1. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that company management will participate in two upcoming investor conferences:

    - The Oppenheimer Fall Healthcare Life Sciences & MedTech Summit taking place Sept. 20-23, 2021. Forma will present on Sept. 22, 2021 at 12:25 p.m. Eastern Time.

    - The Cantor Global Healthcare Conference taking place Sept. 27-30, 2021. Forma will present on Sept. 27, 2021 at 10:40 a.m. Eastern Time.

    Webcast and audio recording of the conference presentations will be available in the "News & Investors" section of Forma's website at www.FormaTherapeutics.com.

    About Forma Therapeutics

    Forma Therapeutics is…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that company management will participate in two upcoming investor conferences:

    - The Oppenheimer Fall Healthcare Life Sciences & MedTech Summit taking place Sept. 20-23, 2021. Forma will present on Sept. 22, 2021 at 12:25 p.m. Eastern Time.

    - The Cantor Global Healthcare Conference taking place Sept. 27-30, 2021. Forma will present on Sept. 27, 2021 at 10:40 a.m. Eastern Time.

    Webcast and audio recording of the conference presentations will be available in the "News & Investors" section of Forma's website at www.FormaTherapeutics.com.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

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  2. Significant progress achieved with pipeline focused on rare hematologic diseases and cancers

    Positive Phase 1 results in patients with sickle cell disease (SCD) presented at European Hematology Association (EHA) Virtual Congress supporting etavopivat's potential to significantly impact RBC health and lifespan

    Phase 1 trial of FT-7051 enrolling men with metastatic castration-resistant prostate cancer (mCRPC); initial results to be presented in October at the NCI/AACR/EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics

    Olutasidenib data in relapsed/refractory acute myeloid leukemia (R/R AML) presented at the American Society of Clinical Oncology (ASCO) and EHA Virtual Congress; new drug application (NDA) preparation

    Significant progress achieved with pipeline focused on rare hematologic diseases and cancers

    Positive Phase 1 results in patients with sickle cell disease (SCD) presented at European Hematology Association (EHA) Virtual Congress supporting etavopivat's potential to significantly impact RBC health and lifespan

    Phase 1 trial of FT-7051 enrolling men with metastatic castration-resistant prostate cancer (mCRPC); initial results to be presented in October at the NCI/AACR/EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics

    Olutasidenib data in relapsed/refractory acute myeloid leukemia (R/R AML) presented at the American Society of Clinical Oncology (ASCO) and EHA Virtual Congress; new drug application (NDA) preparation ongoing

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today reported financial results for the second quarter ended June 30, 2021. The company also highlighted recent progress and upcoming milestones for its pipeline programs.

    "During the second quarter, we presented positive results from our ongoing Phase 1 trial demonstrating etavopivat's highly differentiated profile and multimodal mechanism of action to improve markers of sickle cell disease and red blood cell health that are associated with vaso-occlusion," said Frank Lee, president and chief executive officer of Forma. "These results, in addition to the progress on our other clinical programs this quarter, position us well to deliver on our mission of transforming the lives of patients with rare hematologic diseases and cancers."

    Key Business and Clinical Highlights

    PKR Program in Sickle Cell Disease (SCD):

    • Clinical data presented at EHA Virtual Congress support potential of investigational agent etavopivat to significantly impact RBC health and lifespan. Updated results were presented from the two week multiple ascending dose (MAD) cohorts and initial open-label extension (OLE) results administering etavopivat for up to 12 weeks, including:
      • Sustained increases in hemoglobin levels. In the MAD cohorts 73% of patients (11/15) achieved a hemoglobin increase of ≥ 1 g/dL at the end of two-weeks of treatment. In the OLE, hemoglobin levels increased >1g/dL in 88% of patients (7/8) receiving once daily treatment for at least two weeks, and this increase was sustained in those patients receiving continued treatment for up to 12 weeks.
      • Improvements in RBC oxygenation and deformability. RBC's from 14 patients in the MAD cohorts showed increased hemoglobin-oxygen affinity, a significant shift in the point of sickling (POS), and improved deformability.
      • Significant reduction in hemolysis with markers approaching normal levels. Reticulocyte counts were reduced in 100% of patients (15/15), with normalization in some patients at the end of 2 weeks of treatment. The majority of patients demonstrated a marked decrease in lactate dehydrogenase levels (LDH) and indirect bilirubin levels as compared to baseline levels.
      • Reduction in systemic biomarkers related to inflammation and hypercoagulability. Initial results from the OLE showed improvement in systemic biomarkers such as lower levels of TNF-alpha, a marker of inflammation and decreases in prothrombin 1.2 and D-dimer, markers of coagulation activation.
      • Etavopivat was well tolerated with a safety profile consistent with underlying sickle cell disease. Etavopivat was well tolerated at doses up to 600mg daily (150% of the maximum dose in the ongoing Phase 2/3 Hibiscus Study).

    CPB/p300 Program in Prostate Cancer:

    • FT-7051 Phase 1 clinical trial enrollment is ongoing. In January 2021, Forma announced the first patient dosed in the ongoing Phase 1 clinical trial evaluating FT-7051 for the treatment of mCRPC. The trial is a multicenter, open-label evaluation of the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and preliminary anti-tumor activity, of FT-7051 in men with mCRPC who have progressed despite prior therapy with at least one anti-androgen therapy. The adaptive trial design is intended to accelerate the dose escalation to potentially therapeutic doses and yield important safety information, as well as to identify biomarkers of clinical benefit such as PSA response. Genetic mutation analysis will be conducted to correlate genetic changes with resistance to standard-of-care and will also evaluate expression of the AR-v7 splice variant, for which there are no approved therapies.

    IDH1 Program in AML and Glioma:

    • Phase 2 registrational results for olutasidenib in R/R AML were presented at scientific conferences. Olutasidenib data in R/R AML were presented at both the annual ASCO and EHA meetings in June 2021. The primary efficacy evaluable population, comprised of 123 patients, received 150 mg of olutasidenib twice daily for at least six months prior to the planned interim analysis. The primary endpoint, a composite complete remission (CR) or CR plus CR with partial hematologic recovery (CRh), was achieved in 33.3% (30% CR and 3% CRh) of patients. While the median duration of response was not yet reached, in a sensitivity analysis with hematopoietic stem cell transplant considered as the end of a response, the median duration was 13.8 months. The median overall survival (OS) was 10.5 months. Although a median OS has not yet been reached for the CR/CRh population, 18-month survival is estimated at 87% for that response category, and median survival is 15.0 months for non-CR/CRh responders. In addition, among patients with a CR who were transfusion-dependent at baseline, 56-day transfusion independence was achieved in 100% of patients as measured by platelets and 80% as measured by RBC's. Olutasidenib was well-tolerated, and adverse events were consistent with the late stage disease in this heavily pre-treated patient population. Based upon these results, Forma is preparing an NDA for the R/R AML indication.

    Corporate

    • In June 2021, Forma announced the appointment of John E. Bishop, Ph.D., as chief technology officer. Dr. Bishop leads chemistry, manufacturing and control (CMC)-related functions and quality, encompassing Forma's early pipeline through commercial product. Dr. Bishop's background includes extensive expertise with CMC development in oncology and hematology. Prior to joining Forma, Dr. Bishop served as senior vice president of pharmaceutical sciences at Epizyme, Inc., where he was a member of the executive team and held overall responsibility for the CMC and quality assurance functions.

    Upcoming Milestones

    • Scientific conference presentation of updated Phase 1 etavopivat results in SCD. Updated results of safety, clinical activity, and biomarkers from the 12-week OLE are expected to be presented at a scientific congress in late 2021. Up to 20 patients are being administered etavopivat 400mg once daily and assessed for hematologic and hemolytic response, improvements in RBC oxygenation and deformability, and systemic markers of SCD.
    • Initiation of etavopivat trials in thalassemia and pediatric sickle cell patients. Enrollment in a Phase 2 trial of etavopivat in thalassemia patients is expected to begin prior to the end of the year, with results anticipated in 2022. The trial may enroll up to 60 patients with either thalassemia or SCD who are receiving chronic red blood cell transfusions, or thalassemia without chronic red blood cell transfusions. A trial in pediatric sickle cell disease patients is planned to begin in the first half of 2022.
    • Scientific conference presentation of initial Phase 1 FT-7051 clinical results in mCRPC. An abstract from this ongoing trial has been accepted for presentation at the NCI/AACR/EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics taking place Oct. 7-10, 2021. The presentation will include preclinical data and initial clinical results on safety, tolerability and PK/PD from patients undergoing dose escalation.
    • Possibility of COVID-19 impact remains. The COVID-19 pandemic remains a factor in the successful completion of these milestones and ongoing clinical trials. Many clinical trials across the biopharma industry, including Forma's, have been impacted by the COVID-19 pandemic. Clinical trial sites implementing new policies in response to COVID-19 may result in potential delays to enrollment of clinical trials or changes in the ability to access sites participating in clinical trials.

    Financial Results

    • Cash Position: Cash, cash equivalents and marketable securities were $570.8 million as of June 30, 2021, as compared to $645.6 million as of Dec. 31, 2020. Current cash runway is projected through the third quarter of 2024.
    • Research and Development (R&D) Expenses: R&D expenses were $31.6 million for the quarter ended June 30, 2021, compared to $20.5 million for the quarter ended June 30, 2020. The increase was primarily attributable to etavopivat development, as well as increases in staff and stock-based compensation.
    • General and Administrative (G&A) Expenses: G&A expenses were $12.5 million for the quarter ended June 30, 2021, compared to $6.4 million for the quarter ended June 30, 2020. The increase in was primarily attributable to increased stock-based compensation, executive and staff hiring, professional fees, and insurance.
    • Net Loss: Net loss was $43.6 million for the quarter ended June 2021, compared to net loss of $25.4 million for the quarter ended June 30, 2020.

    Forma will conduct a conference call and webcast Aug.13 at 8:00 a.m. Eastern Daylight Time (EDT) to discuss second quarter 2021 results and business updates. The call can be accessed by dialing (833) 301-1146 in the U.S., and (914) 987-7386 internationally, with conference ID 9155938.

    The live webcast will be available in the "News & Investors" section of Forma's website www.formatherapeutics.com.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the company's beliefs and expectations regarding its: business plans and objectives; future plans for etavopivat, FT-7051 and olutasidenib, including expectations regarding timing, success and data announcements of our current ongoing clinical trials; initial results for the etavopivat open label extension cohort of our Phase 1 clinical trial; therapeutic potential, clinical benefits, mechanisms of action and safety of our product candidates, planned regulatory submissions, including an NDA for olutasidenib, and upcoming milestones for the company's other product candidates; growth as a company; presentation of additional data at upcoming scientific conferences, and other preclinical data and potential data publications in 2021; the potential commercial and collaboration opportunities, including potential future collaborators and parties, as well as value and market, for our product candidates; uses and need of capital, expenses and other 2021 financial results currently or in the future, and the potential impact of COVID-19 on patient retention and enrollment, future operations, clinical trials or investigational new drug (IND) applications. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties associated with the following: the impact of the COVID-19 pandemic on the company's business, operations, patient enrollment and retention , strategy, goals and anticipated milestones; the therapeutic potential of etavopivat, FT-7051, and olutasidenib, the timing and completion of our Phase 1 clinical study in etavopivat and final audit and quality controlled verification of initial data and related analyses, and the timing associated with the initiation or continuation of any trials and success of ongoing clinical trials of etavopivat and FT-7051; Forma's ability to execute on its strategy; the submission and acceptance of a new drug application (NDA) for submission to the U.S. Food and Drug Administration (FDA) for olutasidenib; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; any one or more of Forma's product candidates may not be successfully developed and commercialized; regulatory developments in the United States and foreign countries; Forma's ability to protect and maintain our intellectual property position; the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; Forma's ability to fund operations; Forma's ability to identify satisfactory collaboration opportunities, as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, filed with the United States Securities and Exchange Commission (SEC) and subsequent filings with the SEC. Forma disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Forma's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Forma explicitly disclaims any obligation to update any forward-looking statements.

    Selected Financial Information

    (in thousands except share and per share data)

    (unaudited)

     
    Statement of Operations Items:

    For the Three Months

    Ended June 30,

    For the Six Months

    Ended June 30,

    2021

    2020

    2021

    2020

    Collaboration revenue

    $

     

    $

     

    $

     

    $

     

    Operating expenses:
    Research and development

     

    31,587

     

     

    20,511

     

     

    57,930

     

     

    43,721

     

    General and administrative

     

    12,471

     

     

    6,448

     

     

    22,338

     

     

    15,381

     

    Restructuring charges

     

     

     

    (20

    )

     

     

     

    63

     

    Total operating expenses

     

    44,058

     

     

    26,939

     

     

    80,268

     

     

    59,165

     

    Loss from operations

     

    (44,058

    )

     

    (26,939

    )

     

    (80,268

    )

     

    (59,165

    )

    Other income (expense):
    Gain on Hit Discovery divestiture

     

     

     

     

     

     

     

    23,312

     

    Interest income

     

    309

     

     

    895

     

     

    571

     

     

    1,536

     

    Other income (expense), net

     

    272

     

     

    (2,634

    )

     

    268

     

     

    (2,616

    )

    Total other income (expense), net

     

    581

     

     

    (1,739

    )

     

    839

     

     

    22,232

     

    Loss before taxes

     

    (43,477

    )

     

    (28,678

    )

     

    (79,429

    )

     

    (36,933

    )

    Income tax expense (benefit)

     

    108

     

     

    (3,238

    )

     

    116

     

     

    (22,723

    )

    Net loss and comprehensive loss

    $

    (43,585

    )

    $

    (25,440

    )

    $

    (79,545

    )

    $

    (14,210

    )

    Accretion of cumulative dividends on Series D redeemable convertible preferred stock

     

     

     

    (1,800

    )

     

     

     

    (3,736

    )

    Net loss allocable to shares of common stock, basic and diluted

    $

    (43,585

    )

    $

    (27,240

    )

    $

    (79,545

    )

    $

    (17,946

    )

    Net loss per share of common stock, basic and diluted

    $

    (0.92

    )

    $

    (4.58

    )

    $

    (1.68

    )

    $

    (4.23

    )

    Weighted-average shares of common stock outstanding, basic and diluted

     

    47,339,464

     

     

    5,943,165

     

     

    47,317,361

     

     

    4,245,622

     

    Selected Balance Sheet Items:

    June 30, 2021

    December 31, 2020

    Cash, cash equivalents, and marketable securities

    $

    570,793

    $

    645,588

    Total assets

    $

    613,369

    $

    680,971

    Accounts payable, accrued expenses, and other current liabilities

    $

    29,104

    $

    31,399

    Total stockholders' equity

    $

    579,395

    $

    648,244

     

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  3. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that it will release second quarter 2021 financial results Friday, Aug. 13, 2021. Forma management will host an investment community conference call at 8 a.m. Eastern Time, on Aug. 13, 2021, to discuss these financial results and provide a business update.

    Investors may participate by dialing +1 (833) 301-1146 in the U.S. or Canada, or +1 (914) 987-7386 internationally, and by referring to Conference ID 9155938. A live webcast of the conference call will be available in the "News & Investors" section of Forma's website at www.formatherapeutics.com.

    About Forma Therapeutics

    Forma Therapeutics…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that it will release second quarter 2021 financial results Friday, Aug. 13, 2021. Forma management will host an investment community conference call at 8 a.m. Eastern Time, on Aug. 13, 2021, to discuss these financial results and provide a business update.

    Investors may participate by dialing +1 (833) 301-1146 in the U.S. or Canada, or +1 (914) 987-7386 internationally, and by referring to Conference ID 9155938. A live webcast of the conference call will be available in the "News & Investors" section of Forma's website at www.formatherapeutics.com.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

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  4. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the appointment of John E. Bishop, Ph.D., to the leadership team as senior vice president and chief technology officer. In this role, Dr. Bishop will lead chemistry, manufacturing and control (CMC)-related functions and quality, encompassing Forma's early pipeline through commercial product.

    "We are fortunate to welcome John to Forma at this pivotal time in Forma's history," said Frank Lee, chief executive officer of Forma. "John's extensive expertise in small-molecule pharmaceuticals and proven track record as a leader will help to expedite drug development and commercialization at Forma…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the appointment of John E. Bishop, Ph.D., to the leadership team as senior vice president and chief technology officer. In this role, Dr. Bishop will lead chemistry, manufacturing and control (CMC)-related functions and quality, encompassing Forma's early pipeline through commercial product.

    "We are fortunate to welcome John to Forma at this pivotal time in Forma's history," said Frank Lee, chief executive officer of Forma. "John's extensive expertise in small-molecule pharmaceuticals and proven track record as a leader will help to expedite drug development and commercialization at Forma, speeding us on our mission of transforming the lives of patients with rare hematologic diseases and cancers."

    Dr. Bishop's background includes extensive expertise with CMC development in oncology and hematology. Prior to joining Forma, Dr. Bishop served as senior vice president of pharmaceutical sciences at Epizyme, Inc., where he was a member of the executive team and held overall responsibility for the CMC and quality assurance (QA) functions. Prior to Epizyme, Dr. Bishop held positions of increasing responsibility, including as senior vice president at Momenta Pharmaceuticals, Inc. While at Momenta, Dr. Bishop planned and oversaw expansion of the company's CMC & QA functions from an ad hoc, three-scientist operation to 130 full-time employees. He also developed and executed successful CMC strategies for Momenta's generic versions of two complex drugs, enoxaparin sodium (LOVENOX®) and glatiramer acetate (COPAXONE®), which led to Momenta's establishment of a broad biosimilar portfolio.

    "I look forward to this opportunity to help Forma further establish and scale a truly groundbreaking technical organization that will enable the company to innovate in disease areas in urgent need of new solutions," said Dr. Bishop. "I believe the team at Forma is applying world-class science and a sincere commitment to patients, and I'm delighted to join this passionate group."

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release may contain forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "will," "could," "would," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavors," "potential," "continue," "target" or the negative of such words or other similar expressions can be used to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation risks set forth under the caption "Risk Factors" in Forma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as well as other risks detailed in our subsequent filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although Forma believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither Forma nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release represents Forma's views only as of the date on which it was made. Forma undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

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  5. Clinical results demonstrated durable improvement in hematologic and hemolytic markers, supporting the potential for improvement of red blood cell functional health in those with sickle cell disease

    Initial results from an open-label extension cohort showed sustained hemoglobin increase of >1g/dL in 88% (7 of 8) of patients dosed for at least two and up to 12 weeks, as well as favorable tolerability profile

    Improvement in markers of red blood cell functional health were observed, including data on measures of cell membrane integrity and systemic biomarkers of inflammation and coagulation

    Forma to host webcast today at 8:00 a.m. ET to discuss etavopivat results presented at EHA

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX) a clinical-stage…

    Clinical results demonstrated durable improvement in hematologic and hemolytic markers, supporting the potential for improvement of red blood cell functional health in those with sickle cell disease

    Initial results from an open-label extension cohort showed sustained hemoglobin increase of >1g/dL in 88% (7 of 8) of patients dosed for at least two and up to 12 weeks, as well as favorable tolerability profile

    Improvement in markers of red blood cell functional health were observed, including data on measures of cell membrane integrity and systemic biomarkers of inflammation and coagulation

    Forma to host webcast today at 8:00 a.m. ET to discuss etavopivat results presented at EHA

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX) a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced new data from its ongoing Phase 1 trial of etavopivat (formerly referred to as FT-4202) being presented at the 26th Annual European Hematology Association (EHA) 2021 Virtual Congress. The e-poster presentation includes initial data from the open-label extension (OLE) cohort showing etavopivat improved and sustained hematologic and hemolytic parameters for patients living with sickle cell disease (SCD) receiving 400 mg etavopivat once-daily for at least two weeks and up to 12 weeks. Also being presented are the unblinded results from the two multiple ascending dose (MAD) cohorts, which demonstrate once-daily dosing of 300 mg or 600 mg etavopivat for 14 days improved measures of sickle red blood cell (RBC) functional health, with effects persisting in some patients even after treatment discontinuation.

    "Data presented today, including initial data from the OLE cohort, demonstrate patient responses improved with more than two weeks of dosing with etavopivat, including hemoglobin and markers of hemolysis, RBC functional health, and systemic inflammation and coagulation that together have the potential to reduce the incidence of vaso-occlusive crises with longer-term treatment," said Patrick Kelly, M.D., chief medical officer of Forma Therapeutics. "These results, along with the favorable tolerability profile we have observed, support our recent initiation of the Hibiscus Study – our Phase 2/3 trial in people living with SCD – and bring us one step closer to a potential new treatment option for those affected by SCD."

    Presentation Details

    • Abstract #EP1201: FT-4202 (Etavopivat) improves hematologic and hemolytic parameters in a phase 1 study of patients with sickle cell disease (Robert Clark Brown, M.D., Ph.D)

    The e-poster presentation is available as of Friday, June 11, 2021, at 9:00 Central European Summer Time (CEST) and is accessible for on-demand viewing until Sunday, August 15, 2021, on EHA's virtual congress platform. The abstract and poster presentation are also available on Forma's website.

    Clinical Data Results

    In the combined MAD1 (300 mg QD) and MAD2 (600 mg QD) cohorts, 73% (11 of 15) of patients achieved a hemoglobin increase of greater than 1g/dL over baseline; significant improvement in hematologic and hemolytic markers also included decreased absolute reticulocytes (100%, or 15 of 15), decreased LDH levels (73%, or 11 of 15) and decreased indirect bilirubin levels (93%, or 14 of 15). The osmoscan and oxygenscan results from 14 patients showed a statistically significant improvement.

    Initial results as of May 24, 2021 in the OLE cohort for eight patients receiving etavopivat treatment (400 mg QD) for at least two weeks indicated a hemoglobin increase of greater than 1 g/dL in 88% (7 of 8), with a mean hemoglobin increase of 1.5 g/dL. Patient data indicated a durable response for those patients receiving treatment beyond two weeks, for up to 12 weeks, with improved hematologic and hemolytic parameters. The improvement in RBC functional health extended beyond the 12-week treatment period; in one patient, improved sickle RBC deformability remained for up to four weeks after treatment discontinuation. These initial OLE data support the combined MAD cohort results and show that daily etavopivat treatment also significantly improved hematologic and hemolytic parameters.

    The safety profile in the OLE cohort was consistent with underlying disease. Of note, two patients reported serious adverse events, including one vaso-occlusive crisis and acute chest syndrome, which was not considered related to treatment by the trial investigator. A deep-vein thrombosis (DVT) report was described as possibly related.

    Additional results being presented at the conference are measures of RBC functional health, with RBC elongation and point-of-sickling data analysis showing improvements in cell deformability, including durable changes for up to four weeks following treatment. The data show benefits beyond activation of the glycolytic pathway, including enhanced activity of enzymes involved in preventing and repairing oxidative damage and reduced levels of phosphatidyl serine (PS), a marker of membrane damage observed on the surface of sickle RBCs. Early data from the 12-week OLE cohort show favorable systemic biomarkers including lower levels of erythropoietin (EPO), reduced evidence of activation of coagulation (Prothrombin 1.2 and D-dimers) and decreased activation of innate immunity (TNF-a). These biomarkers suggest the potential for a broader benefit to people living with SCD, including the potential to reduce vaso-occlusive crises.

    Forma Webcast Today

    Forma is hosting a webcast today at 8:00 a.m. ET to discuss these etavopivat results being presented at EHA. The webcast can be accessed in the "News & Investors" section of Forma's website at www.formatherapeutics.com.

    Ongoing Trials

    The blinded, randomized, placebo-controlled portion of the ongoing Phase 1 trial is complete. People with SCD are now directly enrolling into the ongoing 12-week OLE cohort receiving 400 mg etavopivat daily.

    Forma is currently enrolling adults and adolescents with SCD into the Hibiscus Study, a registrational Phase 2/3 randomized, placebo-controlled, double-blind, multicenter trial to further evaluate the safety and efficacy of etavopivat in this patient population. For more information, please visit https://hibiscusstudy.com/ or clinicaltrials.gov/NCT04624659.

    About Sickle Cell Disease (SCD)

    SCD is one of the most common single-gene disorders and is estimated to affect approximately 100,000 people in the United States, as well as approximately 30,000 in France, Germany, Italy, Spain and the United Kingdom. The National Institutes of Health (NIH) reports that prevalence is estimated at more than 20 million individuals globally. From 2010 to 2050, the annual number of newborns with SCD is expected to rise globally by approximately one-third.i Despite recent advances in treatment, most patients with SCD still suffer from pain crises, lifelong disability, significant morbidity and reduced quality of life.

    About Etavopivat

    Etavopivat is a novel investigational selective red blood cell (RBC) pyruvate kinase-R (PKR) activator designed to be a disease-modifying therapy for the treatment of sickle cell disease (SCD). Employing a multimodal approach, etavopivat is designed to work upstream by activating the RBCs' natural PKR activity to decrease 2,3-DPG levels, which leads hemoglobin to hold on to oxygen molecules longer to reduce RBC sickling. The downstream activity of etavopivat is designed to increase ATP levels, the fuel that provides energy to cells, to improve RBC functional health and survival. Together, these effects are anticipated to increase hemoglobin levels and decrease painful vaso-occlusive crises. In preclinical safety studies, etavopivat did not inhibit aromatase activity or affect steroidogenesis, important biological processes responsible for sexual development. Etavopivat has been granted Fast Track, Rare Pediatric Disease and Orphan Drug designations from the U.S. Food and Drug Administration (FDA), and Orphan Drug Designation from the European Commission based on a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency for the treatment of patients with SCD.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding our beliefs and expectations regarding: initial results to date for the etavopivat open label extension cohort of our Phase 1 clinical trial; ; the therapeutic potential and clinical benefits and safety related to etavopivat; whether initial results from our clinical trials are predictive of final trial results or future clinical studies; and our planned presentation of data at the 2021 EHA Virtual Congress;. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related our ability to execute on our strategy; the therapeutic potential and safety of etavopivat; the timing and completion of our Phase 1 study of etavopivat and final audit and quality controlled verification of initial data and related analyses; the timing and success of our Phase 2/3 Hibiscus Study of etavopivat in SCD patients; positive results from initial data analyses may not be predictive of final results; risks related to our planned regulatory submissions and developments; and other risks identified in our SEC filings, including those risks discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

    _________________________

    i Piel, F. B., Hay, S. I., Gupta, S., Weatherall, D. J., & Williams, T. N. (2013). Global burden of sickle cell anaemia in children under five, 2010-2015: Modelling based on demographics, excess mortality, and interventions. PLOS Medicine, 10(7). Retrieved from link.

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  6. Olutasidenib demonstrated a 33.3% composite complete remission rate (CR/CRh) in people living with R/R AML with the IDH1 mutation

    Among those with CR/CRh, estimated 18-month survival is 87%; median overall survival has not yet been reached

    Duration of response of 13.8 months is longest reported in this treatment setting to date

    Favorable tolerability profile following continuous oral treatment with olutasidenib 150mg BID

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX) today announced that topline interim data from its Phase 2 trial of olutasidenib in relapsed/refractory acute myeloid leukemia (R/R AML) will be presented at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 4-8. Olutasidenib…

    Olutasidenib demonstrated a 33.3% composite complete remission rate (CR/CRh) in people living with R/R AML with the IDH1 mutation

    Among those with CR/CRh, estimated 18-month survival is 87%; median overall survival has not yet been reached

    Duration of response of 13.8 months is longest reported in this treatment setting to date

    Favorable tolerability profile following continuous oral treatment with olutasidenib 150mg BID

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX) today announced that topline interim data from its Phase 2 trial of olutasidenib in relapsed/refractory acute myeloid leukemia (R/R AML) will be presented at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 4-8. Olutasidenib, Forma's selective inhibitor for cancers with mutations in isocitrate dehydrogenase 1 (IDH1m), demonstrated positive efficacy and a favorable tolerability profile as a monotherapy in patients with IDH1m R/R AML, achieving the primary endpoint of a composite complete remission (CR) or CR plus CR with partial hematologic recovery (CRh) rate of 33.3% (30% CR and 3% CRh).

    The presentation is based on an interim analysis from a pivotal trial arm evaluating continuous treatment with 150 mg twice daily of oral olutasidenib. The data indicate the duration of CR/CRh for people on treatment was 13.8 months. Among patients with a complete remission (CR) who were transfusion-dependent at baseline, 56-day transfusion independence was achieved in 100% of patients as measured by platelets and 83% as measured by red blood cells.

    "The data being presented at ASCO showcase olutasidenib's meaningful progress for this patient population, which currently has limited options to extend life expectancy," said Patrick Kelly, M.D., chief medical officer of Forma Therapeutics. "The safety data from the treatment cohort are consistent with the findings from our Phase 1 evaluation in this high-risk AML patient population. The data highlight the duration of response, which is nearly six months longer than current standard of care."

    Oral Abstract Session – June 4, 2:30 p.m. ET

    • Abstract #7006: Effect of olutasidenib (FT-2102) on complete remissions in patients with relapsed/refractory (R/R) mIDH1 acute myeloid leukemia (AML): Results from a planned interim analysis of a phase 2 clinical trial

    About the Phase 1/2 Study

    The Phase 1/2 study is a multicenter, open-label, multi-cohort evaluation of the safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of olutasidenib for patients with AML or myelodysplastic syndrome (MDS) with an IDH1 mutation. Phase 1 of the trial, 2102-HEM-101, was an open-label, dose-escalation and expansion study of olutasidenib alone and in combination with azacitidine (AZA). The Phase 2 portion was an open-label, fixed-dose study of olutasidenib as a monotherapy and in combination with AZA in multiple IDH1m AML/MDS populations. The primary efficacy evaluable population is comprised of 123 R/R AML patients enrolled in Cohort 1, who received 150 mg of olutasidenib BID at least six months prior to the interim analysis cutoff date of June 18, 2020. The primary endpoint of the Phase 2 pivotal study is a complete remission (CR) plus a complete remission with partial hematological recovery (CRh) that is defined as <5% blasts in the bone marrow, no evidence of disease and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter).

    Key Study Findings

    Efficacy (n=123)

    • Olutasidenib induced a durable CR/CRh rate of 33.3% (95% CI 25.1, 42.2), which is the primary endpoint of the study:
      • The CR rate was 30.0% (37 of 123 patients) and the CRh rate was 3.0% (4 of 123 patients)
    • While the median duration of response was not yet reached, in a sensitivity analysis with hematopoietic stem cell transplant considered as the end of a response, the median duration was 13.8 months.
    • The median duration of overall response was 11.7 months.
    • The median overall survival (OS) was 10.5 months. The median OS for non-CR/CRh responders was 15.0 months. A median OS has not yet been reached for the CR/CRh population, with an 18-month survival estimate of 87.0%.
    • Transfusion independence was achieved in all response groups at 56 days, particularly in those achieving CR, with 100% independence for platelet transfusions and 83.0% independence for red blood cells.

    Safety (n=153)

    • Olutasidenib was well-tolerated, with adverse events (AEs) consistent with the late stage disease and the heavily pre-treated population. A safety analysis for all 153 patients enrolled in the Phase 2 Cohort 1 found the most common grade 3/4 (≥ 20% or ≥ 10%) treatment-emergent adverse events (TEAEs) were febrile neutropenia (20%), anemia (19%), thrombocytopenia (16%), neutropenia (13%), leukocytosis (9%) and fatigue (<1%). AEs of interest were the following:
      • 14% of patients reported AEs due to Differentiation syndrome, including 7% Grade 3 and 1% Grade 4 AEs. Most resolved with corticosteroids and treatment interruption. However, 1 fatal event was reported.
      • 8% of patients reported AEs due to QTc prolongation, with <1% Grade 3 or 4. No events led to discontinuation.
      • Grade 3 or 4 elevation in liver parameters (ALT/AST/total bilirubin) occurred in 10% and 2% of patients, respectively. Most resolved with treatment interruption and dose reduction. Seven patients (<5%) discontinued study treatment due to LFT abnormalities. No Hy's law cases reported.

    About Olutasidenib

    Olutasidenib is an oral, potent, small-molecule investigational agent designed to selectively bind to and inhibit mutated IDH1 enzymes. This targeted treatment has the potential to provide therapeutic benefit by reducing 2-HG levels and restoring normal cellular differentiation. With the conclusion of the Phase 2 R/R AML trial, Forma has begun preparing a new drug application (NDA) for submission to the U.S. Food and Drug Administration (FDA).

    IDH1 is a natural enzyme that is part of the normal metabolism of all cells; when mutated, its activity can promote blood malignancies and solid tumors. IDH1 mutations are present in 6-8% of patients with AML and as many as 70 to 80% of patients with grade II/III gliomas and secondary glioblastoma. In gliomas, IDH1 mutations occur early in the tumor pathogenesis and persist throughout progression from a neural stem or progenitor cell. Gliomas are the most common, aggressive and difficult-to-treat primary brain tumors, and high-grade gliomas are associated with poor long-term prognosis. Treatment options for relapsed glioma are limited.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding our beliefs and expectations regarding: interim data analysis for olutasidenib in the Phase 2 trial in R/R AML; the therapeutic potential and clinical benefits and safety related to olutasidenib; whether interim results from our clinical trials are predictive of final trial results or future clinical studies; our planned presentation of data at ASCO; and planned regulatory submissions, including the preparation and submission of an NDA for olutasidenib with the FDA. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related our ability to execute on our strategy; the finalization of our Phase 2 study in R/R AML and final audit and quality controlled verification of interim data and related analyses; positive results from interim data analyses may not be predictive of final results; risks related to our planned regulatory submissions and developments; and other risks identified in our SEC filings, including those risks discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

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  7. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that company management will participate in two upcoming investor conferences:

    • The Oppenheimer Rare & Orphan Disease Summit taking place Friday, May 21, 2021. Forma's pre-recorded presentation will be available on May 21 at 8:00 a.m. EDT.
    • The Jefferies Virtual Healthcare Conference taking place June 1-4, 2021. Forma will present on June 2 at 11 a.m. EDT.

    Webcasts/audio recordings of the conference presentations will be available in the "News & Investors" section of Forma's website at www.formatherapeutics.com.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that company management will participate in two upcoming investor conferences:

    • The Oppenheimer Rare & Orphan Disease Summit taking place Friday, May 21, 2021. Forma's pre-recorded presentation will be available on May 21 at 8:00 a.m. EDT.
    • The Jefferies Virtual Healthcare Conference taking place June 1-4, 2021. Forma will present on June 2 at 11 a.m. EDT.

    Webcasts/audio recordings of the conference presentations will be available in the "News & Investors" section of Forma's website at www.formatherapeutics.com.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

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  8. Development pipeline progressing to key upcoming clinical milestones

    Multiple-ascending dose (MAD) cohorts of FT-4202 Phase 1 trial in sickle cell disease completed; hemoglobin increased ≥ 1 g/dL in approximately 71% of patients and improved hematologic and hemolytic markers consistent with improved red blood cell (RBC) health

    Updated MAD results and initial open-label extension trial (OLE) results to date to be presented at European Hematology Association (EHA) Virtual Congress in June

    Phase 1 trial of FT-7051 in metastatic castration-resistant prostate cancer (mCRPC) ongoing, initial results expected fourth quarter of 2021

    Olutasidenib relapsed/refractory acute myeloid leukemia (R/R AML) results presentation in June at American Society

    Development pipeline progressing to key upcoming clinical milestones

    Multiple-ascending dose (MAD) cohorts of FT-4202 Phase 1 trial in sickle cell disease completed; hemoglobin increased ≥ 1 g/dL in approximately 71% of patients and improved hematologic and hemolytic markers consistent with improved red blood cell (RBC) health

    Updated MAD results and initial open-label extension trial (OLE) results to date to be presented at European Hematology Association (EHA) Virtual Congress in June

    Phase 1 trial of FT-7051 in metastatic castration-resistant prostate cancer (mCRPC) ongoing, initial results expected fourth quarter of 2021

    Olutasidenib relapsed/refractory acute myeloid leukemia (R/R AML) results presentation in June at American Society of Clinical Oncology (ASCO), new drug application (NDA) preparation ongoing

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today reported financial results for the first quarter ended March 31, 2021. The company also highlighted recent progress and upcoming milestones for its pipeline programs.

    "During the first quarter, we successfully completed the multiple ascending dose portion of our Phase 1 trial in sickle cell disease, and despite challenges from the COVID-19 pandemic also began enrolling patients in the Phase 2/3 trial of FT-4202, called The Hibiscus Study, as well as in the Phase 1 trial of FT-7051 for metastatic castration resistant prostate cancer," said Frank Lee, President and Chief Executive Officer of Forma. "We look forward to sharing additional pipeline results over the course of 2021 in our mission to transform the lives of people living with rare hematologic diseases and cancers."

    Key Business and Clinical Highlights

    PKR Program in Sickle Cell Disease (SCD):

    • MAD cohorts completed with approximately 71% of participants achieving hemoglobin increase ≥ 1 g/dL from baseline, and improvement across markers of RBC health. Doubling the dose of FT-4202 to 600 mg daily for 14 days compared to the previous 300 mg cohort was well-tolerated with no dose-limiting toxicities or treatment-related adverse events observed. Improvements in hematologic (hemoglobin and reticulocytes) and hemolytic (bilirubin and lactate dehydrogenase) parameters were comparable to that observed with the 300 mg dose, with best response typically observed at the end of the 14-day treatment period. In the combined cohorts, 10 of 14 (71%) patients on FT-4202 achieved a hemoglobin increase ≥ 1 g/dL from baseline to Day 14. Improvement in RBC health was evidenced by increased sickle RBC survival and reduced intravascular hemolysis in patients with SCD based on a reduction in reticulocytes, bilirubin and LDH levels.
    • Patient enrollment began in Phase 2/3 registrational trial, the Hibiscus Study. The Phase 2/3 Hibiscus Study is currently enrolling people living with SCD. This adaptive, randomized, placebo-controlled, double-blind, multi-center trial is expected to enroll approximately 344 adults and adolescents with SCD. FT-4202 doses of 200mg and 400mg administered once-daily are being evaluated in the Phase 2 portion of the trial. Primary endpoints in the Phase 3 portion of the trial are hemoglobin response rate at week 24 (increase of > 1 g/dL from baseline), intended to support accelerated approval, and annualized vaso-occlusive crisis rate during the 52-week blinded treatment period, which if positive is expected to support full approval.

    CPB/p300 Program in Prostate Cancer:

    • FT-7051 Phase 1 clinical trial initiated for the treatment of mCRPC. In January 2021, Forma announced that the first patient was dosed in the ongoing Phase 1 clinical trial evaluating FT-7051 for the treatment of mCRPC. The trial is a multicenter, open-label evaluation of the safety and tolerability, preliminary anti-tumor activity (prostate specific antigen (PSA) and radiographic responses), and pharmacokinetics/pharmacodynamics (PK/PD) of FT-7051 in men with mCRPC who have progressed despite prior therapy with at least one anti-androgen therapy. The trial will include genetic mutation analysis to identify the basis of resistance to standard-of-care and will also evaluate expression of the AR-v7 splice variant, for which there are no approved therapies. The trial utilizes an adaptive trial design, intended to accelerate the escalation to potentially therapeutic doses and yield important safety information, as well as to identify biomarkers of clinical benefit such as PSA response.

    IDH1 Program in AML and Glioma:

    • Olutasidenib NDA preparation for R/R AML. With the conclusion of the Phase 2 R/R AML trial, Forma has begun preparing an NDA for submission to the U.S. Food and Drug Administration (FDA).

    Upcoming Milestones

    • Presentation of updated Phase 1 FT-4202 results in SCD. A poster presentation on FT-4202 in SCD is scheduled for the EHA Virtual Congress taking place June 9-17, 2021. The presentation will include combined unblinded data from the two-week MAD cohorts as well as initial OLE results to date. In addition, full results from the MAD dose cohorts and the OLE are expected to be presented at a scientific congress in late 2021.
    • Initial Phase 1 clinical results from FT-7051 in mCRPC anticipated later this year. This adaptive trial is assessing multiple doses of FT-7051 with dose escalation dependent upon safety and tolerability. Initial results anticipated in the fourth quarter of 2021 may include safety/tolerability, PK/PD results and preliminary biomarker data.
    • Olutasidenib results presentation in R/R AML. Phase 2 registrational results of olutasidenib in R/R AML will be presented at the 2021 ASCO Annual Meeting taking place from June 4-8, 2021, and the EHA Virtual Congress taking place June 9-17, 2021.
    • Possibility of COVID-19 impact remains. The COVID-19 pandemic remains a factor in the successful completion of these milestones. Many clinical trials across the biopharma industry, including ours, have been impacted by the COVID-19 pandemic, with clinical trial sites implementing new policies in response to COVID-19, resulting in potential delays to enrollment of clinical trials or changes in the ability to access sites participating in clinical trials.

    Financial Results

    • Cash Position: Cash, cash equivalents and marketable securities were $603.7 million as of March 31, 2021, as compared to $645.6 million as of December 31, 2020. Current cash runway is projected through the third quarter of 2024.
    • Research and Development (R&D) Expenses: R&D expenses were $26.3 million for the quarter ended March 31, 2021, compared to $23.2 million for the quarter ended March 31, 2020. The increase was primarily attributable to increases in FT-4202 development expenses, partially offset by reduced spending on olutasidenib development.
    • General and Administrative (G&A) Expenses: G&A expenses were $9.9 million for the quarter ended March 31, 2021, compared to $8.9 million for the quarter ended March 31, 2020. The increase in general and administrative expense was primarily attributable to stock compensation expense and insurance, partially offset by a reduction in professional fees.
    • Net Income/Loss: Net loss was $36.0 million for the quarter ended March 31, 2021, compared to net income of $11.2 million for the quarter ended March 31, 2020.

    Forma will conduct a conference call and webcast May 14th at 8 a.m. Eastern Daylight Time (EDT) to discuss first quarter 2021 results and business update. The call can be accessed by dialing (833) 301-1146 in the U.S., and (914) 987-7386 internationally, with conference ID 8597396.

    The live webcast will be available in the "News & Investors" section of Forma's website www.formatherapeutics.com.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the company's beliefs and expectations regarding its: business plans and objectives; future plans for FT-4202, FT-7051 and olutasidenib, including expectations regarding timing and success of the current ongoing clinical trials, therapeutic potential, clinical benefits and safety thereof, planned regulatory submissions, including an NDA for olutasidenib, and upcoming milestones for the company's other product candidates; growth as a company; presentation of additional data at upcoming scientific conferences, and other preclinical data and potential data publications in 2021; the potential commercial and collaboration opportunities, including potential future collaborators and parties, as well as value and market, for our product candidates; uses and need of capital, expenses and other 2021 financial results currently or in the future, and the potential impact of COVID-19 on patient retention and enrollment, future operations, clinical trials or investigational new drug (IND) applications. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties associated with the following: the impact of the COVID-19 pandemic on the company's business, operations, patient enrollment and retention , strategy, goals and anticipated milestones; the therapeutic potential of FT-4202, FT-7051, and olutasidenib, and the timing associated with the initiation or continuation of any trials and success of ongoing clinical trials of FT-4202 and FT-7051; Forma's ability to execute on its strategy; the submission and acceptance of a new drug application (NDA) for submission to the U.S. Food and Drug Administration (FDA) for olutasidenib; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; any one or more of Forma's product candidates may not be successfully developed and commercialized; regulatory developments in the United States and foreign countries; Forma's ability to protect and maintain our intellectual property position; the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; Forma's ability to fund operations; Forma's ability to identify satisfactory collaboration opportunities, as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the United States Securities and Exchange Commission (SEC) and subsequent filings with the SEC.. Forma disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Forma's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Forma explicitly disclaims any obligation to update any forward-looking statements.

     

    Selected Financial Information

    (in thousands except share and per share data)

    (unaudited)

     
    Statement of Operations Items:

    For the Three Months

    Ended March 31,

    2021

    2020

    Collaboration revenue

     $

                       —

     

     $

                       —

     

    Operating expenses:
    Research and development

     

      26,343

     

     

      23,210

     

    General and administrative

     

      9,867

     

     

      8,933

     

    Restructuring charges

     

      —

     

     

      83

     

    Total operating expenses

     

      36,210

     

     

      32,226

     

    Loss from operations

     

      (36,210

    )

     

      (32,226

    )

    Other income, net

     

      258

     

     

      23,971

     

    Loss before taxes

     

      (35,952

    )

     

      (8,255

    )

    Income tax expense (benefit)

     

      8

     

     

      (19,485

    )

    Net (loss) income

     $

             (35,960

    )

     $

              11,230

     

    Accretion of cumulative dividends on Series D redeemable convertible preferred stock

     

      —

     

     

      (1,936

    )

    Undistributed earnings allocable to participating securities

     

      —

     

     

      (3,456

    )

    Net (loss) income allocable to shares of common stock, basic

     $

             (35,960

    )

     $

                 5,838

     

    Change in fair value attributable to warrants to purchase Series B-3 convertible preferred shares

     

      —

     

     

      (20

    )

    Accretion of cumulative dividends on Series D redeemable convertible preferred stock

     

      —

     

     

      1,936

     

    Net (loss) income allocable to shares of common stock, diluted

     $

             (35,960

    )

     $

                 7,754

     

    Net (loss) income per share of common stock:
    Basic

     $

                 (0.76

    )

     $

                   2.29

     

    Diluted

     $

                 (0.76

    )

     $

                   0.36

     

    Weighted-average shares of common stock outstanding:
    Basic

     

      47,295,013

     

     

      2,548,079

     

    Diluted

     

      47,295,013

     

     

      21,392,760

     

     
    Selected Balance Sheet Items:
    March 31, 2021 December 31, 2020
    Cash, cash equivalents, and marketable securities

     $

                        603,724

     

     $

                       645,588

     

    Total assets

     $

                        650,236

     

     $

                       680,971

     

    Accounts payable, accrued expenses, and other current liabilities

     $

                           25,142

     

     $

                          31,399

     

    Total stockholders' equity

     $

                         (93,370

    )

     $

                        (57,410

    )

     

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  9. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that it will release first quarter 2021 financial results on Friday, May 14, 2021. Forma management will host an investment community conference call at 8 a.m. Eastern Time, on May 14, 2021, to discuss these financial results and provide a business update.

    Investors may participate by dialing (833) 301-1146 in the U.S. or Canada, or (914) 987-7386 internationally, and by referring to Conference ID 8597396. A live webcast of the conference call will be available in the "News & Investors" section of Forma's website at www.formatherapeutics.com.

    About Forma Therapeutics

    Forma Therapeutics…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that it will release first quarter 2021 financial results on Friday, May 14, 2021. Forma management will host an investment community conference call at 8 a.m. Eastern Time, on May 14, 2021, to discuss these financial results and provide a business update.

    Investors may participate by dialing (833) 301-1146 in the U.S. or Canada, or (914) 987-7386 internationally, and by referring to Conference ID 8597396. A live webcast of the conference call will be available in the "News & Investors" section of Forma's website at www.formatherapeutics.com.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    View Full Article Hide Full Article
  10. Strong organizational foundation laid in 2020; continued pipeline execution amid COVID-19 and raised gross capital of $595.1 million

    Key 2020 pipeline achievements include proof of concept for FT-4202 in sickle cell disease; successful interim analysis of registrational Phase 2 trial of olutasidenib in R/R AML with IDH1m; and commencement of Phase 1 trial for FT-7051 in mCRPC

    2021 milestones already achieved; top-line results from 600mg dose cohort of Phase 1 FT-4202 trial, enrolling patients in Phase 2/3 FT-4202 trial, and first patient dosed in Phase 1 FT-7051 trial in mCRPC

    Anticipated 2021 milestones include initial results from FT-4202 open label extension in second quarter and initial FT-7051 Phase 1 results in the second half of

    Strong organizational foundation laid in 2020; continued pipeline execution amid COVID-19 and raised gross capital of $595.1 million

    Key 2020 pipeline achievements include proof of concept for FT-4202 in sickle cell disease; successful interim analysis of registrational Phase 2 trial of olutasidenib in R/R AML with IDH1m; and commencement of Phase 1 trial for FT-7051 in mCRPC

    2021 milestones already achieved; top-line results from 600mg dose cohort of Phase 1 FT-4202 trial, enrolling patients in Phase 2/3 FT-4202 trial, and first patient dosed in Phase 1 FT-7051 trial in mCRPC

    Anticipated 2021 milestones include initial results from FT-4202 open label extension in second quarter and initial FT-7051 Phase 1 results in the second half of the year

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today reported financial results for the fourth quarter and full year ended December 31, 2020. The company also highlighted recent progress and upcoming milestones for its pipeline programs.

    "2020 was a very productive year for Forma, starting with our initial public offering in June and including positive clinical data and progress on our key development programs targeting sickle cell disease, AML and glioma, as well as prostate cancer," said Frank Lee, president and chief executive officer of Forma. "With important events in 2021 for our compounds in development, we look forward to furthering our mission to bring breakthrough therapies to people living with rare hematologic diseases and cancers."

    Key Business and Clinical Highlights

    PKR Program in Sickle Cell Disease (SCD):

    • Positive Phase 1 results of FT-4202 presented at scientific conferences. At the European Hematology Association Annual Congress in June 2020, results from a single ascending dose trial demonstrated a favorable tolerability profile and pharmacokinetic/pharmacodynamic (PK/PD) effects in patients with SCD who were administered a 700mg dose of FT-4202. Subsequently, at the American Society of Hematology (ASH) Annual Meeting and Exposition in December 2020, data were presented from the ongoing randomized, placebo-controlled Phase 1 multiple ascending dose (MAD) trial. Results from the 300mg MAD1 dose cohort following 14 days of treatment showed an increase in hemoglobin of 1g/dL or greater in 6 of 7 (86%) patients vs. 0% of patients receiving placebo. In addition, markers of hemolysis such as indirect bilirubin, reticulocytes and lactate dehydrogenasewere improved, and measures of oxygen affinity and deformability suggested improvement in RBC health. FT-4202 was generally well-tolerated with no serious adverse events attributed to treatment with the compound.
    • Positive FT-4202 600 mg multiple ascending dose cohort data support doses being evaluated in Phase 2/3 registrational trial, called the Hibiscus Study. Doubling the dose of FT-4202 to 600 mg daily for 14 days compared to the previous 300 mg cohort was well-tolerated with no dose-limiting toxicities or treatment-related adverse events observed. Improvements in hematologic (hemoglobin and reticulocytes) and hemolytic (bilirubin and LDH) parameters were comparable to that observed with 300 mg dose, with best response typically at the end of the 14-day treatment period. Across 300 mg and 600 mg cohorts, 10 of 14 (71%) patients on FT-4202 for 14 days achieved a hemoglobin increase ≥ 1 g/dL from baseline. The phase 2/3 Hibiscus Study is currently enrolling people living with sickle cell disease (SCD). This adaptive, randomized, placebo-controlled, double-blind, multi-center trial is expected to enroll approximately 344 adults and adolescents with SCD. FT-4202 doses of 200mg and 400mg administered once-daily are being evaluated in the Phase 2 portion of the trial. Primary endpoints in the Phase 3 portion of the trial are hemoglobin response rate at week 24 (increase of > 1 g/dL from baseline), and annualized vaso-occlusive crisis rate during the 52-week blinded treatment period.

    CPB/p300 Program in Prostate Cancer:

    • Preclinical data presented at scientific conference. At the American Association for Cancer Research (AACR) virtual meeting in June 2020, a poster was presented with preclinical data for FT-6876, a potent and selective inhibitor of CBP/p300, a known co-activator of the androgen receptor (AR) and a driver of metastatic castration-resistant prostate cancer (mCRPC). The data demonstrated antitumor activity of FT-6876 in AR-dependent breast cancer cell lines and highlight the possible role of CBP/p300 in proliferation and survival of AR-dependent tumors, such as prostate cancer. FT-6876 is a research compound related to FT-7051, although with differing PK/PD properties.
    • FT-7051 Phase 1 clinical trial initiated for the treatment of metastatic castration-resistant prostate cancer (mCRPC). In January 2021, Forma announced that the first patient was dosed in the ongoing Phase 1 trial. The trial is a multicenter, open-label evaluation of the safety and tolerability, preliminary anti-tumor activity (PSA and radiographic responses), and PK/PD of FT-7051 in men with mCRPC who have progressed despite prior therapy with at least one anti-androgen therapy. The trial will include genetic mutation analysis to identify tumors with AR-v7 splice variants, against which there are no approved therapies. This is an adaptive trial design, intended to accelerate the escalation to potentially therapeutic doses and yield important safety information, as well as the identification of biomarkers of clinical benefit such as prostate specific antigen (PSA).

    IDH1 Program in AML and Glioma:

    • Announced positive registrational data for olutasidenib in relapsed/refractory acute myeloid leukemia (R/R AML). In October 2020, Forma announced positive results from the planned interim analysis (IA2) of the Phase 2 registration trial in R/R AML patients with isocitrate dehydrogenase 1 gene mutations (IDH1m). Olutasidenib demonstrated favorable tolerability as a monotherapy and achieved the primary endpoint of a composite complete remission (CR+CRh, or complete remission plus complete remission with partial hematologic recovery) rate of 33.3% (30% CR and 3% CRh). While a median duration of CR/CRh has not been reached, a sensitivity analysis (with a hematopoietic stem cell transplant as the end of a response) indicated a median duration of CR/CRh to be 13.8 months. Safety results were consistent with previously reported Phase 1 clinical trial results. Additional data and analyses indicate that the overall response rate (ORR), comprised CR, CRh, CRi, partial response (PR), and morphologic leukemia-free state (MLFS), was 46% and the median duration of ORR was 11.7 months. The median overall survival (OS) was 10.5 months. For patients with CR/CRh, the median OS has not yet been reached, but the estimated 18-month survival is 87%. The most frequently reported treatment emergent adverse events (≥20%) were nausea (38%), constipation (25%), increased white blood cell count (25%), decreased RBC count (24%), pyrexia (23%), febrile neutropenia (22%), and fatigue (21%). Grade 3/4 adverse events occurring in greater than 10% of patients, regardless of causality, were febrile neutropenia (20%), decreased RBC count (19%), decreased platelet count (16%), and decreased neutrophil count (13%).
    • An exploratory Phase 1 trial of olutasidenib for glioma showed evidence of disease control. Data presented at the American Society of Clinical Oncology meeting in June 2020 demonstrated the brain penetrant properties of olutasidenib and preliminary clinical activity, which suggest potential for response and prolonged disease control in the enhanced (grade III/IV) R/R IDH1-mutated glioma. Among 24 evaluable patients treated (4 grade II, 13 grade III, 7 grade IV), one patient had a partial response and 11 patients had stable disease, as determined by investigator response assessment in neuro-oncology, or RANO, criteria. Twenty-two of the patients' responses were also evaluated by volumetric changes at a central review, where four patients had more than 50% tumor reduction, one patient had 25% to 50% tumor reduction, and an additional seven patients had prolonged stable disease.

    Corporate Achievements:

    • Successful initial public offering in June 2020 and follow-on equity offering in December 2020. On June 23, 2020, the Company completed an initial public offering (IPO) in which the Company issued and sold 15,964,704 shares of its common stock at a public offering price of $20.00 per share. The Company raised approximately $293.3 million in net proceeds after deducting underwriting discounts and commissions and offering expenses. On December 15, 2020, the Company completed an underwritten public offering of 6,095,000 shares of its common stock at a public offering price of $45.25 per share. The Company raised approximately $258.6 million in net proceeds after deducting underwriting discounts and commissions and offering expenses.
    • Three new board of directors appointments. In July 2020, Wayne A. I. Frederick, M.D., was elected to serve on Forma's board of directors. Dr. Frederick is the President of Howard University, as well as the Charles R. Drew Professor in Surgery at Howard University's College of Medicine, and a distinguished researcher and practicing surgeon.



      In September 2020, Forma announced the appointment of industry veteran Thomas G. Wiggans to its board of directors. Mr. Wiggans has led successful biopharmaceutical companies from start-up stage into the clinic and later global commercialization and served on the boards of numerous public and private companies.



      In January 2021, Forma announced the appointment of Selwyn M. Vickers, M.D., to its board of directors. Dr. Vickers is a world-renowned surgeon, pancreatic cancer researcher and pioneer in health disparities research. He currently serves as senior vice president of medicine and dean of the School of Medicine at The University of Alabama at Birmingham (UAB).

    Upcoming Milestones

    • Phase 1 FT-4202 randomized cohorts successfully completed; open label extension ongoing. Patients with sickle cell disease are now directly enrolling into the 12-week open label extension (OLE) with the 400mg daily dose, which was previously limited to patients who completed the 600mg dose cohort. Initial results from the ongoing 400mg 12-week open label extension are anticipated to be announced at a scientific congress in the second quarter of 2021, and full results expected at a scientific congress in late 2021.
    • Initial Phase 1 clinical results from FT-7051 in mCRPC anticipated later this year. This adaptive trial is designed to assess multiple doses of FT-7051 with dose escalation dependent upon safety and tolerability. Initial results are anticipated in the second half of 2021, which may include safety/tolerability, PK/PD results and preliminary biomarker data.
    • NDA being prepared for olutasidenib in R/R AML. Forma is preparing a new drug application (NDA) for submission to the U.S. Food and Drug Administration for refractory/relapsing AML patients with an IDH1 mutation. In addition, a manuscript is being prepared for publication of Phase 1 glioma results.
    • Possibility of COVID-19 impact remains. The COVID-19 pandemic remains a factor in the successful completion of these milestones. Many clinical trials across the biopharma industry have been impacted by the COVID-19 pandemic, with clinical trial sites implementing new policies in response to COVID-19, resulting in potential delays to enrollment of clinical trials or changes in the ability to access sites participating in clinical trials.

    Financial Results

    • Cash Position: Cash, cash equivalents and marketable securities were $645.6 million as of December 31, 2020, as compared to $173.2 million as of December 31, 2019. Current cash runway is projected through the third quarter of 2024.
    • Research and Development (R&D) Expenses: R&D expenses were $24.9 million and $93.4 million for the quarter and year ended December 31, 2020, compared to $27.0 million and $111.3 million for the quarter and year ended December 31, 2019. The decline was attributable to a decrease in spending on internal research and development primarily due to restructuring in January 2019, and reductions in spending on olutasidenib and FT-8225, which were partially offset by increases in FT-4202 expenses to conduct the Phase 1 trial, clinical product manufacturing, and preparations for the pivotal Phase 2/3 trial.
    • General and Administrative (G&A) Expenses: G&A expenses were $7.9 million and $30.8 million for the quarter and year ended December 31, 2020, compared to $6.8 million and $24.4 million for the quarter and year ended December 31, 2019. The increase in general and administrative expense was primarily attributable to a $3.2 million increase in stock compensation expense; $1.2 million increase in insurance related expenses; $1.2 million increase in professional fees; $0.5 million increase in personnel-related costs due to executive and staff hiring, recruiting and an increase in facilities; and IT related expenses of $0.2 million.
    • Net Income/Loss: Net loss was $28.6 million and $70.4 million for the quarter and year ended December 31, 2020, compared to $24.7 million and $34.8 million for the quarter and year ended December 31, 2019.

    Forma will conduct a conference call and webcast on March 30th at 8 a.m. Eastern Standard Time (EST) to discuss 2020 year-end financial results and business update. The call can be accessed by dialing (833) 301-1146 in the U.S., and (914) 987-7386 internationally, with conference ID 5893542.

    The live webcast will be available in the "News & Investors" section of Forma's website www.formatherapeutics.com.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the company's beliefs and expectations regarding its: business plans and objectives; future plans for FT-4202, and FT-7051 and olutasidenib, including expectations regarding timing and success of the current ongoing clinical trials, therapeutic potential, and clinical benefits and safety thereof, planned regulatory submissions, including an NDA for olutasidenib, and upcoming milestones for the company's other product candidates; growth as a company and the anticipated contribution of the members of our board of directors to our operations and progress; presentation of additional data at upcoming scientific conferences, and other preclinical data and potential data publications in 2021; the potential commercial and collaboration opportunities, including potential future collaborators and parties, as well as value and market, for our product candidates; uses of capital, expenses and other 2020 financial results or in the future, and the potential impact of COVID-19 on patient retention, strategy, future operations, clinical trials or IND submissions. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties associated with the following: the impact of the COVID-19 pandemic on the company's business, operations, strategy, goals and anticipated milestones; the therapeutic potential of FT-4202 and FT-7051, and the timing associated with the initiation or continuation of any of FT-4202 trials and success of ongoing clinical trials of FT-4202 and FT-7051; the initiation of our phase I clinical trial of FT-7051; Forma's ability to execute on its strategy; the submission and acceptance of a new drug application for submission to the U.S. Food and Drug Administration for olutasidenib; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; any one or more of Forma's product candidates may not be successfully developed and commercialized; regulatory developments in the United States and foreign countries; Forma's ability to protect and maintain our intellectual property position; the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; Forma's ability to fund operations; Forma's ability to identify satisfactory collaboration opportunities, as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in the final prospectus dated December 10, 2020 and filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, with the United States Securities and Exchange Commission (SEC) and elsewhere in Forma's filings and reports with the SEC. Forma disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Forma's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Forma explicitly disclaims any obligation to update any forward-looking statements.

     

     

    Selected Financial Information

    (in thousands except share and per share data)

    (unaudited)

     
    Statement of Operations Items:

    For the Three Months

    Ended December 31,

     

    For the Year

    Ended December 31,

     

    2020

     

     

     

    2019

     

     

     

    2020

     

     

     

    2019

     

    Revenue

    $

     

    $

    7,444

     

    $

     

    $

    100,557

     

    Operating expenses
    Research and development

     

    24,866

     

     

    27,042

     

     

    93,367

     

     

    111,315

     

    General and administrative

     

    7,941

     

     

    6,771

     

     

    30,782

     

     

    24,402

     

    Restructuring charges

     

     

     

    (330

    )

     

    63

     

     

    5,290

     

    Total operating expenses

     

    32,807

     

     

    33,483

     

     

    124,212

     

     

    141,007

     

    Loss from operations

     

    (32,807

    )

     

    (26,039

    )

     

    (124,212

    )

     

    (40,450

    )

    Other income, net

     

    1,029

     

     

    752

     

     

    24,079

     

     

    3,809

     

    Loss before taxes

     

    (31,778

    )

     

    (25,287

    )

     

    (100,133

    )

     

    (36,641

    )

    Income tax benefit

     

    (3,190

    )

     

    (631

    )

     

    (29,719

    )

     

    (1,848

    )

    Net loss

    $

    (28,588

    )

    $

    (24,656

    )

    $

    (70,414

    )

    $

    (34,793

    )

    Preferred return and accretion of preferred return and cumulative dividends on preferred securities

     

     

     

    (568

    )

     

    (3,736

    )

     

    (2,963

    )

    Loss on extinguishment of Series A, Series B-1 and Series B-2 convertible preferred stock

     

     

     

    (3,584

    )

     

     

     

    (3,584

    )

    Distribution to holders of preferred securities in excess of accrued preferred return

     

     

     

     

     

     

     

    (11,347

    )

    Tax distribution to holders of Enterprise.1 Incentive Shares

     

     

     

     

     

     

     

    (60

    )

    Net loss allocable to shares of common stock, basic

    $

    (28,588

    )

    $

    (28,808

    )

    $

    (74,150

    )

    $

    (52,747

    )

    Change in fair value attributable to warrants to purchase preferred securities

     

     

     

    (447

    )

     

     

     

    (962

    )

    Net loss allocable to shares of common stock, diluted

    $

    (28,588

    )

    $

    (29,255

    )

    $

    (74,150

    )

    $

    (53,709

    )

    Net loss per share of common stock:
    Basic

    $

    (0.68

    )

    $

    (11.31

    )

    $

    (3.22

    )

    $

    (20.70

    )

    Diluted

    $

    (0.68

    )

    $

    (11.48

    )

    $

    (3.22

    )

    $

    (21.08

    )

    Weighted-average shares of common stock outstanding,
    Basic and diluted

     

    42,239,451

     

     

    2,547,937

     

     

    23,056,975

     

     

    2,547,927

     

     
    Selected Balance Sheet Items:
    December 31, 2020 December 31, 2019
    Cash, cash equivalents, and marketable securities

    $

    645,588

    $

    173,180

    Total assets

    $

    680,971

    $

    183,035

    Accounts payable, accrued expenses, and other current liabilities

    $

    31,399

    $

    23,629

    Redeemable convertible and convertible preferred stock outside of stockholders' equity

    $

    $

    138,131

    Total stockholders' equity

    $

    648,244

    $

    18,246

     

     

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  11. Blinded data from the 600 mg dose cohort support the doses (400 mg v 200 mg v placebo) being evaluated in the Hibiscus Study currently enrolling people living with sickle cell disease (SCD)

    Doubling the dose of FT-4202 to 600 mg daily for 14 days compared to the previous 300 mg cohort was well-tolerated with no dose-limiting toxicities or treatment-related adverse events observed

    Improvements in hematologic (hemoglobin and reticulocytes) and hemolytic (bilirubin and LDH) parameters were comparable to that observed with 300 mg dose, with best response typically at the end of the 14-day treatment period

    Across 300 mg and 600 mg cohorts, 10 of 14 (71%) patients on FT-4202 for 14 days achieved a hemoglobin increase ≥ 1 g/dL from baseline

    Blinded data from the 600 mg dose cohort support the doses (400 mg v 200 mg v placebo) being evaluated in the Hibiscus Study currently enrolling people living with sickle cell disease (SCD)

    Doubling the dose of FT-4202 to 600 mg daily for 14 days compared to the previous 300 mg cohort was well-tolerated with no dose-limiting toxicities or treatment-related adverse events observed

    Improvements in hematologic (hemoglobin and reticulocytes) and hemolytic (bilirubin and LDH) parameters were comparable to that observed with 300 mg dose, with best response typically at the end of the 14-day treatment period

    Across 300 mg and 600 mg cohorts, 10 of 14 (71%) patients on FT-4202 for 14 days achieved a hemoglobin increase ≥ 1 g/dL from baseline

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced new data from its ongoing randomized, placebo-controlled, multi-center Phase 1 trial of FT-4202 in patients with sickle cell disease (SCD) that further support the development of this novel investigational agent, a selective red blood cell (RBC) pyruvate kinase-R (PKR) activator, as a potential disease-modifying therapy. Data previously presented at the 2020 American Society of Hematology (ASH) Annual Meeting were based on the first cohort of patients in the Phase 1 trial dosed with 300 mg of FT-4202 or placebo once daily for 14 days and a 7-day follow up period. The new findings include an analysis of the blinded data from the second cohort of patients randomly assigned to receive 600 mg of FT-4202 or placebo once daily for 14 days and a 7-day follow up period.

    "We are excited to see the favorable safety and tolerability profile of FT-4202 at a 600 mg dose, coupled with the overlap of pharmacodynamic activity and biologic effects across the 300 and 600 mg doses, supporting the evaluation of safety and efficacy at an upper range of 400 mg in our Phase 2/3 trial," said Patrick Kelly, M.D., chief medical officer of Forma. "These results after only 14 days of treatment support the potential of FT-4202 to treat the underlying pathophysiology of the disease by increasing hemoglobin and reducing hemolysis, which may reduce the number and severity of vaso-occlusive crises SCD patients may experience annually."

    Aggregate findings from the placebo-controlled cohorts of the Phase 1 trial demonstrated 10 of 14 patients (71%) who received FT-4202 achieved a hemoglobin increase of greater than or equal to 1 g/dL from baseline with once-daily dosing of FT-4202 during 14 days of treatment. Based on a trend toward increasing response over the treatment period, the potential exists for additional benefit when dosing beyond 14 days; this is being explored in the ongoing open label extension, which is dosing patients at 400 mg daily for 12 weeks.

    The data also showed activation of PKR by FT-4202 increased sickle RBC survival and reduced intravascular hemolysis in patients with SCD based on a reduction in reticulocytes, bilirubin and LDH levels.

    Change in hematologic and hemolytic parameters at end of 14-day treatment as compared to baseline in FT-4202-treated patients (median change)

    Dose Cohort

    Hb ≥ 1 g/dL

    Reticulocytes ↓

    LDH ↓

    Bilirubin ↓

    300 mg

    6/7 (1.2 g/dL)

    7/7 (-60%)

    6/7 (-36%)

    7/7 (-35%)

    600 mg

    4/7 (1.0 g/dL)

    7/7 (-45%)

    4/7 (-5%)

    7/7 (-41%)

    Combined

    10/14 (1.2 g/dL)

    14/14 (-57%)

    10/14 (-20%)

    14/14 (-37%)

    While the data from the 600 mg cohort of patients remain blinded, initial analysis of the cohort suggests FT-4202 has a similar safety and tolerability profile as the 300 mg cohort, despite the doubling of the dose. No dose-limiting toxicities or treatment-related adverse events (AE) were reported, and the overall AE profile of the 600 mg cohort was consistent with the 300 mg cohort.

    Unblinded 600 mg cohort data are expected to be reported at an upcoming medical conference in Summer 2021, in addition to initial results from the ongoing open label extension.

    Ongoing Trials

    The blinded, randomized, placebo-controlled portion of the ongoing Phase 1 study is now complete. People with SCD are now directly enrolling into the 12-week open label cohort receiving 400 mg of FT-4202 daily.

    Forma is currently enrolling adults and adolescents with SCD into the Hibiscus Study, a registrational Phase 2/3 randomized, placebo-controlled, double-blind, multicenter trial to further evaluate the safety and efficacy of FT-4202 in this patient population. For more information, please visit clinicaltrials.gov/NCT04624659.

    About Sickle Cell Disease

    SCD is one of the most common single-gene disorders and is estimated to affect approximately 100,000 people in the United States, as well as approximately 30,000 in France, Germany, Italy, Spain and the United Kingdom. The National Institutes of Health (NIH) reports that prevalence is estimated at more than 20 million individuals globally. From 2010 to 2050, the annual number of newborns with SCD is expected to rise globally by approximately one-third.1 Despite recent advances in treatment, most patients with SCD still suffer from pain crises, lifelong disability, significant morbidity and reduced quality of life.

    About FT-4202

    FT-4202 is a novel investigational selective red blood cell (RBC) pyruvate kinase-R (PKR) activator designed to be a disease-modifying therapy for the treatment of sickle cell disease (SCD). Employing a multimodal approach, FT-4202 is designed to work upstream by activating the RBCs' natural PKR activity to decrease 2,3-DPG levels, which leads hemoglobin to hold on to oxygen molecules longer to reduce RBC sickling. The downstream activity of FT-4202 is designed to increase ATP levels, the fuel that provides energy to cells, to improve RBC health and survival. Together, these effects are anticipated to increase hemoglobin levels and decrease painful vaso-occlusive crises. In preclinical safety studies, FT-4202 did not inhibit aromatase activity or affect steroidogenesis, important biological processes responsible for sexual development. FT-4202 has been granted Fast Track, Rare Pediatric Disease and Orphan Drug designations from the U.S. Food and Drug Administration (FDA), and Orphan Drug Designation from the European Commission based on a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency for the treatment of patients with SCD.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding our beliefs and expectations regarding: our ability to complete our ongoing clinical trials for FT-4202, including their timing and success, our expectations of the therapeutic benefits related to FT-4202, whether positive interim results from a clinical study are predictive of the results of ongoing or future clinical studies, our presentation of additional data at upcoming scientific conferences, and other preclinical data in 2021, our expectations around our future regulatory filings and our growth as a company. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties associated with the following: the therapeutic potential of FT-4202, and the timing and success of ongoing clinical trials of FT-4202; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; any one or more of Forma's product candidates may not be successfully developed and commercialized; and other risks identified in our SEC filings, including those risks discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

    1 Piel, F. B., Hay, S. I., Gupta, S., Weatherall, D. J., & Williams, T. N. (2013). Global burden of sickle cell anaemia in children under five, 2010-2015: Modelling based on demographics, excess mortality, and interventions. PLOS Medicine, 10(7). Retrieved from link.

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  12. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that it will release fourth quarter and year-end 2020 financial results Tuesday, March 30, 2021. Forma management will host an investment community conference call at 8 a.m. Eastern Time, on March 30, 2021, to discuss these financial results and provide a business update.

    Investors may participate by dialing (833) 301-1146 in the U.S. or Canada, or (914) 987-7386 internationally, and by referring to Conference ID 5893542. A live webcast of the conference call will be available in the "News & Investors" section of Forma's website at www.formatherapeutics.com.

    About Forma Therapeutics

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that it will release fourth quarter and year-end 2020 financial results Tuesday, March 30, 2021. Forma management will host an investment community conference call at 8 a.m. Eastern Time, on March 30, 2021, to discuss these financial results and provide a business update.

    Investors may participate by dialing (833) 301-1146 in the U.S. or Canada, or (914) 987-7386 internationally, and by referring to Conference ID 5893542. A live webcast of the conference call will be available in the "News & Investors" section of Forma's website at www.formatherapeutics.com.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

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  13. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that company management will participate in three upcoming investor conferences:

    • The SVB Leerink 10th Annual Global Healthcare Conference taking place Feb. 22-26. Forma will present on Wednesday, Feb. 24 at 1:40 p.m. Eastern Standard Time (EST).
    • The H.C. Wainwright Global Life Sciences Conference taking place March 9-10. Forma will present on Tuesday, March 9 at 7:00 a.m. EST.
    • The Oppenheimer 31st Annual Healthcare Conference taking place March 16-17. Forma will present on Wednesday, March 17 at 8:40 a.m. EST.

    Webcasts of the conference presentations will be available in the "News…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that company management will participate in three upcoming investor conferences:

    • The SVB Leerink 10th Annual Global Healthcare Conference taking place Feb. 22-26. Forma will present on Wednesday, Feb. 24 at 1:40 p.m. Eastern Standard Time (EST).
    • The H.C. Wainwright Global Life Sciences Conference taking place March 9-10. Forma will present on Tuesday, March 9 at 7:00 a.m. EST.
    • The Oppenheimer 31st Annual Healthcare Conference taking place March 16-17. Forma will present on Wednesday, March 17 at 8:40 a.m. EST.

    Webcasts of the conference presentations will be available in the "News & Investors" section of Forma's website at www.formatherapeutics.com.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

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  14. Phase 1 study includes late-line patients and patients with AR-v7 splice variants for whom there are no approved therapies

    FT-7051 is a selective inhibitor of CREB-binding protein/E1A binding protein p300 (CBP/p300) and a co-activator of androgen receptor

    In prostate cancer cell lines in vitro, FT-7051 demonstrated inhibition of AR-dependent gene expression and a reduction in androgen receptor expression; also demonstrated antiproliferative activity in AR-positive prostate cancer cell lines, including resistance variant AR-v7 positive models

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that the first patient has been dosed in…

    Phase 1 study includes late-line patients and patients with AR-v7 splice variants for whom there are no approved therapies

    FT-7051 is a selective inhibitor of CREB-binding protein/E1A binding protein p300 (CBP/p300) and a co-activator of androgen receptor

    In prostate cancer cell lines in vitro, FT-7051 demonstrated inhibition of AR-dependent gene expression and a reduction in androgen receptor expression; also demonstrated antiproliferative activity in AR-positive prostate cancer cell lines, including resistance variant AR-v7 positive models

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that the first patient has been dosed in a Phase 1 clinical trial evaluating FT-7051, a selective inhibitor of CBP/p300, a known co-activator of the androgen receptor (AR) in men with metastatic castration-resistant prostate cancer (mCRPC).

    "While a patient with mCRPC may initially respond to standard anti-androgen therapies, a significant unmet need persists since nearly all patients ultimately become resistant to these treatments," said David N. Cook, Ph.D., chief scientific officer of Forma Therapeutics. "Initiating enrollment in this Phase 1 trial is an important step toward our goal of providing mCRPC patients with an additional therapeutic option to treat this severe illness."

    Study Design

    The Phase 1 trial is a multicenter, open-label evaluation of the safety and tolerability, preliminary anti-tumor activity (PSA and radiographic responses), and pharmacokinetics/pharmacodynamics (PK/PD) of FT-7051 in men with mCRPC who have progressed despite prior therapy and have been treated with at least one potent anti-androgen therapy. This is an adaptive trial design, intended to accelerate the escalation to potentially therapeutic doses and yield important safety information. More information about this trial may be accessed at Clinicaltrials.gov (identifier: NCT04575766).

    About FT-7051

    FT-7051 is a selective inhibitor of CREB-binding protein/E1A binding protein p300 (CBP/p300) and a co-activator of androgen receptor (AR). In prostate cancer cell lines in vitro, FT-7051 demonstrated inhibition of AR-dependent gene expression and reductions in androgen receptor expression. FT-7051 also demonstrated antiproliferative activity in AR-positive prostate cancer cell lines, including resistance variant AR-v7 positive models.

    About Metastatic Castration-resistant Prostate Cancer

    Prostate cancer is the second leading cause of cancer death for men in the U.S., and mCRPC is the most advanced form of this disease. Prostate cancer cell growth is driven by activity of the androgen receptor (AR). Primary treatments of mCRPC include therapies that reduce androgen synthesis or inhibit androgen binding and activation of the AR. Studies have shown that approximately 20% to 40% of mCRPC patients demonstrate primary resistance to enzalutamide and abiraterone acetate, two commonly used therapies, and virtually all patients who demonstrate initial clinical responses eventually acquire resistance. There are currently no approved therapies specifically aimed at mCRPC over-expressing AR variants, including AR-v7; therefore, a novel inhibitor of AR co-activator CBP/p300 may play a role in the suppression of mCRPC driven by AR aberrations.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding: our guidance regarding our business plans and objectives for FT-7051, including the therapeutic potential and clinical benefits thereof as well as the planned study design, the timing and success of ongoing clinical trials, our growth as a company, and the potential impact of COVID-19 on patient retention, strategy, future operations and clinical trials. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the advancement of our clinical programs, our ability to execute on our strategy, that positive interim results from a clinical study may not be necessarily predictive of the results of future or ongoing clinical studies, the regulatory developments in the United States, the risks related to the competitive landscape, and other risks identified in our SEC filings, including those risks discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

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  15. Strong pipeline progress in 2020 positions company well for 2021

    Established proof of concept in SCD for FT-4202

    Potential transformative treatment profile for IDH1 inhibitor olutasidenib in R/R/ AML

    Enrolling Phase 1 FT-7051 trial for prostate cancer - including patient with AR-v7 splice variants

    Completed successful IPO and follow-on equity offering

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today provided a review of corporate highlights from 2020 and outlined anticipated key clinical program milestones for 2021.

    "While 2020 was marked by tremendous challenges due to the COVID-19 pandemic, Forma made important strides due to the courage…

    Strong pipeline progress in 2020 positions company well for 2021

    Established proof of concept in SCD for FT-4202

    Potential transformative treatment profile for IDH1 inhibitor olutasidenib in R/R/ AML

    Enrolling Phase 1 FT-7051 trial for prostate cancer - including patient with AR-v7 splice variants

    Completed successful IPO and follow-on equity offering

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today provided a review of corporate highlights from 2020 and outlined anticipated key clinical program milestones for 2021.

    "While 2020 was marked by tremendous challenges due to the COVID-19 pandemic, Forma made important strides due to the courage of patients and the dedication of our employees. We reported promising results our from our clinical programs including FT-4202 in sickle cell disease, olutasidenib in both AML and glioma, and FT-7051 in prostate cancer, and also raised approximately $695 million in public equity offerings," said Frank Lee, president and chief executive officer of Forma. "In this coming year, we anticipate continued progress, and look forward to advancing drug candidates that we believe have the potential to significantly impact patients living with rare hematologic diseases and cancers."

    Clinical Program Highlights and Milestones

    PKR Program in Sickle Cell Disease (SCD):

    FT-4202 is a novel investigational selective red blood cell pyruvate kinase R (PKR) activator Forma is actively evaluating in a multi-center, placebo-controlled Phase 1 trial in individuals with sickle cell disease ages 12 years and older.

    • In June 2020, encouraging ­single dose cohort data were reported at the 25th European Hematology Association (EHA) Annual Congress. Initial findings from Forma's Phase 1 trial of FT-4202 in patients with SCD demonstrated a favorable tolerability profile and biologic effects, with evidence of pharmacodynamic activity.
    • In December 2020, clinical proof-of-concept data were presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. Forma presented data from a multi-dose cohort of its Phase 1 trial of FT-4202 in patients with SCD, showing that 86% of patients dosed with 300 mg of FT-4202 for 14 days achieved a hemoglobin increase of greater than 1 g/dL from baseline. The observed reduction in hemolysis in conjunction with the biomarker analysis showing improved deformability and hydration of RBCs supports the hypothesis that pyruvate kinase activation may have an impact on vaso-occlusive crises (VOCs).
    • Additional clinical data anticipated from the ongoing Phase 1 randomized placebo-controlled trial in SCD patients. Data from the MAD2 600 mg cohort of the Phase 1 trial is expected to be reported in the first quarter of 2021, followed by results from the 12-week open-label extension in the second quarter of 2021.
    • Expanding FT-4202 development program. Forma has initiated a global pivotal Phase 2/3 trial of FT-4202 in SCD patients, with plans to initiate a Phase 2 trial in thalassemia in the second half of 2021, and a pediatric SCD trial in the first half of 2022.

    IDH1 Program in AML and Glioma:

    Olutasidenib (FT-2102) is a selective inhibitor for cancers with IDH1 mutations Forma is evaluating for the treatment of acute myeloid leukemia (AML) and glioma. Olutasidenib is currently being studied in a registrational Phase 2 trial for relapsed/refractory (R/R) AML and an exploratory Phase 1 trial for glioma.

    • In May 2020, positive data for olutasidenib in glioma was announced at the American Society of Clinical Oncology (ASCO). Forma announced positive preliminary Phase 1 data for olutasidenib in refractory, enhancing glioma at ASCO 2020, suggesting the potential for response and prolonged disease control in relapsed/refractory IDH1-mutated glioma patients.
    • In October 2020, positive data for olutasidenib in a registrational trial for R/R AML was announced. Forma announced positive results from the planned interim analysis of the Phase 2 registration trial of olutasidenib in R/R AML patients with IDH1 gene mutations. Olutasidenib as a monotherapy demonstrated a favorable tolerability profile and achieved a composite complete remission (CR/CRh) rate of 33.3% (30% CR and 3% CRh), the primary efficacy endpoint. While a median duration of CR/CRh has not yet been reached, a sensitivity analysis indicated the median duration of CR/CRh to be 13.8 months. Further data analysis indicates an estimated 87% survival rate at 18 months in patients who respond to treatment with olutasidenib. Olutasidenib's potential transformative treatment profile is based upon three key indicators: durability of response and increased survival for responders, favorable tolerability suggesting ability to combine with other therapies, and properties to support indication expansion to other IDH1 mutated cancers.
    • Forma has begun preparing for a new drug application for olutasidenib in R/R AML.

    CPB/p300 Program in Prostate Cancer:

    FT-7051 is a potent and selective CBP/p300 inhibitor Forma is evaluating for the treatment of metastatic prostate cancer resistant to androgen receptor (AR) signaling inhibitor therapy.

    • In April 2020, preclinical data on FT-6876 (a research compound related to FT-7051) in breast cancer was presented at the American Association for Cancer Research (AACR). Forma presented preclinical data that demonstrated antitumor activity of FT-6876 in AR-dependent breast cancer cell lines, suggesting that FT-6876 could serve as a treatment for patients with other AR-dependent tumors, such as prostate cancer.
    • Phase 1 underway in 2021. In December 2020, Forma initiated recruitment in a Phase 1 trial of FT-7051 in men with metastatic castration-resistant prostate cancer including those with AR-v7 splice variants. Dosing in this trial is anticipated to begin in early in the first quarter of 2021. Forma plans to disclose initial safety, tolerability and preliminary response data in the second half of 2021.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding our beliefs and expectations regarding its: our business plans and objectives; future plans for FT-4202, FT-7051, and olutasidenib, including expectations regarding timing and success of the current ongoing clinical trials as well as planned future clinical trials, therapeutic potential and clinical benefits thereof, and upcoming milestones for our other product candidates; the planned timing and potential submission of new drug applications for olutasidenib in R/R AML, growth as a company and the anticipated contribution of our employees and the members of our board of directors to our operations and progress; presentation of additional data at upcoming scientific conferences, and other preclinical data in 2021; the potential commercial and collaboration opportunities, including potential future collaborators and parties, as well as value and market, for our product candidates; uses of capital, expenses and other 2021 financial results or in the future, and the potential impact of COVID-19 on patient retention, strategy, future operations, clinical trials or IND submissions. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the advancement of our clinical programs and other risks identified in our SEC filings, including those risks discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

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  16. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that Selwyn M. Vickers, M.D., F.A.C.S., has been elected to serve on the company's board of directors.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210107005057/en/

    (Photo: Business Wire)

    (Photo: Business Wire)

    Dr. Vickers is a world-renowned surgeon, pancreatic cancer researcher and pioneer in health disparities research. He currently serves as senior vice president of medicine and dean of the School of Medicine at The University of Alabama at Birmingham (UAB). As dean, Dr. Vickers leads the medical school's main campus in Birmingham and the regional…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that Selwyn M. Vickers, M.D., F.A.C.S., has been elected to serve on the company's board of directors.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210107005057/en/

    (Photo: Business Wire)

    (Photo: Business Wire)

    Dr. Vickers is a world-renowned surgeon, pancreatic cancer researcher and pioneer in health disparities research. He currently serves as senior vice president of medicine and dean of the School of Medicine at The University of Alabama at Birmingham (UAB). As dean, Dr. Vickers leads the medical school's main campus in Birmingham and the regional campuses in Montgomery, Huntsville and Tuscaloosa. He is a practicing clinician and conducts research with a focus on pancreatic cancer. Dr. Vickers is a member of the National Academy of Medicine.

    "I am pleased to welcome Selwyn to our board at this exciting stage of growth for Forma," said Peter Wirth, chair of Forma's board of directors. "Selwyn's expertise in addressing disparities in access to health care resources, especially among minority populations, will inform Forma's work not only to develop drugs that meet the needs of specific patient populations but also to help create systems so that patients can access the drugs developed."

    "In addition to his deep medical knowledge, Selwyn's understanding of the importance of diversity will provide valuable insight as we advance our pipeline of programs through the clinic," said Frank Lee, president and chief executive officer of Forma. "I'm delighted he's decided to be part of our important mission."

    "I am honored to join the board of Forma, whose distinctive patient-driven and culturally-competent approach to impacting disease aligns with my own passion," said Dr. Vickers. "I look forward to sharing my clinical and research expertise to support the company's mission to truly transform the lives of patients."

    Dr. Vickers will serve on the board's audit committee.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the advancement of our clinical programs, our expectations of the therapeutic benefits related thereto, and our growth as a company and the anticipated contribution of the members of our board of directors to our operations and progress. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the advancement of our clinical program, the expected impact and contribution of our board of directors and executives to our business, and other risks identified in our SEC filings, including those risks discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

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  17. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the closing of an underwritten public offering of 6,095,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase up to an additional 795,000 shares of common stock, at a public offering price of $45.25 per share. The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $275.8 million. All of the shares in the offering were offered by Forma.

    Jefferies, SVB Leerink and Credit Suisse acted as joint book-running managers for the offering. Oppenheimer…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the closing of an underwritten public offering of 6,095,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase up to an additional 795,000 shares of common stock, at a public offering price of $45.25 per share. The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $275.8 million. All of the shares in the offering were offered by Forma.

    Jefferies, SVB Leerink and Credit Suisse acted as joint book-running managers for the offering. Oppenheimer & Co acted as lead manager for the offering.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    Registration statements relating to these securities became effective on December 10, 2020. The offering was made only by means of a prospectus, copies of which may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@Jefferies.com; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at syndicate@svbleerink.com; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at usa.prospectus@credit-suisse.com; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at EquityProspectus@opco.com.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers.

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  18. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the pricing of an underwritten public offering of 5,300,000 shares of its common stock at a public offering price of $45.25 per share. All of the shares of common stock in the offering will be offered by Forma. In addition, Forma has granted the underwriters a 30-day option to purchase up to an additional 795,000 shares of common stock. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $239.8 million, excluding any exercise of the underwriters' option to purchase additional shares. The offering…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the pricing of an underwritten public offering of 5,300,000 shares of its common stock at a public offering price of $45.25 per share. All of the shares of common stock in the offering will be offered by Forma. In addition, Forma has granted the underwriters a 30-day option to purchase up to an additional 795,000 shares of common stock. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $239.8 million, excluding any exercise of the underwriters' option to purchase additional shares. The offering is expected to close on or about December 15, 2020, subject to customary closing conditions.

    Jefferies, SVB Leerink and Credit Suisse are acting as joint book-running managers for the offering. Oppenheimer & Co is acting as lead manager for the offering.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    Registration statements relating to these securities became effective on December 10, 2020. The offering will be made only by means of a prospectus, copies of which may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@Jefferies.com; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at syndicate@svbleerink.com; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at usa.prospectus@credit-suisse.com; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at EquityProspectus@opco.com.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers.

    Forward-Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statements that express the current beliefs and expectations of management, including but not limited to express or implied statements related to Forma's ability to complete the offering, the satisfaction of customary closing conditions and the company's use of proceeds. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties associated with market conditions and the advancement of Forma's clinical programs and other risks identified in Forma's SEC filings, including those risks discussed under the heading "Risk Factors" in its Quarterly Report on Form 10-Q, filed on November 12, 2020, as well as the risks identified in the registration statement relating to the offering. Forma cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Forma disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Moreover, except as required by law, neither Forma nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statements contained in this press release represent Forma's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

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  19. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that it has launched a proposed public offering of 4,600,000 shares of its common stock.

    All of the shares of common stock in the offering will be offered by Forma. In addition, Forma expects to grant the underwriters a 30-day option to purchase up to 690,000 additional shares of common stock. Together with its existing cash and cash equivalents, Forma intends to use the net proceeds of the offering for (i) the development of its lead program FT-4202 in sickle cell disease including completion of its ongoing Phase 1 clinical trial and, subject to the results of its Phase 1 clinical trial…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that it has launched a proposed public offering of 4,600,000 shares of its common stock.

    All of the shares of common stock in the offering will be offered by Forma. In addition, Forma expects to grant the underwriters a 30-day option to purchase up to 690,000 additional shares of common stock. Together with its existing cash and cash equivalents, Forma intends to use the net proceeds of the offering for (i) the development of its lead program FT-4202 in sickle cell disease including completion of its ongoing Phase 1 clinical trial and, subject to the results of its Phase 1 clinical trial, the initiation and conduct of its planned, global pivotal Phase 2/3 clinical trial through Phase 3 dose selection and hemoglobin futility and hemoglobin improvement, the initiation and conduct of a clinical trial in pediatric sickle cell disease and the initiation and conduct of a clinical trial in beta thalassemia through an initial data readout; (ii) the advancement of FT-7051 in metastatic castration-resistant prostate cancer, through its planned Phase 1 clinical trial; and (iii) research and development, working capital, and general corporate purposes, including funding pre-approval activities for FT-2102 in acute myeloid leukemia and the completion of other noncore programs. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

    Jefferies, SVB Leerink and Credit Suisse are acting as joint book-running managers for the offering.

    A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission (the "SEC") but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    The proposed offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@Jefferies.com; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at syndicate@svbleerink.com; or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at usa.prospectus@credit-suisse.com.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers.

    Forward-Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statements that express the current beliefs and expectations of management, including but not limited to express or implied statements related to Forma's ability to complete the financing and its use of proceeds. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the advancement of Forma's clinical programs and other risks identified in Forma's SEC filings, including those risks discussed under the heading "Risk Factors" in its Quarterly Report on Form 10-Q, filed on November 12, 2020, as well as the risks identified in the registration statement relating to the offering. Forma cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Forma disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Moreover, except as required by law, neither Forma nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statements contained in this press release represent Forma's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

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  20. 6 of 7 (86%) patients on 300 mg of FT-4202 for 14 days achieved a hemoglobin increase &gt; 1 g/dL from baseline

    Hemolytic markers support the hypothesis that FT-4202 improves red blood cell survival and reduces turnover

    A favorable tolerability profile was observed after once-daily dosing of FT-4202 for 14 days and a 7-day follow up period in patients with SCD

    Initiated 600 mg MAD2 cohort and 12-week open label extension study

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that clinical proof-of-concept in patients with sickle cell disease (SCD) has been observed in the ongoing randomized, placebo-controlled, multi-center Phase…

    6 of 7 (86%) patients on 300 mg of FT-4202 for 14 days achieved a hemoglobin increase > 1 g/dL from baseline

    Hemolytic markers support the hypothesis that FT-4202 improves red blood cell survival and reduces turnover

    A favorable tolerability profile was observed after once-daily dosing of FT-4202 for 14 days and a 7-day follow up period in patients with SCD

    Initiated 600 mg MAD2 cohort and 12-week open label extension study

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that clinical proof-of-concept in patients with sickle cell disease (SCD) has been observed in the ongoing randomized, placebo-controlled, multi-center Phase 1 trial of FT-4202. FT-4202 is a novel, investigational, selective red blood cell (RBC) pyruvate kinase-R (PKR) activator in development as a potential disease-modifying therapy for SCD. In a cohort of nine patients, six of seven patients (86%) who received FT-4202 achieved a hemoglobin increase of greater than 1 g/dL from baseline with once-daily dosing at 300 mg for 14 days. The data, being presented today at the 62nd American Society of Hematology (ASH) Annual Meeting, also demonstrate improvements in hemolytic parameters showing that activation of PKR by FT-4202 decreases reticulocyte counts and sickle RBC hemolysis in patients with SCD.

    "These results are remarkable for a Phase 1 study, and they're encouraging for sickle cell patients," said Marilyn J. Telen, M.D., director of the Duke Comprehensive Sickle Cell Center, Professor of Medicine, Duke University School of Medicine, and one of the study investigators. "The absence of serious treatment-related adverse events, together with increased hemoglobin and reduced markers of hemolysis among the group receiving FT-4202, indicate a potential impact on overall red blood cell health and support further studies."

    "We are pleased to present our clinical proof-of-concept data and continue to see potential for FT-4202 to improve the lives of people living with sickle cell disease," said Patrick Kelly, M.D., chief medical officer of Forma. "As we prepare to initiate Forma's pivotal Phase 2/3 trial, we plan to evaluate whether the combined ability of FT-4202 to increase hemoglobin levels in red blood cells and bring about improved red blood cell health will meaningfully reduce the frequent painful vaso-occlusive crises these patients endure."

    Presentation Overview

    FT-4202, an Allosteric Activator of Pyruvate Kinase-R, Demonstrates Proof of Mechanism and Proof of Concept after a Single Dose and after Multiple Daily Doses in a Phase 1 Study of Patients with Sickle Cell Disease

    The data will be presented in an oral presentation by R. Clark Brown, M.D., Ph.D., Pediatric Hematologist/Oncologist, Medical Director of Sickle Cell at Scottish Rite, Aflac Cancer and Blood Disorders Center of Children's Healthcare of Atlanta, and Associate Professor of Pediatrics, Emory University School of Medicine.

    The results announced today are based on nine patients with SCD (FT-4202 n=7; placebo n=2) randomly assigned to receive a single oral dose of 300 mg daily of FT-4202 or placebo for 14 days. The data show that, from baseline, in patients receiving FT-4202:

    • 6 of 7 achieved a > 1 g/dL increase in hemoglobin (Hb); median 1.2 g/dL increase (range 0, 2.3 g/dL);
    • 2,3-DPG levels were reduced, thus increasing oxygen affinity and decreasing sickle hemoglobin polymerization;
    • Adenosine triphosphate (ATP) levels were increased resulting in improved RBC function and reduced hemolysis;
    • 7 of 7 achieved a reduction in reticulocytes; median 60% decrease (range -39%, -81%);
    • 6 of 7 achieved a reduction in lactate dehydrogenase (LDH); median 36% decrease (range +18%, -57%); and
    • 7 of 7 achieved a reduction in bilirubin; median 35% decrease (range -7%, -63%).

    The tolerability data presented today are based on nine patients enrolled at the time of submission of the presentation to ASH. Since then, findings from these nine patients have been unblinded. Among the seven patients receiving FT-4202, the tolerability analysis indicates:

    • Eighteen adverse events (AEs) were reported;
    • Two Grade 1 AEs considered possibly related to study treatment were reported by one patient each and included headache and nausea;
    • No treatment-related serious AEs were reported.

    Non-treatment-related AEs were consistent with sickle cell disease-related events commonly experienced in this patient population.

    The ongoing Phase 1 study is evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single ascending dose and multiple ascending doses of FT-4202, first in healthy volunteers and now in patients with sickle cell disease. Based on the safety results and tolerability profile observed in the initial multiple dose cohort of patients, a second multiple dose cohort is being enrolled in which patients are randomly assigned to receive a single daily 600 mg oral dose of FT-4202 or placebo for 14 days. Patients who complete this second 14-day dose cohort can then enroll into a 12-week, open label cohort receiving a single daily 400 mg oral dose of FT-4202. For more information, please visit clinicaltrials.gov/NCT03815695.

    The data presented today, along with the results from the single 700 mg dose arm of the study presented in June 2020 at the European Hematology Association (EHA) Annual Congress, support initiation of a randomized, placebo-controlled, double-blind, global multicenter Phase 2/3 registrational study to evaluate the safety and efficacy of FT-4202 in adults and adolescents with SCD in the first quarter of 2021.

    Investor Event

    Forma Therapeutics will conduct a webcast today, Dec. 7, at 6 p.m. Eastern Standard Time (EST) to further discuss the results from the ongoing study and to provide additional details of the company's development plans for FT-4202. A live webcast will be available in the "News & Investors" section of Forma's website: https://ir.formatherapeutics.com/.

    About Sickle Cell Disease

    Sickle cell disease (SCD) is one of the most common single-gene disorders and is estimated to affect approximately 100,000 people in the United States, as well as approximately 30,000 in France, Germany, Italy, Spain and the United Kingdom. The National Institutes of Health (NIH) reports that prevalence is estimated at more than 20 million individuals globally. From 2010 to 2050, the annual number of newborns with SCD is expected to rise globally by approximately one-third.1 Despite recent advances in treatment, most patients with SCD still suffer from pain crises, lifelong disability, significant morbidity and reduced quality of life.

    About FT-4202

    FT-4202 is a novel investigational selective red blood cell (RBC) pyruvate kinase-R (PKR) activator designed to be a disease-modifying therapy for the treatment of sickle cell disease (SCD). Employing a multimodal approach, FT-4202 is designed to work upstream by activating the RBCs' natural PKR activity to decrease 2,3-DPG levels, which leads hemoglobin to hold on to oxygen molecules longer to reduce RBC sickling. The downstream activity of FT-4202 is designed to increase ATP levels, the fuel that provides energy to cells, to improve RBC health and survival. Together, these effects are anticipated to increase hemoglobin levels and decrease painful vaso-occlusive crises. In preclinical safety studies, FT-4202 did not inhibit aromatase activity or affect steroidogenesis, important biological processes responsible for sexual development. FT-4202 has been granted Fast Track, Rare Pediatric Disease and Orphan Drug designations from the U.S. Food and Drug Administration (FDA), and Orphan Drug Designation from the European Commission based on a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency for the treatment of patients with SCD.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding our beliefs and expectations regarding: our ability to complete our ongoing Phase 1 clinical trial for FT-4202, including its timing and success, our expectations of the therapeutic benefits related to FT-4202, , whether positive interim results from a clinical study are predictive of the results of ongoing or future clinical studies, our expectations around our future regulatory filings and our growth as a company. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the advancement of our clinical programs and other risks identified in our SEC filings, including those risks discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

    _______________________

    1Piel, F. B., Hay, S. I., Gupta, S., Weatherall, D. J., & Williams, T. N. (2013). Global burden of sickle cell anaemia in children under five, 2010-2015: Modelling based on demographics, excess mortality, and interventions. PLOS Medicine, 10(7). Retrieved from link.

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  21. Strong pipeline progress amid challenging COVID-19 environment

    Oral presentation of MAD1 results at upcoming 2020 ASH Virtual Annual Meeting from the randomized, placebo-controlled multi-center Phase 1 trial evaluating FT-4202 in people with sickle cell disease

    MAD2 cohort of the Phase 1 trial now enrolling with 600 mg dose

    Registrational Phase 2/3 trial of FT-4202 on track to begin enrolling people living with sickle cell disease in the first quarter of 2021

    Phase 1 trial evaluating FT-7051 in metastatic castration-resistant prostate cancer on track to begin enrolling patients before end of 2020

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers…

    Strong pipeline progress amid challenging COVID-19 environment

    Oral presentation of MAD1 results at upcoming 2020 ASH Virtual Annual Meeting from the randomized, placebo-controlled multi-center Phase 1 trial evaluating FT-4202 in people with sickle cell disease

    MAD2 cohort of the Phase 1 trial now enrolling with 600 mg dose

    Registrational Phase 2/3 trial of FT-4202 on track to begin enrolling people living with sickle cell disease in the first quarter of 2021

    Phase 1 trial evaluating FT-7051 in metastatic castration-resistant prostate cancer on track to begin enrolling patients before end of 2020

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today reported financial results for the third quarter ended September 30, 2020. The company also highlighted recent progress and upcoming milestones for its pipeline programs.

    "We are very pleased with our strong pipeline progress during the quarter amid such challenging times," said Frank Lee, President and Chief Executive Officer of Forma. "We look forward to presenting new data from our ongoing Phase 1 trial of FT-4202 in sickle cell disease at the ASH meeting in December, as well as beginning enrollment of patients for our Phase 1 trial of FT-7051 in men living with metastatic castration-resistant prostate cancer. The recent positive top-line results from the olutasidenib registrational Phase 2 clinical trial in relapsed/refractory acute myeloid leukemia with an IDH1 mutation further underscores our commitment to developing transformative therapies for patients."

    Key Business and Clinical Highlights

    PKR Program in Sickle Cell Disease (SCD):

    • Both planned dose cohorts enrolling in the multiple ascending dose (MAD) trial. The MAD1 cohort is designed to dose 9-12 SCD patients with 300 mg of FT-4202. Clinical measures being assessed include change in hemoglobin, indirect bilirubin, reticulocytes and lactate dehydrogenase, as well as the monitoring of tolerability and safety during the 14-day dosing and 7-day follow-up period. The MAD2 cohort is assessing a higher 600 mg dose and is now enrolling patients. Patients completing the 600 mg MAD2 cohort may enter the 12-week Open Label Extension (OLE) portion of the trial.
    • FT-4202 abstract selected for oral presentation at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition December 5-8, 2020. The FT-4202 abstract describes blinded data from three patients receiving the 300 mg dose, measuring changes in parameters over the 14-day treatment and 7-day follow-up period including hemoglobin and reticulocytes, as well as tolerability and safety. Updated data will be presented at the ASH annual meeting on December 7, 2020.

    CPB/p300 Program in Prostate Cancer:

    • Phase 1 clinical trial of FT-7051 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) on track to start by year end. This trial will enroll patients who have progressed while on standard anti-androgen therapy. Patients' prostate cancer will be profiled for mutations in the androgen receptor (AR)-signaling pathway that drive resistance to AR-receptor antagonists, such as ARv7 mutations.

    IDH1 Program in AML and Glioma:

    • Announced positive data for olutasidenib in relapsed/refractory acute myeloid leukemia (R/R AML). In October 2020, Forma announced positive results from the planned interim analysis (IA2) of the Phase 2 registration trial in R/R AML patients with isocitrate dehydrogenase 1 gene mutations (IDH1m). Olutasidenib demonstrated a favorable tolerability profile as a monotherapy, and for the primary efficacy endpoint of composite complete remission (CR+CRh, or complete remission plus complete remission with partial hematologic recovery), achieved a rate of 33.3% (30% CR and 3% CRh). While a median duration of CR/CRh has not been reached, a sensitivity analysis (with a hematopoietic stem cell transplant as the end of a response) indicates the median duration of CR/CRh to be 13.8 months. Safety results are consistent with previously reported Phase 1 clinical trial results.
    • Olutasidenib is also being evaluated in an exploratory Phase 1 trial for glioma as presented at the American Society of Clinical Oncology meeting in June 2020, as well as in other IDH1m solid tumor indications.

    Corporate:

    • In September 2020, Forma announced the appointment of industry veteran Thomas G. Wiggans to Forma's board of directors. Mr. Wiggans has led successful biopharmaceutical companies from start-up stage into the clinic and later global commercialization, served on the boards of numerous public and private companies, and was instrumental in the formation of the Biotechnology Industry Organization, now Biotechnology Innovation Organization (BIO).

    Upcoming Milestones

    • Results from the ongoing randomized placebo-controlled multicenter Phase 1 trial evaluating FT-4202 in patients with SCD to be presented at ASH. Clinical data on the safety results, PK/PD and laboratory measurements in 9-12 patients from the 300 mg MAD1 cohort will be presented during an oral presentation at the virtual, 62nd American Society of Hematology (ASH) Annual Meeting and Exposition December 5-8, 2020. Subsequently, results from the MAD2 600 mg cohort are expected in the first quarter of 2021, and 12-week OLE results are anticipated in the second quarter of 2021.
    • Initiation of registrational trial of FT-4202 for people living with SCD: The global pivotal Phase 2/3 trial is expected to initiate in the first quarter of 2021. This adaptive, randomized, placebo-controlled, double-blind, multi-center study will enroll approximately 344 adults and adolescents with SCD. The trial will evaluate FT-4202 doses of 200 mg and 400 mg administered once daily in the Phase 2 portion. Primary endpoints in the Phase 3 portion of the trial are hemoglobin response rate at week 24 (increase of > 1 g/dL from baseline), and annualized vaso-occlusive crisis rate during the 52-week blinded treatment period.
    • Initiation of FT-7051 Clinical Development in mCRPC: Patient enrollment in the Phase 1 trial of FT-7051 in mCRPC patients is expected to begin prior to the end of 2020. Safety and tolerability data from the trial are anticipated in 2021 and clinical activity results in 2022.
    • Non-core Partnering Strategy: Following the recent positive registrational trial results in R/R AML with an IDH1 mutation, Forma remains focused on partnership opportunities for olutasidenib, as well as for the non-core FASN inhibitor for NASH (FT-8225).
    • Possibility of COVID-19 Impact: The COVID-19 pandemic remains a factor in the successful completion of these milestones. Many clinical trials across the biopharma industry have been impacted by the COVID-19 pandemic, with clinical trial sites implementing new policies in response to COVID-19, resulting in potential delays to enrollment of clinical trials or changes in the ability to access sites participating in clinical trials.

    Upcoming Investor Events

    • Dec. 7, 2020: Forma will conduct a conference call and webcast on Dec. 7 at 6 p.m. Eastern Standard Time (EST) to discuss updated results from the ongoing Phase 1 trial of FT-4202 in SCD, as well as an overview of the company's development plans for FT-4202. A live webcast will be available in the "News & Investors" section of Forma's website www.formatherapeutics.com.

    Financial Results

    • Cash Position: Cash, cash equivalents and marketable securities were $384.3 million as of September 30, 2020, as compared to $173.2 million as of December 31, 2019.
    • Research and Development (R&D) Expenses: R&D expenses were $24.8 million for the quarter ended September 30, 2020, compared to $27.6 million for the quarter ended September 30, 2019. The decrease was primarily due to planned reductions in spending on FT-2102, FT-4101, FT-8225, research activities, and internal R&D personnel-related costs, which were partially offset by increases in FT-4202 expenses to conduct the Phase 1 trial, clinical product manufacturing, and preparations for the pivotal Phase 2/3 trial.
    • General and Administrative (G&A) Expenses: G&A expenses were $7.5 million for the quarter ended September 30, 2020, compared to $7.0 million for the quarter ended September 30, 2019. The increase in general and administrative expense was primarily attributable to a $1.3 million increase in equity-based compensation, and a $0.6 million increase in insurance related expense, and a $0.5 million increase in other related general and administrative costs, partially offset by a reduction of $2.0 million related to legal, consulting and other professional fee expenses.
    • Net Income/Loss: Net loss was $27.6 million for the quarter ended September 30, 2020, compared to $31.0 million for the quarter ended September 30, 2019.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the company's beliefs and expectations regarding its: business plans and objectives; future plans for FT-4202 and FT-7051, including expectations regarding timing and success of the current ongoing clinical trials, therapeutic potential and clinical benefits thereof, and upcoming milestones for the company's other product candidates; growth as a company and the anticipated contribution of the members of our board of directors to our operations and progress; presentation of additional data at upcoming scientific conferences, and other preclinical data in 2020; the potential commercial and collaboration opportunities, including potential future collaborators and parties, as well as value and market, for our product candidates; uses of capital, expenses and other 2020 financial results or in the future, and the potential impact of COVID-19 on patient retention, strategy, future operations, clinical trials or IND submissions. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties associated with: the impact of the COVID-19 pandemic on the company's business, operations, strategy, goals and anticipated milestones; the therapeutic potential of FT-4202, and the timing associated with the initiation or continuation of any of FT-4202 trials; the initiation of our phase I clinical trial of FT-7051; Forma's ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Forma's ability to fund operations; Forma's ability to identify satisfactory collaboration opportunities, as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in the final prospectus dated June 22, 2020 and filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, with the United States Securities and Exchange Commission (SEC) and elsewhere in Forma's filings and reports with the SEC. Forma disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Forma's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Forma explicitly disclaims any obligation to update any forward-looking statements.

    Selected Financial Information
    (in thousands except share and per share data) 
    (unaudited) 
     
    Statement of Operations Items: Three Months Ended

    September 30,
    Nine Months Ended

    September 30,

    2020

     

    2019

     

    2020

     

    2019

     
    Revenue

     $                -  

     $         3,377

     $                -  

     $       93,113

    Operating expenses
    Research and development

              24,780

              27,558

              68,501

              84,273

    General and administrative

                7,460

                7,025

              22,841

              17,631

    Restructuring charges

                       -  

                   545

                      63

                5,620

    Total operating expenses

              32,240

              35,128

              91,405

            107,524

    Loss from operations

            (32,240)

            (31,751)

            (91,405)

            (14,411)

    Other income, net

                   818

                   766

              23,050

                3,057

    Loss before taxes

            (31,422)

            (30,985)

            (68,355)

            (11,354)

    Income tax benefit

               (3,806)

                       -  

            (26,529)

               (1,217)

    Net loss

     $     (27,616)

     $     (30,985)

     $     (41,826)

     $     (10,137)

    Preferred return and accretion of preferred return and

    cumulative dividends on preferred securities

                       -  

                  (607)

               (3,736)

               (2,395)

    Distribution to holders of preferred securities in excess of

    accrued preferred return

                       -  

                       -  

                       -  

            (11,347)

    Tax distribution to holders of Enterprise.1 Incentive Shares

                       -  

                    (60)

                       -  

                    (60)

    Net loss allocable to shares of common stock, basic 

     $     (27,616)

     $     (45,562)

    Change in fair value attributable to warrants to purchase

    common stock

                      (8)

                       -  

    Net loss allocable to shares of common stock, diluted

     $     (27,624)

     $     (45,562)

    Net loss allocable to shares of Common 1, basic 

     $     (31,652)

     $     (23,939)

    Change in fair value attributable to warrants to purchase

    preferred securities

                  (198)

                  (515)

    Net loss allocable to shares of Common 1, diluted

     $     (31,850)

     $     (24,454)

    Net loss per share of common stock:
    Basic

     $          (0.67)

     $          (2.74)

    Diluted

     $          (0.67)

     $          (2.74)

    Net loss per share of Common 1:
    Basic

     $       (12.42)

     $          (9.40)

    Diluted

     $       (12.50)

     $          (9.60)

    Weighted-average shares of common stock outstanding:  
    Basic

    41,088,261

    16,616,143

    Diluted

    41,088,924

    16,616,143

    Weighted-average shares of Common 1 outstanding, basic

    and diluted

    2,547,924

    2,547,924

    Selected Balance Sheet Items:  
    September 30,   December 31,

    2020

     

    2019

         
    Cash, cash equivalents, and marketable securities

     $

        384,346

     

     $

        173,180

    Total Assets

     $

        447,396

     

     $

        183,035

    Accounts payable, accrued expenses, and other

    current liabilities

     $

           30,215

     

     $

           23,629

    Redeemable convertible and convertible preferred stock outside

    of stockholders' equity

     

     - 

     

     $

        138,131

    Total stockholders' equity

     $

        415,602

     

     $

           18,246

     

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  22. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the European Commission granted Orphan Drug designation to Forma's FT-4202 for the treatment of sickle cell disease (SCD), based on a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA). FT-4202 was previously granted Fast Track, Rare Pediatric Disease and Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for the treatment of patients with SCD.

    "I am pleased to see the regulatory community recognize the urgent need to bring therapies to people living with sickle cell disease," said Frank Lee, president and chief…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the European Commission granted Orphan Drug designation to Forma's FT-4202 for the treatment of sickle cell disease (SCD), based on a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA). FT-4202 was previously granted Fast Track, Rare Pediatric Disease and Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for the treatment of patients with SCD.

    "I am pleased to see the regulatory community recognize the urgent need to bring therapies to people living with sickle cell disease," said Frank Lee, president and chief executive officer of Forma. "Without effective treatment, sickle cell can affect all organs over time and lead to substantial suffering for those born with this genetic disease. We embrace the potential this designation may provide as we prepare to initiate a global registrational Phase 2/3 trial with FT-4202 in the first quarter of 2021."

    Forma is currently enrolling patients with SCD in a randomized, placebo-controlled, multi-center Phase 1 study to evaluate the safety and pharmacokinetics/pharmacodynamics (PK/PD) of FT-4202. For more information on eligibility and study sites for the open Phase 1 study, please visit clinicaltrials.gov/NCT03815695.

    About Orphan Drug Designation in the European Union (EU)

    The European Commission grants Orphan Drug designation (ODD) to investigational drugs intended to diagnose, prevent or treat a rare disease. To qualify for ODD, the potential therapeutic must target a life-threatening or chronically debilitating disease that affects fewer than five (5) in 10,000 persons in the EU. In addition, the investigational drug must either provide a significant benefit over existing therapies or provide a treatment for patients for whom existing therapies do not work or exist. The designation provides financial and regulatory incentives to the sponsor company such as reduced fees, tax waivers, dedicated funds to reimbursement and 10 years of market exclusivity.

    About Sickle Cell Disease

    Sickle cell disease (SCD) is one of the most common single-gene disorders and is estimated to affect more than 70,000 in the EU-27, as well as approximately 100,000 people in the United States. The National Institutes of Health (NIH) reports that prevalence is estimated at more than 20 million individuals globally. From 2010 to 2050, the annual number of newborns with SCD is expected to rise globally by approximately one-third.1 Despite recent advances in treatment, most patients with SCD still suffer from pain crises, lifelong disability, significant morbidity and reduced quality of life.

    About FT-4202

    FT-4202 is a novel selective red blood cell (RBC) pyruvate kinase-R (PKR) activator designed to be a disease-modifying therapy for the treatment of sickle cell disease (SCD). Employing a multimodal approach, FT-4202 works upstream by activating the RBCs' natural PKR activity to decrease 2,3-DPG levels, which leads hemoglobin to hold on to oxygen molecules longer to reduce RBC sickling. The downstream activity of FT-4202 increases ATP levels, the fuel that provides energy to cells, to improve RBC health and survival. Together, these effects are anticipated to increase hemoglobin levels and decrease painful vaso-occlusive crises. In preclinical safety studies, FT-4202 did not inhibit aromatase activity or affect steroidogenesis, important biological processes responsible for sexual development.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the potential regulatory, exclusivity and marketing advantages of Orphan Drug designation by the EU Commission and previously granted Fast Track, Rare Pediatric Disease and Orphan Drug designations from the U.S. Food and Drug Administration (FDA) of FT-4202 for the treatment of patients with SCD,the advancement of our sickle cell disease program, our expectations of the therapeutic benefits related thereto, the timing and success of ongoing clinical trials, and our growth as a company and the anticipated contribution of our executives and employees to our operations and progress. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the advancement of our clinical programs and other risks identified in our SEC filings, including those risks discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

    ____________________

    1Piel, F. B., Hay, S. I., Gupta, S., Weatherall, D. J., & Williams, T. N. (2013). Global burden of sickle cell anaemia in children under five, 2010-2015: Modelling based on demographics, excess mortality, and interventions. PLOS Medicine, 10(7). Retrieved from link.

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  23. Updated data from an ongoing randomized, multi-center, placebo-controlled Phase 1 clinical trial of FT-4202 in sickle cell disease selected for an oral presentation

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that four abstracts – including one oral presentation and three poster presentations – have been accepted for presentation at the 62nd American Society of Hematology (ASH) Virtual Annual Meeting taking place December 5-8, 2020.

    The oral presentation will feature clinical data from the multiple ascending dose cohort of a randomized, multi-center, placebo-controlled Phase 1 trial of FT-4202 in people living with sickle cell…

    Updated data from an ongoing randomized, multi-center, placebo-controlled Phase 1 clinical trial of FT-4202 in sickle cell disease selected for an oral presentation

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that four abstracts – including one oral presentation and three poster presentations – have been accepted for presentation at the 62nd American Society of Hematology (ASH) Virtual Annual Meeting taking place December 5-8, 2020.

    The oral presentation will feature clinical data from the multiple ascending dose cohort of a randomized, multi-center, placebo-controlled Phase 1 trial of FT-4202 in people living with sickle cell disease (SCD). While the trial is currently enrolling patients in the second dose escalation cohort of 600 mg FT-4202 daily, data will be presented on 9-12 patients who have completed the 300 mg FT-4202 daily cohort. A "Trials in Progress" poster presentation will highlight key aspects of the planned registrational Phase 2/3 clinical trial. In addition, two collaborative posters will report the findings of research of FT-4202 in a mouse model of sickle cell anemia and in an ex vivo analysis of blood samples from patients with SCD, respectively.

    "We're pleased the FT-4202 data have been selected for multiple presentations at ASH 2020," said Frank Lee, president and chief executive officer of Forma. "Forma has a deep commitment to advancing science in sickle cell disease. We look forward to sharing data that will further characterize FT-4202 as an investigational treatment for people living with sickle cell disease."

    The abstracts, currently available on the ASH conference website, are:

    Oral Presentation

    Title: FT-4202, an Allosteric Activator of Pyruvate Kinase-R, Demonstrates Proof of Mechanism and Proof of Concept after a Single Dose and after Multiple Daily Doses in a Phase 1 Study of Patients with Sickle Cell Disease

    Date/Time: Monday, December 7, 2020 at 2:00 p.m. PT

    Session: 114. Hemoglobinopathies, Excluding Thalassemia - Clinical: Novel Treatments for Sickle Cell Disease

    Abstract: 679

    Presenter: R. Clark Brown, MD, PhD, Pediatric Hematologist/Oncologist, Medical Director of Sickle Cell at Scottish Rite, Aflac Cancer and Blood Disorders Center of Children's Healthcare of Atlanta, and Associate Professor of Pediatrics, Emory University School of Medicine

    Poster Presentations

    Title: An Adaptive, Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study of Oral FT-4202, a Pyruvate Kinase Activator in Patients with Sickle Cell Disease (PRAISE)

    Date: Monday, December 7, 2020

    Session: 114. Hemoglobinopathies, Excluding Thalassemia - Clinical: Poster III

    Abstract: 2622

    Presenter: Kenneth W. Wood, Executive Director, Project Leadership at Forma Therapeutics, Inc.

    Title: Oral Administration of FT-4202, an Allosteric Activator of Pyruvate Kinase-R, Has Potent Anti-Sickling Effects in a Sickle Cell Anemia (SCA) Mouse Model, Resulting in Improved RBC Survival and Hemoglobin Levels

    Date: Saturday, December 5, 2020

    Session: 113. Hemoglobinopathies, Excluding Thalassemia - New Genetic Approaches to Sickle Cell Disease: Poster I

    Abstract: 784

    Presenter: Archana Shrestha, PhD, Research Associate at Cincinnati Children's Hospital Medical Center

    Title: Ex-Vivo FT-4202 Treatment Improves Hemoglobin Oxygen Affinity and Membrane Health in Red Blood Cells of Patients with Hemoglobin SS and Hemoglobin SC Disease Irrespective of Prior Hydroxyurea Use

    Date: Saturday, December 5, 2020

    Session: 113. Hemoglobinopathies, Excluding Thalassemia—New Genetic Approaches to Sickle Cell Disease: Poster I

    Abstract: 786

    Presenter: Diamantis Konstantinidis, Research Associate at Cincinnati Children's Hospital Medical Center

    About Sickle Cell Disease

    Sickle cell disease (SCD) is one of the most common disorders caused by a single gene mutation. Prevalence of SCD is approximately 100,000 people in the U.S. and approximately 30,000 people in France, Germany, Italy, Spain and the UK. While reporting limitations complicate stating an exact number, the National Institutes of Health reports that prevalence is estimated at over 20 million individuals worldwide. In people living with SCD, red blood cells, or RBCs, spontaneously deform in low oxygen conditions, taking on a sickle-like shape. Sickle cells are stiff and have damaged membranes, causing the RBCs to clump and burst in small blood vessels, resulting in inflammation and vaso-occlusive crises. Repeated deformation also depletes the RBC energy supply, called ATP. One important consequence of this energy depletion is increased levels of a metabolite, 2,3-DPG, that further reduces the RBCs' affinity for oxygen and exacerbates the cycle of repeated deformation and anemia.

    About FT-4202

    FT-4202 is a novel, oral, once-daily pyruvate kinase-R (PKR) activator designed to be a disease-modifying therapy for the treatment of sickle cell disease (SCD). Early studies and trials have shown that FT-4202 works upstream by employing a multi-modal approach and activating the red blood cells' (RBC) natural PKR activity to decrease 2,3-DPG levels, which we believe leads hemoglobin to hold on to oxygen molecules longer to reduce RBC sickling. FT-4202 has also shown downstream activity by increasing ATP levels, the fuel that provides energy to cells, which we believe may improve RBC health and survival. Together, these effects have the potential to increase hemoglobin levels and decrease painful vaso-occlusive crises. In preclinical safety studies, FT-4202 did not inhibit aromatase activity, important biological processes responsible for sexual development.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding FT-4202, our expectations of the therapeutic benefits related thereto, the timing and success of ongoing clinical trials, whether positive interim results from a clinical study are predictive of the results of ongoing or future clinical studies, and our growth as a company. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the advancement of our clinical programs and other risks identified in our SEC filings, including those risks discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

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  24. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that company management will participate in three upcoming investor conferences.

    • The Credit Suisse 29th Annual Healthcare Conference taking place November 9-12. Forma will present via webcast on Wednesday, November 11 at 2:45 p.m. Eastern Standard Time (EST).
    • The Jefferies 2020 Virtual London Healthcare Conference taking place November 17-19. Forma will present via webcast on Wednesday, November 18 at 7:55 p.m. Greenwich Mean Time (GMT).
    • The Virtual SVB Leerink Oncology 1X1 Day taking place November 19. Forma will participate virtually in one-on-one meetings during this event on Thursday…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that company management will participate in three upcoming investor conferences.

    • The Credit Suisse 29th Annual Healthcare Conference taking place November 9-12. Forma will present via webcast on Wednesday, November 11 at 2:45 p.m. Eastern Standard Time (EST).
    • The Jefferies 2020 Virtual London Healthcare Conference taking place November 17-19. Forma will present via webcast on Wednesday, November 18 at 7:55 p.m. Greenwich Mean Time (GMT).
    • The Virtual SVB Leerink Oncology 1X1 Day taking place November 19. Forma will participate virtually in one-on-one meetings during this event on Thursday, November 19.

    A live webcast of the presentations at the Credit Suisse and Jefferies conferences will be available in the "News & Investors" section of Forma's website at www.formatherapeutics.com.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

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  25. FT2102-HEM-101 clinical trial data demonstrate a 30% CR and 3% CRh rate with olutasidenib monotherapy in 123 relapsed or refractory IDH1m AML patients

    While median duration of CR/CRh has not been reached, sensitivity analysis indicates the median duration of CR/CRh to be 13.8 months

    Favorable tolerability profile consistent with Phase 1 study results

    Data will be submitted for discussion at an upcoming medical meeting

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced positive top-line data from a planned interim analysis of a registrational Phase 2 clinical trial of olutasidenib, Forma's selective inhibitor for hematological malignancy…

    FT2102-HEM-101 clinical trial data demonstrate a 30% CR and 3% CRh rate with olutasidenib monotherapy in 123 relapsed or refractory IDH1m AML patients

    While median duration of CR/CRh has not been reached, sensitivity analysis indicates the median duration of CR/CRh to be 13.8 months

    Favorable tolerability profile consistent with Phase 1 study results

    Data will be submitted for discussion at an upcoming medical meeting

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced positive top-line data from a planned interim analysis of a registrational Phase 2 clinical trial of olutasidenib, Forma's selective inhibitor for hematological malignancy cancers with mutations in isocitrate dehydrogenase 1 (IDH1m). Olutasidenib demonstrated a favorable tolerability profile as a monotherapy in patients with IDH1m relapsed/refractory acute myeloid leukemia (R/R AML), and achieved a composite complete remission (CR+CRh, or complete remission plus complete remission with partial hematologic recovery) rate of 33.3% (30% CR and 3% CRh), the primary efficacy endpoint. While a median duration of CR/CRh has not been reached, a sensitivity analysis (with a hematopoietic stem cell transplant or HCST as the end of a response) indicates the median duration of CR/CRh to be 13.8 months.

    Safety results are consistent with previously reported Phase 1 clinical trial results1,2. The most common adverse events (AEs) observed were nausea, constipation, increased white blood cell count, decreased red blood cell count, fever, febrile neutropenia and fatigue.

    "We are pleased to announce these compelling top-line data," said Patrick Kelly, MD, chief medical officer of Forma Therapeutics. "The safety profile and the duration of the response we're seeing supports the potential for olutasidenib to become a leading therapy for R/R IDH1m AML patients. While the multi-cohort Phase 2 trial is ongoing, this specific cohort was designed to serve as a pivotal study; these efficacy data support an early stop in enrollment in favor of moving the program forward."

    Additional analyses and other outcome measures will be presented at an upcoming medical meeting.

    Study Design

    The Phase 1/2 study is a multicenter, open-label, multi-cohort evaluation of the safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of olutasidenib for patients with AML or myelodysplastic syndrome (MDS) with an IDH1 mutation. Phase 1 of the trial, FT2102-HEM-101, was an open-label, dose-escalation and expansion study of olutasidenib alone and in combination with azacitidine (AZA). The pivotal Phase 2 study is an open-label, fixed-dose study of olutasidenib as a monotherapy in IDH1m AML patients. The Phase 2 study includes other cohorts of olutasidenib in combination with AZA in IDH1m AML/MDS populations. The primary efficacy-evaluable population of the pivotal phase 2 study is comprised of 123 R/R AML patients, who received olutasidenib 150 mg BID at least six months prior to the interim analysis cutoff date of June 18, 2020. The primary endpoint is a composite of a complete remission (CR) plus a complete remission with partial hematological recovery (CRh), defined as less than 5% blasts in the bone marrow, no evidence of disease and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter).

    About Olutasidenib

    Olutasidenib is an oral, potent and small molecule investigational agent designed to selectively bind to and inhibit mutated IDH1 enzymes. This targeted treatment has the potential to provide therapeutic benefit by reducing 2-HG levels and restoring normal cellular differentiation. Forma is currently evaluating olutasidenib in a registrational Phase 2 trial for relapsed/refractory AML and in an exploratory Phase 1 trial for glioma and other solid tumors.

    IDH1 is a natural enzyme that is part of the normal metabolism of all cells; when mutated, its activity can promote blood malignancies and solid tumors. IDH1 mutations are present in 6-8% of patients with AML and as many as 70 to 80% of patients with grade II/III gliomas and secondary glioblastoma. In gliomas, IDH1 mutations occur early in the tumor pathogenesis and persist throughout progression from a neural stem or progenitor cell. Gliomas are the most common, aggressive and difficult-to-treat primary brain tumors, and high-grade gliomas are associated with poor long-term prognosis. Treatment options for relapsed glioma are limited.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding: our guidance regarding our business plans and objectives for olutasidenib, including the therapeutic potential and clinical benefits thereof as well as the planned study design, the interim results of the Phase 2 clinical trial of olutasidenib, including its initial primary efficacy, safety and tolerability results, the planned additional analyses of the 2102-HEM-101 study, the timing and success of ongoing clinical trials, our growth as a company, and the potential impact of COVID-19 on patient retention, strategy, future operations and clinical trials. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the advancement of our clinical programs, our ability to execute on our strategy, that positive interim results from a clinical study may not be necessarily predictive of the results of future or ongoing clinical studies, the regulatory developments in the United States, the risks related to the competitive landscape, and other risks identified in our SEC filings, including those risks discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

    __________________________

    1
    J. Watts et al., ASH 2019

    Olutasidenib, an IDH1 Inhibitor as a single agent or in combination with azacitadine, induces deep clinical remissions with mutation clearance in patients with acute myeloid leukemia treated in a Phase I dose escalation and expansion study.

    2 J. Cortes et al., ASH 2019

    Olutasidenib induces rapid remissions in patients with IDH1-mutant myelodysplastic syndrome: Results of Phase 1/2 single-agent treatment and combination with azacitidine

    View Full Article Hide Full Article
  26. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the appointments of Fitzroy Dawkins, M.D., as vice president, clinical development and Ruth du Moulin, Ph.D., as vice president, medical affairs.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200915005321/en/

    Fitzroy Dawkins, M.D. (Photo: Business Wire)

    Fitzroy Dawkins, M.D. (Photo: Business Wire)

    "I am very pleased to welcome our new colleagues to the team," said Frank Lee, president and chief executive officer of Forma. "Fitzroy will be integral to the implementation and execution of our global pivotal Phase 2/3 trial of FT-4202, a potentially foundational, disease-modifying…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the appointments of Fitzroy Dawkins, M.D., as vice president, clinical development and Ruth du Moulin, Ph.D., as vice president, medical affairs.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200915005321/en/

    Fitzroy Dawkins, M.D. (Photo: Business Wire)

    Fitzroy Dawkins, M.D. (Photo: Business Wire)

    "I am very pleased to welcome our new colleagues to the team," said Frank Lee, president and chief executive officer of Forma. "Fitzroy will be integral to the implementation and execution of our global pivotal Phase 2/3 trial of FT-4202, a potentially foundational, disease-modifying therapy for people living with sickle cell disease (SCD) expected to initiate in the first half of 2021, as well as in leading our development team evaluating Forma's CBP/p300 inhibitor for the treatment of metastatic castration-resistant prostate cancer. Ruth is an essential hire for Forma as well. Her comprehensive skillset and broad therapeutic experience position her well to lead a medical affairs team focused on strategic engagement with the medical community, delivering impactful medical communications and ensuring our real-world evidence-generation plans address the needs of our target patient groups."

    Dr. Dawkins, a hematologist/oncologist, brings more than 12 years of experience in academia and more than 14 years in drug development. He most recently served as executive director, oncology drug development at Incyte Corporation where he led numerous clinical trials in hematologic diseases and cancers, including an investigational therapeutic for patients with SCD. Dr. Dawkins earned a Bachelor of Science degree in biology from York College of the City University of New York and a medical degree from SUNY-Buffalo.

    Dr. du Moulin joins Forma from Takeda Oncology Global Business Unit where she served as vice president, medical affairs and head of global oncology medical communications. She has more than 15 years of experience building medical affairs departments and functions, setting medical affairs strategy and executing successful product launches in rare disease settings. Dr. du Moulin earned her Ph.D. in biochemistry at the National University of Ireland, Galway (NUI-G), Ireland, followed by post-doctorate research at the Heart Research Institute (HRI) in Sydney, Australia.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the advancement of our sickle cell disease program, our expectations of the therapeutic benefits related thereto, the timing and success of ongoing clinical trials, and our growth as a company and the anticipated contribution of our executives and employees to our operations and progress.. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the advancement of our clinical programs and other risks identified in our SEC filings, including those risks discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

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  27. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the appointment of industry veteran Thomas G. Wiggans to its board of directors. Mr. Wiggans has led successful biopharmaceutical companies from start-up stage into the clinic and later global commercialization, served on the boards of numerous public and private companies, and was instrumental in the formation of the Biotechnology Industry Organization, now Biotechnology Innovation Organization (BIO).

    "I am delighted to welcome Tom to our board," said Peter Wirth, chair of Forma's board of directors. "Tom's distinguished career as a leader of biopharma companies, as well as an entrepreneur…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the appointment of industry veteran Thomas G. Wiggans to its board of directors. Mr. Wiggans has led successful biopharmaceutical companies from start-up stage into the clinic and later global commercialization, served on the boards of numerous public and private companies, and was instrumental in the formation of the Biotechnology Industry Organization, now Biotechnology Innovation Organization (BIO).

    "I am delighted to welcome Tom to our board," said Peter Wirth, chair of Forma's board of directors. "Tom's distinguished career as a leader of biopharma companies, as well as an entrepreneur, will serve as a critical resource to Forma."

    "Tom brings decades of experience leading the development and commercialization of new therapeutics," said Frank Lee, president and chief executive officer of Forma. "We look forward to leveraging his expertise to execute on our corporate and clinical strategies on behalf of the sickle cell community and those affected by prostate cancer."

    "I am excited to join Forma's board at such a pivotal moment in the company's growth," said Wiggans. "I look forward to working with the executive team and other accomplished board members to contribute to the company's mission of bringing transformative medicines to patients with rare hematologic diseases and cancers."

    About Mr. Wiggans

    Mr. Wiggans is a veteran biopharmaceutical executive, having founded Dermira (NASDAQ:DERM) in 2010 and served as its chairman and chief executive officer until it was acquired by Eli Lilly and Company in February 2020. Prior to founding Dermira, Mr. Wiggans served as chairman and chief executive officer of Peplin, Inc. until Peplin's acquisition by LEO Pharma A/S in 2009. He also served as chairman of the board of directors and chief executive officer of Connetics Corporation until it was acquired by Stiefel Laboratories, Inc. in 2006. Prior to Connetics, he served as president and chief operating officer of CytoTherapeutics Inc. and in various management positions at Ares-Serono S.A., including as president of its U.S. pharmaceutical operations and managing director of its U.K. pharmaceutical operations. He began his career with Eli Lilly and Company.

    Mr. Wiggans has served on the boards of numerous public and private companies including Excaliard, Somaxon, Corthera, Sangamo and Onyx. He is a long-standing member of the board of directors of BIO, as well as a member of the board of trustees of the University of Kansas Endowment Association. He holds a B.S. in pharmacy from the University of Kansas and an M.B.A. from Southern Methodist University.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the advancement of our clinical programs, our expectations of the therapeutic benefits related thereto, the timing and success of ongoing clinical trials, and our growth as a company and the anticipated contribution of the members of our board of directors to our operations and progress. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the advancement of our clinical program, the expected impact and contribution of our board of directors and executives to our business, and other risks identified in our SEC filings, including those risks discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

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  28. Completed upsized IPO in June 2020 raising $319.3 million in gross proceeds

    Advanced pipeline focused on rare hematologic diseases and cancers, including reporting favorable single-dose data for FT-4202 in sickle cell disease (SCD) from a randomized, multi-center, placebo-controlled Phase 1 trial

    Additional data expected the second half of 2020 for FT-4202 in SCD and olutasidenib in acute myeloid leukemia (AML)

    FT-7051 for patients with metastatic castration-resistant prostate cancer (mCRPC) to begin Phase 1 trial in the fourth quarter of 2020

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today reported financial results for the second quarter…

    Completed upsized IPO in June 2020 raising $319.3 million in gross proceeds

    Advanced pipeline focused on rare hematologic diseases and cancers, including reporting favorable single-dose data for FT-4202 in sickle cell disease (SCD) from a randomized, multi-center, placebo-controlled Phase 1 trial

    Additional data expected the second half of 2020 for FT-4202 in SCD and olutasidenib in acute myeloid leukemia (AML)

    FT-7051 for patients with metastatic castration-resistant prostate cancer (mCRPC) to begin Phase 1 trial in the fourth quarter of 2020

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today reported financial results for the second quarter ended June 30, 2020. The Company also highlighted recent progress and upcoming milestones for its pipeline programs.

    "This year, to date, has been very productive for Forma. We completed an upsized initial public offering, which will allow us to advance both our core assets, FT-4202, a potentially foundational, disease-modifying therapy for patients with sickle cell disease, and FT-7051, in development for mCRPC with the potential to address prostate cancer cell resistance related to molecular alterations in androgen receptors. In addition, our board of directors welcomed Dr. Wayne Frederick, who is not only a distinguished doctor and president of Howard University but also lives with sickle cell disease," said Frank Lee, president and chief executive officer of Forma Therapeutics. "We look forward to continuing Forma's momentum by providing several clinical updates before the end of the year, including topline data from our FT-4202 multiple ascending dose study and interim data from a non-core asset, olutasidenib, Phase 2 clinical trial in patients with relapsed/refractory acute myeloid leukemia."

    Key Business and Clinical Highlights

    PKR Program in Sickle Cell Disease (SCD):

    • Received FDA Orphan Drug Designation for FT-4202 in Sickle Cell Disease. FT-4202 is being evaluated in a randomized, multi-center, placebo-controlled Phase 1 trial in SCD patients ages 12 years and older and has been granted fast track, rare pediatric and orphan drug designations. FT-4202 is a potent activator of pyruvate kinase-R (PKR) designed to improve red blood cell (RBC) metabolism, function and survival by decreasing 2,3 DPG and increasing ATP, potentially resulting in both increased hemoglobin levels and reduced vaso-occlusive crises.
    • Reported Favorable Single Dose Cohort Data of Patients with SCD at EHA: Results presented at the 25th European Hematology Association (EHA) Annual Congress in June 2020 demonstrated a favorable tolerability profile and biologic effects of FT-4202, with evidence of pharmacodynamic activity translating into increased oxygen affinity, a shift in the point of sickling to lower oxygen tensions, improved membrane deformability of sickle RBCs and an increased hemoglobin (on average 0.9 g/dL vs. placebo) at 24 hours post-single dose. These initial findings supported the initiation of the multiple ascending dose cohort in patients with SCD and continued planning for the global Phase 2/3 trial in SCD patients.

    CPB Program in Prostate Cancer:

    • Presented Data Demonstrating Antitumor Activity of a Potent and Selective Inhibitor of CBP/p300 at AACR: Forma presented preclinical data on FT-6876, a predecessor molecule to clinical development candidate FT-7501, at the American Association of Cancer Research (AACR) in June 2020 that demonstrated antitumor activity in androgen receptor (AR)-dependent breast cancer cell lines and highlighted the possible role of CREB-binding protein/E1A binding protein p300 (CBP/p300) in proliferation and survival of AR-independent tumors. Inhibition of CBP/p300 in vitro can suppress AR and AR-v7 driven transcription of genes that drive the growth of prostate cancer cells.
    • FDA Cleared Investigational New Drug application for FT-7051. In April 2020, the FDA cleared Forma's investigational new drug application for FT-7051. We expect to initiate a Phase 1 trial in mCRPC patients in the fourth quarter of 2020.

    IDH1 Program in AML and Glioma:

    • Announced Positive IDH1 Inhibitor Data for Olutasidenib in Glioma at ASCO: Forma announced positive preliminary Phase 1 data for olutasidenib in refractory, predominantly enhancing glioma at the 2020 American Society of Clinical Oncology (ASCO), suggesting the potential for response and prolonged disease control in both non-enhancing and enhancing phenotypes of relapsed/refractory IDH1-mutated glioma patients. Olutasidenib is a selective inhibitor for cancers with IDH1 mutations and is being evaluated in a registrational Phase 2 trial for relapsed/refractory acute myeloid leukemia (R/R AML) and an exploratory Phase 1 trial for glioma and other IDH1m solid tumor indications.

    Corporate:

    • Completed Upsized Initial Public Offering: In June 2020, Forma completed an upsized IPO of 15,964,704 shares of common stock, including the full exercise of the underwriter's over-allotment option, resulting in gross proceeds of approximately $319.3 million before deducting underwriting discounts and commissions and other offering expenses.
    • Strengthened Executive Team with Appointment of David N. Cook, Ph.D., as Chief Scientific Officer
    • Transitioned Board of Directors Composition: Following Forma's IPO, Dr. Steve Hall departed the board of directors and Dr. Wayne A. I. Frederick joined.

    Upcoming Milestones

    • Updated Data to Inform Pivotal Trial in SCD: Forma plans to announce topline data from the ongoing trial of FT-4202 in SCD patients in the fourth quarter of 2020, including data from multiple ascending dose cohorts. The results of this trial will inform a global pivotal Phase 2/3 trial for people living with SCD, which is expected to initiate in the first half of 2021.
    • Initiation of Clinical Development in mCRPC: We continue to make progress to initiate a Phase 1 trial of FT-7051 in mCRPC patients in the fourth quarter of 2020.
    • Additional Data from Non-core IDH1 Program: Forma plans to announce topline data from a second interim analysis of the registrational cohort of an olutasidenib trial in relapsed/refractory AML (R/R AML) in the fourth quarter of 2020.
    • Possibility of COVID-19 Impact: The COVID-19 pandemic remains a factor in the successful completion of these milestones. Many clinical trials across the biopharma industry have been impacted by the COVID-19 pandemic, with clinical trial sites implementing new policies in response to COVID-19, resulting in potential delays to enrollment of clinical trials or changes in the ability to access sites participating in clinical trials.

    Financial Results

    • Cash Position: Cash, cash equivalents and marketable securities were $414.3 million as of June 30, 2020, as compared to $173.2 million as of December 31, 2019.
    • Research and Development (R&D) Expenses: R&D expenses were $20.5 million for the quarter ended June 30, 2020, compared to $28.1 million for the quarter ended June 30, 2019. The decrease was primarily due to planned reductions in spending on FT-2101, FT-4101, FT-8225, research, as well as internal R&D personnel-related costs, which were partially offset by increases in FT-4202 expenses to conduct the Phase 1 trial and preparations for our planned pivotal Phase 2/3 trial.
    • General and Administrative (G&A) Expenses: G&A expenses were $6.4 million for the quarter ended June 30, 2020, compared to $5.7 million for the quarter ended June 30, 2019. The increase was primarily due to increases in professional fees and stock-based compensation, partially offset with lower personnel-related costs.
    • Net Income/Loss: Net loss was $25.4 million for the quarter ended June 30, 2020, compared to $14.8 million for the quarter ended June 30, 2019.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the company's beliefs and expectations regarding its: business plans and objectives; future plans for FT-4202 and FT-7051, including expectations regarding timing and success of the current ongoing clinical trials, therapeutic potential and clinical benefits thereof, and upcoming milestones for the company's other product candidates; growth as a company and the anticipated contribution of the members of our board of directors to our operations and progress; uses of capital, expenses and other 2020 financial results or in the future, and the potential impact of COVID-19 on patient retention, strategy, future operations, clinical trials or IND submissions. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties associated with: the impact of the COVID-19 pandemic on the company's business, operations, strategy, goals and anticipated milestones; the therapeutic potential of FT-4202, and the timing associated with the initiation or continuation of any of FT-4202 trials; the initiation of our phase I clinical trial of FT-7051; the timing of the second interim analysis of the registrational cohort of FT-2102 in R/R AML; Forma's ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Forma's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in the final prospectus dated June 22, 2020 and filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, with the United States Securities and Exchange Commission (SEC) and elsewhere in Forma's filings and reports with the SEC. Forma disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Forma's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Forma explicitly disclaims any obligation to update any forward-looking statements.

    Forma Therapeutics Holdings, Inc.
    Condensed Consolidated Statements of Operations
    (unaudited)
    (in thousands except share and per share data) For the three months ended For the six months ended
    June 30,

    2020
    June 30,

    2019
    June 30,

    2020
    June 30,

    2019
     
    Revenue

    $

    -

     

    $

    17,727

     

    $

    -

     

    $

    89,736

     

    Operating expenses

    Research and development

     

    20,511

     

     

    28,065

     

     

    43,721

     

     

    56,715

     

    General and administrative

     

    6,448

     

     

    5,688

     

     

    15,381

     

     

    10,606

     

    Restructuring charges

     

    (20

    )

     

    849

     

     

    63

     

     

    5,075

     

    Total operating expenses

     

    26,939

     

     

    34,602

     

     

    59,165

     

     

    72,396

     

    Income (loss) from operations

     

    (26,939

    )

     

    (16,875

    )

     

    (59,165

    )

     

    17,340

     

    Other income (loss), net

     

    (1,739

    )

     

    793

     

     

    22,232

     

     

    2,291

     

    Income (loss) before taxes

     

    (28,678

    )

     

    (16,082

    )

     

    (36,933

    )

     

    19,631

     

    Income tax benefit

     

    (3,238

    )

     

    (1,325

    )

     

    (22,723

    )

     

    (1,217

    )

    Net income (loss)

    $

    (25,440

    )

    $

    (14,757

    )

    $

    (14,210

    )

    $

    20,848

     

    Preferred return and accretion of preferred return and cumulative dividends on preferred securities

     

    (1,800

    )

     

    (600

    )

     

    (3,736

    )

     

    (1,788

    )

    Distribution to holders of preferred securities in excess of accrued preferred return

     

    -

     

     

    -

     

     

    -

     

     

    (11,347

    )

    Undistributed earnings allocable to participating securities

     

    -

     

     

    -

     

     

    -

     

     

    (5,815

    )

    Net loss allocable to shares of common stock, basic and diluted

    $

    (27,240

    )

    $

    (17,946

    )

    Net income (loss) allocable to shares of Common 1, basic

    $

    (15,357

    )

    $

    1,898

     

    Change in fair value attributable to warrants to purchase preferred securities

     

    (7

    )

     

    (317

    )

    Net income (loss) allocable to shares of Common 1, diluted

    $

    (15,364

    )

    $

    1,581

     

     
    Net loss per share of common stock, basic and diluted

    $

    (4.58

    )

    $

    (4.23

    )

    Net income (loss) per share of Common 1:
    Basic

    $

    (6.03

    )

    $

    0.74

     

    Diluted

    $

    (6.03

    )

    $

    0.61

     

    Weighted-average shares of common stock outstanding, basic and diluted

     

    5,943,165

     

     

    4,245,622

     

    Weighted-average shares of Common 1 outstanding:
    Basic

     

    2,547,924

     

     

    2,547,924

     

    Diluted

     

    2,547,924

     

     

    2,581,952

     

    Forma Therapeutics Holdings, Inc.

    Condensed Consolidated Balance Sheets

    (unaudited)

    (in thousands, except share data)
    June 30,

    2020
    December 31,

    2019
    Assets

    Cash, cash equivalents, and marketable securities

    $

    414,301

    $

    173,180

    Fixed assets

     

    1,901

     

    5,102

    Other assets

     

    51,310

     

    4,753

    Total assets

    $

    467,512

    $

    183,035

     
    Liabilities and stockholders' equity

    Current liabilities

    $

    24,818

    $

    24,868

    Long-term liabilities

     

    4,197

     

    1,790

    Total liabilities

     

    29,015

     

    26,658

    Total stockholders' equity

     

    438,497

     

    156,377

    Total liabilities and stockholders' equity

    $

    467,512

    $

    183,035

     

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  29. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that Wayne A.I. Frederick, M.D., has been elected to serve on the company's board of directors.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200730005190/en/

    Wayne A.I. Frederick, M.D. (Photo: Business Wire)

    Wayne A.I. Frederick, M.D. (Photo: Business Wire)

    Dr. Frederick is the President of Howard University, as well as the Charles R. Drew Professor in Surgery at Howard University's College of Medicine, and a distinguished researcher and practicing surgeon. Before his appointment as President in 2014, Dr. Frederick served as Howard's Provost and Chief Academic Officer. The…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that Wayne A.I. Frederick, M.D., has been elected to serve on the company's board of directors.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200730005190/en/

    Wayne A.I. Frederick, M.D. (Photo: Business Wire)

    Wayne A.I. Frederick, M.D. (Photo: Business Wire)

    Dr. Frederick is the President of Howard University, as well as the Charles R. Drew Professor in Surgery at Howard University's College of Medicine, and a distinguished researcher and practicing surgeon. Before his appointment as President in 2014, Dr. Frederick served as Howard's Provost and Chief Academic Officer. The author of an extensive body of peer-reviewed articles, book chapters, abstracts and editorials, he has also received numerous notable awards for his scholarship and service. Dr. Frederick is a fellow of the American College of Surgeons and a member of many other surgical organizations, including the American Surgical Association.

    "As a practicing physician and experienced medical researcher, coupled with his leadership skills and business acumen, Wayne brings valuable perspective to Forma at this pivotal time of growth for our company, particularly as we look to advance our sickle cell disease program into a Phase 2/3 pivotal trial next year," said Peter Wirth, J.D., chairman, board of directors of Forma.

    "I am delighted to welcome such an experienced and sickle cell community-minded director to join us," said Frank Lee, chief executive officer and board member of Forma. "With his deep understanding of patient needs and his personal commitment to the sickle cell community, Wayne embodies Forma's mission and patient-driven culture."

    "I am honored to join the board of a company that is committed to and passionate about pursuing treatments for rare hematologic diseases and cancers," said Dr. Frederick. "As someone who is living with Sickle Cell, I am personally dedicated to the search for new and better therapeutics to combat this painful and debilitating disease. I am inspired by Frank and the team he has so diligently assembled for this cause."

    Dr. Frederick will serve on the board's audit committee. In addition to his board position at Forma, he currently serves as a board member for Humana, Inc., the United States Chamber of Commerce and Mutual of America Life Insurance Co.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the advancement of our sickle cell disease program, our expectations of the therapeutic benefits related thereto, and our expectations regarding our new director. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the advancement of our sickle cell disease program and other risks identified in our SEC filings, including our Registration Statement on Form S-1, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

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  30. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the closing of its initial public offering of 15,964,704 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 2,082,352 additional shares of common stock, at a public offering price of $20.00 per share. The aggregate gross proceeds to Forma from the offering were approximately $319.3 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares in the offering were offered by Forma.

    Jefferies, SVB Leerink and Credit Suisse acted as joint book-running managers for the offering.

    Registration…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the closing of its initial public offering of 15,964,704 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 2,082,352 additional shares of common stock, at a public offering price of $20.00 per share. The aggregate gross proceeds to Forma from the offering were approximately $319.3 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares in the offering were offered by Forma.

    Jefferies, SVB Leerink and Credit Suisse acted as joint book-running managers for the offering.

    Registration statements relating to these securities have been filed with the Securities and Exchange Commission ("SEC") and became effective on June 18, 2020. The offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@Jefferies.com; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218, or by email at syndicate@svbleerink.com; or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at usa.prospectus@credit-suisse.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers.

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  31. Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the pricing of its initial public offering of 13,882,352 shares of common stock at a public offering price of $20.00 per share. All of the shares are being offered by Forma. The shares are expected to begin trading on the Nasdaq Global Market on June 19, 2020 under the ticker symbol "FMTX." The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Forma, are expected to be approximately $277.6 million. The offering is expected to close on June 23, 2020, subject to the satisfaction of customary closing conditions…

    Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the pricing of its initial public offering of 13,882,352 shares of common stock at a public offering price of $20.00 per share. All of the shares are being offered by Forma. The shares are expected to begin trading on the Nasdaq Global Market on June 19, 2020 under the ticker symbol "FMTX." The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Forma, are expected to be approximately $277.6 million. The offering is expected to close on June 23, 2020, subject to the satisfaction of customary closing conditions. In addition, Forma has granted the underwriters a 30-day option to purchase up to an additional 2,082,352 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

    Jefferies, SVB Leerink and Credit Suisse are acting as joint book-running managers for the offering.

    Registration statements relating to these securities became effective on June 18, 2020. The offering will be made only by means of a prospectus, copies of which may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@Jefferies.com; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218, or by email at syndicate@svbleerink.com; or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at usa.prospectus@credit-suisse.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Forma Therapeutics

    Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers.

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