Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field
of cellular metabolism to treat cancer and genetically defined
diseases, today announced its key 2021 milestones that will drive
its recently announced strategic pivot to focus on developing and
commercializing innovative treatments for genetically defined
diseases, as well as its five-year vision for the company. Agios
will present at the virtual 39th Annual J.P. Morgan Healthcare
Conference on Monday, January 11 at 10:50 a.m. ET, and a live
webcast will be available at investor.agios.com.
“Agios is at an exciting inflection point as we prepare to move
forward with a singular focus on genetically defined diseases,”
said Jackie Fouse, Ph.D., chief executive officer of Agios. “2021
will be a year of significant momentum and further evidence of our
potential to meaningfully impact the lives of patients with unmet
needs in pyruvate kinase deficiency, thalassemia, sickle cell
disease and other genetically defined diseases. This year, we
expect to file for the approval of mitapivat in pyruvate kinase
deficiency, which currently has no disease-modifying treatment
options, and to initiate pivotal development programs in
thalassemia and sickle cell disease. We also expect to further
unlock the potential of PK activation across a range of genetically
defined diseases by advancing our rich and sustainable research
pipeline. As we reimagine the future of Agios, we look forward to
building on our core values and pioneering leadership in cellular
metabolism to expand and accelerate our work on behalf of
patients.”
Anticipated 2021 Key Milestones
Agios expects to achieve the following key milestones in
2021:
Corporate
- Complete sale of oncology portfolio to Servier, in a
transaction worth up to $2 billion plus royalties, in the second
quarter of 2021 subject to shareholder approval and satisfaction of
regulatory conditions, and commence return of at least $1.2 billion
to shareholders post-closing
Genetically Defined Disease Program Milestones
- File for regulatory approval for mitapivat in adults with PK
deficiency: submit new drug application (NDA) in the U.S. in the
second quarter of 2021 and marketing authorization application
(MAA) in the EU in mid-2021
- Initiate two Phase 3 studies of mitapivat, ENERGIZE and
ENERGIZE-T, in not regularly transfused and regularly transfused
adults with thalassemia in the second half of 2021
- Announce pivotal development plan for mitapivat in adults with
sickle cell disease in the first half of 2021 and initiate pivotal
development program by year-end
- Prioritize new indications for pyruvate kinase R (PKR) and
pyruvate kinase M2 (PKM2) activator clinical development by
year-end
Genetically Defined Disease Data Presentations
- Report topline data from the Phase 3 ACTIVATE-T study of
mitapivat in adults with PK deficiency who receive regular
transfusions in the first quarter of 2021
- Submit data from the following clinical studies for
presentation at the European Hematology Association (EHA) Virtual
Congress, which will be held June 9-17, 2021:
- Phase 3 ACTIVATE study of mitapivat in adults with PK
deficiency who do not receive regular transfusions
- Phase 3 ACTIVATE-T study of mitapivat in adults with PK
deficiency who receive regular transfusions
- Phase 2 study of mitapivat in adults with α- and β-thalassemia
who do not receive regular transfusions
- Submit data from ongoing clinical studies of mitapivat in
sickle cell disease for presentation at medical meetings throughout
2021
- Present data from the single ascending dose (SAD) and multiple
ascending dose (MAD) cohorts of the Phase 1 study of AG-946, the
company’s next-generation PKR activator, in healthy volunteers by
year-end
Oncology Milestones & Data Presentations
- Present mature overall survival data from the Phase 3 ClarIDHy
study of TIBSOVO® (ivosidenib tablets) in patients with previously
treated IDH1-mutant cholangiocarcinoma at the American Society of
Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI),
which will be held virtually January 15-17, 2021
- Submit supplemental new drug application (sNDA) in the U.S. for
TIBSOVO® in patients with previously treated IDH1-mutant
cholangiocarcinoma in the first quarter of 2021
- Enrollment in the Phase 3 AGILE trial of TIBSOVO® in
combination with azacitidine in adult patients with previously
untreated IDH1-mutant acute myeloid leukemia is expected to be
complete by year-end
- Enrollment in the relapsed or refractory myelodysplastic
syndrome arm of the TIBSOVO® Phase 1 study of IDH1-mutant
advanced hematologic malignancies is expected to be complete by
year-end
- Full-year net product revenue for TIBSOVO® is expected to be
$160-170 million
Agios 2025 Strategic VisionThe Agios 2025
strategic vision reflects the company’s expected evolution over the
next five years in light of its singular focus on genetically
defined diseases. As part of this vision, Agios expects to achieve
the following milestones by the end of 2025:
- Receive regulatory approval for mitapivat in three initial
indications: PK deficiency, thalassemia and sickle cell
disease
- Advance a broad clinical pipeline of at least 5 molecules
exploring at least 10 indications
- Foster a robust research pipeline poised to deliver an
investigational new drug (IND) every 12-24 months
- Achieve cash-flow positivity
2020 Year-End Cash and GuidanceAgios ended 2020
with approximately $670.5 million of cash, cash
equivalents and marketable securities. The company expects that its
cash, cash equivalents and marketable securities as
of December 31, 2020, together with anticipated product and
royalty revenue, interest income and expense reimbursements under
our collaboration agreements, but excluding any additional
program-specific milestone payments, will enable the company to
fund its planned operating expenses and capital expenditure
requirements to the end of 2022. Following the completion of the
transaction with Servier and the subsequent shareholder returns,
Agios expects its cash runway to extend to cash-flow positivity in
2025.
Presentation at
39th Annual J.P. Morgan
Healthcare ConferenceAgios will webcast its corporate
presentation from the virtual 39th Annual J.P. Morgan
Healthcare Conference on Monday, January 11, 2021 at
10:50 a.m. ET (7:50 a.m. PT). A live webcast of the
presentation can be accessed under “Events & Presentations” in
the Investors section of the company’s website at agios.com. A
replay of the webcast will be archived on the Agios website for at
least two weeks following the presentation.
About AgiosAgios is focused on discovering and
developing novel investigational medicines to treat malignant
hematology, solid tumors and genetically defined 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 Agios’ plans, strategies and expectations for the
preclinical, clinical and commercial advancement of its drug
development programs; the potential benefits of Agios’ products and
product candidates; Agios’ key milestones and guidance for 2021 and
strategic vision for 2025; its financial guidance regarding the
period in which it will have capital available to fund its
operations; expectations regarding the sale of Agios’ oncology
portfolio and associated return of capital to shareholders; and the
potential benefits of Agios’s strategic plans and focus. The words
“anticipate,” “expect,” “goal,” “hope,” “milestone,” “plan,”
“potential,” “possible,” “strategy,” “will,” “vision,” 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. 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: (i) Agios’s sale of its oncology
portfolio, including the occurrence of any event, change or other
circumstance that could give rise to the termination of the
purchase and sale agreement; the failure of Agios to obtain
stockholder approval for the proposed transaction or the failure to
satisfy any of the other conditions to the completion of the
proposed transaction; the effect of the announcement of the
proposed transaction on the ability of Agios to retain and hire key
personnel and maintain relationships with its customers, suppliers,
advertisers, partners and others with whom it does business, or on
its operating results and businesses generally; risks associated
with the disruption of management’s attention from ongoing business
operations due to the proposed transaction; the ability to meet
expectations regarding the timing and completion of the proposed
transaction, including with respect to receipt of required
regulatory approvals; the failure of Agios to receive milestone or
royalty payments under the purchase and sale agreement and the
uncertainty of the timing of any receipt of any such payments; and
the uncertainty of the results and effectiveness of
the use of proceeds from the proposed
transaction; (ii) the impact of the COVID-19 pandemic to Agios’
business, operations, strategy, goals and anticipated milestones,
including its ongoing 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; (iii) Agios’ results of
clinical trials and preclinical studies, including subsequent
analysis of existing data and new data received from ongoing and
future studies; (iv) 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; (v) Agios’ ability to obtain and
maintain requisite regulatory approvals and to enroll patients in
its planned clinical trials; (vi) unplanned cash requirements and
expenditures and competitive factors; (vii) Agios’ ability to
obtain, maintain and enforce patent and other intellectual property
protection for any product candidates it is developing; (viii)
Agios’ ability to maintain key collaborations; and (ix) 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 the Securities 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.
Additional Information and Where to Find ItThis
communication relates to the proposed transaction involving the
sale by Agios Pharmaceuticals, Inc. (“Agios”) of its oncology
business to Servier Pharmaceuticals, LLC. In connection with the
proposed transaction, Agios will file relevant materials with the
U.S. Securities and Exchange Commission (the “SEC”), including
Agios’ proxy statement on Schedule 14A (the “Proxy Statement”).
This communication is not a substitute for the Proxy Statement or
any other document that Agios may file with the SEC or send to its
stockholders in connection with the proposed transaction. BEFORE
MAKING ANY VOTING DECISION, STOCKHOLDERS OF AGIOS ARE URGED TO READ
ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING THE PROXY
STATEMENT, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and
security holders will be able to obtain the documents (when
available) free of charge at the SEC’s website, at
http://www.sec.gov, and Agios’s website, at www.agios.com. In
addition, the documents (when available) may be obtained free of
charge by accessing Agios’s website at www.agios.com under the
heading “Investors” or, alternatively, directing a request to Holly
Manning by email at holly.manning@agios.com or by calling
617-649-8600.
Participants in the SolicitationAgios and its
directors and executive officers may be deemed to be participants
in the solicitation of proxies from the holders of Agios common
stock in respect of the proposed transaction. Information about the
directors and executive officers of Agios is set forth in the proxy
statement for Agios’ 2020 annual meeting of stockholders, which was
filed with the SEC on April 16, 2020, and in other documents filed
by Agios with the SEC. Other information regarding the participants
in the proxy solicitation and a description of their direct and
indirect interests, by security holdings or otherwise, will be
contained in the Proxy Statement and other relevant materials to be
filed with the SEC in respect of the proposed transaction when they
become available.
Contacts
Investors:Holly Manning, 617-844-6630Director,
Investor RelationsHolly.Manning@agios.com
Media:Jessica Rennekamp, 857-209-3286Associate
Director, Corporate CommunicationsJessica.Rennekamp@agios.com
Agios Pharmaceuticals (NASDAQ:AGIO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Agios Pharmaceuticals (NASDAQ:AGIO)
Historical Stock Chart
From Apr 2023 to Apr 2024