Diazepam

Presentation highlights study-enrollment challenges and strategies to overcome potential barriers SAN DIEGO, Nov. 11, 2024 /PRNewswire/ -- Neurelis, Inc., today announced a presentation on insights into study design from the enrollment process for the new Stellina study investigating VALTOCO® (diazepam nasal spray) for the treatment of seizure clusters in patients with epilepsy aged 2 to 5 years. This age group is not included in the current indication of treatment of seizure clusters in patients with epilepsy aged ≥6 years. The poster presentation will be given at the 53rd Child Neurology Society Annual Meeting in San Diego, November 11-14th. "Data from clinical studies of repetitive seizures in early childhood are critical to help advance new treatments for a young population with currently limited alternatives," said Adrian L. Rabinowicz, MD, Neurelis Chief Medical Officer. "We are pleased to join the child neurology community and exchange learnings at this year's annual meeting as we focus on improving health outcomes for people with epilepsy." Highlights of the presentation include the identification of study-enrollment challenges and strategies to overcome potential barriers in young patients with treatment-resistant epilepsy. Identified findings may be helpful in designing future protocols. The poster titled "Challenges Associated with Enrolling Pediatric Patients with Treatment-Resistant Epilepsy Aged 2–5 Years in a Clinical Trial and Lessons Learned for Future Trials" will be presented on Tuesday November 12th from 12:30 PM-1:45 PM and 5:30 PM-7:00 PM PT. The mission of the Child Neurology Society is to raise awareness about the importance of child neurologists and the health needs of children with chronic neurological conditions. About Neurelis Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and neurologic disorders characterized by high unmet medical need. The FDA has approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®, a transmucosal absorption enhancement technology that enables the noninvasive delivery of a broad range of protein, peptide and small-molecule drugs. For more information on VALTOCO, please visit . For the latest scientific information on VALTOCO, please visit . Neurelis is also developing NRL-1004, an investigational, Phase 1 stage intranasal olanzapine for treatment of acute agitation episodes associated with schizophrenia and bipolar disorder. In addition, Neurelis is also developing NRL-1049 (previously known as BA-1049), an investigational, Phase 1 new chemical entity Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit . Important Safety Information about VALTOCO: Indication VALTOCO® (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older. Contraindications: VALTOCO is contraindicated in patients with: Hypersensitivity to diazepam Acute narrow-angle glaucoma Central Nervous System (CNS) Depression Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits. The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior. Glaucoma Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma. Neonatal Sedation and Withdrawal Syndrome Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly. Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including "gasping syndrome," can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Adverse Reactions The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort. Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance. To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (). Please read full Prescribing Information , including Boxed Warning. Contacts: Brittany Bradrick, Chief Operating Officer and Chief Financial Officer, +1 858 251 2100 SOURCE Neurelis, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CHICAGO--( BUSINESS WIRE )--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the third quarter and nine months ended September 30, 2024. “We are proud to report our record-breaking quarter with total revenue of our $54 million led by strong demand of Recorlev® and Gvoke®. Our product revenue growth of 27% marks the 12th consecutive quarter of over 20% growth," said John Shannon, CEO of Xeris. "We have made investments in areas that drive growth, notably Recorlev®, and we are seeing the benefits of those investments. Given our exceptional year-to-date performance, we are raising our revenue guidance to $198-$202 million from the previous $190-$200 million. Looking ahead, our focus remains on continuing to drive greater than 20% product revenue growth and advancing our robust pipeline - namely our Phase 3 ready, XP-8121." “While delivering exceptional revenue growth, we held our total operating expenses relatively flat to last quarter when you exclude non-routine charges,” said Steven Pieper, CFO of Xeris. “We will continue to drive robust revenue growth, maintain our strong margin profile, and diligently manage expenses, which gives us confidence that the business is financially sound and does not require any dilutive financing to fund our growth.” Third Quarter 2024 Highlights Three Months Ended September 30, Change 2024 2023 $ % Product revenue (in thousands): Gvoke $ 22,942 $ 17,735 $ 5,207 29.4 Recorlev 17,726 8,097 9,629 118.9 Keveyis 12,193 15,865 (3,672 ) (23.1 ) Product revenue, net 52,861 41,697 11,164 26.8 Royalty, contract and other revenue 1,407 6,623 (5,216 ) (78.8 ) Total revenue $ 54,268 $ 48,320 $ 5,948 12.3 Commercial Products Gvoke® : Third quarter net revenue was $22.9 million as compared to $17.7 million in the third quarter of 2023 – an increase of approximately 29%. Gvoke prescriptions topped 70,000 for the first time, growing 20% compared to the same period in 2023. Gvoke’s share of the retail TRx glucagon market grew to approximately 36% at the end of October. Recorlev® : Third quarter net revenue was $17.7 million – an increase of 119% compared to the third quarter of 2023. This growth was driven by the average number of patients on Recorlev increasing 125% from the same period in 2023. On a sequential basis, Recorlev net revenue increased 33% versus prior quarter. Keveyis® : Third quarter net revenue was $12.2 million as compared to $15.9 million in the third quarter of 2023 - a decrease of approximately 23% driven by a reduction in patients on therapy. On a sequential basis, net revenue decreased 7% due to pharmacy reimbursement changes. Year-to-Date 2024 Financial Results Nine Months Ended September 30, Change 2024 2023 $ % Product revenue (in thousands): Gvoke $ 59,567 $ 48,406 $ 11,161 23.1 Recorlev 41,663 19,741 21,922 111.0 Keveyis 38,406 42,708 (4,302 ) (10.1 ) Product revenue, net 139,636 110,855 28,781 26.0 Royalty, contract and other revenue 3,335 8,669 (5,334 ) (61.5 ) Total revenue $ 142,971 $ 119,524 $ 23,447 19.6 Gvoke® : Net revenue was $59.6 million for the nine months ended September 30, 2024, a 23% increase compared to prior year. Gvoke prescriptions for the nine months were approximately 194,000, growing approximately 24% compared to the same period in 2023. Recorlev® : Net revenue was $41.7 million for the nine months ended September 30, 2024, a 111% increase from last year, driven by an increase in the number of patients on therapy. Keveyis® : Net revenue was $38.4 million for the nine months ended September 30, 2024, a 10% decrease from last year due to a reduction in patients on therapy. Cost of goods sold increased $5.4 million and $6.3 million for the three and nine months ended September 30, 2024 compared to the same periods ended September 30, 2023. These increases were primarily due to a $3.6 million write-off of Gvoke components resulting from manufacturing process changes required to support ongoing Gvoke capacity expansion efforts. Research and development (R&D) expenses increased slightly by $0.9 million and $3.5 million for the three and nine months ended September 30, 2024 compared to the same periods ended September 30, 2023. R&D increased primarily due to higher spending for pipeline and personnel related expenses. Selling, general and administrative (SG&A) expenses increased by $7.7 million and $14.8 million for the three and nine months ended September 30, 2024 compared to the same periods ended September 30, 2023, primarily due to the costs associated with the CEO succession plan and related restructuring ($6.1 million) as well as higher costs related to the Recorlev expansions, partially offset by lower external spending. Net Loss for the three months ended September 30, 2024, was $15.7 million, or ($0.11) per share, and $49.7 million, or ($0.34) per share, for the nine months ended September 30, 2024. Excluding the impact of the CEO succession plan and related restructuring costs of $6.1 million, earnings per share was ($0.06) for the quarter or ($0.30) for the year-to-date. Cash, cash equivalents, and short-term investments at September 30, 2024 was $69.4 million, compared to $72.5 million at December 31, 2023. Total shares outstanding at October 31, 2024 was 149,081,461. Conference Call and Webcast Details Xeris will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the Company’s financial and operational results. To pre-register for the call, please go to the following link: https://www.netroadshow.com/events/login?show=6c5018a9&confId=72180 After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until Friday, November 22, 2024 at US:1 929 458 6194, US Toll Free: 1 866 813 9403, UK: 0204 525 0658, Canada: 1 226 828 7578, or all other locations: +44 204 525 0658 Access Code: 906920 To join the webcast, please visit “Events” on investor relations page of the Company’s website at www.xerispharma.com or use this link: https://events.q4inc.com/attendee/232807470 About Xeris Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, a proven therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol® and XeriJect®, supporting long-term product development and commercial success. Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com , or follow us on X, LinkedIn , or Instagram . Forward-Looking Statements Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc. including statements regarding the financial outlook for 2024, projections regarding year-end 2024 cash estimates and total revenue, the potential for growth of revenue, the market and therapeutic potential of its products and product candidates, the potential utility of its formulation platforms, the advancement of its pipeline (including XP-8121), and other statements containing the words “will,” “would,” “continue,” “expect,” “should,” “anticipate” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris’ actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements, include, but are not limited to, its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, and its and collaborators’ ability to protect its intellectual property and proprietary technology. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris’ filings, including its most recently filed Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. Forward-looking statements in this communication are based on information available to us, as of the date of this communication and, while we believe our assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, we do not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations. XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Product revenue, net $ 52,861 $ 41,697 $ 139,636 $ 110,855 Royalty, contract and other revenue 1,407 6,623 3,335 8,669 Total revenue 54,268 48,320 142,971 119,524 Costs and expenses: Cost of goods sold 13,593 8,201 27,354 21,075 Research and development 5,888 5,034 19,468 15,959 Selling, general and administrative 44,969 37,287 123,342 108,527 Amortization of intangible assets 2,711 2,711 8,132 8,132 Total costs and expenses 67,161 53,233 178,296 153,693 Loss from operations (12,893 ) (4,913 ) (35,325 ) (34,169 ) Other expense (6,169 ) (7,614 ) (16,666 ) (15,709 ) Net loss before benefit from income taxes (19,062 ) (12,527 ) (51,991 ) (49,878 ) Income tax benefit 3,324 338 2,268 1,013 Net loss $ (15,738 ) $ (12,189 ) $ (49,723 ) $ (48,865 ) Net loss per common share - basic and diluted $ (0.11 ) $ (0.09 ) $ (0.34 ) $ (0.36 ) Weighted average common shares outstanding - basic and diluted 148,993,823 138,059,781 145,962,198 137,523,202 XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) September 30, 2024 December 31, 2023 (unaudited) Assets Current assets: Cash and cash equivalents $ 59,232 $ 67,449 Short-term investments 10,170 5,002 Trade accounts receivable, net 41,138 39,197 Inventory 45,119 38,838 Prepaid expenses and other current assets 7,140 5,778 Total current assets 162,799 156,264 Property and equipment, net 5,613 5,971 Intangible assets, net 101,632 109,764 Goodwill 22,859 22,859 Operating lease right-of-use assets 22,758 23,204 Other assets 5,443 4,540 Total assets $ 321,104 $ 322,602 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 7,451 $ 11,565 Current portion of long-term debt 15,057 — Current operating lease liabilities 6,042 3,495 Other accrued liabilities 23,543 23,510 Accrued trade discounts and rebates 20,519 22,149 Accrued returns reserve 17,723 14,198 Current portion of contingent value rights — 19,109 Other current liabilities 678 1,167 Total current liabilities 91,013 95,193 Long-term debt, net of unamortized debt issuance costs 216,227 190,932 Non-current contingent value rights — 1,379 Non-current operating lease liabilities 33,639 34,764 Deferred tax liabilities — 2,268 Other liabilities 8,548 4,848 Total liabilities 349,427 329,384 Total stockholders’ equity (deficit) (28,323 ) (6,782 ) Total liabilities and stockholders’ equity (deficit) $ 321,104 $ 322,602