0001104659-22-049277.txt : 20220425 0001104659-22-049277.hdr.sgml : 20220425 20220425080107 ACCESSION NUMBER: 0001104659-22-049277 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20220425 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220425 DATE AS OF CHANGE: 20220425 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AYTU BIOPHARMA, INC CENTRAL INDEX KEY: 0001385818 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 470883144 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38247 FILM NUMBER: 22847361 BUSINESS ADDRESS: STREET 1: 373 INVERNESS PARKWAY STREET 2: SUITE 206 CITY: ENGLEWOOD STATE: CO ZIP: 80112 BUSINESS PHONE: (720) 437-6580 MAIL ADDRESS: STREET 1: 373 INVERNESS PARKWAY STREET 2: SUITE 206 CITY: ENGLEWOOD STATE: CO ZIP: 80112 FORMER COMPANY: FORMER CONFORMED NAME: AYTU BIOSCIENCE, INC DATE OF NAME CHANGE: 20150609 FORMER COMPANY: FORMER CONFORMED NAME: AYTU BIOSCIENCE, INC. DATE OF NAME CHANGE: 20150609 FORMER COMPANY: FORMER CONFORMED NAME: Rosewind CORP DATE OF NAME CHANGE: 20070110 8-K 1 tm2213321d1_8k.htm FORM 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 25, 2022

AYTU BIOPHARMA, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-38247		47-0883144
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

373 Inverness Parkway, Suite 206

Englewood, CO 80112

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (720) 437-6580

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		AYTU		The NASDAQ Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 7.01 Regulation FD Disclosure.

On April 25, 2022, the Company issued a press release announcing the positive results from a pre-clinical pilot study whereby administration of the Healight ultraviolet light A (UVA) endotracheal catheter delayed time to development of ventilator-associated pneumonia (VAP) in a novel porcine model. A copy of the press release is attached as Exhibit 99.1.

Item 9.01 Financial Statements and Exhibits.

(d)

Exhibits.

Exhibit		Description

99.1*		Press release dated April 25, 2022

104		Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document)

* In accordance with General Instruction B.2 of Form 8-K, the information in the press release attached as Exhibit 99.1 hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	AYTU BIOPHARMA, INC.

Date: April 25, 2022	By:	/s/ Mark Oki
		Mark Oki
		Chief Financial Officer

EX-99.1 2 tm2213321d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

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

ENGLEWOOD, 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 with VAP.

“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.

About Healight

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 PKCβ 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.

Contact:

Chelcie Lister

THRUST Strategic Communications

chelcie@thrustsc.com

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