ORMP: Preparations for New Phase 3 Trial Advance, While ORMP Leverages Balance Sheet Through Recent Agreements

Zacks Small Cap Research12-02

By M. Marin NASDAQ:ORMP READ THE FULL ORMP RESEARCH REPORT Planning Phase 3 Oral Insulin study under revised protocol, new CRO agreement in place Oramed Pharmaceuticals (NASDAQ:ORMP) has pivoted its ...

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Marin\n NASDAQ:ORMP\nREAD THE FULL ORMP RESEARCH REPORT\nPlanning Phase 3 Oral Insulin study under revised protocol, new CRO agreement in place\nOramed Pharmaceuticals (NASDAQ:ORMP) has pivoted its ...</p>\n\n<a href=\"https://finance.yahoo.com/news/ormp-preparations-phase-3-trial-150900135.html\">Source Link</a>\n\n</div>\n","source":"yahoofinance","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>ORMP: Preparations for New Phase 3 Trial Advance, While ORMP Leverages Balance Sheet Through Recent Agreements</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nORMP: Preparations for New Phase 3 Trial Advance, While ORMP Leverages Balance Sheet Through Recent Agreements\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-12-02 23:09 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/ormp-preparations-phase-3-trial-150900135.html><strong>Zacks Small Cap Research</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>By M. Marin\n NASDAQ:ORMP\nREAD THE FULL ORMP RESEARCH REPORT\nPlanning Phase 3 Oral Insulin study under revised protocol, new CRO agreement in place\nOramed Pharmaceuticals (NASDAQ:ORMP) has pivoted its ...</p>\n\n<a href=\"https://finance.yahoo.com/news/ormp-preparations-phase-3-trial-150900135.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4007","symbol_name":"制药","start_time":0,"source_url":"https://finance.yahoo.com/news/ormp-preparations-phase-3-trial-150900135.html","article_id":"2488376952","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/EP4GReGHAGsQEFwYsSzviA--~B/aD02Mjg7dz0xODYyO2FwcGlkPXl0YWNoeW9u/https://media.zenfs.com/en/scr.zacks.com/f67184b0e7f3b2f8cae39fb577ed8f15"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2488376952","pubTimestamp":1733152140,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Planning Phase 3 Oral Insulin study under revised protocol, new CRO agreement in place. Oramed Pharmaceuticals  has pivoted its clinical R&D focus to prioritize studying ORMD 0801 for subpopulations of patients with pooled specific parameters who responded well to oral insulin in its prior trial. The subpopulation included patients with specific parameters such as body mass index , baseline HbA1c, age, gender and body weight. These subsets exhibited an over 1% placebo adjusted, statistically significant reduction in HbA1c.ORMP intends to launch a Phase 3 oral insulin trial in the U.S. under a differentiated protocol that is aligned with the positive subpopulation data and informed by feedback from discussions with the FDA. ORMP entered into a JV with Hefei Tianhui Biotech Co., Ltd.  as a strategic initiative to move assets forward. Their JV will focus on developing and commercializing innovative products worldwide based on their combined assets and capabilities worldwide. ORMP entered ","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4007":"制药","BMI":"Badger Meter","BK4157":"电子设备和仪器","ORMP":"Oramed Pharmaceuticals Inc."},"translate_title":"ORMP：新3期试验的准备工作取得进展，而ORMP通过最近的协议利用资产负债表","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"BMI":1,"ORMP":1},"content_text":"By M. Marin\n NASDAQ:ORMP\nREAD THE FULL ORMP RESEARCH REPORT\nPlanning Phase 3 Oral Insulin study under revised protocol, new CRO agreement in place\nOramed Pharmaceuticals (NASDAQ:ORMP) has pivoted its clinical R&D focus to prioritize studying ORMD 0801 for subpopulations of patients with pooled specific parameters who responded well to oral insulin in its prior trial. The subpopulation included patients with specific parameters such as body mass index (BMI), baseline HbA1c, age, gender and body weight. These subsets exhibited an over 1% placebo adjusted, statistically significant reduction in HbA1c.\nORMP intends to launch a Phase 3 oral insulin trial in the U.S. under a differentiated protocol that is aligned with the positive subpopulation data and informed by feedback from discussions with the FDA. ORMP entered into a JV with Hefei Tianhui Biotech Co., Ltd. (HTIT) as a strategic initiative to move assets forward. Their JV will focus on developing and commercializing innovative products worldwide based on their combined assets and capabilities worldwide. ORMP entered into a services agreement with a CRO (Clinical Research Organization) in September 2024 related to the planned Phase 3 clinical trial.\n\nORMD–0801 potential treatment for NASH, as well as diabetes… \nMoreover, ORMP’s R&D activities include potentially developing an orally ingestible capsules for delivery of other polypeptides, as well as an orally ingestible insulin capsule for the treatment of diabetes. ORMP has evaluated potential opportunities to advance ORMD–0801 for nonalcoholic steatohepatitis (NASH), and obesity as an appetite suppressant in earlier studies.\nCash position strengthened by various agreements, including with Scilex…\nAt the same time, ORMP is also leveraging its balance sheet – about $142 million in cash, equivalents, short-term investments and deposits and no long-term debt – to optimize its cash position, augmenting its cash with debt principal / interest payments from Scilex Holding Company and a loan agreement to finance a real estate project that is essentially collateralized by the project. On October 7, 2024, ORMP entered into an agreement to refinance a portion of the original Tranche A Note to Scilex.\nCompany purchased shares in 3Q24 under buyback, cash runway ~a year or more \nThrough the end of 3Q24, Oramed had repurchased and retired 539,452 ORMP shares for roughly $1.3 million. Given the cash balance noted above, we expect the company has sufficient capital to maintain share repurchases and continue to advance its strategy.\nSUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. \n \nDISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. 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