TFF Pharmaceuticals Inc (TFFP) 2023 Q3 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the TFF Pharmaceuticals third quarter 2023 corporate update and earnings conference call. As a reminder, this conference is being recorded. I will now turn the call over to our host, Corey Davis with LifeSci Advisors. You may begin your conference.

女士、先生們，下午好，歡迎參加 TFF Pharmaceuticals 2023 年第三季公司更新與收益電話會議。提醒一下，本次會議正在錄製中。我現在會把電話轉給我們的主持人、LifeSci Advisors 的 Corey Davis。您可以開始您的會議了。

Thank you, operator. Hello, everyone, and welcome to TFF Pharmaceuticals third quarter 2023 Corporate update and earnings conference call. With me on the line this afternoon, Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals; Dr. Zamaneh Mikhak, Chief Medical Officer; and Kirk Coleman, Chief Financial Officer.

謝謝你，接線生。大家好，歡迎參加 TFF Pharmaceuticals 2023 年第三季公司更新與收益電話會議。今天下午與我通話的是 TFF Pharmaceuticals 執行長 Harlan Weisman 博士； Zamaneh Mikhak 博士，首席醫療官；柯克‧科爾曼，財務長。

Before we get started, I'd like to remind everyone that this call will contain forward-looking statements, including without limitation, statements about the anticipated timing of achievement of clinical milestones, the potential to see positive effects in our Phase 2 studies, a number of treated patients necessary to make decisions in regards to moving to Phase 3 studies, the market opportunity for our product candidates and the expected timeframe for funding operations with cash and cash equivalents.

在我們開始之前，我想提醒大家，本次電話會議將包含前瞻性陳述，包括但不限於關於實現臨床里程碑的預期時間、在我們的 2 期研究中看到積極效果的潛力、做出有關進入第三階段研究的決定所需的治療患者數量、我們的產品候選者的市場機會以及現金和現金等價物資助業務的預期時間範圍。

These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in all of our filings with the US Securities and Exchange Commission, including the Risk Factors section of our 2022 Annual Report on Form 10-K filed with the SEC.

這些前瞻性陳述受到已知和未知的風險和不確定性的影響，可能導致實際結果與所做陳述有重大差異。我們向美國證券交易委員會提交的所有文件中均描述了可能導致實際結果存在差異的因素，包括向 SEC 提交的 2022 年年度報告 10-K 表格中的「風險因素」部分。

Now it's my pleasure to turn the call over to Dr. Harlan Weisman. Go ahead, Harlan.

現在我很高興將電話轉給 Harlan Weisman 博士。繼續吧，哈倫。

Thank you, Cory, and good afternoon, everyone. And thank you for joining us for our third quarter 2023 corporate Update and earnings conference call. Last quarter we detailed the considerable progress that we've made across a number of key areas in our ongoing Phase 2 studies of TFF VORI and TFF TAC.

謝謝你，科里，大家下午好。感謝您參加我們的 2023 年第三季公司動態與收益電話會議。上個季度，我們詳細介紹了我們正在進行的 TFF VORI 和 TFF TAC 第二階段研究在多個關鍵領域取得的重大進展。

Based on these accomplishments and subsequent progress, we continue to expect initial clinical data from the Phase 2 studies by year-end. Assuming results from both trials are positive, we believe these initial data will serve as a major catalyst for our company by providing the strongest evidence to date of how Thin Film Freezing can improve a drug safety and efficacy in two rare disease patient populations.

基於這些成就和後續進展，我們繼續期望在年底前獲得 2 期研究的初步臨床數據。假設這兩項試驗的結果都是正面的，我們相信這些初步數據將成為我們公司的主要催化劑，提供迄今為止最有力的證據，證明薄膜冷凍如何提高兩種罕見疾病患者群體的藥物安全性和療效。

In anticipation of these data readouts, I'd like to spend most of our time on today's call discussing how TFF defines clinical success for both programs. We will therefore spend time reviewing what endpoints will be presented and their clinical relevance within the context of these two rare disease indications.

考慮到這些數據的讀出，我想在今天的電話會議上花大部分時間討論 TFF 如何定義這兩個項目的臨床成功。因此，我們將花時間檢視將提出哪些終點及其在這兩種罕見疾病適應症的背景下的臨床相關性。

Our Chief Medical Officer, Dr. Zamaneh Mikhak will lead this discussion in a moment. Following her remarks, our Chief Financial Officer, Kirk Coleman, will review our third quarter results. We'll then open up the call for Q&A.

我們的首席醫療官 Zamaneh Mikhak 博士稍後將主持這次討論。在她發表演講後，我們的財務長柯克科爾曼將審查我們第三季的業績。然後我們將開啟問答環節。

Before turning the call over to Zamaneh, I would like to briefly note that we continue to closely manage our expenses while prioritizing how we allocate our capital resources. In August, we closed a $5.7 million equity financing, providing us with sufficient funding to reach the initial data readouts for the TFF VORI and TFF TAC programs, and extending our runway into the second quarter of 2024.

在將電話轉給 Zamaneh 之前，我想簡要說明一下，我們將繼續密切管理我們的開支，同時優先考慮如何分配我們的資本資源。 8 月，我們完成了 570 萬美元的股權融資，為我們提供了足夠的資金來完成 TFF VORI 和 TFF TAC 項目的初始數據讀出，並將我們的跑道延長到 2024 年第二季度。

Anticipating positive data from these studies, we continue to review our longer-term capital planning efforts as we think about advancing our two clinical programs into registration enabling studies. To that end, our 2023 proxy statement contains two voting items that are critical for executing our corporate strategy over the next several months, including a request to increase the company's stock authorization and a request to implement a reverse stock split, should the Board determine that it's necessary.

預計這些研究會產生積極的數據，我們將繼續審查我們的長期資本規劃工作，同時考慮將我們的兩個臨床項目推進註冊支持研究。為此，我們的2023 年股東委託書包含兩項對於在未來幾個月執行我們的公司策略至關重要的投票項目，其中包括增加公司股票授權的請求和實施反向股票分割的請求（如果董事會確定）有必要。

Respectively, these two initiatives could significantly facilitate future fundraising efforts and ensure that we remain in compliance with NASDAQ listing requirements. We hope to have your support for both of these two important voting items.

這兩項措施分別可以大大促進未來的募款工作，並確保我們繼續遵守納斯達克上市要求。我們希望得到您對這兩個重要投票項目的支持。

With that I'll now turn the call over to Zamaneh, who will preview our upcoming data readouts for TFF VORI and TFF TAC Phase 2 programs. Zamaneh?

現在，我將把電話轉給 Zamaneh，他將預覽我們即將發布的 TFF VORI 和 TFF TAC 第 2 階段計劃的數據讀數。紮馬內？

Thank you, Harlan. As Harlan mentioned, I'm pleased to review with you the type of initial data we plan to share by year-end for the TFF VORI and TFF TAC Phase 2 studies, focusing on the endpoints, their clinical relevance and the definition of success.

謝謝你，哈倫。正如 Harlan 所提到的，我很高興與您一起回顧我們計劃在年底前分享的 TFF VORI 和 TFF TAC 2 期研究的初始數據類型，重點關注終點、其臨床相關性和成功的定義。

I'll start the TFF VORI. Let's begin with the unmet medical need and the value proposition for TFF VORI. TFF VORI is being developed as a potential treatment for pulmonary fungal infections, including pulmonary aspergillosis.

我將啟動 TFF VORI。讓我們從 TFF VORI 未滿足的醫療需求和價值主張開始。 TFF VORI 正在開發作為肺部真菌感染（包括肺麴菌病）的潛在治療方法。

Starting with invasive pulmonary aspergillosis or IPA. IPA life-threatening fungal lung infection that primarily affects immunocompromised patients, such as patients with hematologic malignancies or individuals who receive solid organ or stem cell transplantation. Voriconazole is first line therapy for patients with IPA.

從侵襲性肺部麴菌病或 IPA 開始。 IPA 是一種危及生命的真菌肺部感染，主要影響免疫功能低下的患者，例如患有血液系統惡性腫瘤的患者或接受實體器官或幹細胞移植的個體。伏立康唑是 IPA 患者的第一線治療藥物。

However, when administered orally or intravenously, voriconazole is associated with high rates of toxicity and drug-drug interaction. The most common toxicities associated with voriconazole resulting in its discontinuation include liver toxicity, visual disturbances and rashes, other potential serious toxicities are arrhythmias, QT prolongation and photosensitivity.

然而，當口服或靜脈注射時，伏立康唑會產生高毒性和藥物間交互作用。導致停藥的與伏立康唑相關的最常見毒性包括肝毒性、視力障礙和皮疹，其他潛在的嚴重毒性包括心律不整、QT 延長和光敏性。

Drug-drug interactions represent another significant limitation of oral and intravenous voriconazole. Voriconazole can increase or decrease the levels of other drugs needed for the treatment of the patient's underlying illness, such as chemotherapeutic or immunosuppressive agents, driving these drugs to sub-therapeutic or toxic levels respectively.

藥物間交互作用是口服和靜脈注射伏立康唑的另一個顯著限制。伏立康唑可以增加或減少治療患者潛在疾病所需的其他藥物（例如化療藥物或免疫抑制劑）的水平，從而將這些藥物分別推至亞治療水平或毒性水平。

Not surprisingly, the high rates of toxicities and drug-drug interactions lead to a poor prognosis. Patients with IPA have a 12-week mortality rate of approximately 30%, which clearly represents a significant unmet medical need for this rare disease.

毫不奇怪，高發生率的毒性和藥物間相互作用導致預後不良。 IPA 患者的 12 週死亡率約為 30%，這顯然表明這種罕見疾病的醫療需求尚未得到滿足。

For approximately 250,000 patients globally with invasive aspergillosis, which we believe represents significant opportunity for TFF VORI. Thin Film Freezing technology enables us to address this opportunity by delivering voriconazole directly into the lungs where the IPA infection resides. Through localized delivery, we hope to drive efficacy while minimizing the patient's systemic exposure and [thus] systemic toxicities and drug-drug interaction.

全球約有 25 萬名侵襲性麴菌病患者，我們認為這對 TFF VORI 來說是一個重大機會。薄膜冷凍技術使我們能夠透過將伏立康唑直接輸送到 IPA 感染所在的肺部來抓住這個機會。透過局部給藥，我們希望提高療效，同時最大限度地減少患者的全身暴露，從而減少全身毒性和藥物間相互作用。

Our decision to advance TFF VORI into Phase 2 testing with base upon acceptable safety and tolerability results in Phase 1 studies and positive efficacy results in two patients with pulmonary fungal infections treated with TFF VORI on a compassionate use basis.

我們決定將TFF VORI 推進到2 期測試，這是基於1 期研究中可接受的安全性和耐受性結果，以及在同情使用基礎上使用TFF VORI 治療的兩名肺部真菌感染患者的積極療效。

The Phase 1a study with 65 healthy volunteers and a Phase 1b study with 16 mild asthmatics demonstrated that doses up to 80 milligrams twice a day were well tolerated and showed no signs of the toxicities commonly reported for oral and intravenous voriconazole. Results from the two compassionate use patients were also favorable.

對65 名健康志願者進行的1a 期研究和對16 名輕度氣喘患者進行的1b 期研究表明，每天兩次高達80 毫克的劑量具有良好的耐受性，並且沒有顯示出口服和靜脈注射伏立康唑常見的毒性跡象。兩名同情使用患者的結果也令人滿意。

Both patients had a history of recurrent pulmonary fungal infections and systemic toxicities from available antifungal standard of care therapies. As a result of treatment with TFF VORI, lung function stabilized as shown in the middle chart, lung lesions improved as shown on the chart to the far right and fungal infection cleared. Aspergillus in one patient (inaudible) in the other patient.

兩名患者都有復發性肺部真菌感染史，以及現有抗真菌標準護理治療產生的全身毒性。 TFF VORI 治療的結果是，肺功能穩定，如中圖所示，肺部病變得到改善，如最右圖所示，真菌感染被清除。一名患者體內有曲霉菌（聽不清楚），另一名患者體內有曲霉菌。

In both cases, there was no need for hospitalization, treatment with TFF VORI resulted in no drug-drug interactions and no adverse events were reported. Based on the favorable results from the Phase 1 studies and the two compassionate use patients a Phase 2 study was initiated in Europe.

在這兩種情況下，都不需要住院，TFF VORI 治療沒有導致藥物間相互作用，也沒有報告不良事件。基於第一階段研究的良好結果和兩位同情使用患者，第二階段研究在歐洲啟動。

The ongoing Phase 2 trial is a randomized open label study evaluating TFF VORI versus oral voriconazole. The duration of treatment is 13 weeks and the trial endpoints include safety and tolerability, clinical, radiologic and mycological responses as well as all-cause mortality.

正在進行的 2 期試驗是一項隨機開放標籤研究，評估 TFF VORI 與口服伏立康唑的比較。治療持續時間為 13 週，試驗終點包括安全性和耐受性、臨床、放射學和真菌學反應以及全因死亡率。

Before entering this 13 week treatment period, patients are screened to establish the diagnosis of proven or probable IPA. During the screening process to gain an understanding of the patient's underlying condition that renders them immunocompromised and makes them vulnerable to fungal infections like IPA.

在進入這 13 週的治療期之前，對患者進行篩檢以確定已證實或可能的 IPA 的診斷。在篩檢過程中，了解患者的潛在狀況，這些狀況會導致他們免疫功能低下，並容易受到 IPA 等真菌感染。

It confirms that the patient's infection is indeed caused by Aspergillus by visualizing Aspergillus under the microscope or growing it in culture or by detecting its DNA or by detecting galactomannan, which is a piece of the cell rollout Aspergillus [break cause] and enter the bloodstream.

透過在顯微鏡下觀察曲霉菌或在培養物中培養曲霉菌，或透過檢測其DNA 或透過檢測半乳甘露聚醣（半乳甘露聚醣，半乳甘露聚醣是麴菌細胞的一部分[斷裂原因]並進入血液），可以確認患者的感染確實是由曲霉菌引起的。

We document the signs and symptoms caused by the infection with Aspergillus such as fever, testing, coughing up blood and shortness of breath and record their severity. We examine the impact of the infection on lung function.

我們記錄曲霉菌感染引起的徵兆和症狀，例如發燒、檢測、咳血和呼吸急促，並記錄其嚴重程度。我們檢查感染對肺功能的影響。

So spirometry, which is a test of how much air the patient can inhale or exhale and how fast, for example, FEV1 or forced expiratory volume in 1, which measures the maximum amount of air a patient can forcefully exhale in one second can be decreased in the setting of IPA.

因此，可以減少肺活量測定法（測試患者可以吸入或呼出多少空氣以及速度），例如 FEV1 或 1 單位的用力呼氣量，測量患者在一秒鐘內可以用力呼出的最大空氣量在IPA的設定中。

Finally, we assess the impact of the infection on lung structures through chest CT imaging and look for abnormalities such as nodules or spots in the lung cavity. The parameters that establish the disease status at baseline, such as evidence of infection, signs and symptoms, lung function and lung structure abnormalities on the endpoints of the study.

最後，我們透過胸部 CT 影像評估感染對肺部結構的影響，並尋找肺腔內的結節或斑點等異常情況。確定基線疾病狀態的參數，例如研究終點的感染證據、徵兆和症狀、肺功能和肺結構異常。

Overall treatment responses assessed by mycological response, defined as clearance of (inaudible) infection by clinical response, defined as improvement in signs and symptoms or lung function via spirometry and or by radiologic response, defined as improvement in lung structure via chest CT.

透過真菌學反應評估整體治療反應，定義為臨床反應清除（聽不清楚）感染，定義為透過肺活量測定和/或透過放射線反應改善體徵和症狀或肺功能，定義為透過胸部 CT 改善肺結構。

Once through the screening process, patients entered the treatment period of the trial and are randomized in a 3:1 ratio to receive either 80 milligrams of TFF VORI twice a day over 200 milligrams oral voriconazole twice daily. Patients are followed closely for the emergence of adverse events, including all-cause mortality to assess safety and tolerability.

經過篩選過程後，患者進入試驗的治療期，並以 3:1 的比例隨機分配，接受每天兩次 80 毫克 TFF VORI 治療或每天兩次口服 200 毫克伏立康唑治療。密切注意患者不良事件的出現，包括全因死亡率，以評估安全性和耐受性。

In addition, clinical assessments are conducted through the 13 week treatment period for signs and symptoms, lung function and galactomannan. Chest CT repeated after eight weeks and 13 weeks of treatment to detect improvements in lung structural or abnormalities.

此外，在 13 週的治療期間對體徵和症狀、肺功能和半乳甘露聚醣進行臨床評估。治療 8 週和 13 週後重複進行胸部 CT 檢查，以檢測肺部結構或異常的改善。

Now I'd like to briefly discuss our Expanded Access Program or EAP. We launched our EAP in July in partnership with Durbin to provide access to TFF VORI for patients in need who do not qualify for ongoing Phase 2 study.

現在我想簡要討論一下我們的擴展訪問計劃（EAP）。我們於 7 月與 Durbin 合作推出了 EAP，為沒有資格參加正在進行的 2 期研究的有需要的患者提供 TFF VORI 的使用機會。

The EAP provides 12 weeks of treatment with TFF VORI to patients who have limited or no other treatment options or who have had an unfavorable response to adequate standard of care therapy. As you can see, our EAP encompasses many forms of pulmonary aspergillosis and also includes patients who have pulmonary fungal infections other than aspergillosis that are responsive to treatment with voriconazole.

EAP 為那些​​只有有限的或沒有其他治療選擇或對足夠的標準護理治療反應不佳的患者提供 12 週的 TFF VORI 治療。如您所見，我們的 EAP 涵蓋多種形式的肺麴菌病，還包括對伏立康唑治療有反應的曲霉菌病以外的肺部真菌感染患者。

Our US expanded access protocol was submitted to the FDA late last spring, and the EAP is now open in the US, Canada, Australia, the UK and select EU countries. Together, we expect our Phase 2 trial and EAP will provide meaningful evidence for the potential of TFF VORI for the treatment of pulmonary fungal infection.

我們的美國擴展准入協議已於去年春末提交給 FDA，EAP 現已在美國、加拿大、澳洲、英國和部分歐盟國家開放。我們預計 2 期試驗和 EAP 將為 TFF VORI 治療肺部真菌感染的潛力提供有意義的證據。

Given the considerable amount of historical safety and efficacy data with voriconazole in this rare disease indication, we anticipate data from approximately 10 patients will be sufficient to guide a Phase 3 Go/No-Go decision. We plan to share initial data from a subset of these patients by year end and a more complete data set by the end of first quarter 2024.

鑑於伏立康唑在這種罕見疾病適應症中的大量歷史安全性和有效性數據，我們預計來自大約 10 名患者的數據將足以指導 3 期試驗的進行/不進行決策。我們計劃在年底前分享部分患者的初步數據，並在 2024 年第一季末分享更完整的數據集。

The year-end data will include assessment of safety, tolerability and treatment response. And mycological response will be defined by no evidence of Aspergillus in the assays performed post treatment, for example, it decreased a non-detectable galactomannan.

年終數據將包括安全性、耐受性和治療反應的評估。真菌學反應將透過治療後進行的測定中沒有曲霉菌的證據來定義，例如，它減少了不可檢測的半乳甘露聚醣。

The clinical response will be defined as improvement in signs and symptoms and our lung function measures such as FEV1. A radiologic response will be defined by improvement in the abnormal findings and chest CT, such as the number and or size of nodules or spots or cavities, et cetera.

臨床反應將被定義為體徵和症狀以及肺功能指標（例如 FEV1）的改善。放射學反應將透過異常發現和胸部 CT 的改善來定義，例如結節、斑點或空洞的數量和/或大小，等等。

So how do we define success for TFF VORI. We define success as an overall decrease in toxicities commonly seen with oral or intravenous voriconazole, a decrease in drug-drug interactions compared with historical data and evidence of micrologic, clinical and or radiologic response after 12 or 13 weeks of treatment with TFF VORI in the majority of patients.

那我們要如何定義 TFF VORI 的成功呢？我們將成功定義為：與歷史數據和微生物學、臨床和/或放射學反應的證據相比，口服或靜脈注射伏立康唑常見的毒性總體降低，藥物間相互作用減少，在TFF VORI 治療12 或13 週後大多數患者。

Now I'd like to discuss our TFF TAC Phase 2 program. TFF TAC is being developed to address a significant unmet need in lung transplant rejection. By way of background, tacrolimus is the first line calcineurin inhibitor indicated for the prevention of rejection of lung transplant.

現在我想討論一下我們的 TFF TAC 第二階段計劃。 TFF TAC 的開發是為了解決肺移植排斥方面未滿足的重大需求。作為背景，他克莫司是用於預防肺移植排斥反應的一線鈣調神經磷酸酶抑制劑。

However, there are well known significant toxicities associated with the oral and intravenous formulation. TFF TAC has been designed using Thin Film Freezing to deliver an inhaled form of tacrolimus directly into the lung, which is beside of inflammation against the transplanted organ to drive efficacy through immune suppression vocally while limiting systemic exposures and systemic toxicities.

然而，眾所周知，口服和靜脈注射製劑具有顯著的毒性。 TFF TAC 的設計採用薄膜冷凍技術，將吸入形式的他克莫司直接輸送到肺部，除了針對移植器官的發炎之外，還透過聲音免疫抑制來提高療效，同時限制全身暴露和全身毒性。

Similar to TFF VORI, TFF TAC addresses a high unmet medical need. Patients receiving a lung transplant have an expected five-year mortality rate of approximately 50% due to oral tacrolimus narrow therapeutic index, too little immune suppression leads to acute rejection or chronic rejection, leading to chronic lung allograft dysfunction or CLAD.

與 TFF VORI 類似，TFF TAC 解決了未滿足的醫療需求。由於口服他克莫司治療指數狹窄，免疫抑制太少導致急性排斥或慢性排斥，導致接受肺移植的患者預計五年死亡率約50%，導致慢性肺移植功能障礙或CLAD。

Whereas too much immune suppression leads to infections, chronic kidney disease and post-transplant malignancies. There are approximately 40,000 lung transplant patients globally, which represents a significant opportunity to introduce a therapy such as TFF TAC with the potential to improve upon the current standard of care.

而過多的免疫抑制會導致感染、慢性腎臟病和移植後惡性腫瘤。全球約有 40,000 名肺移植患者，這是引入 TFF TAC 等療法的重要機會，有可能改善目前的護理標準。

Similar to TFF VORI, a decision to advance TFF TAC into Phase 2 testing was supported by strong preclinical and Phase 1 data, which demonstrated acceptable safety and tolerability and an attractive differentiated pharmacokinetic profile compared to the oral tacrolimus.

與TFF VORI 類似，將TFF TAC 推進到2 期測試的決定得到了強有力的臨床前和1 期數據的支持，這些數據證明了可接受的安全性和耐受性，以及與口服他克莫司相比具有有吸引力的差異化藥物動力學特徵。

Our preclinical data demonstrated a favorable distribution of tacrolimus, showing high concentrations of the drug in demand relative to systemic blood levels. In our Phase 1 study in healthy subjects, daily dosing of up to 5 milligrams in a single dose and 1.5 milligrams in repeated doses were generally well-tolerated.

我們的臨床前數據證明了他克莫司的良好分佈，顯示相對於全身血液水平，所需藥物的濃度較高。在我們針對健康受試者的 1 期研究中，每日單次劑量最多 5 毫克和重複劑量 1.5 毫克的劑量通常具有良好的耐受性。

Our ongoing Phase 2 trial of TFF TAC is an open label single arm study in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity. This study is designed in two parts. Part A is a 12-week treatment period and Part B is an optional safety extension period.

我們正在進行的 TFF TAC 2 期試驗是一項開放標籤單臂研究，對像是因腎毒性而需要降低他克莫司血液濃度的肺移植患者。本研究分為兩部分。 A 部分是 12 週的治療期，B 部分是可選的安全延長期。

Prior to receiving treatment patients go through a two-week screening period to collect several baseline measurements. Baseline kidney function is documented, and bronchoscopies performed to make sure patients do not have a lung infection.

在接受治療之前，患者要經過兩週的篩檢期，以收集一些基線測量結果。記錄基線腎功能，並進行支氣管鏡檢查以確保患者沒有肺部感染。

A biopsy sample taken during bronchoscopy used for genomics analysis to look for baseline signs of acute rejection. Spirometry is performed to assess the patient's lung function, blood is drawn to measure donor-derived cell-free DNA, which served as a noninvasive biomarker of stress or injury to the transplanted lung due to rejection.

在支氣管鏡檢查期間採集的活檢樣本用於基因組學分析，以尋找急性排斥的基線跡象。進行肺活量測定來評估患者的肺功能，抽取血液來測量捐贈者來源的遊離 DNA，該 DNA 可作為移植肺因排斥反應而受到壓力或損傷的非侵入性生物標記。

Finally, lung imaging is performed to look for infection, inflammation and damage from chronic rejection. Once screening is completed, patient's oral tacrolimus is stopped, and patients entered the 12-week treatment period with TFF TAC.

最後，進行肺部影像以尋找感染、發炎和慢性排斥反應造成的損傷。篩檢完成後，患者停止口服他克莫司，患者進入 TFF TAC 的 12 週治療期。

Clinicians then monitor tacrolimus blood levels and adjust the dose of TFF TAC as needed to achieve tacrolimus blood levels that are approximately two-thirds to one-half of the patient's blood levels on oral tacrolimus. These blood levels are expected to be high enough to avoid rejection, but low enough to reduce toxicities.

然後，臨床醫生監測他克莫司的血液濃度，並根據需要調整TFF TAC 的劑量，以達到他克莫司的血液濃度約為患者口服他克莫司血液濃度的三分之二至二分之一。這些血液水平預計足夠高以避免排斥，但又足夠低以減少毒性。

Following the treatment period, the same endpoints measured during the screening phase of reassess, including spirometry for lung function, bronchoscopy and biopsy for genomics analysis and donor-derived cell-free DNA for signs of stress or injury to the transplanted lung.

治療期結束後，在重新評估的篩選階段測量了相同的終點，包括用於肺功能的肺活量測定、用於基因組分析的支氣管鏡檢查和活檢以及用於檢測移植肺壓力或損傷跡象的供體來源的遊離DNA。

Safety and tolerability are assessed throughout the study, including assessment of kidney function through glomerular filtration rate and creatinine level. Patients has been given the option to enter the [chile or conveyable] extension.

在整個研究過程中評估安全性和耐受性，包括透過腎小球濾過率和肌酸酐水平評估腎功能。患者可選擇進入[智利或可傳送]分機。

Similar to oral voriconazole, there exists a significant amount of historical patient safety and efficacy data for oral tacrolimus. We therefore believe that clinical data from approximately 10 patients will be sufficient to help us determine a Phase 3 Go/No-Go decision. We plan to share initial data from a subset of these patients by year end and a more complete dataset by the end of the first quarter 2024.

與口服伏立康唑類似，口服他克莫司有大量歷史病患安全性和療效數據。因此，我們相信來自大約 10 名患者的臨床數據將足以幫助我們確定 3 期進行/不進行的決定。我們計劃在年底前分享部分患者的初步數據，並在 2024 年第一季末分享更完整的數據集。

So again, how do we define success for TFF TAC at this stage? Because TFF TAC delivers tacrolimus directly into the lungs, we expect to achieve a higher concentration of tacrolimus in the lungs relative to the systemic circulation. As a result, we expect to provide immune suppression sufficient to prevent rejection at lower systemic exposures that is at lower cost of systemic toxicities.

那麼，現階段我們該如何定義 TFF TAC 的成功呢？由於 TFF TAC 將他克莫司直接輸送到肺部，因此我們期望在肺部獲得相對於體循環更高的他克莫司濃度。因此，我們預期提供足夠的免疫抑制，以較低的全身暴露量防止排斥反應，從而降低全身毒性的成本。

We define success as the ability to transition patients from oral tacrolimus to TFF TAC achieve tacrolimus blood levels that are approximately two-thirds to one-half of the patient's blood levels on oral tacrolimus prevents rejection at these diminished tacrolimus blood levels while stabilizing kidney function.

我們將成功定義為使患者從口服他克莫司過渡到TFF TAC 的能力使他克莫司血中濃度約為口服他克莫司患者血中濃度的三分之二至二分之一，在穩定腎功能的同時，可防止出現排斥反應。

As mentioned, bronchoscopy and biopsy will be repeated at the end of the treatment period. Genomic analysis of the biopsy sample will inform presence or absence of rejection. Blood will be obtained and assessed for donor-derived cell-free DNA to book for injury and stress to the transplanted lung and other potential final impact rejection. Lung function will be assessed as well as glomerular filtration rate and creatinine to understand kidney function.

如前所述，治療期結束時將重複進行支氣管鏡檢查和活檢。活檢樣本的基因組分析將告知是否有排斥反應。將採集血液並評估捐贈者來源的無細胞 DNA，以記錄移植肺的損傷和壓力以及其他潛在的最終影響排斥反應。將評估肺功能以及腎小球濾過率和肌酸酐，以了解腎功能。

That conclude my presentation on the upcoming data readouts for our TFF VORI and TFF TAC program. I will now turn the call over to Kirk to review our third quarter financial results. Kirk?

我關於即將推出的 TFF VORI 和 TFF TAC 計劃數據讀出的演講到此結束。我現在將把電話轉給柯克，以審查我們第三季的財務表現。柯克？

Thank you very much, Zamaneh. Our cash and cash equivalents as of September 30, 2023, were $9.7 million based on gross proceeds of $5.7 million received from the financing transaction that closed on August 17th. Our current cash runway is expected to fund operations into the second quarter of 2024.

非常感謝你，紮馬內赫。截至 2023 年 9 月 30 日，我們的現金和現金等價物為 970 萬美元，基於 8 月 17 日結束的融資交易收到的總收益 570 萬美元。我們目前的現金跑道預計將為 2024 年第二季的營運提供資金。

We remain mindful of our capital resources and continue to monitor our expenses to ensure we are only spending on our core activities. Research and development expenses for the third quarter of 2023 were $2.4 million compared to $4 million for the comparable period in 2022. The $1.6 million decrease year-over-year is primarily result of reduced clinical and manufacturing expenses.

我們仍然關注我們的資本資源，並繼續監控我們的支出，以確保我們只將支出用於我們的核心活動。 2023 年第三季的研發費用為 240 萬美元，而 2022 年同期為 400 萬美元。年減 160 萬美元主要是由於臨床和製造費用減少。

General and administrative expenses for the third quarter of 2023 were $2.3 million compared to $3.3 million for the comparable period in 2022. The $1 million decrease year-over-year is primarily related to decreased professional fees, patent expenses, insurance, consulting, market research, payroll and related expenses. The net loss for the third quarter of 2023 of $4.4 million compared to a net loss of $7.3 million for the comparable period in 2022.

2023 年第三季的一般及管理費用為 230 萬美元，而 2022 年同期為 330 萬美元。年減 100 萬美元主要與專業費用、專利費用、保險、諮詢、市場研究的減少有關、薪資及相關費用。 2023 年第三季的淨虧損為 440 萬美元，而 2022 年同期的淨虧損為 730 萬美元。

And now I'll turn the call back over to Harlan.

現在我將把電話轉回給哈倫。

Thank you, Kirk. I hope today's call has provided you with a clear understanding of our TFF VORI and TFF TAC Phase 2 trial designs, clinical endpoints, and most importantly, with the value we hope to bring to patients who are suffering from these two rare diseases.

謝謝你，柯克。我希望今天的電話會議能讓您清楚地了解我們的 TFF VORI 和 TFF TAC 2 期試驗設計、臨床終點，最重要的是，我們希望為患有這兩種罕見疾病的患者帶來價值。

I think it's also worth mentioning once again, they're relative to clinical programs involving new chemical entities. We believe the development risk associated with the TFF VORI and TFF TAC programs significantly reduced given the well-established historical data available for these molecules.

我認為還值得再次提及的是，它們與涉及新化學實體的臨床項目有關。我們相信，鑑於這些分子已有完善的歷史數據，與 TFF VORI 和 TFF TAC 計畫相關的開發風險顯著降低。

Generating positive results in our Phase 2 studies will further validate our technology and demonstrate how our lead pipeline assets, TFF VORI and TFF TAC represent significant improvements over the current standard of care. I would like to thank our shareholders for your continued support and confidence in TFF Pharmaceuticals, and we look forward to updating you on our progress throughout the rest of the year.

我們的第二階段研究取得積極成果將進一步驗證我們的技術，並展示我們的領先管道資產 TFF VORI 和 TFF TAC 如何代表當前護理標準的重大改進。我要感謝我們的股東對 TFF Pharmaceuticals 的持續支持和信心，我們期待向您通報我們在今年剩餘時間取得的最新進展。

That concludes our formal remarks, and I'd now like to open the call up for the question-and-answer session. Operator?

我們的正式演講到此結束，現在我想開始問答環節。操作員？

Ladies and gentlemen, we will now begin the question-and-answer session. (Operator Instructions)

女士們、先生們，我們現在開始問答環節。 （操作員說明）

Jonathan Aschoff, ROTH.

喬納森·阿肖夫，羅斯。

Thank you. Good afternoon, guys. I know you're not giving precise enrollment or any enrollment update. But what can you qualitatively say about how enrollment has improved between now and second quarter call, specifically for VORI?

謝謝。下午好，夥計們。我知道您沒有提供準確的註冊資訊或任何註冊更新資訊。但是，從現在到第二季電話會議，特別是 VORI 的註冊情況如何改善，您能定性地描述一下嗎？

Jonathan, hi. Thanks for your question. I'll turn that over to Zamaneh.

喬納森，嗨。謝謝你的提問。我會把它交給 Zamaneh。

Hi, Jonathan. Thanks for the question. We have 95% of our sites active at this point and 90% of them are actively pre-screening. Because of that, our enrollment rate has increased very significantly and now we match what is generally the enrollment rate in IPA Phase 2 clinical trials.

嗨，喬納森。謝謝你的提問。目前，我們 95% 的網站處於活躍狀態，其中 90% 正在積極進行預篩選。因此，我們的入組率顯著增加，現在我們與 IPA 2 期臨床試驗的入組率相當。

[In order] to enroll a clinical trial, you need to have active facts, that is you need to have hospitals with investigators, health investigators, study coordinators, nurses, pharmacists that are fully trained in the conduct of the study, and you have to have the right equipment there for measuring safety and efficacy parameters.

[為了]參加臨床試驗，你需要有積極的事實，也就是說，你需要有醫院配備經過充分培訓的研究人員、健康調查員、研究協調員、護士、藥劑師，並且你有擁有合適的設備來測量安全性和有效性參數。

And then you have to have drug on site for dosing the patients. We spent pretty much the first half of 2023 activating our clinical trial sites and then amending our protocol to broaden eligibility and also to change the randomization ratio from 1:1 to 3:1 to increase access to TFF VORI through the clinical trial.

然後你必須在現場準備好藥物來給病人用藥。我們幾乎花了2023 年上半年的時間來激活我們的臨床試驗站點，然後修改我們的方案以擴大資格，並將隨機比例從1:1 更改為3:1，以增加通過臨床試驗獲得TFF VORI 的機會。

And through all of these efforts now, we see the active sites participating in pre-screening very effectively. And as a result of that, we're on track to communicate initial data that's available to us by year-end. And then a more complete dataset by the end of Q1 2024.

透過現在所有這些努力，我們看到活躍站點非常有效地參與預篩選。因此，我們預計在年底前傳達可用的初始數據。然後在 2024 年第一季末獲得更完整的數據集。

I'm thinking what is the size of your Phase 2 program, say about what we might expect for Phase 3 enrollment numbers? (multiple speakers) What was that?

我在想你們的第二階段計畫的規模是多少，說說我們對第三階段註冊人數的預期？ （多位發言者）那是什麼？

Sorry, in terms of enrollment rate?

抱歉，就入學率而言？

Enrollment numbers, size of the trial.

註冊人數、試驗規模。

I see, the size of the trial is something that we are still working on. And ultimately, we will need to have FDA feedback before we can finalize any particular type of plan. No matter what the size of the trial, what we expect is that the enrollment rate for the Phase 3 would be in general faster than enrollment for Phase 2.

我明白了，我們仍在研究試驗的規模。最終，我們需要獲得 FDA 的回饋才能最終確定任何特定類型的計劃。無論試驗規模為何，我們預期第 3 階段的入組率通常會快於第 2 階段的入組率。

That's generally the case in Phase 3 trials because -- especially if all-cause mortality or any type of mortality is part of the endpoints of this study, you allow patients that are generally [sicker] into this study. And by the time you're doing a Phase 3, you have more clinical data when that helps in general with enrollment with investigators and patients participating.

第三階段試驗通常就是這種情況，因為－特別是如果全因死亡率或任何類型的死亡率是本研究終點的一部分，你就允許通常[病情較重]的患者參與本研究。當您進行第 3 階段時，您將獲得更多臨床數據，這通常有助於研究人員和患者的參與。

So generally speaking, we expect enrollment rates to be higher for our Phase 3. But in terms of the total sample size and what the number would be, we really have to finalize that after we've had FDA interaction.

所以一般來說，我們預計第三階段的入組率會更高。但就總樣本量和數量而言，我們確實必須在與 FDA 互動後才能最終確定。

Okay. So you said 10 patients is enough for your Go/No-Go stays to decision, but just 10 patients -- is 10 patients -- something that's also sufficient to be able to have an end of Phase 2 meeting with the FDA and get their sign-off for a Phase 3 program designed?

好的。所以你說 10 名患者足以讓你做出繼續/不繼續的決定，但只有 10 名患者——就是 10 名患者——這也足以能夠結束與 FDA 的第 2 階段會議並獲得他們的意見。設計的第3 階段計劃的簽署？

Sure, Harlan, I take that one?

當然，哈倫，我接受那個嗎？

Yes, please.

是的，請。

So we anticipate that data from approximately 10 patients will be sufficient for us to hold a meeting with the FDA to present our thoughts and questions and to get feedback on the Phase 3 trial design. We really go back to the concept that voriconazole is not a new chemical entity. There is a great deal of safety, tolerability and efficacy data about voriconazole and tacrolimus for that matter.

因此，我們預計來自大約 10 名患者的數據足以讓我們與 FDA 舉行會議，提出我們的想法和問題，並獲得有關 3 期試驗設計的回饋。我們確實回到了伏立康唑不是新化學實體的概念。關於伏立康唑和他克莫司，有大量的安全性、耐受性和有效性數據。

We know these are active drug, active ingredients with desired pharmacodynamic effects. And also we know that they're two rare indications. So because of that, we believe the data from 10 patients will be quite informative and it will allow us to interact with the FDA, get feedback. And we plan to do that as early as possible and as often as possible, such as we come to a Phase 3 design that's efficient and optimized for the indication.

我們知道這些是具有所需藥效作用的活性藥物、活性成分。我們也知道它們是兩種罕見的跡象。因此，我們相信來自 10 名患者的數據將提供相當豐富的信息，這將使我們能夠與 FDA 互動並獲得回饋。我們計劃儘早、盡可能頻繁地這樣做，例如我們進行針對適應症的高效且優化的第三階段設計。

Okay. So it is the first time that you're saying year end '23 1st, some amount of data in one-quarter '24. For more data, this is for VORI in particular, I don't think you said that about TAC. What's going to be the difference in those two data releases?

好的。因此，這是您第一次說 23 月 1 日年底，24 年一個季度的一些數據。對於更多數據，這是特別針對 VORI 的，我認為您沒有提到 TAC。這兩次數據發布有何不同？

Is 1Q '24 going to be more patients with the same parameters? Or are you going to have different parameters on the same number of patients (multiple speakers) how these releases going to different?

24 年第一季是否會有更多相同參數的患者？或者您是否會對相同數量的患者（多個發言者）使用不同的參數，這些發布會有何不同？

Sure, it's a combination. We expect to have data on a subset of patients by year-end. And present, all the data we have for some patients will have finished the 12 weeks of treatment and some patients will have finished eight weeks, and some will have finished four weeks, and some will have finished two weeks of treatment.

當然，這是一個組合。我們預計到年底可以獲得一部分患者的數據。目前，我們掌握的所有數據中，有些患者將完成 12 週的治療，有些患者將完成 8 週的治療，有些患者將完成 4 週的治療，有些患者將完成兩週的治療。

So we will present all the data that we have on the subset of patients. And then we will have a more complete dataset with approximately 10 patients and the parameters that we discussed by the end of first quarter 2024.

因此，我們將展示我們擁有的關於患者子集的所有數據。然後，到 2024 年第一季末，我們將獲得包含約 10 名患者的更完整的數據集以及我們討論的參數。

Okay. So it's highly likely, more likely than not that you won't have 10 patients by the end of this year, but you'll have them by the end of [21st] quarter. Is that accurate?

好的。因此，很有可能，到今年年底，你不會有 10 名患者，但到 [21 ] 季度末，你就會有他們。準確嗎？

That it's accurate.

它是準確的。

All right. Thank you very much.

好的。非常感謝。

Justin Walsh, JonesTrading.

賈斯汀·沃爾什，瓊斯交易公司。

Hi, thanks for taking the questions. I guess a couple related to the data release and your potential end-of-Phase 2 meeting with the FDA. I'm just trying to get a sense of what expectations people should be thinking about with respect to the level of efficacy that they would be looking for?

您好，感謝您提出問題。我想有一些與數據發布和你們可能與 FDA 舉行的第二階段結束會議有關。我只是想了解人們對於他們所尋求的功效水平應該考慮什麼期望？

And maybe what other forms of, either adverse events or safety concerns that the FDA might be looking out for, like you mentioned, both voriconazole and tacrolimus are very well known. So I know the overall profile, but I don't know if there's something -- maybe more specific with an inhalable formulation that will -- wanted to have information on. So anymore details on that would be helpful.

也許 FDA 可能會關注其他形式的不良事件或安全問題，就像您提到的那樣，伏立康唑和他克莫司都是眾所周知的。所以我知道總體情況，但我不知道是否有什麼東西——也許更具體的是可吸入製劑——想要獲得資訊。因此，更多有關這方面的詳細資訊將會有所幫助。

Justin, thank you for the question. And again, Zamaneh, that seems that you're best position to answer them.

賈斯汀，謝謝你的提問。再說一次，紮馬內赫，看來你是回答這些問題的最佳人選。

Sure, with respect to safety and tolerability, there are certainly certain adverse events that are very common when you use oral or intravenous voriconazole, three top reasons for discontinuing voriconazole is hepatic toxicity. Liver function tests go up three, four, five times the upper limit of normal.

當然，就安全性和耐受性而言，當您使用口服或靜脈注射伏立康唑時，肯定會出現某些非常常見的不良事件，停止伏立康唑的三個主要原因是肝毒性。肝功能測試比正常上限高出三、四、五倍。

And at some point, physicians decide whether your patient has signs and symptoms of hepatic toxicity, this is getting too uncomfortable, and they stop oral or intravenous voriconazole. Visual disturbances are quite uncomfortable for patients, it's a very common reason for discontinuing treatment. Rashes are very common.

在某些時候，醫生會決定您的患者是否有肝毒性的徵兆和症狀，這太不舒服了，他們會停止口服或靜脈注射伏立康唑。視覺障礙對患者來說非常不舒服，這是停止治療的一個很常見的原因。皮疹很常見。

So we will certainly -- we are certainly looking for all of these types of adverse events and following those, and we expect to certainly report on adverse events in a comparative way, compared with the historical data.

因此，我們當然會——我們肯定會尋找所有這些類型的不良事件並追蹤這些事件，並且我們希望肯定會以與歷史數據相比的比較方式報告不良事件。

With respect to what types of signs and symptoms might be common to or might happen with inhaled therapy, certainly with any type of inhaled therapy look for evidence of bronchospasm or uncontrollable cough or things of this sort, and certainly we follow those, and we also plan to report those in the upcoming data release.

關於吸入療法可能常見或可能發生的體徵和症狀類型，當然，任何類型的吸入療法都會尋找支氣管痙攣或無法控制的咳嗽或此類情況的證據，當然我們會遵循這些，而且我們也計劃在即將發布的數據中報告這些內容。

We will report what we have. We will report the data and that's available to us by end of this year and share that, both in terms of safety, tolerability and efficacy. It will be in a subset of patients. And as I mentioned, patients will have been treated for varying amounts of times.

我們將報告我們所掌握的情況。我們將在今年年底前報告並分享這些數據，包括安全性、耐受性和有效性。它將出現在一部分患者中。正如我所提到的，患者接受的治療次數各不相同。

What we believe what we present will be directionally informative in the same way that the two compassionate use patients that we originally presented was very informative. So we expect that, that will form the base of data or the more complete data set that we'll share by the end of first quarter 2024.

我們相信我們所呈現的內容將具有方向性訊息，就像我們最初呈現的兩位同情使用患者提供了非常豐富的資訊一樣。因此，我們預計這將構成我們將在 2024 年第一季末共享的資料基礎或更完整的資料集。

Great, thanks. And just one more for me. Obviously, the big focus has been on rightly so on TFF VORI and TFF TAC, but maybe just provide a quick commentary on some of the other work that you guys have been doing and maybe some other things that you might be excited about that, possible applications of Thin Film Freezing that you'd like to highlight?

萬分感謝。還給我一個。顯然，重點關注的是 TFF VORI 和 TFF TAC，但也許只是對你們一直在做的其他一些工作提供一個快速評論，也許還有一些您可能對此感到興奮的其他事情，可能您想重點介紹薄膜冷凍的應用嗎？

Yeah. So I'll take that one. Well, we're continuing our collaborations with pharma and biotech companies. And we've been able to demonstrate the technology has utility and creating dry powder formulations for a variety of molecules like monoclonal antibodies, vaccines, RNAs, other biologics as well as small molecules.

是的。所以我就拿那個。嗯，我們正在繼續與製藥和生物技術公司合作。我們已經能夠證明該技術的實用性，並為各種分子（如單株抗體、疫苗、RNA、其他生物製劑以及小分子）創建乾粉製劑。

As an example, last week, we announced the publication of results of our collaboration with Aptar Pharma, where we use the TFF process to convert a monoclonal antibody into [voriconazole] dry powder that we can deliver into the posterior nasal cavity using the after dose nasal spray system.

例如，上週，我們宣佈公佈了與 Aptar Pharma 的合作結果，我們使用 TFF 製程將單株抗體轉化為[伏立康唑]乾粉，我們可以使用後劑量將其輸送到後鼻腔鼻噴霧系統。

But it's just an -- it's important to emphasize because it's too early to say whether any of these collaborations will result in a meaningful business opportunity for the company. And we view all of them as the potential upside to the tremendous potential of TFF VORI and TFF TAC.

但這只是——有必要強調一下，因為現在判斷這些合作是否會為公司帶來有意義的商業機會還為時過早。我們將所有這些視為 TFF VORI 和 TFF TAC 巨大潛力的潛在優勢。

Great. Thanks for taking the questions.

偉大的。感謝您提出問題。

Daniel Carlson, Tailwinds.

丹尼爾卡爾森，《順風》。

Hey, guys. Thanks for taking my questions. Just on VORI and TAC, I know cash is tight. At some point if you had to make a choice between the programs, how would you decide which one to move forward on?

大家好。感謝您回答我的問題。就 VORI 和 TAC 而言，我知道現金緊張。在某些時候，如果您必須在這些計劃之間做出選擇，您將如何決定繼續進行哪一個？

Yeah. Hi, Dan, and thanks for participating and asking your question. Well, of course, we'd like to go forward with both programs, but we're going to let the data drive our decisions. We will have to consider the potential for each commercially, things like acute versus chronic treatment, the competitive environment. It also is going to depend on interactions with the FDA and our ability to raise appropriate funds for both programs.

是的。你好，丹，感謝您參與並提出問題。嗯，當然，我們希望繼續推進這兩個項目，但我們將讓數據來推動我們的決策。我們必須考慮每種藥物的商業潛力，例如急性與慢性治療、競爭環境等。它還將取決於與 FDA 的互動以及我們為這兩個項目籌集適當資金的能力。

Got you. Okay. And then you have a SBIR grant for, I think $3 million for universal flu vaccine program. Can you talk about the status of that?

明白你了。好的。然後你會獲得 SBIR 撥款，我認為是 300 萬美元，用於通用流感疫苗計劃。您能談談它的現狀嗎？

Sure. This is a collaborative research program with the Cleveland Clinic, it's well underway. Although the goal of the program is to develop an IND-ready vaccine, that's probably three years away. Initial work is focused on developing formulations. And once we've completed this formulation work, we'll begin animal testing.

當然。這是與克利夫蘭診所的合作研究項目，目前正在順利進行中。儘管該計劃的目標是開發一種可用於 IND 的疫苗，但這可能還需要三年的時間。最初的工作重點是開發配方。一旦我們完成了這個配方工作，我們就會開始動物測試。

It's important to say that the program underscores the recognition of our technology with entities such as the NIH and our ability to create Thin Film Freezing formulations, which can be applied broadly, including in this program for universal off-the-shelf vaccine. And it's also a perfect example of the potential for additional non-dilutive financing.

重要的是，該計劃強調了 NIH 等實體對我們技術的認可，以及我們創造薄膜冷凍配方的能力，該配方可廣泛應用，包括在通用現成疫苗的計劃中。這也是額外非稀釋性融資潛力的完美例子。

Got you. Okay. Thanks, guys. Appreciate the update, that's all from me.

明白你了。好的。多謝你們。感謝更新，這都是我的。

Thank you. Thanks, Dan.

謝謝。謝謝，丹。

Thank you. There are no further questions at this time, I will now hand the call back to Harlan for closing remarks.

謝謝。目前沒有其他問題，我現在將把電話轉回給哈倫進行結束語。

Well, once again, I appreciate all the participants in today's call and hearing our update, particularly appreciate the support of our investors who have had faith in us, and we're looking forward to presenting the initial data from our clinical programs at the end of the year. Thank you and good evening.

好吧，我再次感謝今天電話會議的所有參與者並聽取了我們的最新消息，特別感謝對我們有信心的投資者的支持，我們期待著在最後展示我們臨床項目的初步數據今年的。謝謝你，晚上好。

Thank you. Ladies and gentlemen, the conference has now ended. Thank you all for joining, and you may all disconnect.

謝謝。女士們、先生們，會議現已結束。感謝大家的加入，大家可以斷開連線。