A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Teprotumumab in Participants With Moderate-to-Severe Active Thyroid Eye Disease

The study consists of a randomized double-masked, placebo-controlled, parallel-group, multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period.

Start Date21 Jun 2024

Sponsor / Collaborator

Amgen, Inc.

JPRN-jRCT2031220730 / RecruitingPhase 3

A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group Multicenter Trial to Evaluate the Efficacy and Safety of HZN-001 in Treating Japanese Participants with Chronic (Inactive) Thyroid Eye Disease

Start Date29 Mar 2023

Sponsor / Collaborator-

NCT06389578 / CompletedPhase 1

A Phase 1b, Open-label, Multicenter Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Two Formulations of a Single Subcutaneous Dose of Teprotumumab Followed by Multiple Intravenous Doses of TEPEZZA in Participants With Thyroid Eye Disease

The main goal of this study is to learn how teprotumumab will be processed in the body (Pharmacokinetics) subcutaneously and whether it is safe and tolerable after administration into adult patients with thyroid eye disease.

Start Date14 Jul 2022

Sponsor / Collaborator

Amgen, Inc.

100 Clinical Results associated with Teprotumumab-TRBW

100 Translational Medicine associated with Teprotumumab-TRBW

100 Patents (Medical) associated with Teprotumumab-TRBW

244

Literatures (Medical) associated with Teprotumumab-TRBW

01 Mar 2024·Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society

Real-World Experience With Teprotumumab in Patients With Dysthyroid Optic Neuropathy

Review

Author: Chen, Yuanyuan ; Tamhankar, Madhura A ; Briceño, César A ; Pradeep, Tejus

Background::

Teprotumumab, an insulin-like growth factor I receptor inhibitory antibody, improved proptosis, diplopia, inflammatory signs/symptoms, and quality of life in patients with active thyroid eye disease (TED) in clinical trials. The trials excluded patients with dysthyroid optic neuropathy (DON). Recently, many case reports and case series have reported the successful use of teprotumumab to treat DON. Here, we review the data from published cases and our clinical experience in treating patients having DON with teprotumumab.

Methods::

A literature search was conducted of patients with DON treated with teprotumumab from January 2020 through September 2022. Data from DON patients from the authors' (M.A.T. and C.A.B.) clinical practice were included. Primary outcome measure was mean (SD) improvements for visual acuity, color vision, and visual fields. Improvements in proptosis and clinical activity score (CAS) and diplopia were compared before and after teprotumumab administration.

Results::

Ten observational studies/case reports were identified along with 2 patients in our practice. In all, there were 24 active TED patients with DON (37 eyes) who were treated with teprotumumab. Mean (SD) age was 66.5 (13.6) years and 13 (54%) were females, disease duration ranged from 2 months to >15 years. 22/24 patients had none, minimal improvement or progression of visual loss with intravenous/oral corticosteroids, orbital decompression (n = 9), and orbital radiation (n = 2). There were 2 patients who received teprotumumab as the only therapy. Overall, 88% (21/24) reported improvement in visual acuity after teprotumumab and in 75% (18/24), improvement in vision was observed after just 2 infusions of teprotumumab. Three eyes had decompression surgery in close proximity to teprotumumab infusions and were excluded from analyses. Mean (SD) improvement in visual acuity was 3.73 lines (SD 3.74), range 2–15 lines in 33 eyes. The mean (SD) improvement in the mean deviation on visual field testing in 15 eyes was 5.6 db (3.0 db). Mean (SD) improvement in proptosis was 4.37 mm (SD: 2.11) (20 patients, 32 eyes); and clinical activity score: mean reduction of 5.1 (1.3) for 18 patients. Teprotumumab was well tolerated in all but one patient. Adverse events reported included fatigue, dysgeusia, hearing loss, nausea, hyperglycemia, and muscle spasms.

Conclusions::

Teprotumumab is an effective treatment for DON in our experience and in published cases in whom treatment with steroids, surgery, or orbital radiation was unsuccessful.

01 Jan 2024·Ophthalmology

Frequency and Patterns of Hearing Dysfunction in Patients Treated with Teprotumumab

Review

Author: Correa, Tatiana ; Shriver, Erin M ; Hansen, Marlan R ; Pham, Chau ; Keen, Jamie A ; Claussen, Alexander D ; Carter, Keith D

PURPOSE:

To better characterize the frequency and patterns of hearing dysfunction in patients who have received teprotumumab to treat thyroid eye disease.

DESIGN:

Noncomparative case series.

PARTICIPANTS:

Patients who underwent audiology testing before and after completion of teprotumumab infusions.

METHODS:

A review of patients who underwent audiology testing before and after completion of teprotumumab infusions was carried out. Additional audiogram testing during treatment was included when available. Hearing function was analyzed using audiogram data measuring threshold hearing levels at specific frequencies. Basic demographic data as well as information regarding otologic symptoms also were obtained and analyzed.

MAIN OUTCOME MEASURES:

Hearing loss demonstrated by a significant change in decibel hearing thresholds or that meets criteria for ototoxicity.

RESULTS:

Twenty-two patients (44 ears) were included in the study, with baseline and most recent audiology testing after treatment ranging from 84 days before to 496 days after treatment. Fifteen patients (30 ears) also underwent testing during treatment starting after the second infusion up until the day of, but before, the eighth infusion. Hearing loss after treatment met criteria for ototoxicity in 17 of the 44 ears (38.6%), with 11 of the 22 patients (50.0%) meeting criteria in at least 1 ear. The pure-tone average decibel hearing levels (HLs) across all 44 ears demonstrated hearing loss after treatment (P = 0.0029), specifically at high (P = 0.0008) and middle frequencies (P = 0.0042), but not at low frequencies (P = 0.8344). Patients who were older also were more likely to experience hearing loss after treatment (P = 0.0048).

CONCLUSIONS:

Audiometric data demonstrate that teprotumumab influences hearing function, most significantly at higher frequencies and in older patients. Audiometric testing is critical for counseling patients regarding teprotumumab treatment. A protocol for monitoring hearing during treatment is needed to detect and manage hearing changes associated with teprotumumab use.

FINANCIAL DISCLOSURE(S):

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

01 Jan 2024·Ophthalmology

Glycemic Trends in Patients with Thyroid Eye Disease Treated with Teprotumumab in 3 Clinical Trials

Article

Author: Holt, Robert J ; Wester, Sara Tullis ; Hsu, Kate ; Smith, Terry J ; Kim, Sun ; Bhattacharya, Rajib K ; Cavida, Dustin ; Barbesino, Giuseppe ; Fu, Qianhong

PURPOSE:

Assess incidence, severity, and glucose excursion outcomes in thyroid eye disease (TED) patients receiving the insulin-like growth factor-1 receptor inhibitor teprotumumab from 3 clinical trials.

DESIGN:

Analysis of pooled glycemic data over time.

PARTICIPANTS:

Eighty-four teprotumumab- and 86 placebo-treated active TED patients from the phase 2 and phase 3 (OPTIC) controlled clinical trials and 51 teprotumumab-treated patients from the OPTIC extension (OPTIC-X) trial.

METHODS:

Eight intravenous infusions were given over 21 weeks. Phase 2 serum glucose was measured at weeks 1, 4, 15, and 21, with fasting measurements at weeks 1 and 4. Serum glucose was measured at each study visit in OPTIC and OPTIC-X, with fasting measurements at weeks 1 and 4 (in patients without diabetes) or all visits (in patients with diabetes). In all studies, hemoglobin A1c (HbA1c) was measured at baseline, 12, and 24 weeks plus weeks 36 and 48 in OPTIC-X.

MAIN OUTCOME MEASURES:

Serum glucose and HbA1c.

RESULTS:

In the phase 2 and 3 studies, 9 hyperglycemic episodes occurred in 8 teprotumumab patients; mean HbA1c level increased 0.22% from baseline to week 24 (to 5.8%; range, 5.0%-7.9%) versus 0.04% in patients receiving the placebo (to 5.6%; range, 4.6%-8.1%). At study end, 78% (59/76) of teprotumumab patients and 87% (67/77) of patients receiving placebo had normoglycemic findings. Normoglycemia was maintained in 84% (57/68) of patients receiving teprotumumab and 93% (64/69) of patients receiving placebo. Among baseline prediabetic patients, 43% (3/7) remained prediabetic in both groups, and 29% (2/7) of teprotumumab patients and 14% (1/7) of patients receiving placebo had diabetic findings at week 24. OPTIC-X patients trended toward increased fasting glucose and HbA1c whether initially treated or retreated with teprotumumab. Fasting glucose commonly rose after 2 or 3 infusions and stabilized thereafter. Most hyperglycemic incidents occurred in patients with baseline prediabetes/diabetes but were controlled with medication. No evidence was found for progression or increased incidence of hyperglycemia with subsequent doses.

CONCLUSIONS:

Serious glycemic excursions are uncommon in patients with normoglycemia before teprotumumab therapy. Patients with controlled diabetes or impaired glucose tolerance can be treated safely if baseline screening, regular monitoring of glycemic control, and timely treatment of hyperglycemia are practiced.

FINANCIAL DISCLOSURE(S):

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

144

News (Medical) associated with Teprotumumab-TRBW

28 May 2024

·www.fiercebiotech.com

Innovent to take IL-23 psoriasis drug to Chinese regulators after phase 3 win

The “strong efficacy” was maintained through Week 52 in both of the picankibart cohorts, Innovent said. Innovent’s psoriasis contender to IL-23 drugs like Tremfya and Skyrizi cleared skin and improved the severity of disease in a phase 3 test, setting up the company to seek approval from Chinese regulators. The anti-IL-23 monoclonal antibody, called picankibart, hit all primary and key secondary endpoints in the late-stage CLEAR-1 trial of 500 Chinese patients with moderate to severe plaque psoriasis. Specifically, 80.3% of patients who received picankibart achieved a 90% or greater improvement in their Psoriasis Area and Severity Index (PASI) score at 16 weeks compared to just 2% of participants who received placebo. A physician’s assessment at the same point—the other primary endpoint of the trial—produced similar results, with 93.5% of patients achieving clear or almost-clear skin compared to 13.1% of the placebo cohort. Patients who received picankibart started with a 200-mg injection and then received the same dose again at weeks 4 and 8 before being split into those who received either a 100-mg or 200-mg dose every 12 weeks. The “strong efficacy” was maintained through Week 52 in both of the picankibart cohorts, said Innovent, although yearlong data were only shared for the 200-mg group. Of these patients, 84.9% still had a PASI score of 90% or above at this point, while 85.9% maintained their clear or almost-clear skin. “These results underpin the long-term robust efficacy of picankibart in treating moderate to severe psoriasis,” the biotech said in the May 27 release. Picankibart is designed to be given less frequently than some rivals. While the FDA has already approved antibodies in the U.S. against the IL23p19 subunit—with Sun Pharma’s Ilumya joining Johnson & Johnson’s Tremfya and AbbVie’s Skyrizi among the authorized products—Innovent sees value in developing an extended half-life treatment that can be dosed less frequently. “Achievement of all primary and key secondary endpoints in CLEAR-1 has supported picankibart's outstanding efficacy and favorable safety as a new generation of IL-23p19 target drugs,” said Lei Qian, M.D., Ph.D., vice president of clinical development at Innovent. Innovent will use yesterday’s results to prepare an application to Chinese regulators to approve picankibart as a “more convenient, friendly and effective treatment regimen for patients with moderate to severe plaque psoriasis,” Qian said. J&J has another IL-23 psoriasis option in the works courtesy of an IL-23R antagonist peptide called JNJ-2113. The Protagonist Therapeutics-partnered candidate fell short of the high bar set by injectable treatments in a phase 2 trial last year, but the convenience of oral delivery means the companies have still pushed the asset into phase 3. The picankibart results mark the latest in a string of clinical wins for Innovent this year. A thyroid eye disease rival to Amgen’s Tepezza hit its phase 3 endpoints, while the GLP-1R/GCGR dual agonist mazdutide licensed from Eli Lilly has demonstrated success in both diabetes and weight loss.

Clinical ResultPhase 3Phase 2

21 May 2024

·www.prnewswire.com

Innovent Announces the New Drug Application of IBI311 (IGF-1R antibody) has been Accepted by the NMPA of China for Thyroid Eye Disease

SAN FRANCISCO and SUZHOU, China, May 20, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases, today announced that the New Drug Application (NDA) for IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, has been accepted and granted priority review designation by the Center for Drug Evaluation (CDE) of the China National Drug Administration (NMPA) for the treatment of Thyroid Eye Disease (TED). IBI311 is the first anti-IGF-1R antibody with NDA submitted in China. As a biological drug with a novel mechanism of action, IBI311 will potentially resolve an over 60-years shortage of innovative TED drugs in China by offering an effective, safe and accessible treatment option for Chinese TED patients. This NDA was accepted based on the positive results of a Phase 3 registration clinical study RESTORE-1 (CTR20223393) in subjects with TED in China. The primary endpoint of the study was successfully met in February 2024. Significant improvements in proptosis, disease activity, and quality of life were observed in the IBI311 group compared to placebo. The overall safety profile of IBI311 was favorable, and no new safety signals were identified. Detailed results of the RESTORE-1 study will be presented at medical conferences or journals in 2024. TED is an autoimmune disease that causes progressive inflammation and damage to tissues around the eyes. The annual incidence of TED is estimated to be 16/100,000 in women and 2.9/100,000 in men [1], with the estimated prevalence of 0.1-0.3%[2].The use of IGF-1R-targeted antibody has been recommended in multiple clinical treatment guidelines worldwide[3, 4, 5]; particularly, IGF-1R-targeted antibody is recommended as first-line therapy for patients with clinically significant proptosis. In China, there exists an urgent need for effective, safe and accessible treatment options. Professor Xianqun Fan, an academician of the Chinese Academy of Engineering and the leading principal investigator of the study, Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, stated, "TED is one of the most common orbital diseases in adults, with proptosis as the most apparent clinical manifestation. The course of TED is protracted, which seriously impairs patients' visual function and appearance, and usually brings a heavy psychological burden to patients. In China, physicians are hampered with limited choice of treatment. IBI311 has shown encouraging efficacy with respect to proptosis and orbital soft tissue inflammation with good safety in clinical studies. As the principal investigator of the RESTORE-1 study, I am proud of the NDA submission based on IBI311's promising efficacy and safety demonstrated in the pivotal study and would like to thank the effort of all investigators from participating sites. We look forward to the approval of IBI311, which will be a great advance in the management of TED and benefit more Chinese patients." Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated, "We are honored to receive the regulatory acceptance of NDA for IBI311 with the support and dedication of participants, investigators and regulatory authorities. IBI311 has demonstrated favorable safety and comprehensive efficacy benefits in the RESTORE-1 study, including relief of proptosis, control of disease activity, and improvement in quality of life. We will actively communicate with the regulatory authorities during the NDA review and hope to provide an effective, safe and more accessible treatment option for Chinese TED patients as soon as possible. Innovent is strategically establishing its innovative commercial and late-stage portfolio in the fields of ophthalmology, autoimmunity, cardiovascular and metabolic (CVM) , aiming to help more people pursue a healthy life." About Thyroid Eye Disease (TED) TED is an autoimmune disease involving ocular tissues and is usually associated with Graves' disease (GD) and is the most common orbit-related disease in adults. TED occurs in approximately 25 to 50% of GD patients and can also be seen in other thyroid diseases, even in euthyroidism[6]. The annual incidence of TED is estimated to be 16/100,000 in women and 2.9/100,000 in men[1]，and the estimated prevalence of clinically relevant TED ranges from 0.1% to 0.3%[2]. According to disease severity, it can be divided into mild, moderate and severe. Although TED appears to affect women more often, severe cases occur more frequently in men. Patients aged 30 to 50 years are most commonly affected, and severe cases occur more frequently in patients over 50 years[7]. At present, the pathogenesis of TED is not fully understood, but several studies have shown that orbital fibrous present in muscle fibers, orbital fibrous connective tissue space are key factors leading to orbital soft tissue enlargement in TED[8]. The natural history of TED is divided into active and inactive phases[9]. The most common symptoms are dry eye, ocular gritty, photophobia, lacrimation, diplopia, and pressure behind the eye, while typical signs include upper eyelid retraction, eyelid edema, periorbital and conjunctival edema, and proptosis. TED is usually mild to moderate, and about 3–5% of patients with TED are severe, manifesting as severe pain, vision-threatening corneal ulcers, or compressive optic neuropathy[10]. In addition to potentially affecting vision, TED can have an extremely severe impact on the patient's appearance and social functioning and quality of life. Currently, the first-line treatment option for moderately severe active TED is intravenous glucocorticoid therapy, which suffers from unsatisfactory improvement of proptosis and systemic side effects, and second-line treatment includes other immunomodulators, which also have risks related to unclear improvement of proptosis and treatment. Teprotumumab, Tocilizumab and Rituximab are recommended by the Chinese Clinical Diagnosis and Treatment Guidelines for Thyroid Eye Disease (2022)[3], the European Group on Graves' orbitopathy (EUGOGO)[4] and the consensus on thyroid eye disease of the American Thyroid Society and the European Thyroid Society[5] as the second-line treatment options for moderate to severe active TED. Teprotumumab targeting IGF-1R is recommended as first-line therapy for patients with clinically significant proptosis. About IBI311 IBI311 is a recombinant anti-IGF-1R antibody developed by Innovent for the treatment of TED. IGF-1R is a transmembrane tyrosine kinase receptor that plays a role in the development, metabolism, and immune regulation, and is overexpressed in OFs, B, and T cells of TED patients[11]. IBI311 can bind IGF-1R, block IGF-1R signaling pathway activation mediated by IGF-1 and other related ligands or agonistic antibodies, reduce the expression of downstream inflammatory factors, thereby inhibiting the synthesis of hyaluronic acid and other glycosaminoglycan caused by OFs activation, as well as related inflammatory reactions including tissue congestion and edema; inhibit adipocyte cellularization of OFs, thereby reducing the disease activity of patients with TED and improving proptosis, diplopia, ocular congestion and edema among other symptoms and signs. In May 2024, the NDA for IBI311 was accepted by the NMPA for the treatment of TED. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable illnesses. Its pioneering therapies to treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 4 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or is otherwise inaccurate. References 1. Li Z, Cestari D M, Fortin E. Thyroid eye disease: what is new to know? Curr Opin Ophthalmol. 2018; 29 (6): 528-534. 2. Bartley G. The epidemiological characteristics and clinical course of ophthalmology associated with autoimmune thyroid disease in Olmsted Country, Minnesota. Trans Am Ophthalmol Soc 1994; 92: 477-588. 3. Hiromatsu Y, Eguchi H, Tani J, Kasaoka M, Teshima Y. Graves' ophthalmopathy: epidemiology and natural history. Intern Med. 2014; 53 (5): 353-60. 4. Edsel I. Thyroid Associated Orbitopathy. Retrieved June 7, 2011, from Medscape Reference: # a1 5. Ali F, Chorsiya A, Anjum V, Ali A. Teprotumumab (TEPEZZA): From the Discovery and Development of Medicines to USFDA Approvals for Active Thyroid Eye Disease (TED) Treatment. Int Ophthalmol. 2021; 41 (4): 1549-1561. 6. Dolman P J. Evaluating Graves' orbitopathy. Best Pract Res Clin Endocrinol Metab. 2012; 26 (3): 229-248. 7. Bahn R S. Graves' ophthalmopathy. N Engl J Med. 2010; 362 (8): 726-738. 8. Bartalena L, Kahaly GJ, Baldeschi L, et al. The 2021 European Group on Graves' Orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' Orbitopathy. Eur J Endocrinol. 2021; 185 (4): G43-G67. 9. Group of Oculoplastic and Orbital Diseases, Chinese Ophthalmology Branch, Chinese Medical Association; Group of Thyroid Diseases, Chinese Endocrinology Branch, Chinese Medical Association. Chinese Guidelines for the Diagnosis and Treatment of Thyroid Associated Ophthalmopathy (2022). Chinese Journal of Ophthalmology. 2022; 58 (9). 10. Burch HB, et al. Management of Thyroid Eye Disease: a Consensus Statement by the American Thyroid Association and the European Thyroid Association. Eur Thyroid J. 2022; 11 (6): e220189. 11. Douglas RS, Naik V, Hwang CJ, et al. B cells from patients with Graves' disease erase express the IGF-1 receptor: implications for disease pathogenesis. J Immunol 2008; 181: 5768-5774. SOURCE Innovent Biologics

NDAClinical ResultPriority ReviewPhase 3

09 May 2024

·www.biospace.com

Xeris Biopharma Reports First Quarter 2024 Financial Results and Recent Events

Q1 2024 Total Revenue of $40.6M – up 22% over Q1 2023 Tightening full-year 2024 total revenue guidance to $175M-$200M Ended Q1 with $87.4M in cash, cash equivalents, and short-term investments, lowered borrowing rate of Hayfin debt by 2.05% Entered into a worldwide license agreement for XeriJect® formulation of teprotumumab Announced an exclusive worldwide agreement with Beta Bionics for development of a new XeriSol™ formulation of glucagon for bi-hormonal pumps and pump systems Hosting conference call and webcast today at 8:30 a.m. ET CHICAGO--(BUSINESS WIRE)-- Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the first quarter ended March 31, 2024 and recent events. “We grew total product revenue 25% in the first quarter compared to last year, despite an estimated $3 million negative impact to Gvoke revenue from the Change Healthcare cyberattack. This strong growth was driven by impressive momentum in Recorlev sales, Keveyis’ resilience in the marketplace, and Gvoke’s growing market share,” said Paul R. Edick, Xeris’ Chairman and CEO. “With these results, a strong start to the second quarter, along with our new technology partnership with Beta Bionics, we are confident in tightening our 2024 total revenue guidance to $175 million to $200 million.” First Quarter 2024 Highlights Three months ended March 31, Change 2024 2023 $ % Product revenue (in thousands): Gvoke $ 16,579 $ 15,033 $ 1,546 10.3 Keveyis 13,085 12,755 330 2.6 Recorlev 10,599 4,477 6,122 136.7 Product revenue, net 40,263 32,265 7,998 24.8 Royalty, contract and other revenue 375 931 (556 ) (59.7 ) Total revenue $ 40,638 $ 33,196 $ 7,442 22.4 Commercial Products Gvoke®: First quarter net revenue was $16.6 million as compared to $15.0 million in the first quarter of 2023 – an increase of approximately 10%. Gvoke’s market share of the retail TRx glucagon market grew to over 36% through late April and weekly Gvoke TRxs broke the 5,000 level in late April. Keveyis®: First quarter net revenue remained very strong at $13.1 million – an increase of approximately 3% compared to the same period in 2023. Keveyis patient referrals remained strong with considerably lower patient loss in the quarter than anticipated. Recorlev®: First quarter net revenue was $10.6 million – an increase of $6.1 million compared to the same period in 2023. The average number of patients on Recorlev increased 139% from the same period in 2023 and 18% compared to the fourth quarter 2023. Pipeline Program XeriSol™ levothyroxine (XP-8121): Successfully completed the Phase 2 clinical study. Data from the Phase 2 study will be available mid-2024. Technology Partnerships XeriSol™: In May, Xeris entered into an exclusive worldwide collaboration and license agreement with Beta Bionics for the development and commercialization of a new and unique formulation of liquid stable glucagon for use in a bi-hormonal pump and pump systems. XeriJect®: In January, Xeris entered into an exclusive worldwide license agreement for Amgen to develop, manufacture, and commercialize a subcutaneous formulation of teprotumumab using Xeris’ XeriJect® technology in Thyroid Eye Disease (TED). Under the terms of the License Agreement, Xeris has the potential to receive $75 million in development, regulatory, and sales-based milestones, as well as escalating single-digit royalties based on future sales of TEPEZZA® using the XeriJect ® technology. Cost of goods sold increased by $0.7 million for the three months ended March 31, 2024 compared to the same period ended in 2023. This increase was mainly attributable to higher product sales. Research and development expenses increased by $3.0 million for the three months ended March 31, 2024 compared to the same period in 2023, driven by strategic investments in our pipeline, notably XP-8121, and our emerging technology partnership business as well as higher personnel costs. Selling, general and administrative expenses increased by $4.8 million for the three ended March 31, 2024 compared to the same period in 2023, due to higher personnel costs and rent expenses related to our headquarter lease, which commenced in April 2023. Net Loss was $19.0 million, or $0.14 per share, for the three months ended March 31, 2024. Cash, cash equivalents, and short-term investments at March 31, 2024 was $87.4 million compared to $72.5 million at December 31, 2023. Shares outstanding at April 30, 2024 was 148,255,663. First Quarter Conference Call and Webcast Details Xeris will host a conference call and webcast on Thursday, May 9, 2024 at 8:30 a.m. Eastern Time. To pre-register for the call, please go to the following link: . 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, May 23, 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: 952508 To join the webcast, please visit “Events” on investor relations page of the Company’s website at or use this link: 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 , 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 total revenue guidance for 2024, Xeris’ potential to receive milestones and royalties under a license agreement with Amgen, the expansion of collaboration partnerships such as with Beta Bionics, the impact of the Change Healthcare cyberattack, the timing of the availability of clinical study data, the market and therapeutic potential of its products and product candidates, the potential utility of its formulation platforms, 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 March 31, 2024 2023 Product revenue, net $ 40,263 $ 32,265 Royalty, contract and other revenue 375 931 Total revenue 40,638 33,196 Costs and expenses: Cost of goods sold 5,971 5,319 Research and development 7,821 4,838 Selling, general and administrative 38,380 33,605 Amortization of intangible assets 2,711 2,711 Total costs and expenses 54,883 46,473 Loss from operations (14,245 ) (13,277 ) Other expense (4,428 ) (3,557 ) Net loss before benefit from income taxes (18,673 ) (16,834 ) Income tax (expense) benefit (307 ) — Net loss $ (18,980 ) $ (16,834 ) Net loss per common share - basic and diluted $ (0.14 ) $ (0.12 ) Weighted average common shares outstanding - basic and diluted 140,513,907 137,142,565 XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) March 31, 2024 December 31, 2023 (unaudited) Assets Current assets: Cash and cash equivalents $ 62,690 $ 67,449 Short-term investments 24,662 5,002 Trade accounts receivable, net 37,414 39,197 Inventory 40,878 38,838 Prepaid expenses and other current assets 7,636 5,778 Total current assets 173,280 156,264 Property and equipment, net 5,783 5,971 Intangible assets, net 107,053 109,764 Goodwill 22,859 22,859 Operating lease right-of-use assets 23,027 23,204 Other assets 4,614 4,540 Total assets $ 336,616 $ 322,602 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 7,094 $ 11,565 Current operating lease liabilities 4,624 3,495 Other accrued liabilities 22,391 23,510 Accrued trade discounts and rebates 22,560 22,149 Accrued returns reserve 14,593 14,198 Current portion of contingent value rights 1,021 19,109 Other current liabilities 801 1,167 Total current liabilities 73,084 95,193 Long-term debt, net of unamortized debt issuance costs 229,674 190,932 Non-current contingent value rights — 1,379 Non-current operating lease liabilities 34,397 34,764 Deferred tax liabilities 2,575 2,268 Other liabilities 6,064 4,848 Total liabilities 345,794 329,384 Total stockholders’ equity (deficit) (9,178 ) (6,782 ) Total liabilities and stockholders’ equity (deficit) $ 336,616 $ 322,602 View source version on businesswire.com: Contacts Investor Contact Allison Wey Senior Vice President, Investor Relations and Corporate Communications awey@xerispharma.com Source: Xeris Biopharma Holdings, Inc. View this news release online at:

License out/inFinancial StatementPhase 2

100 Deals associated with Teprotumumab-TRBW

External Link

KEGG	Wiki	ATC	Drug Bank
-	Teprotumumab-TRBW	L01XC	DB06343

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Graves Ophthalmopathy	US	Horizon Therapeutics Ireland DAC	21 Jan 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced breast cancer	Phase 2	US	Hoffmann-La Roche, Inc.	28 Jan 2009
Advanced Lung Non-Small Cell Carcinoma	Phase 2	US	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	AU	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	BE	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	CA	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	FR	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	DE	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	IE	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	IT	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	PL	Hoffmann-La Roche, Inc.	10 Nov 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04478994 (CTgov)	Phase 1	Scleroderma, Diffuse	3	Placebo	uitlpbtctc(iugwkrvixq) = omayuevcqp uqcbtnbfqu (qakxzlagux, ohqphorkpf - uxvudedgit) View more	-	19 Apr 2024
ARVO2023	Not Applicable	Graves Ophthalmopathy	19	Teprotumumab	cggrnqqlso(muvydfzuyu) = wpcbvmtsng vynxqhmqfj (tojmgupwvz ) View more	-	23 Apr 2023
PA059 (AAO2021)	Not Applicable	Inflammation \| Graves Ophthalmopathy	-	Teprotumumab	ynfoutemgw(gpxlkxirzq) = pgluowfnrp gxywpeasmi (ofpogyurol )	Positive	15 Nov 2021
AAO2021	Not Applicable	Graves Ophthalmopathy	51	Teprotumumab	rtfrgcaedf(oqjjmyijdu) = 40% xjjirjuwlh (nrvrnfmjjg ) View more	-	13 Nov 2021
NCT03461211 (OPTIC-X, CTgov)	Phase 3	Graves Ophthalmopathy	51	Placebo+Teprotumumab (Teprotumumab (OPTIC Placebo))	odpsgsnkvt(lfcbxwqhpm) = oaxqwdbbmq yrritjyzhr (fftsudebiv, jrccjhrvdu - zeorkakrmb) View more	-	19 Jul 2021
NCT03461211 (OPTIC-X, CTgov)	Phase 3	Graves Ophthalmopathy	51	Teprotumumab (Teprotumumab (OPTIC Teprotumumab))	odpsgsnkvt(lfcbxwqhpm) = yembvniyvt yrritjyzhr (fftsudebiv, vyevukcjke - svomznntte) View more	-	19 Jul 2021
2021 ARVO Annual Meeting (ARVO2021)	Not Applicable	Graves Ophthalmopathy	12	Teprotumumab	sgtdohwgfs(wdmungtuwx) = gakppfindt cbyaceabtv (relamqorhm, [-4.5 - -1.1])	Positive	01 Jun 2021
NCT04040894 (ARVO2021)	Not Applicable	Graves Ophthalmopathy	13	Teprotumumab	fjbhfnlymv(azcfjkesmf) = bucoierzji teilsiwrsg (ewbvdtbovr ) View more	-	01 Jun 2021
ARVO2021	Not Applicable	-	22	Teprotumumab	wzhixcslbm(tqocqintwh) = wuvcvxbhcx chkzrtfrlm (wfzjmkpslz ) View more	-	01 Jun 2021
NCT00760929 (CTgov)	Phase 2	Advanced Lung Non-Small Cell Carcinoma \| Non-squamous non-small cell lung cancer	171	erlotinib [Tarceva]+RG1507 (R1507 (9mg/kg iv))	eqxsllsuul(thigmjbpte) = fyiikrexqe hqtmxhnhyy (uwygsmjzkf, qzqifipngk - dbbmdcbpdk) View more	-	05 Jan 2021
NCT00760929 (CTgov)	Phase 2		171	erlotinib [Tarceva]+RG1507 (R1507 (16mg/kg iv))	eqxsllsuul(thigmjbpte) = zryxyoegwv hqtmxhnhyy (uwygsmjzkf, aeawprpafg - bokjnyozyt) View more	-	05 Jan 2021
NCT00796107 (CTgov)	Phase 2	Advanced breast cancer	6	Letrozole+RG1507	ceqfafudzg(bdzrwkahne) = kzafkpvvgq hawedccszt (dbchvqcshr, qodnyjmvci - hzdrhmfclx) View more	-	13 Nov 2020

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis