Aytu Biopharma Inc Stock Price, News & Analysis

Aytu BioPharma announced the listing of its newly issued US patent No. 11,166,947 for Cotempla XR-ODT in the FDA's Orange Book, effective March 23, 2022. This patent covers pediatric dosing methods for treating ADHD with methylphenidate and extends the product's exclusivity through at least 2038. Cotempla XR-ODT, approved by the FDA in June 2017, serves children ages 6-17, offering a unique orally disintegrating tablet form. The CEO emphasized the importance of this patent in protecting the product as the ADHD medication market grows.

Aytu BioPharma (NASDAQ:AYTU) announced its participation in the Cantor Fitzgerald Virtual Rare Orphan Disease Summit on March 29, 2022, at 11:00 a.m. ET. The panel will focus on managing clinical trials for rare diseases during and after COVID-19. Aytu is a pharmaceutical company dedicated to developing treatments for rare, pediatric-onset disorders. Their product line includes medications for ADHD and allergy treatment, and they are advancing their therapeutic pipeline, including AR101 for Vascular Ehlers-Danlos Syndrome, a condition with no existing treatments.

Aytu BioPharma (NASDAQ:AYTU) announced that CFO Mark Oki and CCO Greg Pyszczymuka will participate in a fireside chat at the 34th Annual Roth Conference on March 15, 2022, at 2:00 p.m. PT in Dana Point, California. The conference runs from March 13-15. A live webcast will be accessible on the company’s website and archived for 90 days.

Aytu BioPharma specializes in developing therapeutics for rare pediatric disorders and offers prescription products for ADHD and allergy treatment, along with a pipeline drug, AR101, for vascular Ehlers-Danlos Syndrome.

Aytu BioPharma announced the closing of an underwritten offering, raising $7.6 million through the sale of 3,030,000 shares of common stock and associated warrants. Each share and pre-funded warrant was priced at $1.25, with warrants exercisable for 1.1 shares at $1.30. The proceeds will support growth initiatives, including the PREVEnt Trial for AR101, aimed at treating vascular Ehlers-Danlos Syndrome. There is no public market for the pre-funded and common warrants. Canaccord Genuity and Roth Capital Partners facilitated the offering.

Aytu BioPharma (NASDAQ:AYTU) announced an underwritten offering of 3,030,000 shares of common stock and related warrants to a healthcare-dedicated institutional investor, aiming for approximately $7.6 million in gross proceeds. Each share and pre-funded warrant are priced at $1.25, with associated common warrants exercisable for 1.1 shares at $1.30. The proceeds will support the company’s commercial business growth, advance development of pipeline assets like AR101 for treating vascular Ehlers-Danlos Syndrome, and cover working capital needs. Closing is expected by March 7, 2022.

Aytu BioPharma (NASDAQ:AYTU) announced that the European Commission has granted orphan designation for AR101 (enzastaurin), a PKCβ inhibitor, intended for treating Ehlers-Danlos Syndrome (EDS), particularly the severe subtype vascular EDS (VEDS). This follows a similar designation from the FDA. The company plans to start a clinical trial, PREVEnt, in mid-2022 to evaluate AR101's safety and efficacy in VEDS patients. Orphan designation provides benefits such as reduced regulatory fees and market exclusivity for 10 years.

Aytu BioPharma reported a 53% year-over-year increase in net revenue, reaching $23.1 million for Q2 2022. Prescription sales surged over 103% to $14.6 million, with ADHD products achieving all-time highs. Despite this, net loss widened to $11.5 million or $0.44 per share. Notable advancements include FDA clearance for AR101, designated for treating Vascular Ehlers-Danlos Syndrome, and the initiation of a clinical trial for Healight in SARS-CoV-2 patients. The financial position was bolstered by a $15 million debt refinancing.

Aytu BioPharma (NASDAQ:AYTU) has refinanced its existing senior secured loan facility by entering into a $15 million agreement with Avenue Capital Group.

This refinancing includes an interest rate based on prime plus 7.4% and a flexible repayment structure, allowing up to 36 months of interest-only payments contingent on certain milestones.

The funds will support Aytu's ongoing clinical studies, including a registrational study of AR101 for vascular Ehlers-Danlos Syndrome and a study of Healight for SARS-CoV-2.

Aytu BioPharma (NASDAQ:AYTU) has appointed Mark Oki as its new Chief Financial Officer, effective January 17, 2022. Oki joins the executive committee, reporting to CEO Josh Disbrow. His role will focus on financial operations, accounting, and IT. Oki brings over 20 years of experience in finance within the biotech and pharmaceutical industries, previously serving as CFO of Vivus LLC. Upon starting, he will receive an inducement grant of 100,000 shares, vesting over three years. This appointment aims to enhance growth strategies and leverage financial expertise for Aytu's pipeline advancements.