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. Appili Therapeutics Inc. (TSX: APLI), a biopharmaceutical company focused on drug development for infectious diseases, has closed a $3.5 million convertible security funding agreement.
As part of the deal, Appili received net proceeds of $3.4 million from Lind Global Fund II, LP, an investment entity managed by New York institutional fund manager The Lind Partners. Appili Therapeutics intends to use the funding to support the operations of the Company as it prepares for top-line data from its PRESECO Phase 3 trial evaluating Avigan®/Reeqonus™ (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19. The funding will also be used to advance the broader Appili pipeline, including ATI-2307, a novel clinical stage antifungal expected to enter Phase 2 study in 2022. Source: Appili Therapeutics Inc. IMV Inc. (the “Company” or “IMV”) (TSX: IMV; NASDAQ: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, today announced its financial and operational results and provided an update for the second quarter ended June 30, 2021. "IMV is undergoing a critical transformation and focusing on delivering tangible clinical and scientific data to support further development and commercialization of our unique programs and DPX platform technology. The recent results obtained with the translational analyses in ovarian cancer further validate our lead compound and DPX technology. We are also very excited by the overall expansion of our clinical pipeline across a range of tumor antigens and indications. Our recent financing has strengthened our balance sheet and provided us with the runway to deliver additional confirmatory data to investors and the scientific community." - Andrew Hall, Interim CEO of IMV Inc. Clinical Programs with Maveropepimut-S (MVP-S, Formerly Named DPX-Survivac) Phase 2B Study in Relapsed/Refractory DLBCL ("r/r DLBCL") In the previous Phase 2 clinical study (SPiReL), MVP-S in combination with Merck’s KEYTRUDA and intermittent low dose cyclophosphamide (CPA) showed promising data with 50% Overall Response Rate (ORR) and 78.6% Disease Control Rate (DCR) in evaluable patients. Also, PD-L1 expression has been identified as a potential predictive biomarker of response, as PD-L1+ patients demonstrated 85.7% ORR and 85.7% DCR. Most commonly reported events are Grade 1 and 2 injection site reactions, 20.8% subjects reported Grade 3 or above adverse events. The Company announced in April that it entered into an agreement with Merck (NYSE: MRK) to initiate a Phase 2B clinical trial to evaluate its lead compound, MVP-S, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in a Phase 2B study r/r DLBCL. The trial was initiated in June 2021, and the first sites have since been activated. PD-L1 will be assessed for every potential patient considered for enrollment. Phase 2 DeCidE1 Study in Advanced, Recurrent Ovarian Cancer IMV has recently completed the DeCidE1 clinical trial evaluating MVP-S in association with CPA in patients with advanced recurrent ovarian cancer. The final patient completed the study after more than 2 years of clinical benefit with MVP-S. In this study, many subjects have been through several lines of prior treatment and 57.9% patients were platinum resistant. Overall, the treatment was well tolerated with most adverse events being injection site reactions. At the 2-year cut-off, the overall survival rate in this cohort was 44.9% with a median overall survival of 19.9 months, results that support further clinical evaluation of this treatment. Translational analyses from this trial confirm generation of tumor-antigen directed T cells by MVP-S. The details of these translational analyses have been submitted for presentation at upcoming scientific meetings. These data will also inform the discussion and design of a Phase 2B clinical study to be submitted to the FDA. Recent Financing Strengthens IMV’s Financial Position All dollar amounts noted herein are denominated in United States dollars (unless otherwise noted herein). Public Offering On July 20, 2021, IMV announced the closing of a public offering of 14,285,714 units at a price to the public of $1.75 per Unit, for aggregate gross proceeds to the Corporation of approximately $25 million (Estimated net proceeds are $23 million). Each unit is comprised of one common share and three-quarters of one common share purchase warrant. Each Warrant entitles the holder thereof to purchase one common share at a price of $2.10 per common share, subject to adjustment in certain events, for five years until July 20, 2026. If the warrants are fully exercised, they can represent approximately $22.5M of additional gross proceeds. Overview of Second Quarter 2021 Financial Results On June 30, 2021, the Company had cash and cash equivalents of $22.8 million and working capital of $24.6 million, compared with $36.3 million and $35.6 million, respectively at December 31, 2020. Subsequent to June 30, 2021, the Company completed the above-mentioned public offering of 14,285,714 units at $1.75 per unit for gross process of $25 million (estimated net proceeds of $23 million) resulting in pro-forma cash and cash equivalents of $45.8 million as of June 30, 2021. Based on its current plan, IMV expects its current cash position will be sufficient to fund operations for more than 12 months. Research and development expenses were $5.2 million for the three months ended June 30, 2021, compared with $3.8 million for the three months ended June 30, 2020. This increase of $1.4 million was mainly due to startup costs for the Phase 2B trial in DLBCL, the timing of manufacturing activities for MVP-S and DPX-SurMAGE, and an increase in headcount. These increases were partly offset by a decrease in costs for the pre-clinical development of DPX-COVID-19 and costs for the ongoing basket trial of MVP-S in several cancer indications. General and administrative expenses were $3.4 million for the three months ended June 30, 2021, compared with $2.2 million for the three months ended June 30, 2020. This increase of $1.2 million was mainly attributable an increase in the Company’s Directors and Officers insurance premium as a result of rate increases in mid-2020, an increase in headcount and an increase in recruiting fees for new executives and board members. Government assistance totaled $1.2 million for the three months ended June 30, 2021, compared with $1 million in Q2 2020. This increase in mainly driven by the revaluation of the Nova Scotia loan upon receipt of the 2-year deferral of repayments partly offset by a decrease in various government grants for the development of DPX-COVID-19, consistent with the decrease in development expenses described above. The net loss and comprehensive loss of $7.4 million ($0.11 per share) for the three months ended June 30, 2021, was $2.6 million higher than the net loss and comprehensive loss of $4.8 million ($0.08 per share) for the three months ended June 30, 2020. For the six-month period ended June 30, 2021, the net loss and comprehensive loss of $14.3 million ($0.21 per share) was $2.3 million higher than the net loss and comprehensive loss of $12.0 million ($0.24 per share) for the six-month period ended June 30, 2020. The higher net loss is primarily the result of a $1.1 million increase in R&D expenses and a $2 million increase in general and administrative expenses partly compensated by a $1 million increase in government assistance mainly towards COVID-19 vaccine development as well as the revaluation of the loan with the province of Nova Scotia upon receipt of the above-mentioned amendment. As of August 10, 2021, the number of issued and outstanding common shares was 82,142,629 and a total of 15,705,452 stock options, warrants and deferred share units were outstanding. The Corporation's audited annual consolidated results of operations, financial condition and cash flows for the year ended December 31, 2020 and the related management's discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar as well as the Company’s website at https://www.imv-inc.com/investors/financial-information/financial-results. Selected Upcoming Milestones Maveropepimut-S (MVP-S):
DPX-SurMAGE:
Source: IMV Inc. |
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