Pipeline) Fulcrum is a clinical-stage biopharmaceutical company focused on genetically defined rare diseases, with its lead product losmapimod for FSHD having completed Phase **2b** trial enrollment and FTX-6058 for hemoglobinopathies expected to have an IND submitted in the second half of **2020** - The company's lead product candidate, losmapimod for facioscapulohumeral muscular dystrophy (FSHD), initiated a **Phase 2b** clinical trial in **August 2019**, which completed enrollment in **February 2020**[16](index=16&type=chunk) - The second product candidate, FTX-6058 for hemoglobinopathies (sickle cell disease and ß-thalassemia), is in IND-enabling studies with a planned IND submission in the second half of **2020**[16](index=16&type=chunk)[24](index=24&type=chunk) Fulcrum Therapeutics Pipeline Status | Program (Product Candidate) | Indication | Discovery | Preclinical | Phase 1 | Phase 2 | Phase 3 | Status | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **losmapimod** | FSHD | ✔ | ✔ | ✔ | **✔** | | Completed Ph 2 enrollment | | **FTX-6058** | Sickle Cell Disease | ✔ | **✔** | | | | Submit IND in **2H 2020** | | **FTX-6058** | ß-Thalassemia | ✔ | **✔** | | | | Submit IND in **2H 2020** | | **Discovery Screening** | Duchenne Muscular Dystrophy | **✔** | | | | | Target ID / Validation | | **Discovery Screening** | Friedreich Ataxia | **✔** | | | | | Target ID / Validation | | **Discovery Screening** | Myotonic Dystrophy 1 | **✔** | | | | | Target ID / Validation | | **Discovery Screening** | α-Synucleinopathies | **✔** | | | | | Target ID / Validation | [Our Strategy and Product Engine](index=7&type=section&id=Our%20Strategy%20and%20Product%20Engine) The company's strategy focuses on rapidly developing lead candidates losmapimod and FTX-6058, while continuously expanding its portfolio using a proprietary product engine that integrates patient-derived cell models, libraries, and a database to identify drug targets modulating gene expression - Key strategic components include rapidly developing losmapimod for FSHD, advancing FTX-6058 into clinical trials, and applying the proprietary product engine to grow the portfolio of candidates for genetically defined diseases[30](index=30&type=chunk) - The product engine uses patient-derived tissue-relevant cell models, an annotated small molecule library, and customized CRISPR libraries to identify drug targets[39](index=39&type=chunk)[42](index=42&type=chunk) - FulcrumSeek, a proprietary database, is used with computational biology to generate drug target and biomarker hypotheses by analyzing the effects of perturbagens on human-derived cell systems[48](index=48&type=chunk) - The company focuses on a small molecule approach, citing advantages in biodistribution, tolerability, manufacturing, and patient access compared to other modalities like ASOs or gene therapies[55](index=55&type=chunk) [Our Product Candidate for Facioscapulohumeral Muscular Dystrophy (FSHD)](index=14&type=section&id=Our%20Product%20Candidate%20for%20Facioscapulohumeral%20Muscular%20Dystrophy%20(FSHD)) Fulcrum is developing losmapimod for FSHD, a rare muscular dystrophy caused by aberrant DUX4 gene expression, with a **Phase 2b** trial initiated in **August 2019** and orphan drug designation granted in **January 2020** - FSHD is a rare, progressive muscle wasting disorder with an estimated U.S. patient population of **16,000** to **38,000**, caused by the mis-expression of the DUX4 gene, with no approved therapies[18](index=18&type=chunk)[57](index=57&type=chunk) - Losmapimod, a p38α/ß inhibitor, was identified through Fulcrum's screening process to reduce DUX4 expression and was in-licensed from GSK, which had previously tested it in nearly **3,500** subjects for other indications, providing a substantial safety database[19](index=19&type=chunk)[61](index=61&type=chunk)[62](index=62&type=chunk) - A randomized, double-blind, placebo-controlled **Phase 2b** trial (ReDUX4) was initiated in **August 2019** in **80** patients to evaluate if losmapimod reduces DUX4-driven gene expression in muscle biopsies over a **24**-week period, with enrollment completed in **February 2020**[77](index=77&type=chunk)[113](index=113&type=chunk) - A **Phase 1** trial in healthy volunteers and FSHD patients showed losmapimod was well-tolerated and achieved dose-dependent concentrations in skeletal muscle, supporting the **15** mg twice-daily dose for **Phase 2** trials[111](index=111&type=chunk) [Our Product Candidate for Hemoglobinopathies](index=26&type=section&id=Our%20Product%20Candidate%20for%20Hemoglobinopathies) Fulcrum is developing FTX-6058, a novel small molecule designed to upregulate fetal hemoglobin (HbF) for treating sickle cell disease (SCD) and ß-thalassemia, with an IND submission planned for the second half of **2020** and a **Phase 1** trial in late **2020** - SCD affects approximately **100,000** individuals in the U.S. and is caused by a mutation in the HBB gene, leading to abnormal hemoglobin, where increasing fetal hemoglobin (HbF) is a known compensatory mechanism[127](index=127&type=chunk)[131](index=131&type=chunk)[133](index=133&type=chunk) - FTX-6058 was designed to inhibit a novel drug target identified by Fulcrum's product engine, leading to the elevation of HbF[142](index=142&type=chunk)[143](index=143&type=chunk) - In preclinical studies, FTX-6058 increased HbF levels to approximately **30%** of total hemoglobin in primary human CD34+ cells and showed a greater effect than hydroxyurea[149](index=149&type=chunk) - The company is conducting IND-enabling studies and plans to submit an IND for FTX-6058 in the second half of **2020**, with a **Phase 1** trial in healthy volunteers and SCD patients planned for late **2020**[157](index=157&type=chunk) [Discovery Screening Programs and Collaborations](index=32&type=section&id=Discovery%20Screening%20Programs%20and%20Collaborations) In **2019**, Fulcrum completed four new drug target identification screens and maintains key collaborations with GSK for losmapimod and Acceleron for pulmonary disease, involving potential milestone and royalty payments - The company completed four new drug target identification screens in **2019** for DMD, FA, DM1, and α-synucleinopathies, with identified targets currently under evaluation[160](index=160&type=chunk) - Under the GSK agreement for losmapimod, Fulcrum may be obligated to make milestone payments up to **$37.5 million** for clinical/regulatory events and up to **$60.0 million** for sales milestones, in addition to royalties[172](index=172&type=chunk) - In **December 2019**, Fulcrum entered a collaboration with Acceleron to identify targets for a pulmonary disease, receiving a **$10.0 million** upfront payment, and is eligible for up to **$438.5 million** in various milestone payments plus tiered royalties[176](index=176&type=chunk)[181](index=181&type=chunk) [Intellectual Property, Manufacturing, and Competition](index=35&type=section&id=Intellectual%20Property,%20Manufacturing,%20and%20Competition) Fulcrum's intellectual property strategy combines owned and in-licensed patents, with the losmapimod method-of-use patent expiring in **2038** and reliance on CMOs for clinical supply, facing competition in SCD and ß-thalassemia but none in FSHD - The losmapimod patent portfolio includes in-licensed composition of matter patents from GSK expiring in **2023** and a Fulcrum-owned method-of-use patent for FSHD expiring in **2038**[189](index=189&type=chunk)[190](index=190&type=chunk) - The intellectual property for FTX-6058 includes one owned PCT application; any resulting patents would have a projected expiration in **2039**[191](index=191&type=chunk) - The company does not own manufacturing facilities and relies on third parties, including obtaining losmapimod tablets and API from GSK for current trials and engaging CMOs for future supply[196](index=196&type=chunk) - There are no approved therapies for FSHD, while for SCD and ß-thalassemia, Fulcrum faces competition from existing treatments like hydroxyurea and luspatercept, as well as from companies developing novel small molecules, gene therapies, and gene editing approaches[203](index=203&type=chunk)[205](index=205&type=chunk)[208](index=208&type=chunk) [Government Regulation](index=39&type=section&id=Government%20Regulation) The company's operations are subject to extensive regulation by the FDA and comparable authorities, covering all stages of product development from preclinical studies to post-approval marketing, with potential for expedited pathways and impact from healthcare laws and reforms - Drug development in the U.S. requires completing preclinical testing, submitting an IND to the FDA, conducting three phases of human clinical trials to establish safety and efficacy, and obtaining NDA approval[214](index=214&type=chunk)[229](index=229&type=chunk) - The FDA offers expedited programs such as Fast Track, Breakthrough Therapy, and Accelerated Approval for drugs treating serious conditions with unmet medical needs, which can potentially speed up development and review[245](index=245&type=chunk)[251](index=251&type=chunk) - The company is subject to healthcare fraud and abuse laws, including the federal Anti-Kickback Statute and the False Claims Act, as well as transparency laws like the Physician Payments Sunshine Act[281](index=281&type=chunk)[283](index=283&type=chunk) - Healthcare reform, including the ACA and subsequent legislative actions, impacts drug pricing, coverage, and reimbursement, creating uncertainty and potential downward pressure on prices for any future approved products[288](index=288&type=chunk)[290](index=290&type=chunk) [Risk Factors](index=59&type=page&id=Item%201A.%20Risk%20Factors) The company faces substantial risks, including a history of significant losses and the need for additional capital to fund operations - The company has a history of significant operating losses (**$82.7 million** in **2019**) and expects to incur losses for the next several years, with profitability dependent on successful product development and commercialization[325](index=325&type=chunk) - Substantial additional funding will be required to continue clinical trials and R&D, and failure to raise capital could force delays or elimination of programs[328](index=328&type=chunk) - Clinical drug development is a lengthy, expensive, and uncertain process, where early trial results may not predict future success, and product candidates may fail at any stage[347](index=347&type=chunk) - The company relies on third parties for clinical trials and manufacturing, which introduces risks related to performance, quality, and supply chain continuity[395](index=395&type=chunk)[399](index=399&type=chunk) - Intellectual property risks include the potential inability to obtain and maintain patent protection, the expiration of key patents (losmapimod composition of matter patent in **2023**), and the possibility of infringement lawsuits[416](index=416&type=chunk)[419](index=419&type=chunk)[423](index=423&type=chunk) [Properties](index=103&type=section&id=Item%202.%20Properties) The company's main facility is approximately **28,731** square feet of leased office and laboratory space located in Cambridge, Massachusetts, with the current lease set to expire in **June 2028** - The company's principal facilities consist of approximately **28,731** square feet of leased office and laboratory space in Cambridge, Massachusetts[550](index=550&type=chunk) - The lease for the Cambridge facility expires in **June 2028**[550](index=550&type=chunk) [Legal Proceedings](index=103&type=section&id=Item%203.%20Legal%20Proceedings) As of the reporting date, Fulcrum Therapeutics, Inc. is not a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[551](index=551&type=chunk) [PART II](index=104&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=104&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Fulcrum's common stock began trading on the Nasdaq Global Market under the symbol "FULC" on **July 18, 2019**, with **74** holders of record as of **February 28, 2020**, and the company has never paid cash dividends - The company's common stock began trading on the Nasdaq Global Market under the symbol "FULC" on **July 18, 2019**[554](index=554&type=chunk) - The company completed its IPO on **July 22, 2019**, selling **4,500,000** shares at **$16.00** per share, resulting in net proceeds of **$63.9 million**[563](index=563&type=chunk)[564](index=564&type=chunk) - As of **December 31, 2019**, none of the net proceeds from the IPO had been used to fund operations[565](index=565&type=chunk) - The company has never declared or paid cash dividends and does not intend to in the foreseeable future[556](index=556&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=106&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a net loss of **$82.7 million** for **2019**, a significant increase from the **$32.6 million** loss in **2018**, primarily due to a **$45.9 million** rise in R&D expenses, with **$96.7 million** in cash and cash equivalents expected to fund operations into the third quarter of **2021** [Results of Operations](index=110&type=section&id=Results%20of%20Operations) For the year ended **December 31, 2019**, the company's net loss increased to **$82.7 million** from **$32.6 million** in **2018**, primarily due to a surge in research and development expenses to **$71.1 million** from **$25.2 million**, driven by a **$25.6 million** IPR&D expense and **$9.1 million** in higher clinical trial costs Comparison of Results of Operations (**2019** vs. **2018**) | (in thousands) | **2019** | **2018** | Change ($) | | :--- | :--- | :--- | :--- | | Research and development | **$71,072** | **$25,184** | **$45,888** | | General and administrative | **$13,145** | **$8,314** | **$4,831** | | **Total operating expenses** | **$84,217** | **$33,498** | **$50,719** | | Loss from operations | (**$84,217**) | (**$33,498**) | (**$50,719**) | | Other income, net | **$1,540** | **$910** | **$630** | | **Net loss** | (**$82,677**) | (**$32,588**) | (**$50,089**) | - Research and development expenses increased by **$45.9 million**, primarily due to a **$25.6 million** in-process research and development (IPR&D) expense related to the GSK license agreement and a **$9.1 million** increase in external clinical activity costs for losmapimod[597](index=597&type=chunk) - General and administrative expenses increased by **$4.8 million**, mainly from a **$2.5 million** increase in consulting and professional fees and a **$2.3 million** increase in personnel-related costs due to headcount growth[597](index=597&type=chunk) [Liquidity and Capital Resources](index=112&type=section&id=Liquidity%20and%20Capital%20Resources) As of **December 31, 2019**, Fulcrum had **$96.7 million** in cash and cash equivalents, primarily funded by IPO proceeds and collaborations, with existing cash expected to fund operations into the third quarter of **2021** - As of **December 31, 2019**, the company had cash and cash equivalents of **$96.7 million**[600](index=600&type=chunk) Cash Flow Summary (**2019** vs. **2018**) | (in thousands) | **2019** | **2018** | | :--- | :--- | :--- | | Net cash used in operating activities | (**$39,483**) | (**$22,562**) | | Net cash used in investing activities | (**$944**) | (**$8,981**) | | Net cash provided by financing activities | **$64,343** | **$105,025** | - The company estimates that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the third quarter of **2021**[607](index=607&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=118&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its cash and cash equivalents, with foreign currency exchange rate risk from international vendors, but no material effect from inflation or hedging instruments currently in use - The primary market risk is interest rate sensitivity on cash and cash equivalents of **$96.7 million**, but a **10%** change in rates is not expected to be material[642](index=642&type=chunk) - The company is exposed to foreign currency exchange rate risk due to contracts with vendors outside the U.S., but does not currently hedge this risk[643](index=643&type=chunk) [Financial Statements and Supplementary Data](index=118&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section contains the company's audited consolidated financial statements for the fiscal years ended **December 31, 2019** and **2018**, including the Report of the Independent Registered Public Accounting Firm, Consolidated Balance Sheets, Statements of Operations and Comprehensive Loss, Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit), Statements of Cash Flows, and accompanying Notes Consolidated Balance Sheet Highlights (As of **Dec 31, 2019**) | (In thousands) | Amount | | :--- | :--- | | **Assets** | | | Cash and cash equivalents | **$96,713** | | Total current assets | **$100,083** | | **Total assets** | **$110,439** | | **Liabilities & Equity** | | | Total current liabilities | **$12,140** | | **Total liabilities** | **$23,286** | | Total stockholders' equity | **$87,153** | Consolidated Statement of Operations Highlights (Year Ended **Dec 31, 2019**) | (In thousands) | Amount | | :--- | :--- | | Research and development | **$71,072** | | General and administrative | **$13,145** | | **Total operating expenses** | **$84,217** | | Loss from operations | (**$84,217**) | | **Net loss** | (**$82,677**) | [Controls and Procedures](index=119&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of **December 31, 2019**, with no material changes reported during the fourth quarter of **2019** - Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of **December 31, 2019**[648](index=648&type=chunk) - As a newly public company, the annual report does not include a management assessment or auditor attestation on internal control over financial reporting, per SEC transition rules[649](index=649&type=chunk) [PART III](index=120&type=section&id=PART%20III) [Directors, Executive Officers and Corporate Governance](index=120&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding the company's directors, executive officers, and corporate governance practices is incorporated by reference from the upcoming Definitive Proxy Statement for its **2020** Annual Meeting of Stockholders - Information required for this item will be included in the Definitive Proxy Statement for the **2020** Annual Meeting of Stockholders and is incorporated by reference[654](index=654&type=chunk) [Executive Compensation](index=120&type=section&id=Item%2011.%20Executive%20Compensation) Details concerning executive compensation are incorporated by reference from the company's Definitive Proxy Statement to be filed for its **2020** Annual Meeting of Stockholders - Information required for this item will be included in the Definitive Proxy Statement for the **2020** Annual Meeting of Stockholders and is incorporated by reference[656](index=656&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=120&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership of certain beneficial owners, management, and related stockholder matters is incorporated by reference from the company's Definitive Proxy Statement for its **2020** Annual Meeting of Stockholders - Information required for this item will be included in the Definitive Proxy Statement for the **2020** Annual Meeting of Stockholders and is incorporated by reference[657](index=657&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=120&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) Information about certain relationships, related-party transactions, and director independence is incorporated by reference from the company's Definitive Proxy Statement for its **2020** Annual Meeting of Stockholders - Information required for this item will be included in the Definitive Proxy Statement for the **2020** Annual Meeting of Stockholders and is incorporated by reference[658](index=658&type=chunk) [Principal Accounting Fees and Services](index=120&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Details regarding principal accounting fees and services are incorporated by reference from the company's Definitive Proxy Statement for its **2020** Annual Meeting of Stockholders - Information required for this item will be included in the Definitive Proxy Statement for the **2020** Annual Meeting of Stockholders and is incorporated by reference[659](index=659&type=chunk) [PART IV](index=121&type=section&id=PART%20IV) [Exhibits and Financial Statement Schedules](index=121&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the consolidated financial statements and exhibits filed as part of the Annual Report on Form **10**-K, with financial statement schedules omitted as not applicable - This section includes the consolidated financial statements and lists all exhibits filed with the Form **10**-K, which are incorporated by reference[662](index=662&type=chunk)[665](index=665&type=chunk) ```

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 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: 001-38978 FULCRUM THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 47-4839948 (State or other j ...