Verona Pharma(US:VRNA) Newsfilterยท2024-08-08 06:00Core Viewpoint - Verona Pharma has launched Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults, marking the first novel inhaled product for COPD in over 20 years, with expectations to redefine treatment paradigms [2][4]. Company Updates - The company has initiated patient shipments of Ohtuvayre and has conducted over 2,000 healthcare professional (HCP) visits, with more than 100 unique HCPs prescribing the product [3]. - Near-term milestones include the submission of an investigational new drug application (IND) for a fixed-dose combination of ensifentrine and glycopyrrolate, with plans to start a Phase 2 trial in Q3 2024 [3]. - A Phase 2 clinical trial for nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis is also planned for Q3 2024 [3]. Financial Highlights - As of June 30, 2024, the company reported cash and cash equivalents of $404.6 million, a significant increase from $271.8 million at the end of 2023, supported by a $70 million draw from the debt facility and $100 million from a revenue interest purchase and sales agreement [5][6]. - Research and development (R&D) expenses for Q2 2024 were $19.4 million, compared to a net reversal of costs of $2.5 million in Q2 2023, reflecting increased costs related to milestone payments and pre-launch inventory production [6]. - Selling, general and administrative (SG&A) expenses rose to $49.0 million in Q2 2024 from $12.4 million in Q2 2023, driven by milestone payments, marketing activities, and increased personnel costs [6]. - The net loss for Q2 2024 was $70.8 million, compared to a net loss of $8.8 million in Q2 2023 [7]. Product and Market Context - Ohtuvayre is positioned as a significant advancement in COPD treatment, combining bronchodilator and non-steroidal anti-inflammatory activities in one molecule, with potential applications in other respiratory diseases [10].