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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

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FORM 8-K

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CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

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Date of Report (Date of earliest event reported):  October 29, 2024

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DOGWOOD THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Charter)

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Delaware

001-39811

85-4314201

(State or other jurisdiction
of incorporation)

(Commission
File Number)

(IRS Employer
Identification No.)

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44 Milton Avenue

Alpharetta, GA

30009

(Address of principal executive offices)

(Zip Code)

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Registrant’s telephone number, including area code:  (866) 620-8655

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(Former name or former address, if changed since last report): Virios Therapeutics, Inc.

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

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Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001

DWTX

Nasdaq Capital Market

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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:

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☐

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

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☐

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

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☐

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

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☐

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

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

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.       ☐

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Item 8.01 Other Events.

On October 29, 2024, Dogwood Therapeutics, Inc. (the “Company”) received a letter from The Nasdaq Stock Market LLC (“Nasdaq”) stating that the Company had regained compliance with the minimum bid price requirement of Nasdaq Listing Rule 5550(a)(2), as required by the Hearing Panel’s decision dated June 11, 2024, because the Company’s common stock had a closing bid price of at least $1.00 per share for at least ten consecutive business days, and the matter is now closed.

On October 30, 2024, the Company issued a press release announcing key business developments, which is attached as Exhibit 99.1 to this report.

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Item 9.01 Financial Statements and Exhibits.

(d)Exhibits.

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Exhibit Number

    

Description

99.1

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104

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Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)

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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.

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DOGWOOD THERAPEUTICS, INC.

 

 

 

 

By:

/s/ Angela Walsh

 

Name:

Angela Walsh

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Title:

Chief Financial Officer, Corporate Secretary and Treasurer

October 30, 2024

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Graphic

Exhibit 99.1

Dogwood Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement

ATLANTA, Ga., October 30, 2024 -- Dogwood Therapeutics, Inc. (Nasdaq: DWTX) (the “Company”), formerly Virios Therapeutics, Inc., a clinical‐stage biopharmaceutical company, announced today that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. The listing compliance matter is now closed.

Below are some recent key developments in the business.

Key Highlights

•Top-line results from the Bateman Horne Center’s phase 2a study of IMC-2 for the treatment of Long-COVID are expected to be released in mid-November 2024.
•Integration efforts continue following the Company’s acquisition of Pharmagesic (Holdings) Inc. in early October 2024.

About Dogwood Therapeutics

Dogwood Therapeutics (Nasdaq: DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and fatigue-related disorders. The Dogwood research pipeline includes two separate mechanistic platforms that include a non-opioid analgesic program and an antiviral program. The proprietary non-opioid, Nav 1.7 analgesic program is centered on lead development candidate, Halneuron® which is a voltage-gated sodium channel blocker, a mechanism known to be effective for reducing pain. Halneuron® treatment has demonstrated pain reduction of both general cancer related pain and chemotherapy-induced neuropathic pain (“CINP”).  Interim data from the forthcoming Phase 2 CINP study are expected in 2H 2025.  The antiviral program includes IMC-1 and IMC-2, which are novel, proprietary, fixed dose combinations of nucleoside analog, anti-herpes antivirals and the anti-inflammatory agent, celecoxib, for the treatment of illnesses believed to be related to reactivation of previously dormant herpes viruses, including fibromyalgia (“FM”) and Long-COVID (“LC”). Top-line data from an ongoing IMC-2 Phase 2 LC study are expected in mid-November 2024. IMC-1 is poised to progress into Phase 3 development as a treatment for FM and is the focus of external partnership activities. For more information, please visit www.dwtx.com.

Follow Dogwood Therapeutics

Email Alerts: https://ir.dwtx.com/resources/email-alerts

LinkedIn: https://www.linkedin.com/company/dogwoodther/

Twitter: https://twitter.com/dogwoodther

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Graphic

Exhibit 99.1

Facebook: https://www.facebook.com/dogwoodther

Forward-Looking Statements

Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Dogwood’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion, timing and results of current and future clinical studies relating to Dogwood’s product candidates. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Amended Annual Report on Form 10-K/A for the year ended December 31, 2023, filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Dogwood undertakes no duty to update such information except as required under applicable law.

Contact:

IR@dwtx.com

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Document and Entity Information
Oct. 29, 2024
Document and Entity Information [Abstract]  
Document Type 8-K
Document Period End Date Oct. 29, 2024
Securities Act File Number 001-39811
Entity Registrant Name DOGWOOD THERAPEUTICS, INC.
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 85-4314201
Entity Address, Address Line One 44 Milton Avenue
Entity Address, City or Town Alpharetta
Entity Address, State or Province GA
Entity Address, Postal Zip Code 30009
City Area Code 866
Local Phone Number 620-8655
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
Trading Symbol DWTX
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period false
Entity Central Index Key 0001818844
Amendment Flag false
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