AYTU BioPharma, Inc. - AYTU STOCK NEWS

Aytu BioPharma announces the uninterrupted supply of Adzenys XR-ODT, FDA-approved as a bioequivalent to Adderall XR, amidst reported disruptions affecting generic ADHD medications. Adzenys XR-ODT is an extended-release, orally disintegrating tablet for treating ADHD in patients aged six and older, with a twelve-hour duration of action. The company has ensured consistent production at its Texas facility, offering various strengths. Patients are encouraged to consult their physicians regarding medication options due to ongoing supply issues with other ADHD treatments.

Aytu BioPharma reported record fourth quarter net revenue of $27.4 million, a 17% increase from last year, driven by a 28% growth in the Prescription segment. Full year revenue rose 47% to $96.7 million, with Prescription products achieving 87% growth at $61.1 million. Adjusted EBITDA for Prescription was $1.1 million, contrasting with $(5.5) million last year. Despite a 2% decline in Consumer Health revenue due to supply chain issues, the overall Gross Profit margin improved to 54%. Net loss for the quarter was $(17.7) million, improving from $(19.0) million year-over-year.

Aytu BioPharma (NASDAQ:AYTU) will report its financial results for Q4 and fiscal year ending June 30, 2022, after market close on September 27, 2022. A conference call is scheduled for the same day at 4:30 pm ET to discuss the results. Aytu's product portfolio focuses on novel therapeutics for rare pediatric disorders, including Adzenys XR-ODT and Cotempla XR-ODT for ADHD treatment. The company is also advancing therapies like AR101 for Vascular Ehlers-Danlos Syndrome, which has received multiple designations from the FDA and the European Commission.

Aytu BioPharma announced the addition of its fourth patent for AR101/Enzastaurin, enhancing its intellectual property portfolio for treating Vascular Ehlers-Danlos Syndrome (VEDS). Licensed from Johns Hopkins University, this patent expands the understanding of VEDS pathophysiology, with an expiry date of September 2041. The company plans to start the PREVEnt Trial for AR101 in early 2023, aiming to treat COL3A1-confirmed VEDS, a rare disorder with no approved therapies. Aytu holds Orphan Drug and Fast Track designations for AR101, which targets significant medical needs in VEDS.

Aytu BioPharma (NASDAQ:AYTU), a pharmaceutical company focused on rare pediatric-onset disorders, is set to participate in two upcoming investor conferences. The H.C. Wainwright 24th Annual Global Investment Conference will feature an on-demand presentation from September 12, 2022. Additionally, the Lytham Partners Fall 2022 Investor Conference offers a recorded fireside chat starting September 28, 2022. Both events will include opportunities for 1x1 virtual meetings. These presentations showcase Aytu's commitment to innovative therapeutics.

Aytu BioPharma (NASDAQ:AYTU) announced the issuance of U.S. Patent No. 11,273,148 for AR101 (enzastaurin), marking a significant milestone in its intellectual property portfolio. This patent covers methods for treating inherited aortic aneurysms and related conditions, including Vascular Ehlers-Danlos Syndrome (VEDS), with an expiry date in August 2038. The company aims to initiate the PREVEnt Trial for AR101 in VEDS, expecting to dose the first patient by early 2023. AR101 has received Orphan Drug and Fast Track designations from the FDA, highlighting its potential in addressing unmet medical needs.

Aytu BioPharma (NASDAQ:AYTU) closed its underwritten public offering, raising $10.0 million through the sale of 21,505,814 shares of common stock and 1,750,000 pre-funded warrants. The offering included Common Warrants for an additional 23,255,814 shares. The funds will be used to advance pipeline assets, including the PREVEnt Trial for AR101, aimed at treating vascular Ehlers-Danlos Syndrome, and for general corporate purposes. Total shares outstanding after the offering rose to 62,432,727.

Aytu BioPharma will participate in the Canaccord Genuity 42nd Annual Growth Conference from August 8-11, 2022, in Boston, MA. CEO Josh Disbrow and CFO Mark Oki will conduct one-on-one meetings on August 9 and 10, with a corporate overview presentation scheduled for 4:00 p.m. ET on August 10. A live webcast of the presentation will be available on the company's website, along with an online replay.

Aytu BioPharma focuses on developing therapeutics for rare pediatric disorders, including Vascular Ehlers-Danlos Syndrome.

Aytu BioPharma (NASDAQ:AYTU) announced the launch of the Phase 3 PREVEnt trial for enzastaurin (AR101), targeting patients with Vascular Ehlers-Danlos Syndrome (VEDS), a rare genetic condition. The trial, with over 30 sites across the US and Europe, aims to evaluate enzastaurin's efficacy in reducing serious arterial events. The FDA has granted a Safe to Proceed Letter, and approvals have been obtained in several European countries. Patient recruitment is underway, with the goal of dosing the first patient by early 2023.