Agios Announces “Agios 2025” Strategic Vision and Highlights 2020 Milestones
January 12 2020 - 4:00PM
Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) today announced its
“Agios 2025” six-year strategic vision focused on creating and
commercializing differentiated medicines to treat hematologic
malignancies, solid tumors and rare genetic diseases. Under this
plan, by the end of 2025, the company expects to have four marketed
products across at least eight indications, at least six molecules
in clinical development and be cash-flow positive. Agios will
present at the 38th Annual J.P. Morgan Healthcare Conference in San
Francisco on Monday, January 13 at 7:30 a.m. PT (10:30 a.m. ET),
and a live webcast will be available at investor.agios.com.
“We are entering an exciting new chapter for Agios as we advance
our first rare genetic disease program across three opportunities
in PK deficiency, thalassemia and sickle cell disease and continue
our work to expand the benefit of IDH inhibitors to solid tumors as
well as to additional indications in hematologic malignancies,”
said Jackie Fouse, Ph.D., chief executive officer of Agios. “We
will realize our 2025 vision by continuing to leverage our
unmatched expertise in cellular metabolism, early translational
research and our passionately patient-focused team, the same
attributes that enabled us to discover, develop and market two
targeted oncology medications in just 10 years. With both near- and
long-term value drivers, Agios enters 2020 with strong momentum
that will continue as we work toward achieving our 2025 strategic
vision.”
“AGIOS 2025” STRATEGIC VISION
The “Agios 2025” strategic vision delineates the company’s view
for growth over the next six years with established and expanding
franchises focused on treating hematologic malignancies, solid
tumors and rare genetic diseases. As part of this vision, Agios
expects to achieve the following milestones by the end of 2025:
- 4 marketed medicines discovered and developed
at Agios
- Approvals in 8+ indications spanning
hematologic malignancies, solid tumors and rare genetic
diseases
- 6+ molecules in the clinic generated by the
company’s internal research discovery engine
- Cash-flow positive within the six-year
timeframe
ANTICIPATED 2020 KEY MILESTONES
Agios announced today that it expects to achieve the following
key milestones in 2020:
Hematologic Malignancies
- Deliver full-year U.S. revenue for TIBSOVO® of $105-115
million
- Receive European Medicines Agency CHMP opinion for TIBSOVO® in
relapsed or refractory acute myeloid leukemia (AML) with an IDH1
mutation by year-end
- Complete enrollment of Phase 3 AGILE trial of TIBSOVO® in
combination with azacitidine in adult patients with previously
untreated IDH1 mutant AML by year-end
- Complete enrollment of the relapsed or refractory
myelodysplastic syndrome arm of the TIBSOVO® Phase 1 study of IDH1
mutant advanced hematologic malignancies by year-end
Solid Tumors
- File supplemental new drug application (sNDA) for TIBSOVO® in
previously treated IDH1 mutant cholangiocarcinoma by year-end
Rare Genetic Diseases
- Announce topline data for ACTIVATE and ACTIVATE-T pivotal
trials for mitapivat in adults with pyruvate kinase (PK) deficiency
by year-end
- Submit updated data from the Phase 2 study of mitapivat in
thalassemia for presentation at the European Hematology Association
(EHA) Congress and finalize pivotal development strategy by
year-end
- Achieve proof of concept for mitapivat in sickle cell disease
by mid-2020
- Receive investigational new drug (IND) clearance for AG-946, a
next generation PKR activator, and initiate first-in-human study in
healthy volunteers in the first half of 2020
Research
- Achieve at least one new development candidate by year-end
RECENT
MILESTONES
The company also provided an update on the following 2019 key
milestones:
- Completed enrollment of ACTIVATE-T, a single-arm trial
evaluating mitapivat in regularly transfused adults with PK
deficiency
- Expect to complete enrollment in ACTIVATE, a 1:1 randomized,
placebo-controlled trial in adult PK deficiency patients who do not
receive regular transfusions, in the first quarter of 2020
- Initiated the registration-enabling Phase 3 INDIGO study of
vorasidenib in patients with Grade 2 non-enhancing glioma with an
IDH mutation
2019 Year-End Cash and GuidanceAgios ended 2019
with approximately $718 million of cash, cash equivalents and
marketable securities. The company expects that its cash, cash
equivalents and marketable securities as of December 31, 2019,
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 through at least the
end of 2021.
Presentation at 38th Annual J.P. Morgan Healthcare
ConferenceAgios will webcast its corporate presentation
and break out session from the 38th Annual J.P. Morgan Healthcare
Conference in San Francisco on Monday, January 13, 2020 at 7:30
a.m. PT (10:30 a.m. ET). 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 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 Agios’ plans, strategies and expectations for its and its
collaborator’s preclinical, clinical and commercial advancement of
its drug development programs including TIBSOVO® (ivosidenib),
IDHIFA® (enasidenib), mitapivat, vorasidenib, AG-270 and AG-636;
the potential benefits of Agios' product candidates; Agios’s
strategic vision and goals for 2025; its key milestones for 2020;
its estimates regarding its balance of cash, cash equivalents and
marketable securities for the year ended December 31, 2019;
its plans regarding future data presentations; its financial
guidance regarding the period in which it will have capital
available to fund its operations; and the potential benefit of its
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. 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. 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: 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 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.
Contacts
Investors:Holly Manning, 617-844-6630Associate
Director, Investor RelationsHolly.Manning@agios.com
Media:Jessica Rennekamp, 857-209-3286Associate
Director, Corporate
CommunicationsJessica.Rennekamp@agios.com
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