Aytu BioPharma, Inc. develops and commercializes prescription medicines focused on complex central nervous system diseases. Its recurring company updates center on EXXUA (gepirone) extended-release tablets, an FDA-approved selective serotonin 5HT1a receptor agonist for major depressive disorder in adults, along with its ADHD products and legacy pediatric portfolio.
News from Aytu also covers operational and financial results, commercial launch activity, retail and Aytu RxConnect patient-access distribution, investor presentations, and product-level clinical and safety information for EXXUA. The company is a Nasdaq-listed specialty pharmaceutical issuer with prescription products sold through commercial distribution channels.
Aytu BioPharma announced the publication of laboratory data demonstrating that ultraviolet A (UVA) light used in its Healight technology significantly reduces cytokine release in cells infected with coronavirus. The study, published in Photodiagnosis and Photodynamics Therapy, shows that narrow band UVA therapy decreases pro-inflammatory cytokines such as IL-6 and TNF-α by over 50%. The company plans to initiate a larger Phase 2 clinical study in Europe later in 2021, aiming to further explore Healight's potential as a treatment for severe respiratory infections, including SARS-CoV-2.
Aytu BioPharma recently announced significant findings from a first-in-human clinical trial of its Healight technology, published in Advances In Therapy. The study involved five critically ill COVID-19 patients and demonstrated a substantial reduction in SARS-CoV-2 viral load, achieving log changes of -2.41 (>99%, p=0.0018) by day five and -3.2 (>99.9%, p=0.0005) by day six. WHO clinical severity scores improved by an average of 1.6 points on day 15 and 3.6 points on day 30. Importantly, no serious adverse effects were reported. Aytu plans a larger, randomized study in Europe in early 2022.
Aytu BioPharma (NASDAQ:AYTU) announced that CEO Josh Disbrow will present at two investor conferences in June 2021. The Jefferies Global Healthcare Conference will host a live virtual presentation on June 1 at 3:30 p.m. ET, which can be accessed via this link. The second presentation will be on June 23 at 12:40 p.m. ET at the Raymond James Human Health Innovations Conference. Both presentations will be available on the Aytu website and conference sites.
Aytu BioPharma closed its merger with Neos Therapeutics, creating a $100 million revenue specialty pharmaceutical company. The recent quarter saw net revenue increase to $13.5 million, driven by strong performance in both the consumer health division, which reported $8.4 million, and the Rx division, which achieved $5.1 million. However, the company reported a net loss of $25.5 million, primarily due to merger-related expenses. The company has added AR101, a late-stage pediatric asset, to its pipeline, and appointed Rich Eisenstadt as CFO to support growth.
Aytu BioPharma (AYTU) announced the publication of a study demonstrating that ultraviolet (UV) A light can enhance the expression of mitochondrial antiviral-signaling (MAVS) protein in cells. The manuscript, published in BioRxiv, suggests that UVA light elicits an antiviral effect through cell-to-cell communication, potentially offering therapeutic benefits against SARS-CoV-2 without requiring direct exposure to the light. The study highlights increased MAVS levels in human tracheal epithelial cells exposed to narrow band UVA, with significant results indicating a promising avenue for antiviral therapies.
Aytu BioPharma, Inc. (NASDAQ:AYTU) will hold a conference call on May 17, 2021, at 4:30 p.m. ET to discuss its financial results for the fiscal third quarter ended March 31, 2021. This meeting aims to review recent accomplishments and provide insights into the company's performance. Interested parties can join the call or access the live webcast through the company’s website. Aytu specializes in novel therapeutics and consumer healthcare products, focusing on prescription treatments for pediatric conditions like ADHD.
Aytu BioPharma has secured a global license for AR101 (enzastaurin), targeting vascular Ehlers-Danlos Syndrome (vEDS), a severe genetic disorder lacking FDA-approved treatments. The company paid $1.5 million upfront, with potential milestone payments up to $67.5 million contingent on regulatory and commercial achievements. Two co-founders from Rumpus Therapeutics, Christopher Brooke and Nate Massari, are joining Aytu's executive team to lead the AR101 program. The acquisition aligns with Aytu's strategy to enhance its portfolio in pediatric specialty pharmaceuticals.
Aytu BioPharma (NASDAQ:AYTU) announced the appointment of Richard Eisenstadt as Chief Financial Officer, effective immediately. Eisenstadt brings over 20 years of pharmaceutical finance experience, including capital raising and clinical development. He succeeds David Green, who stepped down on March 31, 2021. Before joining Aytu, Eisenstadt was CFO at Neos Therapeutics, where he raised over $340 million. CEO Josh Disbrow expressed confidence in Eisenstadt’s ability to support the growth of Aytu’s therapeutic portfolio as the company enhances its development pipeline.
Aytu BioPharma (NASDAQ:AYTU) announced a strategic transaction with Acerus Pharmaceuticals, whereby Acerus will acquire all U.S. rights to Natesto. Aytu will receive $7.5M in total, paid in $250,000 monthly installments over 30 months. The deal enables Aytu to focus on pediatric and ADHD therapeutics following their recent merger with Neos Therapeutics. This transition supports Aytu's strategy to enhance shareholder value by concentrating resources on their expanded portfolio of pediatric products.
Aytu BioScience has successfully merged with Neos Therapeutics, becoming Aytu BioPharma. The newly combined company boasts an annual revenue of $100 million, with an anticipated $15 million in cost synergies for 2022. This merger enhances Aytu's position in pediatrics and specialty care markets. Former Neos board members Beth P. Hecht and Gerald McLaughlin join Aytu's board as part of the transition. The merger concluded following approval at shareholder meetings on March 18, 2021, positioning Aytu for future growth and shareholder value enhancement.