Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA), a biotechnology
company focused on discovering and developing novel biologic
therapeutics to treat rare immune-mediated diseases, today provided
a 2019 year-end corporate update and key anticipated milestones for
2020.
“We expect 2020 to be a significant year of value inflection for
Momenta, as we approach key data readouts across our novel auto-
and alloimmune programs. In particular, we start the year with
promising interim data for our M254 program in ITP, with additional
data expected in Q2, and look forward to sharing nipocalimab data
in MG in Q3,” said Craig A. Wheeler, President and Chief Executive
Officer of Momenta Pharmaceuticals. “We also continue to grow our
pipeline, with the goal to initiate a Phase 2 study for M254 in
CIDP later this year and the nomination of a new SIFbody
development candidate. With a strong balance sheet supporting our
efforts, we have multiple new product and potential partnering
opportunities ahead of us.
It has been a pivotal year for Momenta, due to the dedication of
our team and their focus on unraveling the complexity of
immune-mediated diseases. Today we are proud to reveal our new
corporate identity. With a renewed purpose and a strong drive to
make a meaningful difference in the lives of patients with unmet
needs, this new brand is a great way to kickoff 2020.”
Overview of Programs and Anticipated 2020
MilestonesM254 (hsIgG): a hypersialylated
immunoglobulin designed as a high potency alternative for
intravenous immunoglobulin (IVIg)
- The Company’s multi-part Phase 1/2 clinical trial in idiopathic
thrombocytopenic purpura (ITP) has completed Part A and is
progressing through Part B, which is evaluating M254 in a single
ascending dose (SAD) cohort of ITP patients, followed by 1,000
mg/kg of IVIg.
- Five of six ITP patients administered M254 (43 mg/kg to 250
mg/kg) responded and exhibited platelet counts >=50 x
109/L.
- Based on early favorable responses to M254 and variable
responses to IVIg, the Company is augmenting the number of patients
in the Part B cohorts and including a lower dose cohort.
- Enrollment is ongoing and the Company expects to report
additional data from Part B of the study in the second quarter of
2020.
- The Company also plans to initiate a clinical study of M254 in
chronic inflammatory demyelinating polyneuropathy (CIDP) later in
2020.
Nipocalimab (M281): a fully human anti-neonatal
Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal
antibody (mAb)
- Vivacity-MG, the Company’s Phase 2 clinical study of
nipocalimab in generalized myasthenia gravis (gMG), continues to
enroll patients, with 80% of the trial enrolled. The Company
expects to report top-line data from this study in the third
quarter of 2020.
- Unity, the Company’s global multi-center Phase 2 clinical study
of nipocalimab in hemolytic disease of the fetus and newborn
(HDFN), is actively enrolling patients, with four patients
currently enrolled. The Company expects to report top-line data
from this study in 2021.
- Energy, the Company’s adaptive Phase 2/3 clinical study of
nipocalimab in warm autoimmune hemolytic anemia (wAIHA) commenced
in the third quarter 2019. The Company is activating clinical sites
in both the United States and European Union and is enrolling
patients. Nipocalimab has been granted Fast Track and Orphan Drug
designation by the FDA in this indication and the Company expects
to report top-line data from this study around the end of
2021.
M230 (CSL730): a recombinant Fc multimer being
developed in collaboration with CSL
- A Phase 1 clinical trial to evaluate the safety and
tolerability of M230 in healthy volunteers is ongoing and Momenta’s
partner, CSL, looks forward to introducing a subcutaneous
formulation into the phase 1 program.
Momenta’s SIFbody platform combines multiple
Fc’s with antibody fabs to optimally activate Fc and complement
effector function and effectively deplete target cells. CD38 is a
target on plasmacytes, immune system cells responsible for
generating autoantibodies (autoimmune disease) and M protein
(multiple myeloma). Pre-clinical data suggests this CD38 SIFbody
has the potential to be a best-in-class therapeutic for the
management of plasmacyte-mediated diseases such as multiple
myeloma, AL amyloidosis and rare, auto-antibody-mediated
diseases.
- The Company has nominated an early development CD38 SIFbody
candidate and expects to initiate IND enabling studies in
2020.
Financial Guidance Momenta provides non-GAAP
operating expense guidance, which it believes can enhance an
overall understanding of its financial performance when considered
together with GAAP financial measures. Non-GAAP operating expense
is total operating, less stock-based compensation expense,
restructuring expense and collaborative reimbursement revenue.Refer
to the section of this press release below entitled “Non-GAAP
Financial Information and Other Disclosures” for further discussion
of this subject.
- Momenta expects that its non-GAAP operating expense for the
fourth quarter of 2019 will be in line with its previously
announced guidance, which was outlined in its third-quarter 2019
earnings release.
- The Company expects to report approximately $545.1 million of
cash, cash equivalents and marketable securities at December 31,
2019.
- Momenta is providing 2020 full year estimated non-GAAP
operating expense guidance of $220-240 million.
Non-GAAP Financial Information and Other Disclosures
Momenta uses a non-GAAP financial measure, non-GAAP operating
expense, to provide operating expense guidance. Momenta believes
this non-GAAP financial measure is useful to investors because it
provides greater transparency regarding Momenta’s operating
performance as it excludes non-cash stock compensation expense,
restructuring expense and collaborative reimbursement revenue. This
non-GAAP financial measure should not be considered a substitute or
an alternative to GAAP total operating expense and should not be
considered a measure of Momenta’s liquidity. Instead, non-GAAP
operating expense should only be used to supplement an
understanding of Momenta’s operating results as reported under
GAAP. Momenta has not provided forward-looking GAAP operating
expense or GAAP reconciliation for its forward-looking non-GAAP
annual operating expense because Momenta cannot reliably predict
without unreasonable efforts the timing or amount of the factors
that substantially contribute to the projection of stock
compensation expense, which is excluded from the forward-looking
non-GAAP financial measure. The Company does not expect
restructuring expense and collaboration reimbursement revenue to be
material. The preliminary, unaudited financial information provided
or referred to in this release is based on Momenta’s current
estimate of its results for the quarter ended December 31, 2019 and
its cash, cash equivalents, and marketable securities as of
December 31, 2019, and remains subject to change based on closing
and audit procedures, and the execution of Momenta’s internal
control over financial reporting.
About Momenta Momenta Pharmaceuticals is a
biotechnology company with a validated innovative scientific
platform focused on discovering and developing novel therapeutics
to treat rare, immune-mediated diseases and advancing its late
stage biosimilar portfolio. The company is headquartered
in Cambridge, MA.
To learn more about Momenta, please
visit www.momentapharma.com, which does not form a part of
this press release.
Momenta’s logo, trademarks, and service marks are the property
of Momenta Pharmaceuticals, Inc. All other trade names,
trademarks, or service marks are property of their respective
owners.
Forward-Looking Statements
Statements in this press release regarding management's future
expectations, beliefs, intentions, goals, strategies, plans or
prospects, are forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, including but not
limited to statements about the use, design, timing, strategy and
goals of clinical trials, and the availability, timing and amount
of data and results; market potential and product revenues of our
products and product candidates; the efficacy, safety,
tolerability, potency, convenience and commercial potential of our
product candidates, including their potential as best-in-class
agents; and preliminary financial results for 2019 and non-GAAP
operating expense projections for 2020. Forward-looking statements
may be identified by words such as "believe," "continue," "plan
to," "potential," "will," and other similar words or expressions,
or the negative of these words or similar words or expressions.
Such forward-looking statements involve known and unknown risks,
uncertainties and other important factors, including the risk of
the unpredictable nature of early stage development efforts for our
product candidates; safety, efficacy or tolerability problems with
our product candidates; unexpected adverse clinical trial results;
and those referred to under the section "Risk Factors" in the
Company's Quarterly Report on Form 10-Q for the quarter
ended September 30, 2019 filed with the Securities
and Exchange Commission, as well as other documents that may be
filed by the Company from time to time with the Securities and
Exchange Commission. As a result of such risks, uncertainties and
factors, the Company's actual results may differ materially from
any future results, performance or achievements discussed in or
implied by the forward-looking statements contained herein. The
Company is providing the information in this press release as of
this date and assumes no obligations to update the information
included in this press release or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
INVESTOR CONTACT: |
MEDIA
CONTACT: |
Patty Eisenhaur |
Karen Sharma |
Momenta Pharmaceuticals |
MacDougall |
1-617-395-5189 |
1-781-235-3060 |
IR@momentapharma.com |
Momenta@macbiocom.com |
Momenta Pharmaceuticals (NASDAQ:MNTA)
Historical Stock Chart
From Apr 2024 to May 2024
Momenta Pharmaceuticals (NASDAQ:MNTA)
Historical Stock Chart
From May 2023 to May 2024