Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and unique PIN which will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of the company's website at www.fulcrumtx.com or by clicking here. Following the live webcast, an archived replay will also be available. Contact: Chris Calabrese LifeSci Advisors, LLC ccalabrese@lifesciadvisors.com 917-680-5608 CAMBRIDGE, Mass. ...

Company Overview - Fulcrum Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecules aimed at improving the lives of patients with genetically defined rare diseases [3] - The company has two lead programs in clinical development: losmapimod for facioscapulohumeral muscular dystrophy (FSHD) and pociredir for sickle cell disease (SCD) and other hemoglobinopathies [3] - Fulcrum employs proprietary technology to identify drug targets that can modulate gene expression to address the root causes of gene mis-expression [3] Financial Results Announcement - Fulcrum Therapeutics will release its second quarter 2024 financial results on July 31, 2024, before the U.S. financial markets open [2] - Management will host a conference call and webcast at 8:00 a.m. ET on the same day to discuss the results and provide updates on recent corporate developments [2]

Company Overview - Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecules for genetically defined rare diseases with high unmet medical needs [2][3] - The company's lead programs include losmapimod for facioscapulohumeral muscular dystrophy (FSHD) and pociredir for sickle cell disease (SCD) and other hemoglobinopathies [2][3] Upcoming Presentations - Fulcrum Therapeutics announced upcoming presentations at the 31st Annual FSHD Society International Research Congress on June 13-14, 2024, in Denver, Colorado [3] - Presentations will include an abstract on the baseline characteristics of patients in the Phase 3 REACH trial of losmapimod in FSHD [3] Research Focus - The company utilizes proprietary technology to identify drug targets that can modulate gene expression to address the root causes of gene mis-expression [2]

Core Viewpoint - Fulcrum Therapeutics, Inc. (FULC) shows potential for significant upside, with a mean price target of $13.38 indicating a 69.2% increase from the current price of $7.91 [1] Price Targets and Analyst Consensus - The average price target consists of eight estimates ranging from a low of $5 to a high of $19, with a standard deviation of $5.13, indicating variability in analyst predictions [2] - The lowest estimate suggests a decline of 36.8%, while the highest indicates a potential upside of 140.2% [2] - A low standard deviation signifies greater agreement among analysts regarding price movement, which can be a starting point for further research [8] Earnings Estimates and Analyst Optimism - Analysts are optimistic about FULC's earnings prospects, as indicated by a trend of upward revisions in earnings estimates, which historically correlates with stock price movements [10] - Over the past 30 days, the Zacks Consensus Estimate for the current year has increased by 0.5%, with one estimate moving higher and no negative revisions [11] - FULC holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, suggesting strong potential for near-term upside [12]

Financial Performance - As of March 31, 2024, Fulcrum Therapeutics reported total assets of $232.6 million, a decrease from $257.7 million as of December 31, 2023, representing a decline of approximately 9.7%[17] - For the three months ended March 31, 2024, Fulcrum reported a net loss of $26.9 million, compared to a net loss of $24.8 million for the same period in 2023, reflecting an increase in loss of approximately 8.5%[19] - Total operating expenses for the first quarter of 2024 were $29.8 million, up from $28.2 million in the same quarter of 2023, marking an increase of about 5.6%[19] - The company had no collaboration revenue for the first quarter of 2024, a decrease from $295,000 in the same period of 2023[19] - As of March 31, 2024, the accumulated deficit stood at $536.5 million, up from $509.7 million at the end of 2023, indicating an increase of approximately 5.3%[17] - Fulcrum's total stockholders' equity decreased to $213.6 million as of March 31, 2024, from $235.2 million at the end of 2023, a decline of about 9.2%[17] - The company expects to incur substantial operating losses and negative operating cash flows for the foreseeable future due to ongoing research and development activities[151] - The net loss for the year ended December 31, 2023, was $97.3 million, and for the three months ended March 31, 2024, it was $26.9 million, with an accumulated deficit of $536.5 million as of March 31, 2024[167] Cash and Liquidity - The company had cash and cash equivalents of $39.9 million as of March 31, 2024, up from $25.6 million at the end of 2023, indicating a significant increase of 56.7%[17] - The Company expects its cash, cash equivalents, and marketable securities to be sufficient to fund operating expenses and capital expenditures for at least 12 months[34] - As of March 31, 2024, total cash equivalents and marketable securities amounted to $213.3 million, a decrease from $236.2 million as of December 31, 2023[40][43] - The company had cash, cash equivalents, and marketable securities totaling $213.3 million as of March 31, 2024, which, along with the expected $80.0 million payment, is projected to fund operations into 2027[175] - The company anticipates continued reliance on additional financing due to the lengthy and uncertain process of product development, which may not yield commercial success for several years[176] - The company may need to raise additional capital through equity offerings, debt financings, or collaboration arrangements, which could dilute existing stockholders' interests[155] Research and Development - Research and development expenses increased by $3.1 million from $16.7 million in Q1 2023 to $19.8 million in Q1 2024, primarily due to increased external research and development costs[140] - The company plans to continue clinical development of losmapimod and pociredir, advance clinical-stage candidates, and seek regulatory approvals for successful candidates[119] - The Phase 3 clinical trial of losmapimod for the treatment of FSHD completed enrollment in September 2023[174] - The FDA imposed a clinical hold on the IND application for pociredir, which was lifted in August 2023[173] - The company is still in the early stages of development for its product candidates and has not completed development of any product candidates[167] - The company has two product candidates in clinical development, with high risks of failure and no completed pivotal clinical trials[201] Collaboration and Revenue - The Company achieved a $2.5 million specified preclinical milestone under the MyoKardia Collaboration Agreement[68] - The Company received a non-refundable upfront payment of $10.0 million from MyoKardia as part of the collaboration agreement[67] - The Company recognized no collaboration revenue associated with the MyoKardia Collaboration Agreement for the three months ended March 31, 2024, compared to $0.3 million for the same period in 2023[81] - The company expects to recognize revenue from the Sanofi Agreement associated with the $80.0 million upfront payment and potential future milestones and royalties[125] - The company has entered into a collaboration and license agreement with Genzyme Corporation (Sanofi) to commercialize losmapimod outside the U.S., sharing global development costs[110] Stock and Equity - The Company has reserved 17,591,700 shares of common stock for future issuance as of March 31, 2024, an increase from 15,388,773 shares as of December 31, 2023[52] - The Company had outstanding stock options totaling 12,289,352 as of March 31, 2024, compared to 6,876,679 for the same period in 2023[99] - The total stock-based compensation expense for the three months ended March 31, 2024, was $3.916 million, compared to $4.253 million for the same period in 2023[62] - The aggregate intrinsic value of stock options outstanding at March 31, 2024, was $35.107 million[58] - The weighted average grant date fair value of stock options granted in the three months ended March 31, 2024, was $6.23 per share[59] Risks and Challenges - The company has incurred significant operating losses since inception and expects to continue incurring losses over the next several years[167] - Clinical trials are lengthy and expensive, with uncertain outcomes, and the company may face delays or additional costs[203][207] - Serious adverse events or unacceptable side effects during product candidate development may necessitate abandonment or limitation of certain candidates[213] - The commercial potential of the pociredir program may be materially and negatively impacted even if regulatory approval is received[215] - The company may need to conduct additional clinical trials or testing, which could increase development costs and delay marketing approvals[207][209] Legal and Regulatory - The company intends to defend against a class action lawsuit alleging misleading statements related to the FDA's clinical hold on pociredir[165] - The FDA placed the IND for pociredir on clinical hold in February 2023 due to concerns over hematological malignancies, which was lifted in August 2023[214] - Regulatory authorities have substantial discretion in the approval process, making it difficult to predict the time and cost of product candidate development[200]

Exhibit 99.1 Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for First Quarter 2024 ― Entered into a collaboration and ex-U.S. license agreement with Sanofi for the development and commercialization of losmapimod ― ― On track to report topline data for Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD) in the fourth quarter of 2024 ― ― Industry veteran, Patrick Horn M.D., Ph.D., appointed as chief medical of icer ― ― Conference call and webcast ...

― Sanofi receives exclusive rights to commercialize losmapimod in all territories outside the U.S.; Fulcrum retains full U.S. commercialization rights ― ― Fulcrum will receive an upfront payment of $80.0 million, and is eligible to receive $975.0 million in potential milestones, plus royalties on ex-U.S. product sales; parties will share future global development costs 50:50 ― ― Conference call and webcast scheduled for 8:00 a.m. ET today to discuss the collaboration and other recent corporate developments, ...

― Phase 2b ReDUX4 clinical trial indicates improvements in functional, structural, and patient-reported outcomes; findings informed the design and choice of efficacy endpoints in the ongoing Phase 3 clinical trial― ― Topline data for the Phase 3 REACH clinical trial of losmapimod in FSHD expected during 4Q'24― CAMBRIDGE, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically def ...

CAMBRIDGE, Mass., May 06, 2024 (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 its first quarter 2024 financial results will be released on Monday, May 13, 2024 before the U.S. financial markets open. Management will host a conference call and webcast at 8:00 a.m. ET to discuss the results and provide an ...

―Industry veteran with late-stage clinical development, medical affairs, and regulatory experience; well-positioned to advance losmapimod towards a potential regulatory submission and approval ― ― Interim Chief Medical Officer, Iain Fraser, MBChB, DPhil, will continue to serve on Fulcrum's executive leadership team as senior vice president (SVP) of early development ― CAMBRIDGE, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (NASDAQ:FULC), a clinical-stage biopharmaceutical ...