A Phase 1 Randomized, Open-Label, Two-Period,Two-Sequence Crossover Study to Evaluate the Relative Oral Bioavailability of Levoketoconazole and Ketoconazole Tablets in Healthy Subjects

This is a phase 1, randomized, open-label, single-dose, two-period, two-sequence crossover study in healthy male and female subjects to evaluate the relative oral bioavailability of levoketoconazole tablets (the test drug) and ketoconazole tablets (the reference drug product).

开始日期2019-12-16

申办/合作机构

Cortendo AB

NCT03880825 / Completed临床1期

A Phase I Open-Label, Fixed-Sequence Pharmacokinetic Drug Interaction Study to Evaluate the Effect of Levoketoconazole on the Single-Dose Pharmacokinetics of Metformin in Healthy Subjects

This is a phase I, open-label, fixed-sequence drug-drug interaction study to evaluate the effect of levoketoconazole on the single-dose PK of metformin in health subjects.

开始日期2019-03-28

申办/合作机构

Cortendo AB

NCT03621280 / Completed临床3期

An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome

This is a long-term, open-label extension study of levoketoconazole in subjects with endogenous Cushing's Syndrome.

开始日期2019-01-07

申办/合作机构

Cortendo AB

100 项与左旋酮康唑相关的临床结果

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100 项与左旋酮康唑相关的转化医学

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100 项与左旋酮康唑相关的专利（医药）

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项与左旋酮康唑相关的文献（医药）

2024-07-01·Indian Journal of Endocrinology and Metabolism

Efficacy and Safety of Levoketoconazole in Managing Cushing’s Syndrome: A Systematic Review

Review

作者: Dutta, Deep ; Raizada, Nishant ; Patra, Shinjan ; Nagendra, Lakshmi

AbstractNo systematic review has holistically analysed the efficacy and safety of levoketoconazole, a novel purified 2S,4R enantiomer of ketoconazole, believed to be 15- to 25-fold more potent than ketoconazole for managing Cushing’s syndrome (CS). We undertook this meta-analysis to address this knowledge gap. Electronic databases were searched for studies involving patients with CS receiving levoketoconazole in the intervention arm. The primary outcome was to evaluate changes in mean 24-hour urine-free cortisol (mUFC) levels. Secondary outcomes were to evaluate alterations in cortisol and adverse events. SONICS study showed that normalisation of mUFC was seen in 61%, 55%, and 41% of the patients at the end of 6, 9, and 12 months therapy, respectively. The LOGICs study showed that withdrawal of levoketoconazole was associated with a significant increase in mUFC from 81.3 ± 35.7 to 220.8 ± 333.5 nmol/24h. The late-night salivary-cortisol (LNSC) increase during the drug withdrawal phase was 2.6 nmol/L in the placebo group (PG) compared to 2.2 nmol/L in the levoketoconazole group (LG) (P < 0.05). Re-initiation of levoketoconazole in original LG was associated with a decrease in mUFC from 224.3 ± 341.3 to 135.6 ± 87.3 nmol/24h. Initiation of levoketoconazole in the original PG was associated with a decrease in mUFC from 537.9 ± 346.0 to 141.3 ± 130.3 nmol/24h. Normalisation of mUFC was observed in 50.0% patients in LG compared to 4.5% in the placebo group. The median time for the response was 25 days. The median time to loss of therapeutic response was significantly shorter for PG (24 days) compared to LG (62 days) (P < 0.0001). Levoketoconazole has good efficacy and safety in CS. Bigger and longer studies are warranted to establish its superiority over ketoconazole.

2023-05-30·Foods (Basel, Switzerland)

Degradation Dynamics and Residue Analysis of Four Propiconazole Stereoisomers in "Fengtang" Plum during Storage by LC-MS/MS.

Article

作者: Mou, Lianhong ; Deng, Pengyu ; Luo, Xin ; Ou, Guipeng ; Zhang, Yuping ; Hu, Deyu

Herein, an accurate and sensitive method was developed for detecting four stereoisomers of propiconazole in "Fengtang" plum by LC-MS/MS. The mean recovery of four propiconazole stereoisomers ranged from 79.42 to 104.10% at three adding levels with reasonable RSD of 1.54-11.68%, and the LOD and LOQ of the four stereoisomers was 0.0005 mg/kg and 0.004 mg/kg, respectively. In addition, the residue and selective degradation of propiconazole stereoisomers in plums were investigated by storage at 20 °C and 4 °C. The half-lives of propiconazole stereoisomeric during storage were 9.49-15.40 d at 20 °C, and 21.00-28.88 d at 4 °C. The degradation of (2R,4R)-propiconazole and (2R,4S)-propiconazole in stored plums was slightly slower than that of the corresponding enantiomers (2S,4S)-propiconazole and (2S,4R)-propiconazole. The total residues of propiconazole were 0.026-0.487 mg/kg in the plum storage period, and the water washing could remove 49.35% to 54.65% of the propiconazole residue in plum. The hardness of plums treated with propiconazole was generally higher than that of control in the middle and late stages of storage. The effects of propiconazole on the total soluble solid content of plums were different at 20 °C and 4 °C. This study provides a scientific reference for the food safety evaluation of the "Fengtang" plum after the application of propiconazole during the storage period.

2022-12-01·Pituitary

Levoketoconazole in the treatment of patients with endogenous Cushing’s syndrome: a double-blind, placebo-controlled, randomized withdrawal study (LOGICS)

Article

作者: Brue, Thierry ; Elenkova, Atanaska ; Stigliano, Antonio ; Pivonello, Rosario ; Shimon, Ilan ; Badiu, Corin ; Fleseriu, Maria ; Zacharieva, Sabina ; Tóth, Miklós ; Tsagarakis, Stylianos ; Cohen, Fredric ; Georgescu, Carmen Emanuela

AbstractPurposeThe efficacy of levoketoconazole for endogenous Cushing’s syndrome was demonstrated in a phase 3, open-label study (SONICS). This study (LOGICS) evaluated drug-specificity of cortisol normalization.MethodsLOGICS was a phase 3, placebo-controlled, randomized-withdrawal study with open-label titration-maintenance (14–19 weeks) followed by double-blind, randomized-withdrawal (~ 8 weeks), and restoration (~ 8 weeks) phases.Results79 patients received levoketoconazole during titration-maintenance; 39 patients on a stable dose (~ 4 weeks or more) proceeded to randomization. These and 5 SONICS completers who did not require dose titration were randomized to levoketoconazole (n = 22) or placebo (n = 22). All patients with loss of response (the primary endpoint) met the prespecified criterion of mean urinary free cortisol (mUFC) > 1.5 × upper limit of normal. During randomized-withdrawal, 21 patients withdrawn to placebo (95.5%) lost mUFC response compared with 9 patients continuing levoketoconazole (40.9%); treatment difference: − 54.5% (95% CI − 75.7, − 27.4; P = 0.0002). At the end of randomized-withdrawal, mUFC normalization was observed among 11 (50.0%) patients receiving levoketoconazole and 1 (4.5%) receiving placebo; treatment difference: 45.5% (95% CI 19.2, 67.9; P = 0.0015). Restoration of levoketoconazole reversed loss of cortisol control in most patients who had received placebo. Adverse events were reported in 89% of patients during treatment with levoketoconazole (dose-titration, randomized-withdrawal, and restoration phases combined), most commonly nausea (29%) and hypokalemia (26%). Prespecified adverse events of special interest with levoketoconazole were liver-related (10.7%), QT interval prolongation (10.7%), and adrenal insufficiency (9.5%).ConclusionsLevoketoconazole reversibly normalized urinary cortisol in patients with Cushing’s syndrome. No new risks of levoketoconazole treatment were identified.

项与左旋酮康唑相关的新闻（医药）

2024-11-08

·Business Wire

Xeris Biopharma Reports Third Quarter 2024 Financial Results

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

财报

2024-08-22

·Business Wire

Xeris to Participate in Upcoming Investor Conferences

CHICAGO--( BUSINESS WIRE )--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies, today announced that members of its senior management will take part in the following events: 2024 Wells Fargo Healthcare Conference, Boston, MA Meetings only on September 4, 2024 H.C. Wainwright 26 th Annual Global Investor Conference, New York, NY Meetings and fireside chat on September 10, 2024 at 3:30pm ET 2024 Cantor Global Healthcare Conference, New York, NY Meetings only on September 18, 2024 Please check with each conference sponsor to arrange 1x1 meetings. Webcast information for the fireside chat will be available at https://xerispharma.com/investor-relations . About Xeris Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing differentiated and 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 has a pipeline of development and partnered programs using its formulation sciences, XeriSol™ and XeriJect®, to support long-term product development and commercial success. Xeris is headquartered in Chicago, IL. For more information, visit www.xerispharma.com , or follow Xeris on Twitter , LinkedIn or Instagram .

2024-08-08

·Business Wire

Xeris Biopharma Reports Second Quarter 2024 Financial Results

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 second quarter and six months ended June 30, 2024 and recent corporate events. “I am very pleased to report that we posted an outstanding quarter of $48 million in total revenue, which included record product revenue of over $46 million driven by strong demand for all three of our products. Our year-over-year product revenue growth of 26% represents the eleventh consecutive quarter of over 20% growth as our diverse product portfolio of Recorlev ® , Gvoke ® , and Keveyis ® all continue to meet important unmet needs for patients,” said John Shannon, CEO of Xeris Biopharma. “Our strong performance leads us to now envision full year results at the high end of our original range, and we’re tightening our guidance to $190-$200 million from the previous $175-$200 million. We also believe that this performance will enable us to perform at the higher end of our year-end cash range, so we’re tightening that guidance to $60-$75 million.” Mr. Shannon continued, “This is an exciting time for Xeris, and I’m thrilled to be leading as CEO for the next phase of our journey building upon the strong foundation we’ve created to drive our revenues and pipeline to new heights.” Second Quarter 2024 Highlights Three Months Ended June 30, Change 2024 2023 $ % Product revenue (in thousands): Gvoke $ 20,046 $ 15,638 $ 4,408 28.2 Keveyis 13,128 14,088 (960 ) (6.8 ) Recorlev 13,338 7,167 6,171 86.1 Product revenue, net 46,512 36,893 9,619 26.1 Royalty, contract and other revenue 1,553 1,115 438 39.3 Total revenue $ 48,065 $ 38,008 $ 10,057 26.5 Commercial Products Gvoke ® : Second quarter net revenue was $20.0 million as compared to $15.6 million in the second quarter of 2023 – an increase of approximately 28%. Gvoke prescriptions topped 65,000 for the first time, growing 27% compared to the same period in 2023. Gvoke’s share of the retail TRx glucagon market grew to approximately 34% at the end of July. Keveyis ® : Second quarter net revenue was $13.1 million as compared to $14.1 million in the second quarter of 2023 - a decrease of approximately 7% due to generic competition. Net revenue was unchanged from the first quarter of 2024. Recorlev ® : Second quarter net revenue was $13.3 million – an increase of 86% compared to the second quarter of 2023. The average number of patients on Recorlev increased 124% from the same period in 2023 . Technologies Programs XeriSol™ levothyroxine (XP-8121) : In May, Xeris announced positive topline results from its Phase 2 multi-center, open label, study of XP-8121 for the treatment of adults with hypothyroidism. The Company anticipates an end-of-Phase 2 meeting with the FDA before year-end. XeriSol™ glucagon for pumps: In May, Xeris entered into an exclusive worldwide collaboration and license agreement with Beta Bionics, Inc. for the development and commercialization of a unique glucagon product for use in Beta Bionics’ proprietary bi-hormonal pump and pump systems. Year-to-Date 2024 Financial Results Six Months Ended June 30, Change 2024 2023 $ % Product revenue (in thousands): Gvoke $ 36,625 $ 30,671 $ 5,954 19.4 Keveyis 26,213 26,843 (630 ) (2.3 ) Recorlev 23,937 11,644 12,293 105.6 Product revenue, net 86,775 69,158 17,617 25.5 Royalty, contract and other revenue 1,928 2,046 (118 ) (5.8 ) Total revenue $ 88,703 $ 71,204 $ 17,499 24.6 Gvoke ® : Net revenue was $36.6 million for the six months ended June 30, 2024, a 19% increase compared to prior year. Gvoke prescriptions for the first half of 2024 were approximately 124,000 TRx’s, growing approximately 27% compared to the same period in 2023. Keveyis ® : Net revenue was $26.2 million for the six months ended June 30, 2024, a 2% decrease from last year due to generic competition. Recorlev ® : Net revenue was $24.0 million for the six months ended June 30,2024, a 106 % increase from last year, driven primarily by increases in the number of patients on therapy. Cost of goods sold remained relatively flat for the three months ended June 30, 2024 compared to the same period ended June 30, 2023. Cost of goods sold increased by $0.9 million for the six months ended June 30, 2024 compared to the same period ended June 30, 2023. The slight increase was attributable to higher product sales, partially offset by favorable product mix driven by higher sales of products with lower cost of goods sold. Research and development (R&D) expenses decreased slightly by $0.3 million for the three months ended June 30, 2024. For six months ended June 30, 2024, R&D increased by $2.7 million primarily due to higher spending for our pipeline and personnel related expenses. Selling, general and administrative (SG&A) expenses increased by $2.4 million and $7.1 million for the three and six months ended 2024, respectively, compared to the same periods ended June 30, 2023, due to higher personnel costs. Net Loss for the three months ended June 30, 2024, was $15.0 million, or $0.10 per share, and a net loss of $34.0 million, or $0.24 per share, for the six months ended June 30, 2024. Cash, cash equivalents, and short-term investments at June 30, 2024 was $77.6 million compared to $72.5 million at December 31, 2023. Total shares outstanding at July 31, 2024 was 148,998,825. Upcoming Investor Conferences Members of the senior management team will be participating in the following investor conferences: Wells Fargo Healthcare Conference, September 4-6, 2024 HC Wainwright Global Investor Conference, September 9-11, 2024 Cantor Global Healthcare Conference, September 17-19, 2024 Please check with each conference sponsor to arrange 1x1 meetings. 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=44e9222b&confId=68537 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 Thursday, August 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: 840547 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/670337574 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, including 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 expected timing of an end-of-Phase 2 meeting with the FDA, its attendance at investor conferences, the composition of its executive team, 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 June 30, Six Months Ended June 30, 2024 2023 2024 2023 Product revenue, net $ 46,512 $ 36,893 $ 86,775 $ 69,158 Royalty, contract and other revenue 1,553 1,115 1,928 2,046 Total revenue 48,065 38,008 88,703 71,204 Costs and expenses: Cost of goods sold 7,790 7,555 13,761 12,874 Research and development 5,759 6,087 13,580 10,925 Selling, general and administrative 39,993 37,635 78,373 71,240 Amortization of intangible assets 2,710 2,710 5,421 5,421 Total costs and expenses 56,252 53,987 111,135 100,460 Loss from operations (8,187 ) (15,979 ) (22,432 ) (29,256 ) Other expense (6,069 ) (4,538 ) (10,497 ) (8,095 ) Net loss before benefit from income taxes (14,256 ) (20,517 ) (32,929 ) (37,351 ) Income tax (expense) benefit (749 ) 675 (1,056 ) 675 Net loss $ (15,005 ) $ (19,842 ) $ (33,985 ) $ (36,676 ) Net loss per common share - basic and diluted $ (0.10 ) $ (0.14 ) $ (0.24 ) $ (0.27 ) Weighted average common shares outstanding - basic and diluted 148,345,549 137,338,071 144,372,512 137,250,465 XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) June 30, 2024 December 31, 2023 (unaudited) Assets Current assets: Cash and cash equivalents $ 57,604 $ 67,449 Short-term investments 19,964 5,002 Trade accounts receivable, net 42,440 39,197 Inventory 42,977 38,838 Prepaid expenses and other current assets 7,355 5,778 Total current assets 170,340 156,264 Property and equipment, net 5,833 5,971 Intangible assets, net 104,343 109,764 Goodwill 22,859 22,859 Operating lease right-of-use assets 22,864 23,204 Other assets 5,494 4,540 Total assets $ 331,733 $ 322,602 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 5,798 $ 11,565 Current operating lease liabilities 5,307 3,495 Other accrued liabilities 23,494 23,510 Accrued trade discounts and rebates 23,275 22,149 Accrued returns reserve 16,197 14,198 Current portion of contingent value rights 420 19,109 Other current liabilities 997 1,167 Total current liabilities 75,488 95,193 Long-term debt, net of unamortized debt issuance costs 230,481 190,932 Non-current contingent value rights — 1,379 Non-current operating lease liabilities 34,016 34,764 Deferred tax liabilities 3,324 2,268 Other liabilities 7,710 4,848 Total liabilities 351,019 329,384 Total stockholders’ equity (deficit) (19,286 ) (6,782 ) Total liabilities and stockholders’ equity (deficit) $ 331,733 $ 322,602

引进/卖出临床结果财报临床2期

100 项与左旋酮康唑相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10950	左旋酮康唑	-	DB05667

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
内源性库欣综合征	美国	Strongbridge Ireland Ltd.	2021-12-30

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
内源性库欣综合征	临床3期	美国	Cortendo AB	2014-08-01
内源性库欣综合征	临床3期	荷兰	Cortendo AB	2014-08-01
内源性库欣综合征	临床3期	波兰	Cortendo AB	2014-08-01
内源性库欣综合征	临床3期	西班牙	Cortendo AB	2014-08-01
内源性库欣综合征	临床3期	法国	Cortendo AB	2014-08-01
内源性库欣综合征	临床3期	保加利亚	Cortendo AB	2014-08-01
内源性库欣综合征	临床3期	以色列	Cortendo AB	2014-08-01
2型糖尿病	临床3期	新西兰	DiObex, Inc.	2008-01-01
2型糖尿病	临床3期	澳大利亚	DiObex, Inc.	2008-01-01
2型糖尿病	药物发现	美国	DiObex, Inc.	2008-01-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Corporate Publications 人工标引	临床3期	库欣综合征	79	Levoketoconazole	壓鑰糧製選蓋廠構簾廠(顧願範繭壓積糧餘餘醖) = 製醖範簾鬱構夢憲遞憲築繭遞衊築積膚鏇淵艱 (網顧蓋簾繭齋蓋製廠衊 ) 更多	积极	2022-05-12
				Placebo	壓鑰糧製選蓋廠構簾廠(顧願範繭壓積糧餘餘醖) = 醖齋構積選餘夢窪餘鹹築繭遞衊築積膚鏇淵艱 (網顧蓋簾繭齋蓋製廠衊 ) 更多
NCT01838551 (SONICS, CTgov)	临床3期	内源性库欣综合征	94	Levoketoconazole	齋膚顧糧襯淵鑰網襯齋(範鏇繭遞壓窪網顧窪網) = 製構鏇鏇餘網繭膚餘簾遞壓憲觸獵齋淵鏇遞衊 (憲構衊衊觸觸襯鹽繭鏇, 獵憲築顧餘鹽壓壓夢繭 ~ 膚鹽積憲糧淵憲製築糧) 更多	-	2021-04-19
NCT01838551 (SONICS, Pubmed \| Front Endocrinol (Lausanne))	临床3期	糖尿病 \| 库欣综合征	94	Levoketoconazole (Patients with DM)	範選蓋憲衊齋鏇衊顧齋(獵膚壓簾鹹鹹選遞壓淵): P-Value = 0.0006 更多	-	2021-01-01
				Levoketoconazole (Patients without DM)
NCT03277690 (LOGICS, Biospace) 人工标引	临床3期	内源性库欣综合征	44	RECORLEV	餘醖襯範衊製壓顧憲築(鹽淵壓鏇鹽繭觸鹹餘窪) = 構膚糧艱鹽願餘願積淵鏇選願壓鬱鑰艱蓋積餘 (窪網膚夢壓顧壓選淵糧 ) 更多	积极	2020-09-08
				placebo	餘醖襯範衊製壓顧憲築(鹽淵壓鏇鹽繭觸鹹餘窪) = 衊鏇膚構鏇鑰襯餘齋繭鏇選願壓鬱鑰艱蓋積餘 (窪網膚夢壓顧壓選淵糧 ) 更多