Pointer Syndrome

PORTLAND, Ore.--( BUSINESS WIRE )-- Sparrow Pharmaceuticals, a clinical-stage biopharmaceutical company developing novel, targeted therapies to address unmet needs in both endocrinology and rheumatology, today presented pharmacology data during an online poster session on SPI-62, a HSD-1 inhibitor, at the American College of Rheumatology (ACR) Convergence 2022 meeting. The presentation titled, “Toward Safer Glucocorticoid Therapy” examined the ability of SPI-62 to mitigate the adverse effects of exogenously administered corticosterone (CORT) in mouse, with results suggesting SPI-62 has the potential to prevent the adverse effects of glucocorticoids. “Patients with autoimmune conditions such as polymyalgia rheumatica rely on glucocorticoids such as prednisone. The effects of long-term use can be severe, including diabetes, cardiovascular disease, and muscle and skin atrophy. An effective glucocorticoid with fewer side effects would be a breakthrough for them,” said David A. Katz, Ph.D., CSO at Sparrow Pharmaceuticals. “The study data presented at ACR demonstrate that SPI-62 can prevent cardiometabolic, muscular, and dermal adverse side effects of CORT in mouse. That adds to the existing evidence that SPI-62 in combination with a glucocorticoid has potential to be effective, safe, convenient, and cost-effective treatment for patients with polymyalgia rheumatica and other rheumatic diseases. A Phase 2 clinical trial of prednisolone together with SPI-62 is ongoing.” CORT was administered to mice for 5 weeks. The animals were randomized to three different SPI- 62 regimens or vehicle. SPI-62 prevented CORT adverse effects of increased food consumption, accelerated body weight gain, skin atrophy, insulin resistance, skeletal myoatrophy, and reduced grip strength, each in a dose-dependent manner. SPI-62 is a potent HSD-1 inhibitor that is in a Phase 2 clinical trial with prednisolone for polymyalgia rheumatica, a prevalent autoimmune disease that mainly affects people over 50. HSD-1 is an intracellular enzyme that activates glucocorticoids in target tissues in which glucocorticoid medicines are associated with morbidity including liver, adipose, muscle, and skin. SPI-47, a fixed-dose-combination of SPI-62 and prednisolone, is in development. Additionally, SPI-62 is in Phase 2 clinical trials for Cushing’s syndrome and autonomous cortisol secretion. In Phase 1 clinical trials, SPI-62 was generally well tolerated and demonstrated maximal liver HSD-1 inhibition and brain HSD-1 occupancy. To view the abstracts, visit the ACR Convergence website here . To learn more about Sparrow Pharmaceuticals and its clinical pipeline, visit the website at www.sparrowpharma.com . About Sparrow Pharmaceuticals Sparrow Pharmaceuticals aims to spare patients the ravages of steroids. Leveraging underappreciated scientific insights into steroid biology, the company is working to provide better treatment options for serious disorders of hypercortisolism, and to revolutionize the treatment of autoimmune and inflammatory conditions. SPI-62, is an oral, small molecule, novel therapeutic treatment designed to target the source of active intracellular glucocorticoids in key tissues.

MENLO PARK, Calif., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, today reported its results for the quarter ended September 30, 2022. Financial Results Revenue of $101.7 million, compared to $96.1 million in third quarter 2021 Tightened 2022 revenue guidance of $400 – $410 million Diluted net income per common share of $0.30, compared to $0.24 in third quarter 2021 Cash and investments of $401.2 million, compared to $382.0 million at June 30, 2022 Corcept’s third quarter 2022 revenue was $101.7 million, compared to $96.1 million in the third quarter of 2021. Third quarter operating expenses were $69.8 million, compared to $59.9 million in the third quarter of 2021, due to increased clinical trial and sales and marketing activities and expenses to support the expansion of our clinical development and commercial teams. Net income was $34.6 million in the third quarter of 2022, compared to $30.5 million in the third quarter of 2021. Cash and investments of $401.2 million at September 30, 2022 reflects the acquisition in the third quarter of $15.5 million of Corcept common stock in connection with the exercise of employee stock options and vesting of restricted stock grants. “Diagnosing and treating patients with a complex disease such as Cushing’s syndrome requires frequent in-person contact with physicians. Our revenue in the third quarter was affected by fewer than expected in-person interactions as many physician practices have not returned to pre-pandemic patterns of activity. To reflect this near-term challenge, we are tightening our 2022 revenue guidance to $400 to $410 million,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. “We remain extremely optimistic about the present and the future of our Cushing’s syndrome business. Korlym is an excellent treatment for patients with Cushing’s syndrome and there are many eligible patients who have yet to receive it. We are making substantial investments to improve the screening and treatment of these patients and we are confident that these initiatives will contribute to our results in the coming quarters.” Clinical Development “Our clinical trials continue to advance and generate data supporting cortisol modulation’s broad therapeutic potential,” added Dr. Belanoff. “We are very excited about our most recently initiated studies: ROSELLA, our confirmatory Phase 3 trial in platinum-resistant ovarian cancer; and DAZALS, our Phase 2 trial in ALS. We are also looking forward to important readouts from our two Phase 2 trials in antipsychotic-induced weight gain by the end of this year.” Oncology Enrollment continues in ROSELLA – 360-patient pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer Enrollment continues in open-label, Phase 1b trial of relacorilant plus pembrolizumab in patients with adrenal cancer with cortisol excess Randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer to begin next year in collaboration with the University of Chicago “We and our investigators are excited that ROSELLA is active and enrolling patients,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Our goal in this trial is to replicate the positive results of our successful Phase 2 study, which demonstrated improvements in progression-free survival, duration of response and overall survival, all without increasing side effect burden. Women with platinum-resistant ovarian cancer do not have good treatment options and relacorilant plus nab-paclitaxel has the potential to become a new standard of care.” Amyotrophic Lateral Sclerosis (ALS) Enrollment continues in DAZALS – 198-patient, randomized, double-blind, placebo-controlled Phase 2 trial of dazucorilant in patients with ALS “ALS, also known as Lou Gehrig’s disease, is a devastating neuromuscular illness with an urgent need for better treatment,” said Dr. Guyer. “Dazucorilant showed great promise in animal models of ALS – improving motor performance and reducing neuroinflammation and muscular atrophy. We are excited to initiate this important study in collaboration with TRICALS, the leading ALS academic consortium in Europe, to investigate dazucorilant's potential to significantly improve the lives of patients with ALS.” Metabolic Diseases Enrollment completed in GRATITUDE and GRATITUDE II – two double-blind, placebo-controlled Phase 2 trials of miricorilant to reverse recent and long-standing antipsychotic-induced weight gain (AIWG) – data from both trials expected this quarter Enrollment continues in Phase 1b dose-finding trial of miricorilant in patients with presumed non-alcoholic steatohepatitis (NASH) – data expected in the first half of 2023 “We expect our double-blind, placebo-controlled GRATITUDE and GRATITUDE II trials in patients with AIWG to build on the positive data from our Phase 1 studies,” said Dr. Guyer. “There is a substantial opportunity to improve the medical care of these patients as weight gain and other adverse metabolic effects caused by antipsychotic medications dissuade many patients from adhering to their treatment regimen, pose serious health risks and reduce the life expectancy of millions of patients.” “The goal of our Phase 1b dose-finding study in patients with NASH is to identify a dosing regimen that captures the unprecedented rapidity and magnitude of liver fat reduction observed in our prior study without causing excessive liver irritation,” added Dr. Guyer. Cushing’s Syndrome Enrollment continues in Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome – new drug application (NDA) submission expected in second half 2023 Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing’s syndrome caused by adrenal adenomas “We advanced relacorilant to Phase 3 in Cushing’s syndrome based on its extremely promising Phase 2 efficacy and safety data. We expect our GRACE trial to serve as the basis for relacorilant’s NDA in Cushing’s syndrome, which we plan to submit in the second half of 2023,” said Dr. Guyer. “The Phase 3 GRADIENT trial will produce valuable data about an etiology of Cushing’s syndrome that has not been subject to rigorous, controlled study, but affects many patients.” Conference Call We will hold a conference call on November 3, 2022, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number, and a unique access PIN. Each access PIN will accommodate one caller. Additionally, a listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of Hypercortisolism Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism. About Corcept Therapeutics Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol and owns extensive United States and foreign intellectual property covering both their composition and their use to treat a variety of serious disorders. The company is conducting clinical trials of its leading cortisol modulators as potential treatments for patients with Cushing’s syndrome, ovarian, prostate and adrenal cancer, ALS, weight gain caused by the use of antipsychotic medications and liver disease. Corcept’s drug Korlym® was the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with Cushing’s syndrome. Forward-Looking Statements Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business, conduct our clinical trials and achieve our other goals during the COVID-19 pandemic and generate sufficient revenue to fund our activities; the availability of competing treatments for hypercortisolism, including generic versions of Korlym; our ability to obtain acceptable prices and adequate insurance coverage and reimbursement for Korlym; risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements; the timing, cost and outcome of legal disputes and investigations; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website. In this press release, forward-looking statements include, among others, those concerning our expectations regarding the course of the COVID-19 pandemic and its effects on our commercial results and clinical activities; the number of eligible patients who have yet to receive Korlym; our continued revenue growth and 2022 revenue guidance; cortisol modulation’s potential to treat many serious diseases; development of relacorilant as a treatment for Cushing’s syndrome and ovarian, adrenal and prostate cancer, including relacorilant’s clinical attributes, regulatory approvals, mandates and oversight, and other requirements; the potential for relacorilant plus nab-paclitaxel to become a standard of care for patients with recurrent platinum-resistant ovarian cancer; the timing and substance of our results in the GRATITUDE trials of miricorilant in patients with antipsychotic-induced weight gain and our Phase 1b trial in patients with NASH; expectations regarding the GRACE trial as the basis for relacorilant’s NDA in Cushing’s syndrome; the timing and expectations of our DAZALS trial of dazucorilant in patients with ALS; our other pre-clinical and clinical development programs, including the pace of enrollment, study design and timelines, and the accrual and attributes of clinical data; and the timing of regulatory submissions. We disclaim any intention or duty to update forward-looking statements made in this press release. CORCEPT THERAPEUTICS INCORPORATED CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) September 30, 2022 December 31, 2021(1) (Unaudited) Assets Cash and investments $ 401,157 $ 335,812 Trade receivables, net of allowances 29,414 27,625 Inventory 17,073 17,950 Operating lease right-of-use asset 1,707 514 Deferred tax assets, net 57,342 27,455 Other assets 26,562 14,400 Total assets $ 533,255 $ 423,756 Liabilities and Stockholders’ Equity Accounts payable $ 8,178 $ 6,908 Operating lease liabilities 1,707 526 Other liabilities 50,006 40,516 Stockholders’ equity 473,364 375,806 Total liabilities and stockholders’ equity $ 533,255 $ 423,756 (1) Derived from audited financial statements at that date CORCEPT THERAPEUTICS INCORPORATED CONDENSED CONSOLIDATED STATEMENTS OF INCOME (Unaudited) (In thousands, except per share data) Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Revenues Product revenue, net $ 101,728 $ 96,131 $ 298,802 $ 267,156 Operating expenses Cost of sales 1,339 1,275 3,905 3,927 Research and development 33,292 28,091 94,237 85,345 Selling, general and administrative 35,163 30,533 110,525 90,071 Total operating expenses $ 69,794 $ 59,899 $ 208,667 $ 179,343 Income from operations 31,934 36,232 90,135 87,813 Interest and other income 1,070 72 1,780 457 Income before income taxes 33,004 36,304 91,915 88,270 Income tax benefit (expense) 1,604 (5,833) (7,098) (7,811) Net income $ 34,608 $ 30,471 $ 84,817 $ 80,459 Net income attributable to common stockholders $ 34,550 $ 30,471 $ 84,755 $ 80,459 Basic net income per common share $ 0.32 $ 0.26 $ 0.80 $ 0.69 Diluted net income per common share $ 0.30 $ 0.24 $ 0.73 $ 0.63 Weighted-average shares outstanding used in computing net income per common share Basic 107,125 115,791 106,479 116,297 Diluted 116,620 125,136 115,818 127,173 CONTACT: Corcept Therapeutics Investor Relations ir@corcept.com

First prospective long-term levoketoconazole study demonstrating a sustained effect on cortisol levels, as well as improvements in biomarkers of Cushing’s syndrome (CS) comorbidity, clinical signs and symptoms of CS and quality of life (QoL). With a median treatment duration of 15 months, levoketoconazole was well tolerated and no new drug-related safety signals were observed. Further supports a role for levoketoconazole in long-term therapy for patients with endogenous Cushing’s syndrome (CS). CHICAGO--(BUSINESS WIRE)-- Xeris Biopharma, 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 the European Journal of Endocrinology (EJE) published the extended evaluation (EE) results of the SONICS study (NCT01838551) evaluating longer-term effects of levoketoconazole on cortisol levels, biomarkers of Cushing’s syndrome (CS) comorbidities, clinical signs and symptoms of CS, and quality of life.1 The manuscript also reports findings from pituitary adenoma imaging in the SONICS study. For the first time, the longer-term effects of levoketoconazole are reported from the EE phase of the previously published SONICS study1,2. EE study participants (N=60) received maintenance treatment with levoketoconazole (median exposure for entire study of 15 months, range 7.9-22 months) with assessments scheduled at Month 9 and Month 12. The majority (39/60 [65%]) received levoketoconazole doses of 600 mg/day or less at the start of the EE period. Forty-six (77%) patients completed the study (Month 12). Key Study Findings: Sixty patients entered EE at Month 6; 61% (33/54 with data) exhibited normal mean urinary free cortisol (mUFC). At Months 9 and 12, respectively, 55% (27/49) and 41% (18/44) of patients with data had normal mUFC. In addition, reductions in late-night salivary cortisol (LNSC) and random serum cortisol were observed at Month 6, 9, and 12. Mean fasting glucose, total and LDL-cholesterol, body weight, body mass index, abdominal girth, Cushing QoL, and BDI-II scores improved from study baseline at Months 9 and 12. Female patients reported significant mean decreases in hirsutism score at all assessments; mean testosterone levels decreased significantly at Month 6 and were maintained throughout EE period Of 31 patients with tumor measurements at baseline and Month 12 or follow-up, largest tumor diameter was stable in 27 (87%) patients, decreased in 1, and increased in 3 (largest increase 4 mm). Forty-six patients completed Month 12; 4 (6.7%) discontinued during EE due to adverse events. The most common adverse events in EE were arthralgia, headache, hypokalemia, and QT prolongation (6.7% each) No patient experienced ALT or AST >3x ULN, QTcF interval >460 msec, or adrenal insufficiency during EE. "The results from this extended evaluation of the SONICS study provide important new evidence in support of Recorlev and will help inform clinicians’ decisions and individualization of medical therapy for patients with endogenous CS,” said Dr. Ken Johnson, Senior Vice President, Global Development and Medical Affairs at Xeris. "I would like to extend our gratitude to all the investigators, study coordinators and patients who participated in the SONICS trial program. Their contributions are integral in our mission to improve outcomes for patients with this rare, debilitating, and life-threatening condition.” Recorlev received Food and Drug Administration marketing approval in December 2021. The initial approval was based upon safety and efficacy data from two positive Phase 3 studies that evaluated a combined study population of 166 patients, which was representative of the adult drug-treated U.S. population with Cushing’s syndrome.2 The SONICS study met its primary and key secondary endpoints, significantly reducing and normalizing mean urinary free cortisol concentrations without a dose increase (detailed results here).2,3 LOGICS, a double-blind, placebo-controlled randomized-withdrawal study that met its primary and key secondary endpoints, confirmed the efficacy and safety of Recorlev in normalizing and maintaining therapeutic response compared with placebo (detailed results here).2 About Cushing’s syndrome Endogenous Cushing’s syndrome is a rare, serious, and potentially fatal endocrine disease caused by chronic elevated cortisol exposure–often the result of a benign tumor of the pituitary gland. This benign tumor tells the body to overproduce high levels of cortisol for a sustained period of time, which often results in characteristic physical signs and symptoms that are distressing to patients. The disease is most common among adults between the ages of 30–50, and it affects women three times more often than men. Women with Cushing's syndrome may experience a variety of health issues including menstrual problems, difficulty becoming pregnant, excess male hormones (androgens), primarily testosterone, which can cause hirsutism (growth of coarse body hair in a male pattern), oily skin, and acne.4 Additionally, the multisystem complications of the disease are potentially life threatening. These include metabolic changes such as high blood sugar or diabetes, high blood pressure, high cholesterol, fragility of various tissues including blood vessels, skin, muscle, and bone, and psychological disturbances such as depression, anxiety, and insomnia.4 Untreated, the five-year survival rate is only approximately 50%.5 About Recorlev® Recorlev® (levoketoconazole) is a cortisol synthesis inhibitor 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.2 Endogenous Cushing’s syndrome is a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure.2 Recorlev is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor.2 Recorlev has demonstrated in two successful Phase 3 studies to significantly reduce mean urine free cortisol.2 The Phase 3 program for Recorlev included SONICS and LOGICS, two multinational studies designed to evaluate the safety and efficacy of Recorlev when used to treat endogenous Cushing’s syndrome. The SONICS study met its primary and secondary endpoints, significantly reducing and normalizing mean urinary free cortisol concentrations without a dose increase.2,3 The LOGICS study, which met its primary endpoint and key secondary endpoint, was a double-blind, placebo-controlled randomized-withdrawal study of Recorlev that was designed to supplement the efficacy and safety information provided by SONICS.2 The ongoing open-label OPTICS study will gather further useful information related to the long-term use of Recorlev. Recorlev received orphan drug designation from the FDA and the European Medicines Agency for the treatment of endogenous Cushing's syndrome. Indication & Important Safety Information for Recorlev® BOXED WARNING: HEPATOTOXICITY AND QT PROLONGATION HEPATOTOXICITY 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. QT PROLONGATION 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. INDICATIONS AND USAGE Recorlev 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. CONTRAINDICATIONS 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 arrythmias, including torsades de pointes. Prolonged QTcF interval > 470 msec at baseline, history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or prolonged QT syndrome. Hypersensitivity to levoketoconazole, ketoconazole or any excipient in Recorlev. Taking certain drugs that are sensitive substrates of CYP3A4 or CYP3A4 and P-gp. WARNINGS AND PRECAUTIONS Hepatotoxicity Serious hepatotoxicity has been reported in patients receiving Recorlev, irrespective of the dosages used or the treatment duration. Drug-induced liver injury (peak ALT or AST greater than 3 times upper limit of normal) occurred in 13% of patients using Recorlev. Avoid concomitant use of Recorlev with hepatotoxic drugs. Advise patient to avoid excessive alcohol consumption while on treatment with Recorlev. Routinely monitor liver enzymes and bilirubin during treatment. QT Prolongation Use Recorlev with caution in patients with other risk factors for QT prolongation, such as congestive heart failure, bradyarrythmias, and uncorrected electrolyte abnormalities, with more frequent ECG monitoring considered. Routinely monitor ECG and blood potassium and magnesium levels during treatment. Hypocortisolism Recorlev lowers cortisol levels and may lead to hypocortisolism with a potential for life-threatening adrenal insufficiency. Lowering of cortisol levels can cause nausea, vomiting, fatigue, abdominal pain, loss of appetite, and dizziness. Significant lowering of serum cortisol levels may result in adrenal insufficiency that can be manifested by hypotension, abnormal electrolyte levels, and hypoglycemia. Monitor 24-hour urine free cortisol, morning serum or plasma cortisol, and patient’s signs and symptoms for hypocortisolism during treatment. Hypersensitivity Reactions Hypersensitivity to Recorlev has been reported. Anaphylaxis and other hypersensitivity reactions including urticaria have been reported with oral ketoconazole. Risks Related to Decreased Testosterone Recorlev may lower serum testosterone in men and women. Potential clinical manifestations of decreased testosterone concentrations in men may include gynecomastia, impotence and oligospermia. Potential clinical manifestations of decreased testosterone concentrations in women include decreased libido and mood changes. ADVERSE REACTIONS Most common adverse reactions (incidence > 20%) 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. DRUG INTERACTIONS Consult approved product labeling for drugs that are substrates of CYP3A4, P-gp, OCT2, and MATE prior to initiating Recorlev. Sensitive CYP3A4 or CYP3A4 and P-gp Substrates: Concomitant use of Recorlev with these substrates is contraindicated or not recommended. Atorvastatin: Use lowest atorvastatin dose possible and monitor for adverse reactions for dosages exceeding 20 mg daily. Metformin: Monitor glycemia, kidney function, and vitamin B12 and adjust metformin dosage as needed. Strong CYP3A4 Inhibitors or Inducers: Avoid use of these drugs 2 weeks before and during Recorlev treatment. Gastric Acid Modulators: See Full Prescribing Information for recommendations regarding concomitant use with Recorlev. USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed during treatment and for one day after final dose. To report SUSPECTED ADVERSE REACTIONS, contact Xeris Pharmaceuticals, Inc. at 1-877-937-4737 or FDA at 1-800-FDA-1088 or . Please see Full Prescribing Information including Boxed Warning. About Xeris Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patients’ 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®, the first and only FDA-approved 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 Twitter, LinkedIn, or Instagram. Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc., including statements regarding the market and therapeutic potential of Recorlev, results of the SONICS study, the market and therapeutic potential of its products and product candidates, expectations regarding clinical data or results from clinical trials, the timing of clinical trials, the timing or likelihood of regulatory approval and commercialization of its product candidates, the timing or likelihood of expansion into additional markets, the potential utility of its formulation platforms and other statements containing the words “will,” “would,” “continue,” 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, 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. Various factors 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, including the impact of COVID-19 on our business operations and clinical activities, our ability to fund our product development programs or commercialization efforts, whether our clinical trials demonstrate efficacy and safety to the satisfaction of the FDA or other regulatory authorities, and whether our products will achieve and maintain market acceptance. No assurance can be given that our expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional information about economic, competitive, governmental, technological, and other factors that may affect Xeris is set forth in the "Risk Factors" section of the most recently filed Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form a part of, this communication. Forward-looking statements in this communication are based upon information available to Xeris, as of the date of this communication and, while believed to be reasonable, actual results may differ materially. Subject to any obligations under applicable law, Xeris 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. 1. Fleseriu, M. et al. Euro J Endocrinol. (published online ahead of print 2022), EJE-22-0506. 2. Recorlev [prescribing information]. Chicago, IL: Xeris Pharmaceuticals, Inc.; 2021. 3. Fleseriu M, et al. Lancet Diabetes Endocrinol. 2019;7(11):855-865. 4. Pivonello R et al. Lancet Diabetes Endocrinol. 2016; 4: 611-29. 5. Plotz CM, et al. Am J Med. 1952 November;13(5):597-61 Recorlev®, Xeris Pharmaceuticals®, Xeris CareConnectionTM, Keveyis®, Gvoke®, and Ogluo® are trademarks owned by or licensed to Xeris Pharmaceuticals, Inc. All other trademarks referenced herein are the property of their respective owners. All rights reserved.