 -- Interim Phase 2 Vivacity-MG results met primary endpoints, demonstrating nipocalimab was well-tolerated and achieved rapid and durable responses with significant correlation p0.0001 between IgG reduction and MG-ADL clinical benefit in MG; full data expected by Q4 2020 -- Nipocalimab receives rare pediatric disease designation by FDA for HDFN -- CAMBRIDGE, Mass., Aug. 10, 2020 GLOBE NEWSWIRE -- Momenta Pharmaceuticals, Inc. Nasdaq: MNTA, a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today reported its financial results for the second quarter ended June 30, 2020.Momenta has made meaningful progress advancing our novel drug portfolio for auto- and alloimmune diseases, including a substantial data update from our lead program, nipocalimab, said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. In particular, we achieved proof of concept for nipocalimab, establishing a linear and highly statistically significant correlation between rapid and durable IgG reduction and efficacy in MG. We are preparing to engage with regulators on the design for a Phase 3 study in MG and look forward to reporting full results from Vivacity-MG in the fourth quarter of 2020, as we advance ongoing studies of nipocalimab in other indications. Additionally, we were very pleased to receive rare pediatric disease designation for nipocalimab in hemolytic disease of the fetus and newborn HDFN, which emphasizes the need for non-invasive, safe and effective treatment options for pregnant women with alloimmune diseases. Importantly, our data and FDAs action supports nipocalimab as a best-in-class investigational FcRn-inhibitor for dosing precision and flexibility and its utility across IgG-mediated diseases.Lastly, with M254, we recently completed enrollment in Part B of our multi-part Phase 12 clinical trial in idiopathic thrombocytopenic purpura ITP and look forward to sharing the study results later this quarter.Second Quarter 2020 Highlights, Recent Events and Anticipated Upcoming MilestonesNovel Therapeutics Pipeline:Nipocalimab M281: a fully human anti-neonatal Fc receptor FcRn aglycosylated immunoglobulin G IgG1 monoclonal antibody mAb candidate In June 2020, Momenta announced positive topline data from an interim analysis of Vivacity-MG, the Companys Phase 2 study of nipocalimab in generalized myasthenia gravis gMG. The results demonstrated that nipocalimab induced a rapid and durable response in the myasthenia gravis activities of daily living score MG-ADL at all doses and met the studys primary efficacy endpoint, demonstrating a linear and highly statistically significant p0.0001 relationship between Immunoglobulin G IgG reduction and MG-ADL clinical benefit. Nipocalimab was also observed to be well-tolerated, with no adverse events leading to discontinuation. The study is expected to be completed in the third quarter of 2020, and the Company plans to present the full 16-week data in the fourth quarter of 2020. Additionally, Momenta has begun preparations to conduct an end of Phase 2 meeting with the U.S. Food and Drug Administration FDA before the end of 2020 and anticipates initiating a Phase 3 study in the first quarter of 2021. Unity, Momentas 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. FDA recently granted Rare Pediatric Disease Designation and Orphan Drug Designation for nipocalimab in HDFN. Momenta continues to activate sites globally for the Energy Study, the Companys adaptive Phase 23 clinical study of nipocalimab in warm autoimmune hemolytic anemia wAIHA. Patient enrollment was temporarily suspended due to the COVID-19 pandemic but is expected to resume in the fourth quarter 2020. Momenta has amended the study protocol to facilitate remote monitoring procedures.M254 hsIgG: a hypersialylated immunoglobulin candidate designed as a high potency alternative for intravenous immunoglobulin IVIg Patient enrollment is complete in Part B of the Companys Phase 1 2 study in idiopathic thrombocytopenic purpura ITP, which is evaluating M254 in a single ascending dose cohort of ITP patients, followed by 1,000 mgkg of IVIg. The Company intends to release results from this study in the third quarter of 2020 and has initiated patient enrollment in Part C of the study. The Companys planned Phase 2 study of M254 in chronic inflammatory demyelinating polyneuropathy CIDP is expected to initiate in 2021. M230 CSL730: a recombinant Fc multimer candidate being developed in collaboration with CSL Momentas collaboration partner, CSL, plans to introduce a subcutaneous formulation into the Phase 1 program later this year.M267: a SIFbody candidate targeting CD38, designed to combine multiple Fcs with antibody fabs to optimally activate Fc, complement effector function and effectively deplete target cells. IND-enabling studies are ongoing, and the Company expects to submit an IND for M267 in 2021.Necuparanib M402: The Company is currently exploring the utility of necuparanib M402, a former novel oncology candidate, as a potential therapy for treating COVID-19. The Company has confirmed the ability of necuparanib M402 to bind to the SARS-Cov2 spike protein and is assessing the potential to block viral infection of respiratory epithelial cells. As multiple respiratory viruses are believed to utilize binding to heparin sulfate glycoproteins on cells to facilitate infection, the Company is assessing the ability of necuparanib to block cell infection by other coronavirus and respiratory viruses. The Company anticipates completing the initial cell infection studies in the coming weeks.Legacy Products:GLATOPA 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 second quarter of 2020, Momenta recorded 6.6 million in product revenue from Sandozs sales of GLATOPA products.M710: a proposed biosimilar to EYLEA 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.Second Quarter 2020 Financial ResultsRevenue: In the second quarter of 2020, the Company recorded 6.6 million in product revenue from Sandozs sales of GLATOPA, compared to 3.3 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 second quarter of 2020 was less than 0.1 million, compared to 1.8 million for the same period in 2019. The decrease in research and development revenue of 1.8 million, or 99, was primarily due to lower reimbursement revenue for GLATOPA expenses and lower revenue recognized from Mylans upfront payment associated with the biosimilar collaboration.Total revenue for the second quarter of 2020 was 6.6 million compared to 5.2 million for the same period in 2019.Operating Expenses: Research and development expenses for the second quarter of 2020 were 38.8 million, compared to 32.1 million for the same period in 2019. The increase of 6.7 million, or 21, was primarily due to an increase in manufacturing and clinical trial costs for nipocalimab and M254 and an increase in share-based compensation expense, offset in part by lower lease costs.General and administrative expenses for the second quarter of 2020 were 25.3 million, compared with 46.6 million for the same period in 2019. The decrease of 21.3 million, or 46, was primarily due to a payment of 21.0 million in June 2019 reflecting the Companys portion of a settlement payment; lower legal fees and lower depreciation and rent costs due to the modification to the Bent Street lease in 2019; partially offset by an increase in share-based compensation expense.Other operating expenses in the second quarter of 2019 included a 42.9 million charge to be paid between the end of 2020 and 2022, related to Momentas manufacturing agreement with GSK, the supplier of M923. Following the Companys decision to cease development activity relating to M923, Momenta incurred these charges for canceled manufacturing runs scheduled through 2020 and may not use manufacturing runs scheduled for 2021 and 2022.Total GAAP operating expenses were 64.0 million in the second quarter of 2020. Second quarter 2020 non-GAAP operating expense was 44.6 million. Non-GAAP operating expense is total operating expenses, less stock-based compensation expense, restructuring expense and collaborative reimbursement revenue. See Non-GAAP Financial Information and Other Disclosures and the table below entitled Reconciliation of GAAP Results to Non-GAAP Financial Measures for a reconciliation of GAAP operating expense to non-GAAP operating expense.Net Loss: The Company reported a net loss of 57.0 million, or 0.48 per share for the second quarter of 2020 compared to a net loss of 114.0 million, or 1.16 per share for the same period in 2019.Liquidity: At June 30, 2020, Momenta had 450.6 million in cash, cash equivalents, and marketable securities. This compares to 545.1 million at December 31, 2019 in cash, cash equivalents, and marketable securities. 