Virios Therapeutics seeks shareholder approval for a reverse stock split to fund Phase 2 development of IMC-2 for Long-COVID.

TL;DR

Virios Therapeutics is seeking shareholder approval for a reverse stock split to enable future equity financing for the Phase 2 development of its Long-COVID treatment candidate, IMC-2.

AI Summary

Virios Therapeutics, Inc. (DWTX) filed a Proxy Statement (DEF 14A) with the SEC on February 2, 2024. Virios Therapeutics plans to advance its development candidate IMC-2 (valacyclovir and celecoxib) into Phase 2 development for Long-COVID symptoms. There are no FDA-approved treatments for Long-COVID, positioning IMC-2 as a potential first-in-class therapy. The company has sufficient capital to support operations into Q4 2024, including an ongoing exploratory study of IMC-2. Additional funding is required to advance IMC-2 into Phase 2, pursue partnerships, and explore licensing opportunities. A reverse stock split is proposed to increase authorized shares, facilitate future equity funding, and regain Nasdaq listing compliance.

Why It Matters

For investors and stakeholders tracking Virios Therapeutics, Inc., this filing contains several important signals. The proposed reverse stock split is crucial for Virios Therapeutics to secure the necessary capital for advancing IMC-2 into Phase 2 trials and exploring strategic partnerships. Approving the reverse stock split is essential for Virios Therapeutics to maintain compliance with Nasdaq listing requirements, which could be jeopardized by insufficient authorized shares.

Risk Assessment

Risk Level: — Virios Therapeutics, Inc. shows moderate risk based on this filing. The company requires additional funding to advance its lead drug candidate, IMC-2, into Phase 2 development and to maintain Nasdaq listing compliance, necessitating a reverse stock split which can be viewed negatively by investors.

Analyst Insight

Stockholders should consider the strategic necessity of the reverse stock split for future funding and Nasdaq compliance, while monitoring the progress of the IMC-2 Phase 2 trials.

Key Numbers

• Q4 2024 — Capital Runway (Capital to support operations into the fourth quarter of 2024)
• March 1, 2024 — Special Meeting Date (Notice of Special Meeting of Stockholders to be Held on March 1, 2024)

Key Players & Entities

• Virios Therapeutics, Inc. (company) — Registrant
• IMC-2 (company) — development candidate
• valacyclovir (company) — combination with celecoxib
• celecoxib (company) — combination with valacyclovir
• Long-COVID (company) — treatment for symptoms
• FDA (regulator) — agreement on primary endpoint
• Nasdaq (company) — listing requirements

Forward-Looking Statements

• Virios Therapeutics will successfully complete Phase 2 trials for IMC-2 in Long-COVID. (Virios Therapeutics, Inc.) — low confidence, target: 2025-12-31
• IMC-2 will receive FDA approval for treating Long-COVID symptoms. (IMC-2) — low confidence, target: 2028-12-31

FAQ

Risk Factors

• Need for Additional Funding [high — financial]: The company requires additional funding to advance its development candidate IMC-2 into Phase 2 development and to maximize forward strategic options.
• Nasdaq Listing Requirements [medium — regulatory]: The company needs to increase authorized shares through a reverse stock split to regain compliance with Nasdaq listing requirements.

Industry Context

Virios Therapeutics is a biopharmaceutical company focused on developing novel treatments for fatigue-related conditions. The company is targeting the unmet medical need for Long-COVID treatments.

Regulatory Implications

The company is seeking to regain compliance with Nasdaq listing requirements, which often involve minimum share price or market capitalization thresholds.

What Investors Should Do

1. Review the proxy statement for detailed information on the proposed reverse stock split and its implications.
2. Assess the company's financial projections and capital needs for advancing IMC-2 into Phase 2 development.
3. Monitor the outcome of the special meeting and any subsequent actions taken by Virios Therapeutics regarding funding and Nasdaq compliance.

Key Dates

• 2024-03-01: Special Meeting of Stockholders — To approve a reverse stock split to facilitate future funding and Nasdaq compliance.
• 2024-02-02: Filing Date — Definitive Proxy Statement filed

Glossary

IMC-2

A development candidate combining valacyclovir and celecoxib. (Potential treatment for Long-COVID symptoms.)

Long-COVID (LC)

A condition characterized by persistent symptoms following a COVID-19 infection. (The primary indication for IMC-2 development.)

Reverse Stock Split

A corporate action where a company reduces the number of its outstanding shares. (Proposed to increase authorized shares for future equity financing and Nasdaq compliance.)

Year-Over-Year Comparison

This filing is a Definitive Proxy Statement (DEF 14A) related to a special meeting of stockholders, indicating a significant corporate action is being proposed.

Key Financial Figures

• $0.0001 — g shares of our common stock, par value $0.0001 per share (the " Common Stock "), at a
• $12,000 — api Partners LLC a fee of approximately $12,000 plus expenses. Directors, officers, and
• $1.00 — mmon stock had closed below the minimum $1.00 per share requirement for continued lis

Filing Documents

• tmb-20240301xdef14a.htm (DEF 14A) — 214KB
• tmb-20240301xdef14a_a001.jpg (GRAPHIC) — 13KB
• tmb-20240301xdef14a_bg001.jpg (GRAPHIC) — 107KB
• tmb-20240301xdef14a_bg002.jpg (GRAPHIC) — 118KB
• 0001558370-24-000721.txt ( ) — 544KB

From the Filing

DEF 14A 1 tmb-20240301xdef14a.htm DEF 14A Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant Filed by a Party other than the Registrant Check the appropriate box: Preliminary Proxy Statement Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) Definitive Proxy Statement Definitive Additional Materials Soliciting Material under 240.14a-12 VIRIOS THERAPEUTICS, INC. (Name of Registrant as Specified in Its Charter) (Name of Person(s) Filing Proxy Statement, if other than the Registrant) Payment of Filing Fee (Check the appropriate box): No fee required. Fee paid previously with preliminary materials. Fee computed on table in exhibit required by Item 25(b) per Exchange Act Rules 14a-6(i)(1) and 0-11. Table of Contents 44 Milton Avenue Alpharetta, GA 30009 NOTICE OF SPECIAL MEETING OF STOCKHOLDERS To Be Held on March 1, 2024 February 2, 2024 To our Stockholders: We recently announced plans to advance our development candidate IMC-2 (the combination of valacyclovir and celecoxib) into Phase 2 development as a treatment for the symptoms associated with Long-COVID ("LC"). There are currently no FDA-approved LC treatments, thus IMC-2 has potential to be one of the first therapies for addressing LC symptoms. With FDA agreement that fatigue reduction can serve as the primary endpoint in this program, success with LC as our initial indication may allow for extension to other fatigue related illnesses such as Chronic Fatigue Syndrome, thereby expanding our potential market opportunity . We have also communicated that we currently have capital to support operations into the fourth quarter of 2024, including funding an ongoing exploratory placebo-controlled 12-week study of the valacyclovir/celecoxib combination for the treatment of LC. In order to maximize our forward strategic options (e.g. advancing IMC-2 into a Phase 2 program, executing new partnerships and/or license opportunities, etc.), we need to secure additional funding, including, potentially, through the sale and issuance of equity securities. At present, the number of authorized shares available for issuance is not sufficient to facilitate future funding opportunities of this nature. As such, we are recommending that the stockholders approve the reverse stock split, which will result in us having the necessary shares to use equity to fund our development program, while simultaneously enabling the Company to regain compliance with Nasdaq listing requirements. Consistent with the aforementioned plan, you are cordially invited to attend the special meeting of stockholders (the "Special Meeting") of Virios Therapeutics, Inc. (the "Company"), which will be held on March 1, 2024, at 11:00 a.m., Eastern Time. The Special Meeting will be conducted as a completely virtual meeting of stockholders. You can attend the special meeting by visiting https://agm.issuerdirect.com/viri where you will be able to listen to the meeting live, submit questions, view the stockholder list and vote online. Because the Special Meeting is completely virtual and being conducted via the internet, stockholders will not be able to attend the meeting in person physically. Only stockholders who held stock at the close of business on the record date, January 30, 2024, may vote at the Special Meeting, including any adjournment or postponement thereof. At the Special Meeting, you will be asked to consider and vote upon: (1) an amendment to our Certificate of Incorporation to effect a reverse stock split of the outstanding shares of our common stock, par value $0.0001 per share (the " Common Stock "), at a ratio of not less than 1-for-2 and not greater than 1-for-25, with the exact ratio and effective time of the reverse stock split to be determined by our Board of Directors and (2) the transaction of any other business that may properly come before the meeting or any adjournment thereof. Pursuant to our bylaws, no other items of business are expected to be considered at the meeting. The accompanying Proxy Statement more fully describes the details of the business to be conducted at the Special Meeting. After careful consideration, our Board of Directors has unanimously approved the proposal and recommends that you vote FOR the proposal described in the Proxy Statement. Table of Contents Your vote is important. Whether or not you expect to attend the Special Meeting, please vote via the internet or over the telephone as instructed in the enclosed proxy statement and on the enclosed proxy card as soon as possible to ensure that your shares are represented. Information about voting methods is set forth in the accompanying Notice and Proxy Statement. Thank you for your continued support of and owne

View Full Filing

View this DEF 14A filing on SEC EDGAR