CAMBRIDGE, May 07, 2020 (GLOBE NEWSWIRE via COMTEX) -- -- Top-line interim data from nipocalimab Vivacity-MG study expected by Q3 2020 --
-- Full data from Part B of Phase 1/2 study of M254 in ITP expected in Q3 2020 --
-- Initiated IND-enabling studies for M267, a SIFbody candidate targeting CD38 --
Momenta Pharmaceuticals, Inc. /zigman2/quotes/200094979/composite MNTA +1.82% , a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today reported its financial results for the first quarter ended March 31, 2020.
"Despite the turbulence imposed by the COVID-19 pandemic, Momenta has remained focused on advancing our development pipeline for rare, immune-mediated diseases," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "We are targeting key readouts from our lead programs by the end of the third quarter. These readouts will include interim proof-of-concept data from nipocalimab in MG and data from Part B of our Phase 1/2 study of M254 in ITP. We expect data from both programs will further demonstrate the potential of these programs, each with franchise opportunities across a range of large market auto- and alloimmune diseases. Finally, we remain in a strong corporate position, with cash to fund operations through at least the third quarter 2021, as we continue to leverage our platform for growth."
First Quarter 2020 Highlights, Recent Events and Anticipated Upcoming Milestones
Novel Therapeutics Pipeline:
Nipocalimab (M281): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)
-- We announced in February that Vivacity-MG, the Company's Phase 2 clinical study of nipocalimab in generalized myasthenia gravis (gMG), achieved its target enrollment. Momenta remains on track to report top-line interim data from this study by 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), continues to enroll patients at sites where they can be safely accommodated.
-- Momenta continues to activate sites globally for its Energy Study, the Company's adaptive Phase 2/3 clinical study of nipocalimab in warm autoimmune hemolytic anemia (wAIHA), however it has temporarily suspended patient enrollment due to the COVID-19 pandemic.
M254 (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) is progressing through Part B, which is evaluating M254 in a single ascending dose (SAD) cohort of ITP patients, followed by 1,000mg/kg of IVIg. Enrollment is ongoing, however it has slowed due to the COVID-19 pandemic. The Company plans to complete and report data from Part B in the third quarter of 2020 and expects to initiate Part C of the study in the fourth quarter of 2020.
-- The Company's planned Phase 2 study of M254 in chronic inflammatory demyelinating polyneuropathy (CIDP) is expected to initiate in 2021, following completion of Parts C and D from its ongoing Phase 1/2 trial of M254 in ITP.
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. Momenta's partner, CSL, plans to introduce a subcutaneous formulation into the Phase 1 program in 2020.
Momenta's SIFbody platform combines multiple Fc's with antibody Fabs to optimally activate Fc effector function, and to effectively deplete target cells.
-- The Company has initiated IND-enabling studies for M267, a SIFbody candidate targeting CD38. Pre-clinical data suggest this candidate has the potential to be a best-in-class therapeutic to target CD38-expressing cells, which are prevalent in plasmacyte-mediated diseases such as multiple myeloma, AL amyloidosis and other rare, autoantibody-mediated diseases.
GLATOPA(R) 20 mg and 40 mg: U.S. Food and Drug Administration (FDA) approved generic versions of COPAXONE 20 mg and 40 mg, developed and commercialized in collaboration with Sandoz
-- In the first quarter of 2020, Momenta recorded $8.7 million in product revenue from Sandoz's sales of GLATOPA products.
M710: a proposed biosimilar to EYLEA(R) (aflibercept) candidate being developed in collaboration with Mylan
-- Mylan continues its pivotal clinical trial in patients with diabetic macular edema to compare safety, efficacy and immunogenicity of M710 with EYLEA. Mylan expects to target U.S. submission in 2021, while monitoring and navigating potential COVID-19 issues.
-- In April 2020, Momenta provided an update on clinical trial activities and business operations amid the COVID-19 pandemic, including measures implemented to protect the health and safety of its personnel, as well as patients and healthcare professionals involved with its clinical studies; to ensure its clinical studies were able to continue unimpeded for patients already enrolled; and to preserve the integrity of its clinical data, in line with updated guidance from the FDA. These business continuity measures currently remain in place, as the Company continues to closely monitor the situation and guidance from public health authorities. Momenta expects to resume activities for affected studies when conditions permit.
First Quarter 2020 Financial Results
In the first quarter of 2020, the Company recorded $8.7 million in product revenue from Sandoz's sales of GLATOPA, compared to $2.4 million for the same period in 2019. The increase in product revenue from the prior year period was primarily due to higher net sales of GLATOPA, driven by volume increases.
Research and development revenue for the first quarter of 2020 was $0.2 million, compared to $1.8 million for the same period in 2019. The decrease in research and development revenue of $1.6 million, or 89%, was primarily due to lower reimbursement revenue for GLATOPA expenses and lower revenue recognized from Mylan's upfront payment associated with the biosimilar collaboration.
Total revenue for the first quarter of 2020 was $8.9 million compared to $4.1 million for the same period in 2019.
Research and development expenses for the first quarter of 2020 were $34.2 million, compared to $28.0 million for the same period in 2019. The increase of $6.2 million, or 22%, was primarily due to an increase in manufacturing and clinical trial costs for nipocalimab and M254 and increased spending on M710, offset in part by lower lease costs.
General and administrative expenses for the first quarter of 2020 were $14.6 million, compared with $24.2 million for the same period in 2019. The decrease of $9.6 million, or 40%, was primarily due to lower depreciation and rent costs due to the modification of the Bent St. lease and lower legal costs.