PTHrP

Presentation highlights results from 13- and 39-week studies of eneboparatide in non-human primates demonstrating no evidence of deleterious impact on bone quantity or quality as measured by multiple bone parameters Findings further substantiate the potential of eneboparatide as a treatment for hypoparathyroidism, where many patients suffer from, or are at risk of developing osteopenia and osteoporosis LYON, France and CAMBRIDGE, Mass., May 11, 2023 (GLOBE NEWSWIRE) -- Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced that it will deliver an oral presentation at the European Congress of Endocrinology (ECE) 2023 Annual Meeting, which is being held May 13-16 in Istanbul, Turkey. The presentation details the results of two studies of eneboparatide in non-human primates which demonstrated no deleterious impact on bone quantity or quality as measured by multiple bone parameters at 13 and 39 weeks of treatment. Key findings include: In the 13-week study, there was no evidence of a treatment effect of eneboparatide on either bone mineral density (BMD) or histopathologyIn the 39-week study, there were no significant effects of eneboparatide at any dose level on either BMD or histopathology, and analysis of blood samples for the anabolic bone biomarker, N-terminal propeptide of type 1 procollagen (P1NP), and the catabolic bone biomarker, C-terminal telopeptide (CTX), revealed no treatment-related changes. “We are pleased to present these study results at this year’s ECE meeting as they serve to highlight a key potential benefit for patients with hypoparathyroidism – the possibility to treat the underlying disease without compromising bone quantity or quality,” said Thierry Abribat, Ph.D., founder and chief executive officer of Amolyt Pharma. “We believe the clinical profile of eneboparatide observed in trials to date gives it the potential to become the future standard of care for hypoparathyroidism, and to that end, we are eager to initiate our recently announced Phase 3 trial.” Mark Sumeray, M.D., chief medical officer of Amolyt Pharma, added, “Many patients with hypoparathyroidism have, or are at risk of developing osteopenia or osteoporosis, so an optimal treatment for this indication must be able to control serum calcium without the need for oral calcium and vitamin D supplementation, normalize urinary calcium excretion, and avoid deleterious effect on bone. The positive results from these pre-clinical studies contribute to the significant and growing body of evidence suggesting that eneboparatide can achieve these clinical goals without deleteriously affecting bone, even when administered over an extended period. This is a critical potential benefit for eneboparatide, and we look forward to further confirming these findings in our upcoming Phase 3 Calypso clinical trial.” Presentation details: Title:Eneboparatide, a Novel PTH-1 Receptor Agonist, Has No Impact on Bone Parameters Following Chronic Treatment of Non-Human PrimatesFormat:Oral PresentationSession:Oral Communications 8: Calcium and BoneDate:Monday, May 15, 2023Time:2:10 p.m. CEST (8:10 a.m. EDT) The full abstract can be found here:https://www.endocrine-abstracts.org/ea/0090/ea0090oc8.2 About HypoparathyroidismHypoparathyroidism is defined by a deficiency of parathyroid hormone (PTH) that results in decreased calcium and elevated phosphorus levels in the blood. Approximately 80% of the estimated 80,000 people in the U.S. and 110,000 in the European Union with hypoparathyroidism are women. Despite available treatments, patients experience persistent, life-altering symptoms and often develop complications and comorbidities that diminish quality of life and create segments of the patient population with specific clinical needs. Clinical manifestations of hypoparathyroidism impact many tissues and organ systems, in particular, the kidneys and bone. 17% of patients with hypoparathyroidism have osteopenia or osteoporosis and 53% are peri- or postmenopausal women with an increased risk of developing osteoporosis. Approximately 26% of patients with hypoparathyroidism have chronic kidney disease or failure, highlighting the importance of reducing urinary calcium excretion as a key treatment goal. About EneboparatideEneboparatide is an investigational therapeutic peptide designed to target a specific conformation of the parathyroid hormone (PTH) receptor to produce sustained and stable levels of calcium in the blood and thereby manage the symptoms of hypoparathyroidism, and to limit urine calcium excretion by restoring calcium reabsorption by the kidney, with the goal of consequently preventing chronic kidney disease. In addition to its unique receptor profile, eneboparatide is also designed to have a short half-life to potentially preserve bone integrity, an important potential benefit, since the majority of patients are peri- and postmenopausal women with an increased risk of developing osteoporosis. About Amolyt Pharma Amolyt Pharma, a clinical stage biotechnology company, is building on its team’s established expertise to deliver life-changing treatments to patients suffering from rare endocrine and related diseases. Its development portfolio includes eneboparatide (AZP-3601), a long-acting PTH1 receptor agonist as a potential treatment for hypoparathyroidism, and AZP-3813, a peptide growth hormone receptor antagonist for the potential treatment of acromegaly. Amolyt Pharma aims to further expand and develop its portfolio by leveraging its global network in the field of endocrinology and with support from a strong syndicate of international investors. To learn more, visit https://amolytpharma.com/ or follow us on Twitter and LinkedIn. Media Inquiries: Jordyn TemperatoLifeSci Communications jtemperato@lifescicomms.com Investors Inquiries:Ashley RobinsonLifeSci Advisors, LLCarr@lifesciadvisors.com+1.617.430.7577

LYON, France and CAMBRIDGE, Mass., May 05, 2023 (GLOBE NEWSWIRE) -- Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced that the company has had multiple abstracts accepted for presentation at the 25th European Congress of Endocrinology (ECE), which is being held May 13-16 in Istanbul, Turkey, and at the 2023 Endocrine Society Meeting (ENDO), which is being held June 15-18 in Chicago, Illinois. These presentations cover both of Amolyt’s development programs, eneboparatide entering Phase 3 for hypoparathyroidism and AZP-3813 entering Phase 1 for acromegaly. Details of the presentations are as follows: 25th European Congress of Endocrinology (ECE) – May 13-16, Istanbul, Turkey Title: Eneboparatide, a Novel PTH-1 Receptor Agonist, Has No Impact on Bone Parameters Following Chronic Treatment of Non-Human PrimatesFormat: Oral Presentation Session: Oral Communications 8: Calcium and BoneDate: Monday, May 15, 2023Time: 2:00-3:00 p.m. CEST Title: Eneboparatide, a Novel PTH-1 Receptor Agonist, Induces Rapid Reduction and Normalization of Urinary Calcium in Chronic Hypoparathyroid PatientsFormat: Poster / Rapid Oral Presentation Session: Rapid Communications 8: Calcium and Bone Date: Monday, May 15, 2023Time: 3:05-3:40 p.m. CESTPoster Display: 9:40 a.m. CEST on Sunday, May 14 – 3:30 p.m. CEST on Tuesday, May 16 Title: Treatment of Chronic Hypoparathyroidism by Eneboparatide, a Novel PTH Receptor-1 Agonist: Results from a Phase 2a StudyFormat: Poster / Rapid Oral PresentationSession: Rapid Communications 8: Calcium and BoneDate: Monday, May 15, 2023Time: 3:05-3:40 p.m. CESTPoster Display: 9:40 a.m. CEST on Sunday, May 14 – 3:30 p.m. CEST on Tuesday, May 16 Title: AZP-3813, a Bicyclic, 16-Amino Acid Peptide Antagonist of the Human Growth Hormone Receptor, Effectively Suppresses IGF1 in Beagle Dogs Format: Poster / Rapid Oral PresentationSession: Rapid Communication 7: Pituitary and Neuroendocrinology 2Date: Monday, May 15, 2023Time: 3:05-3:40 p.m. CEST Poster Display: 9:40 a.m. CEST on Sunday, May 14 – 3:30 p.m. CEST on Tuesday, May 16 2023 Endocrine Society Meeting (ENDO) – June 15-18, Chicago, Illinois Title: Repeated Treatment with AZP-3813, a Bicyclic, 16-Amino Acid Peptide Antagonist of the Human Growth Hormone Receptor, Induces Enhanced Suppression of IGF1 in Beagle DogsFormat: Poster Presentation Session: Neuroendocrinology: Neuroendocrinology and Pituitary: Growth Hormone and Acromegaly - Basic and TranslationalDate: Thursday, June 15, 2023Time: 12:30-1:30 p.m. CSTPoster Display: 9:00 a.m. – 3:00 p.m. CST on Thursday, June 15 Title: Treatment of Chronic Hypoparathyroidism with Eneboparatide (AZP-3601), a Novel PTH 1 Receptor Agonist: Results from a Phase 2 TrialFormat: Oral Presentation Session: Bone 2 - PTH-Relevant Biology, Pathophysiology, and TherapeuticsDate: Saturday, June 17, 2023Time: 9:45-11:15 a.m. CST Title: Variations in Clinical Practice Patterns for HypoparathyroidismFormat: Poster Presentation Session: Bone and Mineral Metabolism: HypoparathyroidismDate: Saturday, June 17, 2023Time: 1:00-2:00 p.m. CSTPoster Display: 9:00 a.m. – 3:00 p.m. CST on Saturday, June 17 Title: AZP-3601, a Novel PTH 1 Receptor Agonist, Induces Rapid Reduction and Normalization of Urinary Calcium in Chronic Hypoparathyroid PatientsFormat: Poster PresentationSession: Bone and Mineral Metabolism: HypoparathyroidismDate: Saturday, June 17, 2023Time: 1:00-2:00 p.m. CSTPoster Display: 9:00 a.m. – 3:00 p.m. CST on Saturday, June 17 About Amolyt Pharma Amolyt Pharma, a clinical stage biotechnology company, is building on its team’s established expertise to deliver life-changing treatments to patients suffering from rare endocrine and related diseases. Its development portfolio includes eneboparatide (AZP-3601), a long-acting PTH1 receptor agonist as a potential treatment for hypoparathyroidism, and AZP-3813, a peptide growth hormone receptor antagonist for the potential treatment of acromegaly. Amolyt Pharma aims to further expand and develop its portfolio by leveraging its global network in the field of endocrinology and with support from a strong syndicate of international investors. To learn more, visit https://amolytpharma.com/ or follow us on Twitter and LinkedIn. Media Inquiries: Jordyn TemperatoLifeSci Communications jtemperato@lifescicomms.com Investors Inquiries:Ashley RobinsonLifeSci Advisors, LLCarr@lifesciadvisors.com+1.617.430.7577

Amolyt to advance pre-clinical development of anti-PTHR1 monoclonal antibodies as potential treatments of primary hyperparathyroidism (PHPT) and humoral hypercalcemia of malignancy (HHM) Amolyt has obtained the option to license one or more candidates from XOMA for further clinical development worldwide PHPT and HHM are rare endocrine diseases with high unmet needs and these candidates from XOMA represent a natural expansion of Amolyt’s current development pipeline LYON, France and CAMBRIDGE, Mass., Jan. 24, 2023 (GLOBE NEWSWIRE) -- Amolyt Pharma (“Amolyt,” “Amolyt Pharma” or the “Company”), a global company specialized in developing innovative therapies for rare endocrine and related diseases, today announced that the Company has entered into a research agreement and licensing option with XOMA Corporation (“XOMA”) for the pre-clinical evaluation of a select set of monoclonal antibodies that arose from XOMA’s legacy discovery efforts as potential treatments for primary hyperparathyroidism (“PHPT”) and humoral hypercalcemia of malignancy (“HHM”). Amolyt has the option to license one or more of these candidates from XOMA for further clinical development worldwide. Both PHPT and HHM are rare endocrine diseases with high unmet needs and a common target, the parathyroid hormone 1 receptor (“PTHR1”), and are characterized by the hypersecretion of parathyroid hormone (“PTH”) and parathyroid hormone-related peptide (“PTHrP”), respectively, resulting in continuous stimulation of the PTHR1, leading to bone loss, hypercalcemia and hypophosphatemia. The objective of the research agreement is to test the anti-PTHR1 antibodies in relevant animal disease models with the aim of selecting a candidate that can successfully halt the over-stimulation of the PTHR1 caused by excess PTH and PTHrP and eliminate the debilitating symptoms and serious complications associated with PHPT and HHM. “We are continuing to build our portfolio for rare endocrine and related diseases while moving, in parallel, our lead program for hypoparathyroidism into a pivotal trial. This new program for primary hyperparathyroidism and humoral hypercalcemia of malignancy represents a natural expansion of our pipeline and leverages our clinical expertise in the field of calcium and bone metabolism and in the biology of parathyroid hormone and its receptor,” stated Thierry Abribat, Ph.D., chief executive officer of Amolyt Pharma. “We look forward to advancing this pre-clinical work and, if successful, entering into a license agreement with XOMA in order to bring the program to patients, to expand our development pipeline and to establish more opportunities for long-term value creation,” Dr. Abribat concluded. Brad Sitko, chief investment officer of XOMA, added, “Given Amolyt’s established expertise in rare endocrine disorders, and specifically diseases stemming from dysregulation of PTH, we believe they are a great partner to advance the development of these promising antibodies. We look forward to watching Amolyt’s progress, as PHPT and HHM patients are underserved by current standards of care.” About Primary Hyperparathyroidism (“PHPT”)Primary hyperparathyroidism involves excessive PTH production due to enlargement of one or more of the parathyroid glands located at the front and base of the neck that leads to hypercalcemia. Excess serum calcium affects multiple body systems including the skeletal, gastrointestinal, renal (kidney), muscular, cardiovascular, and central nervous systems. Most commonly, primary hyperparathyroidism is seen in people over 60 years of age and is more common in women. Radiation to the head and neck increases the risk of developing the disease as does rare parathyroid carcinoma. In approximately 85% of cases, PHPT is caused by a single adenoma. In approximately 15% of cases, multiple glands are involved (either multiple adenomas or hyperplasia) and management of the disease is more challenging. Prevalence is estimated at ~233/100k women and 85/100k men. About Humoral Hypercalcemia of Malignancy (“HHM”)Approximately 20% of all cancer patients develop hypercalcemia during their clinical course, and 80% of those cases are caused by excessive secretion of PTHrP from tumor cells (HHM). Squamous cell carcinomas of the head, neck, esophagus and lung, and cancers of the cervix, lung and colon are most commonly involved, in addition to renal cell, bladder, breast, endometrial, and ovarian cancers. It is associated with a wide spectrum of symptoms including nausea, vomiting, anorexia, abdominal pain, constipation, polyuria, hypotension, bone pain, bone loss fatigue and confusion. Renal failure or coma can occur; thus, this condition may be considered an oncologic emergency. Current standard of care is focused on bone anti-resorptive therapy, and intravenous hydration to enhance urinary calcium excretion. However there are many limitations to available therapy and unwanted effects include fever, bone pain, renal toxicity, hypocalcemia, and osteonecrosis of the maxilla and mandible. A better tolerated systemic therapy that directly targets the interaction between PTHrP and the PTHR1, rather than the downstream effect on bone resorption, has the potential to provide a safer, more effective alternative. Based on a prevalence study in the United States, HHM represented about 57,000 cases in 2013. About Amolyt PharmaAmolyt Pharma, a clinical stage biotechnology company, is building on its team’s established expertise to deliver life-changing treatments to patients suffering from rare endocrine and related diseases. Its development portfolio includes eneboparatide (AZP-3601), a long-acting PTH1 receptor agonist as a potential treatment for hypoparathyroidism, and AZP-3813, a peptide growth hormone receptor antagonist for the potential treatment of acromegaly. Amolyt Pharma aims to further expand and develop its portfolio by leveraging its global network in the field of endocrinology and with support from a strong syndicate of international investors. To learn more, visit https://amolytpharma.com/ or follow us on Twitter and LinkedIn. Media inquiries:Jordyn TemperatoLifeSci Communicationsjtemperato@lifescicomms.com Investor inquiries:Ashley RobinsonLifeSci Advisors, LLCarr@lifesciadvisors.com+1.617.430.7577