CohBar Inc (CWBR) 2022 Q3 法說會逐字稿

Good afternoon. My name is Matt, and I will be your conference operator for today. At this time, I would like to welcome everyone to CohBar's Third Quarter 2022 Financial Results Conference Call. (Operator Instructions) Please note this event is being recorded.

午安.我叫馬特，今天我將擔任您的會議主持人。現在，我歡迎大家參加 CohBar 2022 年第三季財務業績電話會議。 （操作員指示）請注意，此事件正在被記錄。

I would now like to turn the conference over to Jordyn Tarazi, Director of Investor Relations at CohBar. Please go ahead.

現在，我想將會議交給 CohBar 投資者關係總監 Jordyn Tarazi。請繼續。

Thank you, operator, and thank you, everyone, for joining CohBar's Third Quarter 2022 financial results conference call. Joining me on today's call is Dr. Joe Sarret, CohBar's Chief Executive Officer; Jeff Biunno, CohBar's Chief Financial Officer; and Dr. Kent Grindstaff, Senior Vice President of Research. Following our collective remarks, we will conclude with Q&A, at which time, Dr. Nick Vlahakis, CohBar's Acting Chief Medical Officer, will also join us.

謝謝接線員，也謝謝大家參加 CohBar 2022 年第三季財務業績電話會議。參加今天電話會議的還有 CohBar 執行長 Joe Sarret 博士； Jeff Biunno，CohBar 財務長；以及研究資深副總裁 Kent Grindstaff 博士。在我們集體演講之後，我們將以問答環節結束，屆時 CohBar 代理首席醫療官 Nick Vlahakis 博士也將加入我們。

CohBar's financial results press release was issued earlier today and may be downloaded from our website at cohbar.com.

CohBar 的財務業績新聞稿已於今日早些時候發布，可從我們的網站 cohbar.com 下載。

Before we begin, I'd like to take a moment to remind listeners that except for statements of historical facts, the remarks on today's conference call may include forward-looking statements within the meaning of the securities laws. Forward-looking statements are based on current expectations, projections and interpretations that involve a number of risks and uncertainties that could cause actual results to differ materially from those anticipated by CohBar. These risks and uncertainties are described in our registration statements, reports and other filings with the Securities and Exchange Commission and applicable Canadian securities regulators, which are available on our website at cobar.com, sec.gov and sedar.com as well as in the safe harbor statement included with today's press release.

在我們開始之前，我想花點時間提醒聽眾，除了歷史事實陳述外，今天電話會議上的評論可能包括證券法含義內的前瞻性陳述。前瞻性陳述基於目前的預期、預測和解釋，其中涉及許多風險和不確定性，可能導致實際結果與 CohBar 的預期有重大差異。這些風險和不確定性在我們向美國證券交易委員會及適用的加拿大證券監管機構提交的註冊聲明、報告和其他文件中均有描述，這些文件可在我們的網站 cobar.com、sec.gov 和 sedar.com 上查閱，也可在今天的新聞稿中包含的安全港聲明中查閱。

You are cautioned that such statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. CohBar does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise.

請注意，此類聲明並不能保證未來的業績，我們的實際結果可能與前瞻性聲明中所述的結果有重大差異。 CohBar 不承擔公開更新或修改任何前瞻性聲明或資訊的義務，無論其是由於新資訊、未來事件或其他原因。

Now I'd like to turn the call over to Joe Sarret, CohBar's Chief Executive Officer. Joe?

現在我想將電話轉給 CohBar 的執行長喬·薩雷特 (Joe Sarret)。喬？

Thank you, Jordyn, and thank you, everyone, for joining us this afternoon. On today's call, after my introductory remarks, Kent will comment on our ongoing preclinical activities for our CB5138-3 program, and Jeff will then review our Q3 financial performance.

謝謝你，喬丁，也謝謝大家今天下午加入我們。在今天的電話會議上，在我的開場白之後，肯特將對我們正在進行的 CB5138-3 項目臨床前活動發表評論，然後傑夫將回顧我們第三季度的財務業績。

CohBar's approach to drug development is rooted in the belief that the mitochondrial genome has the potential to serve as a powerful launching point for the development of a novel class of peptide therapeutics. It is increasingly recognized that the mitochondria play an important role in regulating various biological processes, well beyond their traditional function as the powerhouse of the cell. Some of these mitochondrial effects are mediated by peptides encoded in the mitochondrial genome. An area that prior to CohBar has been largely overlooked. For example, a recent paper coauthored by Dr. Pincus Cohen, one of CohBar's founders, described a novel mitochondrial peptide term smooth that may play a role in Alzheimer's disease. While research on this new peptide is still in the early stages, advances such as these contribute to the growing body of research that further supports our underlying hypothesis that the mitochondrial genome is a fruitful source for the development of impactful novel therapeutics.

CohBar 的藥物開發方法根植於這樣的信念：粒線體基因組有可能成為開發新型勝肽療法的強大起點。人們越來越認識到，粒線體在調節各種生物過程中發揮重要作用，遠遠超出了其作為細胞動力工廠的傳統功能。其中一些粒線體效應是由粒線體基因組編碼的勝肽介導的。在 CohBar 之前這個區域基本上被忽視了。例如，CohBar 創始人之一 Pincus Cohen 博士最近合著的一篇論文描述了一種可能在阿茲海默症中發揮作用的新型粒線體勝肽。雖然對這種新勝肽的研究仍處於早期階段，但這些進展有助於促進越來越多的研究，進一步支持了我們的基本假設，即粒線體基因組是開發有影響力的新療法的豐富來源。

We believe that improved versions of many of these native mitochondrial peptides have the potential to treat a wide range of diseases. And as derivatives of natural peptides, may have a better safety and tolerability profile. CohBar has generated promising data from multiple in vitro and preclinical animal models from several different monoclonal peptide families in diverse areas, including metabolism, fibrosis and inflammation.

我們相信，許多這些天然粒線體勝肽的改良版本具有治療多種疾病的潛力。並且作為天然勝肽的衍生物，可能具有更好的安全性和耐受性。 CohBar 已從來自幾種不同單株勝肽家族的多種體外和臨床前動物模型中獲得了有希望的數據，涉及代謝、纖維化和發炎等不同領域。

Additionally, we demonstrated clinical proof of concept for our approach with positive data from our initial clinical trial of CB4211 last year. We continue to believe the best way to move that program forward is in the context of a partnership.

此外，我們利用去年 CB4211 的初步臨床試驗的積極數據，證明了我們方法的臨床概念驗證。我們始終相信，推動該計劃的最佳方式是在合作的背景下。

While we have faced many challenges across several areas of our business, I remain pleased with our team's performance and the progress made on our key priorities. Our top priority continues to be the advancement of CB5138-3 towards the clinic. This product candidate is being developed to treat idiopathic pulmonary fibrosis, or IPF, a devastating progressive lung condition that despite the availability of 2 FDA-approved therapies continues to have significant unmet need with substantial and unacceptably high morbidity and mortality. The current therapies are also quite poorly tolerated, further limiting treatment options for patients and physicians.

儘管我們在業務的多個領域面臨許多挑戰，但我對我們團隊的表現和在關鍵優先事項上取得的進展仍然感到滿意。我們的首要任務仍然是推進 CB5138-3 進入臨床階段。該產品候選藥物正在開發中，用於治療特發性肺纖維化（IPF）。目前的治療方法也耐受性較差，進一步限制了患者和醫生的治療選擇。

During the past quarter, we've been particularly focused on 2 key areas for this program, improving the CB5138-3 formulation and furthering our understanding of the peptides target engagement. As a reminder, we previously announced that we observed local skin reactions at the higher dose levels in our earlier toxicology studies in monkeys. These reactions were not inflammatory in nature, but rather appear to be the result of peptide aggregation or gelling upon injection. This phenomenon is not infrequently seen in the early stages of development of peptide therapeutics, and the team has been working to mitigate this issue by improving the formulation.

在過去的一個季度中，我們特別關注該計劃的兩個關鍵領域，改進 CB5138-3 配方並進一步加深我們對勝肽標靶參與的理解。提醒一下，我們之前宣布過，在早期對猴子進行的毒理學研究中，我們觀察到了較高劑量水平下的局部皮膚反應。這些反應本質上不是炎症，而是注射時勝肽聚集或膠凝的結果。這種現像在勝肽療法開發的早期階段並不少見，研究團隊一直致力於透過改進配方來緩解這個問題。

During our last quarterly update, we mentioned that we had identified several promising formulations based on in vitro data and plan to test those in vivo. This is an important step since enhanced in vitro stability does not always translate to improved in vivo performance. Unfortunately, that turned out to be true in this case. The formulations we have identified continue to demonstrate evidence of peptide aggregation upon in vivo injection. While disappointing, as we have discussed previously, it was always expected that these reformulation activities would be an iterative process.

在我們上一次的季度更新中，我們提到我們已經根據體外數據確定了幾種有前景的配方，並計劃在體內進行測試。這是一個重要的步驟，因為增強的體外穩定性並不總是意味著改善的體內表現。不幸的是，在本例中，情況確實如此。我們所鑑定的配方繼續顯示出體內注射時勝肽聚集的證據。雖然令人失望，但正如我們之前所討論過的，我們一直預計這些重新制定活動將是一個迭代過程。

We have since developed additional formulations that look encouraging in vitro and differentiated from the earlier reformulations based on performance in the presence of cytological stress conditions. We are now in the process of testing these newer formulations in animals. And assuming that these formulations meet our in vivo performance targets, we remain on track to file our IND in the second half of 2023.

此後，我們又開發出其他配方，這些配方在體外看起來令人鼓舞，並且根據細胞壓力條件下的表現與早期的配方有所區別。我們目前正在動物身上測試這些新配方。假設這些配方符合我們的體內表現目標，我們仍有望在 2023 年下半年提交 IND。

And in terms of progress on the business front, on September 23, we completed a 1-for-30 reverse stock split and subsequently received confirmation from NASDAQ that CohBar has regained compliance with their $1 minimum bid price requirement. By implementing the reverse split, we have maintained our listing on the NASDAQ Exchange, which affords us greater access to capital to further fund our pipeline, improve liquidity for shareholders and an increased chance of attracting high-quality institutional investors and commercial partners.

在業務進展方面，9 月 23 日，我們完成了 1 比 30 的反向股票分割，隨後收到納斯達克的確認，CohBar 已重新遵守其 1 美元的最低出價要求。透過實施反向拆分，我們維持了在納斯達克交易所的上市地位，這使我們能夠獲得更多資本來進一步資助我們的產品線，提高股東的流動性，並增加吸引優質機構投資者和商業夥伴的機會。

I will now turn things over to Kent to provide additional detail on our CB5138-3 activities during the third quarter. Kent?

現在我將把事情交給肯特，讓他在第三季提供有關我們 CB5138-3 活動的更多詳細資訊。肯特？

Thank you, Joe. As Joe mentioned, this quarter, we continued to make progress on our preclinical development for CB5138-3 focusing on formulation work and elucidating its molecular target. As we have previously discussed, our initial formulation work focused on enhancing our understanding of the key physical properties of the peptide. This led to the selection of interim formulations with favorable in vitro profile for further in vivo assessment. Based on in vitro analysis, we identified several interim formulations that support solubility of CB5138-3 at projected clinically relevant doses, provided favorable extended stability profiles and exhibited reduced aggregation compared to the formulation we used in our prior toxicology studies. We since tested these formulations in vivo and disappointingly discovered that there was significant deposition of the peptide at the injection site due to persistent aggregation or gelling with these interim formulations.

謝謝你，喬。正如喬所提到的，本季度，我們繼續在 CB5138-3 的臨床前開發方面取得進展，重點關注配方工作和闡明其分子目標。正如我們之前所討論的，我們最初的配方工作重點是增強我們對勝肽的關鍵物理特性的理解。這導致選擇具有良好體外特徵的臨時配方以進行進一步的體內評估。基於體外分析，我們確定了幾種臨時配方，這些配方支持 CB5138-3 在預計的臨床相關劑量下的溶解度，提供有利的延長穩定性特性，並且與我們在先前的毒理學研究中使用的配方相比表現出減少的聚集。我們隨後在體內測試了這些配方，並失望地發現由於這些臨時配方的持續聚集或膠凝，在註射部位出現了大量勝肽沉積。

As Joe mentioned, formulation development is an iterative process, often requiring multiple rounds of in vitro and in vivo work to identify compositions that are both compatible with the physical properties of the drug substance and the route of administration. To this end, we've recently completed the in vitro phase of new formulation work for CB5138-3. The in vitro profile for these most recent formulations show a reduced propensity for aggregation following physiological stress. We are now preparing to test these formulations in animals with the objective of identifying a formulation with performance characteristics that support a clinically relevant range of doses for IPF program.

正如喬所提到的，配方開發是一個迭代過程，通常需要多輪體外和體內工作來確定與藥物物質的物理特性和給藥途徑相容的成分。為此，我們最近完成了CB5138-3新配方工作的體外階段。這些最新配方的體外概況表明，生理壓力後聚集傾向降低。我們現在正準備在動物身上測試這些配方，目的是找到一種具有支持 IPF 計劃臨床相關劑量範圍的性能特徵的配方。

We expect to have clarity in the near term regarding whether our novel formulations have sufficiently derisked the injection site reactions to enable submission of the IND in the second half of 2023 as planned.

我們希望在短期內明確我們的新配方是否充分降低了注射部位反應的風險，以便能夠按計劃在 2023 年下半年提交 IND。

On the discovery side, we're continuing to evaluate CB5138-3 mechanism of action, including further clarifying the relevant molecular pathways. In an effort to identify direct target engagement, we're in the process of completing a broad cell surface receptor screen with CB5138-3 and expect to have preliminary data in the near future.

在發現方面，我們正在繼續評估 CB5138-3 的作用機制，包括進一步明確相關的分子途徑。為了確定直接目標參與，我們正在使用 CB5138-3 完成廣泛的細胞表面受體篩選，並期望在不久的將來獲得初步數據。

Now I'll turn the call over to Jeff to discuss our Q3 financial performance. Jeff?

現在我將電話轉給傑夫，討論我們第三季的財務表現。傑夫？

Thank you, Kent. We ended Q3 2022 with $18.3 million in cash and investments at a quarterly burn rate of approximately $1.9 million, and we have no debt.

謝謝你，肯特。截至 2022 年第三季度，我們擁有 1,830 萬美元的現金和投資，季度消耗率約為 190 萬美元，而且我們沒有債務。

Research and development expenses were $1 million in Q3 2022 compared to $1.6 million in the prior year period, a decrease of approximately $600,000. The decrease in research and development expenses was primarily due to the timing of the expenses incurred for our research programs.

2022 年第三季的研發費用為 100 萬美元，去年同期為 160 萬美元，減少約 60 萬美元。研發費用的減少主要是因為我們研究計畫發生費用的時間安排。

General and administrative expenses were $1.4 million in Q3 2022 compared to $1.8 million in the prior year period, a decrease that was primarily due to lower stock-based compensation costs.

2022 年第三季的一般和行政費用為 140 萬美元，而去年同期為 180 萬美元，下降主要是由於股票薪酬成本下降。

For the quarter ended September 30, 2022, CohBar reported a net loss of $2.4 million or $0.82 per basic and diluted share on a post-split basis compared to a net loss for the quarter ended September 30, 2021, of $3.4 million or $1.61 per basic and diluted share on a post-split basis.

截至 2022 年 9 月 30 日的季度，CohBar 報告淨虧損為 240 萬美元，或拆分後每股基本虧損和稀釋虧損均為 0.82 美元，而截至 2021 年 9 月 30 日的季度淨虧損為 340 萬美元，或拆分後每股基本虧損為 1.61 美元。

Net loss included noncash expenses of approximately $400,000 for the quarter ended September 30, 2022, and approximately $700,000 for the quarter ended September 30, 2021.

淨虧損包括截至 2022 年 9 月 30 日季度的非現金支出約 40 萬美元，以及截至 2021 年 9 月 30 日季度的非現金支出約 70 萬美元。

Overall, we are pleased with our financial performance, and we estimate that we have sufficient capital to finance our operations through the fourth quarter of 2023.

總體而言，我們對我們的財務表現感到滿意，並估計我們有足夠的資本來資助我們到 2023 年第四季的營運。

I'll now turn things back over to Joe. Joe?

現在我將把事情交還給喬。喬？

Thanks, Jeff. This past year has been a challenging one for CohBar, especially given the turbulence in the capital markets, which has had a disproportionate impact on micro-cap biotech companies. I'm pleased with the way our team has remained focused on continuing to advance our programs and our science, and we continue to believe in the power of the mitochondrial genome to deliver therapeutics to address underserved conditions that represent significant market opportunities, such as IPF and NASH.

謝謝，傑夫。過去的一年對 CohBar 來說是充滿挑戰的一年，尤其是考慮到資本市場的動盪，這對小型生物科技公司產生了特別嚴重的影響。我很高興我們的團隊始終專注於繼續推進我們的計畫和科學，我們繼續相信粒線體基因組的力量，它可以提供治療方法來解決代表重大市場機會的服務不足的疾病，例如 IPF 和 NASH。

Throughout this year, we have made progress on advancing CB5138-3 towards IND filing as well as refining our clinical development program for this product candidate. At the same time, as Jeff highlighted, we continue to be prudent financially, closely monitoring our cash spend while prioritizing activities that are expected to derisk key aspects of our IPF program, such as enhancing our understanding of target engagement and developing improved formulations to mitigate against injection site reactions and improve drug exposure.

今年，我們在推進 CB5138-3 的 IND 申請以及完善該產品候選物的臨床開發計劃方面取得了進展。同時，正如傑夫所強調的，我們繼續在財務上保持審慎，密切監控我們的現金支出，同時優先開展有望降低 IPF 計劃關鍵方面風險的活動，例如增強我們對目標參與的理解和開發改進的配方以減輕注射部位反應並改善藥物暴露。

After many months of effort, we now expect data on both of those fronts in the near future, and we look forward to updating you on the outcome of those studies in subsequent calls.

經過數月的努力，我們期待在不久的將來獲得這兩個方面的數據，並期待在後續電話會議中向您通報這些研究的結果。

Operator, can you now please open the line for questions?

接線員，現在可以打開熱線來回答問題嗎？

(Operator Instructions) And our first question will come from Kemp Dolliver with Brookline Capital Markets.

(操作員指示) 我們的第一個問題來自布魯克林資本市場 (Brookline Capital Markets) 的 Kemp Dolliver。

First, apologies for the voice. So I have 2 questions. First, you mentioned you have data available in the near future. Can you put more specificity on that? Is it possible we will see this data by year-end or sometime in '23?

首先，對我的聲音表示歉意。所以我有兩個問題。首先，您提到您近期有可用的數據。您能更具體地說明這一點嗎？我們有可能在年底或23年某個時候看到這些數據嗎？

Kemp, thanks for the for the question. Yes, it's difficult to say the exact timing of data because certain things are dependent upon our contract research partners. So we are hoping to have that data by year-end, but not 100% sure when the timing of that will be.

坎普，謝謝你的提問。是的，很難說出數據的確切時間，因為某些事情取決於我們的合約研究夥伴。因此我們希望在年底前獲得這些數據，但不能 100% 確定具體時間。

Second question is given that you're in the midst of an inner process in getting the formulation and the target engagement questions answered. How many times can you iterate and still stay on track to file in your IND in the second half of next year?

第二個問題是，您正在處於一個內部過程之中，以獲得有關表達和目標參與問題的答案。您可以進行多少次迭代，並且仍能保持在明年下半年提交 IND 的軌道上？

Yes. So the answer to that really depends on sort of what the data we get back next. Our hope is that we think we've -- based on the recent in vitro data that Kent was describing, that these newest formulations will meet our final performance targets. And as I mentioned, assuming that they do, then we're on track. If further work is required, it really is going to depend on what does that data show us? What is the performance that we're seeing? And sort of how do we then figure out where we go from there? And so whether that further required there would have an impact on the time lines really will depend on what does the data show and how close or far are we from where we feel like we need to be. And so it's difficult to answer without actually seeing the data first and sort of what data shows, what sort of lead us to the subsequent answer on next steps and possible impact on timing.

是的。所以這個問題的答案其實取決於我們接下來得到的數據。我們的希望是，根據肯特描述的最新體外數據，這些最新配方將滿足我們的最終性能目標。正如我所提到的，假設他們這樣做，那麼我們就走在了正軌上。如果需要進一步研究，這實際上取決於這些數據向我們展示了什麼？我們看到的表現是什麼樣的？那我們要如何確定接下來要去哪裡呢？因此，是否進一步要求對時間表產生影響，實際上取決於數據顯示的情況，以及我們距離我們認為需要達到的目標還有多遠。因此，如果不先實際查看數據，並且不知道數據顯示了什麼，哪些因素會引導我們得出有關下一步行動的答案以及對時間安排的可能影響，那麼很難回答。

This concludes our question-and-answer session. I would like to turn the conference back over to Joe Sarret, CEO, for any closing remarks.

我們的問答環節到此結束。我想將會議交還給執行長喬·薩雷特 (Joe Sarret)，請他作最後發言。

Thank you, everyone, for joining us this afternoon. I would like to thank our shareholders for their continued support, and we look forward to keeping you updated on our future progress. Matt, would you please conclude the conference call?

感謝大家今天下午加入我們。我要感謝我們的股東一直以來的支持，我們期待向您通報我們未來的進展。馬特，你能結束電話會議嗎？

Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

謝謝。會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。