Form 8-K - Current report

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): July 31, 2023

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 July 31, 2023, Aytu issued a press release titled “Aytu BioPharma Announces Exclusive Agreement with Medomie Pharma Ltd. To Commercialize Adzenys XR-ODT^® and Cotempla XR-ODT^® in Israel and the Palestinian Authority.”

A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. The information in this Item 7.01 and the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

Item 9.01. Financial Statements and Exhibits

(d) Exhibits


Exhibit No.		Description
99.1		Press release dated July 31, 2023
104		Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document)

SIGNATURE

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: July 31, 2023	By:	/s/ Mark K. Oki
		Mark K. Oki
		Chief Financial Officer

Exhibit 99.1

Aytu BioPharma Announces Exclusive Agreement with Medomie Pharma Ltd. to Commercialize Adzenys XR-ODT® and Cotempla XR-ODT® in Israel and the Palestinian Authority

After the completion of local regulatory approvals, Aytu anticipates exporting to Medomie both of its novel, orally disintegrating, extended-release tablets for the treatment of ADHD

ENGLEWOOD, CO and GIVATAYIM, ISRAEL/ July 31, 2023 / Aytu BioPharma, Inc. (the Company or "Aytu") (NASDAQ: AYTU), a pharmaceutical company focused on commercializing novel therapeutics, and Medomie Pharma Ltd, a privately owned pharmaceutical company focused on distributing and selling innovative branded medicines, biosimilars and niche generic products for patients in Israel and the Palestinian Authority, today announced the signing of an exclusive collaboration, distribution and supply agreement for Aytu’s Adzenys XR-ODT® and Cotempla XR-ODT® product lines. Medomie will seek local regulatory approvals and marketing authorizations for both Adzenys and Cotempla. This agreement represents Aytu’s first international commercial agreement for Adzenys and Cotempla.

Josh Disbrow, CEO of Aytu BioPharma stated, “We look forward to working with Medomie’s dedicated team to help bring our novel extended-release orally disintegrating tablet ADHD medicines to clinicians and patients in both Israel and the Palestinian Authority. ADHD patients are underserved in many areas of the world, and we hope that by working together, Aytu and Medomie can provide these markets with novel medications that enhance therapeutic outcomes while also helping to improve patient compliance and reduce potential therapy misuse.”

Avi Revivo, Founder and CEO of Medomie said, “This agreement ties directly into our core strategy of working with high quality partners and distributing their innovative, branded products for patients in Israel and the Palestinian Authority. We look forward to successfully building out and commercializing both the Adzenys and Cotempla brands here while addressing the needs of the area’s ADHD patient population. We look forward to a successful partnership with Aytu BioPharma.”

About Aytu BioPharma, Inc.

Aytu BioPharma is a pharmaceutical company commercializing a portfolio of commercial prescription therapeutics and consumer health products. 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), Karbinal® ER (carbinoxamine maleate), an extended-release antihistamine suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary fluoride-based prescription vitamin product lines available in various formulations for infants and children with fluoride deficiency. Aytu's consumer health segment markets a range of over-the-counter medicines and consumer health products addressing a range of common conditions including diabetes, allergy, hair regrowth, and gastrointestinal conditions. To learn more, please visit aytubio.com.

About Medomie Pharma, Ltd.

Medomie is a privately owned pharmaceutical company focused on distributing and selling innovative, branded medicines, biosimilars and niche generic products for patients in Israel and the Palestinian Authority. As an innovative and ﬂexible pharmaceutical specialist, Medomie is active in high-potential segments of the pharmaceutical market, with expertise in rapidly and efficiently identifying unexploited potential in known and unknown molecules and bringing them to market quickly. Medomie specializes in

ﬁnding those speciﬁc molecules with added value both for its partners and the local markets. The company places special emphasis on quality assurance, pharmacovigilance, and full compliance to GMP /GDP guidelines on import, storage and distribution in Israel and The Palestinian Authority.

Forward-Looking Statement

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. All statements other than statements of historical facts contained in this press release, are forward-looking statements. 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, risks associated with the Company's ability to successfully commercialize its products directly and through the Company’s current and future partnerships. We also refer you to (i) the risks described in ''Risk Factors'' in Part I, Item 1A of Aytu's most recent Annual Report on Form 10-K and in the other reports and documents it files with the Securities and Exchange Commission.

Contacts for Investors:

Mark Oki, Chief Financial Officer

Aytu BioPharma, Inc.

moki@aytubio.com

Robert Blum or Roger Weiss

Lytham Partners

AYTU@lythampartners.com

Document and Entity Information	Jul. 31, 2023
Cover [Abstract]
Document Type	8-K
Document Period End Date	Jul. 31, 2023
Entity File Number	001-38247
Entity Registrant Name	AYTU BIOPHARMA, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	47-0883144
Entity Address, Address Line One	373 Inverness Parkway
Entity Address, Adress Line Two	Suite 206
Entity Address, City or Town	Englewood
Entity Address, State or Province	CO
Entity Address, Postal Zip Code	80112
City Area Code	720
Local Phone Number	437-6580
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	AYTU
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Entity Central Index Key	0001385818
Amendment Flag	false