Appili Therapeutics Provides Update on Phase 3 PRESECO Clinical Trial Evaluating Avigan®/Reeqonus™11/12/2021 Infectious disease-focused biopharmaceutical company, Appili Therapeutics Inc., today announced that the Phase 3 PRESECO clinical trial evaluating oral antiviral Avigan®/Reeqonus™(favipiravir) for the treatment of mild-to-moderate COVID-19 did not achieve statistical significance on the primary endpoint of time to sustained clinical recovery. Additional analyses of the trial data are ongoing. The clinical trial enrolled 1,231 patients with mild-to-moderate COVID-19 from 38 study sites across the United States, Mexico, and Brazil.
“While we are disappointed by the topline results of the PRESECO trial, we remain steadfast in our belief that safe and effective oral antivirals are urgently needed for patients who are still struggling to overcome COVID-19. We wish to thank all the patients who participated, and hope that information obtained from our trial can help guide research and development around more potential treatment options for COVID-19,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Appili remains committed to addressing the challenges posed by infectious diseases and we will continue developing our pipeline to improve patient lives around the world.” The Phase 3 PRESECO (PREventing SEvere COVID-19 Disease) study is a double-blind, placebo-controlled, randomized, multi-center, global superiority trial investigating the safety and efficacy of oral Avigan/Reeqonus in the early treatment for adults infected with COVID-19 and showing mild-to-moderate symptoms. Participants were enrolled at multiple clinical trial sites in the United States, Brazil and Mexico. Participants were outpatients with mild-to-moderate symptoms who have had a recent positive COVID-19 test (within 72 hours of enrollment). Participants self-administered the drug regimen in their homes, with clinical investigators monitoring patients remotely. Avigan/Reeqonus is a broad-spectrum antiviral in oral tablet form. It is a selective inhibitor of viral RNA-dependent RNA polymerase (RdRP) with potent antiviral activity against single-stranded RNA viruses, including coronaviruses. Developed by FUJIFILM Toyama Chemical Co., Ltd. (FFTC) and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza. Unlike most other interventions that researchers are evaluating in COVID-19, Avigan/Reeqonus has already been thoroughly studied in human trials and has a well-known safety profile, with over 3,000 subjects receiving at least one dose of the drug. Avigan/Reeqonus’ oral tablet form is shelf-stable and has an established commercial manufacturing process, which may provide advantages over other COVID-19 interventions, which often require temperature-controlled storage and/or injection or intravenous administration. Source: Appili Therapeutics Inc.
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DRI Healthcare Trust Doubles Quarterly Distribution to Unitholders Following Third Quarter Results11/8/2021 DRI Healthcare Trust (TSX: DHT.UN) (TSX: DHT.U) ("DRI" or "the Trust") today announced its results for the quarter ended September 30, 2021.
"We had a very active third quarter, executing multiple transactions and demonstrating our commitment and ability to build our cash flows and asset base," said Behzad Khosrowshahi, Chief Executive Officer of DRI Healthcare Trust. "Our existing assets continued to perform well during the quarter, and our recent transactions contribute meaningfully to our objective of generating sustainable growth in cash flow. We are pleased that this has allowed us to increase our quarterly distribution to unitholders." Third Quarter Highlights
Subsequent to Quarter End
Asset Performance During the third quarter, the Trust's portfolio included 17 royalty streams on 13 products that address medically necessary therapeutic areas, such as oncology, rare diseases, ophthalmology, endocrinology, autoimmune and vaccines. On September 30, 2021, the royalty asset portfolio had a book value, net of accumulated amortization, of US$306.6 million and generated Total Cash Royalty Receipts of US$15.4 million in the third quarter, on a pro forma basis. In addition, the Trust held a loan receivable with an outstanding gross principal balance of US$50.0 million at September 30, 2021. Liquidity and Capital On September 30, 2021, the Trust had cash on hand of US$33.8 million and an additional US$7.4 million funds held in trust. The Trust's secured notes had an outstanding balance of US$47.1 million on September 30, 2021, which was subsequently reduced with a principal payment of US$4.2 million made on October 15, 2021 from the funds held in trust, following which the remaining balance in funds held in trust was released to the Trust. On October 22, 2021 the remaining secured notes were fully retired using proceeds of a new credit facility as described below. The Trust had units outstanding of 40,107,407 on September 30, 2021, all of which were issued in connection with the IPO and concurrent private placement on February 19, 2021. On September 30, 2021, the Trust was granted approval by the Toronto Stock Exchange for the proposal to acquire, from time to time, if considered advisable, up to 1,500,000 units of the Trust for cancellation between October 5, 2021 and October 4, 2022. As at November 1, 2021, the Trust had acquired 70,152 units at an average unit price of US$6.64. About DRI Healthcare Trust DRI Healthcare Trust provides unitholders with differentiated exposure to the anticipated growth in the global pharmaceuticals and biotechnology markets. Our business model is focused on managing and growing a diversified portfolio of pharmaceutical royalties with the aim to deliver attractive growth in cash royalty receipts over the long term. DRI Healthcare Trust is an unincorporated open-ended trust governed by the laws of the Province of Ontario, externally managed by its manager, DRI Capital Inc. DRI Healthcare Trust's units are listed and trade on the Toronto Stock Exchange in Canadian dollars under the symbol "DHT.UN" and in U.S. dollars under the symbol "DHT.U". Source: DRI Healthcare Trust Study expected to include patients with top priority COVID-19 variants, including Delta
Infectious disease company, Appili Therapeutics (TSX: APLI; OTCQX: APLIF), has completed enrollment in its global Phase 3 PRESECO (PREventing SEvere COVID-19) trial evaluating Avigan®/Reeqonus™(favipiravir) as an oral treatment for COVID-19. Appili expects to report top-line data from this trial in approximately 60 days. With today’s announcement, the double-blind, placebo-controlled, randomized, global, multi-center trial has enrolled 1,231 patients from 38 study sites across the United States, Mexico, and Brazil. “Completing enrollment in this large Phase 3 pivotal trial in just ten months is a tremendous accomplishment for Appili. With this major milestone now achieved, we have a clear path to completing the PRESECO data analysis in the coming weeks and determining if Avigan/Reeqonus has the potential to meet the urgent global clinical need for a safe and effective oral treatment for this deadly disease,” said Armand Balboni, M.D., Ph.D., Chief Executive Officer, Appili Therapeutics. The primary goal of PRESECO is to evaluate the impact of oral Avigan/Reeqonus on time to COVID-19 symptom resolution. The study also aims to evaluate the effect of oral treatment on progression to more severe COVID-19 disease. Finally, this Phase 3 clinical trial includes a viral shedding sub-study, which is evaluating impact of the treatment on time to viral clearance. Viral isolates will also be sequenced for identification of COVID-19 variants. “As we have seen over the past 18 months, this virus continues to mutate, enhancing its ability to infect and cause significant symptoms, especially in those who have not been vaccinated. My hope is that Avigan/Reeqonus will emerge as a standard of care treatment for mild to moderate COVID-19 patients, resolve patient’s symptoms more rapidly, and limit progression to more severe disease” said Yoav Golan, M.D., Chief Medical Officer, Appili Therapeutics. About the PRESECO Clinical Trial The Phase 3 PRESECO (PREventing SEvere COVID-19 Disease) study is a double-blind, placebo-controlled, randomized, multi-center, global superiority trial investigating the safety and efficacy of oral Avigan/Reeqonus in the early treatment for adults infected with COVID-19 and showing mild-to-moderate symptoms. Participants were enrolled at multiple clinical trial sites in the United States, Brazil and Mexico. Participants are outpatients with mild-to-moderate symptoms who have had a recent positive COVID-19 test (within 72 hours of enrollment). Participants self-administer the drug regimen in their homes, with clinical investigators monitoring patients remotely. About Avigan/Reeqonus Avigan/Reeqonus is a broad-spectrum antiviral in oral tablet form. It is a selective inhibitor of viral RNA-dependent RNA polymerase (RdRP) with potent antiviral activity against single-stranded RNA viruses, including coronaviruses. Developed by FUJIFILM Toyama Chemical Co., Ltd. (FFTC) and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza. Unlike most other interventions that researchers are evaluating in COVID-19, Avigan/Reeqonus has already been thoroughly studied in human trials and has a well-known safety profile, with over 3,000 subjects receiving at least one dose of the drug. Avigan/Reeqonus’ oral tablet form is shelf-stable and has an established commercial manufacturing process, which may provide advantages over other COVID-19 interventions, which often require temperature-controlled storage and/or injection or intravenous administration. Appili has joined a consortium of companies, including Dr. Reddy’s Laboratories, Global Response Aid, and FFTC, for the worldwide development and distribution of Avigan/Reeqonus tablets for the potential treatment and prevention of COVID-19 (excluding Japan, China, and Russia). This consortium is designed to ensure that Avigan/Reeqonus is thoroughly evaluated in rigorous clinical studies and, if it receives the proper regulatory approvals, has the infrastructure in place to support worldwide manufacturing and distribution. Source: Appili Therapeutics Inc. New Funds Will Help Expedite Completion of Recently Expanded Pivotal Phase 3 Study on Oral Antiviral Medicine
Infectious disease company, Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF), has entered into an agreement with FUJIFILM Toyama Chemical Co., Ltd. (“FFTC”), that will provide funding support for its Phase 3 PRESECO (PREventing SEvere COVID-19) clinical trial. The new funding of $1,000,000 USD was secured from FFTC, one of the Company’s partners in a global consortium focused on the worldwide development, commercialization, and distribution of Avigan®/Reeqonus™ (favipiravir) tablets for the potential treatment and prevention of COVID-19. The new funding will support various components of the recently expanded PRESECO trial, including study close-out activities as the Company prepares for database lock and top-line results. Enrollment targets for PRESECO and the viral shedding sub-study were recently increased to enable additional enrollment of COVID-19 variant cases and maximize the number of patients in the final analysis. As part of the agreement, FFTC will receive direct access to PRESECO data in support of local regulatory submissions in Japan. PRESECO is investigating the safety and efficacy of Avigan/Reeqonus in the early treatment outpatient setting for adults infected with COVID-19. “FFTC recognizes the unmet need of this pandemic, which is the lack of safe, effective oral antiviral medicines to treat mild-to-moderate COVID-19 patients. With FFTC’s support, we are one step closer to determining if Avigan/Reeqonus will meet this need,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. Avigan/Reeqonus is a broad-spectrum antiviral in oral tablet form. It is a selective inhibitor of viral RNA-dependent RNA polymerase (RdRP) with potent antiviral activity against single-stranded RNA viruses, including coronaviruses. Developed by FFTC and originally approved in Japan as a treatment for pandemic influenza, this product is one of the few oral antiviral candidates in Phase 3 clinical development to treat newly diagnosed COVID-19 patients. “We share the sense of urgency that so many physicians and nurses have expressed globally for the need of new treatments developed that will help bring this pandemic to an end. We remain confident Avigan/Reeqonus will play an important role in North America, Japan, and around the world in the treatment of COVID-19 now, and in the near future,” said Junji Okada, President, FUJIFILM Toyama Co., Ltd. About the PRESECO Clinical Trial The Phase 3 PRESECO (PREventing SEvere COVID-19 Disease) study is a double-blind, placebo-controlled, randomized, multi-center superiority trial investigating the safety and efficacy of Avigan/Reeqonus in the early treatment for adults infected with COVID-19 and showing mild-to-moderate symptoms. Investigators are enrolling participants at multiple clinical trial sites in the United States, Brazil and Mexico. Participants are outpatients with mild-to-moderate symptoms who have had a recent positive COVID-19 test (within 72 hours of enrollment). Participants self-administer the drug regimen in their homes, with clinical investigators monitoring patients remotely. About Avigan/Reeqonus Avigan/Reeqonus is a broad-spectrum antiviral in oral tablet form. It is a selective inhibitor of viral RNA-dependent RNA polymerase (RdRP) with potent antiviral activity against single-stranded RNA viruses, including coronaviruses. Developed by FUJIFILM Toyama Chemical Co., Ltd. (FFTC) and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza. Unlike most other interventions that researchers are evaluating in COVID-19, Avigan/Reeqonus has already been thoroughly studied in human trials and has a well-known safety profile, with over 3,000 subjects receiving at least one dose of the drug. Avigan/Reeqonus’ oral tablet form is shelf-stable and has an established commercial manufacturing process, which may provide advantages over other COVID-19 interventions, which often require temperature-controlled storage and/or injection or intravenous administration. Source: Appili Therapeutics Inc. NeuPath Health Inc. (TSXV:NPTH), (“NeuPath” or the “Company”), owner and operator of a network of clinics delivering category-leading chronic pain treatment announced today a Memorandum of Understanding (“MoU”) with Texas-based Cynergi Health Partners (“Cynergi”), a leading multidisciplinary company recognized for clinical excellence and for cutting edge treatment technologies for addiction and psychiatry, to evaluate the effectiveness of Cynergi’s virtual reality (“VR”) program targeting chronic pain management. Rilaxta VRx, Cynergi’s category leading software, will be used in combination with other treatments offered at NeuPath. The companies will work on developing and co-marketing a combined offering – consisting of Rilaxta VRx and NeuPath’s remote pain management and virtual care platform – across Canada and the US. “Numerous studies show the benefits of pairing VR based software with more conventional interventions. Working with a leading group like Cynergi allows us to bring innovative, behavioral pain treatments to our patients. In addition, collaborating with Cynergi and co-marketing Rilaxta VRx with NeuPath’s virtual care platform creates a compelling offering that will open new markets in Canada and the US.” - Grant Connelly, CEO of Neupath. About NeuPath NeuPath is a vertically integrated health care provider utilizing research, data-driven insights, technology, and interdisciplinary care to help restore function for patients impacted by chronic pain, spinal injuries, sport-related injuries, and concussions. With equity ownership in fifteen clinics in Ontario and Alberta, NeuPath is building out a large-scale network to better serve patients across Canada and the United States. NeuPath is focused on transforming the hope of a better life into the reality of a life more fully lived. About Cynergi Cynergi Health Partners, a pioneer in addiction medicine and psychiatry, offers best-in-class patient care as well as access to a network of award-winning physicians, medical detox services, innovative technology, and cutting-edge detox protocols. Cynergi’s unique, proprietary virtual reality software is used to painlessly minimize and alleviate withdrawal symptoms of anxiety or panic associated with, but not limited to, alcohol, opiate, and benzodiazepine addiction. Improved patient outcomes are accomplished using soothing imagery and sounds along with proven psychological techniques that make the detox process easier and smoother. Source: NeuPath Health Inc. Medical Facilities Corporation ("Medical Facilities," "MFC," or the "Corporation") (TSX: DR), reported its financial results today for the three-month and six-month periods ended June 30, 2021. All amounts are expressed in U.S. dollars unless indicated otherwise. Q2 2021 Summary (For continuing operations1 compared to Q2 2020)
"The volume recovery continued in the second quarter as we neared pre-pandemic levels. We continue to be cautiously optimistic in our outlook for the remainder of 2021. While vaccines continue to roll out across the country, there is still a lot of uncertainty due to the Delta variant. Our balance sheet remains strong and we are well-positioned to evaluate the right growth opportunities in the back half of 2021." - Robert O. Horrar, President and CEO of Medical Facilities. Medical Facilities Corporation Q2 2021 Earnings Call - August 12, 2021 During the quarter, MFC paid a quarterly cash dividend of C$0.07 per common share (or C$0.28 per share on an annualized basis), which represented an annualized yield of 3.99% on the June 30, 2021 closing price of $7.01 per common share.
As at June 30, 2021, MFC had consolidated net working capital of $48.1 million, compared to $45.0 million on December 31, 2020. MFC's financial statements and management's discussion and analysis, for the three-month and six-month periods ended June 30, 2021, will be filed on SEDAR at www.sedar.com on Thursday, August 12, 2021, and will also be available on Medical Facilities' website at www.medicalfacilitiescorp.ca. Source: Medical Facilities Corporation |
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