News Release

Xeris Biopharma Reinforces Leadership in Endocrinology With Data Disclosures Spanning Commercial Portfolio and Pipeline at Multiple Scientific Meetings

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Clinical and scientific data presentations in support of Gvoke® (glucagon) injection, Recorlev® (levoketoconazole), and the investigational XP-8121 program underscore Xeris's leadership in endocrinology, including the treatments for Severe Hypoglycemia, Cushing's Syndrome, and Hypothyroidism

CHICAGO--(BUSINESS WIRE)--Oct. 15, 2026-- Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a leading, endocrine and rare disease biopharmaceutical company committed to helping people realize better lives through the development and commercialization of innovative medicines, today announced clinical and scientific data presentations from its commercial portfolio and development pipeline at three scientific meetings this fall: Breakthrough T1D Clinical & Research Congress (CRC), the 21st Annual Cardiometabolic Health Congress (CMHC), and the American Thyroid Association (ATA) Annual Meeting.

“These presentations reflect the breadth and depth of our scientific work and collaborations across endocrinology, as well as our commitment to advancing care at every stage, from established therapies to emerging treatment approaches,” said Anh Nguyen, MD, Chief Medical Officer of Xeris Biopharma. “By sharing real-world experience with Recorlev and new research on Gvoke, we continue to build the evidence supporting therapies patients rely on today. At the same time, our TriNetX analysis expands our understanding of real-world biochemical control among patients with hypothyroidism treated with oral levothyroxine.”

Presentation Highlights

  • Severe Hypoglycemia – Gvoke at the 2026 Breakthrough T1D Clinical & Research Congress
    • New real-world data examines the gap between HCP awareness of American Diabetes Association standard of care treatment guidelines for prescribing ready-to-use glucagon, when compared to actual prescribing practices. Data underscores the unmet clinical unmet need and ongoing opportunity to increase adoption of ready-to-use glucagon products.
  • Hypercortisolism in Cushing’s Syndrome and associated cardiometabolic comorbidities – Recorlev at the 2026 Cardiometabolic Health Congress
    • A compelling case study demonstrates normalization of cortisol following treatment with levoketoconazole, accompanied by meaningful improvements in multiple cardiometabolic parameters, in a patient with uncontrolled Type 2 diabetes, hypertension, and multiple comorbidities. This case study highlights the important role of cortisol normalization in cardiometabolic health.
  • Hypothyroidism – Characterization of a real-world hypothyroid population using linked levothyroxine treatment and TSH data at the 2026 American Thyroid Association Annual Meeting
    • First public presentation of a real-world analysis using linked levothyroxine treatment records and TSH laboratory data to characterize patients with hypothyroidism and explore approaches for longitudinal assessment.

Presentation Details

  • Breakthrough T1D Clinical & Research Congress (CRC 2026): October 9–10, 2026, Philadelphia, PA
    • Abstract title: Ensuring Readiness: A Case For Proactive Glucagon Prescribing For Patients At Increased Risk of Severe Hypoglycemia
    • Presenter: Natasha Ferguson, PhD (Xeris Biopharma)
    • Presentation: Friday, October 9, 2026 (already presented)
  • Annual Cardiometabolic Health Congress (CMHC 2026): October 15–16, 2026, Boston, MA
  • American Thyroid Association (ATA 2026) Annual Meeting: November 4–7, 2026, Philadelphia, PA
    • Abstract title: Characterization of a Real-World Hypothyroid Population Using Linked Levothyroxine Treatment and TSH Data: A TriNetX Analysis
    • Presenter: James M. Meyer, PharmD, MBA (Xeris Biopharma)
    • Presentation: Friday, November 6, 2026, 10:00 a.m. EST

ABOUT RECORLEV®

Indication

RECORLEV (levoketoconazole) is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.

Limitations of use: RECORLEV is not approved for the treatment of fungal infections.

Important Safety Information

WARNING: HEPATOTOXICITY AND QT PROLONGATION

  • Cases of hepatotoxicity with fatal outcome or requiring liver transplantation have been reported with oral ketoconazole. Some patients had no obvious risk factors for liver disease. RECORLEV is associated with serious hepatotoxicity. Evaluate liver enzymes prior to and during treatment.
  • RECORLEV is associated with dose-related QT interval prolongation. QT interval prolongation may result in life-threatening ventricular dysrhythmias such as torsades de pointes. Perform ECG and correct hypokalemia and hypomagnesemia prior to and during treatment.

  • RECORLEV is contraindicated in patients:
    • With cirrhosis, acute liver disease or poorly controlled chronic liver disease, baseline AST or ALT >3 times the upper limit of normal, recurrent symptomatic cholelithiasis, a prior history of drug-induced liver injury due to ketoconazole or any azole antifungal therapy that required discontinuation of treatment, or extensive metastatic liver disease
    • Taking drugs that cause QT prolongation associated with ventricular arrhythmias, including torsades de pointes
    • With prolonged QTcF interval >470 msec at baseline, history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or long QT syndrome
    • With hypersensitivity to levoketoconazole, ketoconazole, or any excipient in RECORLEV
    • Taking certain drugs that are sensitive substrates of CYP3A4 or CYP3A4 and P-gp
  • RECORLEV may lead to hypocortisolism with a potential for life-threatening adrenal insufficiency. Dosage reduction or interruption may be necessary
  • Hypersensitivity to RECORLEV has been reported. Anaphylaxis has been reported with oral ketoconazole
  • RECORLEV may lower serum testosterone in men and women. Inform patients to report associated symptoms
  • Most common adverse reactions are nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, abnormal uterine bleeding, erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper respiratory infection, myalgia, arrhythmia, back pain, insomnia/sleep disturbances, and peripheral edema
  • Avoid use of strong CYP3A4 inhibitors and inducers 2 weeks before and during RECORLEV treatment. Consult approved product labeling for drugs that are substrates of CYP3A4, P-gp, OCT2, and MATE prior to initiating RECORLEV. For atorvastatin, metformin, and gastric acid modulators, see full Prescribing Information for recommendations regarding concomitant use with RECORLEV
  • Breastfeeding is not recommended during treatment and for one day after final dose

Please see full Prescribing Information, including Boxed Warning, for RECORLEV.

ABOUT GVOKE®

Indication

GVOKE (glucagon) is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged 2 years and older with diabetes.

Important Safety Information

  • GVOKE is contraindicated in patients with:
    • Pheochromocytoma because of the risk of substantial increase in blood pressure
    • Insulinoma because of the risk of hypoglycemia
    • Prior hypersensitivity reaction to glucagon or to any of the excipients. Serious hypersensitivity reactions have been reported with glucagon, including generalized rash, and anaphylactic shock with breathing difficulties and hypotension
  • GVOKE may stimulate the release of catecholamines from the tumor. If patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate intravenously has been shown to be effective in lowering blood pressure
  • In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, administration may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of GVOKE, give glucose orally or intravenously
  • Patients with insufficient hepatic stores of glycogen may not respond to GVOKE for treatment of severe hypoglycemia. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation, or in patients with adrenal insufficiency or chronic hypoglycemia
  • A skin rash called necrolytic migratory erythema (NME), has been reported post-marketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. GVOKE is not approved for continuous infusion. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks
  • Most common adverse reactions reported in adult patients were nausea, vomiting, injection site edema raised 1 mm or greater, and headache
  • Most common adverse reactions reported in pediatric patients were nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, injection site discomfort and reaction, and urticaria
  • Patients taking concomitant beta-blockers may have a transient increase in pulse and blood pressure. In patients taking concomitant indomethacin, GVOKE may lose its ability to raise glucose or may produce hypoglycemia. GVOKE may increase the anticoagulant effect of warfarin

Please see full Prescribing Information for GVOKE.

About Xeris Biopharma

Xeris Biopharma Holdings, Inc. (Nasdaq: XERS) is a leading endocrine and rare disease biopharmaceutical company committed to helping people realize better lives through the development and commercialization of innovative medicines for serious diseases with significant unmet medical need. Xeris has three commercially available products: Recorlev®, a cortisol synthesis inhibitor for the treatment of endogenous Cushing’s syndrome; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; and Keveyis®, a proven therapy for primary periodic paralysis. Xeris also has a pipeline of development programs led by XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for the treatment of hypothyroidism, as well as multiple early-stage programs leveraging Xeris’ technology platforms, XeriSol® and XeriJect®, for Xeris and its partners.

Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, please visit us at xerispharma.com and follow 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, opportunities, and prospects for the Company, including statements, among other things, the market and therapeutic and commercial potential of its products and product candidates, the potential utility of its formulation platforms, the advancement of its pipeline the Company's plans regarding clinical developments, and other statements containing the words "achieve," "anticipate," “believe,” “continue,” “expect,” “potential,” “should,” “will,” “would,” 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, market opportunity 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, its and collaborators’ ability to protect its intellectual property and proprietary technology, the accuracy and completeness of its assumptions and its ability to accurately estimate future financial results and market opportunities, and general macroeconomic and geopolitical conditions, including the possibility of an economic downturn, political unrest, trade disputes, changes in U.S. governmental priorities and resources, announced or implemented tariffs or export controls and market volatility. 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 Annual Report on Form 10-K and subsequent filings with the U.S. Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. The risks described herein and in Xeris’ U.S. Securities and Exchange Commission filings are not the only risks the Company faces. Additional risks and uncertainties not currently known to it or that it currently deems immaterial may also impact its business operations or financial results. Forward-looking statements in this communication are based on information available to management, as of the date of this communication and, while the Company believes its assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, the Company does 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.

US-GVK-26-00109 (v1) 10/26

Investor & Media Contact
Cristi Barnett
Vice President, Investor Relations
ir@xerispharma.com

Source: Xeris Biopharma Holdings, Inc.

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