GlobeNewswire Inc | Nov 4, 2020 11:46AM EST

November 04, 2020

CAMBRIDGE, Mass., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that a broad set of clinical and translational data from its oncology and rare genetic diseases programs will be presented at the American Society of Hematology (ASH) Annual Meeting being held virtually December 58, 2020.

In total, eight abstracts led by Agios will be presented, as well as three abstracts led by external collaborators. The accepted abstracts are listed below and are available online on the ASH conference website: https://www.hematology.org/meetings/annual-meeting/abstracts.

Presentations by Agios

Oral Presentation

Abstract #625 Ivosidenib Improves Overall Survival Relative to Standard Therapies in Relapsed or Refractory Mutant IDH1 AML: Results from Matched Comparisons to Historical ControlsDate & Time Monday, December 7, 2020 at 10:15 a.m. PSTOral Session 903. Health Services Research Malignant Conditions (Myeloid Disease): Treatment and Publication Patterns in Myeloid Malignancies

Poster Presentations Rare Genetic Diseases

Abstract #1627 Mortality Among Veterans with a Diagnosis of Pyruvate Kinase (PK) Deficiency: A Real-World Study Using US Veterans Health Administration DataPoster Session Date & Time Saturday, December 5, 2020 from 7:00 a.m. - 3:30 p.m. PSTPoster Session 904. Outcomes Research Non-Malignant Conditions: Poster I

Abstract #1679 Early-Onset Osteopenia and Osteoporosis in Patients with Pyruvate Kinase DeficiencyPoster Session Date & Time Sunday, December 6, 2020 from 7:00 a.m. - 3:30 p.m. PSTPoster Session 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster II

Abstract #2538 Baseline Characteristics of Patients in Peak: A Global, Longitudinal Registry of Patients with Pyruvate Kinase Deficiency Poster Session Date & Time Monday, December 7, 2020 from 7:00 a.m. - 3:30 p.m. PSTPoster Session 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster III

Abstract #2600 Proof of Concept for the Oral Pyruvate Kinase Activator Mitapivat in Adults with Non-Transfusion-Dependent Thalassemia: Interim Results from and Ongoing, Phase 2, Open-Label, Multicenter StudyPoster Session Date & Time Monday, December 7, 2020 from 7:00 a.m. - 3:30 p.m. PSTPoster Session 112. Thalassemia and Globin Gene Regulation: Poster III

Poster Presentations Oncology

Abstract #1943 Molecular Characterization of Clinical Response and Relapse in Patients with IDH1-Mutant Newly Diagnosed Acute Myeloid Leukemia Treated with Ivosidenib and Azacitidine Poster Session Date & Time Sunday, December 6, 2020 from 7:00 a.m. - 3:30 p.m. PSTPoster Session 615. Acute Myeloid Leukemia: Commercially Available Therapy, excluding Transplantation: Poster II

Abstract #2814 AGILE: Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Ivosidenib in Combination with Azacitidine in Adults with Newly Diagnosed Acute Myeloid Leukemia and an IDH MutationPoster Session Date & Time Monday, December 7, 2020 from 7:00 a.m. - 3:30 p.m. PSTPoster Session 613. Acute Myeloid Leukemia: Clinical Studies: Poster III

Abstract #2900 Longitudinal Molecular Profiling in Patients with IDH1-Mutant Newly Diagnosed Acute Myeloid Leukemia Treated with IvosidenibPoster Session Date & Time Monday, December 7, 2020 from 7:00 a.m. - 3:30 p.m. PSTPoster Session 617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis Prognosis: Poster III

Presentations by External Collaborators

Oral Presentations

Abstract #84 The Pyruvate Kinase Activator AG-348 ameliorates anemia and prevents iron overload in a mouse model of hereditary spherocytosisDate & Time Saturday, December 5, 2020 at 10:15 a.m. PSTOral Session 101. Red Cells and Erythropoiesis, Structure, and Functions, Metabolism, and Survival, Excluding Iron: Mechanisms, Diagnosis and Treatment of InheritedPresenter Alessandro Matt, BSc, PhD University of Verona and AOUI Verona

Abstract #681 Phase 1 Multiple Ascending Dose Study of Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Mitapivat (AG-348) in Subjects with Sickle Cell DiseaseDate & Time Monday, December 7, 2020 at 2:30 p.m. PSTOral Session 114. Hemoglobinopathies Excluding Thalassemia Clinical: Novel Treatments for Sickle Cell DiseasePresenter Julia Z. Xu, Sickle Cell Branch, National Heart, Lung, and Blood Institute

Poster Presentation

Abstract #2402 A Phase I Study of the IDH2 inhibitor enasidenib as maintenance therapy for IDH2-mutant myeloid neoplasms following hematopoieticDate & Time Sunday, December 6, 2020 from 7:00 a.m. - 3:30 p.m. PSTPosterSession 723. Clinical Allogeneic and Autologous Transplantation: Late Complications and Approaches to Disease Recurrence: Post II

Event and Webcast InformationAgios will host a virtual investor event on December 8, 2020 at 8:00 a.m. ET to review the data from the company's rare genetic diseases program. The event will be webcast live and can be accessed under "Events & Presentations" in the Investors section of the company's website at www.agios.com. The archived webcast will be available on the company's website beginning approximately two hours after the event.

About AgiosAgios is focused on discovering and developing novel investigational medicines to treat malignant hematology, solid tumors and rare genetic diseases through scientific leadership in the field of cellular metabolism. In addition to an active research and discovery pipeline across these three therapeutic areas, Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development. For more information, please visit the company's website at www.agios.com.

Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the potential benefits of ivosidenib, enasidenib and mitapivat; Agios plans regarding future data presentations; and the potential benefit of its strategic plans and focus. The words anticipate, expect, intend, potential, milestone, goal, will, on track, upcoming, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from Agios' current expectations and beliefs. For example, there can be no guarantee that any product candidate Agios or its collaborators is developing will successfully commence or complete necessary preclinical and clinical development phases, or that development of any of Agios' product candidates will successfully continue. Moreover, there can be no guarantee that the two approved oncology precision medicines being commercialized by Agios and its collaborators will receive commercial acceptance. There can be no guarantee that any positive developments in Agios' business will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other important factors, including, without limitation: risks and uncertainties related to the impact of the COVID-19 pandemic toAgiosbusiness, operations, strategy, goals and anticipated milestones, includingitsongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products; Agios results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S.FDA, the EMA or other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Agios ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials; unplanned cash requirements and expenditures; competitive factors; Agios' ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing; Agios ability to maintain key collaborations; and general economic and market conditions. These and other risks are described in greater detail under the caption "Risk Factors" included in Agios public filings with theSecurities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Agios expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

Investors:Holly Manning, 617-844-6630Director, Investor RelationsHolly.Manning@agios.com

Media:Jessica Rennekamp, 857-209-3286Associate Director, Corporate CommunicationsJessica.Rennekamp@agios.com