MNK

eFFECTOR Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, March 25, 2024

SOLANA BEACH, Calif. and REDWOOD CITY, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, today reported financial results for the fourth quarter and year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • The primary analysis will reflect 37 PFS events, which provides approximately 80% power to detect a PFS hazard ratio of 0.65 at a p≤0.2.
  • Revenue: Revenue was zero for the quarter ended December 31, 2023, compared to approximately $0.7 million for the same quarter of 2022.
  • Research and Development (R&D) Expenses: R&D expenses were $6.1 million for the quarter ended December 31, 2023, compared to $6.6 million for the same quarter of 2022.
  • The earn-out period expired in August 2023 resulting in a reduction of the corresponding earn-out liability to zero as of December 31, 2023.

eFFECTOR Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023

SOLANA BEACH, Calif. and REDWOOD CITY, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • SOLANA BEACH, Calif. and REDWOOD CITY, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.
  • These results, if positive, would enable activities, including interactions with regulatory agencies, intended to support initiation of a Phase 3 registrational trial.
  • Research and Development (R&D) Expenses: R&D expenses were $5.4 million for the quarter ended September 30, 2023, compared to $6.6 million for the same quarter of 2022.
  • Other Income (Expense): Other expense was $0.4 million for the quarter ended September 30, 2023, compared to $0.3 million for the same quarter of 2022.

eFFECTOR Therapeutics to Collaborate with the Northwestern University Division of Hematology and Oncology on an Investigator-Initiated Phase 1 Dose Escalation Trial Evaluating Tomivosertib in Patients with Acute Myeloid Leukemia

Retrieved on: 
Tuesday, October 24, 2023

The trial will be conducted at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and chaired by Shira Dinner, M.D., Associate Professor of Medicine (Hematology and Oncology).

Key Points: 
  • The trial will be conducted at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and chaired by Shira Dinner, M.D., Associate Professor of Medicine (Hematology and Oncology).
  • Tomivosertib is an inhibitor of mitogen-activator protein kinase interacting kinase (MNK) 1 and 2 and blocks phosphorylation of eukaryotic initiation factor 4E (eIF4E).
  • “AML is one of the most common types of acute leukemia, and unfortunately, development of resistance to existing therapies leads to relapse in too many patients,” said Dr. Platanias.
  • “Additionally, for older and high-risk younger adult patients who cannot tolerate intensive chemotherapy, there are few treatment options.

NYSE American to Commence Delisting Proceedings Against Mallinckrodt plc (MNK)

Retrieved on: 
Monday, August 28, 2023

NYSE American LLC (“NYSE American” or the “Exchange”) announced today that the staff of NYSE Regulation has determined to commence proceedings to delist the Ordinary Shares of Mallinckrodt plc (the “Company”) — ticker symbol MNK — from NYSE American.

Key Points: 
  • NYSE American LLC (“NYSE American” or the “Exchange”) announced today that the staff of NYSE Regulation has determined to commence proceedings to delist the Ordinary Shares of Mallinckrodt plc (the “Company”) — ticker symbol MNK — from NYSE American.
  • NYSE Regulation has determined that the Company is no longer suitable for listing and will commence delisting proceedings pursuant to Section 1003(c)(iii) of the NYSE American Company Guide in light of the disclosure on August 28, 2023 that the Company and certain of its subsidiaries today initiated voluntary prepackaged Chapter 11 proceedings in the U.S. Bankruptcy Court for the District of Delaware.
  • NYSE Regulation noted that the Company’s Restructuring Support Agreement, entered into on August 23, 2023, provides for the cancellation of the Company’s Ordinary Shares for no consideration.
  • The NYSE American will apply to the Securities and Exchange Commission to delist the Company’s Ordinary Shares upon completion of all applicable procedures, including any appeal by the Company of the NYSE Regulation staff’s decision.

eFFECTOR Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, August 8, 2023

SOLANA BEACH, Calif. and REDWOOD CITY, Calif., Aug. 08, 2023 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, today reported financial results for the second quarter ended June 30, 2023 and provided a corporate update.

Key Points: 
  • “It was another productive quarter for eFFECTOR as we made considerable progress on all fronts,” remarked Steve Worland, Ph.D., president and chief executive officer of eFFECTOR.
  • Topline data are anticipated in the second half of 2023.
  • $16.2 million in gross proceeds raised from two registered direct financings, extending cash runway into second quarter of 2024. eFFECTOR completed two registered direct financings during the second quarter of 2023.
  • eFFECTOR anticipates that its current cash, cash equivalents and short-term investments will be sufficient to fund operations into the second quarter of 2024.

ROSEN, TRUSTED INVESTOR COUNSEL, Encourages Mallinckrodt plc Investors with Over $1 Million in Losses to Secure Counsel Before Important Deadline in Securities Class Action – MNK, MNKPF

Retrieved on: 
Thursday, July 13, 2023

WHAT TO DO NEXT: To join the Mallinckrodt class action, go to https://rosenlegal.com/submit-form/?case_id=13407 or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the Mallinckrodt class action, go to https://rosenlegal.com/submit-form/?case_id=13407 or call Phillip Kim, Esq.
  • toll-free at 866-767-3653 or email [email protected] or [email protected] for information on the class action.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

ROSEN, TRUSTED NATIONAL TRIAL COUNSEL, Encourages Mallinckrodt plc Investors with losses in Excess of $100K to Secure Counsel Before Important Deadline in Securities Class Action - MNK, MNKPF

Retrieved on: 
Tuesday, July 11, 2023

WHAT TO DO NEXT: To join the Mallinckrodt class action, go to https://rosenlegal.com/submit-form/?case_id=13407 or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the Mallinckrodt class action, go to https://rosenlegal.com/submit-form/?case_id=13407 or call Phillip Kim, Esq.
  • toll-free at 866-767-3653 or email [email protected] or [email protected] for information on the class action.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the European Association for the Study of the Liver (EASL) Congress 2023

Retrieved on: 
Thursday, June 15, 2023

DUBLIN, June 15, 2023 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced that two scientific posters detailing Mallinckrodt's latest research findings on the clinical outcomes of treatment with TERLIVAZ® (terlipressin) for injection and clinical management criteria for adult patients with hepatorenal syndrome (HRS) will be presented at the European Association for the Study of the Liver (EASL) Congress 2023 in Vienna, Austria, taking place June 21-24, 2023. Both posters will be presented on June 24, 2023, 9:00 a.m. – 5:00 p.m. CEST / 3:00 a.m. – 11:00 a.m. EDT.

Key Points: 
  • Both posters will be presented on June 24, 2023, 9:00 a.m. – 5:00 p.m. CEST / 3:00 a.m. – 11:00 a.m. EDT.
  • The CONFIRM trial is the largest-ever prospective, randomized clinical trial of terlipressin compared to placebo in patients with HRS type 1 (HRS-1).
  • Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.

Mallinckrodt Announces Publication of Real-World Data on the Use of Extracorporeal Photopheresis (ECP) in Heart Transplant Patients

Retrieved on: 
Tuesday, June 13, 2023

DUBLIN, June 13, 2023 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced the publication of findings from a retrospective, observational, single arm, European chart review study assessing the real-world use of extracorporeal photopheresis (ECP) and its impact on clinical outcomes in the modern era of heart transplantation.1 An online version of the data manuscript – the largest-known study of ECP in heart transplant patients – is currently published on the Journal of Heart and Lung Transplantation website in advance of print publication in the second half of 2023.

Key Points: 
  • - Results from the largest European and first multicenter, retrospective, observational chart review study investigating the real-world use of ECP in heart transplant patients reinforce its use as a treatment for heart transplant rejection and prevention of rejection1 -
    DUBLIN, June 13, 2023 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced the publication of findings from a retrospective, observational, single arm, European chart review study assessing the real-world use of extracorporeal photopheresis (ECP) and its impact on clinical outcomes in the modern era of heart transplantation.1 An online version of the data manuscript – the largest-known study of ECP in heart transplant patients – is currently published on the Journal of Heart and Lung Transplantation website in advance of print publication in the second half of 2023.
  • Interim results of this study were presented in a late-breaking session at the 20th Congress of the European Society for Organ Transplantation (ESOT) in 2021 in Milan, Italy.2
    The study, titled "European Multicenter Study on The Real-World Use and Clinical Impact of Extracorporeal Photopheresis After Heart Transplantation," examined data from the medical charts of 105 patients who received ECP following heart transplantation at seven medical centers in Austria, Germany, France, Hungary, and Italy between 2015 – 2021.
  • At time of data extraction, 58 patients (55.2%) had completed their ECP treatment and 47 patients' (44.8%) ECP treatment was ongoing.1
    "These findings from the largest European and first multicenter study investigating the real-world use of ECP in heart transplant patients support ECP as a treatment for various types of graft rejection and in prevention of graft rejection with varied treatment schedules,1" said Markus Barten, M.D., Surgical Director of Heart Failure Clinic, University Heart and Vascular Center Hamburg.
  • "This data not only builds upon the growing body of real-world evidence supporting the use of ECP in heart transplant patients, but also reflects the importance of supporting clinicians with treatment modalities for transplant rejection and stabilization.1"

AUM Biosciences Doses First Patient in Phase 2 Clinical Trial of AUM001 in Metastatic Colorectal Cancer

Retrieved on: 
Tuesday, May 30, 2023

Ltd. (“AUM”), a global clinical-stage biotechnology company focused on discovering and developing precision oncology therapeutics, announced today that the first patient has been dosed in its Phase 2 clinical trial evaluating AUM001 for the treatment of metastatic colorectal cancer (MSS CRC).

Key Points: 
  • Ltd. (“AUM”), a global clinical-stage biotechnology company focused on discovering and developing precision oncology therapeutics, announced today that the first patient has been dosed in its Phase 2 clinical trial evaluating AUM001 for the treatment of metastatic colorectal cancer (MSS CRC).
  • AUM001 is a mRNA translation inhibitor that targets MNK 1/2 and the chokepoint of multiple pro-oncogenic signalling pathways for the treatment of MSS CRC.
  • “Dosing the first patient in AUM001’s Phase 2 trial is a major milestone in advancing our mission to build an industry-leading portfolio of innovative therapies designed to reverse cancer resistance,” said Vishal Doshi, Chairman and CEO of AUM.
  • "While colorectal cancer is the third most common cancer globally, there are limited therapeutic options due to the resistance associated with current treatments.