BioLine RX Ltd (BLRX) 2026 Q1 法說會逐字稿

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  • Operator

    Operator

  • Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx first-quarter 2026 financial Results Conference. (Operator Instructions) I would now like to turn over the call to Chuck Padala, Investor Relations. Chuck, please go ahead.

    各位女士、先生,感謝您稍候。歡迎參加 BioLineRx 2026 年第一季財務業績電話會議。(接線員指示)現在我想把電話交給投資人關係負責人 Chuck Padala。Chuck,請開始。

  • Charles Padala - Investor Relations

    Charles Padala - Investor Relations

  • Thank you, operator, and welcome, everyone, and thank you for joining us on our quarterly 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. I'd like to remind everyone that certain statements we make during the call will be forward-looking.

    謝謝接線員,歡迎各位,也感謝大家參加我們的季度業績電話會議。今天稍早我們已發布新聞稿,副本可於我們網站的投資人關係專區取得,並且也已以 6-K 形式提交。我想提醒各位,我們在本次電話會議中所作的某些陳述將屬於前瞻性陳述。

  • 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.

    由於此類陳述涉及未來事件,且受多項風險與不確定性影響,實際結果可能與前瞻性陳述中所述存在重大差異。關於這些風險與不確定性的完整討論,請查閱我們向美國證券交易委員會提交的 20-F 年報以及 6-K 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.

    此刻,我很榮幸把電話交給 BioLineRx 執行長 Phil Serlin 先生。

  • Philip Serlin - Chief Executive Officer

    Philip Serlin - Chief Executive Officer

  • Thank you, Chuck, and good morning, everyone, and thank you for joining us on today's call. As has been our practice, I will begin with a few prepared remarks before turning the call over to Mali Zeevi, our Chief Financial Officer, to briefly recap our financials. Afterwards, we will take your questions. Ella Sorani, our Chief Development Officer, is also available for Q&A. I would like to begin this morning with an update on GLIX1, a highly innovative molecule for the treatment of glioblastoma or GBM and other cancers that we obtained through our collaboration with Hemispherian.

    謝謝你,Chuck。各位早安,感謝大家參加今天的電話會議。依照我們一貫的做法,我將先做幾點準備好的說明,接著把電話交給我們的財務長 Mali Zeevi,簡要回顧財務表現。之後我們將回答各位的提問。我們的研發長 Ella Sorani 也將出席問答。我今天早上想先就 GLIX1 提供最新進展;GLIX1 是一種高度創新的分子,用於治療膠質母細胞瘤(glioblastoma,GBM)及其他癌症,係我們透過與 Hemispherian 的合作取得。

  • In March, we were pleased to announce the initiation of a Phase 1/2a first-in-human trial of GLIX1 for the treatment of GBM. And a few weeks later, the first patient was dosed at NYU Langone Health under the supervision of Dr. Alexandra Miller, Chief of Neuro-Oncology and Co-Director of the Brain and Spine Tumor Center, Perlmutter Cancer Center at Langone Health

    3 月,我們很高興宣布啟動 GLIX1 用於治療 GBM 的第 1/2a 期首次人體(first-in-human)臨床試驗。幾週後,在 NYU Langone Health、由神經腫瘤科主任暨 Langone Health 佩爾穆特癌症中心腦與脊髓腫瘤中心共同主任 Alexandra Miller 醫師監督下,首位病患已完成給藥。

  • A total of three renowned academic centers will participate in this clinical trial. In addition to Langone Health, Northwestern University led by Dr. Roger Stupp and Dr. Ditte Primdahl; and Moffit Cancer Center led, by Dr. Patrick Grogan will also be recruiting and treating patients. Additional sites may be added to the study at a later date as well.

    本項臨床試驗將由三家知名學術中心參與。除 Langone Health 外,還包括由 Roger Stupp 醫師與 Ditte Primdahl 醫師領導的西北大學(Northwestern University),以及由 Patrick Grogan 醫師領導的莫菲特癌症中心(Moffitt Cancer Center),也將招募並治療病患。未來亦可能在較晚階段新增其他試驗中心。

  • The Phase 1 part of the trial is expected to recruit up to 30 patients with recurrent GBM and other high-grade gliomas. The objective is to establish a maximum tolerated dose and/or recommended dose based on safety, PK/PD and preliminary efficacy. We expect to provide periodic updates on the trial during the second half of 2026, with full results on the dose escalation part in 2027.

    試驗的第 1 期部分預計招募最多 30 名復發性 GBM 及其他高級別膠質瘤患者。目標是基於安全性、PK/PD 與初步療效,確立最大耐受劑量和/或建議劑量。我們預期在 2026 年下半年期間定期提供試驗更新,並於 2027 年公布劑量遞增部分的完整結果。

  • The Phase 2a expansion part of the trial is planned to include additional indications, including newly diagnosed GBM as well as select cancers with GLIX1 as monotherapy or in combination with standard of care, including in combination with PARP inhibitors. These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimization data, serving as the basis for a rapid and effective advanced clinical development plan. As a reminder, GLIX1 is an oral small molecule with a novel mechanism of action applicable to a broad range of cancers.

    試驗的第 2a 期擴增部分規劃納入其他適應症,包括新診斷 GBM,以及若干選定癌症;GLIX1 將以單藥治療或與標準治療合併使用,包括與 PARP 抑制劑合併。這些隊列預期可辨識初步療效、PD 評估與劑量最佳化資料,作為快速且有效的後續臨床開發計畫之基礎。提醒各位,GLIX1 為口服小分子,具新穎作用機轉,可適用於廣泛癌症。

  • By restoring TET2 activity, GLIX1 selectively targets DNA damage repair in cancer cells only. Glioblastoma was selected as the first indication for GLIX1 due to the low level of TET2 activity in this aggressive brain cancer for which there remains a high unmet medical need for novel and more effective treatments. In addition, GLIX1 has demonstrated its ability to cross the blood-brain barrier, which is a highly significant differentiator for treating GBM and gives us hope that it may show effect where others have failed in this exceedingly difficult indication.

    透過恢復 TET2 活性,GLIX1 可選擇性地僅在癌細胞中鎖定 DNA 損傷修復。由於此侵襲性腦癌的 TET2 活性偏低,且對新穎且更有效治療仍存在高度未被滿足的醫療需求,因此我們選擇膠質母細胞瘤作為 GLIX1 的首個適應症。此外,GLIX1 已展現其穿越血腦屏障的能力,這是治療 GBM 的重要差異化優勢,也讓我們期待它可能在這個極其困難的適應症上展現其他療法未能達成的效果。

  • Expanding upon our extensive preclinical work, we were very excited to announce just last week new data demonstrating that GLIX1 achieved robust dose-dependent tumor growth inhibition and survival benefit in several studies in two orthotopic cell-derived xenograft or CDx models in GBM. In addition, in a newly completed subcutaneous temozolamide-resistant patient-derived xenograft or PDX model in GBM, GLIX1 demonstrated a robust antitumor effect, while no effect was observed with temozolomide.

    在我們大量臨床前研究的基礎上,我們非常興奮地於上週宣布新數據:在 GBM 的兩種原位(orthotopic)細胞來源異種移植(cell-derived xenograft,CDx)模型中的多項研究裡,GLIX1 達成強勁且具劑量依賴性的腫瘤生長抑制與存活獲益。此外,在新近完成的 GBM 皮下(subcutaneous)替莫唑胺(temozolomide)抗性病患來源異種移植(patient-derived xenograft,PDX)模型中,GLIX1 展現強勁的抗腫瘤效果,而替莫唑胺則未觀察到效果。

  • These results are very encouraging, highlighting the potential to address the high unmet need in GBM, especially since more than half of GBM patients are resistant to temozolomide, which is the current standard of care chemotherapy. We also look forward to engaging with the broader oncology community over the next few days at this year's ASCO meeting with two abstracts featuring GLIX1 that have been accepted for online publication. The abstracts highlight the wealth of preclinical data that support GLIX1's novel mechanism of action designed to induce tumor selective DNA damage in a broad range of cancers, thus providing rationale for the development of GLIX1 in GBM and additional cancers as well.

    這些結果令人振奮,凸顯其有望滿足 GBM 的高度未被滿足需求,尤其是因為超過一半的 GBM 病患對替莫唑胺(目前標準治療的化療藥物)具有抗性。我們也期待在接下來幾天於今年 ASCO 年會與更廣泛的腫瘤學社群交流;其中有兩篇以 GLIX1 為主題的摘要已獲接受並將於線上發表。這些摘要凸顯大量臨床前數據,支持 GLIX1 的新穎作用機轉:旨在於廣泛癌症中誘導腫瘤選擇性的 DNA 損傷,從而為 GLIX1 在 GBM 及其他癌症的開發提供依據。

  • They also highlight the compelling mechanistic rationale for combining GLIX1 with PARP inhibitors, supported by a synergistic effect in cell lines across diverse cancers, including tumor types typically less responsive to PARP inhibition. Taken together, the results of our extensive preclinical program for GLIX1 strongly support its continued advancement in the ongoing Phase 1/2a first-in-human study, both in GBM and in other cancer indications.

    摘要亦強調將 GLIX1 與 PARP 抑制劑合併使用的有力機轉性理由;在涵蓋多種癌症的細胞株中觀察到協同效應,包括通常對 PARP 抑制反應較差的腫瘤類型。綜合而言,我們針對 GLIX1 的廣泛臨床前計畫結果,強力支持其在進行中的第 1/2a 期首次人體研究中持續推進,涵蓋 GBM 以及其他癌症適應症。

  • The unmet need in glioblastoma is significant. It is the most common and aggressive form of primary brain cancer. GBM occurs at all ages, but peaks with individuals in their 50s and 60s with an increasing incidence driven by an aging global population. New and better treatments are desperately needed that can improve survival, maintain quality of life and delay tumor progression. The current standard of care was established more than 20 years ago with only limited improvement since that time.

    膠質母細胞瘤的未被滿足需求相當巨大。它是最常見且最具侵襲性的原發性腦癌。GBM 可發生於各年齡層,但以 50 至 60 多歲族群達到高峰,且在全球人口老化推動下,發生率正持續上升。迫切需要能改善存活、維持生活品質並延緩腫瘤進展的新且更佳治療方式。現行標準治療在 20 多年前即已確立,自那時以來僅有有限改善。

  • Treatment includes surgical resection, followed by radiotherapy and concomitant and adjuvant chemotherapy, as mentioned, temozolomide. But the prognosis for patients is poor with median survival of approximately 12 to 18 months following diagnosis. By 2030, the annual incidence of GBM is expected to be approximately 18,500 patients in the US and approximately 13,500 patients across the EU 4 plus 1, France, Germany, Italy, Spain and the United Kingdom.

    治療方式包括手術切除,接著進行放射治療,以及同步與輔助化學治療,如前所述為替莫唑胺。然而,患者預後不佳,診斷後的中位存活期約為 12 至 18 個月。預計到 2030 年,美國 GBM 年發生數約為 18,500 名患者;歐盟 4+1(法國、德國、義大利、西班牙與英國)合計約為 13,500 名患者。

  • This translates into total addressable markets across both the newly diagnosed and recurrent settings of more than $3.7 billion in the US and Europe alone. We view this as a wide-open market with few competitors. We are incredibly pleased to have brought this highly innovative molecule into our pipeline, and we look forward to keeping you apprised of our progress as we pursue its development in a wide range of cancers.

    這意味著僅在美國與歐洲,新診斷與復發兩種情境合計的可服務總市場(total addressable market)超過 37 億美元。我們認為這是一個競爭者不多、機會廣闊的市場。我們非常高興能將這一高度創新的分子納入我們的產品線,並期待在推進其於多種癌症的開發過程中,持續向各位通報我們的進展。

  • Turning now to pancreatic cancer or PDAC. Recall that we retained the rights to develop motixafortide in PDAC as part of the Ayrmid out-licensing agreement, and we continue to support its ongoing development in this indication. Columbia University, supported by both Regeneron and BioLineRx is executing a randomized Phase 2b clinical trial known as CheMo4METPANC, and we are pleased to report that enrollment continues to track well.

    現在轉到胰臟癌(pancreatic cancer,或 PDAC)。請回想,作為與 Ayrmid 的對外授權協議之一部分,我們保留了在 PDAC 領域開發 motixafortide 的權利,並持續支持其在此適應症的開發。哥倫比亞大學在 Regeneron 與 BioLineRx 的共同支持下,正在執行一項名為 CheMo4METPANC 的隨機分派第 2b 期臨床試驗,我們很高興報告,受試者入組進度仍維持良好。

  • This trial is evaluating motixafortide in combination with the PD-1 inhibitor, cemiplimab, and standard chemotherapies, gemcitabine and nab-paclitaxel. A prespecified interim futility analysis is planned for when 40% of progression-free survival events are observed, which is still anticipated later this year.

    本試驗正在評估 motixafortide 與 PD-1 抑制劑 cemiplimab 以及標準化學治療藥物吉西他濱(gemcitabine)與白蛋白結合型紫杉醇(nab-paclitaxel)的合併療法。預先規劃的期中無效性(futility)分析將在觀察到 40% 的無惡化存活期(PFS)事件時進行,預期仍將於今年稍晚進行。

  • I'd now like to briefly touch on APHEXDA's performance. The Ayrmid team continues to make progress driving APHEXDA adoption, generating sales of $2.5 million in the first quarter of 2026 compared with $1.4 million of sales in Q1 2025, resulting in $0.5 million of royalty revenue to BioLineRx. We remain optimistic about the role that APHEXDA can play in the new multiple myeloma treatment paradigm and look forward to continued growth in the future.

    接下來我想簡要談談 APHEXDA 的表現。Ayrmid 團隊持續推動 APHEXDA 的採用並取得進展,2026 年第一季銷售額為 250 萬美元,相較於 2025 年第一季的 140 萬美元,帶動 BioLineRx 取得 50 萬美元的權利金收入。我們仍對 APHEXDA 在新的多發性骨髓瘤治療典範中可扮演的角色抱持樂觀,並期待未來持續成長。

  • Furthermore, recall that when we executed the Ayrmid out-licensing agreement last year, they obtained not only the rights to commercialize APHEXDA in stem cell mobilization for multiple myeloma, but also the rights to develop motixafortide across all other indications, excluding solid tumor indications and in all territories other than Asia. This includes the evaluation of motixafortide in sickle cell disease.

    此外,請回想我們去年執行與 Ayrmid 的對外授權協議時,Ayrmid 不僅取得在多發性骨髓瘤之幹細胞動員(stem cell mobilization)領域商業化 APHEXDA 的權利,也取得在除實體腫瘤適應症之外的所有其他適應症、且在亞洲以外所有地區開發 motixafortide 的權利。這也包括對 motixafortide 在鐮狀細胞疾病(sickle cell disease)中的評估。

  • Indeed, Ayrmid are continuing the development of motixafortide in this indication and have previously reported encouraging results, and we are optimistic that this might contribute to future revenues, given the high unmet need for better mobilization agents in this indication. The current standard of care mobilization agent, G-CSF, is contraindicated in patients with sickle cell disease.

    確實,Ayrmid 正持續推進 motixafortide 在此適應症的開發,且先前已報告令人鼓舞的結果;鑑於此適應症對更佳動員藥物仍有高度未被滿足的需求,我們樂觀認為這可能有助於未來收入。在鐮狀細胞疾病患者中,目前標準照護的動員藥物 G-CSF 為禁忌使用。

  • So there is an urgent need for an agent that can reliably produce the exceptionally large quantities of stem cells that manufacturing and transplantation require in this indication, more than 20 million CD34 positive cells per kilogram without further burdening already constrained apheresis capacity.

    因此,迫切需要一種藥物,能在不進一步加重本已受限的單採(apheresis)產能負擔下,可靠地產生此適應症於製造與移植所需的極大量幹細胞——每公斤超過 2,000 萬個 CD34 陽性細胞。

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

    現在我把電話交給 Mali,請她提供更詳細的財務更新。Mali,請開始。

  • Mali Zeevi - Chief Financial Officer

    Mali Zeevi - Chief Financial Officer

  • Thank you, Phil. As is our practice, I will only go over the most significant items in our financial statements, revenues, research and development expenses, general and administrative expenses, nonoperating income, net loss and cash. I invite you to review the 6-K that we filed this morning that contains our financials and press release. Revenues for the three months ended March 31, 2026, were $0.5 million, an increase of $0.2 million compared to revenues of $0.3 million for the 3 months ended March 31, 2025. The increase in revenues from 2025 to 2026 reflects an increase in royalties paid by Ayrmid from the commercialization of APHEXDA.

    謝謝你,Phil。依照我們的慣例,我只會說明財務報表中最重要的項目:營收、研發費用、一般及行政費用、營業外收入、淨損以及現金。我也邀請各位查閱我們今天早上提交的 6-K,其中包含我們的財務資料與新聞稿。截至 2026 年 3 月 31 日止三個月的營收為 50 萬美元,較截至 2025 年 3 月 31 日止三個月的 30 萬美元增加 20 萬美元。2025 年至 2026 年營收增加,反映 Ayrmid 因 APHEXDA 商業化而支付的權利金增加。

  • Research and development expenses for the three months ended March 31, 2026, were $2.5 million, an increase of $0.9 million compared to $1.6 million for the three months ended March 31, 2025. The increase resulted primarily from expenses related to the new GLIX1 project. General and administrative expenses for the three months ended March 31, 2026, were $0.9 million, an increase of $0.1 million compared to $1 million for the three months ended March 31, 2025. The decrease resulted primarily from a decrease in legal expenses as well as a decrease in a number of other general and administrative expenses. Net nonoperating income amounted to $0.5 million for the three months ended March 31, 2026, compared to net nonoperating income of $7.6 million for the three months ended March 31, 2025.

    截至 2026 年 3 月 31 日止三個月的研發費用為 250 萬美元,較截至 2025 年 3 月 31 日止三個月的 160 萬美元增加 90 萬美元。增加主要來自新 GLIX1 專案相關費用。截至 2026 年 3 月 31 日止三個月的一般及行政費用為 90 萬美元,較截至 2025 年 3 月 31 日止三個月的 100 萬美元增加 10 萬美元。下降主要來自法律費用減少,以及其他多項一般及行政費用的下降。截至 2026 年 3 月 31 日止三個月的淨營業外收入為 50 萬美元,相較於截至 2025 年 3 月 31 日止三個月的淨營業外收入 760 萬美元。

  • Nonoperating income for the period primarily relates to noncash fair value adjustment of warrant liabilities as a result of changes in the company's share price, offset by warrant offering expenses. Net loss for the quarter ended March 31, 2026, was $2.6 million compared to net income of $5.1 million for the quarter ended March 31, 2025. In terms of cash, we ended the quarter with cash and equivalents of $17.4 million, which is sufficient to fund our operating plan as currently contemplated into the first half of 2027.

    本期間的營業外收入主要與認股權證負債的非現金公允價值調整有關,該調整係因公司股價變動所致,並由認股權證發行費用所抵銷。截至 2026 年 3 月 31 日止季度的淨損為 260 萬美元,相較於截至 2025 年 3 月 31 日止季度的淨利 510 萬美元。就現金而言,本季度末我們的現金及約當現金為 1,740 萬美元,足以依目前規劃的營運計畫支應至 2027 年上半年。

  • And with that, I'll turn the call back over to Philip.

    以上,我把電話交回給 Philip。

  • Philip Serlin - Chief Executive Officer

    Philip Serlin - Chief Executive Officer

  • Thank you, Mali, and thank you to everyone joining this call. Operator, we will now open the call to questions.

    謝謝你,Mali,也謝謝所有參與本次電話會議的各位。接線員,我們現在開放提問。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Justin Walsh, JonesTrading.

    Justin Walsh,JonesTrading。

  • Justin Walsh - Equity Analyst

    Justin Walsh - Equity Analyst

  • Hi. Thanks for taking the question. Now that dosing is underway for the Phase 1/2a trial, it would be great to hear your thoughts on the current development landscape in GBM and how challenging or competitive it is to enroll patients in this population?

    嗨,謝謝讓我提問。既然第 1/2a 期試驗已開始給藥,很希望聽聽你們對 GBM 目前研發版圖的看法,以及在這個族群招募病患的難度或競爭程度如何?

  • Philip Serlin - Chief Executive Officer

    Philip Serlin - Chief Executive Officer

  • Yeah, hi. Good morning. So I mean, this is sort of a wide-open area right now. There are a number of drugs in development, but it's still -- there really -- nothing is really working at this point. I mean there are some medical devices, for example, the TT fields device. But in GBM, in biological area, the biologics or pharmaceuticals therapeutics, there just is not that much. And so, we are not seeing any significant problem with recruitment at this point, and we don't expect any.

    是的,嗨,早安。我的意思是,這目前算是一個相當開放的領域。有不少藥物正在開發中,但仍然——真的——到目前為止沒有什麼真正有效。我是說,有一些醫療器材,例如 TT fields 裝置。但在 GBM 的生物領域,也就是生物製劑或藥物治療方面,確實沒有太多。因此,我們目前沒有看到招募上有任何顯著問題,也不預期會有。

  • Ella, would you like to add anything?

    Ella,你想補充什麼嗎?

  • Ella Sorani - Chief Development Officer

    Ella Sorani - Chief Development Officer

  • Yes. I would. Hi, Justin, it's Ella. Just to elaborate on what Phil is saying, you know that the current study is being performed in recurrent and progressive GBM patients. So for this patient population, currently, there is no real competition in terms of recruitment. So we expect recruitment, unfortunately, of course, for the patients. But in terms of the recruitment for this study with this patient population, we don't see any issue with recruitment.

    是的,我想補充。嗨,Justin,我是 Ella。為了更詳細說明 Phil 的意思,你知道目前這項研究是在復發與進展中的 GBM 病患中進行。因此,就這個病患族群而言,目前在招募方面並沒有真正的競爭。所以我們預期招募——當然,對病患而言很不幸——但就本研究在此病患族群的招募而言,我們不認為會有任何招募問題。

  • Justin Walsh - Equity Analyst

    Justin Walsh - Equity Analyst

  • Great. Thanks for taking the question.

    很好,謝謝讓我提問。

  • Operator

    Operator

  • Joe Pantginis, HC Wainwright.

    Joe Pantginis,HC Wainwright。

  • Unidentified Participant

    Unidentified Participant

  • Morning. This is Josh on for Joe. Thanks for taking our questions. So for our first one, could you provide an update on activation status at Northwestern and Moffitt? Are all three centers now open and screening and enrolling patients? And now that the first patient has been dosed with GLIX1, are there any initial safety observations you're able to share with us?

    早安。我是 Josh,代 Joe 發言。謝謝回答我們的問題。第一個問題,能否提供 Northwestern 與 Moffitt 的啟動狀態更新?目前三個中心是否都已開放並開始篩選與入組病患?另外,既然第一位病患已接受 GLIX1 給藥,是否有任何初步的安全性觀察可以與我們分享?

  • Philip Serlin - Chief Executive Officer

    Philip Serlin - Chief Executive Officer

  • Hi. So we can't really -- we haven't really given disclosure about the status of each one of the sites. Obviously, NYU is up and recruiting. We are working with the other sites, but that's really all I can say about now. But they will be open very shortly. As far as -- what was the second part of the question?

    嗨。所以我們其實——我們尚未就各個研究中心的狀態提供揭露。很明顯,NYU 已經啟動並正在招募。我們正在與其他中心合作,但目前我能說的也就只有這些。不過它們很快就會開放。至於——問題的第二部分是什麼?

  • Ella Sorani - Chief Development Officer

    Ella Sorani - Chief Development Officer

  • If you can update on the sales.

    如果你能更新一下銷售情況。

  • Philip Serlin - Chief Executive Officer

    Philip Serlin - Chief Executive Officer

  • Yeah, we can't really do that. I'm sorry. But we do plan to give periodic updates and not wait until the very end. But right now, we -- there's nothing really we can say.

    是的,我們其實無法那樣做。很抱歉。但我們確實計畫定期提供更新,而不是等到最後才說。不過目前我們——真的沒有什麼可以說的。

  • Unidentified Participant

    Unidentified Participant

  • Okay. Thank you so much.

    好的。非常感謝。

  • Operator

    Operator

  • John Vandermosten, Zacks.

    John Vandermosten,Zacks。

  • John Vandermosten - Analyst

    John Vandermosten - Analyst

  • Thank you. And good to hear you guys' voices, Phil, Mali and Ella. I thought I'd start with a question on the CheMo4METPANC trial. And just trying to get a sense -- I want to get a sense of anticipated next steps if it's successful and anticipated conclusion of it, thinking about modeling purposes, just in timing and what might be coming up in the next few quarters, years?

    謝謝。也很高興聽到你們的聲音,Phil、Mali 和 Ella。我想先從 CheMo4METPANC 試驗的問題開始。想了解一下——如果試驗成功,預期的下一步是什麼,以及預期何時結束;就建模用途而言,主要是時間點,以及未來幾個季度、幾年可能會有哪些進展?

  • Philip Serlin - Chief Executive Officer

    Philip Serlin - Chief Executive Officer

  • Yeah. So hi, John, it's good to hear your voice as well. So we've already indicated that we expect to have an interim futility analysis sometime later this year when 40% of the PFS events occur, and that's still on track, et cetera. As far as next steps, I mean, I think that we can't ignore the fact that there was new data from Revolution Medicine that has come out that may have a significant effect on the PDAC landscape at this point. And so obviously, that's good news for the patients.

    是的。嗨,John,也很高興聽到你的聲音。我們已經指出,我們預期在今年稍晚、當 40% 的 PFS 事件發生時,會進行一次期中無效性分析(interim futility analysis),目前仍按計畫進行等等。至於下一步,我的意思是,我們不能忽視 Revolution Medicine 最近公布的新數據,這些數據在此時點可能會對 PDAC 的治療格局產生重大影響。所以很明顯,這對病患來說是好消息。

  • But we are looking at what the signals -- what signal we would like to see and what would support CXCR4 inhibition as sort of a backbone agnostic adjunctive strategy across various treatment platforms because we expect probably the treatment platform and the treatment paradigm will be changing in the next couple of years. And so I think that we have to look at the data that we see and then make some decisions later on about how best to proceed.

    但我們正在評估我們希望看到哪些訊號——哪些訊號能支持 CXCR4 抑制作為一種不依賴特定骨幹療法(backbone agnostic)的輔助策略,能跨各種治療平台使用,因為我們預期在未來幾年內,治療平台與治療典範可能會改變。因此我認為,我們必須先看我們所看到的數據,然後再於稍後做出如何最佳推進的決策。

  • John Vandermosten - Analyst

    John Vandermosten - Analyst

  • Got it. And shifting over to the APHEXDA efforts. I was wondering if you could provide any metrics or just kind of perhaps your discussions with Ayrmid because they're a private company and they don't really provide data. But just in terms of regions covered, sales professionals allocated to the product, I also had listed your payer coverage, marketing budget, digital strategies used, just kind of the general topics that one would think about when launching a product in the first few years of commercialization?

    了解。接著談 APHEXDA 的推進。我想請問你們是否能提供任何指標,或是大致分享你們與 Ayrmid 的討論情況,因為他們是私人公司,不太提供數據。但就涵蓋的區域、配置到該產品的銷售人員數量,我也列了你們的付款方覆蓋(payer coverage)、行銷預算、使用的數位策略等——也就是一般在產品商業化前幾年上市時會考量的主題?

  • Philip Serlin - Chief Executive Officer

    Philip Serlin - Chief Executive Officer

  • Yeah. I mean those are really good questions. And I mean, there's very little I can give you any detail about. We're not giving guidance on what Ayrmid is doing. But I will say I can point out to the fact that, as I mentioned on the call, their sales -- the sales of APHEXDA in this Q1 2026 versus 2025 have significantly increased from, I think, $1.3 million or $1.4 million last year to $2.5 million this year.

    是的。這些問題都很好。但我能提供的細節非常有限。我們不會就 Ayrmid 正在做什麼提供指引。不過我可以指出,如同我在電話會議中提到的,他們在 2026 會計年度第一季(Q1 2026)相較於 2025 年的 APHEXDA 銷售額顯著增加,從去年約 130 萬或 140 萬美元增加到今年的 250 萬美元。

  • So this is, I think, at least from our perspective, is good news because we're seeing after sort of the year that we did the initial launch and then they took over for us and then sort of it took them a while to get things moving. And so I think from our perspective, this is very good news because it shows a significant increase from last year, and we hope that this will sort of be the new line, so to speak, or the new curve going up for the future. That's really all I can say at this point regarding APHEXDA sales.

    所以我認為,至少從我們的角度來看,這是好消息,因為我們看到在我們完成初始上市的那一年之後,他們接手,然後他們花了一些時間才讓事情運轉起來。因此從我們的角度看,這非常正面,因為它顯示相較去年有顯著成長,我們也希望這會成為未來所謂的新基準線,或是新的上升曲線。就 APHEXDA 的銷售而言,目前我只能說到這裡。

  • John Vandermosten - Analyst

    John Vandermosten - Analyst

  • Okay. Thanks, Phil. And then last question on GLIX1. You had put out some discussions of the preclinical data that's going to be presented later. And one of the metrics was, I think, up to 2,000 milligrams per kg were used in rats. What dose level do you think would be the absolute maximum in the clinical trials?

    好的。謝謝,Phil。最後一個關於 GLIX1 的問題。你們先前提到稍後將發表的臨床前數據,其中一個指標是,我記得在大鼠中使用了最高達每公斤 2,000 毫克的劑量。你認為在臨床試驗中,絕對最高的劑量水準會是多少?

  • Ella Sorani - Chief Development Officer

    Ella Sorani - Chief Development Officer

  • We haven't disclosed the doses yet.

    我們尚未揭露劑量。

  • Philip Serlin - Chief Executive Officer

    Philip Serlin - Chief Executive Officer

  • Yeah. I'm sorry, we haven't disclosed the doses at this point. So there's not much that we can tell you. There are -- I think there are a number of dose levels in this particular trial, but I don't think that we can give you that information. It's primarily from a trade secret perspective at this point.

    是的,很抱歉,我們目前尚未揭露劑量。所以我們能告訴你的不多。這項試驗中——我想有若干個劑量水準,但我不認為我們可以提供該資訊。就目前而言,主要是出於商業機密的考量。

  • John Vandermosten - Analyst

    John Vandermosten - Analyst

  • Okay. Well, we'll keep our eyes open for updates on the GLIX1 trial.

    好的。我們會持續關注 GLIX1 試驗的更新。

  • Ella Sorani - Chief Development Officer

    Ella Sorani - Chief Development Officer

  • Just to elaborate on that, you referred to the dose of 2,000 milligram in rats in terms of the safety. So this gives us, in any case, a huge safety margin with regards to doses expected to be given in the clinic. So we have --

    補充說明一下,你提到在大鼠中 2,000 毫克的劑量是就安全性而言。因此無論如何,這都顯示相對於預期在臨床給藥的劑量,我們有非常大的安全邊際。所以我們——

  • John Vandermosten - Analyst

    John Vandermosten - Analyst

  • Right. And that was my thought. I mean maybe it's 100 or 1,000 times what it might be. I guess that's what I was trying to get a sense for.

    對。這也是我的想法。我的意思是,也許那是可能臨床劑量的 100 倍或 1,000 倍。我想我是在試著掌握這個量級。

  • Ella Sorani - Chief Development Officer

    Ella Sorani - Chief Development Officer

  • We haven't disclosed the doses to be used, but we have a huge safety margin with regards to -- based on the excellent safety we had in the tox study as compared to the doses we are going to give in the clinic.

    我們尚未揭露將使用的劑量,但就——基於我們在毒理研究(tox study)中所得到的優異安全性、相較於我們將在臨床給予的劑量而言,我們確實有非常大的安全邊際。

  • John Vandermosten - Analyst

    John Vandermosten - Analyst

  • Okay. Thank you, Ella. Appreciate it.

    好的。謝謝你,Ella。感謝。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • 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 先生進行結語之前,我想提醒各位與會者,本次電話會議的重播預計將在會議結束 2 小時後開始。在美國,請撥打 1 (888) 295-2634。在以色列,請撥打 (03) 9255-904。國際來電,請撥打 9723-9255-904。

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

    Serlin 先生,您是否要發表結語?

  • Philip Serlin - Chief Executive Officer

    Philip Serlin - Chief Executive Officer

  • Yes. Thank you, operator. In closing, we remain very excited about our recent progress, and we believe that we are well positioned to drive meaningful innovation for patients with some of the most challenging cancer types. I remain very optimistic about what the future holds for BioLineRx this year and beyond. Thank you all very much for your continued interest in BioLineRx. Be safe and have a great day.

    是的。謝謝你,接線員。最後,我們對近期的進展仍感到非常振奮,並相信我們已做好充分準備,能為一些最具挑戰性的癌症類型患者帶來有意義的創新。我對 BioLineRx 今年及未來的發展仍非常樂觀。非常感謝各位持續關注 BioLineRx。請注意安全,祝各位有美好的一天。

  • Operator

    Operator

  • This concludes the BioLineRx investors call. Thank you for your participation. You may go ahead and disconnect.

    BioLineRx 投資人電話會議到此結束。感謝各位的參與。您現在可以掛線。