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Arch Biopartners Announces First Patient Successfully Dosed at Toronto General Hospital in Phase II Trial of LSALT Peptide Targeting Cardiac Surgery-Associated Acute Kidney Injury
Globenewswire· 2025-08-06 11:25
Core Insights - Arch Biopartners Inc. has initiated dosing in its Phase II trial for LSALT peptide aimed at preventing cardiac surgery-associated acute kidney injury (CS-AKI) with the first patient successfully dosed at Toronto General Hospital [1][9] - The trial is a multi-center, randomized, double-blind, placebo-controlled study targeting 240 patients, with the primary objective to evaluate the incidence of acute kidney injury within seven days post cardiac surgery [4][12] - The company is expanding its clinical trial sites in Canada and the United States, with St. Michael's Hospital expected to be the next site activated [3][9] Company Overview - Arch Biopartners is focused on developing drugs targeting the dipeptidase-1 (DPEP1) pathway to prevent organ damage caused by inflammation, particularly in the kidneys, lungs, and liver [14][10] - LSALT peptide is the lead drug candidate, which has shown a strong safety profile in previous trials and aims to address the significant unmet medical need for therapies preventing CS-AKI [13][10] Trial Details - The ongoing Phase II trial involves a dosing regimen of 10mg of LSALT peptide administered intravenously twice daily for five days, with subjects randomized to receive either the peptide or a placebo [4][10] - The trial's completion is estimated for August 2026, reflecting the time required for Canadian sites to prepare and obtain necessary approvals [6] Clinical Significance - CS-AKI is a common complication in cardiac surgery, affecting up to 30% of patients undergoing on-pump procedures, leading to serious health risks and increased mortality [12][8] - The LSALT peptide represents a potential first-in-class therapeutic approach to mitigate inflammation injury in this high-risk patient population [13][10]
Arch Biopartners Announces Start of Patient Recruitment in Phase II PONTIAK Trial Targeting Drug-Toxin-Related Acute Kidney Injury (AKI)
Globenewswire· 2025-07-22 11:30
Core Insights - Arch Biopartners Inc. has initiated patient recruitment for the Phase II trial named "Prevention Of NephroToxin Induced Acute Kidney Injury with Cilastatin" (PONTIAK) in Alberta, Canada [1][2] Company Overview - Arch Biopartners is a late-stage clinical trial company focused on preventing acute kidney injury (AKI) and organ damage caused by inflammation [11] - The company is developing a platform of novel drugs targeting the dipeptidase-1 (DPEP1) inflammation pathway prevalent in the kidneys, lungs, and liver [11] Clinical Trial Details - The PONTIAK study aims to evaluate the efficacy of cilastatin in preventing AKI associated with nephrotoxic pharmaceuticals, enrolling approximately 698 patients across five hospital sites in Alberta [2][3] - The trial has secured $1.5 million in funding from the Canadian Institutes of Health Research (CIHR) and an additional $400,000 from the Accelerating Clinical Trials (ACT) initiative [3] Drug Information - Cilastatin was originally developed in the early 1980s to limit the breakdown of imipenem, a β-lactam antibiotic, and is currently marketed in combination with imipenem [7] - Arch Biopartners has manufactured the first-ever stand-alone cilastatin drug product for the trial and holds exclusive method-of-use patents to repurpose cilastatin for AKI treatment [4][8] Market Context - Drug toxins account for approximately 30% of AKI cases in hospitalized patients, with common culprits including antibiotics and chemotherapy agents [6] - There is currently no specific therapeutic treatment available on the market that prevents AKI, highlighting a significant unmet medical need [5][12]
Arch Biopartners Announces Toronto General Hospital Ethics Board Approval to Join the Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury (CS-AKI)
Globenewswire· 2025-04-22 10:55
Core Viewpoint - Arch Biopartners Inc. has received ethics approval for its Phase II trial of LSALT peptide aimed at preventing cardiac surgery-associated acute kidney injury (CS-AKI) [1][2] Group 1: Trial Details - The CS-AKI Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study targeting 240 patients [3] - The primary objective is to evaluate the percentage of subjects with acute kidney injury within seven days following on-pump cardiac surgery, based on KDIGO criteria [3][4] Group 2: Recruitment and Locations - Toronto General Hospital is the seventh site activated globally and the second in Canada for patient recruitment [2] - The company plans to reduce recruitment in Turkey and increase it in Canada to enhance the trial's geographic and demographic data [2] Group 3: Background on CS-AKI and LSALT Peptide - CS-AKI is often caused by ischemia-reperfusion injury, leading to kidney cell damage, with no current therapeutic treatments available for this condition [5][6] - LSALT peptide is the lead drug candidate targeting the DPEP1 pathway, showing promise in preventing ischemia-reperfusion injury in pre-clinical models [6][8] Group 4: Incidence and Impact of CS-AKI - The prevalence of CS-AKI can be as high as 30% in patients undergoing on-pump cardiac surgeries, which is associated with increased morbidity and mortality [7]
Arch Biopartners Closes Non-Brokered Private Placement
Globenewswire· 2025-03-14 20:30
Core Points - Arch Biopartners Inc. has closed a non-brokered private placement offering of 145,000 common shares at CAD $1.55 and 90,000 common shares at USD $1.15, totaling gross proceeds of CAD $374,000 [1][2] - The final amount of the offering increased by CAD $24,000 from the initial disclosure on March 5, 2025, and the proceeds will be used for general working capital and research expenses [2] - All common shares issued will be subject to a hold period of four months and one day from the closing date, with finders' fees totaling CAD $5,425 to be paid [3] Company Overview - Arch Biopartners Inc. is focused on preventing acute kidney injury and organ damage caused by inflammation, developing novel drugs targeting the dipeptidase-1 (DPEP1) inflammation pathway [4] - The company's lead drug candidates, LSALT peptide and cilastatin, aim to address significant unmet medical needs related to kidney injury caused by inflammation or toxins [4] - The company has 65,856,366 common shares outstanding [5]
Arch Biopartners Arranges Non-Brokered Private Placement
Globenewswire· 2025-03-05 12:23
Core Points - Arch Biopartners Inc. announced a non-brokered private placement offering of 225,806 common shares at a price of $1.55 per share, aiming for gross proceeds of $350,000 CAD [1][2] - The proceeds will be utilized for general working capital and expenses not covered by existing funding grants, with the offering set to close on March 6, 2025, pending regulatory approvals [2][3] - All shares issued will have a hold period of four months and one day from the closing date, with finders' fees totaling $13,500 to be paid [3] Company Overview - Arch Biopartners Inc. is focused on late-stage clinical trials aimed at preventing acute kidney injury and organ damage due to inflammation [4] - The company is developing novel drugs targeting the dipeptidase-1 (DPEP1) inflammation pathway, with lead candidates LSALT peptide and cilastatin addressing significant unmet medical needs related to kidney injury [4] - The company has 65,621,366 common shares outstanding [5]
Shares for Interest Debt Settlement
Globenewswire· 2025-02-03 12:45
Core Points - Arch Biopartners Inc. has arranged a shares for debt transaction to settle $57,246.57 in interest on a deferred convertible note as of February 1, 2025 [1][2] - The transaction involves issuing 31,112 common shares at a deemed price of $1.84, pending approval from the TSX Venture Exchange [2][3] - The total notional value of the note is $500,000 CAD, which will convert into 561,798 common shares at maturity [3] Company Overview - Arch Biopartners Inc. is focused on preventing acute kidney injury and organ damage caused by inflammation, developing drugs targeting the dipeptidase-1 (DPEP1) inflammation pathway [4] - The lead drug candidates include LSALT peptide and cilastatin, aimed at addressing significant unmet medical needs related to kidney injury [4] - The company has 64,940,956 common shares outstanding [5]
Arch Resources and CONSOL Energy Announce Stockholder Approvals in Respect of Pending Merger
Prnewswire· 2025-01-09 15:00
Company Overview - Arch Resources, Inc. is a leading producer of high-quality metallurgical products for the global steel industry, operating modern and efficient mines that set industry standards for safety and environmental stewardship [2] - CONSOL Energy Inc. is based in Canonsburg, Pennsylvania, and specializes in the production and export of high-Btu bituminous thermal coal and metallurgical coal, with significant operations in the Northern Appalachian Basin [3] - CONSOL's Pennsylvania Mining Complex has a production capacity of approximately 28.5 million tons of coal per year, and the company controls around 1.3 billion tons of coal reserves across major coal-producing basins in the eastern United States [3] Merger Announcement - Arch Resources and CONSOL Energy announced that stockholders of both companies approved all proposals related to their pending combination, which is expected to close on January 14, 2025 [1] - The combined entity will be renamed "Core Natural Resources, Inc." and will be headquartered in Canonsburg, Pennsylvania, with its common stock trading under the ticker symbol "CNR" starting January 15, 2025 [1]
Arch Biopartners Announces Ontario Research Ethics Board Approval to Proceed with Phase II Trial for LSALT Peptide Targeting Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI)
Globenewswire· 2025-01-08 12:25
Core Insights - Arch Biopartners Inc. has received provincial ethics approval for its Phase II trial of LSALT peptide aimed at preventing and treating cardiac surgery-associated acute kidney injury (CS-AKI) [1][3] - The trial will recruit a total of 240 patients across multiple sites, including Toronto General Hospital, St. Michael’s Hospital, University of Calgary Hospital, and five clinical sites in Turkey [2][3][4] - The primary objective of the trial is to assess the percentage of subjects experiencing acute kidney injury within seven days post cardiac surgery, following KDIGO criteria [4] Company Developments - Arch Biopartners has entered a one-year marketing and consulting contract with Outside The Box Capital Inc. to enhance awareness of the company’s news [10] - The company will pay $25,000 per month and grant 150,000 stock options with a strike price of $2.00 per share as part of the contract [11] - Arch Biopartners is focused on developing drugs targeting the dipeptidase-1 (DPEP1) inflammation pathway, with LSALT peptide being its lead candidate for preventing kidney injury [12] Clinical Context - CS-AKI is a common complication following on-pump cardiac surgeries, with a prevalence rate of up to 30%, leading to increased morbidity and mortality [8] - LSALT peptide aims to address the unmet medical need for therapeutic treatments to prevent AKI in patients undergoing cardiac surgery [6][12] - The drug has shown promise in pre-clinical models for preventing ischemia-reperfusion injury to the kidneys, providing a scientific basis for its use in the ongoing trial [7]
Kuehn Law Encourages USAP, CYTH, ARCH, and FLIC Investors to Contact Law Firm
Newsfilter· 2024-12-16 14:07
Group 1: Proposed Mergers - Universal Stainless & Alloy Products, Inc. is set to merge with Aperam for $45.00 per share in cash, resulting in Universal becoming a wholly owned subsidiary of Aperam [1] - Cyclo Therapeutics, Inc. will be acquired by Rafael Holdings, with Cyclo shares valued at $0.95 each [2] - Arch Resources, Inc. has a definitive agreement with CONSOL Energy Inc. for 1.326 shares of CONSOL common stock for each Arch stock, leading to Arch shareholders holding approximately 45% ownership in the combined company post-transaction [3] - The First of Long Island Corporation is merging with ConnectOne Bancorp, Inc. for 0.5175 shares of ConnectOne common stock for each share of Long Island common stock [3] Group 2: Shareholder Involvement - Kuehn Law is investigating potential claims related to the proposed mergers, focusing on whether the Boards acted to maximize shareholder value and disclosed material information [1] - Shareholders are encouraged to get involved to contribute to the integrity and fairness of financial markets, with Kuehn Law covering all case costs [4]
Arch Resources: Another Attractive Coal Company
Seeking Alpha· 2024-11-07 03:08
Core Viewpoint - Arch Resources reported a net loss of $6.2 million and an adjusted profit of $44.2 million for Q3 2024, indicating a year-over-year decline in revenues and profits [1]. Financial Performance - The company experienced a net loss of $6.2 million in Q3 2024 [1]. - Adjusted profits for the same period were reported at $44.2 million [1]. Company Overview - Arch Resources is recognized as one of the major coal miners in the United States, producing both thermal and metallurgical coal [1].