Day: May 12, 2023

Completed business combination and listing on Nasdaq generating gross proceeds of approximately $70 million BackBeat CNT™ global pivotal study in hypertensive pacemaker patients on track for initiation in the second half of 2023 in collaboration with Medtronic Virtue SAB® U.S. pivotal study in coronary in-stent restenosis (“ISR”) start planned for the second half of 2023 in collaboration with TerumoNEW HOPE, Pa., May 12, 2023 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today reported its first quarter 2023 financial results and provided a business update. “The first quarter of 2023 was a transformational period for Orchestra BioMed marked by our successful...

Key Highlights:Continued progress has been made in advancing an investigator-initiated clinical trial to gain human proof-of-concept for Cholesterol Efflux Mediator™ VAR 200 in patients with renal disease Announced publication of several peer-reviewed journal articles supporting ASC inhibition as a promising therapeutic target – data continue to demonstrate that multiple types of inflammasomes are activated in various conditions (Alzheimer’s disease, traumatic brain injury, and injury from intracortical implants), and substantiate that extracellular release of ASC specks to neighboring cells heighten and perpetuate damaging inflammation leading to disease progression in conditions such as Parkinson’s disease and alcoholic hepatitis Added three internationally recognized experts in the field of glomerular disease to Renal...

– Randomized clinical trial of IGM-8444 plus FOLFIRI and bevacizumab in second line metastatic colorectal cancer underway – – Plans to present additional non-randomized clinical data for 3 mg/kg of IGM-8444 plus FOLFIRI, with and without bevacizumab, in the middle of 2023 – – Plans to begin clinical testing of imvotamab in severe systemic lupus erythematosus and severe rheumatoid arthritis – MOUNTAIN VIEW, Calif., May 12, 2023 (GLOBE NEWSWIRE) — IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the first quarter ended March 31, 2023 and provided an update on recent developments. “We are pleased to be underway in our randomized clinical trial of IGM-8444 in combination with standard of care FOLFIRI chemotherapy...

FREMONT, Calif., May 12, 2023 (GLOBE NEWSWIRE) — Actelis Networks, Inc. (NASDAQ: ASNS) (“Actelis” or the “Company”), a market leader in cyber-hardened, rapid deployment networking solutions for wide area IoT applications, today reported financial results for the fiscal first quarter ended March 31, 2023. First Quarter 2023 Financial Highlights:Revenue decreased 1.1% year-over-year to $1.85 million for the first quarter ended March 31, 2023, due to a logistical and regulatory delay in product delivery to a first-time customer destination. Gross Margin increased to 37% for the first quarter ended March 31, 2023, compared to 31% for the three months ended March 31, 2022, driven by a favorable product mix and lower logistics cost. Net Loss decreased 59% year-over-year to $1.9 million, compared to a net loss of $4.6 million for the...

MIAMI, May 12, 2023 (GLOBE NEWSWIRE) — Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the first quarter ended March 31, 2023. “Avenue is progressing its neuro-focused clinical stage pipeline and 2023 is off to a strong start with AJ201, a first in class small molecule for the treatment of Spinal and Bulbar Muscular Atrophy (“SBMA”), now in an ongoing Phase 1b/2a clinical trial, and BAER-101, a potentially more tolerable drug for the treatment of epilepsy and acute anxiety, advancing toward Phase 1b studies in each indication. We also held collaborative discussions with the Food and Drug Administration...

Conducted meetings with U.S. and select European regulatory agencies Received Notice of Exercise and upfront cash of $0.45 million from Advocate for the sale of Purnovate assets and business Ended 2023 first quarter with cash and cash equivalents of $2.3 million CHARLOTTESVILLE, Va., May 12, 2023 (GLOBE NEWSWIRE) — Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today provided a business update and reported its financial results for the first quarter of 2023. Cary Claiborne, President and Chief Executive Officer of Adial, stated, “We continue to pursue our highly focused regulatory strategy and have conducted meetings with the U.S. Food and Drug Administration...

NEXUS Phase 2 Clinical Trial of NX-13 for Ulcerative Colitis Initiated NEXUS Top-line Results Planned for Q4 2024 Sufficient Cash to Fund Planned Operations into First Half of 2025 NEW YORK, May 12, 2023 (GLOBE NEWSWIRE) — Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2023. “We continue to execute on a focused strategy for the NX-13 program to maximize value for our shareholders,” said Gregory Oakes, President and CEO of Landos. “Our NEXUS Phase 2 study of NX-13 in UC is designed to advance this important program with a goal to generate meaningful data and build on the promising early signals of clinical improvement from...

Table 1 FDA Required Primary Efficacy EndpointFigure 2 Study BDX-22-006 Primary EndpointFigure 3 Study BDX-22-006Announced Positive Top-Line Final Results from Phase 2 Randomized Clinical Trial of BX1000 Hosted Key Opinion Leader Webinar to Highlight Potential of BX1000 and Neuromuscular Blocking Agent Portfolio Secured $4 Million in Gross Proceeds from Public Offering in May MALVERN, Pa., May 12, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (Nasdaq:BXRX) (the “Company”), a pharmaceutical company focused on innovative products for hospital and related settings, today reported financial results for the quarter ended March 31, 2023, and provided a business update. “During the first quarter we made significant progress advancing our neuromuscular blocking agent (NMB) portfolio, announcing positive topline results from our Phase...