Teduglutide Recombinant

Trial taking place at Sheikh Khalifa Medical City, a flagship tertiary hospital in the United Arab Emirates POC data generated from this study could potentially lead to reimbursed early patient access in certain European countries for crofelemer for MVID Crofelemer, Jaguar's novel plant-based prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for both MVID and short bowel syndrome with intestinal failure (SBS-IF) SAN FRANCISCO, CA / ACCESS Newswire / January 22, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics today announced that the first patient has been dosed in the independent investigator-initiated POC trial of crofelemer, Jaguar's novel plant-based anti-diarrheal prescription drug, for the rare disease indication of MVID in pediatric patients. POC data generated from this study potentially in the first half of 2025 could lead to reimbursed early patient access to crofelemer for this indication in certain European countries. The trial will also include pediatric patients with SBS-IF. It is being conducted by Dr. Mohamad Miqdady, a recognized leader in pediatric gastroenterology who is the Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division at Sheikh Khalifa Medical City (SKMC), a flagship tertiary hospital in the UAE and the largest teaching medical center in Abu Dhabi . "Dosing of the first patient in this unblinded study is an important milestone in clinical development efforts for crofelemer for MVID and SBS-IF - both of which are rare and severe diseases requiring intensive parenteral nutrition and support," said Lisa Conte , Jaguar's founder, president, and CEO. The trial is taking place at SKMC. Autosomal recessive disorders and congenital anomalies such as MVID are more prevalent in the Middle East and North Africa (MENA) region. "This study is one of five clinical efforts in rare diseases - three POC IIT studies and two Phase 2 studies - for crofelemer for the orphan disease indications of MVID and/or SBS-IF in the United States , European Union , and/or MENA regions," Conte said. "The Company's Phase 2 study to evaluate the efficacy of crofelemer for MVID in pediatric patients has been initiated, as has the independent IIT in the U.S. to evaluate crofelemer for SBS-IF in adults. The two additional studies are expected to initiate in early Q1 2025, with the availability of the first POC IIT result potentially in H1 2025, and with additional POC IIT results expected throughout 2025. In accordance with the guidelines of specific EU countries, published data from clinical investigations in MVID and SBS-IF could support reimbursed early patient access to crofelemer for these debilitating conditions." MVID and SBS-IF, rare and severe diseases requiring intensive parenteral nutrition and support, have severe morbidity and mortality implications and impact the quality of life of both patients and their caregivers. MVID is a pediatric disease with an estimated prevalence of a couple of hundred patients globally. It is characterized by severe diarrhea and malabsorption, requiring intensive parenteral support for nutritional and fluid management. Each MVID patient is a unique patient; their journey requires very careful management of their nutritional needs, and there are currently no approved drug treatments for MVID. SBS affects approximately 10,000 to 20,000 people in the U.S. , according to the Crohn's & Colitis Foundation , and it is estimated that the population of SBS patients in Europe is approximately the same size. Pediatric SBS is a malabsorptive condition caused by surgical intestinal resection due to congenital abnormalities, vascular insufficiency or severe inflammatory intestinal disease. The incidence of pediatric SBS varies between 0.02% to 1.2% of live births.1 Based on an estimate of 3.6 million live births in the U.S. in 2023,2 the maximal incidence of pediatric SBS is estimated to be approximately 43,000. Pediatric SBS-IF is associated with significant morbidity and mortality; and high medical expenses, and the patients also have severe chronic diarrhea. The associated sequelae from chronic diarrhea include significant dehydration, metabolic acidosis or alkalosis, and malnutrition. Crofelemer has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for MVID and SBS . Dr. Miqdady is an Adjunct Professor at Khalifa University's medical school in Abu Dhabi , and serves as a member of Napo's Scientific Advisory Board . He completed his Fellowship in Pediatric Gastroenterology at Baylor College of Medicine and Texas Children's Hospital in Houston . About Crofelemer Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health , visit https://jaguar.health Napo Pharmaceuticals , visit www.napopharma.comNapo Therapeutics, visit napotherapeutics.comMagdalena Biosciences, visit magdalenabiosciences.com Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that another IIT and another Phase 2 study of crofelemer will initiate in early Q1 2025, Jaguar's expectation that POC data from the MVID IIT in Abu Dhabi may be available in H1 2025, Jaguar's expectation that additional POC IIT results for crofelemer may be available throughout 2025, and Jaguar's expectation that, in accordance with the guidelines of specific EU countries, published data from clinical investigations could support early patient access to crofelemer for SBS-IF or MVID in these countries. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. 1 Beth A. Carter , MD, et al. Outcomes from a 12-Week, Open-Label, Multicenter Clinical Trial of Teduglutide in Pediatric Short Bowel Syndrome. The Journal of Pediatrics , 2017; 181:102-112 https://www.ncbi.nlm.nih.gov/books/NBK607756/ Contact: hello@jaguar.healthJaguar-JAGX SOURCE: Jaguar Health, Inc.

JERUSALEM, May 10, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and small therapeutic proteins, today reported financial results and key business updates for the quarter ended March 31, 2024. “Entera is off to a strong start in 2024 thanks to the growth strategy we implemented in 2023, expanding our N-Tab™ therapeutic pipeline with potential first in class oral GLP-2, GLP-1/glucagon and PTH(1-34) peptide treatments for patients with GYN/endocrine, metabolic and gastrointestinal disorders. We thank our shareholders for their support. We are continuing on our mission to build Entera into a premier oral peptide therapeutic company and look forward to delivering key updates across all of our programs as this year progresses,” said Miranda Toledano, CEO of Entera. EB613: First Oral PTH(1-34) Daily Osteoanabolic Tablets for Osteoporosis In March 2024, Entera echoed the American Society for Bone and Mineral Research (ASBMR) announcement that U.S. Food and Drug Administration (FDA) expects to provide a ruling qualifying bone mineral density (BMD) as a surrogate endpoint for fractures within 10 months. FDA’s expected ruling is a key catalyst to the potential initiation of EB613’s pivotal phase 3 study. 200 million women globally are estimated to be afflicted with osteoporosis. No new drugs have been approved for osteoporosis since 2019. Fracture rates, morbidity and mortality rates are rising despite effective injectable treatments. EB613 is the first and only PTH(1-34) bone building peptide in tablet format.In April 2024, Entera announced that the Journal of Bone and Mineral Research (JBMR) published EB613 placebo controlled Phase 2 Trial results, highlighting its dual mechanism of action, differentiated BMD profile versus injectable PTH(1-34) treatment and its potential to address the treatment chasm in this serious disease. EB612: First Oral PTH(1-34) Peptide Replacement Therapy Tablets for Hypoparathyroidism In April 2024, Entera submitted to the Endocrine Society Annual Meeting (ENDO 2024) pharmacokinetic (PK) and early PD data from a Phase 1 study evaluating an unmodified PTH(1-34) peptide and a new generation of Entera’s N-Tab™ platform. First GLP-2 Peptide Tablets for Short Bowel Syndrome In March 2024, Entera announced positive in vivo PK results from its program combining OPKO Health, Inc.’s (Nasdaq: “OPK”) long acting GLP-2 analogue with N-Tab™ technology. Oral GLP-2 tablets exhibited significant systemic exposure with plasma levels that were approximately 10-fold higher than therapeutic plasma concentrations reported for teduglutide (Gattex®). Pharmacology data is expected early in the second half of 2024 First GLP-1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity Collaborative work is ongoing combining N-Tab™ with OPKO’s long-acting Oxyntomodulin (OXM) analogues for potential treatment for obesity and other metabolic diseases. We expect to report PK data for the oral OXM tablet in mid-2024, pursuant to which a pharmacology study would be initiated. EB613: First Oral PTH(1-34) Osteoanabolic Tablets to Treat Intense Sport and Military Stress Injuries Entera is collaborating with leading researchers in orthopedics and sports medicine to contribute its proprietary oral PTH(1-34) tablets for an investigator sponsored Phase 2 Study seeking to treat young women athletes who experience stress fractures as a result of intense sports training. Enter expects to provide more details on this study in the second half of 2024. Financial Results for the Quarter Ended March 31, 2024 As of March 31, 2024, Entera had cash and cash equivalents of $9.2 million. The Company expects that its existing cash resources are sufficient to meet its projected operating requirements into the third quarter of 2025, which includes the capital required to fund our ongoing operations, including the completion of the Phase 1 PK study related to our new generation platform and the GLP-2/OXM collaborative research with OPKO. Research and development expenses for the three months ended March 31, 2024 were $0.7 million, as compared to $0.9 million for the three months ended March 31, 2023. General and administrative expenses for both the three months ended March 31, 2024 and 2023 were $1.3 million. For the three months ended March 31, 2024, there was a decrease of $0.1 million in D&O insurance costs and an increase of $0.1 million in compensation, consultant and other fees. Operating expenses for the period ended March 31, 2024 were $2.1 million, as compared to $2.2 million for the quarter ended March 31, 2024. Net loss was $2.0 million, or $0.05 per ordinary share (basic and diluted), for the period ended March 31, 2024, as compared to $2.2 million, or $0.08 per ordinary share (basic and diluted), for the period ended March 31, 2023. About Entera Bio Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab™) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram. Cautionary Statement Regarding Forward Looking Statements Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law. ENTERA BIO LTD.CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands) March 31,2024 December 31,2023 (Unaudited) (Audited) Cash and cash equivalents9,189 11,019 Accounts receivable and other current assets562 238 Property and equipment, net87 100 Other assets, net401 408 Total assets10,239 11,765 Accounts payable and other current liabilities1,121 1,091 Total non-current liabilities255 288 Total liabilities1,376 1,379 Total shareholders' equity8,863 10,386 Total liabilities and shareholders' equity10,239 11,765 ENTERA BIO LTD.CONSOLIDATED STATEMENTS OF OPERATIONS(U.S. dollars in thousands, except share and per share data) (Unaudited) Three Months EndedMarch 31, 2024 2023 OPERATING EXPENSES: Research and development 735 931 General and administrative 1,327 1,294 Other income- (13) TOTAL OPERATING EXPENSES2,062 2,212 OPERATING LOSS2,062 2,212 FINANCIAL EXPENSES (INCOME), NET (45) (22) NET LOSS2,017 2,190 BASIC AND DILUTED LOSS PER SHARE0.05 0.08 WEIGHTED AVERAGE NUMBER OF SHARESOUTSTANDING USED IN COMPUTATION OFBASIC AND DILUTED LOSS PER SHARE 36,735,429 28,809,922