Beyond Air, Inc. - XAIR STOCK NEWS

Beyond Cancer, Ltd., an affiliate of Beyond Air (NASDAQ: XAIR), has announced the treatment of the first patient in a Phase 1 study evaluating the safety and immune response of its ultra-high concentration nitric oxide (UNO) therapy for solid tumors. This significant milestone aims to explore the therapy's potential to prevent metastasis and relapse in cancer patients. Initial clinical data is expected in early 2023. The study will assess the maximum tolerated dose, safety, and immune biomarkers, contributing to the development of innovative cancer treatments.

Beyond Air, Inc. (NASDAQ: XAIR) launched LungFit® PH for treating neonates with hypoxic respiratory failure, following FDA approval on June 28, 2022. The company reported a net loss of $11.7 million for the first fiscal quarter ended June 30, 2022, with R&D expenses rising to $3.2 million and general and administrative expenses increasing to $8.2 million. Cash and cash equivalents stand at $72.8 million. Future milestones include a CE Mark expected in H2 2022, and the initiation of clinical trials for LungFit® PRO in late 2023.

Beyond Air, Inc. (NASDAQ: XAIR) will report its financial results for Q1 fiscal 2022 on August 11, 2022. The company specializes in developing inhaled nitric oxide treatments for respiratory conditions and solid tumors. Beyond Air's LungFit® system has received FDA approval for treating persistent pulmonary hypertension in newborns. The management team will host a conference call at 4:30 PM ET on the same day to discuss the results.

Beyond Air (NASDAQ: XAIR) announced FDA approval for its LungFit® PH system for treating hypoxic respiratory failure in neonates on June 28, 2022. The U.S. commercial launch has begun, with a CE Mark expected later this year. The company presented positive data on high-concentration nitric oxide therapies at multiple conferences, showing safety and efficacy in various patient groups. Financially, XAIR reported a net loss of $44.1 million for the fiscal year ending March 31, 2022, an increase from the previous year's loss of $22.9 million. Cash on hand stands at $80.2 million.

Beyond Air announced FDA approval for LungFit® PH, the first nitric oxide generator for treating term and near-term neonates with hypoxic respiratory failure. This innovative device uses ambient air to produce unlimited, on-demand nitric oxide, thus eliminating the need for traditional gas tanks, reducing logistical burdens for healthcare providers. The commercial launch is set for the first half of 2023. The company claims this advancement validates their Ionizer™ technology, which may lead to future product approvals targeting various respiratory diseases.

Beyond Air (NASDAQ: XAIR) has rescheduled its financial results announcement for the fiscal fourth quarter and year ending March 31, 2022, to June 28, 2022. The management team will host a conference call and webcast at 4:30 PM ET on the same day. Beyond Air is focused on developing inhaled nitric oxide for respiratory conditions and ultra-high concentration nitric oxide for solid tumors. The LungFit® system is pivotal for treating pulmonary diseases and is currently in clinical trials for various lung infections, including acute viral pneumonia.

Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR), has appointed Dr. Jedidiah Monson as Chief Medical Officer, effective June 1, 2022. Dr. Monson, a board-certified radiation oncologist with over 25 years of experience, will oversee the first-in-human trial of ultra-high concentration nitric oxide (UNO) therapy for solid tumors in Israel, slated to begin mid-2022. The company aims to leverage UNO therapy's potential anti-cancer properties to improve treatment outcomes for patients with solid tumors, amidst growing anticipation in the oncology field.

Beyond Air, Inc. (NASDAQ: XAIR) announced positive interim data from the LungFit® GO pilot study for at-home treatment of severe nontuberculous mycobacterial lung disease. A total of 2,323 inhalations were self-administered by 15 subjects, demonstrating high treatment compliance and no related discontinuations. The study showed that all participants successfully titrated to a target of 250 ppm NO without requiring dose reductions. Results indicate strong safety profiles and improvements in quality of life metrics, particularly for NTM symptoms.

Beyond Cancer, an affiliate of Beyond Air (NASDAQ: XAIR), has appointed Susan Howell Jones as Chief Financial Officer. Jones brings over 30 years of financial experience, including significant roles in the bioscience sector. She was pivotal in a $4B acquisition at BASF and significantly increased revenues at Summit Agro USA. The company is poised to begin its first-in-human trial for its innovative ultra-high concentration nitric oxide (UNO) therapy targeting solid tumors. This strategic appointment is expected to enhance the company’s financial leadership during a critical growth phase.