Biora Therapeutics Inc (BIOR) 2023 Q3 法說會逐字稿

Greetings and welcome to the Biora Therapeutics Third Quarter 2023 earnings call. At this time, all participants are in a listen only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions)

歡迎參加 Biora Therapeutics 2023 年第三季財報電話會議。此時，所有參與者都處於只聽模式。正式演講後將舉行簡短的問答環節。 （操作員說明）

As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Chuck Pedala, Managing Director with LifeSci Advisors. Thank you, Chuck, you may begin.

提醒一下，本次會議正在錄製中。現在我很高興向您介紹主持人，LifeSci Advisors 董事總經理 Chuck Pedala。謝謝你，查克，你可以開始了。

Thank you, operator. Good afternoon and welcome to the Biora Therapeutics Third Quarter 2023 Corporate Update and Financial Results Conference Call. Joining me on the call are Adi Mohanti, Chief Executive Officer; Eric d'Esparbes, Chief Financial Officer.

謝謝你，接線生。下午好，歡迎參加 Biora Therapeutics 2023 年第三季公司最新動態與財務業績電話會議。與我一起參加電話會議的還有執行長 Adi Mohanti；艾瑞克‧德斯帕布 (Eric d'Esparbes)，財務長。

Before I turn the call over to Mr. Mohanty, I would like to remind you that today's call will include forward-looking statements within the meaning of the federal securities laws, including but not limited to the types of statements identified as forward-looking in our quarterly reports Form 10-Q that we'll file later today in our subsequent reports filed with the SEC, which are available on our website in the investor section.

在我將電話轉交給莫漢蒂先生之前，我想提醒您，今天的電話會議將包括聯邦證券法含義內的前瞻性陳述，包括但不限於被認定為前瞻性陳述的類型我們的季度報告表格10-Q，我們將在今天稍後在向SEC 提交的後續報告中提交該報告，這些報告可在我們網站的投資者部分找到。

These forward-looking statements represent our views only as of the date of this call, [bobs] potential risks and uncertainties, including many that are beyond our control. Please note the actual results could differ materially from those expressed in the forward-looking statements.

這些前瞻性陳述僅代表我們截至本次電話會議之日的觀點，[鮑伯]潛在的風險和不確定性，包括許多我們無法控制的風險和不確定性。請注意，實際結果可能與前瞻性陳述中表達的結果有重大差異。

For a further description of the risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements, as well as risks related to our business, please see the company's periodic reports filed with the SEC.

有關可能導致實際結果與前瞻性陳述中表達的結果存在重大差異的風險和不確定性以及與我們業務相關的風險的進一步描述，請參閱公司向 SEC 提交的定期報告。

With that, I will now turn the call over to Adi Mohanty, CEO of Biora Therapeutics.

現在，我將電話轉給 Biora Therapeutics 執行長 Adi Mohanty。

Thanks, Chuck, and thank you, everyone, for joining us. During the third quarter, we continued to make excellent progress with both of our platform technologies. The NaviCap platform is rapidly advancing towards initiation of a Phase 1 clinical trial by year end, and development of the BioJet platform has accelerated with an increased pace of data generation from several molecules, including those of our pharma collaborators.

謝謝查克，也謝謝大家加入我們。在第三季度，我們的兩種平台技術持續取得出色進展。 NaviCap 平台正在迅速推進，爭取在年底啟動一期臨床試驗，而 BioJet 平台的開發也隨著多個分子（包括我們的製藥合作者的分子）數據生成速度的加速而加快。

First, an update on our NaviCap targeted therapeutics platform with our lead program, BT-600 in ulcerative colitis. Research suggests there is a minimum level of drug needed in the tissue at the site of disease to achieve better therapeutic outcomes in ulcerative colitis or UC. Our technology can potentially increase tissue concentration without systemic toxicity, which could provide improved outcomes for UC patients. We hope to demonstrate this with a Phase 1 clinical trial, which we are on track to initiate by end of this year.

首先，更新我們的 NaviCap 標靶治療平台以及我們的主導項目 BT-600 治療潰瘍性結腸炎。研究表明，為了在潰瘍性結腸炎或 UC 中獲得更好的治療效果，疾病部位的組織中需要最低水平的藥物。我們的技術可以潛在地增加組織濃度，而不會產生全身毒性，從而改善 UC 患者的預後。我們希望透過一期臨床試驗來證明這一點，我們預計在今年年底啟動該試驗。

Earlier, we filed our IND application with the FDA as planned. The IND for BT-600 includes extensive manufacturing, preclinical, and toxicology data, as well as clinical device function data from our four separate studies in both healthy volunteers and UC patients. So that's a sizable filing that includes over 300 documents larger than a typical submission, because we have both drug and device information.

在此之前，我們已按計劃向 F​​DA 提交了 IND 申請。 BT-600 的 IND 包括廣泛的製造、臨床前和毒理學數據，以及我們對健康志願者和 UC 患者進行的四項獨立研究的臨床設備功能數據。因此，這是一份相當大的文件，其中包含 300 多份文件，比典型提交的文件還要多，因為我們同時擁有藥品和設備資訊。

The FDA often generates questions and requests information as they review these types of filings. Towards the end of the FDA review period, we received some question that required us to provide additional information, which we have. We discussed the questions with the agency, and as a result of our conversation, it became clear that it was appropriate for us to refile -- which we did.

FDA 在審查此類備案時經常會提出問題並要求提供資訊。在 FDA 審查期即將結束時，我們收到了一些問題，要求我們提供額外的信息，而我們已經掌握了這些信息。我們與該機構討論了這些問題，根據我們的談話，很明顯，我們重新提交文件是合適的——我們確實這樣做了。

This allows the FDA to have additional time to review our application and the additional information. We continue to have a constructive dialogue with the FDA, and it's understandable that the extensiveness of the information supporting our R&D would require additional time for review. We hope the review will be satisfactorily completed by the end of this month.

這使得 FDA 有更多的時間來審查我們的申請和附加資訊。我們繼續與 FDA 進行建設性對話，支持我們研發的大量資訊需要更多時間進行審查，這是可以理解的。我們希望檢討工作能在本月底圓滿完成。

If so, we anticipate maintaining our timeline to initiate a Phase 1 trial before the end of this year. We are, to our knowledge, the first company to file an IND for a drug and ingestible device combination. While other companies have pursued clinical studies that's outside the US, we believe it's important to engage US regulators as early as possible as it takes the most rigorous path to approval. We've successfully completed four human studies in which the NaviCap device performed as designed across a range of expected differences in GI motility in both healthy volunteers and UC patients.

如果是這樣，我們預計將維持在今年年底之前啟動第一階段試驗的時間表。據我們所知，我們是第一家為藥物和可攝入設備組合提交 IND 的公司。雖然其他公司已經在美國境外進行臨床研究，但我們認為儘早與美國監管機構接觸非常重要，因為它需要最嚴格的審批途徑。我們已經成功完成了四項人體研究，在這些研究中，NaviCap 設備按照設計在健康志願者和 UC 患者中的胃腸道運動的一系列預期差異中發揮作用。

The next step is to use the NaviCap device to deliver to upper segments. We aim to prove our treatment hypotheses by confirming that we can achieve sufficient drug levels in the colon tissue along with low systemic exposure. We anticipate exiting Phase 1 with not only safety data, but also with critical data on potential exposure in both plasma and tissue, which would be much more informative than a typical Phase ` trial.

下一步是使用NaviCap設備傳送到上層段。我們的目標是透過確認我們可以在結腸組織中達到足夠的藥物水平以及較低的全身暴露來證明我們的治療假設。我們預計在退出第一階段時，不僅會提供安全數據，還會提供有關血漿和組織中潛在暴露的關鍵數據，這將比典型的第一階段試驗提供更多資訊。

In addition to progressing towards Phase 1, we continue to expand our intellectual property coverage for the NaviVap platform. Recently, we received notice of allowance of a new patent that encompasses the novel treatment paradigm of our BT-600 program with its this targeted delivery of JAK inhibitors to the GI tract. We will share more details in the coming weeks when the patent issues.

除了第一階段的進展之外，我們也持續擴大 NaviVap 平台的智慧財產權覆蓋範圍。最近，我們收到了一項新專利的核准通知，該專利涵蓋了我們 BT-600 計畫的新穎治療範例，該計畫將 JAK 抑制劑標靶遞送至胃腸道。我們將在未來幾週專利發佈時分享更多細節。

Earlier this year, we were awarded another group of US and European patents that expanded our coverage for additional therapeutic targets for UC. We hold one of, if not the world's most comprehensive IP portfolio for drug delivery using ingestible devices with 30 patent families for the NaviCap platform alone.

今年早些時候，我們獲得了另一組美國和歐洲專利，擴大了我們對 UC 其他治療標靶的覆蓋範圍。我們擁有世界上最全面的使用可攝取設備進行藥物輸送的智慧財產權組合之一（如果不是的話），光是 NaviCap 平台就有 30 個專利族。

As we progress our UC program, we gain more data on the overall platform, and the combination of IP and platform development will allow us to expand our pipeline organically with additional programs.

隨著我們 UC 專案的進展，我們在整個平台上獲得了更多數據，IP 和平台開發的結合將使我們能夠透過其他專案有機地擴展我們的管道。

Moving on to our BioJet systemic therapeutics platform. Our goal with the BioJet platform is to provide needle-free oral delivery of therapeutic molecules. The BioJet platform is based on a small capsule that, once swallowed, is designed to deliver drug into the wall of the small intestine using liquid jet injection.

繼續我們的 BioJet 全身治療平台。我們 BioJet 平台的目標是提供治療分子的無針口腔遞送。 BioJet 平台基於一個小膠囊，一旦吞嚥，就會透過液體噴射注射將藥物輸送到小腸壁。

We believe the BioJet platform can provide an alternative to needle-based delivery of complex molecules, and could also enable those molecules to more efficiently reach the liver for delivery into the small intestine.

我們相信 BioJet 平台可以提供複雜分子針輸送的替代方案，並且還可以使這些分子更有效地到達肝臟並輸送到小腸中。

As planned, during Q3, we continued development and testing to confirm the performance of our next-gen BioJet 2 device, which allowed us progressed further and began testing our pharma collaborators' molecules with the device. In October, we presented new data at the European Association for the Study of Diabetes, so we confirmed that our BioJet 2 device exceeded its performance targets.

按照計劃，在第三季度，我們繼續開發和測試，以確認下一代 BioJet 2 設備的性能，這使我們能夠取得進一步的進展，並開始使用該設備測試我們的製藥合作夥伴的分子。 10 月份，我們在歐洲糖尿病研究協會上公佈了新數據，因此我們確認我們的 BioJet 2 設備超出了其性能目標。

Across three studies, in a porcine model, 96% of animal showed semaglutide, its systemic circulation at clinically relevant levels, for up to 10 days following administration. Among the 22 animals dosed with semaglutide, oral bioavailability averaged 20.5%, which exceeds both the device performance and bioavailability targets set by us and our collaborators.

在三項研究中，在豬模型中，96% 的動物在給藥後長達 10 天內表現出索馬魯肽（其體循環處於臨床相關水平）。在服用索馬魯肽的 22 隻動物中，口服生物利用度平均為 20.5%，這超出了我們和我們的合作者設定的設備性能和生物利用度目標。

Data analysis from animal studies were also completed with one of our collaborators' molecules to demonstrate the potential of the BioJet platform to achieve uptake of large molecules into the liver. Many disease targets reside in the liver, and it's a key area of focus for RNA-based therapeutics, such as antisense oligonucleotides, or SI RNA-based drug.

我們還利用我們合作者的一種分子完成了動物研究的數據分析，以證明 BioJet 平台實現肝臟攝取大分子的潛力。許多疾病標靶位於肝臟，它是基於 RNA 的療法（例如反義寡核苷酸或基於 SI RNA 的藥物）的重點領域。

Large molecules must typically be delivered via IV or subcu injection because they cannot survive the stomach acid, and are too large for absorption through the small intestine. The challenge with IV or subcu delivery is most of the drug is metabolized before it reaches the liver. Our technology uses liquid jet injection into the small intestine, which is an optimal delivery pathway to the liver. So the BioJet platform to provide a unique advantage for liver targeted oral delivery of large molecules.

大分子通常必須透過靜脈注射或皮下注射來遞送，因為它們不能在胃酸中存活，並且太大而無法透過小腸吸收。靜脈注射或皮下注射的挑戰是大部分藥物在到達肝臟之前就被代謝。我們的技術使用液體噴射注射到小腸中，這是到達肝臟的最佳輸送途徑。因此BioJet平台為肝臟標靶口服大分子遞送提供了獨特的優勢。

While we aren't clear to share data yet, I can say that the results of the study with our collaborator's molecule were extremely encouraging. We also recently completed another set of animal studies for a second collaborator, and are in the process of having the hundreds of samples analyzed. These data will provide further support for the BioJet platform's ability to deliver large molecules.

雖然我們還不清楚共享數據，但我可以說，我們合作者分子的研究結果非常令人鼓舞。我們最近也為第二位合作者完成了另一組動物研究，並且正在分析數百個樣本。這些數據將為BioJet平台輸送大分子的能力提供進一步的支援。

In addition, we're initiating preclinical studies with a [forward] pharma collaborator. As we continue the progress of the budget platform and produce further data, we have seen increasing interest from potential partners, and we're actively negotiating an agreement with a [forward] potential pharma collaborator.

此外，我們正在與[前沿]製藥合作者啟動臨床前研究。隨著我們繼續推進預算平台並產生更多數據，我們看到潛在合作夥伴的興趣日益濃厚，並且我們正在積極與[前瞻性]潛在製藥合作者就協議進行談判。

It is common for research collaborations to have strict confidentiality requirements early on, particularly those involving very large companies and highly competitive drugs. We appreciate the need to share as much information as possible with our stakeholders, but we rely on our collaborators' permission and timing to share information. We'll continue to be as transparent as possible, while being good partners and respecting the disclosure rules established with our collaborators.

研究合作在早期就有嚴格的保密要求是很常見的，特別是那些涉及非常大的公司和競爭激烈的藥物的合作。我們理解與利害關係人分享盡可能多的資訊的必要性，但我們依賴合作者的許可和時間來分享資訊。我們將繼續盡可能保持透明，同時成為良好的合作夥伴並尊重與合作者制定的揭露規則。

We believe we are well positioned with the BioJet platform several advantages -- its ability to achieve category-leading bioavailability of complex molecules -- its ability to deliver existing liquid formulations and large payloads in the multi milligram range, and its potential to enable liver-targeted delivery of large molecules. We're excited to see the accelerating development of the BioJet platform, and we look forward to sharing more about the progress with our existing and new collaborators and potential partner.

我們相信，BioJet 平台的幾個優勢使我們處於有利地位——它能夠實現複雜分子的同類領先​​的生物利用度——它能夠提供現有的液體製劑和多毫克範圍內的大有效負載，以及它使肝臟-大分子的標靶遞送。我們很高興看到 BioJet 平台的加速發展，我們期待與我們現有的和新的合作者以及潛在的合作夥伴分享更多有關進展的資訊。

To summarize our anticipated milestones, for our NaviCap platform, we await the FDA's response to our NDA application, and we anticipate initiating our Phase 1 trial before the end of the year. Initial Phase 1 data is anticipated early next year, and if we begin the trial before the end of this year as planned, we expect to complete the execution of the trial in Q1 with final data coming after that.

總結一下我們的預期里程碑，對於我們的 NaviCap 平台，我們正在等待 FDA 對我們的 NDA 申請的答复，我們預計在今年年底之前啟動我們的 1 期試驗。第一階段的初始數據預計於明年初獲得，如果我們按計劃在今年年底前開始試驗，我們預計將在第一季完成試驗的執行，最終數據將在之後公佈。

For our BioJet platform, we expect to continue generating data from animal studies with the molecules of our pharma collaborators during the fourth quarter. With three existing and potentially a fourth new collaboration, all generating data that adds to the overall development dataset of the platform, we anticipate accelerating interest from others

對於我們的 BioJet 平台，我們預計在第四季度繼續利用我們的製藥合作者的分子進行動物研究以產生數據。透過現有的三個合作以及可能的第四個新合作，所有這些都會產生添加到平台整體開發數據集的數據，我們預計其他人的興趣將會加速

With that, I will now turn the call over to Eric for a review of our financial results and capital market activities.

現在，我將把電話轉給埃里克，要求他審查我們的財務表現和資本市場活動。

Thanks, Adi, and good afternoon, everyone. We had a number of financial activities during the third quarter.

謝謝阿迪，大家下午好。第三季我們開展了多項財務活動。

We made significant progress on optimizing our capital structure by materially reducing our convertible note balance by $50 million through the notes exchange agreement. We remain actively engaged with convertible note holders to further enhance our capital structure to be more aligned with our company profile. I'm happy to share that we're making progress to further reduce that our convertible note balance through a new potential note exchange, with the possibility to generate additional funding for the company. We expect to have further announcement on this in the near term.

透過票據交換協議，我們的可轉換票據餘額大幅減少了 5,000 萬美元，在優化資本結構方面取得了重大進展。我們仍積極與可轉換票據持有人合作，進一步增強我們的資本結構，使其更符合我們的公司概況。我很高興與大家分享，我們正在透過新的潛在票據交換進一步減少可轉換票據餘額，並有可能為公司產生額外資金。我們預計近期就此發布進一步公告。

As a result of those activities, we have some non-recurring and non-cash entry in our Q3 financial results, which I will explain in more detail.

由於這些活動，我們在第三季的財務業績中包含了一些非經常性和非現金條目，我將對此進行更詳細的解釋。

Operating expenses were $23.3 million for the first three months ended September 30, 2023, compared to $14.9 million for the three months ended June 30th, 2023. The increase was mainly attributable to a one-time stock-based compensation, non-cash charge of approximately $9 million related to vesting of employees' restricted stock units.

截至2023 年9 月30 日止的前三個月營運費用為2,330 萬美元，而截至2023 年6 月30 日止的前三個月營運費用為1,490 萬美元。這一增長主要歸因於一次性股票薪酬、非現金費用約 900 萬美元與員工限制性股票單位的歸屬有關。

As a result, operating expenses, excluding stock-based compensation expenses, effectively remained stable at $12.8 million with continued investment in device development, preclinical studies, and IND-enabling activities.

因此，隨著對設備開發、臨床前研究和 IND 支援活動的持續投資，營運費用（不包括股票補償費用）實際上穩定在 1,280 萬美元。

Breaking this down, G&A expenses in the third quarter were $6.9 million excluding stock-based compensation expenses, while R&D expenses in the third quarter were $5.9 million also excluding stock-based compensation expenses. We continued to streamline our G&A expenses and are making good progress in focusing our investments on R&D programs.

細分來看，第三季的一般管理費用為 690 萬美元，不包括以股票為基礎的補償費用，而第三季的研發費用為 590 萬美元，也不包括以股票為基礎的補償費用。我們持續精簡一般管理費用，並在將投資集中於研發項目方面取得良好進展。

While legacy spend has substantially been reduced over the last few quarters, it still represented more than 30% of our G&A cash spend in Q3, and we continue working actively to reduce it going forward with further substantial changes by early next year.

雖然過去幾季遺留支出大幅減少，但它仍然占我們第三季一般管理和行政費用現金支出的 30% 以上，我們將繼續積極努力減少這筆支出，並在明年初進行進一步的重大改變。

Our core OpEx spend remains focused on our R&D programs as we rapidly move towards the clinic. We maintain our guidance of an average monthly operating cash burn of approximately $4 million. Net loss for the quarter was $73.5 million. This includes non-cash charges to stock-based compensation expenses of $9 million noted earlier, and a non-cash charge of $53.2 million attributable to the convertible note exchange implemented by the company in September. As a result, our effective operating cash burn for the quarter was $12.7 million.

隨著我們快速走向臨床，我們的核心營運支出仍然集中在我們的研發項目上。我們維持每月平均營運現金消耗約 400 萬美元的指引。該季度淨虧損為 7,350 萬美元。這包括先前提到的 900 萬美元的基於股票的補償費用的非現金費用，以及由於公司 9 月份實施的可轉換票據交換而產生的 5320 萬美元的非現金費用。因此，本季我們的有效營運現金消耗為 1,270 萬美元。

On the fundraising front, we successfully raised almost $6 million in gross proceeds through different sources since our last call. We successfully monetized some remaining legacy assets, including our Ann Arbor lab building. We continue to target non-dilutive sources of funding, and actively engage with the investor community to ensure access to the necessary capital needed to fund the development of our programs.

在募款方面，自上次電話會議以來，我們透過不同來源成功籌集了近 600 萬美元的總收益。我們成功地將一些剩餘的遺留資產貨幣化，包括我們的安娜堡實驗室大樓。我們繼續以非稀釋性資金來源為目標，並積極與投資者群體接觸，以確保獲得為我們的專案開發提供資金所需的必要資本。

We've also seen keen interest from investors in supporting our programs through direct capital investments in Biora, and we've already raised meaningful capital through that channel so far this quarter.

我們也看到投資者對透過對 Biora 的直接資本投資來支持我們的專案表現出濃厚的興趣，本季度到目前為止，我們已經透過該管道籌集了有意義的資金。

With that, I will now turn the call back over to Adi.

現在，我將把電話轉回給阿迪。

Thanks, Eric. Biora continues to make strides with both our NaviCap platform, where we are focused on entering the clinic with our BT-600 program and our BioJet platform where we're focused on progressing our pharma collaboration. We look forward to providing further updates as we achieve our milestones.

謝謝，埃里克。 Biora 繼續在我們的 NaviCap 平台和 BioJet 平台上取得長足進步，在 NaviCap 平台上，我們專注於透過 BT-600 專案進入臨床，在 BioJet 平台上，我們專注於推進我們的製藥合作。我們期待在實現里程碑時提供進一步的更新。

Operator, we're now ready for questions.

接線員，我們現在準備好提問了。

Thank you. We'll now be conducting a question-and-answer session. (Operator Instructions) One moment please while we poll for questions.

謝謝。我們現在將進行問答環節。 （操作員說明）請稍等一下，我們將輪詢問題。

Joe Pantginis, H.C. Wainwright.

喬潘吉尼斯，H.C.溫賴特。

Hey, guys, good afternoon. Thanks for taking the question. So first question on the BT-600 IND. Was this more of just providing more understanding and clarification in your answers? Or is there anything rate limiting in the answers and responses expected with regard to getting the study started?

嘿，夥計們，下午好。感謝您提出問題。第一個問題是關於 BT-600 IND 的。這是否只是在您的答案中提供更多理解和澄清？或者在開始研究時預期的答案和回應是否有任何速率限制？

Yes, Hi, Joe. So I think we mentioned in the script that the FDA asked some clarifying questions, and several of them were related to our device, and you know, about the early development of the device. We had the information, and so which is why we were able to provide that and turn it around within a few days. And so, at this point all the information is back. We hope that the FDA is quickly finishing the rest of their review.

是的，嗨，喬。所以我認為我們在劇本中提到 FDA 提出了一些澄清問題，其中有幾個與我們的設備有關，你知道，與設備的早期開發有關。我們擁有這些信息，這就是為什麼我們能夠提供這些資訊並在幾天內扭轉局面。所以，此時所有的資訊都回來了。我們希望 FDA 盡快完成其餘的審查。

No, that's great. Thank you.

不，那太好了。謝謝。

I guess for both programs, but also for BT-600 and beyond for NaviCap, sort of the continuum of manufacturing. Where do you stand right now with regard to being able to supply all the patients for the Phase 1 program and any potential near-term needs for that as well as the BioJet program?

我想對於這兩個程序，以及 BT-600 和 NaviCap 來說，這都是製造的連續體。對於能夠為第一階段專案的所有患者以及該專案以及 BioJet 專案的任何潛在的近期需求提供服務，您現在的立場如何？

Yes, good question. So for BT-600, along with this review, we're doing everything on our end that we can control to get ready for a Phase 1 trial, which means getting our sites ready, getting our partners, the CROs ready, doing everything we can including doing supply. So we have already produced what we expect to use for the Phase 1 trial. So, we'll be ready with the site, the protocols, the supply, everything ready to go for the BT-600.

是的，好問題。因此，對於BT-600，除了這次審查之外，我們正在盡我們所能控制為第一階段試驗做好準備，這意味著讓我們的網站做好準備，讓我們的合作夥伴、CRO 做好準備，盡我們所能可以包括做供應。因此，我們已經生產了預期用於第一階段試驗的產品。因此，我們將準備好場地、協議、供應以及 BT-600 所需的一切。

Slightly different for BioJet. We don't really need to make a lot of these at this point, even though we use 10, 20 different animals and a few doses -- it is still only a handful of devices, and we're able to make those on an ongoing basis. We're making some great progress with multiple studies coming back to back to back ,but it's still a very manageable number of devices, and we're able to easily make those and continue progressing our programs.

BioJet 略有不同。儘管我們使用了 10、20 種不同的動物和少量的劑量，但我們目前並不需要製作很多這樣的設備——它仍然只是少數設備，而且我們能夠持續進行。我們透過多項連續研究取得了一些巨大進展，但設備數量仍然非常易於管理，我們能夠輕鬆地實現這些並繼續推進我們的專案。

Great. Thanks for the color.

偉大的。謝謝你的顏色。

Julian Harrison, BTIG.

朱利安·哈里森，BTIG。

Hi. Thank you for taking my questions. I guess some more on the IND resubmission. Can you talk more about the expected timeline to turn this around? Is this standard 30 days -- something longer, something shorter? And then also do you plan to press release first human dose?

你好。感謝您回答我的問題。我想還有一些關於 IND 重新提交的資訊。您能否詳細談談扭轉此局面的預期時間表？標準的 30 天是長還是短？那麼您是否計劃發布首個人體劑量的新聞稿？

Hi, Julian. So in terms of the review, you know, we very much appreciate that the FDA's workload, you can imagine, has been already busy. They've had a lot to do, and that's also apparent from some other places where they've needed more time.

嗨，朱利安。所以在審查方面，你知道，我們非常讚賞FDA的工作量，你可以想像，已經很忙了。他們有很多事情要做，從其他一些他們需要更多時間的地方也可以看出這一點。

They don't have a great mechanism for adding time to the 30-day cycle, which is what we were kind of talking about that look towards the end of the cycle when they had these questions, even though we only needed a couple of days to gather the information, turn it around, it would have ended with the 30 day clock running out. And so the best thing to do was to to resubmit.

他們沒有一個很好的機制來增加 30 天週期的時間，這就是我們在談論週期結束時他們提出這些問題時所討論的，儘管我們只需要幾天收集信息，扭轉局面，30天的時間就結束了。所以最好的方法就是重新提交。

So the resubmission was more of a just a tactical -- let's just go ahead and provide the information, resubmit -- and it goes back now into a standard 30-day clock. So what we hope is that they finish their review very quickly and that in November, we get a clearance from the FDA. And that's how we're preparing. We're preparing -- given the interaction we've had -- they've been great.

因此，重新提交更多地只是一種策略——讓我們繼續提供信息，然後重新提交——現在又回到了標準的 30 天時鐘。所以我們希望他們能夠很快完成審查，並在 11 月獲得 FDA 的許可。這就是我們正在做的準備。我們正在準備——考慮到我們之間的互動——他們非常棒。

We appreciate the way they've worked with us. We've had several conversations. And so we hope that they'll finish the review. We expect that we get a clearance in November, which is why we're doing everything prepare for start of trial in December.

我們感謝他們與我們合作的方式。我們已經進行過幾次交談。因此我們希望他們能夠完成審查。我們預計在 11 月獲得許可，這就是為什麼我們正在為 12 月開始試驗做一切準備。

Thanks very much.

非常感謝。

John Vandermosten, Zacks.

約翰范德莫斯坦，扎克斯。

Alright, thank you and hello, Andy and Eric. Can you just give us a sense of any other checklist items that need to be completed besides the FDA clearance on the BT-600 trial before you can start your first administration?

好的，謝謝你們，你們好，安迪和艾瑞克。在開始第一次給藥之前，除了 FDA 對 BT-600 試驗的批准之外，您能否讓我們了解還需要完成的任何其他清單項目？

Yes, hi, John. So like I said, what we're doing is going through that checklist of everything that we control. And so making enough material; getting all the supply ready; getting the site ready; getting our partners, the CROs ready; getting the protocols ready; getting the IRB ready. We're doing all of those, and they're well on track and we would be ready with all of those any day that we get the clearance from the FDA.

是的，嗨，約翰。就像我說的，我們正在做的就是檢查我們控制的一切的清單。這樣就製作了足夠的材料；準備好所有供應；準備好網站；讓我們的合作夥伴、CRO 做好準備；準備好協議；讓 IRB 做好準備。我們正在做所有這些事情，而且進展順利，只要我們獲得 FDA 的許可，我們就會做好準備。

What we're not controlling is the review with the FDA. So we're working closely with them, and we're hoping that we get that done in November. And so tentatively, we're planning that all the stuff we have to get ready on that checklist really is done, and that in December, as soon as we get the clearance, we go activate the sites, do what we need to do -- and I think like somebody else mentioned, we can then share when we have started the trial in December.

我們無法控制的是 FDA 的審查。因此，我們正在與他們密切合作，希望能在 11 月完成這項工作。因此，我們暫時計劃在清單上準備的所有內容都已完成，並且在 12 月，一旦獲得許可，我們就會激活這些站點，做我們需要做的事情 - - 我認為就像其他人提到的那樣，我們可以在12 月開始試驗時分享。

Okay. Very good. It sounds like you could start very shortly after you get the clearance. And then moving onto on to BioJet, when do you think you have serious discussions with the BioJet partners on going to the next step, which would be in the clinic? And would you -- might include potential and milestones and things like that. When do you achieve or reach that stage?

好的。非常好。聽起來你獲得許可後很快就可以開始了。然後轉向 BioJet，您認為您何時會與 BioJet 合作夥伴認真討論下一步，即在診所進行？你會嗎——可能包括潛力和里程碑之類的東西。你什麼時候達到或到達那個階段？

That's an interesting question. So the way I would hope we're being clear people to understand. What we have now are research collaborations. These are great. These are ways where large companies work with innovative technologies, like ours, because they find that there is a potential that they could use that. They're interested in it, but they'd like to learn how our technology and their molecules kind of work, and this is a way where we can get some cost-sharing, but the main idea here is to learn how to work together.

這是一個有趣的問題。所以我希望我們能夠讓人們清楚地理解。我們現在擁有的是研究合作。這些都很棒。這些都是像我們這樣的大公司使用創新技術的方式，因為他們發現有潛力利用這些技術。他們對此很感興趣，但他們想了解我們的技術和他們的分子是如何運作的，這是我們可以分攤成本的一種方式，但這裡的主要想法是學習如何一起工作。

Progressing through those is what leads to the next stage of conversations, which then is about what I would call the partnerships. So I'm qualifying these relationships, which we have, which are very much like partners, but they really are research collaborations.

透過這些進展將導致下一階段的對話，這就是我所說的夥伴關係。因此，我對我們之間的這些關係進行了限定，它們非常類似於合作夥伴，但它們實際上是研究合作。

And progressing those into partnerships, which then look like what many people might be used to seeing, whether it's a licensing or some other sort of partnership that comes with an upfront payment, a plan, milestones -- that's when you get into discussions about what kind of molecule, what kind of kind of indications, what maybe a clinical plan might look like. There might be some situations where the company, like ours, helps them with those. There might be some where we allow them to run with it and they come up with their own plans.

然後將這些發展為合作夥伴關係，這看起來就像許多人可能習慣看到的那樣，無論是許可還是其他類型的合作夥伴關係，都附帶預付款、計劃、里程碑——那時你就開始討論什麼什麼樣的分子，什麼樣的適應症，臨床計畫可能會是什麼樣子。在某些情況下，像我們這樣的公司可能會幫助他們解決這些問題。可能有些地方我們允許他們運行，然後他們提出自己的計畫。

So I think what needs to be more near-term focus is that we are seeing tremendous progress with these collaborations. Over the last several months, we have gotten way better at execution, right? We've made the BioJet 2 which is our next-gen device. We've done the animal studies to make sure that the device works. We then showed it to our collaborators who agree that the device works to a point where they want to include their molecules.

因此，我認為近期需要關注的是我們看到這些合作取得了巨大進展。在過去的幾個月裡，我們的執行力已經好多了，對吧？我們已經製造了 BioJet 2，這是我們的下一代設備。我們已經進行了動物研究以確保設備有效。然後我們向我們的合作者展示了它，他們同意該設備可以工作到他們想要包含他們的分子的程度。

We run their molecules in our device, and we've gotten that initial first one's data. We're expecting the second one's data. In a month or two, we'll get the third one's data. Those data are what enable us to then have the conversation of, okay, given that this combination works, how do you see this relationship?

我們在我們的設備中運行他們的分子，並且我們已經獲得了最初的第一個數據。我們正在等待第二個數據。一兩個月後，我們就會得到第三個的數據。這些數據使我們能夠進行這樣的對話：好吧，鑑於這種組合有效，您如何看待這種關係？

So those could be near term, pretty interesting inflections, and they lay out certainly what the development path is. But for a small company, they could mean significant things in terms of how investors might view our relationships with, at that point, partners.

因此，這些可能是近期的、非常有趣的變化，它們明確地列出了發展道路。但對於一家小公司來說，就投資者如何看待我們與合作夥伴的關係而言，它們可能意義重大。

The data obviously is getting good enough, which is why I mentioned that we're seeing the accelerated interest. We're getting more incoming people asking us about working with us, and that's why we were we were able to say we've already got a discussion with a fourth collaborator that could lead to a research collaboration in the near term -- another big company.

數據顯然已經足夠好了，這就是為什麼我提到我們看到人們的興趣加速成長。我們越來越多的人詢問我們與我們合作的情況，這就是為什麼我們能夠說我們已經與第四位合作者進行了討論，這可能會導致短期內的研究合作——另一項重大合作公司。

So we see that this data generation translating into what could be meaningful partnerships being the short term thing to focus on with BioJet, and then later next year, worry about what a clinical plan might look like.

因此，我們看到這些數據生成轉化為有意義的合作夥伴關係，成為 BioJet 短期關注的事情，然後在明年晚些時候，擔心臨床計劃可能會是什麼樣子。

Okay. And now this fourth collaborator, since you've done a lot of the preclinical work already, and so have some of your partners, are they coming in at kind of a later stage where they already know what to expect? And you might be a lot closer to moving on to an advanced relationship with the fourth partner? Where does that stand just given all the preliminary work that's already been done for BioJet?

好的。現在，第四位合作者，由於您已經完成了大量的臨床前工作，您的一些合作夥伴也做了很多工作，他們是否在後期階段進入，他們已經知道會發生什麼？您可能會更接近與第四位合作夥伴建立更深入的關係？考慮到 BioJet 已經完成的所有初步工作，這意味著什麼？

Yes, I think the way I see it is that several -- whatever, a year or two ago -- when we have these other collaborations, those discussions were around some early stage. Our first gen, our BioJet device, and so we work with these collaborators to do things like establish success criteria, which is why we talk about meeting targets and establishing development of our device milestones.

是的，我認為我的看法是，有幾個——無論如何，一兩年前——當我們進行其他合作時，這些討論都處於早期階段。我們的第一代 BioJet 設備，因此我們與這些合作者合作，制定成功標準等事情，這就是我們談論實現目標和建立設備里程碑開發的原因。

All of those, now that we've completed, we're now looking at the next stage of, okay, go ahead and try our molecule. So this fourth collaborator would come in at that stage of, go ahead and try our molecule. Because I've seen this other data, and that's what encourages me, right? That people are seeing that we've done the development work. We've done the core work. We now have several molecules that we have run with this device, and it's all meeting those general commercial performance targets that people want to see.

所有這些，既然我們已經完成了，我們現在正在考慮下一階段，好吧，繼續嘗試我們的分子。因此，第四位合作者將在這個階段加入，繼續嘗試我們的分子。因為我看到了其他數據，這就是鼓勵我的原因，對吧？人們看到我們已經完成了開發工作。我們已經完成了核心工作。現在，我們已經有了幾種與該設備一起運行的分子，它們都滿足了人們希望看到的一般商業性能目標。

And so now it's about working with their molecule, and depending on how that goes, quickly progressing that relationship. So certainly that should move much faster than our earlier collaborators -- collaborations that moved. But we're excited about all of them. So we are at that point, right, with the other collaborators, where we're starting to get data with their molecules that allows us to have those next conversations.

所以現在是與他們的分子合作，並根據進展情況，快速推進這種關係。因此，當然，這應該比我們早期的合作者進展得更快——合作已經發生了變化。但我們對所有這些都感到興奮。因此，我們現在正與其他合作者一起，開始獲取他們的分子數據，以便我們進行接下來的對話。

Great. Right. Thank you, Adi. Appreciate it.

偉大的。正確的。謝謝你，阿迪。欣賞它。

Thank you. If there are no further questions at this time, I'd like to hand the call back over to Adi Mohanty for any closing comment.

謝謝。如果此時沒有其他問題，我想將電話轉回給 Adi Mohanty 以徵求結束意見。

Well, thank you again for joining us today for our financial results call. We're excited about the progress we're making, and we look forward to keeping you updated. Thank you. Have a good evening.

好吧，再次感謝您今天參加我們的財務業績電話會議。我們對所取得的進展感到興奮，並期待向您通報最新情況。謝謝。祝你晚上愉快。

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

今天的會議到此結束。此時您可以斷開線路。感謝您的參與。