BioLine RX Ltd (BLRX) 2024 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by.

女士們先生們，謝謝你們的支持。

Welcome to the BioLineRx second quarter 2024 financial results conference call.

歡迎參加 BioLineRx 2024 年第二季財務業績電話會議。

(Operator Instructions) Following management's formal presentation, instructions will be given for the question-and-answer session.

（操作員指示）管理層正式介紹後，將給予問答環節的指示。

I would now like to hand the call over to John Lacey, Head of Investor Relations, and Corporate Communications.

我現在想將電話轉交給投資者關係和企業傳播主管約翰·萊西 (John Lacey)。

John, please go ahead.

約翰，請繼續。

Thank you, operator.

謝謝你，接線生。

Welcome, everyone.

歡迎大家。

Thank you for joining us on our second quarter 2024 results conference call.

感謝您參加我們的 2024 年第二季業績電話會議。

Earlier today, we issued a press release, a copy of which is available in the Investor Relations section of our website.

今天早些時候，我們發布了一份新聞稿，您可以在我們網站的投資者關係部分獲得該新聞稿的副本。

It was also filed as a 6-K.

它也被歸檔為 6-K。

I'd like to remind you that certain statements we make during the call will be forward-looking.

我想提醒您，我們在電話會議中所做的某些陳述將具有前瞻性。

Because such statements deal with future events, and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements.

由於此類陳述涉及未來事件，並受到許多風險和不確定性的影響，因此實際結果可能與前瞻性陳述中的結果有重大差異。

For a full discussion of these risks, and uncertainties, please review our annual report on Form 20-F and our quarterly reports on Form 6-K that are filed with the US Securities and Exchange Commission.

如需對這些風險和不確定性進行全面討論，請查看我們向美國證券交易委員會提交的 20-F 表格年度報告和 6-K 表格季度報告。

On the call today, we will have Phil Serlin, Chief Executive Officer of BioLineRx; Holly May, President of BioLineRx USA; and Mali Zeevi, our Chief Financial Officer; in addition, Ella Sorani, our Chief Development Officer, will be joining the call for Q&A.

在今天的電話會議上，我們將邀請 BioLineRx 執行長 Phil Serlin； Holly May，BioLineRx USA 總裁；和我們的財務長 Mali Zeevi；此外，我們的首席開發長 Ella Sorani 將參加問答活動。

At this time, it is now my pleasure to turn the call over to Phil.

此時此刻，我很高興將電話轉給菲爾。

Thank you, John, and good morning, everyone, and thank you for joining us on today's call.

謝謝約翰，大家早安，謝謝您參加今天的電話會議。

Following our strong second quarter 2024 performance and the encouraging progress of APHEXDA to launch to date.

繼我們 2024 年第二季的強勁業績以及 APHEXDA 迄今為止推出的令人鼓舞的進展之後。

I wanted to highlight that today's BioLineRx is a fully integrated leader in stem cell mobilization with promising label expand opportunities.

我想強調的是，今天的 BioLineRx 是乾細胞動員領域完全整合的領導者，具有前景廣闊的標籤擴展機會。

This is a stark change from last year, and we are well positioned to deliver value to all of our stakeholders.

與去年相比，這是一個明顯的變化，我們有能力為所有利害關係人創造價值。

I will begin with a brief update on the important progress that we are making on our APHEXDA launch then turn the call over to Holly who'll go into our commercialization and life cycle management progress in more detail.

我將首先簡要介紹我們在 APHEXDA 發布方面所取得的重要進展，然後將電話轉給 Holly，她將更詳細地介紹我們的商業化和生命週期管理進展。

Mali will review our financial results, and then I will give a brief summary of our upcoming milestones.

馬裡將審查我們的財務業績，然後我將簡要總結我們即將實現的里程碑。

We will then open up all for your questions.

然後我們將開放所有問題來解答您的問題。

Let me begin with an effect to commercialization update.

讓我從商業化更新的影響開始。

Last quarter, we set an important goal.

上個季度，我們設定了一個重要目標。

We said that among our targeted top 80 transplant centers, by the end of the second quarter, we would secure formulary placement at institutions managing 35% of stem cell transplant procedures.

我們表示，在我們的目標前 80 家移植中心中，到第二季末，我們將確保在管理 35% 幹細胞移植手術的機構中進行處方安置。

And I'm happy to say that we surpassed this goal by June 30, with formulary placement at institutions managing 37% of transplant procedures.

我很高興地說，到 6 月 30 日，我們已經超越了這一目標，在管理 37% 移植手術的機構中進行了處方安排。

We continue to make steady progress on this most important launch metric and remain on track to achieve our year-end target of 60%.

我們繼續在這項最重要的發布指標上取得穩步進展，並繼續實現 60% 的年終目標。

Additionally, last quarter, we achieved formulary status at two of the largest transplant centers in the US, and we also doubled the number of centers ordering product.

此外，上個季度，我們在美國最大的兩家移植中心獲得了處方地位，訂購產品的中心數量也增加了一倍。

We are pleased with this continued positive momentum in only the second full quarter of our commercialization program.

我們對商業化計劃第二個完整季度的持續積極勢頭感到高興。

Each week, we learn about patients who have failed to collect enough stem cells on other mobilization agents putting their path to transplant at risk.

每週，我們都會了解到一些患者未能透過其他動員劑收集足夠的幹細胞，使他們的移植之路面臨風險。

These patients were then given APHEXDA and they achieved their stem cell mobilization goals, many in a single apheresis session.

然後，這些患者接受了 APHEXDA，他們實現了乾細胞動員目標，其中許多是在單次血漿分離術中實現的。

Transplant centers are seeing the tremendous efficacy that APHEXDA can provide in this new era for multiple myeloma patients, where patients more often are older and increasingly received quad induction therapy which can increase mobilization risk.

移植中心看到了 APHEXDA 在這個新時代為多發性骨髓瘤患者提供的巨大功效，這些患者通常年齡較大，並且越來越多地接受四聯誘導治療，這可能會增加動員風險。

In July, the FDA granted approval of an important quad therapy approach for transplant eligible, newly diagnosed multiple myeloma patients, including daratumumab and lenalidomide which can negatively impact stem cell yields.

7 月，FDA 批准了一種重要的四聯療法，適用於符合移植條件的新診斷多發性骨髓瘤患者，其中包括達雷妥尤單抗和來那度胺，這兩種療法可能會對幹細胞產量產生負面影響。

The approval was based on the tremendous efficacy results seen in the perseus trial, which compared the quad therapy to the leading triple therapy.

此次批准是基於 Perseus 試驗中所見的巨大療效結果，該試驗將四聯療法與領先的三聯療法進行了比較。

The quad therapy lowered the risk of disease progression or death by 60%.

四聯療法將疾病進展或死亡的風險降低了 60%。

Physicians have been treating patients with quad therapies prior to this approval.

在此批准之前，醫生一直在使用四聯療法治療患者。

However, we believe that the data from this trial and the subsequent FDA approval will accelerate the process of quad therapy becoming the new standard of care, which, while beneficial to patients has the potential to further increase the need for APHEXDA.

然而，我們相信，該試驗的數據以及隨後 FDA 的批准將加速四聯療法成為新護理標準的進程，雖然對患者有益，但有可能進一步增加對 APHEXDA 的需求。

Our team is excited to be introducing a new standard of care for the mobilization of stem cells for multiple myeloma in this new era of care for patients.

我們的團隊很高興能夠在這個患者護理的新時代引入一種新的多發性骨髓瘤幹細胞動員護理標準。

At this point, I'd like to turn the call over to Holly May, President of BioLineRx US, to discuss our commercialization efforts and some of our life cycle management initiatives.

此時，我想將電話轉給 BioLineRx US 總裁 Holly May，討論我們的商業化工作和一些生命週期管理舉措。

Holly, please go ahead.

霍莉，請繼續。

Thank you, Phil.

謝謝你，菲爾。

Last quarter, I discussed APHEXDA benefits on center efficiency and economics, and in conversations with transplant center key decision-makers, including physicians, pharmacists and apheresis unit Managing Directors.

上個季度，我在與移植中心關鍵決策者（包括醫生、藥劑師和單採術部門董事總經理）的對話中討論了 APHEXDA 對中心效率和經濟效益的好處。

These two factors continue to be a significant determinant in transplant center formulary adoption.

這兩個因素仍然是移植中心處方採用的重要決定因素。

We launched effect into a mobilization agent market that included generic plerixafor which had just entered generic status a few months before our approval.

我們向動員劑市場發起了影響，其中包括仿製藥 Plerixafor，該藥物在我們批准前幾個月才剛進入仿製藥狀態。

At the same time, transplant centers were realizing the impact that new induction therapy approaches have on stem cell collection yields.

同時，移植中心意識到新的誘導治療方法對幹細胞收集產量的影響。

These factors quite naturally created many questions for centers, centers that have, for many years, had long-standing protocols.

這些因素自然地為中心帶來了許多問題，這些中心多年來一直有長期的協議。

It is within this changing landscape that institutions have also come to understand effective innovative benefits for patients and are actively studying how our product can benefit their center and members of our field force are supporting them in this effort with our efficiency modeling tools.

正是在這種不斷變化的環境中，各機構也開始了解為患者帶來的有效創新益處，並正在積極研究我們的產品如何使他們的中心受益，我們的現場人員正在使用我們的效率建模工具支持他們的這項努力。

Additionally, we are publishing important health economic data and continues to work on additional research.

此外，我們正在發布重要的健康經濟數據，並繼續進行更多研究。

Our health economic presentations in April at the American Society for Apheresis Annual Meeting and at the International Society for Pharmacoeconomics and Outcomes Research demonstrated the economic advantages for centers using G-CSF plus APHEXDA over G-CSF alone or G-CSF plus plerixafor.

我們四月在美國單採協會年會和國際藥物經濟學和結果研究學會上的健康經濟學演講展示了使用G-CSF 加APHEXDA 的中心相對於單獨使用G-CSF 或G-CSF 加普樂沙福的經濟優勢。

Given the efficacy, efficiency and economic benefits that APHEXDA provides, we believe that key decision-makers will continue to move toward our best in class mobilizer.

鑑於 APHEXDA 提供的功效、效率和經濟效益，我們相信關鍵決策者將繼續向我們一流的動員者邁進。

Let me transition now to our life cycle management efforts.

現在讓我談談我們的生命週期管理工作。

Our vision is to maximize the potential of APHEXDA in its current indication and to expand into key areas with high unmet need.

我們的願景是最大限度地發揮 APHEXDA 在當前適應症中的潛力，並擴展到需求未被滿足的關鍵領域。

There is significant interest by independent investigators to evaluate APHEXDA across a number of areas associated with myeloma, including mobilization studies in patients treated with quad therapies or for post-CAR T cytopenia management.

獨立研究人員對評估 APHEXDA 在與骨髓瘤相關的多個領域表現出濃厚的興趣，包括對接受四聯療法治療或 CAR T 後血球減少症管理的患者進行的動員研究。

We are also actively speaking with physician researchers across a number of additional disease states that have high unmet need in the area of stem cell mobilization.

我們也積極與許多其他疾病狀態的醫生研究人員進行對話，這些疾病狀態在幹細胞動員領域有很高的未滿足需求。

One critical area that continues to make progress is evaluating APHEXDA stem cell mobilization potential in patients with sickle cell disease undergoing gene therapy.

持續取得進展的關鍵領域是評估接受基因治療的鐮狀細胞疾病患者的 APHEXDA 幹細胞動員潛力。

This type of gene therapy is an area where I have significant experience based on my prior roles.

根據我之前的角色，我在這種類型的基因治療領域擁有豐富的經驗。

The two currently approved gene therapies for sickle cell disease require significant quantities of stem cells to produce the therapies.

目前核准的兩種鐮狀細胞疾病基因療法需要大量的幹細胞來產生療法。

And in speaking with leaders in the field using a mobilization agent that could speed the collection process would be a great advantage for patients.

在與該領域的領導者交談時，使用可以加快收集過程的動員劑對患者來說將是一個巨大的優勢。

Our two ongoing sickle cell disease Phase 1 investigator-initiated studies with Washington University in St. Louis and St.

我們與聖路易斯華盛頓大學和聖路易斯華盛頓大學正在進行兩項正在進行的鐮狀細胞疾病第一階段研究。

Jude's Children's Research Hospital in Memphis, were designed by significant key opinion leaders in this research area.

位於孟菲斯的聖裘德兒童研究醫院是由該研究領域的重要意見領袖設計的。

We anticipate early data from the Washington collaboration in the second half of this year and the first patient dosed in the St. Jude study in September.

我們預計今年下半年來自華盛頓合作的早期數據以及 9 月聖裘德研究中第一位患者接受給藥的數據。

Overall, in the next 12 months, we anticipate several independent investigators to initiate studies that will provide BioLine with critical data and insights to aid our ongoing life cycle management efforts.

總體而言，在接下來的 12 個月內，我們預計幾位獨立研究人員將啟動研究，為 BioLine 提供關鍵數據和見解，以幫助我們正在進行的生命週期管理工作。

Now let me turn the call over to Mali to provide a financial update.

現在讓我把電話轉給馬裡，提供最新的財務資訊。

Thank you, Holly.

謝謝你，霍莉。

As is our practice, I will only go over the most significant items in our financial statements.

按照我們的慣例，我只會討論我們財務報表中最重要的項目。

Revenues, cost of revenues research and development expenses, sales and marketing expenses, net profit and cash.

收入、收入成本、研發費用、銷售和行銷費用、淨利和現金。

I invite you to review the filings we made this morning, which contain our financials and press release.

我邀請您查看我們今天早上提交的文件，其中包含我們的財務數據和新聞稿。

Total revenue for the three months ended June 30, 2024, was $5.4 million.

截至 2024 年 6 月 30 日的三個月總收入為 540 萬美元。

We did not record any revenue during the second quarter of 2023.

我們在 2023 年第二季沒有記錄任何收入。

Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.6 million as well as $1.8 million of net revenue from product sales of APHEXDA in the US Cost of revenue for the three months ended June 30, 2024, was $0.9 million.

本季營收反映了 Gloria Biosciences 授權預付款的一部分，金額為 360 萬美元，以及 APHEXDA 在美國產品銷售的淨收入 180 萬美元 截至 2024 年 6 月 30 日止三個月的收入成本，為90 萬美元。

We did not record any cost of revenue during the second quarter of 2023.

我們在 2023 年第二季沒有記錄任何收入成本。

Cost of revenue for the quarter primarily reflects the amortization of intangible assets royalties on net product sales of APHEXDA in the US and cost of goods sold on product sales.

本季的收入成本主要反映了 APHEXDA 在美國產品淨銷售中的無形資產特許權使用費攤銷以及產品銷售中的銷售成本。

Research and development expenses for the three months ended June 30, 2024, were $2.2 million compared to $3 million for the same period in 2023.

截至 2024 年 6 月 30 日止三個月的研發費用為 220 萬美元，而 2023 年同期為 300 萬美元。

The decrease resulted primarily from lower expenses related to motixafortide activities the termination of the development of AGI-134 and the decrease in share-based compensation.

這一減少主要是由於與 motixafortide 活動相關的費用減少、AGI-134 開發的終止以及股權激勵的減少。

Sales and marketing expenses for the three months ended June 30, 2024, were $6.4 million compared to $5.6 million for the same period in 2023.

截至 2024 年 6 月 30 日止三個月的銷售和行銷費用為 640 萬美元，而 2023 年同期為 560 萬美元。

The increase resulted primarily from the ramp-up in head count costs associated with fully hired field team.

這一增長主要是由於與滿員現場團隊相關的人員編製成本增加所致。

Net income for the three months ended June 30, 2024, was $0.5 million compared to a net loss of $18.5 million for the same period in 2023.

截至 2024 年 6 月 30 日的三個月淨利為 50 萬美元，而 2023 年同期淨虧損為 1,850 萬美元。

The net income for the 2024 period included $7.8 million in nonoperating income compared to nonoperating expenses of $7.7 million for the same period in 2023, both mainly related to the noncash revaluation of warrants.

2024 年期間的淨利潤包括 780 萬美元的營業外收入，而 2023 年同期的營業外支出為 770 萬美元，兩者主要與認股權證的非現金重估有關。

As of June 30, 2024, the company had cash, cash equivalents and short-term bank deposits of $40.1 million.

截至2024年6月30日，該公司擁有現金、現金等價物及短期銀行存款4,010萬美元。

The company anticipates that this amount will be sufficient to fund operations as currently planned into 2025.

該公司預計這筆資金將足以為目前計劃到 2025 年的營運提供資金。

And with that, I'll turn the call over to Phil.

然後，我會將電話轉給菲爾。

Thank you, Mali.

謝謝你，馬裡。

In closing, as is our custom, I would like to take a few moments to summarize our upcoming milestones.

最後，按照我們的慣例，我想花一些時間總結我們即將到來的里程碑。

We anticipate first patient dosed in the St Jude sickle cell disease gene therapy Phase 1 trial in September.

我們預計 9 月將在聖裘德鐮狀細胞疾病基因治療第一期試驗中對第一位患者進行給藥。

The Phase 1 clinical trial is an open-label multicenter study evaluating the safety, tolerability and feasibility of single-agent motixafortide for the mobilization and collection of CD34-plus hematopoietic stem cells in 12 patients, aged 18 and older with sickle cell disease.

1 期臨床試驗是一項開放標籤多中心研究，評估單藥 motixafortide 在 12 名 18 歲及以上鐮狀細胞病患者中動員和收集 CD34+ 造血幹細胞的安全性、耐受性和可行性。

We anticipate the initiation of the bridging study by collaboration partner, Gloria Biosciences to support approval of APHEXDA in stem cell mobilization for multiple myeloma in China in the second half of this year.

我們預計合作夥伴 Gloria Biosciences 將在今年下半年啟動橋接研究，以支持 APHEXDA 在中國用於多發性骨髓瘤幹細胞動員的批准。

Also in the second half of this year, as Holly mentioned, we anticipate a presentation on early data from the wash use sickle cell disease gene therapy Phase 1 trial, evaluating motixafortide as a monotherapy and in combination with natalizumab for stem cell mobilization.

同樣在今年下半年，正如 Holly 所提到的，我們預計將介紹洗滌使用鐮狀細胞病基因治療 1 期試驗的早期數據，評估 motixafortide 作為單一療法以及與那他珠單抗聯合用於幹細胞動員。

Additionally, working with Gloria Bio, we completed the study design of the Phase 2b combination study evaluating motixafortide in first-line pancreatic cancer.

此外，我們與 Gloria Bio 合作，完成了評估 motixafortide 在一線胰腺癌中的 2b 期聯合研究的研究設計。

We anticipate that Gloria will submit the study designed for regulatory review in 2024 with the study initiating in 2025.

我們預計 Gloria 將在 2024 年提交旨在進行監管審查的研究，並於 2025 年啟動研究。

Finally, we continue recruitment in the CheMo4METPANC IIb randomized clinical trial in first-line metastatic pancreatic cancer sponsored by Columbia University and in partnership with regeneron.

最後，我們繼續招募哥倫比亞大學贊助並與再生元合作的 CheMo4METPANC IIb 一線轉移性胰腺癌隨機臨床試驗。

We anticipate that this trial, which had very encouraging pilot phase data published at ASCO this quarter will be fully enrolled by 2027.

我們預計該試驗將於 2027 年全部入組，該試驗本季在 ASCO 上發布了非常令人鼓舞的試驗階段數據。

With that, we have now concluded the formal part of our presentation.

至此，我們現在結束了演示的正式部分。

Operator, we will now open the call up for questions.

接線員，我們現在開始提問。

(Operator Instructions) John Vandermosten, Zacks.

（操作員說明）John Vandermosten，Zacks。

Great.

偉大的。

Thank you.

謝謝。

So the summer is usually known to have kind of negative seasonal effects for both, I guess, therapy use and with hospital staff, especially in academic settings.

因此，我認為夏季通常會對治療使用和醫院工作人員產生負面的季節性影響，尤其是在學術環境中。

And I'm wondering if you could comment on how you expect seasonally the effort to go with sales of APHEXDA.

我想知道您是否可以評論一下您對 APHEXDA 銷售的季節性努力的預期。

Do you anticipate a strong pickup activity in September?

您預計 9 月的提貨活動會強勁嗎？

And was this summer, I guess it's not over yet, but I guess was this summer as you had expected?

今年夏天是嗎，我想還沒結束，但我想今年夏天是你所期望的嗎？

Yes.

是的。

So John, good morning, and thanks for the question and joining the call.

約翰，早安，感謝您提出問題並加入通話。

So I'll turn it over to Holly in a moment.

所以我一會兒就把它交給霍莉。

But our results are through June 30.

但我們的結果截至 6 月 30 日。

So we're talking now about the second quarter, which is really the spring.

所以我們現在談論的是第二季度，這實際上是春天。

I would like to, again, mention that we doubled our sales in Q2 from Q1.

我想再次提及，我們第二季的銷售額比第一季翻了一番。

And so I'm not sure the results at this point really reflect any kind of slowdown seasonal slowdown in the summer.

因此，我不確定目前的結果是否真的反映了夏季季節性放緩的任何形式。

We're looking things are looking very, very good at the moment.

我們認為目前情況看起來非常非常好。

I'll let Holly expand on that, if she'd like.

如果霍莉願意的話，我會讓她進一步闡述這一點。

Yes.

是的。

Thanks, Phil, and good morning John.

謝謝，菲爾，早安，約翰。

So we have actually analyzed some of the seasonality on a month-to-month basis. because this is indicated for multiple myeloma, and it's very dependent on patients needing to get timely transplants.

因此，我們實際上按月分析了一些季節性。因為這適用於多發性骨髓瘤，並且非常依賴需要及時移植的患者。

We don't necessarily see those same kind of seasonality effects with a product like APHEXDA as you may with others.

我們不一定會像 APHEXDA 這樣的產品看到與其他產品相同的季節性影響。

That's a very general answer, but that is not something that we are terribly concerned about and have huge downturns built into any kind of forecasting for that reason.

這是一個非常籠統的答案，但這並不是我們非常擔心的事情，並且因此而在任何類型的預測中都考慮到了巨大的衰退。

Does that answer your question?

這能回答你的問題嗎？

Yes, it does.

是的，確實如此。

And how would you characterize the reorder rate?

您如何描述再訂購率？

It seems like based on kind of a top-down view that it's fairly good.

從自上而下的角度來看，它似乎相當不錯。

Would you characterize it that way as well?

您也會這樣描述它嗎？

Holly, you want to take that?

荷莉，你想要那個嗎？

Yes, I would love to.

是的，我很樂意。

So yes, so once I think we've spoken about this before.

所以是的，所以我想我們之前已經討論過這個問題了。

Once a product is on formulary, that's the biggest hurdle to begin utilization adoption and utilization and an uptake in sales.

一旦產品進入處方集，這就是開始使用、使用和銷售的最大障礙。

And so our field teams are continuing to do both things to onboard institutions that have approved us for formulary through their P&T.

因此，我們的現場團隊正在繼續為那些透過其 P&T 批准我們進入處方集的機構做這兩件事。

So that is a significant part of future growth as well as then working on institutions where we already have formulary acceptance and continuing to do selling efforts in those hospitals to increase the quantities where we are on formulary.

因此，這是未來成長的重要組成部分，也是我們在已經獲得處方接受的機構上開展工作的重要組成部分，並繼續在這些醫院進行銷售工作，以增加我們在處方中的數量。

So the team very early on, the field teams very early on were singularly focused on assuring the readiness of P&T committees to put us on formulary.

因此，團隊很早就、現場團隊很早就特別專注於確保 P&T 委員會準備好將我們納入處方集。

That work continues, but now we are also looking at selling efforts in those institutions that have us on formulary to increase there.

這項工作仍在繼續，但現在我們也在考慮那些讓我們在處方上增加的機構的銷售努力。

So we see revenues from both sources, new accounts and existing accounts as we move throughout the year.

因此，隨著我們全年的變化，我們會看到來自新帳戶和現有帳戶這兩個來源的收入。

Okay.

好的。

And final question on sickle cell and gene therapy.

最後一個問題是關於鐮狀細胞和基因療法。

I guess I guess I was surprised to see two studies in the same gene therapy indication.

我想我很驚訝地看到兩項針對同一基因治療適應症的研究。

And I guess I guess that's because of all that you had maybe you can tell me why that is.

我想我想那是因為你擁有的一切也許你可以告訴我為什麼會這樣。

And then are there any other gene therapy indications that would also be kind of the next a place to go for using metrics are for time to collect the proper number of cells?

那麼是否有其他基因治療適應症也可能是下一個使用指標來衡量收集適當數量細胞的時間的地方？

Yes.

是的。

So let me ask Ella, maybe you can talk about the differences between the two studies a little bit.

那麼讓我問 Ella，也許你可以稍微談談這兩項研究之間的差異。

Yes.

是的。

I'm sorry, but the design of the St. Jude study is not I don't think that we have disclosed it yet.

抱歉，聖裘德研究的設計不是我認為我們還沒有披露。

The design there is a difference between the two studies in terms of

兩項研究的設計存在差異

-- (multiple speakers)

——（多位發言者）

Yes.

是的。

I guess you're right.

我想你是對的。

Yes, perhaps you can't disclose that yet.

是的，也許你還不能透露這一點。

I mean are there different they're I'm wondering if I just don't remember whether we've disclosed that.

我的意思是它們有什麼不同嗎？

You're sure we haven't disclosed it?

你確定我們沒有透露過嗎？

Yes.

是的。

So John, I'm sorry about that.

所以約翰，我對此感到抱歉。

There are differences in the studies based on whether there are single administrations or multiple administrations and the size of the studies but I don't think, like as Ellen said, I don't think that we've spoken about the design yet.

根據是否有單次給藥或多次給藥以及研究的規模，研究存在差異，但我不認為，就像艾倫所說，我認為我們還沒有談論過設計。

There are publication and embargoes and those kind of things that we can't really discuss it at this point.

有出版和禁運以及諸如此類的事情我們目前無法真正討論。

I apologize.

我道歉。

Okay.

好的。

Well then and then I guess you know whether any other kind of gene therapy indications that would be equally of interest from sponsors to use metrics before tied to collect enough ourselves?

好吧，然後我想你知道是否有任何其他類型的基因治療適應症會引起贊助商同樣的興趣，在我們自己收集足夠的數據之前使用指標？

Because I assume that's why the sickle cell was chosen because compared to others, they just need more cells.

因為我認為這就是選擇鐮狀細胞的原因，因為與其他細胞相比，它們只需要更多的細胞。

Yes.

是的。

Well, it's more complicated than that.

嗯，事情比這更複雜。

I mean, I'll turn it over to Holly, but I'll just say one of the reasons why mobilization is so difficult in sickle cell patients is because the underlying mobilization agent G-CSF is contraindicated in sickle cell patients.

我的意思是，我會把它交給 Holly，但我只想說鐮狀細胞患者的動員如此困難的原因之一是因為鐮狀細胞患者禁用潛在的動員劑 G-CSF。

And therefore, they can only get what you'd call in air quotes, a booster, plerixafor or like APHEXDA.

因此，他們只能得到你所說的空氣報價、助推器、普樂沙福或 APHEXDA 之類的東西。

So they can't get the underlying G-CSF, which is given to patients like multiple myeloma before they're given booster agent, so to speak.

因此，他們無法獲得潛在的 G-CSF，可以這麼說，多發性骨髓瘤等患者在接受加強劑之前會獲得 G-CSF。

So that's one of the main reasons why this is an area that is extreme that has a clear unmet medical need in mobilization.

因此，這就是為什麼這是一個極端的領域，其動員醫療需求明顯未被滿足的主要原因之一。

But Holly, if you'd like to expand on that, please feel free.

但是霍莉，如果您想對此進行擴展，請隨意。

Yes, I'm happy to talk about that a little bit.

是的，我很高興能談一下這個問題。

So there are different types of gene therapy, some like AV therapy that do not require hematopoietic stem cells and others, like the sickle cell approved therapies right now by Bluebird and Vertex that do require stem cells in order to complete the gene therapy.

因此，基因療法有不同類型，有些像 AV 療法不需要造血幹細胞，而有些則像目前由 Bluebird 和 Vertex 批准的鐮狀細胞療法，需要幹細胞才能完成基因療法。

And so certainly, sickle cell based on the things that Phil just said is the ideal place to begin using a product like APHEXDA for the mobilization of stem cells to complete that type of gene therapy.

因此，可以肯定的是，基於菲爾剛才所說的東西的鐮狀細胞是開始使用 APHEXDA 這樣的產品來動員幹細胞來完成此類基因治療的理想場所。

But we do see that there could be other types of gene therapies that do require CD34 stem cells, which could very easily benefit from APHEXDA in the future.

但我們確實看到可能有其他類型的基因療法確實需要 CD34 幹細胞，這在未來很容易從 APHEXDA 中受益。

But currently, we are focused on generating the data in sickle cell because of the high unmet.

但目前，由於未滿足的條件很高，我們專注於產生鐮狀細胞中的數據。

Understood.

明白了。

Thank you, Holly.

謝謝你，霍莉。

Yes, thanks, John.

是的，謝謝，約翰。

(Operator Instructions) John Vandermosten, Zacks.

（操作員說明）John Vandermosten，Zacks。

Great.

偉大的。

Thanks for allowing me a follow-up.

感謝您允許我跟進。

Have there been any inquiries from investigators for use that APHEXDA outside of multiple myeloma, expanding more into some other leukemias?

研究人員是否詢問過在多發性骨髓瘤之外使用 APHEXDA，並將其擴展到其他一些白血病？

As Holly mentioned, and I think I'll let her expand on it a little bit.

正如霍莉所提到的，我想我會讓她稍微擴展一下。

We have a number of requests from investigators to perform investigate initiated studies in potentially different indications, et cetera?

我們收到了許多研究人員的請求，要求對潛在的不同適應症進行調查啟動的研究，等等？

Holly, do you maybe want to expand on that a little bit?

荷莉，你想擴展一下嗎？

Yes.

是的。

I guess I'm looking for some guidance here as sort of what I can and can't say.

我想我正在這裡尋找一些指導，例如我能說什麼和不能說什麼。

Some we are in the process of these ISS.

有些我們正在國際太空站的進程中。

We are in the process of signing for what I would call kind of indication enhancing data and other investigators are very interested in other areas of study and investigation where mobilization of stem cells is required.

我們正在簽署我所說的指示增強數據，其他研究人員對需要動員幹細胞的其他研究和調查領域非常感興趣。

So I think the easiest way to say this is we have a very active IFS program that we have launched here since that we have initiated since launch, and we continue to review all of those proposals, but there does seem to be a lot of interest in motixafortide to be studied in areas to improve on things like multiple myeloma and then in other indications as well.

所以我認為最簡單的說法是我們有一個非常活躍的 IFS 計劃，我們自啟動以來就在這裡啟動了該計劃，並且我們繼續審查所有這些提案，但似乎確實有很多興趣motixafortide 將在改善多發性骨髓瘤等領域進行研究，然後也在其他適應症中進行研究。

Okay, great.

好的，太好了。

Thank you.

謝謝。

Thanks, John.

謝謝，約翰。

There are no further questions at this time.

目前沒有其他問題。

Before I ask Mr. Phil Serlin to go ahead with his closing statement, I would like to remind participants that a replay of this call is scheduled to begin two hours after the conference.

在我請 Phil Serlin 先生繼續他的結束語之前，我想提醒與會者，本次電話會議的重播計劃在會議結束後兩小時開始。

In the US, please call 1-888-295-2634.

在美國，請致電 1-888-295-2634。

In Israel, please call 03-925-5904.

在以色列，請致電 03-925-5904。

Internationally, please call 972-3-925-5904.

國際請致電 972-3-925-5904。

Mr. Serlin, would you like to make your concluding statement?

Serlin先生，您願意做一下總結發言嗎？

Yes, I would.

是的，我會的。

Thank you, operator.

謝謝你，接線生。

In closing, we are progressing through 2024 with significant momentum both with the ongoing commercial ramp-up of APHEXDA as well as the advancement of our development programs in sickle cell disease and pancreatic cancer.

最後，隨著 APHEXDA 的持續商業化以及鐮狀細胞疾病和胰腺癌開發項目的進展，我們將在 2024 年以強勁的勢頭向前邁進。

I'm excited to what we are poised to accomplish over the remainder of the year and next.

我對我們將在今年剩餘時間和明年完成的工作感到興奮。

Thank you all very much for your continued interest in BioLineRx.

非常感謝大家對 BioLineRx 的持續關注。

We look forward to providing our next comprehensive quarterly update in November.

我們期待在 11 月提供下一次全面的季度更新。

Be safe, and have a good day.

注意安全，祝你有美好的一天。

This concludes BioLineRx second quarter 2024 conference call.

BioLineRx 2024 年第二季電話會議到此結束。

Thank you for your participation.

感謝您的參與。

You may now go ahead and disconnect.

您現在可以繼續並斷開連接。