Oxygen toxicity

Clearside Biomedical’s Versatile Suprachoroidal Injection Platform Highlighted in Four Ophthalmic Indications in Clinical Data Presentations at AAO 2023 Annual Meeting

Retrieved on: 
Tuesday, November 7, 2023

“The AAO meeting held over the past week was exceptionally positive for Clearside and our clinical development partners,” said, George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer.

Key Points: 
  • “The AAO meeting held over the past week was exceptionally positive for Clearside and our clinical development partners,” said, George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer.
  • Two of our partners, REGENXBIO and Aura Biosciences, presented new, positive Phase 2 safety and clinical efficacy data from their respective programs utilizing our SCS Microinjector.
  • The findings from the survey indicated that physicians found the XIPERE injection easy to learn, with patient outcomes consistent with clinical trial data.
  • Clearside’s medical meeting presentations can be accessed on the Company’s Publications and Presentations page.

atai Life Sciences Reports First Quarter 2023 Financial Results and Announces Pipeline Highlights and Updates

Retrieved on: 
Thursday, May 11, 2023

The Company’s $250M cash position and committed term loan funding is expected to fund operations into 1H 2026.

Key Points: 
  • The Company’s $250M cash position and committed term loan funding is expected to fund operations into 1H 2026.
  • NEW YORK and BERLIN, May 11, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, reported first quarter 2023 financial results and provided corporate updates.
  • “This past quarter we made significant progress, including the dosing of the first patient with RL-007 in a randomized, placebo-controlled Phase 2 study.
  • In January 2023, Phase 1 results were announced from the study of GRX-917 in healthy volunteers.

Avalyn Pharma Publishes Phase 1b ATLAS Results Demonstrating Stabilization of Lung Function at 24 and 48 Weeks with AP01 and Favorable Safety Profile

Retrieved on: 
Thursday, March 23, 2023

The study assessed safety and efficacy of AP01 (inhaled pirfenidone) in adults with idiopathic pulmonary fibrosis (IPF) through 72 weeks.

Key Points: 
  • The study assessed safety and efficacy of AP01 (inhaled pirfenidone) in adults with idiopathic pulmonary fibrosis (IPF) through 72 weeks.
  • Efficacy and safety results at weeks 24 and 48 are also reported.
  • “While oral pirfenidone has the potential to improve lung function by reducing fibrosis, its utility is limited by its poor tolerability profile,” explained Lyn Baranowski, Avalyn’s CEO .
  • “Although the ATLAS study's primary endpoint was safety, secondary measures of efficacy showed a trend towards disease stabilization in participants with IPF who administered high-dose AP01.

Pulmocide Raises $52 Million to Fund Additional Late-Stage Development of Opelconazole

Retrieved on: 
Tuesday, December 6, 2022

Proceeds from the financing will be used to further fund clinical development, manufacturing scale-up, and preparation for potential commercialization of opelconazole.

Key Points: 
  • Proceeds from the financing will be used to further fund clinical development, manufacturing scale-up, and preparation for potential commercialization of opelconazole.
  • Opelconazole is a potent, novel triazole antifungal that has been specifically designed for use as an inhaled therapy against pulmonary aspergillosis.
  • The Company is also conducting a Phase 2b clinical trial using opelconazole as a monotherapy for prophylaxis against aspergillus infections in patients following lung transplant surgery.
  • Under the United Kingdom’s Special Needs provision, opelconazole was found to be generally well tolerated and demonstrated remarkable clinical responses.

Jeito Capital strengthens its support in Pulmocide with participation in $52 million financing

Retrieved on: 
Tuesday, December 6, 2022

Jeito previously led an oversubscribed $92 million raise in Pulmocide, and has since provided continuous support to the Company in line with its unique investment strategy.

Key Points: 
  • Jeito previously led an oversubscribed $92 million raise in Pulmocide, and has since provided continuous support to the Company in line with its unique investment strategy.
  • Jeito’s further investment in Pulmocide demonstrates our commitment to support the most innovative biopharmaceutical companies and accelerate the development of much-needed treatments for patients.
  • Jeito Capital has €534 million under management and a rapidly growing portfolio of investments.
  • A late-stage clinical program has been initiated to support registration in patients who have failed prior therapy for IPA.

Avalyn Pharma Invited to Participate in the Annual Evercore ISI HealthCONx Conference

Retrieved on: 
Monday, November 28, 2022

SEATTLE , Nov. 28, 2022 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc. , a clinical-stage biopharmaceutical company focused on development of targeted therapies for life-threatening pulmonary diseases, announced that Lyn Baranowski and Marc Schneebaum , Avalyn Pharmas chief executive and chief financial officers will participate in the 5th Annual Evercore ISI HealthCONx Conference being held virtually November 29 December 1, 2022.

Key Points: 
  • SEATTLE , Nov. 28, 2022 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc. , a clinical-stage biopharmaceutical company focused on development of targeted therapies for life-threatening pulmonary diseases, announced that Lyn Baranowski and Marc Schneebaum , Avalyn Pharmas chief executive and chief financial officers will participate in the 5th Annual Evercore ISI HealthCONx Conference being held virtually November 29 December 1, 2022.
  • Ms. Baranowski will join Evercore biotechnology research analyst, Josh Schimmer, MD for a fireside chat on November 29, 2022, at 1:00pm ET.
  • In addition, Ms. Baranowski and Mr. Schneebaum will be available to participate in one-on-one meetings with investors during the conference.
  • The fireside chat may be accessed by registered attendees from the Evercore ISI platform.

Avalyn Pharma Appoints Lyn Baranowski Chief Executive Officer

Retrieved on: 
Monday, October 17, 2022

Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted therapies for life-threatening pulmonary diseases, announced the appointment of Lyn Baranowski as chief executive officer.

Key Points: 
  • Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted therapies for life-threatening pulmonary diseases, announced the appointment of Lyn Baranowski as chief executive officer.
  • Ms. Baranowski brings more than two decades of experience leading a vast array of functions in biotech, big pharma and venture capital firms.
  • Under his leadership, Avalyn built a strong scientific foundation, from which it will be well positioned to advance its business and clinical development objectives, stated Niall O'Donnell, chairman of the Avalyn board of directors.
  • Prior to joining Avalyn, Ms. Baranowski served as chief operating officer at Altavant Sciences, a biopharmaceutical company developing a portfolio of therapies for rare respiratory diseases.

Humanigen Reports Year-End 2021 Financial Results

Retrieved on: 
Monday, February 28, 2022

Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm with its lead drug candidate, lenzilumab, today reported financial results for the year ended December 31, 2021, and announced corporate objectives for 2022.

Key Points: 
  • Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm with its lead drug candidate, lenzilumab, today reported financial results for the year ended December 31, 2021, and announced corporate objectives for 2022.
  • Net cash used in operating activities, net of balance sheet changes, was $184.0 million for the year ended December 31, 2021.
  • Subsequent to December 31, 2021, the company raised net proceeds of approximately $3.7 million under its At-the-Market offering program.
  • A summary of key financial highlights as of and for the years ended December 31, 2021 and 2020 is as follows ($ in thousands):
    Three Months Ended December 31,

Pulmocide Receives Investment from the Cystic Fibrosis Foundation

Retrieved on: 
Monday, December 6, 2021

People with cystic fibrosis (CF), particularly those who have undergone lung transplants, are highly susceptible to invasive Aspergillus fungal infections in their airways.

Key Points: 
  • People with cystic fibrosis (CF), particularly those who have undergone lung transplants, are highly susceptible to invasive Aspergillus fungal infections in their airways.
  • The CF Foundations funding will support a multicenter Phase 2 study of Pulmocides opelconazole.
  • The study will assess the treatments safety and tolerability when used to prevent invasive pulmonary fungal infections in lung transplant recipients.
  • Aspergillus infection also plays an important role in severe asthma and cystic fibrosis and has been correlated with poorer clinical outcomes in patients with chronic obstructive pulmonary disease.

Gemini Therapeutics Announces Presentation of Previously Released Data from Its Ongoing Phase 2a Study of GEM103 at Clinical Trials at the Summit

Retrieved on: 
Monday, August 30, 2021

We were pleased to have the opportunity to present at the Clinical Trials at the Summit to further discuss our initial data released from our Phase 2a ReGAtta study of GEM103 in patients with GA secondary to dry AMD, said Dr. Barone.

Key Points: 
  • We were pleased to have the opportunity to present at the Clinical Trials at the Summit to further discuss our initial data released from our Phase 2a ReGAtta study of GEM103 in patients with GA secondary to dry AMD, said Dr. Barone.
  • The current ongoing Phase 2a study is open-label, uncontrolled, and was not designed to detect statistically significant treatment effect.
  • Additional 26 patients were enrolled in a second cohort and received three monthly doses of 500g of GEM103 intravitreally.
  • Gemini Therapeutics is a clinical stage precision medicine company developing novel therapeutic compounds to treat genetically defined age-related macular degeneration (AMD).