BioRestorative Therapies Inc (BRTX) 2025 Q1 法說會逐字稿

Good afternoon, everyone, and welcome to the BioRestorative Therapies first-quarter 2025 investor call. (Operator Instructions) Please note, this conference is being recorded.

大家下午好，歡迎參加 BioRestorative Therapies 2025 年第一季投資人電話會議。（操作員指示）請注意，本次會議正在錄音。

I will now turn the conference over to your host, Stephen Kilmer, Investor Relations. Stephen, the floor is yours.

現在我將會議交給主持人、投資人關係部門 Stephen Kilmer。史蒂芬，現在請你發言。

Thank you, Jenny. Good afternoon, everyone. Let me start by pointing out that this conference call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are based on BioRestorative Therapies' current beliefs, assumptions, and expectations, and such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. No forward-looking statement can be guaranteed.

謝謝你，珍妮。大家下午好。首先我要指出的是，本次電話會議將包括 1995 年《私人證券訴訟改革法案》所定義的前瞻性陳述。所有前瞻性陳述均基於 BioRestorative Therapies 目前的信念、假設和期望，此類陳述涉及已知和未知的風險、不確定性和其他因素，可能導致實際結果、業績或成就與此類陳述所暗示的結果、業績或成就有重大差異。無法保證任何前瞻性陳述。

For details on factors, among others, that could affect expectations, see Part 1 Item 1A of our annual report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. BioRestorative undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by law.

有關可能影響預期的因素等的詳細信息，請參閱我們向美國證券交易委員會提交的截至 2024 年 12 月 31 日的 10-K 表年度報告第 1 部分第 1A 項。敬請聽眾不要過度依賴這些前瞻性陳述，這些陳述僅代表本次電話會議召開之日的觀點。除非法律要求，BioRestorative 不承擔公開更新或修改任何前瞻性聲明的義務，無論是否出現新資訊、未來事件或其他原因。

On the call today representing the company are Lance Alstodt, BioRestorative's Chairman and Chief Executive Officer; Francisco Silva is Vice President of Research and Development; and Robert Kristal, the company's Chief Financial Officer.

今天參加電話會議的代表公司有 BioRestorative 董事長兼執行長 Lance Alstodt、研發副總裁 Francisco Silva 和公司財務長 Robert Kristal。

With that said, I now I'll now turn the call over to Lance.

話雖如此，我現在將電話轉給蘭斯。

Thank you, Stephen. Good afternoon, everyone. Welcome to our first-quarter conference call. On behalf of BioRestorative, I'd like to thank you for your interest in our company. And for those of you who are shareholders, as always, we appreciate your support.

謝謝你，史蒂芬。大家下午好。歡迎參加我們的第一季電話會議。我謹代表 BioRestorative 感謝您對我們公司的關注。對於那些股東，我們一如既往地感謝你們的支持。

As you can see from the press release we issued just a short time ago, we have continued to execute well across all areas of our business since the start of 2025. And we have a lot of exciting things to look forward to as we move throughout the year.

正如您從我們不久前發布的新聞稿中看到的，自 2025 年初以來，我們在所有業務領域都表現良好。隨著一年的進展，我們有很多令人興奮的事情值得期待。

With that said, I'm going to ask Rob to provide a brief overview of our first-quarter financial results.

話雖如此，我將請羅布簡要概述我們的第一季財務表現。

Thanks, Lance. Good afternoon, everyone. To streamline the presentation of the financial results, all of the numbers I will refer to have been rounded so they are approximate.

謝謝，蘭斯。大家下午好。為了簡化財務結果的呈現，我將引用的所有數字都已四捨五入，因此它們是近似值。

For the first-quarter 2025, revenues were $25,000 compared to $35,000 in the same period last year. First year (sic - "quarter") 2025 deferred revenues were $150,000 compared to nil in the first quarter of 2024. I point this number out because it represents a timing difference on when we booked revenue versus when we received such revenue. We are encouraged with the momentum in the underlying fundamentals of this revenue line.

2025 年第一季的營收為 25,000 美元，而去年同期的營收為 35,000 美元。2025 年第一年（原文如此 - 「季度」）的遞延收入為 150,000 美元，而 2024 年第一季為零。我指出這個數字是因為它代表了我們預訂收入和收到收入的時間差異。我們對這條收入線的基本面動能感到鼓舞。

The company's first-quarter 2025 loss from operations was $4.8 million compared to $4.1 million for the comparable period 2024. The company's first-quarter 2025 net loss was $5.3 million, or $0.64 per share, compared to a net loss of $2.2 million, or $0.33 per share, for the first quarter of 2024. The change was primarily due to a gain on the exchange of warrants in Q1 2024.

該公司 2025 年第一季的營業虧損為 480 萬美元，而 2024 年同期的營業虧損為 410 萬美元。該公司 2025 年第一季淨虧損為 530 萬美元，即每股 0.64 美元，而 2024 年第一季淨虧損為 220 萬美元，即每股 0.33 美元。這項變更主要是由於 2024 年第一季認股權證交換收益所致。

Cash used in operating activities in the first quarter of 2025 was $2.8 million, and the company ended the quarter in a strong financial position with cash, cash equivalents, and marketable securities of $9.1 million and no outstanding debt.

2025 年第一季經營活動所用現金為 280 萬美元，本季末財務狀況良好，現金、現金等價物及有價證券為 910 萬美元，無未償債務。

With that, I'll turn the call over to Francisco.

說完這些，我將把電話轉給弗朗西斯科。

Thanks, Rob. For the benefit of those who are new to the BioRestorative story, I would like to take a moment to summarize our developmental programs.

謝謝，羅布。為了讓那些剛了解 BioRestorative 故事的人受益，我想花點時間總結我們的發展計畫。

Our lead clinical-stage candidate, BRTX-100, is a novel cell-based therapeutic engineered to target areas of the body that have little or no blood flow. The product is formulated using autologous or a person's own cultured mesenchymal stem cells collected from the patient's bone marrow.

我們的主要臨床階段候選藥物 BRTX-100 是一種新型的基於細胞的治療方法，專門針對身體血流很少或沒有血流的部位。本產品採用從患者骨髓中採集的自體或自身培養的間質幹細胞配製而成。

The safety and efficacy of BRTX-100 in treating chronic lumbar disc disease, or cLDD, is being evaluated in an ongoing Phase II prospective, randomized, double-blinded, and controlled study. A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites across the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX or sham or placebo.

一項正在進行的 II 期前瞻性、隨機、雙盲對照研究正在評估 BRTX-100 治療慢性腰椎間盤疾病 (cLDD) 的安全性和有效性。美國各地多達 16 個臨床地點將招募總共多達 99 名符合條件的受試者。參與試驗的受試者將以 2:1 的比例隨機分配接受 BRTX 或假治療或安慰劑治療。

In a podium presentation that I gave in February in 2025 Orthopedic Research Society Annual Meeting, I reviewed 26- to 52-week blinded data from the first 15 subjects with cLDD enrolling in the study. No serious adverse events were reported, and there was no dose-limiting toxicity at 26 to 52 weeks.

我在 2025 年 2 月骨科研究協會年會的演講中回顧了參與研究的前 15 名 cLDD 患者的 26 至 52 週盲法數據。沒有報告嚴重不良事件，且在 26 至 52 週內沒有劑量限制性毒性。

Preliminary blinded visual analog scale, or VAS; and Oswestry Disability Index, or ODI, data collected at weeks 26 and 52 post-injection demonstrated an exceptionally positive trend compared to baseline. We were also really excited to see that a 52-week comparison of MRI images compared to baseline that appears to demonstrate morphological changes that potentially demonstrate disc microenvironment remodeling.

注射後第 26 週和第 52 週收集的初步盲法視覺類比量表 (VAS) 和奧斯維斯特里殘障指數 (ODI) 數據顯示，與基線相比呈現異常積極的趨勢。我們也非常高興地看到，與基線相比，52 週的 MRI 影像對比似乎顯示出可能表明椎間盤微環境重塑的形態變化。

More recently, just last week, in fact, I presented preliminary 26, 52 and 104-week blinded preliminary Phase II BRTX-100 data from the same 15 subjects at the International Society for Cell and Gene Therapy 2025 Annual Meeting. The longer-term preliminary blinded data continues to trend positively compared to baseline. And if these trends continue, we believe that the Phase II trial will meet its primary and secondary end points.

事實上，就在上週，我在國際細胞和基因治療學會 2025 年年會上展示了來自同 15 名受試者的初步 26、52 和 104 週盲法 II 期 BRTX-100 數據。與基線相比，長期初步盲法數據持續呈現正面趨勢。如果這些趨勢持續下去，我們相信第二階段試驗將達到其主要和次要終點。

Partly based on the preliminary data, we have achieved two important FDA milestones since the beginning of 2025. The first of those was the FDA granting fast track designation for our BRTX-100 cLDD program. The FDA's fast track program is aimed to facilitate the development and expedite the review of the investigational treatments that are designed to treat serious conditions and have the potential to address significant unmet medical needs.

部分基於初步數據，自 2025 年初以來，我們已經實現了兩個重要的 FDA 里程碑。其中第一個是 FDA 授予我們的 BRTX-100 cLDD 專案快速通道資格。FDA 的快速通道計畫旨在促進開發和加快審查旨在治療嚴重疾病並有可能解決重大未滿足醫療需求的試驗性治療方法。

Benefits of the program include early and frequent interaction with the FDA during the clinical development process and stem cell product candidates with fast track designation may also be eligible for priority review and accelerated BLA biologics license application approval. Achieving fast track designation was an important milestone for BioRestorative, and we look forward to working more closely with the FDA as we continue to advance our lead BRTX-100 clinical program.

該計劃的優勢包括在臨床開發過程中與 FDA 進行早期和頻繁的互動，並且具有快速通道指定的干細胞產品候選者也可能有資格獲得優先審查和加速 BLA 生物製劑許可申請批准。獲得快速通道資格對於 BioRestorative 來說是一個重要的里程碑，我們期待在繼續推進我們領先的 BRTX-100 臨床計畫的同時與 FDA 進行更緊密的合作。

The second milestone achieved since the start of 2025 was the FDA clearing our investigational drug application for a Phase II clinical trial for BRTX-100 in chronic cervical discogenic pain, or CCDP. As a result, BRTX-100 is now the first and only stem cell-based product candidate in the world, cleared by the FDA to be evaluated in the cervical degeneration disc disease setting.

自 2025 年初以來實現的第二個里程碑是 FDA 批准了我們針對慢性頸椎間盤源性疼痛 (CCDP) 進行 BRTX-100 的 II 期臨床試驗的藥物研究申請。因此，BRTX-100 現在是世界上第一個也是唯一一個經 FDA 批准在頸椎退化性椎間盤疾病環境中進行評估的基於幹細胞的候選產品。

Moving to our core preclinical metabolic program, ThermoStem. We are developing cell-based therapy candidates to treat target obesity and metabolic disorders using brown adipose or fat-derived stem cells or BADSCs to generate brown adipose tissue, or BAT, as well as exosome secreted by the BADSC. That is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans and is involved in weight loss.

轉向我們的核心臨床前代謝計劃，ThermoStem。我們正在開發基於細胞的治療候選藥物，使用棕色脂肪或脂肪衍生的幹細胞或 BADSC 來生成棕色脂肪組織或 BAT，以及 BADSC 分泌的外泌體來治療目標肥胖和代謝紊亂。其目的是模擬自然產生的棕色脂肪庫，調節人體代謝穩態並參與減肥。

While further work is needed to fully understand the mechanism of action of ThermoStem's impact on weight loss and metabolism, we have not seen nor do we expect the same negative secondary effects of GLP-1 pharmaceuticals such as loss of muscle mass and negative cardiovascular effects.

雖然需要進一步研究才能完全了解 ThermoStem 對減肥和新陳代謝影響的作用機制，但我們尚未看到也不會預期出現 GLP-1 藥物的相同負面副作用，例如肌肉質量損失和心血管負面影響。

As awareness of the promise that our ThermoStem-based stem cells hold for the treatment of obesity and related metabolic disorders continues to grow, it is important that this potentially game-changing opportunity is well protected, both for us and any current and our future potential licensing partners. Accordingly, we have methodically built comprehensive pattern portfolio of issued patents that cover both the US and international markets. And we are pleased to see that our already formidable IP estate expanded again in the first quarter.

隨著人們越來越意識到我們基於 ThermoStem 的幹細胞在治療肥胖症和相關代謝紊亂方面的潛力，重要的是，無論對於我們還是對於我們當前和未來的潛在許可合作夥伴來說，都要很好地保護這個可能改變遊戲規則的機會。因此，我們有條不紊地建立了覆蓋美國和國際市場的全面已發布專利模式組合。我們很高興地看到，我們原本就強大的智慧財產權資產在第一季再次擴大。

On a final note, our previously reported substantial discussion with undisclosed commercial stage regenerative medicine company with regard to a potential license agreement for our ThermoStem metabolic disease programs are continuing. While we cannot provide interim progress updates, not provide any assurances that we will come to a mutually acceptable agreement, we are committing to closing the loop on this as soon as practical.

最後要說的是，我們之前報道過的與未公開的商業階段再生醫學公司就我們的 ThermoStem 代謝疾病項目的潛在許可協議進行的實質性討論仍在繼續。雖然我們無法提供中期進展更新，也無法保證我們將達成雙方均可接受的協議，但我們承諾盡快完成此事。

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

說完這些，我會把電話轉回給蘭斯。

Thank you, Francisco. And as you can see from what Francisco and Rob just reviewed, we've had an exciting and productive beginning of 2025. And while that progress continues, we're carefully managing all of our resources as we advance our two core clinical development programs, BRTX-100 and of course Thermostem.

謝謝你，弗朗西斯科。正如您從 Francisco 和 Rob 剛才的評論中所看到的，我們在 2025 年迎來了一個令人興奮且富有成效的開端。在不斷取得進展的同時，我們正在謹慎管理所有資源，推進我們的兩個核心臨床開發項目，BRTX-100 和 Thermostem。

So to summarize, we're making exceptionally good progress with our Phase II trial for BRTX-100, while the data is still blinded, the initial trends continue to be very encouraging. Reflecting the positive preliminary Phase II trial data being to date, the FDA has granted Fast Track designation to the program. We intend to present more data from this trial with a larger patient population very soon, and we remain very optimistic that this data will be consistent with the previous trends.

總而言之，我們的 BRTX-100 II 期試驗取得了非常好的進展，雖然數據仍然是盲測，但初步趨勢仍然非常令人鼓舞。由於迄今為止初步的 II 期試驗數據是積極的，FDA 已授予該項目快速通道資格。我們打算很快公佈更多來自更大患者群體的試驗數據，並且我們仍然非常樂觀地認為這些數據將與先前的趨勢一致。

We have now also expanded our advanced clinical pipeline for BRTX-100 to include the treatment of both chronic lower back pain and neck pain via the FDA clearance of our IND for a Phase II trial in cervical. As you know, we skipped to Phase I, and we did not have to do any preclinical work within that program. This was a function of our data associated with our lumbar trial and very solid conversations with the FDA.

我們現在也擴展了 BRTX-100 的先進臨床管線，透過 FDA 批准我們的頸椎 II 期試驗 IND，將慢性下背部疼痛和頸部疼痛的治療納入其中。如您所知，我們直接進入了第一階段，並且我們不必在該計劃內進行任何臨床前工作。這是我們腰椎試驗相關數據以及與 FDA 進行非常可靠的對話的結果。

We are continuing to proactively expand the already formidable ThermoStem intellectual property estate to help ensure a long-term market exclusivity. We continue to be in substantive discussions with regard to a potential license of the ThermoStem metabolic IP and other assets that we possess from a technology perspective.

我們將繼續積極擴大已經強大的 ThermoStem 智慧財產權資產，以協助確保長期的市場獨佔權。我們將繼續就 ThermoStem 代謝 IP 以及我們從技術角度擁有的其他資產的潛在許可進行實質討論。

Finally, we ended the quarter in a very strong financial position with cash, cash equivalents, and marketable securities of $9.1 million as of March 31, 2025, and we will continue to efficiently manage our cash reserves while executing upon our strategic goals.

最後，截至 2025 年 3 月 31 日，我們以非常強勁的財務狀況結束了本季度，現金、現金等價物和有價證券為 910 萬美元，我們將繼續有效管理我們的現金儲備，同時執行我們的策略目標。

Thank you. And with that concluding our introductory remarks, we're happy to take any questions you may have.

謝謝。我們的開場白到此結束，我們很樂意回答您的任何問題。

(Operator Instructions) Jonathan Aschoff, ROTH.

（操作員指示）Jonathan Aschoff，ROTH。

Congrats on the progress, guys. I had a question. You called the endpoint, the efficacy endpoint of greater than or equal to 30% improvements, a preliminary end point. I've never really heard of an endpoint called preliminary data, yes, not an endpoint. And then then you're showing us greater than 50% improvement in this last week's presentation.

祝賀你們取得的進步，夥計們。我有一個問題。您將療效改善程度大於或等於 30% 的終點稱為初步終點。我從來沒有真正聽說過稱為初步數據的終點，是的，不是終點。然後，您在上週的演示中向我們展示了超過 50% 的改進。

So is that some kind of foreshadowing that the endpoint that you're going to have to hit is no longer going to be greater than or equal to 30% and more, like greater than or equal to 50%?

那麼，這是否預示著你必須達到的終點不再大於或等於 30% 或更多，例如大於或等於 50%？

No, no. Good question. But no, we're not changing the endpoint. It's still both just a 30% improvement.

不，不。好問題。但不，我們不會改變端點。這仍然只是 30% 的改善。

So what's the preliminary word for?

那麼preliminary 的意思是啥呢？

Well, because the primary endpoint is safety of the study. It's not efficacy. But the FDA, the target is the safety since it's the first-in-man study. The word preliminary is there a meaning that it's not the primary. So the secondary endpoints are related to efficacy.

嗯，因為主要終點是研究的安全性。這不是功效。但由於這是首次人體試驗，FDA 的目標是安全性。「初步」一詞的意思是它不是主要的。因此次要終點與療效有關。

Okay. I noticed in the second slide presentation last week versus February. There was no more line about potential interim analysis of 26 weeks. So is that out? Or will that still be performed?

好的。我注意到上週的第二張幻燈片演示與二月份的相比有所差異。不再有關於 26 週潛在中期分析的內容。那麼這樣可以嗎？或者這仍會被執行嗎？

We haven't determined that we're going to do an interim, it's a potential, and that's still something that's on the table as an option. We don't want to compromise the trial in terms of having an interim analysis that could impact the long-term development.

我們還沒有確定是否要採取臨時措施，這是一種可能性，並且仍然是一個可以考慮的選擇。我們不想因為中期分析而損害試驗，因為這可能會影響長期發展。

Currently, right now, we're having strategy talks with our team internally as well as preparing some FDA communications to see where we could take this trial within the Phase III and potentially leverage this data to shorten the regulatory process for BLA approval. So an interim analysis could impact that since we would have to unblind. But that's, again, still something that's on the table, but we removed it from the presentation.

目前，我們正在與內部團隊進行策略討論，並準備一些 FDA 溝通資料，以了解我們可以在 III 期試驗中進行哪些試驗，並可能利用這些數據來縮短 BLA 批准的監管流程。因此，中期分析可能會對此產生影響，因為我們必須揭開盲法。但這仍然是一個正在討論的問題，但我們已將其從簡報中刪除。

I think we -- Jonathan, just to add to that, I think we just need some more feedback from the FDA on that, and those discussions are ongoing. But I appreciate that comment.

我認為我們——喬納森，補充一點，我認為我們只是需要 FDA 就此提供更多反饋，這些討論仍在進行中。但我很欣賞這個評論。

Okay. And the last one is the 45 subject data being presented in HK or China. Where are those 45 patients coming from?

好的。最後一個是在香港或中國呈現的45個主題資料。那45名病人是從哪裡來的？

From the current study. So these are patients that have already been dosed at different time points within the visitation in the weeks. So some of it might be 26, some of it might be 52.

從目前的研究來看。因此，這些患者已經在數週的訪視內的不同時間點接受過藥物治療。所以有些可能是 26，有些可能是 52。

So when is that presentation?

那麼示範什麼時候舉行？

That's in June.

那是在六月。

June. Okay. So the trial a lot more along in enrollment than one would glean from yesterday's press release.

六月。好的。因此，試驗的招募進度比昨天新聞稿中透露的要快得多。

Yeah. Actually, so I just want to be --

是的。事實上，我只是想--

Yeah, the 15 patients is just to keep it sort of consistent with what we've shown in the past and trying to keep those same patients a longer time period of looking at metrics. But it doesn't represent the enrollment and it doesn't represent how many patients have been dosed. That we would comfortably say is significantly higher.

是的，這 15 名患者只是為了與我們過去所展示的情況保持一致，並試圖讓同一批患者在更長的時間內觀察指標。但它並不代表入組人數，也不代表有多少患者接受了治療。我們可以肯定地說，這個數字要高得多。

And the 15, they made it to week 12 and not yet to week 26, correct?

而第 15 組，他們已經進入第 12 週，但還沒進入第 26 週，對嗎？

The 15 patients at the presentation (multiple speakers)

出席演講的 15 名患者（多位發言者）

It's the only way the percentages work out, yeah.

是的，這是計算百分比的唯一方法。

Correct.

正確的。

Like you had 13 at week 26. It looks like it's 2 out of 15 that give you that 13.3% for 12 weeks.

就像你在第 26 週有 13 個一樣。看起來，15 個中會有 2 個在 12 週內為您帶來 13.3% 的收益。

Right.

正確的。

Jason McCarthy, Maxim Group.

傑森麥卡錫，馬克西姆集團。

Looks like you're making significant progress. In terms of speed of enrollment, I understand enrollment is much further along than the 15-patient update that we saw. Do you expect enrollment to continue at its current pace, kind of what is that pace and as we head into summer, do you expect enrollment potentially to slow a little bit with people kind of taking holiday?

看起來你取得了重大進展。就入組速度而言，據我了解，入組速度比我們看到的 15 名患者更新速度快得多。您是否預期入學人數會以目前的速度持續成長，大概是多少？隨著夏季的到來，您是否預計由於人們休假，入學人數可能會放緩？

No. Actually, I think just the reverse actually, we're starting to see a real uptick in patients because of some of the strategies that we've been employed from a recruitment perspective. So we've kind of opened up a whole host of new strategies that seem to be working better than what has been done in the past.

不。事實上，我認為恰恰相反，由於我們從招募角度採取了一些策略，我們開始看到患者數量真正增加。因此，我們開闢了一系列新策略，這些策略似乎比過去的策略效果更好。

As you know, this is a very difficult and challenging environment in order to find a single disc patient with discogenic pain with given how strict the criteria is we obviously believe in the criteria in order to have the cleanest and most valid data possible relative to other trials that are out there.

如您所知，這是一個非常困難和具有挑戰性的環境，為了找到一個患有椎間盤源性疼痛的單椎間盤患者，考慮到標準的嚴格程度，我們顯然相信該標準，以便獲得相對於其他試驗最乾淨和最有效的數據。

So we're going to continue to stay with the protocol. I think the enrollment is picking up. Historically, we've seen a bit of a slowdown during the summer, but I think we'll counteract that with some of the new strategies that we've employed in terms of recruitment.

因此我們將繼續遵守該協議。我認為入學人數正在增加。從歷史上看，我們在夏季經歷了一些放緩，但我認為我們會透過在招聘方面採用的一些新策略來抵消這種影響。

Got it. And in terms of your interactions with FDA, have there been more emphasis from them on pain or function or do they want to see both? Reduction of pain with functional improvement.

知道了。就您與 FDA 的互動而言，他們更注重疼痛還是功能，或者他們希望看到兩者兼而有之？減輕疼痛並改善功能。

Well, I will tell you that I think it's all open for discussion. We haven't had specific feedback that, for example, function would be dropped from the protocol. I know in some cases, it has been in the past, but we continue to collect data on both of our secondary end points in our primary efficacy end points. We'll continue to work with the FDA and discuss a whole host of matters, including what they really want to focus on as we get closer to enrollment.

好吧，我會告訴你，我認為這一切都是可以討論的。我們還沒有收到具體的回饋，例如，功能將從協議中刪除。我知道在某些情況下，這已經是過去的事情了，但我們會繼續收集主要療效終點中的兩個次要終點的數據。我們將繼續與 FDA 合作並討論一系列問題，包括在我們接近註冊時他們真正想要關注的問題。

So I think what we can look forward to is certainly pain will be a very meaningful end point. Function, I think, is something that we have a little bit more flexibility in terms of discussing.

所以我認為我們可以期待的是痛苦肯定會是一個非常有意義的終點。我認為，功能是我們在討論時具有更多靈活性的東西。

And have you provided any additional enrollment or patient characteristics? Are the patients older, younger, middle age, where do you think you're seeing the most response potentially?

您是否提供了任何額外的入學資訊或患者特徵？患者是老年人、年輕人或中年人，您認為哪種治療方法最有可能產生療效？

Well, it's been ranging. We do have younger patients that are in their early 20s. But then again, we have older patients that are in their late 50s. Blinded data, so we don't know who or who has not been dosed. And so we got to be careful in terms of how we report the data. But from a very high level, it looks pretty consistent that trends are being formed across the demographics.

嗯，它一直在變化。我們確實有一些 20 歲出頭的年輕患者。但話說回來，我們有一些年齡較大的患者，他們已經 50 多歲了。盲法數據，所以我們不知道誰服用了藥物，誰沒有服用藥物。因此，我們在報告數據方面必須謹慎。但從非常高的層次來看，整個人口統計中形成的趨勢看起來相當一致。

Got it. Last question. Can you just give us a little bit more detail on -- you had mentioned morphological changes in response to the cells. Can you discuss a little bit more about what was observed?

知道了。最後一個問題。您能否提供我們更多細節—您提到了細胞的形態變化。能否進一步討論一下所觀察到的情況？

Yeah. So -- and again, this is still very early, but it's very encouraging to see these morphological changes, for example, in one subject. And again, we have -- it's more than just one that's experiencing this. But in one particular subject that was presented at baseline, the patient had a protrusion and annular tear as well.

是的。所以 — — 再說一次，這還為時過早，但看到這些形態變化，例如在一個受試者身上，是非常令人鼓舞的。再說一次，我們經歷過這種情況的不只一個人。但在基線時出現的一個特定受試者中，患者也出現了突出和環狀撕裂。

And at 52 weeks compared to baseline, using the same MRI magnet, we see that there's increased hydration. So there's an increased T2 signal within the disc. There's a decrease in size of the pertrusion. And really interesting is that you see a decrease in the annular tear signal. So that is showing very aggressive morphological remodeling within the extracellular matrix within the disc and the annulus as well.

與基線相比，在 52 週時使用相同的 MRI 磁鐵，我們發現水合物增加。因此椎間盤內的 T2 訊號增強。突出的尺寸有所減少。真正有趣的是，你會看到環狀撕裂訊號的減少。這顯示椎間盤和椎間盤內的細胞外基質發生了非常積極的形態重塑。

In another patient compared to baseline at 52 weeks, T2 signal begins to decrease. So there's less hydration. The purtrusion appears to be very notably worse than compared to baseline, and you could see an evolution of extrusion within the disc lesion. So in that case, the patient got worse as compared to the previous patient that I spoke about, the patient is actually improving.

與另一名患者在 52 週時的基線相比，T2 訊號開始下降。因此水分較少。與基線相比，椎間盤突出的情況似乎明顯惡化，您可以看到椎間盤病變內出現擠壓。因此，在這種情況下，與我之前談到的那個病人相比，這個病人的情況變得更糟，但實際上病人正在好轉。

Wasn't there also a resolution of annular care in that patient that you're referring to?

您所提到的那個病人不是也有一個環狀護理的解決方案嗎？

Yes. Yes, I mentioned that there's a decrease in the signal that's apparent there baseline what -- there is an annular tear, and then at 52 weeks, the annular tear is nearly resolved.

是的。是的，我提到過，基線時訊號明顯下降——存在環狀撕裂，然後在 52 週時，環狀撕裂幾乎得到解決。

Okay. Then just as a follow-up to that, do you think with more mature morphological data that, that could be supplemental in your data package to FDA ultimately and maybe even reduce the size of what could be a registration study next?

好的。那麼作為後續問題，您是否認為有了更成熟的形態學數據，最終可以補充您向 FDA 提供的數據包，甚至可能減少下一步註冊研究的規模？

We believe so. I mean, that's one of the reasons we're very careful how we're managing the trial and the data because we really don't want to compromise how we could use this potential data going forward. So currently, right now, the environment for cell-based therapies, it's a little bit more positive than it has been ever. So we definitely want to leverage the BRTX product. It's autologous by nature, the safety profile that we're seeing.

我們相信如此。我的意思是，這就是我們非常謹慎地管理試驗和數據的原因之一，因為我們真的不想損害我們今後如何使用這些潛在數據。因此，目前，細胞療法的環境比以往任何時候都更加積極。所以我們肯定希望利用 BRTX 產品。就其本質而言，它是自體的，我們看到了它的安全性。

I mean, again, there's 45-patient data that's going to be presented in Hong Kong. And again, part of that is safety in addition to looking at the function and pain scales that were going to be presented itself. We're very encouraged. And hopefully, we have positive discussions going forward with the FDA.

我的意思是，再次重申一下，有 45 名患者的數據將在香港公佈。再次強調，除了查看即將呈現的功能和疼痛量表之外，部分原因還在於安全性。我們非常受鼓舞。希望我們能與 FDA 進行積極的討論。

(Operator Instructions) Okay. We don't appear to have any further questions. I'll now hand back over to the management team for any closing remarks.

（操作員指示）好的。我們似乎沒有其他問題了。現在我將把發言權交還給管理團隊，請他們做最後的總結發言。

Okay, great. Well, thank you very much. Appreciate everyone in attendance, and we look forward to talking to you next quarter, if not sooner. Have a great day.

好的，太好了。嗯，非常感謝。感謝各位出席，我們期待下個季度甚至更早與您交談。祝你有美好的一天。

Thank you very much. That does conclude today's conference call. You may disconnect your phone lines at this time, and have a wonderful day. We thank you for your participation.

非常感謝。今天的電話會議到此結束。現在您可以斷開電話線，並享受美好的一天。我們感謝您的參與。