Viloxazine Hydrochloride

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

New Data Underscore the Need for New OSA Treatments That Go Beyond Weight Loss to Address the Neuromuscular Root Cause of the DiseaseOral Presentations include Rationale and Design of SynAIRgy Phase 3 Study for AD109, a Potential Nighttime Oral Drug Treatment for OSA“Shining a Light on Living with Sleep Apnea” Symposium Features Premiere Sneak Preview of “Out of Breath” Film Featuring Struggles of Living with OSA, Followed by Panel Discussion CAMBRIDGE, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Apnimed, Inc., a clinical-stage pharmaceutical company focused on discovery, development and commercialization of novel oral therapies for the treatment of obstructive sleep apnea (OSA) and other sleep disorders, announced a series of five data presentations and a dinner symposium at the SLEEP 2024 annual meeting. Presentations include an epidemiologic study of the prevalence of obesity in OSA, which demonstrates that the majority of people with OSA are not obese. OSA is estimated to affect more than 50 million in the United States, though underdiagnosis continues to be a serious problem. “Apnimed is making significant contributions toward understanding the characteristics of people with OSA and the impact symptoms of OSA have on those who are not being treated. The data being presented at SLEEP 2024 reaffirm that this market has significant unmet needs,” said Larry Miller, MD, CEO of Apnimed. “AD109, our novel oral nighttime drug for OSA, currently in Phase 3 clinical development, has the potential to help patients across a broad spectrum of OSA severity and body mass index by addressing the neuromuscular root cause of OSA. Because there are no FDA approved products that specifically address the neuromuscular causes of OSA, the door is open for an oral therapy that can meet the needs of a broad range of OSA patients.” Additional presentations related to Apnimed’s pipeline of potential OSA treatments include both an oral and a poster discussion concerning the study design and rationale of SynAIRgy, the second Phase 3 registrational study for AD109, and data from the VicTor Study, a Phase 2 crossover study that evaluated an oral combination drug related to Apnimed’s pipeline development candidate AD817. SLEEP, the premier clinical and scientific sleep conference, is a joint meeting of the American Academy of Sleep Medicine (APSS) and the Sleep Research Society. SLEEP 2024, the 38th annual meeting of the APSS, will be held at the George R. Brown Convention Center in Houston from June 1-5. Apnimed SLEEP 2024 Presentation Details: POSTER:P-09, #147Prevalence of Obesity in Obstructive Sleep Apnea within a Large Community-based Cohort of Middled-aged/Older AdultsTime: Monday, June 3, 10:00-10:45 AM CTLocation:George R. Brown Convention Center, Hall A3Presenter:Neda Esmaeili, PhD, Brigham and Women's Hospital POSTER:P-08, #133Fatigue Negatively Impacts the Lives of Individuals Living with OSA: A Closer Look with Patient Reported Outcomes (PRO) MeasuresTime:Monday, June 3, 10:00-10:45 AM CTLocation:George R. Brown Convention Center, Hall A3Presenter:Helene Emsellem, MD, Director, The Center for Sleep & Wake Disorders & Sleep Health Institute SYMPOSIUM:Shining a Light on Living with Sleep ApneaSneak Preview:“Out of Breath,” an independent film about living with OSA followed by a panel discussion with the film’s director and starsTime:Tuesday, June 4, 6:15-8:30PM CTLocation:Marriott Marquis, Houston, Salon A-BRegister:https://bit.ly/3y2gbqe ORAL:O-26Aroxybutynin and Atomoxetine for the Treatment of OSA: Rationale and Design of theSynAIRgy Phase 3 RCTSession:Updates on Non-PAP Therapy for Sleep-Related Breathing DisordersTime: Wednesday, June 5, 2:15-2:30PM CTLocation:George R. Brown Convention Center, Room 362Presenter:Patrick Strollo, Jr., MD, Professor of Medicine and Clinical and Translational Science,Vice Chair of Medicine for Veterans Affairs, University of Pittsburgh School of Medicine POSTER:P-41, #274Aroxybutynin and Atomoxetine for the Treatment of OSA: Rationale and Design of the SynAIRgy Phase 3 RCTTime: Wednesday, June 5, 11:00-11:45 AM CTLocation: George R. Brown Convention Center, Hall A3Presenter:Patrick Strollo, Jr., MD, Professor of Medicine and Clinical and Translational Science, Vice Chair of Medicine for Veterans Affairs, University of Pittsburgh School of Medicine ORAL:O-26The Effect of Viloxazine and Trazodone in Obstructive Sleep Apnea Patients: A Randomized, Placebo-controlled, Crossover StudySession:Updates on Non-PAP Therapy for Sleep-Related Breathing DisordersTime: Wednesday, June 5, 2:30-2:45PM CTLocation:George R. Brown Convention Center, Room 362Presenter:Atqiya Aishah, PhD, Brigham and Women’s Hospital About the SynAIRgy StudyThe SynAIRgy Study (clinicaltrials.gov identifier NCT05813275) is a randomized, double blind, placebo-controlled, parallel-arm 6-month study of a fixed dose combination of aroxybutynin/atomoxetine (AD109) in adult participants with OSA who are intolerant of, or currently refuse, positive airway pressure (PAP) therapy. The SynAIRgy Study examines the use of AD109 in a range of OSA patients across all types of OSA from mild to severe and ranges of body mass index (BMI) from normal to obese. Participants (n=640) will be randomized 1:1 to either AD109 or placebo. The primary endpoint is designed to evaluate reduction of airway obstructions (AHI4) for AD109 vs. placebo. A key secondary endpoint is evaluating OSA symptoms based on the PROMIS-Fatigue scale for AD109 vs. placebo. Other standard objective and subjective metrics of OSA will also be evaluated. The trial also includes an additional cohort of up to 100 participants concomitantly on AD109 and a stable dose of a GLP-1 agonist for weight loss. The trial will include up to 65 enrolling centers across the US and Canada. SynAIRgy is continuing enrollment. Interested participants may check their eligibility at www.sleepapneatrial.com. Topline Phase 3 data for both AD109 registrational trials, LunAIRo and SynAIRgy, are expected in mid-2025. About AD109AD109 has the potential to be the first oral drug that could both treat the underlying nighttime airway obstruction and hypoxia that characterize OSA, as well as improve the daytime consequences of OSA, such as fatigue. It is a potential first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease severity. AD109 combines Apnimed’s novel selective antimuscarinic (aroxybutynin) with a selective norepinephrine reuptake inhibitor (atomoxetine) in a fixed dose combination. AD109 targets key neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep. AD109 has the potential to become a safe, effective, and convenient treatment for OSA, addressing some of the key limitations of approved treatments that are often poorly tolerated (e.g., CPAP and oral devices) and/or invasive (e.g., surgery or implanted devices). AD109 has been granted Fast Track designation by the FDA and is currently in Phase 3 clinical trials. About the VicTor StudyThe VicTor Study (clinicaltrials.gov identifier NCT05793684) is a Phase 2 randomized double-blind placebo-controlled multiple-dose 3-period crossover study comparing a fixed dose combination of viloxazine/trazodone to viloxazine alone and to placebo in obstructive sleep apnea. About Obstructive Sleep Apnea Obstructive sleep apnea is one of the most common and serious sleep disorders. It is estimated to affect more than 50 million and as many as 80 million people in the United States, though underdiagnosis continues to be a serious problem and the number of affected Americans may be far greater. OSA impacts people across the spectrum of sex, age, ethnicity and BMI ranges from normal to obese. OSA is characterized by partial or complete upper airway collapse that occurs during sleep, which can cause dramatic reductions in overnight oxygen levels and often leads to poor sleep, and in the long term, has been shown to increase the risk of hypertension, diabetes, cardiovascular disease, and stroke. Additionally, OSA can impair work productivity, reduce daytime functional abilities, and lower quality of life. Sleep-related neuromuscular dysfunction is the key mechanism that causes a reduction in neuromuscular tone of the upper airway during sleep. The vast majority of diagnosed patients are prescribed positive air pressure therapy devices such as continuous positive airway pressure, or CPAP, but many patients are dissatisfied with these mechanical nighttime devices and fewer than half are compliant long term, leaving a significant population untreated or undertreated and at risk. Some OSA patients are overweight or obese, and sustained weight loss can reduce the severity of airway collapse and some symptoms. However, even substantial weight loss may not fully address the symptoms of OSA or reduce the need for treatments that help maintain an open airway during sleep, and if patients regain weight, OSA and its symptoms tend to return. About ApnimedApnimed is a clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Apnimed’s lead development program, AD109, targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Based in Cambridge, Mass., the company is developing a portfolio of novel pharmacologic therapies for sleep apnea and other sleep disorders. Apnimed has a pipeline of novel, oral pharmacologic programs including several that are part of our Joint Venture with Shionogi & Co., Ltd. called Shionogi-Apnimed Sleep Science, LLC. Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact:Amanda BreedingScient PRamanda@scientpr.com Mikala Whitaker Spectrum Sciencemwhitaker@spectrumscience.com Investor Contact:Brian Ritchie LifeSci Advisorsbritchie@lifesciadvisors.com