{"id":457489,"date":"2021-03-15T08:08:07","date_gmt":"2021-03-15T12:08:07","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=457489"},"modified":"2021-03-15T08:08:07","modified_gmt":"2021-03-15T12:08:07","slug":"cyclo-therapeutics-provides-business-update-and-reports-fourth-quarter-and-full-year-2020-financial-results","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-provides-business-update-and-reports-fourth-quarter-and-full-year-2020-financial-results\/","title":{"rendered":"Cyclo Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwlistdisc { list-style-type: disc }\n.bwuline { text-decoration: underline }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Cyclo Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results<\/b><\/p>\n<p class=\"bwalignc\"><i>&#8211; Multiple value-driving milestones expected throughout 2021<\/i><\/p>\n<p class=\"bwalignc\"><i>&#8211; Trappsol<sup>\u00ae<\/sup> Cyclo\u2122 Niemann Pick Disease Type C (NPC) clinical program on track to imminently report topline results from Phase 1\/2 study<\/i><\/p>\n<p class=\"bwalignc\"><i>&#8211; Company expects to commence enrollment in pivotal Phase 3 study of Trappsol<sup>\u00ae<\/sup> Cyclo\u2122 for NPC in Q2 2021<\/i><\/p>\n<p class=\"bwalignc\"><i>&#8211; IND filing for Trappsol<sup>\u00ae<\/sup> Cyclo\u2122 Alzheimer\u2019s Disease program on track for H2 2021<\/i><\/p>\n<p class=\"bwalignc\"><i>&#8211; Strengthened balance sheet with exercise of warrants<\/i><\/p>\n<p>GAINESVILLE, Fla.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.cyclotherapeutics.com%2F&amp;esheet=52395604&amp;newsitemid=20210315005155&amp;lan=en-US&amp;anchor=Cyclo+Therapeutics%2C+Inc.&amp;index=1&amp;md5=2557292780a51d723620c65390bba9ea\">Cyclo Therapeutics, Inc.<\/a> (Nasdaq: CYTH) (\u201cCyclo Therapeutics\u201d or the \u201cCompany\u201d), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families suffering from diseases, today reported its financial results for the fourth quarter and full year 2020, and provided a business update.\n<\/p>\n<p>\n\u201cI am incredibly pleased with the progress we as a company have made over the past year. On the clinical development front, we completed our Phase 1 study and reported positive interim data from its extension study. We also saw positive interim results from our Phase 1\/2 study in NPC and expect to report topline results from the study imminently. Additionally, our team has been working diligently with regulators, patient advocacy groups and clinicians to design our upcoming, pivotal Phase 3 study which is expected to commence next quarter,\u201d commented N. Scott Fine, CEO of Cyclo Therapeutics.\n<\/p>\n<p>\n\u201cOn the corporate side, we have been working to bolster our leadership team and made multiple key hires including a Chief Commercial Officer and Chief Medical Officer, both of whom bring tremendous value as we begin to plan for success and the potential approval of Trappsol<sup>\u00ae<\/sup> Cyclo\u2122 for the treatment of NPC,\u201d continued Mr. Fine. \u201cOur team is extremely excited for 2021 and, we believe, is poised to achieve a number of value-driving milestones.\u201d\n<\/p>\n<p><b>Trappsol<sup>\u00ae<\/sup> Cyclo\u2122 Clinical Program Update<\/b><\/p>\n<p>\nTrappsol<sup>\u00ae <\/sup>Cyclo\u2122 is a proprietary formulation of hydroxypropyl beta cyclodextrin, used intravenously (IV) and currently in development for the treatment of NPC, a rare genetic disorder causing cholesterol accumulation in lysosomes of cells, organ dysfunction and premature death. The Company is also planning a clinical study to evaluate Trappsol<sup>\u00ae <\/sup>Cyclo\u2122 for the treatment of Alzheimer\u2019s Disease, targeting the reduction of amyloid beta and tau.\n<\/p>\n<p><span class=\"bwuline\">Expected Upcoming Milestones<\/span><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nReport topline results from Phase 1\/2 study evaluating Trappsol<sup>\u00ae<\/sup> Cyclo\u2122 for the treatment of NPC in March 2021;\n<\/li>\n<li>\nEnroll and dose the first patient in pivotal Phase 3 study for NPC in Q2 2021;\n<\/li>\n<li>\nNPC pivotal Phase 3 study interim analysis topline results expected in Q4 2022;\n<\/li>\n<li>\nCommence commercial-scale batch runs for NPC in Q3 2021; and\n<\/li>\n<li>\nFiling IND in H2 2021 for potential Phase 2 study evaluating Trappsol<sup>\u00ae<\/sup> Cyclo\u2122 for the treatment of Alzheimer\u2019s Disease.\u00a0\n<\/li>\n<\/ul>\n<p><b>Summary of Financial Results for Fiscal Year 2020<\/b><\/p>\n<p>\nNet loss for the year ended December 31, 2020 was approximately $8.9 million. Research and development expenses increased 25% to $6.0 million for 2020, from $4,869,000 for 2019. The increase in research and development expenses is due to increased activity in our International Clinical Program and U.S. clinical trials. We expect research and development costs to further increase in 2021 as we continue to seek regulatory approval for the use of Trappsol<sup>\u00ae<\/sup> Cyclo\u2122 in the treatment of NPC and Alzheimer\u2019s disease. In December 2020, the Company closed a public offering including the exercise of the underwriter\u2019s over-allotment option resulting in total gross proceeds of $14.4 million. Subsequent to the closing of the public offering through March 12, 2021, warrants to purchase an aggregate of 1,654,184 shares of Common Stock were exercised resulting in gross proceeds to the Company of $8.3 million. The Company ended the year with approximately $12.9 million of cash.\n<\/p>\n<p><b>About Cyclo Therapeutics<\/b><\/p>\n<p>\nCyclo Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families suffering from disease. The Company\u2019s Trappsol<sup>\u00ae<\/sup> Cyclo\u2122, an orphan drug designated product in the United States and Europe, is the subject of three ongoing formal clinical trials for Niemann-Pick Disease Type C, a rare and fatal genetic disease, (ClinicalTrials.gov <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT02939547%3Fterm%3DNCT02939547%26rank%3D1&amp;esheet=52395604&amp;newsitemid=20210315005155&amp;lan=en-US&amp;anchor=NCT02939547&amp;index=2&amp;md5=fdd09ba10605c40c94d5e834fe264867\">NCT02939547<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT02912793%3Fterm%3DNCT02912793%26rank%3D1&amp;esheet=52395604&amp;newsitemid=20210315005155&amp;lan=en-US&amp;anchor=NCT02912793&amp;index=3&amp;md5=2cfdfeab288e2bcfae4b000f2d52386d\">NCT02912793<\/a> and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03893071%3Fterm%3DNCT03893071%26rank%3D1&amp;esheet=52395604&amp;newsitemid=20210315005155&amp;lan=en-US&amp;anchor=NCT03893071&amp;index=4&amp;md5=ccd33865f5b4d4ff97b2b168f58352c8\">NCT03893071<\/a>). The company is planning an early phase clinical trial using Trappsol<sup>\u00ae<\/sup> Cyclo\u2122 intravenously in Alzheimer\u2019s Disease based on encouraging data from an Expanded Access program for late-onset Alzheimer\u2019s Disease (<a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03624842%3Fterm%3DNCT03624842%26rank%3D1&amp;esheet=52395604&amp;newsitemid=20210315005155&amp;lan=en-US&amp;anchor=NCT03624842&amp;index=5&amp;md5=f5021ce50ca1c3efa1e8e7de68f3d0e5\">NCT03624842<\/a>). Additional indications for the active ingredient in Trappsol<sup>\u00ae<\/sup> Cyclo\u2122 are in development. For additional information, visit the company\u2019s website: <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.cyclotherapeutics.com&amp;esheet=52395604&amp;newsitemid=20210315005155&amp;lan=en-US&amp;anchor=www.cyclotherapeutics.com&amp;index=6&amp;md5=df83df0951405e89402d93365f69950e\">www.cyclotherapeutics.com<\/a>.\n<\/p>\n<p><b>Safe Harbor Statement<\/b><\/p>\n<p>\nThis press release contains \u201cforward-looking statements\u201d about the company\u2019s current expectations about future results, performance, prospects and opportunities, including, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering. Statements that are not historical facts, such as \u201canticipates,\u201d \u201cbelieves\u201d and \u201cexpects\u201d or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual results in future periods to differ materially from what is expressed in, or implied by, these statements. The factors which may influence the company\u2019s future performance include the company\u2019s ability to obtain additional capital to expand operations as planned, success in achieving regulatory approval for clinical protocols, enrollment of adequate numbers of patients in clinical trials, unforeseen difficulties in showing efficacy of the company\u2019s biopharmaceutical products, success in attracting additional customers and profitable contracts, and regulatory risks associated with producing pharmaceutical grade and food products. These and other risk factors are described from time to time in the company\u2019s filings with the Securities and Exchange Commission, including, but not limited to, the company\u2019s reports on Forms 10-K and 10-Q. Unless required by law, the company assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20210315005155r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20210315005155\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20210315005155\/en\/<\/a><\/span><\/p>\n<p><b>Investors:<br \/>\n<\/b><br \/>JTC Team, LLC<br \/>\n<br \/>Jenene Thomas<br \/>\n<br \/>(833) 475-8247<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:CYTH@jtcir.com\">CYTH@jtcir.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> United States North America Florida<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Health Hospitals Managed Care General Health Clinical Trials Pharmaceutical Biotechnology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\" \/>\n","protected":false},"excerpt":{"rendered":"<p>Cyclo Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results &#8211; Multiple value-driving milestones expected throughout 2021 &#8211; Trappsol\u00ae Cyclo\u2122 Niemann Pick Disease Type C (NPC) clinical program on track to imminently report topline results from Phase 1\/2 study &#8211; Company expects to commence enrollment in pivotal Phase 3 study of Trappsol\u00ae Cyclo\u2122 for NPC in Q2 2021 &#8211; IND filing for Trappsol\u00ae Cyclo\u2122 Alzheimer\u2019s Disease program on track for H2 2021 &#8211; Strengthened balance sheet with exercise of warrants GAINESVILLE, Fla.&#8211;(BUSINESS WIRE)&#8211;Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (\u201cCyclo Therapeutics\u201d or the \u201cCompany\u201d), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families suffering from diseases, today reported &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-provides-business-update-and-reports-fourth-quarter-and-full-year-2020-financial-results\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Cyclo Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-457489","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Cyclo Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results - Market Newsdesk<\/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:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-provides-business-update-and-reports-fourth-quarter-and-full-year-2020-financial-results\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cyclo Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Cyclo Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results &#8211; Multiple value-driving milestones expected throughout 2021 &#8211; Trappsol\u00ae Cyclo\u2122 Niemann Pick Disease Type C (NPC) clinical program on track to imminently report topline results from Phase 1\/2 study &#8211; Company expects to commence enrollment in pivotal Phase 3 study of Trappsol\u00ae Cyclo\u2122 for NPC in Q2 2021 &#8211; IND filing for Trappsol\u00ae Cyclo\u2122 Alzheimer\u2019s Disease program on track for H2 2021 &#8211; Strengthened balance sheet with exercise of warrants GAINESVILLE, Fla.&#8211;(BUSINESS WIRE)&#8211;Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (\u201cCyclo Therapeutics\u201d or the \u201cCompany\u201d), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families suffering from diseases, today reported &hellip; Continue reading &quot;Cyclo Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-provides-business-update-and-reports-fourth-quarter-and-full-year-2020-financial-results\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-03-15T12:08:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20210315005155r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cyclo-therapeutics-provides-business-update-and-reports-fourth-quarter-and-full-year-2020-financial-results\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cyclo-therapeutics-provides-business-update-and-reports-fourth-quarter-and-full-year-2020-financial-results\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Cyclo Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results\",\"datePublished\":\"2021-03-15T12:08:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cyclo-therapeutics-provides-business-update-and-reports-fourth-quarter-and-full-year-2020-financial-results\\\/\"},\"wordCount\":996,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cyclo-therapeutics-provides-business-update-and-reports-fourth-quarter-and-full-year-2020-financial-results\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20210315005155r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cyclo-therapeutics-provides-business-update-and-reports-fourth-quarter-and-full-year-2020-financial-results\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cyclo-therapeutics-provides-business-update-and-reports-fourth-quarter-and-full-year-2020-financial-results\\\/\",\"name\":\"Cyclo Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results - 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