XORTX Moving to the Next Level - Phase 3 Clinical Trials February 04, 2022 - Baystreet.ca eResearch Corp. (www.eresearch.com) published a 25-page update Equity Research Report on XORTX Therapeutics Inc. (TSXV:XRTX | NASDAQ:XRTX | FSE:ANU) pertaining to its recent financings to “set the stage” for the initiation of late-stage clinical trials of therapies to treat progressive kidney disease. XORTX, a biopharmaceutical company, engages in research and development to optimize the delivery of existing drugs to treat specific patient populations with kidney disease. Frequently this increased bioavailability is accompanied by increased efficacy and drug tolerability. The recent uplisting to the NASDAQ exchange and concurrent US$12 million financing has fully funded the company to advance it towards the initiation of Phase 3 clinical trials and the approval of its first product within the next 18-24 months. XORTX's most advanced therapeutic, XRx-008, is aimed at the treatment of autosomal dominant polycystic kidney disease (ADPKD), an orphan indication with more than 150,000 patients in the USA. ADPKD is a genetic condition that is a progressive disease and causes the creation of cysts to develop in the kidneys that can eventually lead to kidney failure. XORTX’s other clinically advanced product in development is XRx-101 for acute kidney injury (AKI) associated with COVID-19 infections. The recent financing has provided the company with resources for the documentation completion and initiation of Phase 3 clinical trial of both drugs: XRx-008 for the treatment of ADPKD and XRx-101 for the treatment of AKI found in COVID-19 patients. XRx-101 could be approved within the next 18 months while XRx-008 could have an orphan drug indication on the market in 2025. Claude Camiré, Senior Equity Research Analyst with eResearch commented, “When compared to peer companies, either developing orphan drugs at a similar stage of development or new companies that became public in the last two years, XORTX is undervalued.” The recent financing enables the company to initiate the clinical trials for both XRx-008 and XRx-101 but we expect a commercial partner, a global pharma or biotech company, will emerge as the clinical trials advance. Partnership interests are likely to become more active as recent examples of commercial licenses in the kidney disease treatment space bode well for XORTX. Two recent examples include Travere Therapeutics (NASDAQ:TVTX) and Vifor Pharma (SWX:VIFN) announcing a licensing for Sparsentan, and MERCK KGaA (XTRA:MRK) entering into an out-licensing agreement with Vera Therapeutics (NASDAQ:VERA) for atacicept. The analyst expects a commercial partner to show interest if the FDA provides orphan drug status to XRx-008 for the treatment of ADPKD and this designation would significantly de-risk the drug development. According to the company, current research being conducted will be used to file for orphan drug designation with the FDA in 2022. The analyst continues to value the stock using a sum-of-the-parts methodology that includes Discount Cash Flow (“DCF”) calculations for the two main assets (XRx-008 and XRx-101) and he assigns no value to other drugs under development. For more information about eResearch's 25-page update Equity Research Report on XORTX, please visit eResearch's website (www.eresearch.com).Disclaimer / No representations, express or implied, are made by eResearch as to the accuracy, completeness or correctness of its research. Opinions and estimates expressed in its research represent eResearch’s judgment as of the date of its reports, are subject to change without notice, and are provided in good faith and without legal responsibility. Its research is not an offer to sell or a solicitation to buy any securities. The securities discussed may not be eligible for sale in all jurisdictions. Neither eResearch, nor any person employed by eResearch, accepts any liability whatsoever for any direct or indirect loss resulting from any use of its research or the information it contains. eResearch reports may not be reproduced, distributed, or published without the express permission of eResearch. eResearch accepts advertising and other fees from companies, financial institutions, other third parties, and Institutional and Retail Investors. The purpose of this policy is to defray the cost of researching small and medium capitalization stocks which otherwise receive little or no research coverage. To ensure complete independence and editorial control over its research reports, eResearch follows the CFA Institute’s “Best Practice Guidelines Governing Analyst/Corporate Issuer Relations”.
XORTX Moving to the Next Level - Phase 3 Clinical Trials February 04, 2022 - Baystreet.ca eResearch Corp. (www.eresearch.com) published a 25-page update Equity Research Report on XORTX Therapeutics Inc. (TSXV:XRTX | NASDAQ:XRTX | FSE:ANU) pertaining to its recent financings to “set the stage” for the initiation of late-stage clinical trials of therapies to treat progressive kidney disease. XORTX, a biopharmaceutical company, engages in research and development to optimize the delivery of existing drugs to treat specific patient populations with kidney disease. Frequently this increased bioavailability is accompanied by increased efficacy and drug tolerability. The recent uplisting to the NASDAQ exchange and concurrent US$12 million financing has fully funded the company to advance it towards the initiation of Phase 3 clinical trials and the approval of its first product within the next 18-24 months. XORTX's most advanced therapeutic, XRx-008, is aimed at the treatment of autosomal dominant polycystic kidney disease (ADPKD), an orphan indication with more than 150,000 patients in the USA. ADPKD is a genetic condition that is a progressive disease and causes the creation of cysts to develop in the kidneys that can eventually lead to kidney failure. XORTX’s other clinically advanced product in development is XRx-101 for acute kidney injury (AKI) associated with COVID-19 infections. The recent financing has provided the company with resources for the documentation completion and initiation of Phase 3 clinical trial of both drugs: XRx-008 for the treatment of ADPKD and XRx-101 for the treatment of AKI found in COVID-19 patients. XRx-101 could be approved within the next 18 months while XRx-008 could have an orphan drug indication on the market in 2025. Claude Camiré, Senior Equity Research Analyst with eResearch commented, “When compared to peer companies, either developing orphan drugs at a similar stage of development or new companies that became public in the last two years, XORTX is undervalued.” The recent financing enables the company to initiate the clinical trials for both XRx-008 and XRx-101 but we expect a commercial partner, a global pharma or biotech company, will emerge as the clinical trials advance. Partnership interests are likely to become more active as recent examples of commercial licenses in the kidney disease treatment space bode well for XORTX. Two recent examples include Travere Therapeutics (NASDAQ:TVTX) and Vifor Pharma (SWX:VIFN) announcing a licensing for Sparsentan, and MERCK KGaA (XTRA:MRK) entering into an out-licensing agreement with Vera Therapeutics (NASDAQ:VERA) for atacicept. The analyst expects a commercial partner to show interest if the FDA provides orphan drug status to XRx-008 for the treatment of ADPKD and this designation would significantly de-risk the drug development. According to the company, current research being conducted will be used to file for orphan drug designation with the FDA in 2022. The analyst continues to value the stock using a sum-of-the-parts methodology that includes Discount Cash Flow (“DCF”) calculations for the two main assets (XRx-008 and XRx-101) and he assigns no value to other drugs under development. For more information about eResearch's 25-page update Equity Research Report on XORTX, please visit eResearch's website (www.eresearch.com).Disclaimer / No representations, express or implied, are made by eResearch as to the accuracy, completeness or correctness of its research. Opinions and estimates expressed in its research represent eResearch’s judgment as of the date of its reports, are subject to change without notice, and are provided in good faith and without legal responsibility. Its research is not an offer to sell or a solicitation to buy any securities. The securities discussed may not be eligible for sale in all jurisdictions. Neither eResearch, nor any person employed by eResearch, accepts any liability whatsoever for any direct or indirect loss resulting from any use of its research or the information it contains. eResearch reports may not be reproduced, distributed, or published without the express permission of eResearch. eResearch accepts advertising and other fees from companies, financial institutions, other third parties, and Institutional and Retail Investors. The purpose of this policy is to defray the cost of researching small and medium capitalization stocks which otherwise receive little or no research coverage. To ensure complete independence and editorial control over its research reports, eResearch follows the CFA Institute’s “Best Practice Guidelines Governing Analyst/Corporate Issuer Relations”.