{"id":477910,"date":"2021-04-19T08:04:21","date_gmt":"2021-04-19T12:04:21","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/ovid-provides-update-on-ov101-program-and-the-prioritization-of-its-resources\/"},"modified":"2021-04-19T08:04:21","modified_gmt":"2021-04-19T12:04:21","slug":"ovid-provides-update-on-ov101-program-and-the-prioritization-of-its-resources","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/ovid-provides-update-on-ov101-program-and-the-prioritization-of-its-resources\/","title":{"rendered":"OVID Provides Update on OV101 Program and the Prioritization of its Resources"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"center\">\n        <em>Completed Soticlestat Agreement with Takeda Provides Significant Resources to Advance and Enrich OVID\u2019s Pipeline, Including OV882 for Angelman Syndrome<\/em><br \/>\n        \n      <\/p>\n<p align=\"center\">\n        <em>Company Reiterates Anticipated <\/em><br \/>\n        <em>Quarterly Operating Expenses Guidance of <\/em><br \/>\n        <br \/>\n        <em>Between $8 Million\u00a0and $10 Million Beginning in 2Q 2021<\/em>\n      <\/p>\n<p align=\"justify\">NEW YORK, April  19, 2021  (GLOBE NEWSWIRE) &#8212; Ovid Therapeutics Inc.\u00a0(NASDAQ: OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced an update on its OV101 program and the prioritization of its resources to focus on the development of its robust early-stage pipeline, including OV882, a short hairpin RNA therapy targeting UBE3A gene expression in neurons, as a potential treatment for Angelman syndrome. As part of this update, Ovid will discontinue development of OV101 (gaboxadol), a delta (\u03b4)-selective GABAA\u00a0receptor agonist, in Angelman syndrome. Furthermore, Ovid does not plan to initiate further clinical studies of OV101 in Fragile X syndrome. Following these updates, Ovid is reiterating its previous guidance of anticipated quarterly operating expenses, excluding non-cash expenses, to be in the range of\u00a0$8 million\u00a0to\u00a0$10 million starting in the second quarter of 2021.<\/p>\n<p align=\"justify\">\u201cOvid has always taken a disciplined approach to its investments, with a keen focus on achieving the highest level of return,\u201d said Jeremy M. Levin, DPhil, MB, BChir, Chairman and Chief Executive Officer of Ovid Therapeutics. \u201cWhile we are disappointed in the outcome for OV101, our resources are now squarely focused on a very promising pipeline in rare neurological diseases, including Angelman syndrome. This focus is supported by the significant resources delivered through our agreement with Takeda for soticlestat, a program in which we maintain substantial financial interest and no additional financial obligations. Ovid would like to thank everyone who participated in our OV101 clinical trials, including those with Angelman syndrome and Fragile X syndrome, families and investigators, to whom we remain committed to finding solutions for rare neurological disorders.\u201d<\/p>\n<p>As announced on March 30, 2021, Ovid closed a Royalty, License and Termination agreement with Takeda Pharmaceutical Company Limited under which Takeda secured global rights from Ovid to develop and commercialize the investigational medicine soticlestat (TAK-935\/OV935) for the treatment of developmental and epileptic encephalopathies. Under the agreement, Ovid received or is eligible to receive meaningful financial consideration, including an upfront payment of $196 million, up to $660 million in development, regulatory and sales milestones, and tiered double-digit royalties up to 20 percent on sales of soticlestat, if approved and commercialized.<\/p>\n<p>Our proforma cash, cash-equivalents and short-term investments as of December 31, 2020 is over $250 million, reflecting the receipt of the upfront payment from Takeda. These resources enable a robust, long-term investment in the development of the Company\u2019s pipeline, and OVID\u2019s ability to assess novel assets and technologies that are complementary to this pipeline.<\/p>\n<p align=\"justify\">The decision to discontinue clinical study of OV101 in Angelman syndrome and Fragile X syndrome is based on the totality of the clinical results generated to date, including results from the STARS, NEPTUNE, ELARA, and ROCKET trials. While OV101 was well tolerated, with no significant safety signals observed, the Company believes that efficacy outcomes observed in these trials do not support its further development in these conditions.<\/p>\n<p>\n        <strong>About Ovid Therapeutics<\/strong>\n      <\/p>\n<p align=\"justify\">Ovid Therapeutics Inc.\u00a0is a\u00a0New York-based biopharmaceutical company using its BoldMedicine\u00ae approach to develop medicines that transform the lives of patients with rare neurological disorders.\u00a0 We believe these disorders represent an attractive area for drug development as the understanding of the underlying biology has grown meaningfully over the last few years and today represents a substantial opportunity medically and commercially. Based on recent scientific advances in genetics and the biological pathways of the brain, we aim to identify, discover and acquire novel compounds for the treatment of rare neurological disorders. We have built a deep knowledge of such disorders, how to treat them and how to develop the clinically meaningful endpoints required for development of a compound in these disorders. We continue to execute on our strategy to build this pipeline by discovering, in-licensing and collaborating with leading biopharmaceutical companies and academic institutions. Ovid\u2019s emerging pipeline programs include OV329, a small molecule GABA aminotransferase inhibitor for seizures associated with\u00a0Tuberous Sclerosis Complex\u00a0and Infantile Spasms; OV882, a short hairpin RNA therapy approach for Angelman syndrome; OV815, a genetic therapy approach for KIF1A associated neurological disorder; and other non-disclosed research targets. Additionally, Ovid maintains a financial interest in OV935 which is now being developed by Takeda. For more information on\u00a0Ovid, please visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=xUGiQo3bZxhezWNlWSV9svUt4Fn0Cl3X7Yl_PVQLR-cOH_FyxA0gRi0X4jlmquebaygk9UUUR0U1zUzk8DWkc_RK5U4AIypzdPwzFnObUKpuILzAe52fJI-uZ3LZKT2Vyh058-xw3zSLqI_28hpi-nOlAJl1N89iIe_R7hhpc5-PgiOe4RW_3y50Mk1j2B3nm8bPlGnHYwXbd2yVp9fKIRFNezsoWOtDQvQNO7juFEo=\" rel=\"nofollow noopener\" target=\"_blank\"><u>www.ovidrx.com<\/u><\/a>.<\/p>\n<p>\n        <strong>Forward-Looking Statements<\/strong>\n      <\/p>\n<p align=\"justify\">This press release includes certain disclosures that contain \u201cforward-looking statements,\u201d including, without limitation, statements regarding the clinical and regulatory development and commercialization of Ovid\u2019s programs and the potential value and benefits of the Royalty, License and Termination Agreement with Takeda, Ovid\u2019s expectations regarding its operating expenses, and use of its cash, cash equivalents and short-term investments to development the Company\u2019s pipeline. You can identify forward-looking statements because they contain words such as \u201cwill,\u201d \u201cappears,\u201d \u201cbelieves\u201d and \u201cexpects.\u201d Forward-looking statements are based on Ovid\u2019s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include Ovid\u2019s ability to discover and successfully complete preclinical and clinical development of, obtain regulatory approval for, and, if approved, successfully commercialize its current and future drug candidates in a timely manner, uncertainties in the development and regulatory approval processes, the fact that initial data from pre-clinical and clinical trials may not be indicative, and are not guarantees, of the final results of the trials and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and\/or more patient data become available. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth in Ovid\u2019s filings with the\u00a0Securities and Exchange Commission\u00a0under the caption \u201cRisk Factors.\u201d Such risks may be amplified by the COVID-19 pandemic and its potential impact on Ovid\u2019s business and the global economy. Ovid assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.<\/p>\n<p align=\"justify\">\n        <strong>Contacts<\/strong>\n      <\/p>\n<p>\n        <strong>Investors and Media:<\/strong><br \/>\n        <br \/>Ovid Therapeutics Inc.<br \/>Investor Relations &amp; Public Relations<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=gqSZHnf5fHiCWsxcn7QAVT_18QUAiyTYWH7qxketopGyRkGvKst1o9YlOGaZTTCawGk0zoyySx41fbou7RwxUA==\" rel=\"nofollow noopener\" target=\"_blank\">irpr@ovidrx.com<\/a><\/p>\n<p>OR<\/p>\n<p>\n        <strong>Investors:<\/strong><br \/>\n        <br \/>Argot Partners<br \/>Dawn Schottlandt<br \/>212-600-1902<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=dihT0Dw0NDdHOhYtig3un6jS9a7pCTTX1pbOnAsOP75DRDtHT6c0EWYjiOmmboWVLuO0K_rMqHDGTU6EgpIBF1uiTCGfHVQkTxgBo5I-jvo=\" rel=\"nofollow noopener\" target=\"_blank\">ovid@argotpartners.com<\/a><\/p>\n<p>\n        <strong>Media:<\/strong><br \/>\n        <br \/>Dan Budwick<br \/>1AB<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=7P5CEf5ru8Q_kV3lNhIVcAt3d87U4LjHYjLVK9fcJBqkqaWOXU1xbe901vFsTKnEgWKKZfoJZ0Ms1BykjXHkGg==\" rel=\"nofollow noopener\" target=\"_blank\">dan@1abmedia.com<\/a><\/p>\n<\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODIxOTA0NCM0MTI2NjkwIzIwNzAyNjA=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/3f07c60f-062e-4acf-a4c9-f514b2a45d1b\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Completed Soticlestat Agreement with Takeda Provides Significant Resources to Advance and Enrich OVID\u2019s Pipeline, Including OV882 for Angelman Syndrome Company Reiterates Anticipated Quarterly Operating Expenses Guidance of Between $8 Million\u00a0and $10 Million Beginning in 2Q 2021 NEW YORK, April 19, 2021 (GLOBE NEWSWIRE) &#8212; Ovid Therapeutics Inc.\u00a0(NASDAQ: OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced an update on its OV101 program and the prioritization of its resources to focus on the development of its robust early-stage pipeline, including OV882, a short hairpin RNA therapy targeting UBE3A gene expression in neurons, as a potential treatment for Angelman syndrome. As part of this update, Ovid will discontinue development of OV101 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/ovid-provides-update-on-ov101-program-and-the-prioritization-of-its-resources\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;OVID Provides Update on OV101 Program and the Prioritization of its Resources&#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-477910","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>OVID Provides Update on OV101 Program and the Prioritization of its Resources - 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\/ovid-provides-update-on-ov101-program-and-the-prioritization-of-its-resources\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"OVID Provides Update on OV101 Program and the Prioritization of its Resources - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Completed Soticlestat Agreement with Takeda Provides Significant Resources to Advance and Enrich OVID\u2019s Pipeline, Including OV882 for Angelman Syndrome Company Reiterates Anticipated Quarterly Operating Expenses Guidance of Between $8 Million\u00a0and $10 Million Beginning in 2Q 2021 NEW YORK, April 19, 2021 (GLOBE NEWSWIRE) &#8212; Ovid Therapeutics Inc.\u00a0(NASDAQ: OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced an update on its OV101 program and the prioritization of its resources to focus on the development of its robust early-stage pipeline, including OV882, a short hairpin RNA therapy targeting UBE3A gene expression in neurons, as a potential treatment for Angelman syndrome. 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/ovid-provides-update-on-ov101-program-and-the-prioritization-of-its-resources\/","og_locale":"en_US","og_type":"article","og_title":"OVID Provides Update on OV101 Program and the Prioritization of its Resources - Market Newsdesk","og_description":"Completed Soticlestat Agreement with Takeda Provides Significant Resources to Advance and Enrich OVID\u2019s Pipeline, Including OV882 for Angelman Syndrome Company Reiterates Anticipated Quarterly Operating Expenses Guidance of Between $8 Million\u00a0and $10 Million Beginning in 2Q 2021 NEW YORK, April 19, 2021 (GLOBE NEWSWIRE) &#8212; Ovid Therapeutics Inc.\u00a0(NASDAQ: OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced an update on its OV101 program and the prioritization of its resources to focus on the development of its robust early-stage pipeline, including OV882, a short hairpin RNA therapy targeting UBE3A gene expression in neurons, as a potential treatment for Angelman syndrome. 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