Safinamide mesylate

Net sales of Qelbree® increased 92% in the second quarter of 2024, compared to the same period in 2023. $59.4 million and $104.5 million of net sales in the second quarter and first six months of 2024, respectively. Net sales of GOCOVRI® increased 10% in the second quarter of 2024, compared to the same period in 2023. $31.7 million and $58.3 million of net sales in the second quarter and first six months of 2024, respectively. Total revenues were $168.3 million in the second quarter of 2024, an increase of 24% compared to the same period in 2023. Total revenues excluding Trokendi XR® and Oxtellar XR® net product sales (non-GAAP)(1) increased 32% in the second quarter of 2024, compared to the same period in 2023. Operating income of $22.6 million and $19.4 million in the second quarter and first six months of 2024.Adjusted operating earnings (non-GAAP)(1) was $45.5 million and $67.7 million in the second quarter and first six months of 2024, respectively, compared to $10.0 million and $40.5 million in the same periods in 2023.Raising full year 2024 guidance for total revenues and operating earnings (GAAP and Non-GAAP). ROCKVILLE, Md., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the second quarter of 2024 and associated Company developments. Business Highlights Total IQVIA prescriptions for Qelbree were 184,342 in the second quarter 2024, an increase of 26% compared to the same period in the prior year.In August 2024, the Company resubmitted its New Drug Application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations ("off" episodes) in Parkinson’s disease. “In the second quarter of 2024, we delivered strong net sales growth from our key growth drivers, Qelbree and GOCOVRI, as well as strong growth in adjusted operating earnings. We also advanced our product pipeline, announcing interim results from our open-label Phase 2a clinical study of SPN-817 for treatment-resistant seizures, and continued to progress SPN-820 through two Phase 2 studies in patients with depression," said Jack Khattar, President and CEO of Supernus. “Continued growth from Qelbree and GOCOVRI, together with pipeline progress, gives us confidence in delivering on our increased guidance and our operational objectives for 2024." Product Pipeline Update SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression Nearly three-quarters of the planned patients have been enrolled in the ongoing Phase IIb multi-center randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment-resistant depression. The study will examine the efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 268 patients in up to 50 clinical sites. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. Topline data from the Phase IIb trial are expected in the first half of 2025.Enrollment is ongoing in the Phase II open-label study in patients with major depressive disorder (MDD). The primary objective of the study is to assess efficacy in MDD, as well as onset of efficacy. Topline results from the study are expected by the end of 2024. SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy In May 2024, the Company announced data from the planned interim analysis of its exploratory open-label Phase IIa clinical study of SPN-817 for treatment-resistant seizures. The interim analysis was based on 41 enrolled subjects, of which 19 completed the maintenance period. The Company continues to expect topline results for the full study in the second half of 2024. A Phase IIb randomized, double-blind, placebo-controlled study in patients with treatment resistant focal seizures is expected to start by the end of 2024. SPN-443 – Novel stimulant for ADHD/CNS The Company plans to initiate a Phase I single dose study in healthy adults in 2024 following submission of an Investigational New Drug application. The primary objective of the study is to assess safety and tolerability. Financial Highlights This section includes information on non-GAAP financial measures. See “Non-GAAP Financial Information” section for information on non-GAAP financial measures. In addition, a reconciliation of applicable GAAP to non-GAAP financial information is included at the end of this press release. Revenues The following table provides information regarding total revenues (dollars in millions): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 Change % 2024 2023 Change %Net product sales Qelbree$59.4 $31.0 92% $104.5 $56.8 84%GOCOVRI 31.7 28.8 10% 58.3 54.8 6%Oxtellar XR 29.5 23.8 24% 56.5 52.7 7%APOKYN 17.3 17.6 (2)% 33.9 34.8 (2)%Trokendi XR 17.1 19.3 (12)% 33.1 54.1 (39)%Other(2) 7.5 7.8 (4)% 14.7 15.7 (6)%Total net product sales 162.5 128.3 27% 301.0 268.9 12%Royalty, licensing and other revenues(3) 5.8 7.2 (20)% 11.0 20.4 (46)%Total revenues$168.3 $135.5 24% $312.0 $289.3 8% Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP)(1)$121.7 $92.4 32% $222.4 $182.5 22% Total revenues were $168.3 million and $312.0 million for the three and six months ended June 30, 2024, compared to $135.5 million and $289.3 million in the same period in 2023. Total net product sales were $162.5 million and $301.0 million for the three and six months ended June 30, 2024, compared to $128.3 million and $268.9 million in the same period in 2023, respectively. The increase in both periods was primarily due to the increase in net sales of Qelbree, GOCOVRI and Oxtellar XR, partially offset by the decline in net product sales of Trokendi XR due to generic erosion.Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP) increased 32% and 22% for the three and six months ended June 30, 2024, compared to the same period in 2023. Other Financial Highlights Operating earnings was $22.6 million and $19.4 million for the three and six months ended June 30, 2024, compared to operating loss of $(17.6) million and $(12.4) million for the same periods in 2023, respectively. The positive increase in both periods was primarily due to an increase in total net product sales.Adjusted operating earnings (non-GAAP) were $45.5 million and $67.7 million for the three and six months ended June 30, 2024, compared to $10.0 million and $40.5 million for the same periods in 2023, respectively.Net earnings (loss) and diluted earnings (loss) per share were $19.9 million and $0.36 for the three months and $20.0 million and $0.36 for the six months ended June 30, 2024, respectively, compared to $(0.8) million and $(0.02) for the three months and $16.1 million and $0.29 for the six months ended June 30, 2023, respectively.At June 30, 2024, cash, cash equivalents, and current and long-term marketable securities were approximately $347.2 million compared to $271.5 million as of December 31, 2023. This increase was primarily due to cash generated from operations. Full Year 2024 Financial Guidance For the full year 2024, the Company is increasing prior financial guidance for total revenues, GAAP operating earnings (loss) and non-GAAP operating earnings, and maintaining guidance for combined R&D and SG&A expenses as set forth below (dollars in millions). Current Guidance(as of August 6, 2024) Previous Guidance(as of May 8, 2024)Total revenues (includes approximately $135 - $145 million of Trokendi XR and Oxtellar XR)(4)(5)$600 - $625 $580 - $620Combined R&D and SG&A expenses$430 - $460 $430 - $460Operating earnings (loss)$0 - $20 $(30) - $(0)Adjusted operating earnings (non-GAAP)(1)$100 - $125 $80 - $110 Non-GAAP Financial Information This press release contains financial measures that present financial information which do not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measures should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP adjusted operating earnings on a historical and projected basis adjusts for non-cash share-based compensation expense, depreciation and amortization, intangible asset impairment charges and changes to fair value of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and excludes those costs, expenses, and other specified items presented in the reconciliation tables in this press release. In addition to non-GAAP adjusted operating earnings, we also present total revenues excluding net product sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP), which is a non-GAAP measure and is calculated as total revenues (GAAP) less net product sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP). Beginning in the year a product loses exclusivity due to generic entrants we generally do not expect net product sales of such products to constitute a significant part of our revenue in the future. We believe that the use of non-GAAP financial measures provides useful supplemental information to management, investors, analysts and others regarding the Company’s revenue and results of operations and assist management, investors, analysts, and others in understanding and evaluating our revenue growth and the performance of the business. There are limitations associated with the use of non-GAAP financial measures and therefore comparability may be limited. These limitations include: non-GAAP financial measures that may not be entirely comparable to similarly titled measures used by other companies; these may not reflect all items of income and expense, as applicable, that affect our operations; there may be potential differences among calculation methodologies; these may differ from the non-GAAP information used by other companies, including peer companies. We mitigate these limitations by reconciling the non-GAAP financial measure to the most comparable GAAP financial measure. Investors are encouraged to review the reconciliation. The Company’s 2024 financial guidance is also being provided on both a GAAP and a non-GAAP basis. End Notes (1) See the section titled “Non-GAAP Financial Information” for information about this non-GAAP financial measure. A reconciliation of each non-GAAP financial measure to the most directly comparable GAAP financial measure is included at the end of this press release.(2) Includes net product sales of MYOBLOC®, XADAGO® and Osmolex ER®.(3) Royalty, licensing, and other revenues include royalties on generic Trokendi XR, other licensed products and intellectual property.(4) Includes net product sales and royalty, licensing, and other revenue.(5) Reflects continued generic erosion of Trokendi XR and generic erosion of Oxtellar XR beginning in September 2024. Conference Call Details Supernus will host a conference call and webcast today, August 6, 2024, at 4:30 p.m. Eastern Time to discuss these results. A live webcast will be available in the Events & Presentations section of the Company’s Investor Relations website www.supernus.com/Investors. Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time. Following the live call, a replay will be available on the Company's Investor Relations website www.supernus.com/Investors. The webcast will be available on the Company’s website for 60 days following the live call. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson's disease (PD), cervical dystonia, chronic sialorrhea, and dyskinesia in PD patients receiving levodopa-based therapy. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. For more information, please visit www.supernus.com. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase its net revenue from its products and the products of its subsidiaries; the Company’s ability to commercialize its products and the products of its subsidiaries; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events. Supernus Pharmaceuticals, Inc.Condensed Consolidated Balance Sheets(in thousands, except share data) June 30, December 31, 2024 2023 (unaudited) Assets Current assets Cash and cash equivalents$52,089 $75,054 Marketable securities 295,098 179,820 Accounts receivable, net 152,494 144,155 Inventories, net 68,155 77,408 Prepaid expenses and other current assets 23,166 16,676 Total current assets 591,002 493,113 Long-term marketable securities — 16,617 Property and equipment, net 12,274 13,530 Intangible assets, net 559,644 599,889 Goodwill 117,019 117,019 Other assets 35,890 37,505 Total assets$1,315,829 $1,277,673 Liabilities and stockholders’ equity Current liabilities Accounts payable and accrued liabilities$82,611 $79,569 Accrued product returns and rebates 175,119 154,274 Contingent consideration, current portion 47,303 52,070 Other current liabilities 3,623 4,283 Total current liabilities 308,656 290,196 Contingent consideration, long-term 697 1,380 Operating lease liabilities, long-term 30,294 33,196 Deferred income tax liabilities, net 11,440 24,963 Other liabilities 7,288 6,422 Total liabilities 358,375 356,157 Stockholders’ equity Common stock, $0.001 par value; 130,000,000 shares authorized; 55,046,049 and 54,723,356 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively 55 55 Additional paid-in capital 455,170 439,493 Accumulated other comprehensive loss, net of tax (372) (593)Retained earnings 502,601 482,561 Total stockholders’ equity 957,454 921,516 Total liabilities and stockholders’ equity$1,315,829 $1,277,673 Supernus Pharmaceuticals, Inc.Condensed Consolidated Statements of Earnings (Loss)(in thousands, except share and per share data) Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 (unaudited) (unaudited)Revenues Net product sales$162,538 $128,336 $300,999 $268,911 Royalty, licensing and other revenues 5,787 7,227 10,970 20,416 Total revenues 168,325 135,563 311,969 289,327 Costs and expenses Cost of goods sold(a) 17,916 21,091 34,225 44,551 Research and development 26,183 24,379 51,113 45,591 Selling, general and administrative 85,904 86,782 172,420 172,379 Amortization of intangible assets 20,108 20,108 40,245 40,074 Contingent consideration expense (gain) (4,355) 790 (5,450) (857)Total costs and expenses 145,756 153,150 292,553 301,738 Operating earnings (loss) 22,569 (17,587) 19,416 (12,411) Other income (expense) Interest and other income, net 3,733 1,370 7,129 6,716 Interest expense — (910) — (2,415)Total other income (expense) 3,733 460 7,129 4,301 Earnings (loss) before income taxes 26,302 (17,127) 26,545 (8,110) Income tax expense (benefit) 6,386 (16,296) 6,505 (24,227)Net earnings (loss)$19,916 $(831) $20,040 $16,117 Earnings (loss) per share Basic$0.36 $(0.02) $0.37 $0.30 Diluted$0.36 $(0.02) $0.36 $0.29 Weighted average shares outstanding Basic 54,978,781 54,502,993 54,890,265 54,442,463 Diluted 55,724,283 54,502,993 55,675,474 59,035,154 (a) Excludes amortization of intangible assets. Supernus Pharmaceuticals, Inc.Reconciliations of GAAP to Non-GAAP Financial Information(Unaudited) Reconciliation of GAAP Total revenues to Non-GAAP Total revenues excluding Trokendi XR and Oxtellar XR net product sales An itemized reconciliation between total revenues on a GAAP basis and Total revenues excluding Trokendi XR and Oxtellar XR net product sales, a non-GAAP measure, is as follows (dollars in millions): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 Change % 2024 2023 Change %Total revenues (GAAP)(1)$168.3 $135.5 24% $312.0 $289.3 8%Adjustments: Trokendi XR net product sales (17.1) (19.3) (12)% (33.1) (54.1) (39)%Oxtellar XR net product sales (29.5) (23.8) 24% (56.5) (52.7) 7%Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP)(1)$121.7 $92.4 32% $222.4 $182.5 22% (1) Includes net product sales and royalty, licensing, and other revenues. Reconciliation of GAAP Operating earnings (loss) to Non-GAAP Adjusted Operating earnings An itemized reconciliation between operating earnings (loss) on a GAAP basis and adjusted operating earnings on a non-GAAP basis is as follows (dollars in millions): Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 Operating earnings (loss) - As Reported (GAAP)$22.6 $(17.6) $19.4 $(12.4)Adjustments: Amortization of intangible assets 20.1 20.1 40.2 40.1 Share-based compensation 6.6 6.1 12.4 12.4 Contingent consideration expense (gain) (4.4) 0.8 (5.5) (0.9)Depreciation 0.6 0.6 1.2 1.3 Operating earnings - As Adjusted (non-GAAP)$45.5 $10.0 $67.7 $40.5 Non-GAAP adjusted operating earnings adjusts for non-cash items including amortization of intangible assets, share-based compensation expense, change in fair value of contingent consideration, and depreciation. Reconciliation of Full Year 2024 Financial Guidance - GAAP Operating earnings (loss) to Non-GAAP Adjusted Operating earnings An itemized reconciliation between projected operating earnings (loss) on a GAAP basis for the full year 2024 and projected adjusted operating earnings on a non-GAAP basis for the full year 2024 is as follows (dollars in millions): Current Guidance(as of August 6, 2024) Previous Guidance(as of May 8, 2024)Operating earnings (loss) - GAAP$0 - $20 $(30) - $0Adjustments: Amortization of intangible assets$78 - $80 $80 - $81Share-based compensation$27 - $29 $27 - $29Contingent consideration expense (gain)$(7) - $(7) $1 - $2Depreciation$2 - $3 $2 - $3Operating earnings - As Adjusted (non-GAAP)$100 - $125 $80 - $110 CONTACTS: Jack A. Khattar, President and CEOTimothy C. Dec, Senior Vice President and CFOSupernus Pharmaceuticals, Inc.(301) 838-2591 or INVESTOR CONTACT:Peter VozzoICR Westwicke(443) 213-0505peter.vozzo@westwicke.com

Clinical results and new findings of mechanism of action indicate evenamide would be uniquely effective in patients with treatment resistant schizophrenia Leading schizophrenia experts predict earlier use of evenamide would benefit patients with inadequate response Evenamide’s unique mechanism of action targets the core abnormalities in patients with schizophrenia and reduces hippocampal dopaminergic activity, improving symptoms of psychosis, social interactions and cognition Long-term benefits of evenamide as an add-on therapy were presented: 25% of treated patients met the criteria for remission suggesting evenamide may positively affect the long-term course of schizophrenia in TRS patients MILAN & MORRISTOWN, N.J.--(BUSINESS WIRE)-- Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system (CNS), welcomed investors, analysts and media today to its well-attended investor day in New York City. The event focused on the Company’s clinical, scientific and commercial plans for evenamide, its investigational drug candidate in Phase III clinical development for the potential treatment of patients with chronic and TRS. This press release features multimedia. View the full release here: Newron Pharmaceuticals 2024 Investor Day The event featured three leading schizophrenia experts who presented on the unmet medical needs in schizophrenia, as well as new concepts and recent neurobiological findings for treating poor responders and patients with TRS. An outline of Newron’s Phase III clinical development plan in TRS was also presented. Breakthrough pre-clinical data supporting evenamide in the treatment of TRS Anthony Grace, Ph.D., Editor-in-Chief, International Journal of Neuropsychopharmacology, Distinguished Professor of Neuroscience, and Professor of Psychiatry and Psychology at the University of Pittsburgh, stated, “The hippocampal hyper dopaminergic activity in patients with schizophrenia contributes to the development of symptoms of psychosis, loss of functioning, decreased social interactions and deterioration of cognition.” Dr. Grace further stated, “Evenamide’s glutamate modulation has produced dramatic effects in the MAM model of schizophrenia, which closely mimics the changes observed in patients with schizophrenia. In this model, evenamide reversed abnormal hippocampal neuronal activity, normalized dopamine neuron population activity, improved cognition and normalized social interactions. Its effects on neuronal firing, which persisted well beyond its half-life, indicated that it induces neuronal plasticity and may help with neuronal repair. Furthermore, by acting at the site of pathology, evenamide might also be effective for negative symptoms and cognitive dysfunction.” Data from first evenamide placebo-controlled randomized study John Kane, M.D., Co-Director and Professor, Institute of Behavioural Science, Feinstein Institutes for Medical Research, and Professor of Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell stated: “A substantial proportion of patients with schizophrenia do not respond well to first-line medications, and this is true even at the onset of illness. This may be because there are biological changes in the brains of patients that show reduced benefit and non-response to treatments, compared with patients who respond adequately to treatment.” “Patients who are poor responders are likely to relapse more than patients who respond to medication,” stated Kane. “To date, there are no studies which have demonstrated that the addition of one antipsychotic to another, or switching antipsychotics, has produced any benefit to inadequate responders and TRS patients.” Dr Kane continued, “The evenamide 008A study is unique in demonstrating a significant benefit in patients who were moderately to severely psychotic, while being compliant with their antipsychotic medication. This therapeutic benefit may derive from evenamide’s glutamate modulation activity. The drug was extremely well tolerated, without any of the usual side effects of available antipsychotics.” Results from an open label, long-term study of evenamide as add-on therapy in TRS Stephen R. Marder, M.D., Distinguished Professor of Psychiatry, Semel Institute of Neuroscience & Human Behavior, and Director, Section on Psychosis, UCLA Neuropsychiatric Institute stated: “One-third of patients with schizophrenia are treatment resistant and the only drug available, clozapine, is used in less than 5% of patients. The use of higher doses, the addition of another antipsychotic, or switching to another drug is unsuccessful in patients with TRS.” Dr. Marder continued, “The one-year results from studies where evenamide was added to antipsychotics are noteworthy, as the sustained and continuous improvement across all efficacy measures is virtually unknown in patients with TRS. Similarly, the conversion of TRS patients to a non-resistant state, as well as the finding that 25% of patients met criteria for remission, is remarkable and unprecedented.” A new placebo controlled, one-year trial in patients with TRS who are receiving other antipsychotics is in planning with Dr. Marder as the Principal Investigator. An outline of the late-stage clinical development for evenamide in TRS Ravi Anand, MD, Newron’s Chief Medical Officer, provided an update on evenamide’s clinical program, outlining that evenamide’s promising results will be evaluated in a Phase III randomized, double-blind, one-year trial. The trial will compare evenamide to placebo as add-on treatments in at least 400 TRS patients. The primary efficacy endpoint will be change from baseline in PANSS1 scores at 12 weeks. Following this initial period, subjects will continue on their assigned treatment until week 26, for the second, maintenance efficacy endpoint, and then on to 1 year for read-out of the third (one-year, long term) efficacy endpoint. The long-term extension will also serve to evaluate the long-term safety and tolerability of evenamide. Stefan Weber, Chief Executive Officer of Newron Pharmaceuticals, commented: “As highlighted by the three world-leading KOLs, evenamide has enormous potential, if approved, in addressing the significant unmet medical needs of patients with chronic and treatment-resistant schizophrenia. We continue to explore all options, including partnering, that could enable us to complete the Phase III clinical development of evenamide, which we believe could have blockbuster potential.” A replay of the event is available on the Company’s website for one month after the date of the event: About evenamide Evenamide, an orally available new chemical entity, specifically blocks voltage-gated sodium channels (VGSCs) and is devoid of biological activity at >130 other CNS targets. It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels, due to inhibition of VGSCs. Combinations of ineffective doses of evenamide and other APs, including clozapine, were associated with benefit in animal models of psychosis, suggesting synergies in mechanisms that may provide benefit in patients who are poor responders to current APs, including clozapine. About Newron Pharmaceuticals Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, Italy. Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea, and is commercialized by Newron’s Partner Zambon. Supernus Pharmaceuticals holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with symptoms of schizophrenia. For more information, please visit: Important Notices This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron's strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron's research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever. ________________________________ 1 Positive and Negative Syndrome Scale (PANSS) is widely used in clinical trials of schizophrenia and is considered the “gold standard” for assessment of antipsychotic treatment efficacy (Innvo Clin Neurosci, 2017: ) View source version on businesswire.com: Contacts For more information, please contact: Newron Stefan Weber CEO +39 02 6103 46 26 pr@newron.com UK/Europe Simon Conway / Ciara Martin / Natalie Garland-Collins FTI Consulting +44 20 3727 1000 SCnewron@fticonsulting.com Switzerland Valentin Handschin IRF +41 43 244 81 54 handschin@irf-reputation.ch Germany/Europe Anne Hennecke / Caroline Bergmann MC Services +49 211 52925222 newron@mc-services.eu USA Paul Sagan LaVoieHealthScience +1 617 374 8800, Ext. 112 psagan@lavoiehealthscience.com Source: Newron Pharmaceuticals S.p.A. 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