{"id":37388,"date":"2023-03-30T09:04:17","date_gmt":"2023-03-30T07:04:17","guid":{"rendered":"https:\/\/kapitalpartner.dk\/?p=37388"},"modified":"2023-03-30T09:04:17","modified_gmt":"2023-03-30T07:04:17","slug":"biosergen-starts-phase-2-trial-in-q2-with-potential-price-trigger-already-in-q4-this-year","status":"publish","type":"post","link":"https:\/\/kapitalpartner.dk\/en\/biosergen-starts-phase-2-trial-in-q2-with-potential-price-trigger-already-in-q4-this-year\/","title":{"rendered":"Biosergen starts phase 2 trial in Q2 with potential price trigger already in Q4 this year"},"content":{"rendered":"\n<p><strong>Biosergen:<\/strong> 1.5 million people die each year from fungal infections. Biosergen, which has FDA orphan drug status, is developing an antifungal drug that is more effective and has a significantly better side effect profile than existing antifungal drugs developed 40-70 years ago. With USD 16.7 billion spent annually on antifungal drugs, Biosergen&#8217;s drug has blockbuster potential (annual sales of more than USD 1 billion) and is expected to be launched in Q2 2026.<\/p>\n\n\n\n<p><em>Biosergen: Ticker: BIOSGN | Price: SEK 1,218 | Market Cap: 52 MSEK | YTD price performance: 16%<\/em><\/p>\n\n\n\n<p><strong>Price trigger<\/strong> <strong>in the near future<\/strong><\/p>\n\n\n\n<p>After the positive results of the phase 1 trials in the first quarter of this year, Biosergen is already ready with a phase 2 trial. The first patients are expected to be enrolled at the end of the second quarter of this year, and will consist of 15 patients with invasive fungal infection, including &#8220;Balck Fungus&#8221;, who as a last treatment option are or have been treated with Amphotericin B, but who are taken off this treatment due to life-threatening side effects such as kidney failure. The serious side effects mean that 20-40% of people treated with Amphotericin B are taken off treatment again, leaving them with no other treatment option. The study is being conducted in India and top-line results are expected already after 6 months, corresponding to late 2023\/early 2024.<\/p>\n\n\n\n<p>Biosergen&#8217;s treatment for invasive fungal infection has just shown in the phase 1 trials that it does not have the serious side effects of the most effective treatments. If the results of the phase 2 study show that the agent is also effective (efficacy) for the treatment of patients with no other treatment options, the way is paved for further phase 2 studies, approval and launch potentially in 2025 &#8211; as well as the possibility of partnerships. Positive results will therefore be a significant price trigger.<\/p>\n\n\n\n<p><strong>Partnership rather than capital<\/strong><\/p>\n\n\n\n<p>Biosergen does not need new capital for the completion of the phase 2 study. If positive results are obtained, Biosergen will design phase 2 studies targeting approval of BSG005 for the treatment of an indication &#8211; for example, aspergillosis, for which Biosergen has Orphan Drug Designation, or mucormucosis. As there is a real possibility that Biosergen&#8217;s drug will be used as the first line of treatment &#8211; i.e. the primary drug &#8211; there is blockbuster sales material (sales of over USD 1 billion). Therefore, Biosergen will also be in a good position to be attractive to Big Pharma and thus obtain financing from them &#8211; and thus without further capital increases.<\/p>\n\n\n\n<p><strong>Upcoming price triggers<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Initiation of the phase 2 study in India and first patient<\/li><li>Presentation of data to FDA and discussion of Phase II study Q2 2023<\/li><li>Topline results for the Indian Phase 2 study in Q4 2023\/Q1 2024<\/li><\/ul>\n\n\n\n<p><strong>The price development for Biosergen vs. Kapital Partner Healthcare Index (KPHC) the past year<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1195\" height=\"490\" src=\"https:\/\/kapitalpartner.dk\/wp-content\/uploads\/2023\/03\/image-29.png\" alt=\"\" class=\"wp-image-37182\" srcset=\"https:\/\/kapitalpartner.dk\/wp-content\/uploads\/2023\/03\/image-29.png 1195w, https:\/\/kapitalpartner.dk\/wp-content\/uploads\/2023\/03\/image-29-300x123.png 300w, https:\/\/kapitalpartner.dk\/wp-content\/uploads\/2023\/03\/image-29-768x315.png 768w\" sizes=\"(max-width: 1195px) 100vw, 1195px\" \/><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Biosergen: 1.5 million people die each year from fungal infections. Biosergen, which has FDA orphan drug status, is developing an antifungal drug that is more effective and has a significantly better side effect profile than existing antifungal drugs developed 40-70 years ago. With USD 16.7 billion spent annually on antifungal drugs, Biosergen&#8217;s drug has blockbuster [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":37185,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"mc4wp_mailchimp_campaign":[],"footnotes":""},"categories":[151,165],"tags":[],"class_list":["post-37388","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company-cases","category-investment-cases"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Biosergen starts phase 2 trial in Q2 with potential price trigger already in Q4 this year | Kapital Partner A\/S<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kapitalpartner.dk\/en\/biosergen-starts-phase-2-trial-in-q2-with-potential-price-trigger-already-in-q4-this-year\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Biosergen starts phase 2 trial in Q2 with potential price trigger already in Q4 this year | Kapital Partner A\/S\" \/>\n<meta property=\"og:description\" content=\"Biosergen: 1.5 million people die each year from fungal infections. Biosergen, which has FDA orphan drug status, is developing an antifungal drug that is more effective and has a significantly better side effect profile than existing antifungal drugs developed 40-70 years ago. 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