FULC Fulcrum Therapeutics Inc.

17.64
+0.51  (+3%)
Previous Close 17.13
Open 17.13
52 Week Low 4.37
52 Week High 22.96
Market Cap $483,382,270
Shares 27,402,623
Float 18,215,337
Enterprise Value $388,250,931
Volume 52,545
Av. Daily Volume 81,412
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Upcoming Catalysts

Drug Stage Catalyst Date
Losmapimod
Facioscapulohumeral muscular dystrophy (FSHD)
Phase 2b
Phase 2b
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Losmapimod
COVID-19
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
FTX-6058
Sickle Cell Disease
Phase 1
Phase 1
Phase 1 trial to be initiated by the end of 2020.
Losmapimod
Facioscapulohumeral muscular dystrophy (FSHD)
Phase 2
Phase 2
Phase 2 open-label trial has completed enrolment - noted March 5, 2020.

Latest News

  1. CAMBRIDGE, Mass., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that management will participate in the following virtual investor conferences:

    • BTIG Virtual Biotechnology Conference 2020
      Tuesday, August 11, 2020 at 1:00 p.m. ET

    • Canaccord Genuity 40th Annual Growth Conference
      Thursday, August 13, 2020 at 1:30 p.m. ET

    Live audio webcasts of the presentations will be available through the Investor Relations section of the Fulcrum website at https://ir.fulcrumtx.com/events-and-presentations. Archived replays will be available on the Company's website for 90 days after each conference…

    CAMBRIDGE, Mass., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that management will participate in the following virtual investor conferences:

    • BTIG Virtual Biotechnology Conference 2020

      Tuesday, August 11, 2020 at 1:00 p.m. ET



    • Canaccord Genuity 40th Annual Growth Conference

      Thursday, August 13, 2020 at 1:30 p.m. ET

    Live audio webcasts of the presentations will be available through the Investor Relations section of the Fulcrum website at https://ir.fulcrumtx.com/events-and-presentations. Archived replays will be available on the Company's website for 90 days after each conference.

    About Fulcrum Therapeutics 

    Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and is advancing losmapimod to Phase 3 for the treatment of COVID-19. Fulcrum also anticipates a regulatory filing in the second half of 2020 with FTX-6058 for the treatment of sickle cell disease. 

    Please visit www.fulcrumtx.com.

    Contact:

    Stephanie Ascher

    Stern Investor Relations, Inc.



    212-362-1200

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  2. CAMBRIDGE, Mass., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that its second quarter 2020 financial results will be released on Tuesday, August 11, 2020 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 update on recent corporate developments.

    Dial-in Number
    U.S./Canada Dial-in Number: 800-527-6973
    International Dial-in Number: 470-495-9162
    Conference ID: 9625789

    Replay Dial-in Number: 855-859-2056
    Replay International Dial-in Number: 404-537-3406
    Conference ID: 9625789

    An…

    CAMBRIDGE, Mass., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that its second quarter 2020 financial results will be released on Tuesday, August 11, 2020 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 update on recent corporate developments.

    Dial-in Number

    U.S./Canada Dial-in Number: 800-527-6973

    International Dial-in Number: 470-495-9162

    Conference ID: 9625789

    Replay Dial-in Number: 855-859-2056

    Replay International Dial-in Number: 404-537-3406

    Conference ID: 9625789

    An audio webcast will be accessible through the Investor Relations section of the company's website https://ir.fulcrumtx.com/events-and-presentations. Following the live webcast, an archived replay will also be available.

    About Fulcrum Therapeutics

    Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and is advancing losmapimod to Phase 3 for the treatment of COVID-19. Fulcrum also anticipates a regulatory filing in the second half of 2020 with FTX-6058 for the treatment of sickle cell disease.

    Please visit www.fulcrumtx.com.

    Contact:

    Christi Waarich

    Director, Investor Relations and

    Corporate Communications

    617-651-8664

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  3. BRISBANE, Calif. and CAMBRIDGE, Mass., July 21, 2020 (GLOBE NEWSWIRE) -- MyoKardia, Inc. (NASDAQ:MYOK), a clinical-stage biopharmaceutical company discovering and developing targeted therapies for the treatment of serious cardiovascular diseases and Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, announced today that they have entered into a strategic collaboration and license agreement to discover, develop and commercialize novel targeted therapies for the treatment of genetic cardiomyopathies.

    Under the agreement, MyoKardia will access Fulcrum's unique, proprietary target discovery engine to identify therapeutics that…

    BRISBANE, Calif. and CAMBRIDGE, Mass., July 21, 2020 (GLOBE NEWSWIRE) -- MyoKardia, Inc. (NASDAQ:MYOK), a clinical-stage biopharmaceutical company discovering and developing targeted therapies for the treatment of serious cardiovascular diseases and Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, announced today that they have entered into a strategic collaboration and license agreement to discover, develop and commercialize novel targeted therapies for the treatment of genetic cardiomyopathies.

    Under the agreement, MyoKardia will access Fulcrum's unique, proprietary target discovery engine to identify therapeutics that control the expression of genes that are known to be underlying drivers of genetic cardiomyopathies. The collaboration focuses joint discovery efforts on certain undisclosed genetic targets. MyoKardia will be responsible for all development and commercialization activities for, and will have global rights to, any potential therapeutics identified through this collaboration.

    Fulcrum will receive a payment of $12.5 million at the close of the transaction and may be eligible to receive research, development and commercial milestone payments and additional research reimbursement of up to $302.5 million for a first product to progress through development and commercialization. If MyoKardia chooses to develop and commercialize products directed to additional targets under the collaboration, Fulcrum may be eligible for up to $150.0 million in milestone payments. Fulcrum may also be eligible to receive tiered royalty payments in the mid-single-digit to low double-digit range on net sales for any products under the collaboration that are commercialized.

    MyoKardia intends to select targets for further exploration under this collaboration informed by its integrated research and development engine, which includes capabilities in translational research, proprietary and novel disease models, clinical development, and patient engagement and identification. Potential diseases associated with such undisclosed targets are expected to share common characteristics with indications currently being pursued by MyoKardia: strong and genetically-validated mechanistic rationale, high unmet patient need, potentially efficient pathway to approval, and synergy with the commercial organization that MyoKardia is building.

    "This partnership is a natural extension of MyoKardia's investments over the last eight years in building a world-leading cardiovascular research, translational, clinical and commercial organization. We believe this collaboration will enable us to leverage our unique strengths to expand thoughtfully in identifying new therapeutic candidates for the potential treatment of heritable cardiomyopathies," said Robert S. McDowell, Ph.D., MyoKardia's Chief Scientific Officer. "We have been impressed by Fulcrum's ability to discover new biology around genetic muscle disorders. By working together, we hope to further our mission to treat patients suffering from serious cardiovascular disease."

    "This collaboration highlights the broad applicability of our product engine to discover and develop new treatments in genetically defined rare diseases with high unmet need," said Robert J. Gould, Ph.D., Fulcrum's President and Chief Executive Officer.  "We are pleased to partner with MyoKardia, a leader in the field of precision cardiovascular medicine and look forward to leveraging their unique capabilities to rapidly advance potential treatments to serve patients in urgent need."

    About MyoKardia

    MyoKardia is a clinical-stage biopharmaceutical company discovering and developing targeted therapies for the treatment of serious cardiovascular diseases. The company is pioneering a precision medicine approach to its discovery and development efforts by (1) understanding the biomechanical underpinnings of disease; (2) targeting the proteins that modulate a given condition; (3) identifying patient populations with shared disease characteristics; and (4) applying learnings from research and clinical studies to inform and guide pipeline growth and product advancement. MyoKardia's initial focus is on small molecule therapeutics aimed at the proteins of the heart that modulate cardiac muscle contraction to address diseases driven by excessive contraction, impaired relaxation, or insufficient contraction. Among its discoveries are three clinical-stage therapeutics: mavacamten (formerly MYK-461); danicamtiv (formerly MYK-491) and MYK-224.

    MyoKardia's mission is to change the world for people with serious cardiovascular disease through bold and innovative science.

    About Fulcrum Therapeutics

    Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and is advancing losmapimod to Phase 3 for the treatment of COVID-19. Fulcrum also anticipates a regulatory filing in the second half of 2020 with FTX-6058 for the treatment of sickle cell disease.

    Please visit www.fulcrumtx.com.

    MyoKardia ContactsFulcrum Contacts
    Michelle CorralChristi Waarich
    Executive Director, Corporate Communications and Investor RelationsDirector, Investor Relations and
    MyoKardia, Inc.Corporate Communications
    650-351-4690617-651-8664 
     
      
    Hannah Deresiewicz (investors)Stephanie Ascher (investors)
    Stern Investor Relations, Inc.Stern Investor Relations, Inc.
    212-362-1200212-362-1200
      
    Julie Normant (media)Kaitlin Gallagher (media)
    W2OBerry & Company Public Relations
    628-213-3754212-253-8881
      

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  4. CAMBRIDGE, Mass., June 24, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that it received early notification from the U.S. Food and Drug Administration (FDA) that the company may proceed with initiating a Phase 3, randomized, double-blind, placebo-controlled trial of losmapimod in higher risk hospitalized adults with COVID-19. Losmapimod is an orally available selective p38α/β mitogen activated protein kinase (MAPK) inhibitor.

    The LOSVID trial is a Phase 3, international, multicenter trial designed to assess the safety and efficacy of a 15 mg twice per day oral dose of losmapimod…

    CAMBRIDGE, Mass., June 24, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that it received early notification from the U.S. Food and Drug Administration (FDA) that the company may proceed with initiating a Phase 3, randomized, double-blind, placebo-controlled trial of losmapimod in higher risk hospitalized adults with COVID-19. Losmapimod is an orally available selective p38α/β mitogen activated protein kinase (MAPK) inhibitor.

    The LOSVID trial is a Phase 3, international, multicenter trial designed to assess the safety and efficacy of a 15 mg twice per day oral dose of losmapimod compared to placebo for 14 days on top of standard of care in approximately 400 patients hospitalized with COVID-19 and at risk of progression to critical illness based on older age and elevated systemic inflammation. The primary endpoint is the proportion of patients who progress to death or respiratory failure by day 28. Additional secondary endpoints include clinical status on days seven and 14 as measured on the nine point WHO ordinal scale of COVID-19 severity, total number of study days free of oxygen supplementation, all-cause mortality, length of hospitalization and ICU stay, adverse events and viral clearance.

    An interim analysis will be conducted in the fourth quarter of 2020 for futility and sample size re-estimation by an independent data monitoring committee when approximately 50 percent of subjects complete the 28-day visit. Topline data is expected to be reported in the first quarter of 2021.

    "We believe that losmapimod has the potential to be a differentiated treatment option in the global fight against COVID-19," said Robert J. Gould, Ph.D., president and chief executive officer. "The speed with which we have advanced this program reflects our deep understanding of the mechanism of action of losmapimod, the pressing need for treatment options and the commitment of our team to develop therapies that result in meaningful outcomes for patients. We are encouraged by the feedback we have received from investigators, and we expect to have all sites participating in the trial to be activated in the coming weeks."

    "We look forward to conducting this important trial in parallel with our ongoing clinical program for losmapimod as a potential treatment of facioscapulohumeral muscular dystrophy (FSHD)," continued Dr. Gould.  "We have several anticipated upcoming data readouts in the next six to 12 months from both the COVID-19 and FSHD trials and we look forward to the outcomes of these trials which will tell us more about losmapimod's impact in both these patient populations. Additionally, we continue our progress with FTX-6058 towards the clinic for the potential treatment of sickle cell disease."

    Based on its mechanism of action and preclinical and clinical studies, Fulcrum believes that inhibiting the p38 MAPK pathway with losmapimod has the potential to treat COVID-19 by reducing the acute exaggerated pro-inflammatory responses to SARS-CoV-2 infection and restoring the antigen-specific immune responses needed for viral clearance potentially leading to improved clinical outcomes. 

    "Studies in elderly people indicating that p38 inhibition can decrease inflammatory responses but enhance T-cell responses to a viral antigen suggest that losmapimod could ameliorate the pathology of COVID-19 in multiple ways," said Robert Finberg, MD, Professor of Medicine, University of Massachusetts Medical School. "Losmapimod is a promising treatment candidate that could address multiple key contributors to the pathogenesis of COVID-19 and already has an extensive amount of safety and tolerability data across multiple age groups, including the elderly. The rapid initiation of this pivotal trial reflects the data supporting this research and the pressing need for effective therapies that reduce the morbidity associated with COVID-19."

    The Potential Role of p38 Inhibition in the Treatment of COVID-19

    p38 MAPK is well known as an important mediator of acute response to stress, including acute inflammation.  Multiple preclinical and clinical studies have shown that activation of the p38 MAPK significantly contributes to the pathogenesis of coronavirus infections including COVID-19. In two clinical studies reported in the literature, an oral dose of 15 mg twice per day of losmapimod in older individuals decreased inflammatory responses and enhanced normal immune responses. Additionally, in prior human clinical trials predominantly in chronic inflammatory conditions, losmapimod had an immediate effect on a number of inflammatory biomarkers that have been associated with poor prognosis in COVID-19, including C-reactive protein (CRP) and interleukin-6 (IL-6).  p38 inhibition has also been demonstrated to reduce Ang II-induced endothelial and organ damage in several experimental models and may address the renin-angiotensin system imbalance that is believed to contribute to key morbidities in COVID-19 patients.



    About Losmapimod

    Losmapimod is a selective p38α/β mitogen activated protein kinase (MAPK) inhibitor that was exclusively in-licensed from GSK by Fulcrum Therapeutics following Fulcrum's discovery of the role of p38α/β inhibitors in the reduction of DUX4 expression and an extensive review of known compounds. Utilizing its internal product engine, Fulcrum discovered that inhibition of p38α/β reduced expression of the DUX4 gene in muscle cells derived from patients with FSHD.  Researchers at Fulcrum believe that losmapimod has the potential to treat COVID-19 by reducing the acute exaggerated pro-inflammatory responses to SARS-CoV-2 infection and restoring the antigen-specific immune responses needed for viral clearance, potentially leading to improved clinical outcomes. Losmapimod has been evaluated in more than 3,600 subjects in prior clinical research across multiple other indications, including in several Phase 2 trials and a large Phase 3 trial in acute myocardial infarction. No safety signals were attributed to losmapimod in any of these trials. Fulcrum is currently conducting Phase 2 trials investigating the safety, tolerability, and efficacy of losmapimod to treat the root cause of FSHD and initiating a Phase 3 trial investigating the safety, tolerability, and efficacy of losmapimod to treat hospitalized patients with COVID-19.

    About Fulcrum Therapeutics

    Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and is advancing losmapimod to Phase 3 for the treatment of COVID-19. Fulcrum also anticipates a regulatory filing in the second half of 2020 with FTX-6058 for the treatment of sickle cell disease.

    Please visit www.fulcrumtx.com.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the Company's initiation of a clinical trial and evaluation, and the potential benefits, of losmapimod as a potential treatment for COVID-19, the development status of the Company's product candidates, including the planned timing of submission of the Company's IND for FTX-6058, and the timing of availability of clinical trial data. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company's strategy, future operations, future financial position, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with Fulcrum's ability to obtain and maintain necessary approvals from the FDA and other regulatory authorities; continue to advance its product candidates in clinical trials; initiate and enroll clinical trials on the timeline expected or at all; correctly estimate the potential patient population and/or market for the Company's product candidates; replicate in clinical trials positive results found in preclinical studies and/or earlier-stage clinical trials of losmapimod and its other product candidates; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; obtain, maintain or protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties and other important factors, in the Company's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

    Contact:

    Investors:

    Christi Waarich

    Director, Investor Relations and

    Corporate Communications

    617-651-8664

    Stephanie Ascher

    Stern Investor Relations, Inc.

     

    212-362-1200

    Media:

    Kaitlin Gallagher

    Berry & Company Public Relations



    212-253-8881

    Primary Logo

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  5. CAMBRIDGE, Mass., June 10, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC) today announced the closing of a $68.5 million private placement pursuant to a securities purchase agreement with a group of institutional investors and accredited investors.

    The private placement includes a mix of new and existing investors, including EcoR1 Capital, LLC, Alyeska Investment Group, L.P., Boxer Capital, Casdin Capital LLC, Perceptive Advisors LLC, Samsara BioCapital, Monashee Investment Management LLC and Foresite Capital. 

    SVB Leerink acted as the exclusive placement agent to the Company in connection with the private placement.

    In the private placement, the Company sold 4,029,411 shares of common stock at a price of $17.00…

    CAMBRIDGE, Mass., June 10, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC) today announced the closing of a $68.5 million private placement pursuant to a securities purchase agreement with a group of institutional investors and accredited investors.

    The private placement includes a mix of new and existing investors, including EcoR1 Capital, LLC, Alyeska Investment Group, L.P., Boxer Capital, Casdin Capital LLC, Perceptive Advisors LLC, Samsara BioCapital, Monashee Investment Management LLC and Foresite Capital. 

    SVB Leerink acted as the exclusive placement agent to the Company in connection with the private placement.

    In the private placement, the Company sold 4,029,411 shares of common stock at a price of $17.00 per share. The private placement priced on June 8, 2020.

    The Company expects to use net proceeds from the private placement to fund research and development expenses, including the ongoing clinical development of losmapimod for facioscapulohumeral muscular dystrophy (FSHD), the initiation of clinical development of losmapimod for COVID-19 pending review of the Company's recently filed investigational new drug application by the U.S. Food and Drug Administration, the advancement of its hemoglobinopathies program into clinical development and the advancement of both its discovery efforts and product engine capabilities, as well as working capital and other general corporate purposes.

    The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction's securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock issued in the private placement no later than the 15th day after the date of the securities purchase agreement for the private placement.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

    About Fulcrum Therapeutics

    Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and has completed extensive pre-clinical research for FTX-6058 for the treatment of sickle cell disease and beta-thalassemia.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the anticipated use of proceeds from the private placement; the filing of a registration statement to register the resale of the shares issued and sold in the private placement; and the Company's plans, strategies and prospects for its business, including the Company's plans to evaluate losmapimod as a potential treatment for COVID-19. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company's strategy, future operations, future financial position, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with Fulcrum's ability to obtain and maintain necessary approvals from the FDA and other regulatory authorities; continue to advance its product candidates in clinical trials; replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of losmapimod and its other product candidates; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials, if at all; obtain, maintain or protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties and other important factors, in the Company's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

    Contact:

    Investors:

    Christi Waarich

    Director, Investor Relations and

    Corporate Communications

    617-651-8664

    Stephanie Ascher

    Stern Investor Relations, Inc.



    212-362-1200

    Media:

    Kaitlin Gallagher

    Berry & Company Public Relations



    212-253-8881

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