Dogwood Therapeutics Inc (DWTX) 2024 Q1 法說會逐字稿

Good morning, and welcome to the Virios Therapeutics Incorporated First Quarter 2024 Earnings Call. At this time, all participants have been placed on a listen-only mode. Please be advised that today's call is being recorded at the company's request.

早安，歡迎參加 Virios Therapeutics Incorporated 2024 年第一季財報電話會議。此時，所有參與者均已置於僅聽模式。請注意，應公司要求對今天的通話進行錄音。

At this time, I'd like to turn the call over to Angela Walsh, Senior Vice President of Finance and Treasurer for Virios Therapeutics. Please proceed, Angela.

現在，我想將電話轉給 Virios Therapeutics 財務高級副總裁兼財務主管 Angela Walsh。請繼續，安琪拉。

Good morning, everyone, and thank you for joining us on today's conference call. We are pleased to be with you today to discuss Virios Therapeutics' first quarter financial results, and to provide a corporate update. Please note that our financial results press release is now available on our website.

大家早安，感謝您參加今天的電話會議。我們很高興今天與您一起討論 Virios Therapeutics 第一季的財務業績，並提供公司最新情況。請注意，我們的財務業績新聞稿現已發佈在我們的網站上。

Before we begin, I'd like to remind everyone that statements made during this conference call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially from the information expressed or implied by these forward-looking statements. For more information regarding such risks and uncertainties, please see the risk factors outlined in the company's filings with the SEC.

在開始之前，我想提醒大家，本次電話會議期間所做的陳述將包括1995 年《私人證券訴訟改革法案》含義內的前瞻性陳述，其中涉及可能導致實際結果存在重大差異的風險和不確定性這些前瞻性陳述明示或暗示的資訊。有關此類風險和不確定性的更多信息，請參閱該公司向 SEC 提交的文件中概述的風險因素。

Any forward-looking statements are made only as of today, and we disclaim any obligation to update these forward-looking statements other than as required by law. Please see the forward-looking statements section in our financial results press release issued this morning for more information.

任何前瞻性陳述僅截至今日作出，除法律要求外，我們不承擔任何更新這些前瞻性陳述的義務。請參閱今天上午發布的財務業績新聞稿中的前瞻性聲明部分，以了解更多資訊。

Now it is my pleasure to turn the call over to our CEO, Greg Duncan.

現在我很高興將電話轉給我們的執行長格雷格鄧肯。

Thank you very much, Angela. The team and I are excited to convey a few key progress highlights from the first three months of this year as the first part of today's update. First, let's start with the ongoing investigator-initiated Bateman Horne Center Long-COVID Phase 2 study. Clearly, this ongoing study is important to Virios Therapeutics shareholders. However, we can't forget it's also important to the millions of patients who are suffering from the symptoms of Long-COVID illness. It seems each week new research highlights the growing burden of Long-COVID illness.

非常感謝你，安吉拉。作為今天更新的第一部分，我和團隊很高興傳達今年前三個月的一些關鍵進度亮點。首先，讓我們從正在進行的由研究者發起的貝特曼·霍恩中心 Long-Covid 2 期研究開始。顯然，這項正在進行的研究對 Virios Therapeutics 股東來說非常重要。然而，我們不能忘記，這對數百萬患有長效新冠病毒症狀的患者也很重要。似乎每週都有新的研究強調長效新冠疾病的負擔日益加重。

Recently published scientific literature demonstrate a growing belief that reactivation of previously dormant herpesviruses, the target of our therapies, notably an Epstein-Barr virus and Herpes simplex 1 may be triggering Long-COVID illness in at least a portion of those suffering from Long-COVID sequelae. The Center For Disease Control or CDC, as you may know it, estimates that approximately 7% of the US population representing approximately 23 million US citizens have suffered from Long-COVID symptoms at some point, since the beginning of the pandemic.

最近發表的科學文獻表明，人們越來越相信，先前休眠的皰疹病毒（我們的治療目標）的重新激活，特別是Epstein-Barr 病毒和單純皰疹1 型，可能會在至少一部分患有長期新冠肺炎的患者引發長期新冠肺炎疾病。如您所知，美國疾病管制中心 (CDC) 估計，自大流行開始以來，約 7% 的美國人口（即約 2,300 萬美國公民）曾在某個時候出現過長效新冠肺炎症狀。

The CDC further estimates that 3.4% of US adults are presently right now suffering from active Long-COVID sequelae, representing 11.2 million potential patient targets. That's patient targets here just in the US Unfortunately, there are no FDA approved Long-COVID treatments. We believe valacyclovir and celecoxib or IMC-2 as we call it has the potential to be a market leading option to address this major need for millions of patients worldwide. The ongoing BHC-202 study is a 3-arm study comparing two dose levels of the valacyclovir/celecoxib combination versus placebo over 12 weeks to treat their symptoms of Long-COVID illness.

CDC 進一步估計，目前有 3.4% 的美國成年人患有活動性長新冠病毒後遺症，這意味著 1,120 萬潛在患者目標。這只是美國的患者目標。我們相信伐昔洛韋和塞來昔布或我們所說的 IMC-2 有潛力成為市場領先的選擇，以滿足全球數百萬患者的這一主要需求。正在進行的 BHC-202 研究是一項 3 臂研究，比較了伐昔洛韋/塞來昔布組合與安慰劑的兩種劑量水平在 12 週內治療長期新冠肺炎症狀的效果。

I'm pleased to report that patient enrollment is going well and has surpassed the 50% enrollment level. Encouragingly and consistent with prior research, a planned preliminary safety analysis of the BAC-202 study data indicates that the combination of valacyclovir and celecoxib has been very well tolerated to date with no serious adverse events reported and only a few transient or temporary treatment emergent adverse events being reported throughout the study. This Phase 2 trial follows on from the previous proof-of-concept study results we've reported last year featuring the combination of valacyclovir and celecoxib as a potential new treatment for Long-COVID.

我很高興地報告，患者入組進展順利，已超過 50% 的入組水準。令人鼓舞的是，與先前的研究一致，計劃對BAC-202 研究數據進行的初步安全性分析表明，伐昔洛韋和塞來昔布的組合迄今為止具有良好的耐受性，沒有報告嚴重的不良事件，只有少數短暫或暫時的治療緊急不良事件在整個研究過程中報告的事件。這項 2 期試驗是我們去年報告的概念驗證研究結果的延續，該研究結果表明伐昔洛韋和塞來昔布的組合可以作為長效新冠肺炎的潛在新療法。

In this study, as you may recall, IMC-2 demonstrated clinical and statistical improvement in Long-COVID patients' fatigue, orthostatic intolerance, anxiety, and pain, as well as an improvement in overall health as compared with age, gender, duration of illness and previously vaccinated matched-control patients. These results are particularly important for several reasons, most notably given the current dearth of treatments available to address patients' Long-COVID symptoms.

您可能還記得，在這項研究中，IMC-2 證明了長新冠肺炎患者的疲勞、直立不耐受、焦慮和疼痛的臨床和統計改善，以及與年齡、性別、持續時間相比整體健康狀況的改善。基於多種原因，這些結果特別重要，最值得注意的是，目前缺乏可用於解決患者長效新冠症狀的治療方法。

Furthermore, we believe these data validate our approach to addressing the reactivation of secondary herpesviruses rather than targeting the SARS-CoV-2 virus itself as a unique approach to treating Long-COVID patient symptoms. This approach and these data may explain why treatments like Paxlovid that specifically target the SARS-CoV-2 virus have failed to date to exhibit benefits in treating Long-COVID symptoms.

此外，我們相信這些數據驗證了我們解決繼發性皰疹病毒重新活化的方法，而不是針對 SARS-CoV-2 病毒本身作為治療長新冠病毒患者症狀的獨特方法。這種方法和這些數據可以解釋為什麼像 Paxlovid 這樣專門針對 SARS-CoV-2 病毒的治療方法迄今為止未能在治療 Long-COVID 症狀方面表現出益處。

We also now know that the risk of developing Long-COVID increases with each acute infection and that COVID vaccines do not prevent patients from progressing from Long-COVID illness. In short, there's a major need to advance new therapies like IMC-2 in the hopes of addressing this emerging health problem. Top-line results from this landmark study are expected in the second half of 2024 and in our view represent a significant value inflection opportunity for Virios shareholders on the near term horizon.

我們現在也知道，每次急性感染都會增加長新冠病毒的風險，新冠病毒疫苗並不能阻止患者發展為長新冠病毒疾病。簡而言之，迫切需要推進 IMC-2 等新療法，以期解決這個新出現的健康問題。這項具有里程碑意義的研究的主要結果預計將於 2024 年下半年得出，我們認為，這對 Virios 股東來說代表了近期的重大價值拐點機會。

On a related Long-COVID program note, Virios' global patent for IMC-2 covering combination antiviral treatment of both Long-COVID as well as Alzheimer's disease was recently published. This enables the company to streamline the process for obtaining patent protection globally. If ultimately granted, this will provide us with intellectual property protection for use of IMC-2 in both treating Long-COVID and Alzheimer's disease until approximately 2044.

在相關的 Long-COVID 項目說明中，Virios 的 IMC-2 全球專利最近發布，涵蓋了 Long-COVID 和阿茲海默症的聯合抗病毒治療。這使該公司能夠簡化在全球範圍內獲得專利保護的流程。如果最終獲得批准，這將為我們在 2044 年左右使用 IMC-2 治療長新冠病毒和阿茲海默症提供智慧財產權保護。

Moving beyond the IMC-2 Long-COVID program, I also wanted to share that discussions are ongoing as we seek a partner to advance our second development candidate IMC-1, a fixed dosage combination of famciclovir and celecoxib into Phase 3 development for the treatment of fibromyalgia. In particular, we are evaluating opportunities with partners who are focused on developing and commercializing non-opioid pain treatments.

除了IMC-2 Long-COVID 專案之外，我還想分享的是，我們正在尋找合作夥伴來推進我們的第二個開發候選產品IMC-1（泛昔洛韋和塞來昔布的固定劑量組合）進入3期治療開發，討論仍在進行中纖維肌痛。特別是，我們正在與專注於開發和商業化非鴉片類疼痛治療的合作夥伴評估機會。

And finally, the company continues to actively explore complementary opportunities that can build shareholder value through strategic partnerships, collaborations, or other forms of transactions. In particular, we are assessing both pain and anti-infective development candidates as potential complements to our focus with IMC-1 and IMC-2.

最後，公司繼續積極探索互補機會，透過策略夥伴關係、合作或其他形式的交易來建立股東價值。特別是，我們正在評估疼痛和抗感染開發候選藥物，作為我們重點關注的 IMC-1 和 IMC-2 的潛在補充。

Now I will turn it back over to Angela to discuss our quarter one financial update.

現在我將把它轉回給安吉拉討論我們第一季的財務更新。

Thank you, Greg. With respect to our income statement, as a development stage biotechnology company, we do not generate revenue during the three months ended March 31, 2024 or during the year ago quarter. We reported research and development expenses of $0.3 million for the first quarter of 2024 as compared to $0.5 million for the first quarter of 2023. The $0.2 million decrease was due to decreases in expenses for toxicology studies of $0.1 million and regulatory consulting cost of $0.1 million.

謝謝你，格雷格。就我們的損益表而言，作為一家處於發展階段的生技公司，我們在截至 2024 年 3 月 31 日的三個月或去年同期沒有產生收入。我們報告 2024 年第一季的研發費用為 30 萬美元，而 2023 年第一季的研發費用為 50 萬美元。減少 20 萬美元的原因是毒理學研究費用減少了 10 萬美元，監管諮詢費用減少了 10 萬美元。

In addition, we reported general and administrative expenses of $1 million for the first quarter of 2024 as compared to $1.1 million for the first quarter of 2023. The $0.1 million decrease quarter-over-quarter was due to a decrease in insurance expenses associated with being a public company.

此外，我們報告 2024 年第一季的一般和管理費用為 100 萬美元，而 2023 年第一季為 110 萬美元。環比減少 10 萬美元是由於與上市公司相關的保險費用減少。

Finally, we reported a net loss of $1.3 million for the first quarter of 2024 as compared to a net loss of $1.5 million for the year ago quarter. The lower net loss was primarily due to the decreases in research and development and operating costs that I just discussed. As of March 31, 2024, we had $2.4 million in cash as compared to $3.3 million as of December 31, 2023. We expect our current capital to fund operations into the fourth quarter of 2024.

最後，我們報告 2024 年第一季淨虧損 130 萬美元，而去年同期淨虧損 150 萬美元。淨虧損較低主要是因為我剛才討論的研發和營運成本的下降。截至 2024 年 3 月 31 日，我們擁有 240 萬美元現金，而截至 2023 年 12 月 31 日，我們擁有 330 萬美元現金。我們預計我們現有的資本可以為 2024 年第四季的營運提供資金。

At this time, I will turn the call back over to Greg, who will moderate the Q&A session of the call. Greg?

此時，我會將電話轉回給格雷格，他將主持電話的問答環節。格雷格？

Thank you, Angela. [Holly], we are now ready for questions.

謝謝你，安吉拉。 [Holly]，我們現在準備好提問了。

Thank you. Ladies and gentlemen, the floor is now open for questions. (Operator Instructions)

謝謝。女士們、先生們，現在可以提問。（操作員說明）

David Bautz, Zacks Small-Cap Research.

David Bautz，Zacks 小型股研究公司。

Hey, good morning, everyone, and thanks for taking the questions this morning. Greg, I'll start with, for the 202 study, what -- can you remind us again what kind of data are we, should we be expecting when those results are released? And do you expect them to be released, basically through a press release? Or is this going to be at a scientific meeting?

嘿，大家早上好，感謝您今天早上提出問題。Greg，首先，對於 202 研究，您能否再次提醒我們，當這些結果發佈時，我們應該期待哪些數據？您是否希望它們基本上透過新聞稿發布？還是這是在科學會議上？

Hi, David. Greg here. And thank you for the question. So the design of a Phase 2 study, the BHC-202 study is quite similar to the prior trial and that is by design. And it is consistent with the discussions we've had with the FDA regarding what would be required to advance a drug, potentially the first drug to treat Long-COVID sequelae or symptoms as we speak to them. The primary endpoint in that study is fatigue. It is to the best of our knowledge, the first time FDA has agreed with using fatigue as a primary endpoint and we're excited about that for two reasons.

嗨，大衛。格雷格在這裡。謝謝你的提問。因此，BHC-202 研究的第 2 期研究的設計與先前的試驗非常相似，而且是有意設計的。這與我們與 FDA 就推進藥物所需的條件進行的討論是一致的，正如我們與他們交談的那樣，該藥物可能是第一種治療長期新冠後遺症或症狀的藥物。研究的主要終點是疲勞。據我們所知，這是 FDA 第一次同意使用疲勞作為主要終點，我們對此感到興奮有兩個原因。

Number one, this combination, famciclovir and valacyclovir when used with celecoxib either as IMC-1 or IMC-2 as we call it, has consistently shown in both fibro clinical research and in Long-COVID clinical research significant reduction in fatigue. Three point change is considered clinically meaningful. We've seen between a three and a seven point change across all of those three studies. And as a consequence, we believe frankly that this may be the symptom that best responds to treatment with this particular combination.

第一，這種組合（泛昔洛韋和伐昔洛韋）與塞來昔布（我們稱之為IMC-1 或IMC-2）一起使用時，在纖維臨床研究和長新冠肺炎臨床研究中一致表明，可顯著減少疲勞。三點變化被認為具有臨床意義。我們在所有這三項研究中看到了三到七點的變化。因此，我們坦率地相信，這可能是對這種特定組合治療最有效的症狀。

So the primary endpoint for this 12-week study is fatigue. The secondary endpoints include orthostatic intolerance. You may know this as orthostatic hypotension when people get dizzy, when they get up quickly or when they move. Unfortunately, that happens for patients in this particular category with this illness all day long. And this is arguably as debilitating as the fatigue itself. So fatigue, orthostatic intolerance, pain will be assessed, we'll also look at pain, anxiety and overall global health.

因此，這項為期 12 週的研究的主要終點是疲勞。次要終點包括直立不耐受。當人們感到頭暈、快速起身或移動時，您可能會知道這是直立性低血壓。不幸的是，對於這一類整天患有這種疾病的患者來說，這種情況就會發生。可以說，這與疲勞本身一樣令人衰弱。因此，我們將評估疲勞、直立不耐受、疼痛，我們還將關注疼痛、焦慮和整體全球健康狀況。

So those outcomes, as I referenced in my earlier remarks are the ones we were so excited to see improved in the first BHC, the 201 study. And that led us to progress to this double blind placebo controlled trial. And we are very hopeful and encouraged by past performance and are looking to read out those results in the second half of this year. It is pretty material, so I think we'll probably announce those results directly, at least top line from Virios Therapeutics. And certainly, we'll be looking and are exploring what might be the best scientific venue, Dave, to announce those results to make sure that the entire scientific community, not just the investment community is aware of those results.

因此，正如我在先前的評論中提到的，這些結果是我們非常高興看到第一個 BHC 201 研究中得到改善的結果。這使我們取得了雙盲安慰劑對照試驗的進展。我們對過去的表現充滿希望和鼓舞，並希望在今年下半年讀出這些結果。這是相當重要的，所以我認為我們可能會直接宣布這些結果，至少是 Virios Therapeutics 的頂線。當然，我們將尋找並正在探索什麼可能是最好的科學場所，戴夫，宣布這些結果，以確保整個科學界，而不僅僅是投資界都知道這些結果。

Okay. Great. And so assuming positive results, what do you envision as the next step for that program? Do you think you'll be doing a Phase 2b? Do you think you can go to a Phase 3? Maybe you can talk about, kind of how you foresee things moving there?

好的。偉大的。因此，假設取得了積極的成果，您對該計劃的下一步有何設想？您認為您會進行 2b 階段嗎？你認為你可以進入第三階段嗎？也許你可以談談，你如何預見那裡的事情會改變？

Yes, I think with positive results and remember, the goal of this trial is to help design not necessarily the endpoints per se, those will be consistent. We've agreed that with FDA. We want to progress with the same endpoints as the destination for assessing patient care. What this trial will do is it will allow us to assess the effect size. So how many patients will we need to see a particular effect on fatigue, orthostatic, intolerance, et cetera. So the inputs from this study will dictate the design for the next study, which we believe will likely be a Phase 2b study.

是的，我認為取得了積極的結果，並記住，這項試驗的目標是幫助設計不一定是終點本身，這些將是一致的。我們已與 FDA 達成協議。我們希望以與評估患者護理的目的地相同的終點來取得進展。這項試驗的目的是讓我們能夠評估效果大小。那我們需要多少患者才能看到對疲勞、直立性、不耐受等的特殊效果。因此，本研究的輸入將決定下一項研究的設計，我們認為下一項研究可能是 2b 期研究。

I'm not sure we could go directly to a Phase 3, but ultimately, now that we've scoped out the parameters that are required to get a drug approved, we would certainly design the study even as a Phase 2b in a way that's consistent with Phase 3 and decide what else might be required beyond that study, which we would hope to begin executing towards the beginning of next year that will be the rough time.

我不確定我們是否可以直接進入第 3 階段，但最終，既然我們已經確定了獲得藥物批准所需的參數，我們肯定會以以下方式設計該研究，即使是第 2b 階段：與第三階段保持一致，並決定除了該研究之外還可能需要什麼，我們希望在明年年初開始執行，那將是一個艱難的時期。

Okay. And, so it sounds like you're holding off on the fibromyalgia program until you get a partner there. Do you think you could move the Long-COVID program on your own or would you also want to partner that program?

好的。而且，聽起來你要推遲纖維肌痛治療計劃，直到你找到合作夥伴為止。您認為您可以自行推動 Long-COVID 計劃還是也想與該計劃合作？

Certainly, we will choose the path that is most value enriching for shareholders and expeditious to get to the endpoints. So we feel comfortable we can execute the IMC 201 COVID program independently, but there are companies we know that have an interest in the space, I think, David, the fatigue people had for COVID vaccines is now waning. And I think as I referenced again in my earlier remarks, the scientific community is seeing, it seems to me on a weekly basis, new research highlighting the role of reactivation of secondary viruses.

當然，我們會選擇最能豐富股東價值並快速到達終點的道路。因此，我們對能夠獨立執行 IMC 201 COVID 計劃感到放心，但我們知道有些公司對該領域感興趣，我認為，大衛，人們對 COVID 疫苗的疲勞現在正在減弱。我認為，正如我在先前的演講中再次提到的那樣，在我看來，科學界似乎每週都會看到新的研究強調二次病毒重新活化的作用。

And so I think this disease, which is really frankly pretty well known on Main Street is now coming back into focus for the scientific community on Wall Street. And so our hope is that there's great interest in this in general, and we certainly wouldn't rule out potential partnership. It's the right economics, the efficient way to deliver value for Virios shareholders emerge following report out of those results.

因此，我認為這種疾病，坦白說，在大街上眾所周知，現在又重新成為華爾街科學界的焦點。因此，我們希望人們對此普遍感興趣，我們當然不會排除潛在的合作關係。這是正確的經濟學，是為 Virios 股東創造價值的有效方式，這些結果的報告將隨之而來。

Okay, great. Thanks for taking the questions this morning.

好的，太好了。感謝您今天早上提出問題。

Of course.

當然。

Thank you. (Operator Instructions) Okay. As we have no further questions at this time, I will hand it back to Mr. Duncan for any closing comments you may have.

謝謝。（操作員指示）好的。由於目前我們沒有其他問題，我會將其交還給鄧肯先生，以供您提出任何結束意見。

Thank you very much, Ali. And thank you for the team for participating, and thank you to those of you who dialed in or clicked in on the webcast. In short, just to summarize that BHC-202 study, the 3-arm study is enrolling well. We've passed the 50% enrollment level, and we're very excited about top-line results for the second half of this year, both for Virios shareholders, but also because as we articulated, there are literally millions of people who are suffering today here in the US

非常感謝你，阿里。感謝團隊的參與，感謝那些撥打或點擊網路廣播的人。簡而言之，總結 BHC-202 研究，3 組研究的入組情況良好。我們已經超過了 50% 的入學率，我們對今年下半年的頂線業績感到非常興奮，不僅對 Virios 股東而言，而且因為正如我們所闡明的，實際上有數百萬人正在遭受苦難今天在美國

And probably tens, if not 100s of millions worldwide if that epidemiology data in other countries is the same in the US, patients really need something to treat this particular disease. That preliminary safety analysis of the data indicates that the combination of valacyclovir and celecoxib has been very well tolerated and that's very consistent with what we've observed through the clinical development of both of our assets.

如果其他國家的流行病學數據與美國相同，那麼全世界可能有數十甚至數百萬人，而患者確實需要一些東西來治療這種特殊的疾病。數據的初步安全性分析顯示伐昔洛韋和塞來昔布的組合具有良好的耐受性，這與我們透過這兩種資產的臨床開發觀察到的情況非常一致。

We published our global patent earlier this year, and I'm pleased to tell you that discussions are ongoing as we seek a partner with advanced IMC-1 into Phase 3 development for the treatment of fibromyalgia. And I should mention, as I mentioned earlier, just to close-up, we continue to explore other complementary opportunities to build shareholder value. In particular, we're looking at other potential pain opportunities and/or anti-infectives with a focus on antivirals to complement IMC-1 and IMC-2.

我們在今年稍早發布了我們的全球專利，我很高興地告訴您，討論正在進行中，我們正在尋找具有先進 IMC-1 的合作夥伴，進入治療纖維肌痛的 3 期開發。我應該提到，正如我之前提到的，只是為了特寫，我們繼續探索其他互補機會來建立股東價值。特別是，我們正在尋找其他潛在的止痛藥物和/或抗感染藥物，重點是抗病毒藥物，以補充 IMC-1 和 IMC-2。

We appreciate your time and attention this morning, and we'll report out the progress on all of those matters in a very timely manner. Thank you, and have a great day.

感謝您今天上午的時間和關注，我們將非常及時地報告所有這些問題的進展。謝謝您，祝您有美好的一天。

Thank you. This concludes today's conference call. You may disconnect your lines at this time and we thank you for your participation.

謝謝。今天的電話會議到此結束。此時您可以斷開線路，我們感謝您的參與。