Fulcrum Therapeutics Inc (FULC) Q1 2025 Earnings Call May 01, 2025 08:00 AM ET Speaker0 Good morning, and welcome to Falcon Therapeutics First Quarter twenty twenty five Financial Results and Business Update Conference Call. Currently, all participants are in a listen only mode. This Speaker1 call Speaker0 is being webcast live and can be accessed on the Investors section of Falcum's website at www.falcumtx.com and is being recorded. Please be reminded that remarks during this call may contain forward looki ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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, 2025 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 jur ...

Exhibit 99.1 Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for First Quarter 2025 ― Enrollment complete in the 12 mg dose cohort (n=16) of the Phase 1b PIONEER trial of pociredir in sickle cell disease (SCD); initiated the 20 mg dose cohort ― ― On track to provide clinical data from the 12 mg dose cohort in early Q3 2025 and the 20 mg dose cohort by the end of 2025 ― ― Ended Q1 2025 with $226.6 million in cash, cash equivalents, and marketable securities; cash runway into a ...

― Enrollment complete in the 12 mg dose cohort (n=16) of the Phase 1b PIONEER trial of pociredir in sickle cell disease (SCD); initiated the 20 mg dose cohort ― ― On track to provide clinical data from the 12 mg dose cohort in early Q3 2025 and the 20 mg dose cohort by the end of 2025 ― ― Ended Q1 2025 with $226.6 million in cash, cash equivalents, and marketable securities; cash runway into at least 2027 ― ― Conference call and webcast scheduled for 8:00 a.m. ET today ― CAMBRIDGE, Mass., May 01, 2025 (GLOB ...

CAMBRIDGE, Mass., March 04, 2025 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (the “Company”) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today announced that management will participate in a fireside chat at the Leerink Partners Global Healthcare Conference in Miami, FL on March 11, 2025 at 8:40 am ET. The webcast of the fireside chat will be accessible HERE and by visiting the " ...

Fulcrum Therapeutics, Inc. (NASDAQ:FULC) Q4 2024 Earnings Conference Call February 25, 2025 8:00 AM ET Company Participants Alex Sapir - President & CEO Alan Musso - CFO Iain Fraser - SVP, Early Development Conference Call Participants Rick Miller - Cantor Fitzgerald Joseph Schwartz - Leerink Partners Matthew Biegler - Oppenheimer Edward Tenthoff - Piper Sandler Anish Nikhanj - RBC Capital Operator Good morning, and welcome to Fulcrum Therapeutics Fourth Quarter and Full Year 2024 Financial Results and Busi ...

Financial Performance - The company reported net losses of $9.7 million and $97.3 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $519.4 million as of December 31, 2024[447]. - The company has not generated any revenue from product sales and does not expect to do so for several years, if at all[451]. - Collaboration revenue increased by $77.2 million from $2.8 million in 2023 to $80.0 million in 2024, primarily due to an upfront license payment from the Sanofi collaboration agreement[472]. - The company expects substantial additional funding will be needed to support ongoing operations and growth strategy[448]. - The company expects to incur substantial operating losses and negative operating cash flows for the foreseeable future due to ongoing research and development activities[484]. Research and Development - Research and development expenses totaled $63.4 million for the year ended December 31, 2024, a decrease from $71.8 million in 2023[463]. - The company plans to submit an IND for DBA during the fourth quarter of 2025, focusing on inherited aplastic anemias[445]. - The company has reinitiated the Phase 1b clinical trial for pociredir at the 12 mg dose level, with 10 patients enrolled and expected clinical data by mid-2025[442]. - The Phase 3 REACH trial of losmapimod did not achieve its primary endpoint, leading to the suspension of its future development[443]. - A strategic plan was announced to reprioritize R&D activities, resulting in a workforce reduction from 80 to 51 employees, expected to save approximately $10.0 million annually starting Q1 2025[444]. - Research and development expenses decreased by $8.4 million from $71.8 million in 2023 to $63.4 million in 2024, mainly due to reduced external research costs and laboratory expenses[473][474]. Cash and Funding - The company had $241.0 million in cash, cash equivalents, and marketable securities as of December 31, 2024, expected to fund operations into at least 2027[450]. - Net cash used in operating activities was $2.2 million in 2024, a decrease of $88.8 million compared to $91.0 million in 2023, largely due to the $80.0 million upfront license payment received[481]. - Net cash provided by investing activities was $32.2 million in 2024, an increase of $68.9 million compared to net cash used of $36.7 million in 2023, driven by net maturities of marketable securities[482]. - The company entered into a controlled equity offering agreement in February 2024 for an at-the-market offering program with an aggregate offering price of up to $100.0 million[478]. - The company expects to finance cash needs through equity offerings, debt financings, and collaboration arrangements, with no current credit facility or committed sources of capital[489]. Expenses and Cost Management - General and administrative expenses decreased by $5.2 million from $41.7 million in 2023 to $36.4 million in 2024, attributed to lower employee compensation and facility costs[475]. - A restructuring plan announced in September 2024 reduced the workforce from 80 to 51 full-time employees to focus on key research and development activities[469]. - Stock-based compensation expense is expected to increase in future periods due to existing unrecognized expenses and additional awards granted[505]. Accounting and Financial Reporting - The company recognizes revenue under ASC 606 when control of promised goods or services is obtained, reflecting expected consideration[494]. - The company assesses collaboration arrangements to determine if they involve joint operating activities and applies appropriate recognition methods[492]. - The company accounts for uncertain tax positions using a more-likely-than-not threshold, with no uncertain tax positions reported as of each balance sheet date[508]. - The company evaluates its estimates and assumptions regarding accrued expenses on an ongoing basis, with no material differences reported to date[502]. Market and Economic Conditions - The company is exposed to interest rate sensitivity, but a 10% change in interest rates would not materially affect the fair market value of its investment portfolio[510]. - The company does not currently hedge foreign currency exchange rate risk, with minimal or no liabilities denominated in foreign currencies as of December 31, 2024[511]. - Inflation has not had a material effect on the company's business or financial condition during the years ended December 31, 2024, and 2023[512].

Financial Position - Fulcrum Therapeutics expects to report approximately $240 million in cash, cash equivalents, and marketable securities as of December 31, 2024[4] - The financial results for the fourth quarter and fiscal year ended December 31, 2024, are still being finalized and are subject to change[5] - The audit of Fulcrum's consolidated financial statements for the year ended December 31, 2024, is ongoing[5] - The information provided in the corporate presentation is unaudited and preliminary, lacking comprehensive details on Fulcrum's financial condition[5] - The report does not include all necessary information for a complete understanding of Fulcrum's financial condition[5] Corporate Information - The company is classified as an emerging growth company under the Securities Act[3] - Fulcrum's common stock is traded on the Nasdaq Global Market under the symbol FULC[2] - The company has not elected to use the extended transition period for complying with new financial accounting standards[3] - The information in the report is not deemed "filed" for purposes of the Securities Exchange Act[6] Corporate Presentation - An updated corporate presentation was published on January 13, 2025, which includes preliminary financial information[7]

― On track to provide clinical data from the 12 mg dose cohort from the Phase 1b PIONEER trial of pociredir in SCD in mid-2025 and the 20 mg dose cohort by the end of 2025 ― ― Ended 2024 with $241.0 million in cash, cash equivalents, and marketable securities; cash runway into at least 2027 ― ― Conference call and webcast scheduled for 8:00 a.m. ET today ― CAMBRIDGE, Mass., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focu ...

Core Viewpoint - Fulcrum Therapeutics, Inc. is set to release its fourth quarter and full year 2024 financial results on February 25, 2025, and will host a conference call to discuss these results and recent corporate developments [1]. Group 1: Financial Results Announcement - The financial results will be released before the U.S. financial markets open on February 25, 2025 [1]. - A conference call and webcast will take place at 8:00 a.m. ET on the same day to discuss the results [1]. Group 2: Company Overview - Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecules for genetically defined rare diseases [3]. - The company's lead program is pociredir, aimed at increasing fetal hemoglobin expression for treating sickle cell disease [3]. - Fulcrum employs proprietary technology to identify drug targets that can modulate gene expression to address the root causes of gene mis-expression [3].