Lantern Pharma Inc (LTRN) 2024 Q1 法說會逐字稿

Good afternoon, and welcome to our first-quarter 2024 earnings call. (Operator Instructions) A webcast replay of today's conference call will be available on our website at lanternpharma.com shortly after the call.

下午好，歡迎參加我們的 2024 年第一季財報電話會議。（操作員說明）今天電話會議的網路廣播重播將在電話會議結束後不久在我們的網站 Lanternpharma.com 上提供。

We issued a press release after market close today, summarizing our financial results and progress across the company for the first quarter ended March 31, 2024. A copy of this release is available through our website at lanternpharma.com, where you will also find a link to the slides management will be referencing on today's call.

今天收盤後，我們發布了一份新聞稿，總結了截至 2024 年 3 月 31 日的第一季的財務表現和整個公司的進展。新聞稿的副本可透過我們的網站 Lanternpharma.com 取得，您也可以在其中找到指向今天電話會議中將引用的幻燈片管理的連結。

We would like to remind everyone that remarks about future expectations, performance, estimates, and prospects constitute forward-looking statements for purposes of Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Lantern Pharma cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated.

我們想提醒大家，有關未來預期、績效、估計和前景的言論構成前瞻性陳述，符合 1995 年《私人證券訴訟改革法案》中的安全港條款。Lantern Pharma 警告稱，這些前瞻性聲明存在風險和不確定性，可能導致實際結果與預期有重大差異。

A number of factors could cause actual results to differ materially from those indicated by forward-looking statements, including results of clinical trials and the impact of competition. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements can be found in our annual report on Form 10-K for the year ended December 31, 2023, which is on file with the SEC and available on our website.

許多因素可能導致實際結果與前瞻性陳述所示的結果有重大差異，包括臨床試驗結果和競爭的影響。有關可能導致實際結果與前瞻性陳述中的結果存在重大差異的因素的更多信息，請參閱我們截至 2023 年 12 月 31 日的 10-K 表格年度報告，該報告已向 SEC 備案並可供查閱在我們的網站上。

Forward-looking statements made on this conference call are as of today, May 9, 2024, and Lantern Pharma does not intend to update any of these forward-looking statements to reflect events from circumstances after today, unless required by law. The webcast replay of the conference call and webinar will be available on Lantern's website.

本次電話會議中所做的前瞻性陳述截至今天，即 2024 年 5 月 9 日，除非法律要求，否則 Lantern Pharma 不打算更新任何這些前瞻性陳述以反映今天之後發生的事件。電話會議和網路研討會的網路直播重播將在 Lantern 網站上提供。

On today's webcast, we have Lantern Pharma CEO, Panna Sharma; and CFO, David Margrave. Panna will start things off with an overview of Lantern's strategy and business model and highlight recent achievements in our operations, after which, David will discuss our financial results. This will be followed by some concluding comments from Panna, and then we'll open the call for Q&A.

在今天的網路直播中，我們有 Lantern Pharma 執行長 Panna Sharma；財務長大衛·馬格雷夫。Panna 將首先概述 Lantern 的策略和商業模式，並重點介紹我們最近在營運中的成就，之後 David 將討論我們的財務表現。接下來是 Panna 的一些總結性評論，然後我們將開始問答環節。

I'd now like to turn the call over to Panna Sharma, President and CEO of Lantern Pharma. Panna, please go ahead.

我現在想將電話轉給 Lantern Pharma 總裁兼執行長 Panna Sharma。潘娜，請繼續。

Thanks, Maddie. And good afternoon, everyone. Thank you for joining us to hear about productive first quarter of 2024 and our financial results as well as other corporate progress.

謝謝，麥迪。大家下午好。感謝您加入我們，了解 2024 年第一季的富有成效的情況、我們的財務表現以及其他公司進展。

As many of you have heard me say in the past, computational and AI-driven approaches are increasing their presence in usage at both large and emerging pharma companies for all facets of drug discovery and development. At no time has this been more evident than now in early 2024, where every facet of pharma development from design of molecules to disease modeling to simulations, and even in areas like manufacturing and clinical trial recruiting, are being rethought as a result of the widespread availability of computational capabilities, high-quality data, and automation.

正如你們許多人過去聽我說過的那樣，計算和人工智慧驅動的方法正在增加大型和新興製藥公司在藥物發現和開發各個方面的使用。這在 2024 年初最為明顯，從分子設計到疾病建模再到模擬，甚至在製造和臨床試驗招募等領域，製藥開發的各個方面都在重新考慮，因為廣泛的計算能力、高品質數據和自動化的可用性。

Our company's leadership in the innovative use of AI and machine learning to transform costs and timelines and the development of precision oncology therapies should yield significant returns for investors and patients as our industry matures and adopts an AI-centric data-first approach to drug development. We recently demonstrated this with our newly formed collaboration with Oregon Therapeutics, where we will help them accelerate their path to the clinic and also receive upside and benefits as a result of the insights and IP from the collaborations.

隨著我們的行業日趨成熟並採用以人工智慧為中心的數據優先方法進行藥物開發，我們公司在創新利用人工智慧和機器學習來改變成本和時間表以及開發精準腫瘤治療方面的領導地位將為投資者和患者帶來可觀的回報。我們最近透過與 Oregon Therapeutics 新建立的合作證明了這一點，我們將幫助他們加速進入臨床的道路，並從合作中獲得見解和智慧財產權，從而獲得好處和好處。

We expect more activity and deals where we can continue to use our AI platform, RADR, as currency for collaborations, partnerships, and co-development opportunities. 2023 was a transformational year for Lantern Pharma across many measures, and I shared that with all of you who listened in on our March 18 earnings call.

我們期待更多的活動和交易，讓我們能夠繼續使用我們的人工智慧平台 RADR，作為合作、夥伴關係和共同開發機會的貨幣。從許多方面來看，2023 年對 Lantern Pharma 來說都是轉型的一年，我與所有收聽我們 3 月 18 日財報電話會議的人分享了這一點。

But so far in this quarter, we continue to see the pace of progress and this includes across our entire three AI guided molecules that are now in clinical trials: LP-184, LP-284, and LP-300. And each one of them is in areas of high unmet need, with LP-184 on track for a clinical readout later this year. We expect in late summer, early fall.

但本季到目前為止，我們繼續看到進展的步伐，其中包括目前正在進行臨床試驗的全部三種人工智慧引導分子：LP-184、LP-284 和 LP-300。它們中的每一個都屬於需求未被滿足的領域，LP-184 預計將在今年稍後進行臨床試驗。我們預計夏末秋初。

Some of the other highlights, besides 184 and 284, include obtaining regulatory allowance to begin our Phase 2 in Japan and Taiwan, where we expect more rapid enrollments, especially since 30% to 35% of all lung cancer cases occur in never smokers in those countries. We've so far had a great safety profile with Phase 1 clinical trials for both of our synthetic lethal drug candidates, LP-184 and LP-284. They continue to advance in cohorts, but we see no dose limiting toxicities in any of the cohorts enrolled and dosed to date. These two drugs combined have annual global sales potential of over $12 billion.

除了184 和284 之外，其他一些亮點包括獲得監管津貼，以便在日本和台灣開始我們的第二階段，我們預計這些地區的入組速度會更快，特別是因為所有肺癌病例中有30% 至35% 發生在這些國家的從不吸煙者。到目前為止，我們的兩種合成致命候選藥物 LP-184 和 LP-284 的 1 期臨床試驗都具有良好的安全性。他們在隊列中繼續取得進展，但我們在迄今為止登記和給藥的任何隊列中都沒有發現劑量限制性毒性。這兩種藥物的全球年銷售潛力合計超過 120 億美元。

We're also advancing Starlight. It's our subsidiary focused on CNS and brain cancers. With STAR-001, we filed a clinical trial protocol for the Phase 1b dose optimization and expansion cohort in a very malignant form of brain cancer, recurrent IDH wild-type high-grade gliomas. We also had ongoing advancements in our AI power module for ADC development, where we can streamline and guide the differentiated development of new ADCs, which will be instrumental in the next generation of drug candidates, not only for industry, but also for Lantern Pharma and our collaborators.

我們也在推進星光計劃。這是我們專注於中樞神經系統和腦癌的子公司。透過 STAR-001，我們提交了一個非常惡性的腦癌（復發性 IDH 野生型高級別神經膠質瘤）的 1b 期劑量優化和擴展隊列的臨床試驗方案。我們在用於ADC 開發的AI 電源模組方面也取得了持續進步，我們可以簡化和指導新ADC 的差異化開發，這將有助於下一代候選藥物的開發，不僅對工業界，而且對Lantern Pharma和我們的合作者。

And also, we established an AI-driven collaboration with Oregon Therapeutics, a very unique French biotech that's using a very unique small molecule to transform cancer metabolism. We'll be leveraging RADR there for this novel first-in-class inhibitor.

此外，我們還與 Oregon Therapeutics 建立了人工智慧驅動的合作，這是一家非常獨特的法國生物技術公司，它使用一種非常獨特的小分子來改變癌症代謝。我們將利用 RADR 來開發這種新型的一流抑制劑。

Let's talk a little bit first about our pipeline. Many of the initial observations that were made with the help of RADR are now being witnessed in the clinic. As many of you know, RADR has guided the rapid and efficient development of our three AI-guided drugs into clinical trials at a pace and cost that is traditionally unheard of in our industry. Let me walk you through some of the highlights of our portfolio before I start talking about Starlight and our emerging portfolio in ADCs.

讓我們先談談我們的管道。在 RADR 的幫助下進行的許多初步觀察現在正在診所得到證實。正如你們許多人所知，RADR 指導我們的三種人工智慧引導藥物快速且有效率地開發進入臨床試驗，其速度和成本在我們行業中是聞所未聞的。在開始談論 Starlight 和我們在 ADC 領域的新興產品組合之前，讓我先向您介紹一下我們產品組合的一些亮點。

With LP-184 first, many clinicians are particularly excited about and interested in the programs for these first-in-human synthetically lethal drug candidates. We've now gone through five cohorts of patients in LP-184, comprised of dose levels one through five in escalating doses. We're now in dose level six. This is a first-in-human Phase 1 trial across multiple solid tumor indications. And these solid tumors are typically advanced or refractory to existing standard of care therapies.

憑藉 LP-184，許多臨床醫生對這些首個人體合成致死候選藥物的計畫感到特別興奮和感興趣。我們現在已經對 LP-184 的五組患者進行了研究，其中劑量水平從一到五，劑量逐漸遞增。我們現在處於六級劑量。這是針對多種實體腫瘤適應症的首次人體第 1 期試驗。這些實體腫瘤通常是晚期或現有標準護理療法難以治療。

In fact, the trial is now enrolling at dose level six, and these are typically about, what we've seen so far, median prior lines of therapy have been about four lines of prior therapy for these patients. And so far, again, no observed dose-limiting toxicities. The company believes that enrollment should be complete at this summer and on track for readout of the data soon thereafter. Our current enrollment efforts are focused, especially on cancer patients that had DNA damage repair deficiency or what we'll refer to as DDR deficient tumors.

事實上，該試驗現在正在以六級劑量進行招募，這些通常是關於我們迄今為止所看到的，這些患者的先前治療中位數約為四線。到目前為止，再次沒有觀察到劑量限制性毒性。該公司認為，註冊工作應在今年夏天完成，並預計在隨後不久讀出數據。我們目前的招募工作主要集中在 DNA 損傷修復缺陷的癌症患者或我們稱為 DDR 缺陷腫瘤的患者。

For those of you that have looked at the press release, you probably have saw that we had a great publication focused on DDR deficient tumors and their sensitivity to LP-184. But many of the genomic alterations, both especially non-CNS in solid tumors include BRCA 1 and 2, PTEN, PRKDC, ATR, POLE, ERCC6, ERCC3, FANCM, DDB1, SLX4, MLH3, MDC1. It's an alphabet soup, but what that tells us, most importantly, it is a wide range of genetically defined tumors that we will include as the definition of DDR deficient. And many of these are already available in mutation and expression panels that are available today.

對於看過新聞稿的人來說，您可能已經看到我們有一篇很棒的出版物，重點關注 DDR 缺陷腫瘤及其對 LP-184 的敏感性。但許多基因組改變，尤其是實體瘤中的非 CNS 改變，包括 BRCA 1 和 2、PTEN、PRKDC、ATR、POLE、ERCC6、ERCC3、FANCM、DDB1、SLX4、MLH3、MDC1。這是一個字母湯，但最重要的是，它告訴我們的是，我們將把它納入 DDR 缺陷的定義中，這是一個廣泛的基因定義的腫瘤。其中許多已經在今天可用的突變和表達面板中提供。

So that's great news. But also what we've done is we submitted a Supplement A and Supplement B. These are both supplements to the FDA related to LP-184. Supplement A is specifically focused in non-CNS solid tumors, including TNBC. And Supplement B is also dose optimization and expansion protocol in recurrent IDH wild type, and that's Lantern in collaboration with Starlight. So we're already beginning to plan for the next phases. We think we'll have some results to share and move these into some very, very targeted, extremely exciting indications.

這是個好消息。但我們所做的是提交了補充文件 A 和補充文件 B。補充劑 A 特別關注非 CNS 實體瘤，包括 TNBC。Supplement B 也是針對複發性 IDH 野生型的劑量優化和擴展方案，這是 Lantern 與 Starlight 合作的。所以我們已經開始計劃下一階段。我們認為我們將會有一些結果來分享，並將這些結果轉化為一些非常非常有針對性、非常令人興奮的適應症。

Genomics identification of these patients is important and biomarker characterization of their underlying tumor is central to our focus of personalizing treatment, and more importantly, developing efficient later-stage clinical trials. To further this effort, what we've done is also initiated development of a PCR-based molecular diagnostic tests that will help us in the identification of cancer patients with the highest likelihood of response. So I think we're making great progress with 184 across multiple measures.

這些患者的基因組學鑑定非常重要，其潛在腫瘤的生物標記特徵是我們個人化治療的核心，更重要的是，開發有效的後期臨床試驗。為了進一步推進這項工作，我們所做的也啟動了基於 PCR 的分子診斷測試的開發，這將幫助我們識別最有可能緩解的癌症患者。因此，我認為我們在 184 多項措施中取得了巨大進展。

In 284, the initial two cohorts of patients have been dosed. And again, we see no dose-limiting toxicities so far in the Phase 1a clinical trial. We expect to continue opening up new sites. Phase 1 for both 184 and 284 are a little bit staggered, with 284 a few months behind where we are with 184. But 284 has shown nanomolar potency across multiple -- in multiple in-vitro and in-vivo studies, including mantle cell, double-hit lymphomas, advanced NHL cancer subtypes that are fairly aggressive, and also, with certain sarcomas that have DDR deficiencies.

284，最初的兩組患者已經接受了給藥。再說一遍，到目前為止，我們在 1a 期臨床試驗中沒有發現劑量限制性毒性。我們預計將繼續開設新站點。184 和 284 的第一階段有點交錯，284 比我們的 184 落後幾個月。但在多項體外和體內研究中，284 已顯示出納摩爾級的效力，包括套細胞癌、雙重打擊淋巴瘤、具有相當侵襲性的晚期 NHL 癌症亞型，以及某些具有 DDR 缺陷的肉瘤。

With our drug LP-300, it's very unique drug candidate, which is aimed at never smokers that have been impacted by non-small cell lung cancer. It's a growing problem, not only in the US but globally. And we have been successful in achieving regulatory allowance to commensurate trials in Japan and Taiwan, where the incidence rate for non-small cell lung cancer is 2.5 to 3 times that here in the US.

我們的藥物 LP-300 是非常獨特的候選藥物，針對的是受非小細胞肺癌影響的從不吸菸者。這是一個日益嚴重的問題，不僅在美國，而且在全球。我們已經成功地在日本和台灣獲得了相應試驗的監管許可，這些地方的非小細胞肺癌發病率是美國的 2.5 至 3 倍。

That's going to get us to accelerate the collection of patient and response data. And what that means is we'll get to some readouts quicker than we have experienced so far. We've also enrolled the help of one of the premier physicians and researchers focused on lung cancer at the National Cancer Center of Japan, Dr. Yashushi Goto. And Dr. Goto will be our lead PI and collaborator and will be leading the Phase 2 trial in Japan.

這將使我們加快患者和反應數據的收集。這意味著我們將比迄今為止更快獲得一些讀數。我們也聘請了日本國家癌症中心專注於肺癌研究的頂尖醫生和研究人員之一 Yashushi Goto 博士的協助。Goto 博士將成為我們的首席 PI 和合作者，並將領導在日本的第二階段試驗。

We believe that this improves the positioning for LP-300 to develop collaborative and co-development partnerships with global biopharma companies, especially those that have a focus to serve the Asian markets.

我們相信，這改善了 LP-300 的定位，使其能夠與全球生物製藥公司，特別是那些專注於服務亞洲市場的生物製藥公司建立合作和共同開發夥伴關係。

Let's turn quickly to Starlight. We've made some good progress on the launch of our clinical stage CNS and brain cancer focused subsidiary, Starlight Therapeutics. It's a company that has been largely developed as a result of data. Computational approaches to optimize and maximize our insights, understand mechanisms. And these insights have allowed us to create a whole -- what we think is a wholly new company serving a tremendous need.

讓我們快速轉向星光。我們在推出專注於中樞神經系統和腦癌臨床階段的子公司 Starlight Therapeutics 方面取得了一些良好進展。這是一家很大程度上依靠數據而發展的公司。優化和最大化我們的見解、理解機制的計算方法。這些見解使我們能夠創建一個整體——我們認為這是一個全新的公司，可以滿足巨大的需求。

Starlight and our new CMO, Dr. Chamberlain, continued advancements. They filed a clinical trial protocol for the Phase 1b dose optimization, which I mentioned earlier, Supplement B and expansion in recurrent IDH wild type high-grade gliomas. IDH wild type glioblastomas are the most malignant glial tumors with a median survival of about 15 months after diagnosis. So it's a really, really aggressive poor prognosis and very poor, even worse than that in recurrent GBMs, that are IDH wild type.

Starlight 和我們的新任 CMO 張伯倫博士繼續取得進展。他們提交了一份 1b 期劑量優化的臨床試驗方案，我之前提到過，補充 B 和復發性 IDH 野生型高級別神經膠質瘤的擴展。IDH野生型膠質母細胞瘤是最惡性的膠質瘤，診斷後中位存活期約15個月。因此，這是一種非常非常嚴重的不良預後，而且非常差，甚至比 IDH 野生型復發性 GBM 更糟糕。

So in addition to the GBM clinical trial, several other indications have been published on and could be pursued as part of advancing Starlight. These findings, especially in brain mets for TNBC, brain mets in non-small cell lung cancer, especially those that are STK11 or KEAP mutant, and also in a number of pediatric CNS cancers, ATRT, where we've published with the NCI in a major publication in [Frontiers in Cancer], and also diffuse midline gliomas, which include DIPG and other midline gliomas. Again, very poor outcomes.

因此，除了 GBM 臨床試驗之外，其他幾個適應症也已經發表，並且可以作為推進 Starlight 的一部分進行探索。這些發現，特別是在 TNBC 的腦代謝檢查、非小細胞肺癌的腦代謝檢查（尤其是 STK11 或 KEAP 突變體）以及許多兒科中樞神經系統癌症 ATRT 中，我們已與 NCI 一起發表了這些發現[Frontiers in Cancer] 上的主要出版物，以及瀰漫性中線神經膠質瘤，其中包括DIPG 和其他中線神經膠質瘤。再次，結果非常糟糕。

So for us, Starlight's pipeline isn't just focused on one indication. It's focus on, what we believe, is -- could be a cornerstone and focused on multiple indications. Now remember, this is a program that we've been able to develop between $1 million and $2 million per program. It's a milestone unheard of in the realm of oncology drug discovery, including drug manufacturing. And this is driven in large part due to our AI-centric business model. We think this is what more and more of the industry will adopt simply because it massively compresses the timeline in early-stage development, indication selection, mechanistic refinement, and biomarker signature creation.

因此，對我們來說，星光的產品線不僅僅專注於一種適應症。我們相信，它的重點是——可能是一個基石，並專注於多種適應症。現在請記住，我們已經能夠為每個項目開發 100 萬至 200 萬美元的資金。這是腫瘤藥物發現領域（包括藥物製造領域）前所未聞的里程碑。這在很大程度上是由於我們以人工智慧為中心的商業模式所推動的。我們認為，越來越多的產業將採用這種方法，因為它大大壓縮了早期開發、適應症選擇、機製完善和生物標記特徵創建的時間線。

These are things that historically have taken years and years and quarters. We can compress these down. We've also made major progress in developing the next major leg of our discovery efforts, which will be focused on drug conjugates, including antibody drug conjugates. Specifically, we have cryptophycin-linked ADC. It's a very, very novel drug, novel payload, novel mechanism, which so far we're developing in collaboration with our partners in Germany. We'll talk about that later in the call.

從歷史上看，這些事情需要花費數年、數年、數季的時間才能完成。我們可以將這些壓縮下來。我們在開發我們發現工作的下一個主要階段方面也取得了重大進展，該階段將重點關注藥物綴合物，包括抗體藥物綴合物。具體來說，我們有隱藻素連接的 ADC。這是一種非常非常新穎的藥物，新穎的有效負載，新穎的機制，到目前為止，我們正在與德國的合作夥伴合作開發。我們稍後會在電話中討論這個問題。

So we believe we continue to be a leader in this AI golden age that we're hitting in medicine. It's just the beginning. It's powered by large-scale, highly available computing power. It continues to morph a valve with literally every quarter. There's massive data that's available. It's being fed by more high-quality healthcare data, high-quality patient cancer biomarker data. And these capabilities are now being adopted by leading tech bio companies like ourselves, but also very importantly, biopharma is beginning to increasingly turn to it.

因此，我們相信我們將繼續成為醫學領域人工智慧黃金時代的領導者。這只是個開始。它由大規模、高可用的運算能力提供支援。它幾乎每個季度都會對閥門進行變形。有大量可用數據。它由更多高品質的醫療保健數據、高品質的患者癌症生物標記數據提供支援。這些功能現在正被像我們這樣的領先科技生物公司所採用，但同樣非常重要的是，生物製藥也開始越來越多地轉向它。

We believe we're one of the leaders in this transformation at transforming the pace, the risks, and the cost of oncology drug discovery and development. This transformation has a promise not only to make medicines faster and cheaper, but also with greater precision for patients and change the direction of R&D productivity, and more importantly, add value to groups of cancer patients that today don't necessarily always have great medicine and great therapeutic options.

我們相信，在改變腫瘤藥物發現和開發的速度、風險和成本方面，我們是這項轉型的領導者之一。這種轉變不僅有望使藥品更快、更便宜，而且還能為患者提供更高的精確度並改變研發生產力的方向，更重要的是，為當今不一定總是有優質藥物的癌症患者群體增加價值和很好的治療選擇。

So let's turn our focus down to our financial update and highlights with our CFO, David Magrave, who we'll turn the call over to. And David will walk us through our financials. David?

因此，讓我們將注意力轉向我們的財務更新和我們的財務長 David Magrave 的重點，我們將把電話轉給他。大衛將帶我們了解我們的財務狀況。大衛？

Thank you, Panna, and good afternoon, everyone. I'll now share some financial highlights from our first quarter ended March 31, 2024. We recorded a net loss of approximately $5.4 million for the first quarter of 2024 or $0.51 per share compared to a net loss of approximately $3.9 million or $0.36 per share for the first quarter of 2023.

謝謝潘納，大家下午好。現在，我將分享截至 2024 年 3 月 31 日的第一季的一些財務亮點。我們的 2024 年第一季淨虧損約為 540 萬美元，即每股 0.51 美元，而 2023 年第一季的淨虧損約為 390 萬美元，即每股 0.36 美元。

For the first quarter of 2024, our R&D expenses were approximately $4.3 million, up from approximately $2.6 million for the first quarter of 2023. This increase was largely driven by an increase in clinical trial activity and clinical trial site initiations. These R&D increases in Q1 2024 were partially offset by decreases in product candidate manufacturing-related expenses of approximately $204,000.

2024 年第一季度，我們的研發費用約為 430 萬美元，高於 2023 年第一季的約 260 萬美元。這一增長主要是由臨床試驗活動和臨床試驗中心啟動的增加所推動的。2024 年第一季的研發成長被候選產品製造相關費用約 204,000 美元的減少部分抵銷。

Our general and administrative expenses for the first quarter of 2024 were approximately $1.5 million, down slightly from $1.7 million for Q1 2023. The decrease was primarily attributable to decreases in payroll and compensation expense and other professional fees. Our R&D expenses continue to exceed G&A expenses by a strong margin, reflecting our focus on advancing our product candidates and pipeline.

我們 2024 年第一季的一般和管理費用約為 150 萬美元，略低於 2023 年第一季的 170 萬美元。減少的主要原因是工資和薪酬費用以及其他專業費用的減少。我們的研發費用持續大幅超過一般管理費用，反映出我們專注於推進我們的產品候選人和管道。

Our loss from operations in the first quarter of 2024 was partially offset by interest income and other income net, totaling approximately $291,000. Our cash position, which includes cash equivalents and marketable securities, was approximately $38.4 million as of March 31, 2024. We anticipate this balance will provide us with a cash runway into at least Q3 of 2025. Importantly, we believe our solid financial position will fuel continued growth and evolution of our RADR AI platform, accelerate the development of our portfolio of targeted oncology drug candidates, and allow us to introduce additional targeted programs and collaboration opportunities efficiently and effectively.

我們 2024 年第一季的營運損失被利息收入和其他收入淨額部分抵消，總計約 291,000 美元。截至 2024 年 3 月 31 日，我們的現金部位（包括現金等價物和有價證券）約為 3,840 萬美元。我們預計這一餘額將為我們提供至少到 2025 年第三季的現金跑道。重要的是，我們相信我們穩健的財務狀況將推動我們的RADR AI 平台的持續成長和發展，加速我們的標靶腫瘤候選藥物組合的開發，並使我們能夠高效、有效地引入更多的有針對性的項目和合作機會。

As of March 31, 2024, we had 10,758,805 shares of common stock, outstanding warrants to purchase 81,496 shares and outstanding options to purchase 1,077,292 shares. These warrants and options, combined with our outstanding shares of common stock, give us a total fully diluted shares outstanding of approximately 11.92 million shares as of March 31, 2024.

截至2024年3月31日，我們擁有10,758,805股普通股，尚未行使的認股權證可購買81,496股，未行使的選擇權可購買1,077,292股。這些認股權證和選擇權，加上我們已發行的普通股，截至 2024 年 3 月 31 日，我們的完全稀釋後已發行股票總數約為 1,192 萬股。

Lantern issued 20,132 shares of common stock during Q1 2024 relating to the cashless exercise of warrants to purchase 79,021 shares. Also in Q1 2024, Lantern issued 17,481 shares of common stock for aggregate proceeds of approximately $55,000 relating to the exercise of warrants for cash. With these warrant exercises, the amount of common shares covered by warrants was reduced by approximately 97,000 shares. Following these warrant exercises, Lantern now has warrants outstanding to purchase 81,496 shares at a weighted average exercise price of $16.55 per share.

Lantern 在 2024 年第一季發行了 20,132 股普通股，涉及以非現金方式行使認股權證以購買 79,021 股。同樣在 2024 年第一季度，Lantern 發行了 17,481 股普通股，與現金認股權證的行使相關的總收益約為 55,000 美元。透過這些認股權證行使，認股權證所涵蓋的普通股數量減少了約 97,000 股。在這些認股權證行使之後，Lantern 現在擁有未償還認股權證，可以以每股 16.55 美元的加權平均行使價購買 81,496 股股票。

Our team continues to be very productive under a hybrid operating model. We currently have approximately 20 employees and four FTE consultants, focused primarily on leading and advancing our research and drug development efforts. We see this number expanding slightly in coming quarters as we add additional experienced and talented individuals to help advance our mission.

我們的團隊在混合營運模式下持續保持高效率。我們目前擁有約 20 名員工和 4 名 FTE 顧問，主要致力於領導和推進我們的研究和藥物開發工作。隨著我們增加更多經驗豐富、才華橫溢的人員來幫助推進我們的使命，我們預計這一數字在未來幾季將略有擴大。

I'll now turn the call back to Panna for an update on some of our development programs. Panna?

現在我將把電話轉回潘納，以了解我們一些開發計劃的最新情況。潘納？

David, thank you very much. In the past three years, we've successfully developed and launched a lot of additional programs, a testament to the agility, efficiency, and groundbreaking nature of our approach. On average, these programs are advancing from initially AI insights to first-in-human clinical trials in just 2.5 years and an average cost of $2 million to $3 million per program. These are metrics unheard of in oncology drug discovery. This is something even larger biotech companies have not been able to achieve on a consistent basis.

大衛，非常感謝你。在過去三年中，我們成功開發並啟動了許多其他項目，證明了我們方法的敏捷性、效率和突破性。平均而言，這些項目從最初的人工智慧洞察進展到首次人體臨床試驗只花了短短 2.5 年的時間，每個項目的平均成本為 200 萬至 300 萬美元。這些都是腫瘤藥物發現中未曾聽過的指標。這是即使是較大的生技公司也無法持續實現的目標。

Today, we have multiple full drugs dosing patients. We're not just conjecturing about how AI could make drugs. We're actually designing drugs, developing indications, validating them, getting them patented, manufacturing these drugs, and launching them into clinical trials at a pace and cost that's really unheard of. So it's a reminder that the changes that big pharma need to make in terms of the pace can be done.

今天，我們有多名服用完整藥物的患者。我們不僅僅是猜測人工智慧如何製造藥物。我們實際上正在設計藥物、開發適應症、驗證它們、獲得專利、製造這些藥物，並將它們投入臨床試驗，其速度和成本確實是聞所未聞的。因此，這提醒人們，大型製藥公司需要在步伐方面做出的改變是可以完成的。

And these startling figures serve as a stark reminder that the traditional model of big pharma R&D is not sustainable. It's not an effective strategy,. And it's not the right approach to actually improve drug pricing or drug availability. With escalating economic and political pressures over drug prices, drug cost, drug availability, it's clear that our industry needs to rethink its approach fundamentally, and we believe that the increasing adoption of AI- and data-driven technologies and computational approaches will elevate this issue into the future of drug development in pharma.

這些令人震驚的數字清楚地提醒我們，大型製藥公司的傳統研發模式是不可持續的。這不是一個有效的策略。這並不是真正改善藥品定價或藥品供應的正確方法。隨著藥品價格、藥品成本、藥品供應的經濟和政治壓力不斷升級，很明顯，我們的行業需要從根本上重新思考其方法，我們相信，人工智慧和數據驅動技術以及計算方法的日益採用將加劇這問題進入製藥業藥物開發的未來。

The specific instances of value creation along the development of an entirely new company, which will be at clinical stage it at its birth, Starlight Therapeutics, continues to be at the forefront of a transformative approach to oncology drug discovery, and we believe, can set a new standard in cancer drug development. We think Starlight really could be one of many new innovative opportunities to generate new assets and potential new long-term cancer companies.

Starlight Therapeutics 是一家全新公司，在其誕生時就處於臨床階段，其發展過程中創造價值的具體實例繼續處於腫瘤藥物發現變革方法的前沿，我們相信，可以設定癌症藥物開發的新標準。我們認為星光確實可能成為產生新資產和潛在新的長期癌症公司的眾多新創新機會之一。

On June 26, our CMO of Starlight, Dr. Mark Chamberlain, will be discussing the highlights of START-001 and discussing the future development plans as well as the upcoming trials. Please join us at 1:00 PM on June 26. Mark is a walking encyclopedia, neuro oncology and neurology-focused knowledge and trials and papers, and you'll find them absolutely, absolutely fascinating.

6 月 26 日，我們星光公司的首席行銷長 Mark Chamberlain 博士將討論 START-001 的亮點，並討論未來的開發計劃以及即將進行的試驗。請於 6 月 26 日下午 1:00 加入我們。馬克是一本行走的百科全書，以神經腫瘤學和神經病學為中心的知識、試驗和論文，你會發現它們絕對非常令人著迷。

So let me highlight some of the things that get me excited about STAR-001. First of all, it is a uniquely potent molecule that has anti-tumor effect of 3,000 times higher than the existing standard-of-care drug, temozolomide. And unlike temozolomide, it actually doesn't care about the MGMT status. As you know, with MGMT, the tumors become nonresponsive increasingly. Some tumors are MGMT positive at onset. Some develop MGMT methylation as a way to combat chemotherapies like temozolomide or nitrous urea or other forms of attacking the cancer.

那麼讓我重點介紹一些讓我對 STAR-001 感到興奮的事情。首先，它是一種獨特的強效分子，其抗腫瘤效果比現有標準治療藥物替莫唑胺高 3,000 倍。與替莫唑胺不同的是，它實際上並不關心 MGMT 狀態。如您所知，使用 MGMT 後，腫瘤會變得越來越無反應。有些腫瘤在發病時呈現 MGMT 陽性。有些人將 MGMT 甲基化作為對抗替莫唑胺或亞硝酸尿素等化療藥物或其他形式的癌症治療的一種方法。

So what we did is we looked at the very central question. Can we find temozolomide-resistant GBM cell lines? Can we find temozolomide nib responsive? And in both cases, our drug seems to work with super potency.

所以我們所做的就是研究非常核心的問題。我們能找到對替莫唑胺有抗藥性的 GBM 細胞係嗎？我們能找到替莫唑胺筆尖有反應嗎？在這兩種情況下，我們的藥物似乎都具有超強功效。

In some of the studies that we did, both MGMT negative and MGMT positive, superior potency across the board and sometimes super high-potency, especially in one of the cell lines that was MGMT positive and didn't respond at all to temozolomide, which you can see on the far -- I believe, probably your far right on the slide.

在我們所做的一些研究中，無論是 MGMT 陰性還是 MGMT 陽性，都具有全面的優異效力，有時甚至是超高效力，特別是在 MGMT 陽性且對替莫唑胺根本沒有反應的細胞系之一中，這你可以看到遠處——我相信，可能是你在幻燈片的最右邊。

So no single therapy agent has been approved in adult GBM. We have an orphan drug designation to treat malignant gliomas, including GBM. We've shown effectiveness in both, which will actually help us with the trial. And we're going to go after recurrent IDH wild type, which, again, as I pointed out earlier in our discussion, there's an area of high critical need. We plan on launching this in the second half of 2024.

因此，尚未批准單一治療藥物治療成人 GBM。我們擁有治療惡性膠質瘤（包括 GBM）的孤兒藥資格。我們在這兩個方面都表現出了有效性，這實際上對我們的試驗有幫助。我們將追蹤復發性 IDH 野生型，正如我在前面的討論中指出的那樣，這是一個迫切需要的領域。我們計劃在 2024 年下半年推出此服務。

There's also a couple of other reasons why I would like to talk about how this drug is positioned. Actually, it's a prodrug. And it's -- we think it could be a central fixture in GBM, what they call the armamentarium. So it's got a -- like I mentioned, a wonderful IC50 value kind of ranges.

我想談談這種藥物的定位還有其他幾個原因。實際上，它是一種前藥。我們認為它可能是 GBM 的核心裝置，他們稱之為軍備庫。所以它有一個——就像我提到的那樣，一個很棒的 IC50 值範圍。

Sometimes even sub-100 nanomolar in some cancers, some CNS cancers. But on average, we've seen it very sub-micromolar kind of 100 to 200 nanomolar potency, which is much more potent than some of the current mainstay approved GBMs.

有時，在某些癌症（某些中樞神經系統癌症）中甚至低於 100 納摩爾。但平均而言，我們已經看到它的效力非常亞微摩爾，為 100 至 200 納摩爾，這比目前批准的一些主流 GBM 更有效。

It works through alkylation, which is an accepted well understood way to create DNA breaks. And unlike most of the temzolimide and some of the nitrous ureas as well, it creates double-stranded breaks in a unique position at the adenosine position. And these double-stranded bricks can't repair themselves. And the elimination period that we've seen so far, that can be about 30 minutes.

它透過烷基化發揮作用，這是一種公認的、眾所周知的造成 DNA 斷裂的方式。與大多數替莫利胺和一些亞硝脲不同，它在腺苷位置的獨特位置上產生雙股斷裂。而且這些雙股磚塊無法自我修復。到目前為止，我們看到的淘汰期大約是 30 分鐘。

Now the bioctivation, the prodrug I mentioned, this is a very unique feature because the bioctivation occurs intracellularly. That means once it's inside the cancer cell, so its ability to damage the cells that are outside is pretty low. And we'll see the safety data continues to come in from our trials. But again, as I mentioned, we haven't seen a dose-limiting toxicity.

現在，生物激活，我提到的前藥，這是一個非常獨特的特徵，因為生物激活發生在細胞內。這意味著一旦它進入癌細胞內部，那麼它損害外部細胞的能力就非常低。我們將看到我們的試驗繼續提供安全數據。但正如我所提到的，我們還沒有看到劑量限制性毒性。

But like other alkylating agents, we do think it will probably have the typical alkylating agent kind of nausea and vomiting potentially as we increase doses, but those can be easily managed in the clinic. So bioactivation inside the cancer cell, intracellularly through PTGR1. It has a wonderful IC50 value and a well-known mechanism of elimination in about a 30-minute period.

但與其他烷化劑一樣，我們確實認為，當我們增加劑量時，它可能會出現典型的烷化劑類型的噁心和嘔吐，但這些在臨床上很容易控制。因此，癌細胞內的生物活化是透過細胞內的 PTGR1 進行的。它具有出色的 IC50 值和眾所周知的在大約 30 分鐘內消除的機制。

And these are some strong unique features of this drug. It has shown to be also active in, like I mentioned, a number of different CNS cancers. So this drug really was born from lots of data points. And this is critical because we naturally moved from in vitro to in vivo to more advanced in vivo models. And now we're moving it to humans.

這些是這種藥物的一些強大的獨特功能。正如我所提到的，它已被證明對許多不同的中樞神經系統癌症也很活躍。所以這種藥物確實是從大量的數據點誕生。這很重要，因為我們自然地從體外轉向體內，轉向更先進的體內模型。現在我們正在將其轉移到人類身上。

In fact, in the current Phase 1a safety trial, we have enrolled GBM patients. And so we're watching them very carefully to see what we can understand and learn about the GBM dosing, GBM response, and also the safety features early on that will guide and inform the later Starlight trials.

事實上，在目前的 1a 期安全性試驗中，我們已經招募了 GBM 患者。因此，我們正在非常仔細地觀察它們，看看我們可以理解和了解 GBM 劑量、GBM 反應以及早期的安全特徵，這些特徵將為以後的星光試驗提供指導和資訊。

Now, another area that we've been working in is a highly promising area of antibody drug conjugates. It's a very high-growth area. And we -- this will be incorporated entirely, obviously, into our RADAR module. And so in the radar platform, we've been able to actually advance the development of our -- the current RADAR module by identifying targets and indications for clinically valuable and needed indications. And that has allowed us to also rescue -- repurpose a lot of the code inside of our RADAR module.

現在，我們一直在研究的另一個領域是非常有前途的抗體藥物偶聯物領域。這是一個非常高成長的地區。顯然，這將完全納入我們的雷達模組中。因此，在雷達平台中，我們已經能夠透過識別具有臨床價值和所需適應症的目標和適應症來實際推進當前雷達模組的開發。這使我們能夠重新利用雷達模組內的許多程式碼。

So moving on to some of the data that we saw, we announced that with the University Bellefield that we advance our cryptophycin for the Magicbullet Consortium, the cryptophycin ADC. And we were quite excited because we did this in a period of about 6 months. where we're able to show picomolar potency in a wide range of solid tumors.

因此，繼續討論我們看到的一些數據，我們宣布與貝爾菲爾德大學合作，為 Magicbullet 聯盟推進我們的 Cryptophycin，即 Cryptophycin ADC。我們非常興奮，因為我們在大約 6 個月的時間內做到了這一點。我們能夠在多種實體瘤中顯示皮摩爾效力。

We shared that data earlier this year in the preclinical work. We produced the cryptophycin ADC in 80% cancer cell kill rate, which was much more than other commonly used ADCs. And so that got us very excited. In fact, it was also the case with medium and low HER2 expression cancers.

我們今年稍早在臨床前工作中分享了這些數據。我們生產的隱藻素 ADC 的癌細胞殺傷率為 80%，遠高於其他常用的 ADC。這讓我們非常興奮。事實上，HER2 中低表達癌症的情況也是如此。

So outside of breast, HER2 does get expressed in other cancers like gastric, bladder, even some colorectal, and even ovarian. The expression level of HER2 there doesn't seem to really trigger the right kind of ADC response with some of the existing HER2 ADCs, even some of the bispecifics that are coming out. But with the cryptophycin, we get really good expression levels, about 10x more potent than some of the existing molecules in the market.

因此，除了乳癌之外，HER2 確實在其他癌症中表達，如胃癌、膀胱癌，甚至某些大腸癌，甚至是卵巢癌。HER2 的表達量似乎並沒有真正引發某些現有 HER2 ADC 的正確類型的 ADC 反應，甚至是即將推出的一些雙特異性抗體。但透過隱藻素，我們獲得了非常好的表達水平，比市場上一些現有分子的效力大約高 10 倍。

So this is exciting preclinical data. We're going to continue to develop it, go after many of these low and medium expressing HER2 cancers. But also, as I mentioned, we have several additional targets.

所以這是令人興奮的臨床前數據。我們將繼續開發它，追蹤許多低表達和中表達 HER2 的癌症。而且，正如我所提到的，我們還有幾個額外的目標。

So we've gone through thousands and thousands of targets to look at which targets we really want to go through after, and we've modeled how we can go after them, not only with cryptophycin, but actually with unique other payloads as well.

因此，我們已經檢查了成千上萬的目標，以了解我們真正想要檢查的目標，並且我們已經模擬瞭如何追蹤它們，不僅使用 Cryptophycin，而且實際上還使用獨特的其他有效負載。

And so we're really beginning to monetize this very unique asset that we've been building up with our ADC module, and we hope that we can select and characterize potent and super potent payloads but literally overnight. We can predict the synergy of those payloads and antibodies against certain tumors. But more importantly, we can also understand what tumors it really will work on based on the microenvironment and the mutation of those tumors because the mutations affect the availability of some of those mechanisms that we want to see in those tumors.

因此，我們確實開始將我們使用 ADC 模組構建的這個非常獨特的資產貨幣化，我們希望能夠在一夜之間選擇和表徵有效和超有效的有效負載。我們可以預測這些有效負載和抗體針對某些腫瘤的協同作用。但更重要的是，我們還可以根據微環境和這些腫瘤的突變來了解它真正對哪些腫瘤起作用，因為這些突變會影響我們希望在這些腫瘤中看到的一些機制的可用性。

And so the target expression patterns can be very, very different even though you have similarly expressed targets. So we think this is pretty exciting. And very importantly, the ultimate goal of doing all this isn't just to be smarter about ADCs but to do it faster, to do it cheaper, and to develop a litany, a library of ADCs that we can bring to the clinic faster.

因此，即使您有類似表達的目標，目標表達模式也可能非常非常不同。所以我們認為這非常令人興奮。非常重要的是，做這一切的最終目標不僅僅是讓ADC 變得更智能，而是做得更快、更便宜，並開發一長串ADC 庫，讓我們可以更快地將其推向臨床。

And so in the preclinical work we've seen, we think this is very doable. We actually are now experimenting with other payloads. We're experimenting with bispecific type structures, fragment-based structures, biparatopic structures. These are all things that a year ago, we couldn't do. And more importantly, this is going to be a very important area for the future of oncology drug development.

因此，在我們看到的臨床前工作中，我們認為這是非常可行的。實際上我們現在正在嘗試其他有效負載。我們正在試驗雙特異性類型結構、基於片段的結構、雙互補位結構。這些都是一年前我們做不到的事。更重要的是，這將成為未來腫瘤藥物開發的一個非常重要的領域。

We want to share a lot of these insights more widely. We think with the community, we've launched an effort called Webinar Wednesdays. It's a big part of our focus to inform, educate, and share with the general public and the oncology community, what we're doing. I want to share with our investors, our stakeholders because there's a lot of details in these programs.

我們希望更廣泛地分享許多這些見解。我們與社區一起發起了一項名為「週三網路研討會」的活動。我們重點關注的一個重要部分是向公眾和腫瘤學界通報、教育和分享我們正在做的事情。我想與我們的投資者、利害關係人分享，因為這些計劃中有很多細節。

And so every month, we'll have a webinar Wednesday, which will focus on one of the efforts. We just did our very first one on LP-300. We'd great feedback. In fact, it actually spurred some inbound activity as a result from patient groups and also from groups that promoted it socially to various groups like EGFR groups and groups that focus on never smokers, Breath of Hope groups. So this is great because it lowers our cost of attracting patients to these important trials.

因此，每個月，我們都會在星期三舉辦一次網路研討會，重點討論其中一項工作。我們剛剛在 LP-300 上完成了第一個專案。我們希望得到很好的回饋。事實上，它實際上刺激了一些入站活動，這些活動來自於患者團體，也來自於社會推廣它的團體，以及各種團體，如 EGFR 團體和關注從不吸煙者的團體、希望呼吸團體。所以這很棒，因為它降低了我們吸引患者參加這些重要試驗的成本。

We have a number of webinars coming up, one in pancreatic, one in bladder, both areas of high unmet need. We've got global experts, KOLs, from Fox Chase, Dr. Igor, who's been a great collaborator for a number of years. He's kind of a luminary in the pancreatic cancer field and most importantly, a wonderful human being. And he'll be hosting that webinar in pancreatic cancer.

我們即將舉辦許多網路研討會，一場是關於胰臟的，一場是關於膀胱的，這兩個領域的需求都未滿足。我們有來自 Fox Chase 的全球專家、KOL、伊戈爾博士，多年來他一直是我們的優秀合作者。他是胰臟癌領域的傑出人物，最重要的是，他是個了不起的人。他將主持有關胰臟癌的網路研討會。

And followed up also with Dr. Helle Pappot of the University of Copenhagen. We've had interactions with her. She's just brilliant in this GU cancer specifically.

哥本哈根大學的 Helle Pappot 博士也進行了跟進。我們和她有過互動。她在 GU 癌症方面尤其出色。

In bladder cancer, we've seen tremendous response. And also about 35% of bladder cancers have -- what's called, what I referred to earlier, as DNA damage repair deficiency, very important because our drug seems to have super potency in these DDR deficient tumors. And that's a big part of bladder cancer tumors.

在膀胱癌中，我們看到了巨大的反應。而且大約 35% 的膀胱癌存在——我之前提到的 DNA 損傷修復缺陷，這非常重要，因為我們的藥物似乎對這些 DDR 缺陷的腫瘤具有超強效力。這是膀胱癌腫瘤的很大一部分。

So again, these Webinar Wednesdays will give people updates. And we really look forward to sharing them. It's a major way to stay informed.

同樣，週三的網路研討會將為人們提供最新資訊。我們真的很期待分享它們。這是了解情況的主要方式。

Let's talk about some of our publications and posters. As I mentioned earlier in the call, we had a very exciting poster at the AACR annual meeting around our drug candidate LP-284. It's a highly potent TP53 mutation agnostic DNA damaging agent works really well, we believe, in lymphomas, non-Hodgkin's lymphomas, and we're in a Phase 1a/1b clinical trial today.

讓我們來談談我們的一些出版物和海報。正如我之前在電話會議中提到的，我們在 AACR 年會上圍繞我們的候選藥物 LP-284 發布了一張非常令人興奮的海報。我們相信，它是一種高效的 TP53 突變不可知 DNA 損傷劑，在淋巴瘤、非何杰金氏淋巴瘤中效果非常好，我們今天正在進行 1a/1b 期臨床試驗。

Again, we've seen no dose-limiting toxicities, we're now active in the third cohort. It's not fully enrolled, but it's beginning to be dosed we've seen no issues in the first two cohorts. We also have published a very exciting paper with our Lantern Research scientists and Georgetown University and Cancer Research Communications and it focuses on the lethal activity of 184 against a diverse range of solid tumors that it causes double-stranded breaks in DNA and what's called HRD deficient or HR deficient homologous repair deficiencies.

同樣，我們沒有看到任何劑量限制性毒性，我們現在活躍在第三組。它還沒有完全註冊，但已經開始給藥，我們在前兩個隊列中沒有看到任何問題。我們也與 Lantern Research 的科學家、喬治城大學和癌症研究通訊發表了一篇非常令人興奮的論文，重點關注 184 對多種實體瘤的致命活性，它會導致 DNA 雙股斷裂和所謂的 HRD 缺陷或HR 缺陷同源修復缺陷。

These are basically BRCA2 or ATM, and so we've seen that our drug is up to about 12 times more sensitive when it sees a range of these HRD homologus repair deficiencies, again, a subset of DNA damage repair deficiencies. A link to the publication is available in our PR, also on our LinkedIn on our website. And we're very excited about the publication because that opens up the opportunity for lots of very exciting well we think combination trials.

這些基本上是 BRCA2 或 ATM，因此我們發現，當我們的藥物發現一系列 HRD 同源修復缺陷（同樣是 DNA 損傷修復缺陷的子集）時，其敏感性高達約 12 倍。我們的 PR 以及我們網站上的 LinkedIn 上都提供了該出版物的連結。我們對這篇文章的發表感到非常興奮，因為這為許多我們認為非常令人興奮的組合試驗提供了機會。

Now BRCA drugs and HRD drugs make up a little over $2 billion in annual sales and we think this is a very, very synergistic mechanism. In fact, the SHAP scores in the SHAP ratios for the combination of 184 plus many of these PARP inhibitors is amongst some of the highest that I've seen.

現在 BRCA 藥物和 HRD 藥物的年銷售額略高於 20 億美元，我們認為這是一個非常非常協同的機制。事實上，184 加上許多這些 PARP 抑制劑的組合的 SHAP 比率中的 SHAP 分數是我所見過的最高分數之一。

So this is a very unique molecule to be combining with PARP inhibitors because the theory is that we can lower the amount of PARP dosage and reintroduce PARP towards oftentimes becomes unusable for -- in patients. And we can also have a complementary mechanism part works by inhibiting the repair. So when the DNA tries to repair itself, it and blocks at enzyme and so it's not available to the cancer cells DNA to try to fix it.

因此，這是一種與 PARP 抑制劑結合的非常獨特的分子，因為理論上我們可以降低 PARP 劑量，並針對經常無法使用的患者重新引入 PARP。我們還可以有一個補充機制部分透過抑制修復來發揮作用。因此，當 DNA 嘗試自我修復時，它會阻斷酶，因此癌細胞 DNA 無法嘗試修復它。

Now that's very complementary because remember LP-184 and 284 they work by causing these very lethal breaks. So 184 introduces the double-stranded breaks and lower dose, even apart from will inhibit the repair enzyme. And so we think we can create a longer perhaps more durable and more sensitive response to these tumors.

現在這是非常互補的，因為記住 LP-184 和 284 它們是透過引起這些非常致命的斷裂來發揮作用。因此184引入了雙股斷裂和較低的劑量，甚至除了會抑制修復酵素。因此，我們認為我們可以對這些腫瘤產生更長、或許更持久、更敏感的反應。

And that's a big range of tumors about one in five to one in four tumors have some element of DNA damage repair available, so that's a big market for 184. That's a 2023 is a pivotal year for us, where we really strengthened our insights. We launched our trials 2024 has emerged as a year of great progress where our insights are now impacting patients in their journeys to fight cancer.

這是一個很大的腫瘤範圍，大約五分之一到四分之一的腫瘤具有一些可用的 DNA 損傷修復元件，因此這對 184 來說是一個很大的市場。2023 年對我們來說是關鍵的一年，我們真正增強了我們的洞察力。我們在 2024 年啟動了試驗，這是取得巨大進展的一年，我們的見解現在正在影響患者的抗癌之旅。

It's also influencing the development decisions for future trials, future drugs and the progress of other cancer companies. Our collective efforts and dedication have fostered a transformational shift, not only for our company, but it's in a time of transformation for the industry.

它也影響未來試驗、未來藥物的開發決策以及其他癌症公司的進展。我們的集體努力和奉獻精神不僅促進了我們公司的轉型，而且正處於整個行業的轉型時期。

We're in an exciting trajectory toward the future where we can improve the lives of cancer patients, not only today, but actually set the stage for creating affordable, effective and more importantly, economically viable solutions faster. And that pace of innovation, I think, will continue to accelerate.

我們正處於通往未來的令人興奮的軌道上，我們不僅可以改善癌症患者的生活，而且實際上為更快地創建負擔得起的、有效的、更重要的是經濟上可行的解決方案奠定了基礎。我認為，創新的步伐將繼續加快。

So with that, I'd like to now open the call to any questions or clarifications. If you'd like to ask a question, you can do so in one of two ways. You can type your question using the Q&A tool here at the Zoom webinar or you can click on the raise hand tool to speak directly, and we'll try to unmute your line and make it available. So we'll take a break for some questions.

因此，我現在想打開電話詢問任何問題或澄清。如果您想提出問題，可以透過以下兩種方式之一進行。您可以使用 Zoom 網路研討會上的問答工具輸入您的問題，也可以點擊舉手工具直接發言，我們將嘗試取消您的線路靜音並使其可用。所以我們會休息一下回答一些問題。

First question from John. John, thanks for your question. Because I read through it. The Oregon arrangement is another AI collaboration.

第一個問題來自約翰。約翰，謝謝你的問題。因為我讀過它。俄勒岡州的安排是另一項人工智慧合作。

That's a great question in terms of what they saw it. And I think what they saw is they have a lot of exciting opportunities with this inhibitor that they have worked through a very unique mechanism that's a first-in-class drug and it inhibits cancer metabolism. And because of that, it seems to be very potent across a pretty good range of cancers.

就他們所看到的內容而言，這是一個很好的問題。我認為他們看到的是，他們透過這種抑制劑獲得了很多令人興奮的機會，他們透過一種非常獨特的機制進行研究，這是一種一流的藥物，可以抑制癌症代謝。正因為如此，它似乎對多種癌症都非常有效。

Now these PDI enzymes that are out there, there's lots of PDI enzymes about 20 year or so I believe that Oregon has talked about, but which ones do you want to inhibit and which ones -- and they also have crossed purpose, so becomes a real combinatorial real problem.

現在這些 PDI 酶已經存在，有很多 PDI 酶大約有 20 年左右的時間，我相信俄勒岡州已經討論過，但是你想抑制哪些酶，哪些酶——而且它們也有交叉的目的，所以成為一個真實的組合真實問題。

Now their drug seems to inhibit four various central ones to cancer cell metabolism and which ones to go after and should they combine it with other drugs are really combinatorial on data-driven questions. And so these questions will help guide the construction of a trial that could be successful or unsuccessful.

現在，他們的藥物似乎可以抑制癌細胞代謝的四種不同的核心藥物，而應該選擇哪些藥物以及是否應該與其他藥物結合使用，這實際上是數據驅動問題的組合。因此，這些問題將有助於指導可能成功或不成功的試驗的建構。

So it's very, very important and so what they see is the ability to model this data and get some in silico insights and then rapidly go to the lab to validate very, very targeted insights and perhaps also, most importantly, generate some new IP.

所以這非常非常重要，所以他們看到的是對這些數據進行建模並獲得一些電腦見解的能力，然後快速進入實驗室驗證非常非常有針對性的見解，也許最重要的是產生一些新的知識產權。

So that when they go to a larger pharma partner, they've got IP around combinations, targeted IP around going after specific subtypes of cancer and maybe even insights on what to go after in terms of the model. The benefits for Lantern are very clear, we'll own this collaboration IP alongside Oregon. We also have rights to license their drug.

因此，當他們尋求更大的製藥合作夥伴時，他們擁有圍繞組合的智慧財產權、圍繞特定癌症亞型的有針對性的智慧財產權，甚至可能對模型方面的追求有深入的了解。Lantern 的好處非常明顯，我們將與俄勒岡州一起擁有這個合作 IP。我們也有權許可他們的藥物。

So if we're really excited about it, I think it could be fits into the way we think about some of the molecules that are exciting. It's unique, it's super potent. And work across cancers that has the ability to combine. So it fits a lot of the kind of key things that we'd like to see.

因此，如果我們真的對此感到興奮，我認為它可能符合我們思考一些令人興奮的分子的方式。它很獨特，而且非常強大。並在具有結合能力的癌症領域開展工作。所以它符合我們希望看到的許多關鍵內容。

And of course, we'll have to get deeper in the collaboration, but I think it could be a good drug that gets across the finish line process in a number of cancers. And so we're excited about helping Oregon and also helping the molecule.

當然，我們必須更深入地合作，但我認為這可能是一種很好的藥物，可以跨越多種癌症的終點線。因此，我們很高興能夠幫助俄勒岡州並幫助該分子。

Thank you.

謝謝。

I think I'm going to -- we have a hand up, I believe from Ashok. Ashok we're going to let you talk. It's the right thing we can do that. Can I unmute the line if you're still available?

我想我會－－我相信是阿肖克（Ashok）舉手了。阿肖克，我們讓你談談。我們這樣做是正確的。如果您還有空，我可以取消線路靜音嗎？

Well, can you hear me?

嗯，你聽得到我說話嗎？

Yes.

是的。

Hi. I have three part question. So the AI driven, ADC development program seems to be progressing well, pretty clinically. So what are the key inflection points and time lines to potentially advance an easy candidates into the clinic. And then the Starlight therapeutics again appears to be gaining momentum with the Phase Ib protocol filing for the Star one. So what are the anticipated milestones and timing to initiate adult and pediatric clinical trials?

你好。我有三個部分的問題。因此，人工智慧驅動的 ADC 開發計劃似乎進展順利，非常臨床化。那麼，有哪些關鍵的拐點和時間表可以將簡單的候選人推進臨床。隨著 Star 療法的 Ib 期協議申請，Starlight 療法似乎再次獲得了動力。那麼啟動成人和兒科臨床試驗的預期里程碑和時機是什麼？

And the last question -- part of the question is the Oregon therapeutics represents an interesting AI collaboration opportunities. How do you see the RADAR platform accelerating to drive drug development efforts and how might this collaboration expand over time?

最後一個問題——部分問題是俄勒岡州的療法代表了一個有趣的人工智慧合作機會。您如何看待 RADAR 平台加速推動藥物開發工作以及隨著時間的推移，這種合作將如何擴展？

Great questions. Can you hear me now? Yeah. Okay. So let's start with the ADC. We think the key inflection points for us is to zero in if HER2 or maybe if HER2 or HER3 bispecific is a better option. We're playing around the target a little bit. We've seen extraordinary data and low expressing -- low and Medium expressing. So we're looking at the landscape to see is that the right place or should we do bispecific HER2 or HER3, which is also available.

很好的問題。你聽得到我嗎？是的。好的。那麼讓我們從 ADC 開始。我們認為，如果 HER2 或 HER2 或 HER3 雙特異性藥物是更好的選擇，我們認為關鍵的拐點為零。我們正在圍繞目標進行一些嘗試。我們看到了非凡的數據和低表達——低表達和中表達。因此，我們正在尋找合適的地方，或者我們應該做雙特異性 HER2 或 HER3，這也是可用的。

So I think we've got a few more months of some preclinical analysis that we've modeled, now we want to take it back to some wet lab studies. And then to really we've got to get through IND studies and manufacturing. So this for us is a 2025 event in terms of getting it into the clinic.

所以我認為我們還有幾個月的時間進行一些我們已經建模的臨床前分析，現在我們想將其帶回一些濕實驗室研究。然後我們真的必須完成 IND 研究和製造。因此，對我們來說，將其推向臨床是 2025 年的大事。

We know obviously, I'd love to beat that. But manufacturing and these complex biologics takes time. We are looking at some new formats that we think could change it. We're looking at fragment design, we're looking at maybe doing some things, kind of more in parallel there are some new FDA guidelines in terms of manufacturing of ADCs is that we just I think they just came out very recently, actually, which are very favorable, especially if we go after with antibodies that are already known -- already characterized and already in the clinic.

我們顯然知道，我很想打敗它。但製造和這些複雜的生物製劑需要時間。我們正在研究一些我們認為可以改變它的新格式。我們正在研究片段設計，我們正在考慮做一些事情，更多的是並行的，FDA 在 ADC 製造方面有一些新的指南，我認為它們最近才發布，實際上，這是非常有利的，特別是如果我們使用已知的抗體—已經被表徵並且已經在臨床中使用。

So we're going look at all pathways to compress the manufacturing and IND studies. There are also opportunities for us to license some technology, that gets us the clinic faster as well. So we're looking at all those. But in either case, 2024 for us is to execute on our existing trials and 2025, we think is to execute the next wave, which is the ADC and other drug conjugates.

因此，我們將研究壓縮製造和 IND 研究的所有途徑。我們還有機會獲得一些科技的許可，這也能讓我們更快進入診所。所以我們正在研究所有這些。但無論哪種情況，我們認為 2024 年都是執行我們現有的試驗，而 2025 年我們認為是執行下一波試驗，即 ADC 和其他藥物偶聯物。

In regards to STAR001, we expect to hear back from the FDA on this new, what we call supplement B to the IB and beyond for Starlight. And we also expect to continue to recruit some people for Starlight and potentially look at some independent financing and funding for Starlight to launch. So I think those are this year events. Starlight for us is definitely -- this year in ADC is the next chapter. So hopefully that gives you some sense of the time lines.

關於 STAR001，我們希望從 FDA 收到關於這個新產品的回复，我們稱之為 IB 補充劑 B 以及 Starlight 的補充品。我們也預計將繼續為星光招募一些人員，並可能考慮為星光推出一些獨立的融資和資金。所以我認為這些都是今年的事件。星光對我們來說絕對是——今年的 ADC 將會翻開新的篇章。希望這能讓您對時間軸有所了解。

We've another question. Is that you want to -- John is are you raising your hand or answering the questions.

我們還有另一個問題。約翰是你想舉手還是回答問題？

Okay. let me the read the question out for everybody. His question is, does the Oregon therapeutics partnership serve as a template for other potential partnerships?

好的。讓我把這個問題讀給大家聽。他的問題是，俄勒岡州的治療夥伴關係是否可以作為其他潛在合作關係的模板？

I think it does, we always like to think of being able to stamp something, but we've got one with actuate, we have one with TTC. We have one now with Oregon each of those very unique molecules and each good teams good -- because as you get into collaboration, you're not only collaborating betting on your capabilities you are also betting on the partner. These are real partnerships.

我認為確實如此，我們總是喜歡考慮能夠標記某些東西，但我們有一個帶有 Actuate 的，我們有一個帶有 TTC 的東西。我們現在與俄勒岡州合作，每一個非常獨特的分子和每一個優秀的團隊都很好——因為當你進入合作時，你不僅在合作押注於你的能力，而且還押注於合作夥伴。這些都是真正的夥伴關係。

And so we like the teams and all companies, we'd like to molecule, we like their path because if they don't succeed, we don't succeed right, we're getting upside in equity in those molecules. So we're pretty focused on making sure we pick the right kind of chances to win.

所以我們喜歡這些團隊和所有公司，我們想要分子，我們喜歡他們的道路，因為如果他們不成功，我們就沒有成功，我們在這些分子的股權上獲得了上升。因此，我們非常注重確保選擇正確的獲勝機會。

And our platform helps us do that right we can really understand a lot about the molecule and the indication and the unmet need just even during conversations because we start doing that modeling and analysis with RADAR even prior to looking at their data.

我們的平台幫助我們正確地做到這一點，即使在對話期間，我們也可以真正了解很多關於分子、指示和未滿足的需求，因為我們甚至在查看他們的數據之前就開始使用RADAR 進行建模和分析。

Now tech companies, as I mentioned in the last call, we are in discussion with tech companies for partnerships, I don't know long this take, but we're having discussions with many of the ones you can imagine. Those things just take time. I think we're not one of the big names like a recursion that and Exscientia. Unfortunately had some issues with their management or benevolent, again there are some business model issues.

現在，科技公司，正如我在上次電話會議中提到的，我們正在與科技公司討論合作夥伴關係，我不知道這需要多長時間，但我們正在與許多你能想像到的公司進行討論。這些事情只是需要時間。我認為我們不是像遞歸和 Exscientia 這樣的大牌公司之一。不幸的是，他們的管理或仁慈存在一些問題，同樣存在一些商業模式問題。

But there's some great big companies that setup all the air in the room. So I think as we sure proof points and have more discussions with the Amazons and Apples and the videos and Googles and others, there's whole range of Tier 2 players as well. I think they all can be suitable long-term tech partners to enable our platform to get to a scale that can be monetized independently longer-term.

但有一些偉大的大公司在房間裡安裝了所有的空氣。因此，我認為，當我們確定證據並與亞馬遜、蘋果、影片、谷歌等進行更多討論時，也有各種各樣的二級玩家。我認為他們都可以成為合適的長期技術合作夥伴，使我們的平台達到可以長期獨立貨幣化的規模。

Another question from John is -- great question, John, I'm going to -- do you want to ask it or do I'm going to read it? Read it. Okay.

約翰的另一個問題是──好問題，約翰，我要──你想問還是我要讀？閱讀。好的。

So when will the sites be finalized for the Harmonic trial in Asia? And when will we see any sites outside of Japan and Taiwan?

那麼，亞洲 Harmonic 試驗的地點何時最終確定呢？我們什麼時候才能看到日本和台灣以外的網站？

I think we'll do that in a phased manner. I mean, I think we've got some very good sites now. In Japan, five that we've identified, I believe that right David. David will be visiting those sites along with our Head of Clinical Development next month, along with Dr. Goto and getting the sites up and running.

我認為我們將分階段進行。我的意思是，我認為我們現在已經有了一些非常好的網站。在日本，我們已經確定了五個，我相信大衛是對的。下個月，David 將與我們的臨床開發主管以及 Goto 博士一起訪問這些站點，並負責這些站點的啟動和運作。

And then we have five additional sites, I believe also in Taiwan. So it will be 10 sites and those 10 sites can really give us the bulk of the patients that we need so far. We do have a couple of other countries that I mentioned in prior calls. We are looking at South Korea as well. Unfortunately, South Korea is on a going through some issues with their doctors striking in some of their major hospitals.

然後我們還有另外五個站點，我相信也在台灣。因此，這將是 10 個站點，這 10 個站點確實可以為我們提供迄今為止所需的大部分患者。我們確實還有我在之前的電話中提到的其他幾個國家。我們也在關注韓國。不幸的是，韓國正在經歷一些問題，一些主要醫院的醫生正在罷工。

So it's not an ideal time for, I think, a foreign new clinical trial from a small company to enter. But we have a lot of excitement in South Korea because the numbers in South Korea for never smokers with lung cancer is actually even higher than Japan.

因此，我認為，對於小公司進行的國外新臨床試驗來說，現在並不是進入的理想時機。但我們在韓國感到非常興奮，因為韓國從不吸菸者罹患肺癌的人數實際上甚至比日本還要高。

So we had a lot of very initial excitement, but the doctors that are going on strike in South Korea gave us pause because we didn't want to be spending time, energy, and money if in fact, our trial was going to be stalled.

所以我們一開始非常興奮，但韓國即將罷工的醫生讓我們暫停了，因為我們不想花費時間、精力和金錢，如果事實上我們的試驗將陷入停滯的話。

So we've kind of backed off of South Korea near term, even though it looks very, very promising because the number of patients and the centralization of patients. But we think we can get similar kind of activity just as easily in Japan and actually just as easily in Taiwan and even more cost effective in Taiwan than Japan.

因此，我們近期對韓國有所退縮，儘管它看起來非常非常有希望，因為患者數量和患者集中度。但我們認為，我們可以在日本同樣輕鬆地開展類似的活動，實際上在台灣也同樣容易，而且在台灣比在日本更具成本效益。

So I think we will look at new sites, but we have 10 coming onboard in those two countries that could be very, very productive and could supply us the bulk of what we need for the trial. But thank you for that question, John.

因此，我認為我們會考慮新的站點，但我們在這兩個國家有 10 個站點，這些站點可能非常非常高效，可以為我們提供試驗所需的大部分資源。但謝謝你提出這個問題，約翰。

So in closing I've coming up in 50 minutes. I want to express my deep gratitude first of all, to our team for making this happen. I know these webinars and the slides and the scripts. It's not easy. You've got gather a lot of information. You've got a delivery of understand it.

最後，我將在 50 分鐘內趕到。首先，我想對我們的團隊讓這一切發生表示深深的謝意。我知道這些網路研討會、投影片和腳本。這並不容易。你已經收集了很多資訊。你已經明白了。

And of course, the broadcast is great and people get to look at it any time. So I want to thank my team for the constant support and information, but also to our partners and stakeholders for their unwavering support. I think together, we're really building a much, much better scalable, brighter future in oncology.

當然，廣播很棒，人們可以隨時觀看。因此，我要感謝我的團隊不斷提供的支持和訊息，也要感謝我們的合作夥伴和利害關係人的堅定支持。我認為，透過共同努力，我們確實正在為腫瘤學領域創造一個更可擴展、更光明的未來。

We're solving real-world problems with proprietary AI solutions and with a real pragmatic approach, I think the rapid development of genomically guided targeted therapies can alter the cost and time lines in oncology drug development. And I think it's going to place us long-term at the forefront of a new golden age of unprecedented productivity in the development of medicines.

我們正在透過專有的人工智慧解決方案和真正務實的方法解決現實世界的問題，我認為基因組引導標靶治療的快速發展可以改變腫瘤藥物開發的成本和時間線。我認為這將使我們長期處於藥物開發生產力空前的新黃金時代的最前線。

Thank you, everyone, for your time today.

謝謝大家今天抽出時間。

Thanks very much.

非常感謝。