BioLine RX Ltd (BLRX) 2024 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx third-quarter 2024 financial results conference call. (Operator Instructions)

女士們先生們，謝謝你們的支持。歡迎參加 BioLineRx 2024 年第三季財務業績電話會議。（操作員說明）

I would now like to turn over the call to John Lacey, Head of Investor Relations and Corporate Communications. John, please go ahead.

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

Thank you, operator. Welcome, everyone. Thank you for joining us on our third quarter 2024 results conference call. Earlier today, we issued a press release, a copy of which is available in the Investor Relations section of our website. It was also filed as a 6-K.

謝謝你，接線生。歡迎大家。感謝您參加我們的 2024 年第三季業績電話會議。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。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. 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. 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.

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。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。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。

At this time, it is now my pleasure to turn the call over to Mr. Phil Serlin, Chief Executive Officer of BioLineRx.

此時此刻，我很高興將電話轉給 BioLineRx 執行長 Phil Serlin 先生。

Thank you, John, and good morning, everyone, and thank you for joining us on today's call. I'll begin this morning with a recap of the significant licensing agreement that we announced last week with Ayrmid Ltd., followed by a review of our third-quarter performance. And then Mali Zeevi, our Chief Financial Officer, will briefly recap our financials. Afterwards, we will take your questions. Ella Sorani, our Chief Development Officer, is also available for Q&A.

謝謝約翰，大家早安，謝謝您參加今天的電話會議。今天上午，我將首先回顧我們上週與 Ayrmid Ltd. 宣布的重要許可協議，然後回顧我們第三季度的業績。然後我們的財務長 Mali Zeevi 將簡要回顧我們的財務狀況。之後，我們將回答您的問題。我們的首席開發長 Ella Sorani 也可以參加問答。

Last week, we announced that we executed an exclusive license agreement with Ayrmid Ltd., the parent company of Gamida Cell Ltd., for motixafortide, which is sold in the US under the brand name APHEXDA. Recall that APHEXDA is our FDA-approved and commercially available stem cell mobilization agent indicated in combination with G-CSF for the collection and subsequent autologous transplantation in patients with multiple myeloma.

上週，我們宣布與 Gamida Cell Ltd. 的母公司 Ayrmid Ltd. 簽署了 motixafortide 的獨家許可協議，該藥物在美國以 APHEXDA 品牌銷售。回想一下，APHEXDA 是我們 FDA 批准的市售幹細胞動員劑，可與 G-CSF 聯合用於多發性骨髓瘤患者的收集和隨後的自體移植。

The agreement covers all indications with the notable exception of solid tumors like pancreatic ductal carcinoma, or PDAC, and all territories with the exception of Asia, where we previously entered into a license agreement with Gloria Biosciences for motixafortide in that region. This transaction is very beneficial for BioLineRx, with a $10 million upfront payment, $87 million of potential commercial milestones, and very healthy royalties of between 18% and 23%.

該協議涵蓋了除胰腺導管癌（PDAC）等實體瘤之外的所有適應症，以及除亞洲以外的所有地區，我們之前與 Gloria Biosciences 在該地區簽署了 motixafortide 的許可協議。這筆交易對 BioLineRx 來說非常有利，預付款為 1000 萬美元，潛在商業里程碑價值為 8700 萬美元，特許權使用費非常健康，介於 18% 至 23% 之間。

In addition, we received another $9 million in the form of an equity investment from Highbridge Capital. This aggregate cash influx has enabled the company to finalize an agreement with BlackRock to repay a significant portion of its outstanding debt and restructure the remaining debt on favorable terms. With the transfer of our commercial program to Ayrmid Gamida Cell, we have also reduced our cash burn in a very substantial manner, with our cash runway now extending into 2026. And I will provide more financial details about this shortly.

此外，我們還獲得了 Highbridge Capital 的 900 萬美元股權投資。這一總現金流入使該公司能夠與貝萊德敲定協議，償還其未償債務的很大一部分，並以優惠條件重組剩餘債務。隨著我們的商業計劃轉移到 Ayrmid Gamida Cell，我們也大幅減少了現金消耗，我們的現金跑道現已延長至 2026 年。我將很快提供更多有關此事的財務細節。

Lastly, the agreement allows us to return to our drug development roots, with a streamlined organization that has a proven track record in clinical development and regulatory affairs. To that end, we will continue to support development of motixafortide in metastatic pancreatic cancer through our existing collaborations, which have the potential to create near-term value for shareholders. Over the next year, we also plan to evaluate early-stage clinical assets in the areas of oncology and rare disease, where we think we can leverage our expertise in complex drug development and create long-term shareholder value.

最後，該協議使我們能夠回歸藥物開發根源，建立一個在臨床開發和監管事務方面擁有良好記錄的精簡組織。為此，我們將透過現有的合作繼續支持莫替沙福肽治療轉移性胰臟癌的開發，這些合作有可能為股東創造短期價值。明年，我們還計劃評估腫瘤學和罕見疾病領域的早期臨床資產，我們認為我們可以利用我們在複雜藥物開發方面的專業知識並創造長期股東價值。

We believe the choice of Gamida Cell as our commercial partner is a fortuitous one. Gamida Cell adds a highly differentiated mobilization agent in APHEXDA to a commercial portfolio that already includes OMISIRGE, the first and only FDA-approved NAM-modified cell therapy for patients with hematologic malignancies in need of an allogeneic hematopoietic cell transplant.

我們相信選擇 Gamida Cell 作為我們的商業合作夥伴是一個偶然。Gamida Cell 將APHEXDA 中的高度差異化動員劑添加到商業產品組合中，該產品組合已包括OMISIRGE，這是FDA 批准的第一個也是唯一一個經NAM 修飾的細胞療法，用於治療需要同種異體造血細胞移植的血液惡性腫瘤患者。

We envision Gamida Cell meaningfully growing APHEXDA sales by leveraging its portfolio for improved access to its transplant center customers. As part of this transaction, Gamida Cell is seeking to transition a significant number of former members of the BioLineRx commercial team who have been so instrumental in the early commercial success of APHEXDA, driving penetration to over 40% of our target centers and capturing 10% of the market at the end of Q3.

我們預計 Gamida Cell 透過利用其產品組合來改善接觸移植中心客戶的機會，從而有意義地增加 APHEXDA 銷售。作為本次交易的一部分，Gamida Cell 正在尋求對BioLineRx 商業團隊的大量前成員進行過渡，他們在APHEXDA 的早期商業成功中發揮了重要作用，推動滲透到我們超過40% 的目標中心，並佔領了10 %第三季末的市場。

In addition, recall that APHEXDA is also being evaluated in patients with sickle cell disease undergoing gene therapy, with two Phase I investigator-initiated trials ongoing, one at Washington University in St. Louis and the other St. Jude Children's Research Hospital. We view this as another opportunity for long-term value creation.

此外，APHEXDA 也正在接受基因治療的鐮狀細胞疾病患者中進行評估，兩項 I 期研究者發起的試驗正在進行中，一項在聖路易斯華盛頓大學，另一項在聖裘德兒童研究醫院進行。我們認為這是創造長期價值的另一個機會。

Quickly reviewing the terms of the agreement. In exchange for the license, we received a $10 million upfront payment. We also are eligible to receive up to an additional $87 million of potential commercial milestones, plus royalties on net sales of APHEXDA ranging from 18% to 23%.

快速查看協議條款。作為許可證的交換，我們收到了 1000 萬美元的預付款。我們還有資格獲得高達 8,700 萬美元的額外潛在商業里程碑，以及 APHEXDA 淨銷售額 18% 至 23% 的特許權使用費。

We will also supply motixafortide on a cost-plus basis both for commercial and development supply. In addition, certain funds managed by Highbridge Capital Management have made a $9 million equity investment in BioLineRx. This equity investment and the combined future potential commercial milestones from licensing agreements with Ayrmid and Gloria Biosciences as well as royalties on net sales are expected to provide a strong foundation for our company.

我們也將在成本加成的基礎上為商業和開發供應提供 motixafortide。此外，Highbridge Capital Management 管理的某些基金已對 BioLineRx 進行了 900 萬美元的股權投資。這項股權投資以及與 Ayrmid 和 Gloria Biosciences 的許可協議以及淨銷售額特許權使用費的結合未來潛在的商業里程碑預計將為我們公司提供堅實的基礎。

Looking now at the new BioLineRx. Concurrent with the partnering transaction, we are shutting down our US commercial operations. I would like to thank Holly May, who headed our US commercial operations, for her tireless commitment to building a world-class team and ensuring a successful launch. It is largely due to her efforts that we are experiencing strong momentum for APHEXDA, particularly among top-tier transplant centers that are leaders with respect to installing new therapies on formulary and into daily clinical practice.

現在看看新的 BioLineRx。在合作交易的同時，我們將關閉我們在美國的商業業務。我要感謝負責我們美國商業運營的霍莉·梅 (Holly May)，感謝她不懈地致力於打造世界一流的團隊並確保成功推出。很大程度上得益於她的努力，我們 APHEXDA 經歷了強勁的勢頭，特別是在頂級移植中心中，這些中心在將新療法納入處方和日常臨床實踐方面處於領先地位。

This transformation, along with additional cost reductions, will allow us to reduce our annual cash burn by more than 70% effective January 1, 2025, and we focus our efforts on clinical development in Israel. With the proceeds from this transaction, we entered into an agreement with BlackRock to repay $16.5 million of the approximately $29 million in outstanding debt, with the remaining balance restructured at terms very favorable to our company, including at the pre-existing annual interest rate of 9.5%. With potential revenue from two licensing agreements together with a significantly streamlined organization with a greatly reduced cost structure and restructured debt, we are very well positioned to advance our near- and long-term value creation strategy for investors.

自 2025 年 1 月 1 日起，這項轉型加上額外的成本削減，將使我們的年度現金消耗減少 70% 以上，並且我們將重點放在以色列的臨床開發上。利用此次交易的收益，我們與貝萊德簽訂了一項協議，償還約2,900 萬美元未償債務中的1,650 萬美元，其餘餘額則按照對我們公司非常有利的條款進行重組，包括按照先前的年利率9.5%。憑藉兩項授權協議帶來的潛在收入，以及大幅精簡的組織、大幅降低的成本結構和重組的債務，我們完全有能力為投資者推進近期和長期的價值創造策略。

At this point, I'd like to review our PDAC program, which we continue to advance through our existing collaborations that require de minimis investment. Recall that motixafortide is an inhibitor of CXCR4, which plays a critical role in establishing and maintaining tumors. It is highly expressed in over 20 different tumor types, and it is estimated that greater than 70% of PDAC patients show an overexpression of CXCR4.

此時，我想回顧一下我們的 PDAC 計劃，我們將透過需要最低限度投資的現有合作繼續推進該計劃。回想一下，motixafortide 是 CXCR4 的抑制劑，CXCR4 在腫瘤的形成和維持中發揮關鍵作用。它在 20 多種不同的腫瘤類型中高表達，估計超過 70% 的 PDAC 患者表現出 CXCR4 的過度表達。

PD-1 and PD-L1 inhibitors have demonstrated significant efficacy in multiple solid tumor types but no survival benefit in a large randomized PDAC trial comparing combination immunotherapy and standard-of-care chemotherapy versus standard-of-care chemotherapy alone. In contrast, a Phase II trial in second-line patients with motixafortide plus PD-1 inhibitor plus standard-of-care chemotherapy demonstrated improvements across all study endpoints. So while PDAC is an inherently challenging cancer to treat, there is very strong scientific and clinical rationale for continued development.

PD-1 和PD-L1 抑制劑已在多種實體腫瘤類型中表現出顯著療效，但在一項大型隨機PDAC 試驗中，比較了聯合免疫療法和標準護理化療與單獨標準護理化療的療效，但沒有帶來生存獲益。相較之下，在接受莫替沙福肽加 PD-1 抑制劑加標準護理化療的二線患者中進行的一項 II 期試驗表明，所有研究終點均有所改善。因此，雖然 PDAC 本質上是一種治療起來具有挑戰性的癌症，但繼續開發有非常強大的科學和臨床理由。

Motixafortide is being evaluated in an active Phase IIb study led by Columbia University, known as CheMo4METPANC, which is supported equally by BioLineRx and Regeneron. Recall that this trial had an initial pilot phase, and based on the results of this pilot phase, an assessment would be made on advancing to an expansion phase of the study. 7 of 11 patients in the pilot phase, or 64%, experienced a partial response, of which 5 were confirmed PRs as of the July 2023 cutoff date, with 1 patient experiencing complete resolution of the metastatic lesion in the liver.

Motixafortide 正在哥倫比亞大學領導的一項名為 CheMo4METPANC 的 IIb 期研究中進行評估，該研究得到 BioLineRx 和 Regeneron 的同等支持。回想一下，該試驗有一個初始試驗階段，根據該試驗階段的結果，將對進入研究擴展階段進行評估。試驗階段的 11 名患者中有 7 名（即 64%）出現部分緩解，截至 2023 年 7 月截止日期，其中 5 名患者被確認為 PR，其中 1 名患者的肝臟轉移病灶完全消退。

Along with the three patients, or 27%, experiencing stable disease, this resulted in a disease control rate of 91%. These findings compare favorably to historic partial response and disease control rates of 23% and 48%, respectively, reported with the current standard of care.

加上 3 名患者（即 27%）病情穩定，疾病控制率為 91%。這些發現與目前護理標準報告的歷史部分緩解率和疾病控制率（分別為 23% 和 48%）相比是有利的。

Based on these compelling data, we, along with Columbia and Regeneron, agreed to amend the original expansion phase of the study from a single-arm expansion study with a target enrollment of 30 patients to a much larger randomized Phase IIb study of 108 patients with two arms: motixafortide, Regeneron's PD-1 inhibitor cemiplimab and standard-of-care chemotherapy versus standard-of-care chemotherapy alone.

基於這些令人信服的數據，我們與Columbia 和Regeneron 同意將研究的最初擴展階段從目標招募30 名患者的單組擴展研究修改為包含108 名患有以下疾病的患者的更大規模的隨機IIb期研究兩組：motixafortide、Regeneron 的 PD-1 抑制劑 cemiplimab 和標準護理化療與單獨標準護理化療的比較。

The trial's primary endpoint is progression-free survival. Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit, and overall survival. To further accelerate enrollment, Columbia plans to activate an additional three trial sites over the next two quarters in addition to the two that are currently enrolling. We anticipate that the trial should be fully enrolled by 2027.

本試驗的主要終點是無惡化存活期。次要目標包括安全性、緩解率、疾病控制率、臨床獲益持續時間和總存活期。為了進一步加快註冊速度，除了目前正在註冊的兩個試驗中心之外，哥倫比亞還計劃在未來兩個季度啟動另外三個試驗中心。我們預計該試驗應在 2027 年完成全部入組。

Motixafortide is also planned to be evaluated in a planned Phase IIb PDAC study in China led by Gloria Biosciences, pursuant to the license agreement that we signed with Gloria in October of last year. That study will evaluate motixafortide in combination with Gloria's commercially approved PD-1 inhibitor zimberelimab and standard-of-care combination chemotherapy in first-line pancreatic cancer.

根據我們去年 10 月與 Gloria Biosciences 簽署的許可協議，Motixafortide 還計劃在由 Gloria Biosciences 領導的計劃在中國進行的 IIb 期 PDAC 研究中進行評估。研究將評估 motixafortide 與 Gloria 商業批准的 PD-1 抑制劑 zimberelimab 和標準聯合化療聯合治療一線胰臟癌的效果。

The opportunity for us to help patients in dire need of effective new treatment options while addressing a multibillion-dollar market opportunity is significant. PDAC is a very difficult cancer to treat given that it is often asymptomatic until Stage IV. It has the highest mortality rate among solid tumor malignancies. Globally, nearly 0.5 million people were diagnosed with PDAC in 2020 alone. We look forward to keeping you up to date on our progress in this important program.

我們有機會幫助急需有效新治療方案的患者，同時抓住數十億美元的市場機會。PDAC 是一種非常難以治療的癌症，因為它通常在第四階段之前都沒有症狀。它是實體腫瘤惡性腫瘤中死亡率最高的。光是 2020 年，全球就有近 50 萬人被診斷出患有 PDAC。我們期待向您通報這項重要計劃的最新進展。

Now I'd like to briefly review some key performance indicators for APHEXDA during the third quarter, as I believe they reflect the many benefits to transplant centers and patients that key decision makers are increasingly realizing, particularly as they pertain to center efficiency and economics. As we've noticed previously, transplant centers, the end users of APHEXDA, are well-defined group in the US.

現在我想簡要回顧一下APHEXDA 第三季度的一些關鍵績效指標，因為我相信它們反映了關鍵決策者越來越意識到的對移植中心和患者的許多好處，特別是與中心效率和經濟效益有關的好處。正如我們之前註意到的，移植中心（APHEXDA 的最終用戶）是美國明確定義的群體。

Approximately 80 of the 212 centers in the US performed roughly 85% of all transplant procedures. Among those 80 centers by the end of the third quarter, we secured formulary placement at institutions managing over 40% of transplant procedures. We also continue to see steady growth in the number of centers reordering product.

美國 212 個中心中約有 80 個中心完成了約 85% 的移植手術。截至第三季末，在這 80 個中心中，我們在管理超過 40% 的移植手術的機構中獲得了處方安置。我們也繼續看到重新訂購產品的中心數量穩定成長。

Furthermore, we saw an approximate 40% increase in the number of institutions ordering APHEXDA during the third quarter as compared to the second quarter. As the third quarter was only the third full quarter since launch, we are very pleased with the traction that we've seen, especially with the availability of plerixafor or generic MOZOBIL, which entered the market shortly before our launch.

此外，我們發現第三季訂購 APHEXDA 的機構數量比第二季增加了約 40%。由於第三季度只是推出以來的第三個完整季度，我們對所看到的吸引力感到非常滿意，特別是在我們推出前不久進入市場的普樂沙福或仿製藥 MOZOBIL 的上市。

In fact, during the third quarter, we achieved a 10% market share milestone of total CXCR4 inhibitor usage in the US, which compares APHEXDA to branded MOZOBIL and generic plerixafor across all indications. We believe that this strong growth trajectory will continue through Gamida Cell's commercial program, building on the strong foundation in place.

事實上，在第三季度，我們在美國 CXCR4 抑制劑總使用量中實現了 10% 的市佔率里程碑，這將 APHEXDA 與品牌 MOZOBIL 和仿製藥 Plerixafor 在所有適應症上進行了比較。我們相信，這種強勁的成長軌跡將透過 Gamida Cell 的商業計劃繼續下去，建立在現有的堅實基礎上。

As we have discussed on prior conference calls, there are a number of factors that are driving the need for more effective mobilization regimens. First, multiple myeloma patients are getting older, and these patients are more challenged to achieve the required stem cell yields for transplantation.

正如我們在先前的電話會議上討論的那樣，有許多因素推動了對更有效動員方案的需求。首先，多發性骨髓瘤患者年齡越來越大，這些患者在達到移植所需的幹細胞產量方面面臨更大的挑戰。

In addition, the growing use of quad induction therapies, while beneficial to patients, can negatively impact stem cell yields. Last quarter, we cited the PERSEUS trial in which a recent FDA-approved quad therapy was shown to reduce risk of disease progression or death in multiple myeloma patients by 60%, pointing to the trend towards quad therapies as a new standard-of-care induction therapy.

此外，四元誘導療法的日益普及雖然對患者有益，但也會對幹細胞產量產生負面影響。上個季度，我們引用了 PERSEUS 試驗，其中最近 FDA 批准的四聯療法被證明可以將多發性骨髓瘤患者的疾病進展或死亡風險降低 60%，表明四聯療法作為新的護理標準的趨勢誘導治療。

It is against this backdrop of a rapidly changing stem cell mobilization treatment landscape that we believe APHEXDA can address significant unmet needs in the market. We are pleased to have entrusted its future success to an ideal partner like Gamida Cell with the expertise and infrastructure to maximize APHEXDA's commercial potential.

正是在幹細胞動員治療格局快速變化的背景下，我們相信 APHEXDA 可以解決市場上未滿足的重大需求。我們很高興將其未來的成功託付給像 Gamida Cell 這樣擁有專業知識和基礎設施的理想合作夥伴，以最大限度地發揮 APHEXDA 的商業潛力。

Now let me turn the call over to Mali to provide a financial update. Mali, please go ahead.

現在讓我把電話轉給馬裡，提供最新的財務資訊。馬裡，請繼續。

Thank you, Phil. As is our practice, I will go over the most significant items in our financial statements: revenues, cost of revenues, research and development expenses, sales and marketing expenses, net loss and cash. I invite you to review the 6-K filing we made this morning that contains our financials and press release.

謝謝你，菲爾。按照我們的慣例，我將回顧我們財務報表中最重要的項目：收入、收入成本、研發費用、銷售和行銷費用、淨虧損和現金。我邀請您查看我們今天早上提交的 6-K 文件，其中包含我們的財務數據和新聞稿。

Total revenue for the three months ended September 30, 2024, was $4.9 million. The company did not record any revenue during the third quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.2 million as well as $1.7 million for the net revenue from product sales of APHEXDA in the US.

截至 2024 年 9 月 30 日的三個月總收入為 490 萬美元。該公司在 2023 年第三季沒有記錄任何收入。本季度收入反映了 Gloria Biosciences 許可預付款的一部分，金額為 320 萬美元，以及 APHEXDA 在美國產品銷售的淨收入 170 萬美元。

Cost of revenue for the three months ended September 30, 2024, was $0.8 million. The company did not record any cost of revenue during the third quarter of 2023. 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.

截至 2024 年 9 月 30 日止三個月的收入成本為 80 萬美元。該公司在 2023 年第三季沒有記錄任何收入成本。本季的收入成本主要反映無形資產攤銷、APHEXDA 在美國產品淨銷售的特許權使用費以及產品銷售的商品成本。

Research and development expenses for the three months ended September 30, 2024, were $2.6 million compared to $2.7 million for the same period in 2023. The decrease resulted primarily from lower expenses related to the termination of the development of AGI-134 and the decrease in payroll and share-based compensation.

截至 2024 年 9 月 30 日止三個月的研發費用為 260 萬美元，而 2023 年同期為 270 萬美元。這一減少主要是由於與 AGI-134 開發終止相關的費用減少以及工資和股權激勵的減少。

Sales and marketing expenses for the three months ended September 30, 2024, were $5.5 million compared to $8.1 million for the same period in 2023. The decrease resulted primarily from lower expenses of commercialization activities related to motixafortide. The higher expenses in the corresponding period of 2023 reflect the ramp-up of pre-commercialization activities related to motixafortide.

截至 2024 年 9 月 30 日的三個月銷售和行銷費用為 550 萬美元，而 2023 年同期為 810 萬美元。這一減少主要是由於與莫替沙福肽相關的商業化活動費用降低。2023年同期費用較高反映了與motixafortide相關的預商業化活動的增加。

General and administrative expenses for the three months ended September 30, 2024, were $1.4 million compared to $1.5 million for the same period in 2023. The decrease resulted primarily from small decreases in a number of G&A items.

截至 2024 年 9 月 30 日止三個月的一般及行政費用為 140 萬美元，而 2023 年同期為 150 萬美元。這一下降主要是由於一些一般管理費用項目小幅下降所致。

Net loss for the three months ended September 30, 2024, was $5.8 million compared to a net loss of $16 million for the same period in 2023. The net loss for the 2024 period included $0.8 million in non-operating income compared to non-operating expenses of $3.1 million for the same period in 2023, both primarily related to non-cash revaluation of warrants.

截至 2024 年 9 月 30 日的三個月淨虧損為 580 萬美元，而 2023 年同期淨虧損為 1,600 萬美元。2024 年期間的淨虧損包括 80 萬美元的營業外收入，而 2023 年同期的營業外支出為 310 萬美元，兩者主要與認股權證的非現金重估有關。

As of September 30, 2024, the company had cash, cash equivalents and short-term bank deposits of $29.2 million. Following the out-license to Ayrmid, the equity investment from Highbridge and the debt repayment to BlackRock, the company's cash, cash equivalents and short-term bank deposits are expected to be approximately $20 million, which we believe will be sufficient to fund operations into '26 as currently planned.

截至2024年9月30日，該公司擁有現金、現金等價物及短期銀行存款2,920萬美元。繼向 Ayrmid 授出許可、Highbridge 的股權投資以及向 BlackRock 償還債務後，該公司的現金、現金等價物和短期銀行存款預計約為 2000 萬美元，我們相信這將足以為該公司的運營提供資金'26按目前計劃。

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. In closing, I would like to take a moment to summarize our revised milestones. Over the next two quarters, we anticipate adding three new clinical trial sites to the ongoing CheMo4METPANC Phase IIb randomized clinical trial in first-line PDAC sponsored by Columbia University and anticipate interim data in 2026.

謝謝你，馬裡。最後，我想花點時間總結一下我們修訂後的里程碑。在接下來的兩個季度中，我們預計將在由哥倫比亞大學贊助的一線 PDAC 正在進行的 CheMo4METPANC IIb 期隨機臨床試驗中增加三個新的臨床試驗中心，並預計在 2026 年獲得中期數據。

Working with Gloria Bio, we look forward to continued progress with the planned stem cell mobilization bridging study and the Phase IIb combination study, evaluating motixafortide in first-line pancreatic cancer. Finally, in 2025, we will evaluate additional early-stage clinical assets for in-licensing and further development, seeking to add one new asset in 2025 and an additional one in 2026.

我們期待與 Gloria Bio 合作，計劃中的幹細胞動員橋接研究和 IIb 期聯合研究繼續取得進展，以評估 motixafortide 在一線胰腺癌中的作用。最後，到 2025 年，我們將評估額外的早期臨床資產，以進行許可和進一步開發，力求在 2025 年增加一項新資產，並在 2026 年增加一項新資產。

With that, we have now concluded the formal part of our presentation. Operator, we will now open the call to questions.

至此，我們現在結束了演示的正式部分。接線員，我們現在開始提問。

(Operator Instructions) Joe Pantginis, H.C. Wainwright.

（操作員說明）Joe Pantginis, H.C.溫賴特。

Got a few questions, if you don't mind. So first, Phil, I just wanted to make sure I heard you correctly with regard to pipeline growth. Did you say potential in-licensing of one asset in '25 and one in '26?

如果你不介意的話，有幾個問題。首先，菲爾，我只是想確保我聽到的有關管道增長的信息是正確的。您是否說過 25 年一項資產和 26 年一項資產可能獲得許可？

Yes, I think that's what our plan is. We have a number of assets that we're already looking at. It's hard to say. BD things don't always go exactly according to plan. But I think overall, that's our plan.

是的，我認為這就是我們的計劃。我們已經在考慮許多資產。很難說。BD 的事情並不總是完全按照計劃進行。但我認為總的來說，這就是我們的計劃。

No, of course. Okay. So then going to your current announcement and thank you for all the details today that were very helpful. With regard to, say, the pancreatic program, I guess, how do we mix that with the potential for motixafortide in additional solid tumor indications, plus the ability to potentially have a business development discussions around that? And can you discuss the level of maturity of these discussions?

不，當然。好的。那麼，請轉到您當前的公告，感謝您今天提供的所有非常有幫助的詳細資訊。比方說，關於胰臟項目，我想我們如何將其與莫替沙福肽在其他實體瘤適應症中的潛力結合起來，以及圍繞該項目進行業務開發討論的能力？您能否討論一下這些討論的成熟程度？

Yes. So as far as the PDAC, I think that we look at PDAC as sort of as a prototype, so to speak, for other solid tumors. We are probably not going to put a lot more money at this point into PDAC. As you know, we have the two collaborations that are ongoing that are really running in the background with -- at a very low cost to the company, basically drug -- the supply of drug product.

是的。就 PDAC 而言，我認為我們將 PDAC 視為其他實體瘤的原型。目前我們可能不會向 PDAC 投入更多資金。如您所知，我們正在進行兩項合作，這些合作實際上是在後台運行的，以非常低的公司成本（基本上是藥品）供應藥品。

And so we think the best use for our current capital is to bring some new assets into the pipeline while these programs are still ongoing. And we hope that there will be some initial data sometime next year -- I'm sorry, next -- in 2026, some interim data from the Columbia study, which then would serve as probably the launching-off point for some potential business development discussions, et cetera.

因此，我們認為當前資本的最佳用途是在這些計劃仍在進行的同時將一些新資產引入管道。我們希望明年某個時候——對不起，是明年——2026 年，哥倫比亞大學的研究得出一些中期數據，然後這些數據可能會成為一些潛在業務發展的啟動點討論等。

That's very helpful. And then with regards to the Ayrmid APHEXDA sale, a couple of things here. So just from a logistical standpoint, do they have any potential option on the solid tumor program?

這非常有幫助。關於 Ayrmid APHEXDA 銷售，這裡有幾件事。那麼，僅從後勤的角度來看，他們在實體腫瘤項目上有任何潛在的選擇嗎？

They do not.

他們沒有。

They do not. Okay. That's simple enough. And I guess two things here. So with regard to the company restructuring, it sounds like that it's mostly or largely the field force that they'll be assimilating.

他們沒有。好的。這很簡單。我想這裡有兩件事。因此，就公司重組而言，聽起來他們將主要吸收的是現場人員。

Not necessarily. I mean I don't think we're at liberty to tell you -- to speak for them. But they have -- they are taking a piece of our organization or a number of our personnel. And I don't think it's only limited to field -- to customer-facing employees.

未必。我的意思是，我認為我們沒有自由告訴你——為他們說話。但他們已經——他們正在奪走我們組織的一部分或我們的一些人員。我認為這不僅限於現場——面向客戶的員工。

Okay. And then my last question is, I guess, from a financial standpoint and the important details you shared with regard to the drug launch to date, how should we view to the level of detail you can the integration time within their program of APHEXDA and how that might impact any potential lags or dips in sales, especially as we go into the first quarter and insurance resets, et cetera?

好的。我想，我的最後一個問題是，從財務角度以及您迄今為止分享的有關藥物上市的重要細節來看，我們應該如何看待您在 APHEXDA 計劃中的整合時間的詳細程度以及如何這可能會影響銷售的任何潛在滯後或下降，特別是當我們進入第一季和保險重置等時？

Yes. So I'm hoping that there won't be too much of a lag in anything. I mean they're taking, like I said, a significant number of employees with them. According to the agreement, we're providing them with transition services for the next number of months. And so we think we're going to ASH.

是的。所以我希望任何事情都不會出現太大的延遲。我的意思是，正如我所說，他們帶走了大量員工。根據協議，我們將在接下來的幾個月內為他們提供過渡服務。所以我們認為我們將採用 ASH。

We'll probably going to Tandem as well. So I think that we believe that the transition period should be quite seamless. And I don't believe there will be a significant lag in sales or in the uptick of sales.

我們可能也會去 Tandem。所以我認為我們認為過渡期應該是非常無縫的。我不認為銷售或銷售成長會出現明顯的延遲。

Justin Walsh, Jones Trading.

賈斯汀·沃爾什，瓊斯貿易公司。

I wonder if you can provide some color on where you view the company's core competencies as we wait to hear more about the addition of potential assets to your pipeline?

我想知道在我們等待更多有關向您的管道添加潛在資產的資訊時，您是否可以提供一些關於您如何看待公司核心競爭力的資訊？

Thanks, Justin. So I mean, as we mentioned, we'll be returning to our roots as an Israeli-based development company. But with many -- I think we have many positive attributes that other companies may not have. We have a highly experienced development team with fully validated capabilities from early-stage projects all the way to approval, and of course, commercialization, but I'll just talk about until approval.

謝謝，賈斯汀。所以我的意思是，正如我們所提到的，我們將回歸以色列開發公司的根源。但我認為我們擁有許多其他公司可能沒有的正面特質。我們擁有一支經驗豐富的開發團隊，具有從早期專案一直到批准，當然還有商業化的經過充分驗證的能力，但我只談論直到批准為止。

So those are some of our capabilities. We have a full -- our Israeli team has full capabilities in regulatory affairs, in CMC, in quality assurance, in clinical operations, in preclinical development, et cetera. So I mean, we've got -- in medical affairs and et cetera. So we've got a full complement of the disciplines necessary to move forward in development.

這些是我們的一些能力。我們的以色列團隊在監管事務、CMC、品質保證、臨床操作、臨床前開發等方面擁有全面的能力。所以我的意思是，我們在醫療事務等方面都有。因此，我們擁有推動發展所需的完整學科。

I think just even to go further with that, I think that we also have cash flows from two partnering arrangements that will provide commercial milestones and royalty revenues on an ongoing basis that other development companies might have. And we also have -- as I mentioned, we have the significant trials in PDAC that are ongoing under these meaningful collaborations that are really moving forward at a de minimis cost to the company. So I think all in all, I think that we feel that we're very well-placed moving forward.

我認為，甚至更進一步，我認為我們還擁有來自兩個合作安排的現金流，這將持續提供其他開發公司可能擁有的商業里程碑和特許權使用費收入。正如我所提到的，我們也在 PDAC 中進行了重大試驗，這些試驗正在這些有意義的合作下進行，這些合作確實以對公司而言微乎其微的成本向前推進。所以我認為總而言之，我認為我們感覺我們處於非常有利的位置，可以繼續前進。

And again, as I mentioned, we're looking to bring in two new assets in the 2025, 2026 period. We have a list of potential in-license candidates. All of them meet our criteria of a low upfront payment in oncology and rare disease with relatively modest and affordable clinical development program. So I mean that's sort of how we see ourselves moving forward. I hope that gave you a comprehensive answer to your question.

正如我所提到的，我們希望在 2025 年和 2026 年期間引入兩項新資產。我們有一份潛在的許可候選人名單。所有這些都符合我們在腫瘤學和罕見疾病方面的低預付款標準，以及相對適度且負擔得起的臨床開發計劃。所以我的意思是，這就是我們如何看待自己前進的方式。我希望這能為您的問題提供全面的答案。

John Vandermosten, Zacks.

約翰范德莫斯坦，扎克斯。

Looking at the 2025 expenses, I think you indicated there would be a 70% reduction in spend next year. And I guess if we look at kind of the estimates out there, it seems like we just take out sales and marketing expense and leave R&D and G&A as they have been. Is that a fair way to look at it? And also, obviously, take out the cost of goods sold as well.

看看 2025 年的支出，我認為您表示明年的支出將減少 70%。我想，如果我們看一下那裡的估計，我們似乎只是去掉了銷售和行銷費用，而將研發和一般行政費用保持原樣。這是一個公平的看待它的方式嗎？顯然，還要扣除銷售商品的成本。

I think it's going to be a little bit more than that. I think we're going to -- as a company that also had operations in the US, besides the actual US commercial operations, I think that some of our spend from Israel, having a US subsidiary that was active, created some additional spend. So I think it's a little bit more than that. I think you can expect a decrease in G&A expenses as well and et cetera.

我認為會比這個多一點。我認為，作為一家在美國也有業務的公司，除了實際的美國商業運營之外，我認為我們在以色列的一些支出，以及一家活躍的美國子公司，創造了一些額外的支出。所以我認為還不止於此。我認為您可以預期一般管理費用也會減少等等。

So we're looking to be lean and mean going forward. And as I said, we believe that we will be on the right track with moving forward with development only in Israel. Again, I think I also want to mention that Israel itself is sort of a low-cost place to have development, and so I think that we are looking at that over 70% reduction overall in the spend.

因此，我們希望未來能夠保持精簡精簡。正如我所說，我們相信，只有在以色列推動發展，我們才會走在正確的軌道上。再次，我想我還想提一下，以色列本身是一個低成本的發展之地，因此我認為我們正在考慮將總體支出減少 70% 以上。

Okay. And then on the R&D side, should we think of that continuing on at the same level? And what are those obligations going to be? I mean, I think there's PDAC in there. Is there anything else in there that's ongoing?

好的。那麼在研發方面，我們是否應該考慮在同一水平上繼續下去？這些義務是什麼？我的意思是，我認為裡面有 PDAC。裡面還有其他正在進行的事情嗎？

Yes. So we are -- we have some obligations regarding some five-year commitment, post marketing commitment with the FDA, but that's not very significant. And as well our PDAC commitments are more -- our drug supply plus some small grant, nothing significant. So I mean we're going to be having two PDACs -- two Phase IIb studies, hopefully ongoing at almost no cost to the company. The post marketing commitment will be quite low. And then the rest of our spend will be on new projects as we bring them in.

是的。因此，我們對 FDA 的五年承諾、上市後承諾負有一些義務，但這並不是很重要。我們的 PDAC 承諾也更多——我們的藥品供應加上一些小額贈款，沒什麼重要的。所以我的意思是，我們將進行兩項 PDAC——兩項 IIb 期研究，希望公司幾乎無需承擔任何成本即可進行。上市後的承諾將相當低。然後，當我們引入新項目時，我們的其餘支出將用於新項目。

Okay. And as we look at potentially a pivotal or registrational trial in PDAC, I guess you seem to indicate that that would be taken over by partners and that you would probably have limited contribution there.

好的。當我們考慮 PDAC 中潛在的關鍵或註冊試驗時，我猜您似乎表明該試驗將由合作夥伴接管，並且您在那裡的貢獻可能有限。

Yes. I mean, listen, everything is possible. But I think we believe that something of this size in solid tumors in general, it would make sense to partner, especially if we have very robust data from the Phase IIb or from the Phase IIbs. So I think our probably -- our main pathway forward would be to look to partner it out. And this being such a blockbuster indication, we don't really think that it would be difficult, depending, of course, on the data.

是的。我的意思是，聽著，一切都有可能。但我認為我們相信，對於實體腫瘤中這種規模的藥物，合作是有意義的，特別是如果我們有來自 IIb 期或 IIb 期的非常可靠的數據。所以我認為我們主要的前進道路可能是尋求合作。這是一個如此重磅的跡象，我們不認為這會很困難，當然這取決於數據。

Okay. So that seems to orient your attention more towards earlier-stage products. So I guess how would you think about adding a new product? I mean what stage of development would it be in? I think oncology probably is an area where you have some experience.

好的。因此，這似乎會讓您的注意力更多地轉向早期產品。所以我猜你會如何考慮增加新產品？我的意思是它會處於什麼發展階段？我認為腫瘤學可能是你有一些經驗的領域。

How would you -- time to commercialization, stage of development, indication, what are those kind of factors that you're thinking about when you're looking at something to layer on?

您會如何－商業化時間、開發階段、適應症，當您考慮分層時會考慮哪些因素？

Yes. So I mean, I said I think we're looking at oncology, rare disease. We're looking at early-stage clinical assets. I can't say that that's the only thing that we'd look at, maybe something very, very late stage, preclinical, but I think our focus is primarily on early-stage clinical assets with best-in-class potential and with small molecules, peptides, things that we have a lot of experience with previously and to sort of leverage our capabilities going forward.

是的。所以我的意思是，我說我認為我們正在研究腫瘤學、罕見疾病。我們正在尋找早期臨床資產。我不能說這是我們唯一關注的東西，也許是非常非常晚期的臨床前東西，但我認為我們的重點主要是具有一流潛力且規模較小的早期臨床資產。經驗並在未來發揮我們能力的東西。

Okay. And then on China, it seemed like you had mentioned that there's a clearance there, I guess, in some areas that don't require the bridging study. When would you expect the first revenues to show up from that region?

好的。然後關於中國，您似乎提到過，我想，在某些不需要過渡性研究的領域，有一個許可。您預計該地區何時會出現第一批收入？

That's hard to say. I mean it could -- it's hard for us to say right now, and we haven't given any guidance on that. We're hoping that 2025 will be a year where there is revenues, although we don't have a lot of control over what's going -- what Gloria is doing. We're obviously meeting with them on a regular basis. I would imagine that, that first sale should occur sometime in 2025.

這很難說。我的意思是它可以——我們現在很難說，而且我們還沒有對此給出任何指導。我們希望 2025 年將是有收入的一年，儘管我們對正在發生的事情（格洛麗亞正在做什麼）沒有太多控制權。顯然我們會定期與他們會面。我想，第一次銷售應該會在 2025 年的某個時候發生。

(Operator Instructions) John Vandermosten, Zacks.

（操作員說明）John Vandermosten，Zacks。

Great. On Gamida Cell, are they -- is the only other product that they're commercializing the OMISIRGE product? Or do they have something else besides that?

偉大的。在 Gamida Cell 上，他們是否是他們將 OMISIRGE 產品商業化的唯一其他產品？或者說他們除此之外還有其他的東西嗎？

I think right now, that's what they have. I think they may have plans to bring in some additional products. But right now, they have OMISIRGE, and of course, now they have APHEXDA.

我想現在，這就是他們所擁有的。我認為他們可能計劃引入一些額外的產品。但現在，他們有了 OMISIRGE，當然，現在他們有了 APHEXDA。

There are no further questions at this time. 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 2 hours after the conference. In the US, please call 1 (888) 295-2634. In Israel, please call 03-9255-904. Internationally, please call 9723-9255-904.

目前沒有其他問題。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 2 小時開始。在美國，請致電 1 (888) 295-2634。在以色列，請致電 03-9255-904。國際請致電 9723-9255-904。

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. Thank you, operator. In closing, we are very pleased to have entered into this license agreement with Ayrmid Gamida Cell, which allows us to return to our drug development roots while simultaneously benefiting from APHEXDA's long-term commercial potential in stem cell mobilization, sickle cell disease and other non-solid tumor indications. We believe this path forward best positions us to create value for our shareholders while developing novel new therapies for patients with cancer and serious rare diseases.

是的。謝謝你，接線生。最後，我們非常高興與 Ayrmid Gamida Cell 簽訂這項許可協議，這使我們能夠回歸藥物開發根源，同時受益於 APHEXDA 在幹細胞動員、鐮狀細胞疾病和其他非實體瘤適應症。我們相信，這條前進道路最有利於我們為股東創造價值，同時為癌症和嚴重罕見疾病患者開發新穎的療法。

Thank you all very much for your continued interest in BioLineRx. We look forward to providing our next comprehensive quarterly update in March. Be safe and have a great day.

非常感謝大家對 BioLineRx 的持續關注。我們期待在三月提供下一個全面的季度更新。請注意安全，祝您有個愉快的一天。

Thank you. This concludes the BioLineRx Third Quarter 2024 Conference Call. Thank you for your participation. You may go ahead and disconnect.

謝謝。BioLineRx 2024 年第三季電話會議到此結束。感謝您的參與。您可以繼續並斷開連線。