Dogwood Therapeutics, Inc. (DWTX) Earnings Call Transcript & Summary

Greetings. Welcome to the Virios Therapeutics, Inc. Annual Shareholder Meeting. [Operator Instructions]. Just a reminder, if you have not voted your shares yet, you can also do so at this meeting simply by clicking yes and providing your e-mail. Please note, this conference is being recorded. I will now turn the conference over to your host, Greg Duncan, Chairman and CEO of Virios Therapeutics, Inc. Greg, please go ahead.

Thank you very much, Kelly. Good morning, and welcome to the 2023 Annual Stockholders Meeting of Virios Therapeutics, Inc. I am Greg Duncan, Chief Executive Officer and Chairman of the Board of Virios Therapeutics, and I have been appointed Chairman of this meeting. I would like to welcome you and express thanks of the entire Virios Therapeutics Board of Directors and management team for your attendance today. The team and I are excited to be hosting this virtual meeting, which allows us to be more inclusive and reach a greater number of stockholders via the web portal. We will conduct the formal business portion of our meeting first and then present a brief corporate update at the end of today's meeting. I now officially call this meeting to order. To start, I would like to introduce the directors and executive officers of Virios Therapeutics, Inc. In addition to myself, the directors are Rick Burch, Rick has served as a Director since December 2020. Mr. Burch is the former President of Virios Therapeutics, Inc. Dr. Abel De La Rosa, Abel served as an independent Director since December 2020. David Rick Keefer. Rick has served as an independent director since 2018. Dr. William, aka. Skip Pridgen. Skip has served as a director since April 2019. Dr. Pridgen is the Founder and former Chief Executive Officer of Virios Therapeutics, Inc. John Thomas, John has served as an independent director since December 2020. And last but certainly not least, Dr. Richard Whitley. Rich has served as an independent director since December 2020. Also in attendance today are Angela Walsh, our Senior Vice President of Finance and our Treasurer; Dr. Michael Gendreau, our Chief Medical Officer; and Ralph Grosswald, our Senior Vice President of Operations. Attending today are representatives of FORVIS, LLP, the company's independent registered public accounting firm. Emily White, with Issuer Direct has been appointed as the Inspector of Election for today's meeting, and Emily has previously taken her oath as Inspector of Elections. Now let me turn the proceedings over to Angela Walsh, who will provide instructions for today's meeting. Angela?

Good morning, everyone. Stockholders will have the opportunity to ask questions during today's meeting. To submit questions to today's presenters, please type your questions into the Q&A pane of the control panel. You may send your questions at any time during the meeting. We will collect these and address questions that are appropriate and relevant for the agenda items at this meeting. At this time, I will turn the meeting back over to Greg.

Thank you, Angela. The following 3 documents will be incorporated in the company's records as part of the minutes of today's meeting. Number one, a copy of the notice of Annual Meeting of Stockholders stating the date, time, place and purposes of this meeting; second, a copy of the proxy statement for this meeting; and third, the affidavit of Broadridge showing that each stockholder of record on the record date was mailed and deposited with the United States Post Office, packages containing the notice of annual meeting, the proxy statement, form of proxy card and the annual report on Form 10-K. I will turn it back over to Angela as we now proceed with the formal business of this meeting.

April 25, 2023, was a record date set by the Board of Directors for stockholders entitled to notice of and to vote at this meeting. A certified list of the stockholders of the company as of the close of business on the record date has been provided to the company by the company's transfer agent, Broadridge. That list is available for inspection during this meeting and shows that on the record date, there were 18,330,390 shares of common stock of the company issued and outstanding. On each proposal brought before this meeting, stockholders are entitled to one vote for each share of common stock registered in their name. I have been advised that more than 1/3 of the outstanding shares entitled to vote are present. Therefore, I declare that a quorum is present, and this meeting may now proceed. Let me turn it over to Greg to review the proposal.

Sure. The first matter requiring the vote of stockholders is the election of 7 director nominees to serve until the 2024 Annual Meeting of Stockholders and until their successors are duly elected and qualified. The 7 nominees receiving the highest number of votes of shares present virtually or by proxy at this meeting will be elected as directors. The candidates who are nominated for election are Richard Burch, Dr. Abel De La Rosa, myself, Greg Duncan; David Rick Keefer, Dr. William Pridgen, John C. Thomas, Jr. and Dr. Richard Whitley. Each of these nominees currently serves as a Director of the company. No other person has been properly nominated under the procedures required by the bylaws and I declare the nominations now closed. The Board of Directors recommends that stockholders vote for each of the director nominees. We will now move to proposal #2, the ratification of the selection of FORVIS, LLP to serve as the company's independent registered public accounting firm for the fiscal year ending December 31, 2023. The Board of Directors recommend that stockholders vote for ratification of the appointment of FORVIS, LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2023. And finally, we progressed to proposal #3, approval of an amendment to our certification of incorporation to effect the Reverse Stock Split of the outstanding shares of our common stock at a ratio of not less than 1-for-2 and not more than 1-for-25 with the exact ratio within this range to be determined by our Board of Directors in its sole discretion. Approval of this proposal does not commit the company to executing a Reverse Stock Split, and our Board of Directors may elect not to affect any Reverse Stock Split and not file any certificate of amendment to our certification of incorporation. There is no further business to come before this meeting. Before proceeding to vote, if any stockholder would like to ask a question regarding any of these proposals, please submit your question through the questions' chat pane on the control panel. Angela will now report on any questions received.

Greg, there are no stockholder questions to be addressed at this time.

Thank you very much. Angela, we will now move to voting. It's now 11:12 a.m. and the polls are now open for voting. In order to vote, you may click on the hyperlink provided in the questions' chat pane and follow the prompts. If you have voted your shares prior to the start of the annual meeting, your vote has been received by the company's Inspector of Elections, and there is no need to vote those shares again during this meeting unless you wish to revoke or change your vote. We will now provide roughly a minute or 2 for stockholders to finish voting. [Voting]

Okay. There's now 11:16 a.m. and I declare that the polls are closed. I will now provide the preliminary report of the Inspector of Elections. Based on the preliminary report of the Inspector of Elections, I hereby declare that each of Richard Burch, Dr. Abel De La Rosa, Greg Duncan, David Rick Keefer, Dr. William Pridgen, John C. Thomas Jr. and Dr. Richard Whitley have received the affirmative vote of more than a plurality of the shares present at the meeting and entitled to vote on the election of Directors and each of them has been elected to serve as a Director of the company. I also hereby declare the appointment of FORVIS, LLP to serve as the company's independent registered public accounting firm for the fiscal year ending December 31, 2023, has been ratified by the affirmative vote of at least the majority of the shares present and entitled to vote on this proposal. And finally, I hereby declare that a majority of the shares of common stock outstanding have not voted in favor of proposal #3. Accordingly, we will not file an amendment to our certificate of incorporation to affect a Reverse Stock Split of the outstanding shares of common stock. As there are no other matters to be considered, the Annual Meeting of Stockholders of Virios Therapeutics Inc. is now adjourned. Thank you for your attendance. Now that we have concluded the formal portion of the 2023 Annual Meeting of Stockholders, I will provide a brief update for those interested in remaining connected to the webcast for a few more minutes. As I'm sure most of you know, Virios Therapeutics is focused on developing combination antiviral medicines to treat patients with chronic debilitating diseases that we believe are triggered by activation of previously dormant herpes viruses. Our dual mechanism, combination antiviral development candidates have been designed to inhibit replication of activated herpes viruses. We believe that by converting activated viruses back into a dormant state, we can deliver clinical benefits to patients suffering from several diseases, including fibromyalgia. Our belief is founded on both preclinical and clinical research and our team has been working diligently to create a forward development path for our lead development compound, IMC-1, a dual mechanism of action, combination antiviral therapy. We conducted a Phase IIa proof-of-concept trial, which demonstrated at IMC-1, a fixed-dose combination of famciclovir and celecoxib improved both the pain and fatigue associated with fibromyalgia as well as improve the anxiety and depression that is often associated with a fibromyalgia diagnosis. Importantly, IMC-1's ability to reduce pains is measured on the very same endpoint used by FDA to approve new fibromyalgia treatments. This trial led to the decision to advance IMC-1 to Phase IIb development in our recently completed FORTRESS trial. The full 422 patient FORTRESS Phase IIb study did not achieve statistical significance on the primary endpoint of pain reduction. However, post-hoc analysis, subs analysis of the 175 patients who are either new to fibromyalgia research and/or did not have a prior relationship with our clinical research sites revealed clinically and statistically significant improvements in fibromyalgia related symptoms, including pain, fatigue, anxiety and depressed mood. Based on extensive analysis of these data and input from experts in the field, in March of this year, the company proposed to the Food and Drug Administration that IMC-1 be advanced into Phase III development. Our Phase III program proposal targets community-based fibromyalgia patients who have not recently participated in prior fibromyalgia research trials. The currently proposed Phase III program consists of 4 primary components as followed. A pharmacokinetic and food effect study is in the proposed Phase III dose and a revised formulation; 2 adequate and well-controlled pivotal clinical studies, one of which will be a full factorial design with each of the individual components of IMC-1 a separate comparator arms. Effectively in the study, you'll have IMC-1, placebo, celecoxib as monotherapy and famciclovir as monotherapy will be a form on multifactorial study. In addition, the fourth component of the program is a long-term safety study. The FDA conveyed initial feedback that they were amenable to our initial Phase III proposal, albeit this feedback is subject to review of the final data from our chronic toxicology program. Last month, we communicated that we have submitted the final toxicology program results in support of our proposal to advance IMC-1 to Phase III development and await further feedback from the FDA. Following FDA review of the chronic toxicology data, if the agency provides our formal consent to progress IMC-1 to Phase III development, we anticipate providing shareholders with an update on the planned Phase III program, inclusive of any further feedback from the FDA. While the Phase III fibromyalgia program garners the lion's share of the Virios team's time and attention, we're also excited about a second ongoing study focused on the combination of valacyclovir and celecoxib as a potential dual therapy to treat symptoms associated with long COVID syndrome. Why is this important? Well according to the Center for Disease Control, or CDC, as you may note it, data from the 2023 household poll survey shows that more than 50% of adults in the U.S. reported having COVID-19 in the past. And that 5.6% of the U.S. population are currently still having symptoms of long COVID. Simply translated, these data suggest that as many as 18.5 million U.S. citizens may presently be suffering from the symptoms commonly associated with long COVID illness. These symptoms include fatigue, concentration impairment or brain fog and is more commonly known by patients, depression and different levels of pain. For reference, the World Health Organization defines long COVID illness as the continuation of development of new symptoms 3 months after an acute illness and lasting 2 months without further explanation. While estimates vary, we do see very high levels of morbidity associated with long COVID, resulting in approximately 2% of the U.S. workforce being unable to work due to long COVID illness, which portends into an economic cost of long COVID illness, ranging from $50 billion to upwards of $230 billion annually here in the U.S. according to the Journal for Global Health. The ongoing exploratory, open-label trial we have -- we are executing, has been designed to assess whether or not patients suffering from long COVID sequelae were treated with both valacyclovir and celecoxib exhibit improvement versus the current standard of care for long COVID. Symptoms being assessed in this open-label study include the incidence and severity of long COVID-related fatigue, concentration difficulties, autonomic symptoms and related symptoms, which caused the morbidity associated with this particular symptom. As we have previously conveyed, we expect to announce top line results from this program at the end of June. This is a program supported by an investigational [ group ] to the Bateman Horne Center, and they actually control the execution of this program. Based on the actual timing of the enrollment of the final patient in the study, we now expect to be able to provide top line results from the signal-seeking study by mid-July, approximately 2 weeks later than originally projected. If our mechanistic hypothesis focused on activation of secondary herpes viruses, as a catalyst for long COVID sequelae is supported by this exploratory data, our plan will be to engage our scientific advisers to help shape our proposal to present to FDA with the end goal of more formally assessing the role of combination antiviral therapy as a potential treatment for fatigue-related disorders, including long COVID. Are there any questions from the brief corporate update, I have just provided.

We have a question here about when we will be getting the long COVID data and do you expect the FDA to respond before the 60 days on IMC-1? For the first question, as I just referenced, we're a couple of weeks behind our original projection. We don't control the rate of enrollment in a long COVID program, but I think it's safe to say winning an additional 2 weeks has got too much of a burden. And we should have data -- top line data from the exploratory open-label long COVID program sometime in mid-July. The FDA is not on the call to respond to our recent chronic toxicology program results that we submitted in support of the IMC-1 fibromyalgic program. But as referenced earlier in the discussion, we will provide an update expeditiously after we receive that feedback. I don't see any other further questions from today. So this concludes our brief corporate update. As of today's meeting, we want to thank you for your attendance today and continued support. I wish you a great day, and I'll turn it back to our moderator, Kelly.

Thank you. This does conclude today's call, and you may disconnect at this time. Thank you for your participation.