IMNN: Meeting with FDA in Preparation for Phase 3 Ovarian Cancer Trial

Zacks Small Cap Research11-11 18:00

By David Bautz, PhD NASDAQ:IMNN READ THE FULL IMNN RESEARCH REPORT Business Update Preparations Underway for Phase 3 Ovarian Cancer Trial; Set to Initiate in 1Q25 Imunon, Inc. (NASDAQ:IMNN) ...

Source Link

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2482737616?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2024-11-11 18:00","share_image_url":"https://static.laohu8.com/5f26f4a48f9cb3e29be4d71d3ba8c038","id":"2482737616","market":"us","top_or_hot":-1,"title":"IMNN: Meeting with FDA in Preparation for Phase 3 Ovarian Cancer Trial","media":"Zacks Small Cap Research","content":"<div>\n<p>By David Bautz, PhD\n NASDAQ:IMNN\nREAD THE FULL IMNN RESEARCH REPORT\nBusiness Update\nPreparations Underway for Phase 3 Ovarian Cancer Trial; Set to Initiate in 1Q25\nImunon, Inc. (NASDAQ:IMNN) ...</p>\n\n<a href=\"https://finance.yahoo.com/news/imnn-meeting-fda-preparation-phase-100000450.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>IMNN: Meeting with FDA in Preparation for Phase 3 Ovarian Cancer Trial</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\">\nIMNN: Meeting with FDA in Preparation for Phase 3 Ovarian Cancer Trial\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-11-11 18:00 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/imnn-meeting-fda-preparation-phase-100000450.html><strong>Zacks Small Cap Research</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>By David Bautz, PhD\n NASDAQ:IMNN\nREAD THE FULL IMNN RESEARCH REPORT\nBusiness Update\nPreparations Underway for Phase 3 Ovarian Cancer Trial; Set to Initiate in 1Q25\nImunon, Inc. (NASDAQ:IMNN) ...</p>\n\n<a href=\"https://finance.yahoo.com/news/imnn-meeting-fda-preparation-phase-100000450.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":"OS","symbol_name":"Onestream Inc","start_time":0,"source_url":"https://finance.yahoo.com/news/imnn-meeting-fda-preparation-phase-100000450.html","article_id":"2482737616","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2482737616","pubTimestamp":1731319200,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Preparations Underway for Phase 3 Ovarian Cancer Trial; Set to Initiate in 1Q25. Imunon, Inc.  previously reported positive topline results from the Phase 2 OVATION 2 trial of IMNN-001 in patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. IMNN-001 is a DNA immunotherapeutic drug that consists of an interleukin -12 plasmid that allows for targeted expression of IL-12 to avoid toxicities and poor pharmacokinetics of systemically administered IL-12.As of September 30, 2024, Imunon had approximately $10.3 million in cash, cash equivalents, investments, and interest receivable. We estimate that the company has sufficient capital to fund operations into the third quarter of 2025. Imunon currently has approximately 14.5 million common shares outstanding and, when factoring in stock options and","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"OS":"Onestream Inc","IMNN":"Imunon, Inc.","BK4097":"系统软件","BK4139":"生物科技"},"translate_title":"IMNN：与FDA会面，为卵巢癌3期试验做准备","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"IMNN":1,"OS":1},"content_text":"By David Bautz, PhD\n NASDAQ:IMNN\nREAD THE FULL IMNN RESEARCH REPORT\nBusiness Update\nPreparations Underway for Phase 3 Ovarian Cancer Trial; Set to Initiate in 1Q25\nImunon, Inc. (NASDAQ:IMNN) previously reported positive topline results from the Phase 2 OVATION 2 trial of IMNN-001 in patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. IMNN-001 is a DNA immunotherapeutic drug that consists of an interleukin (IL)-12 plasmid that allows for targeted expression of IL-12 to avoid toxicities and poor pharmacokinetics of systemically administered IL-12.\nThe standard of cancer in ovarian cancer has not changed appreciably in the last 25 years. In addition, only recently has a treatment showed an overall survival (OS) benefit in ovarian cancer. With that context, we view the results from the OVATION 2 trial as an exciting advancement in the treatment of ovarian cancer, which were recently presented at the SITC 39th Annual Meeting. The results showed that treatment with IMNN-001 in addition to standard of care increased OS by 11.1 months and for those patients that received at least 20% of protocol-specified treatments the increase was 15.7 months. For the patients that were also on a PARP inhibitor (approximately 40%), the median OS was not reached for those also receiving IMNN-001 compared to 37.1 months for those not receiving IMNN-001. In regards to safety, IMNN-001 was well tolerated with the most common adverse events were abdominal pain, nausea, and vomiting. The abdominal pain was well controlled with standard of care pain medicines. \nImunon is now developing the protocol for a Phase 3 trial of IMNN-001 in ovarian cancer patients. As part of the process, the company will be conducting an ‘End-of-Phase 2’ meeting with the FDA later this month to get input from the agency on their proposed trial design. The study is likely to include approximately 500 patients, which will allow for stratification according to PARP inhibitor exposure. We anticipate the study initiating in the first quarter of 2025. \nFinancial Update\nOn November 7, 2024, Imunon announced financial results for the third quarter of 2024. As expected, the company did not report any revenue during the third quarter of 2024. R&D expenses in the third quarter of 2024 were $3.3 million compared to $2.0 million in the third quarter of 2023. The increase was primarily due to higher costs associated with the OVATION 2 study and CMC costs. G&A expenses in the third quarter of 2024 were $1.7 million compared to $1.9 million for the third quarter of 2023. The decrease was primarily due to lower legal fees.\nAs of September 30, 2024, Imunon had approximately $10.3 million in cash, cash equivalents, investments, and interest receivable. We estimate that the company has sufficient capital to fund operations into the third quarter of 2025. Imunon currently has approximately 14.5 million common shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 21.2 million. \nConclusion\nWe anticipate an update on the upcoming Phase 3 study of IMNN-001 following the company’s meeting with the FDA and receipt of the meeting minutes. Assuming Imunon can come into alignment with the FDA regarding the study design, we anticipate the trial initiating in the first quarter of 2025. We also expect an update on the company’s plans for financing the Phase 3 study, however at this point there is sufficient capital to initiate the trial. With no changes to our model our valuation remains at $8.00 per share. \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. Full Disclaimer HERE.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.1","shortVersion":"4.29.1","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2482737616"}