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Aytu BioPharma Announces Positive Preclinical Data in Ventilator-Associated Pneumonia with its Novel, Proprietary Healight Delivery Technology Preclinical Proof-of-Concept Study Demonstrates Effectiveness of Healight in

Key Takeaway: Aytu BioPharma Announces Positive Preclinical Data in Ventilator-Associated Pneumonia with its Novel, Proprietary Healight Delivery Technology Preclinical Proof-of-Concept Study Demonstrates Effectiveness of Healight in Delaying Time to Development of Ventilator-Associated Pne

Full Press Release Details

Aytu BioPharma Announces Positive Preclinical
Data in Ventilator-Associated Pneumonia with its Novel, Proprietary Healight Delivery Technology
Preclinical Proof-of-Concept Study Demonstrates
Effectiveness of Healight in Delaying Time to Development of Ventilator-Associated Pneumonia
CO - April 25, 2022 - Aytu BioPharma, Inc. (Nasdaq: AYTU), a pharmaceutical company focused on developing
and commercializing novel therapeutics, today announced positive results from a preclinical pilot study showing that administration of
its Healight ultraviolet light A (UVA) endotracheal catheter delayed the time to development of ventilator-associated pneumonia
(VAP) in a novel porcine model. Healight is the company's patented, investigational medical device technology employing proprietary
methods of administering intermittent UVA light delivered via a novel respiratory endotracheal catheter.
VAP has a reported mortality rate approaching 50% in some patient populations,
making it one of the most difficult-to-treat and deadly infections affecting hospitalized patients. Approximately 86% of nosocomial pneumonias
are associated with mechanical ventilation and result in VAP. Between 250,000 and 300,000 VAP cases per year occur in the United States
alone, which is an incidence rate of 5 to 10 cases per 1,000 hospital admissions. VAP afflicts up to 15% of mechanically ventilated patients
in intensive care units.
Aytu's proof-of-concept study with
Healight was conducted at Hospital Clinic de Barcelona under the supervision of principal investigator Antonio Torres, M.D., Ph.D.,
FERS, FCCP, ATSF, Senior Consultant, Pulmonology Department - one of the only centers worldwide with access to this
well-characterized porcine model of VAP caused by oropharyngeal secretions colonized by Pseudomonas aeruginosa. In the study,
administration of the Healight UVA endotracheal catheter resulted in a 46% reduction in multidrug-resistant Pseudomonas
aeruginosa (PA C1-17) versus controls following two separate 20-minute treatments. Based on these positive data, Hospital Clinic
de Barcelona and Aytu have initiated a second, larger porcine VAP study to guide the future development of Healight for patients
"Data from this study are critically important as they establish
proof-of-concept for Healight as a potential treatment for VAP, a frequently occurring and life-threatening infection that develops in
severely ill ventilated patients, which results in poor clinical outcomes and high rates of mortality," said Josh Disbrow, chief
executive officer of Aytu BioPharma. "VAP is an area of tremendous clinical need, and our mission is to bring therapeutic solutions
to patients with complex diseases. We're very encouraged by these positive data that demonstrate the effectiveness of Healight in
a well-established and validated model. We look forward to advancing Healight into the next phase of development in VAP and evaluating
potential additional indications that could benefit from our novel delivery technology."
Aytu plans to report data from the ongoing, larger preclinical study
of Healight in VAP later in 2022, which will guide the company's development plans in VAP and potential additional indications.
Healight is a patented, investigational medical device technology employing
proprietary methods of administering intermittent ultraviolet (UV)-A light via a novel respiratory endotracheal catheter. Originally developed
at Cedars-Sinai Medical Center, Aytu BioPharma owns an exclusive worldwide license for all respiratory applications of the Healight UV-A
light-based technology. Proof of concept clinical findings for Healight demonstrated significant reductions in SARS-CoV-2 viral load and
improvement in clinical outcomes in a small number of mechanically ventilated SARS-CoV-2 patients. Earlier published preclinical findings
indicated the technology's significant impact on eradicating a wide range of viruses and bacteria, inclusive of human coronavirus. Pre-clinical
studies are now underway to assess the safety and efficacy of Healight in ventilator-associated pneumonia.
About Aytu BioPharma, Inc.
Aytu BioPharma is a pharmaceutical company with a portfolio of commercial
prescription therapeutics and consumer health products, and a growing therapeutics pipeline focused on treating rare, pediatric-onset
disorders. The company's prescription products include Adzenys XR-ODT (amphetamine) extended-release orally disintegrating tablets
(see Full Prescribing Information, including Boxed WARNING) and Cotempla XR-ODT (methylphenidate) extended-release orally disintegrating
tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of attention deficit hyperactivity disorder (ADHD),
as well as Karbinal ER (carbinoxamine maleate), an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous
allergic conditions, and Poly-Vi-Flor and Tri-Vi-Flor , two complementary fluoride-based prescription vitamin product lines containing
combinations of fluoride and vitamins in various formulations for infants and children with fluoride deficiency. Aytu is also building
a therapeutic pipeline, which includes AR101 (enzastaurin), a PKC inhibitor in development for the treatment of vascular Ehlers-Danlos
Syndrome (VEDS). VEDS is a rare genetic disease typically diagnosed in childhood resulting in high morbidity and a significantly shortened
lifespan, and for which there are no currently approved treatments. AR101 has received Orphan Drug designation and Fast Track designation
from the U.S. Food and Drug Administration and has received Orphan Drug designation from the European Medicines Agency. Aytu is also researching
and advancing the development of the Healight ultraviolet light A (UVA) endotracheal catheter, a patented, investigational medical device
with potential application in the treatment of severe, difficult-to-treat respiratory infections. To learn more, please visit aytubio.com.
Forward Looking Statements
This press release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or
the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking
statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,''
''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,''
''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology.
Forward-looking statements, including but not limited to any statements regarding the intellectual property and product information
presented in this press release. These statements are just predictions and are subject to risks and uncertainties that could cause
the actual events or results to differ materially. These risks and uncertainties include, among others: the future growth potential
of our commercial portfolio and the anticipated start dates, durations and completion dates of the pre-clinical and clinical studies
associated with our product candidates and the potential safety and efficacy of our product candidates. We also refer you to the
risks described in ''Risk Factors'' in Aytu's Annual and Quarterly Reports on Form 10-K and 10-Q and in the other reports and
documents it files with the Securities and Exchange Commission.
THRUST Strategic Communications
Last updated: Apr 25, 2022