Puma Biotechnology Inc (PBYI) 2026 Q1 法說會逐字稿

Good afternoon. My name is John, and I'll be your conference call operator today. (Operator Instructions)

下午好。我叫 John，今天將由我擔任本次電話會議的接線員。(接線員指示)

As a reminder, this call is being recorded.

提醒各位，本次通話將被錄音。

And I would now like to turn the conference call over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. Thank you. You may begin your conference.

接下來我想把電話會議交給 Puma Biotechnology 投資人關係資深總監 Mariann Ohanesian。謝謝。您可以開始會議。

Thank you, John. Good afternoon and welcome to Puma's conference call to discuss our results for the first quarter of 2026.

謝謝你，John。下午好，歡迎參加 Puma 的電話會議，討論我們 2026 年第一季的業績結果。

Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of Puma Biotechnology; Maximo Nogues, Chief Financial Officer; Heather Blaber, Senior Vice President of Marketing; and Roger Storm, Senior Vice President of Sales.

今天與我一同參與電話會議的有：Puma Biotechnology 執行長、總裁暨董事會主席 Alan Auerbach；財務長 Maximo Nogues；行銷資深副總裁 Heather Blaber；以及銷售資深副總裁 Roger Storm。

After the close today, Puma issued a news release detailing results for the first quarter of 2026. That news release, the slides that Alan and Roger will refer to and a webcast to this call are accessible via the homepage in investor sections of our website at pumabiotechnology.com.

今日收盤後，Puma 發布新聞稿，詳述 2026 年第一季的業績結果。該新聞稿、Alan 與 Roger 將引用的投影片，以及本次通話的網路直播，皆可透過我們網站 pumabiotechnology.com 首頁的投資人專區取得。

The webcast and presentation slides will be archived on our website and available for replay for the next 90 days. Today's conference call will include statements about Puma's future expectations, plans, and prospects that constitute forward-looking statements for purposes of federal securities laws.

網路直播與簡報投影片將存檔於我們網站，並在未來 90 天內提供重播。今天的電話會議將包含關於 Puma 未來預期、計畫與展望的陳述，依聯邦證券法之目的，構成前瞻性陳述。

Such statements are subject to risks and uncertainties, and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10-K for the year ended December 31, 2025.

此類陳述受風險與不確定性影響，實際事件與結果可能與這些前瞻性陳述所表達者不同。如需完整了解相關風險與不確定性，請查閱我們不時向 SEC 提交的定期與即時報告，包括截至 2025 年 12 月 31 日止年度的 Form 10-K 年報。

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this live conference call, May 7, 2026. Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law.

敬請注意勿過度依賴這些前瞻性陳述；其內容僅截至本次即時電話會議日期（2026 年 5 月 7 日）為準。除法律要求外，Puma 不承擔在本次電話會議日期之後，因事件或情況變化而修訂或更新任何前瞻性陳述之義務。

During today's call, we may refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures. We believe these non-GAAP metrics may be useful to investors as a supplement to, but not a substitute for our GAAP financial measures. Please refer to our first quarter 2026 release for a reconciliation of our GAAP to non-GAAP results.

在今天的通話中，我們可能會提及某些非 GAAP 財務衡量指標，該等指標涉及對 GAAP 數字的調整。我們認為，這些非 GAAP 指標可作為 GAAP 財務衡量指標的補充，對投資人可能有用，但不能取代 GAAP 財務衡量指標。請參閱我們 2026 年第一季新聞稿中 GAAP 與非 GAAP 結果的調節表。

I will now turn the call over to Alan.

接下來我把電話交給 Alan。

Thank you, Mariann, and thank you all for joining our call today. Today, Puma reported total revenue for the first quarter of 2026 of $44.8 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales, as well as royalties from our sub-licensees.

謝謝你，Mariann，也謝謝各位今天加入我們的電話會議。今天，Puma 公布 2026 年第一季總營收為 4,480 萬美元。總營收包含產品淨營收（完全由 NERLYNX 銷售構成），以及來自我們次授權合作夥伴的權利金收入。

Product revenue net was $42 million in the first quarter of 2026, a decline from $59.9 million reported in Q4 2025 and $43.1 million reported in Q1 2025. As a reminder to investors, Puma's reported NERLYNX sales included both US net sales and product supply revenues of NERLYNX to Puma's ex-US partners.

2026 年第一季產品淨營收為 4,200 萬美元，較 2025 年第四季的 5,990 萬美元以及 2025 年第一季的 4,310 萬美元有所下降。提醒投資人，Puma 所報告的 NERLYNX 銷售同時包含美國淨銷售，以及向 Puma 的美國以外合作夥伴供應 NERLYNX 產品所產生的供貨收入。

Product revenue for the first quarter of 2026 was impacted by approximately $7.9 million of inventory drawdown at our specialty pharmacies and specialty distributors. Royalty revenue was $2.8 million in the first quarter of 2026 compared to $15.6 million in Q4 2025 and $2.9 million in Q1 of 2025.

2026 年第一季的產品營收受到我們專科藥局與專科經銷商約 790 萬美元庫存回落（inventory drawdown）的影響。2026 年第一季權利金收入為 280 萬美元，相較於 2025 年第四季的 1,560 萬美元以及 2025 年第一季的 290 萬美元。

As noted in our last call, royalty revenue in 2025, in Q4 2025 was driven by the shipment to our partner in China. We reported 2,328 bottles of NERLYNX sold in the first quarter of 2026, compared to 3,298 bottles sold in Q4 2025.

如我們上次電話會議所述，2025 年的權利金收入（即 2025 年第四季）主要由對中國合作夥伴的出貨所帶動。我們報告 2026 年第一季 NERLYNX 銷售 2,328 瓶，相較於 2025 年第四季的 3,298 瓶。

In Q1 2026, we estimate that inventory decreased by 439 bottles. In Q1 2026, new prescriptions. Were up approximately 25% compared to Q4 2025, and total prescriptions were down approximately 4% compared to Q4 2025. Roger will provide further details in his comments and slides.

在 2026 年第一季，我們估計庫存減少 439 瓶。在 2026 年第一季，新處方數。較 2025 年第四季增加約 25%，而總處方數較 2025 年第四季下降約 4%。Roger 將在他的評論與投影片中提供更多細節。

I will now present the interim data from Puma's ongoing Phase 2 trials of Alisertib in small cell lung cancer and HER2-negative positive breast cancer, also referred to as the ALISCA Lung-1 and ALISCA Breast-1 trials.

接下來我將呈現 Puma 目前進行中的 Alisertib 第二期臨床試驗在小細胞肺癌與 HER2 陰性陽性乳癌的期中數據，亦稱為 ALISCA Lung-1 與 ALISCA Breast-1 試驗。

Heather Blaber and Roger Storms will add additional color on NERLYNX commercial activity. Maxima Nougues will follow with highlights of the key components of our financial statements for the fourth quarter of 2025.

Heather Blaber 與 Roger Storms 將就 NERLYNX 的商業活動補充更多說明。接著 Maxima Nougues 將說明我們 2025 年第四季財務報表的關鍵重點。

We now move to the ALISCA Lung interim presentation. As a reminder, in clinical trials to date, Alisertib has shown single-agent activity and activity in combination with other cancer drugs in the treatment of many different types of cancers, including hormone receptor-positive breast cancer, triple-negative breast cancer, small cell lung cancer, and head and neck cancer. The drug has also shown activity in previous clinical trials in peripheral T-cell lymphoma and non-Hodgkin's lymphoma.

我們現在進入 ALISCA Lung 的期中簡報。提醒各位，迄今的臨床試驗顯示，Alisertib 具有單藥活性，並且與其他抗癌藥物合併使用時亦展現活性，可用於治療多種不同癌症類型，包括荷爾蒙受體陽性乳癌、三陰性乳癌、小細胞肺癌，以及頭頸癌。該藥亦在先前針對周邊 T 細胞淋巴瘤與非何杰金氏淋巴瘤的臨床試驗中顯示活性。

Takeda's previous clinical development program with Alisertib was extensive, and due to this, there is a large, well-characterized clinical safety database with over 1,300 patients who were treated across 22 company-sponsored trials.

武田（Takeda）先前針對 Alisertib 的臨床開發計畫相當廣泛，因此已建立一個大型且特徵明確的臨床安全性資料庫，涵蓋超過 1,300 名病患，這些病患在 22 項公司贊助試驗中接受治療。

From a preclinical perspective, it has been shown that aurora kinase A&C-Myc upregulate each other, which suggests the existence of a positive feedback loop. C-Myc upregulates the cyclin complex, which leads to cell proliferation. So by inhibiting aurora kinase A with Allisertib, it also inhibits C-Myc, which decreases cell proliferation. Additionally, preclinical data has shown that Allisertib. Inhibited growth of cells with C-Myc overexpression and in xenograft models that expressed high levels of C-Myc, tumor growth was inhibited.

從臨床前角度來看，研究顯示 aurora kinase A 與 C-Myc 會彼此上調，這暗示存在正向回饋迴路。C-Myc 會上調 cyclin 複合體，進而導致細胞增殖。因此，透過以 Allisertib 抑制 aurora kinase A，也會抑制 C-Myc，從而降低細胞增殖。此外，臨床前數據顯示 Allisertib。可抑制 C-Myc 過度表現細胞的生長；在表現高水平 C-Myc 的異種移植（xenograft）模型中，腫瘤生長亦受到抑制。

Puma's Phase 2 trial, ALISCA-Lung-1, which is also referred to as study PUMA-ALI-4201, was designed to enroll up to 60 patients with small cell lung cancer who had received prior treatment with a platinum-based chemotherapy and immunotherapy. The trial enrolls both second-line and third-line patients. Patients must provide tissue-based biopsies so that biomarkers can be analyzed.

Puma 的第二期試驗 ALISCA-Lung-1（亦稱研究 PUMA-ALI-4201）設計為最多納入 60 名小細胞肺癌病患，這些病患先前已接受含鉑類化療與免疫治療。本試驗同時納入二線與三線治療病患。病患必須提供組織切片檢體，以便進行生物標記分析。

Alisertib was initially dosed at 50 milligrams BID on days one to seven of a 21-day cycle. As investors are aware, the trial was then amended to increase the dose to 60-milligram BID, and the company is now in the process of increasing the dose to 70 milligrams BID.

Alisertib 初始給藥為每次 50 毫克、每日兩次（BID），於 21 天週期的第 1 至第 7 天給藥。如投資人所知，之後試驗修訂將劑量提高至每次 60 毫克 BID，而公司目前正進行將劑量提高至每次 70 毫克 BID 的流程。

The primary endpoint of the trial is to determine whether any biomarker correlates with Alisertib response with endpoints of overall response rates, duration of response, disease control rate, progression-tree survival, and overall survival. The secondary endpoints include investigator-assessed efficacy and survival. Mandatory G-CSF prophylaxis is also given in the trial in an effort to reduce the neutropenia that was shown to be dose-limiting in the previous clinical trials with Alisertib.

本試驗的主要終點為判定是否有任何生物標記與 Alisertib 反應相關；評估終點包括總反應率、反應持續時間、疾病控制率、無惡化存活期，以及總存活期。次要終點包括研究者評估的療效與存活。試驗亦要求強制性 G-CSF 預防性用藥，以期降低先前 Alisertib 臨床試驗中被證實為劑量限制因素的嗜中性白血球低下。

Slide 6 shows the baseline characteristics for the 52 patients treated at 50 milligrams BID and the 27 patients treated at 60 milligram BID that are included in this interim analysis.

投影片 6 顯示本次期中分析所納入的基線特徵：以每日兩次（BID）50 毫克治療的 52 名患者，以及以每日兩次（BID）60 毫克治療的 27 名患者。

Slide 7 shows the summary of the prior treatments the patients received prior to entering the study. Of note, all of these patients were treated in either the second line or third line in this trial. To first discuss the safety in the trial. In previous clinical trials of Alisertib, the treatment emergent adverse events seen were those characteristic of a cell cycle inhibitor with neutropenia being the main AE seen in the highest percentage. In this trial, the all-grade neutropenia was 19.2% in the 50-milligram arm and 22% in the 60-milligram arm.

投影片 7 顯示患者在入組研究前所接受既往治療的摘要。值得注意的是，本試驗中所有這些患者皆在第二線或第三線接受治療。首先討論本試驗的安全性。在先前 Alisertib 的臨床試驗中，所觀察到的治療期間出現不良事件屬於細胞週期抑制劑的典型特徵，其中以中性球減少症為發生比例最高的主要不良事件（AE）。在本試驗中，全等級中性球減少症在 50 毫克組為 19.2%，在 60 毫克組為 22%。

Slide 10 shows the rates of Grade 3 and 4 AEs seen in the trial. Of note, the grade 3 or higher neutropenia rate was 13.5% in a 50-milligram arm and 11.1% in the 60-milligram arm.

投影片 10 顯示本試驗中觀察到的第 3 級與第 4 級不良事件發生率。值得注意的是，第 3 級或以上中性球減少症的發生率在 50 毫克組為 13.5%，在 60 毫克組為 11.1%。

Slide 11 compares the Grade 3 and Grade 4 AE rates seen in the ALISCA Lung 1 trial to those that were seen in the previous Phase II trial of ALISCA monotherapy in small cell lung cancer, referred to as Study C14007. C14007 was previously published in Lancet Oncology in 2010.

投影片 11 比較 ALISCA Lung 1 試驗中觀察到的第 3 級與第 4 級不良事件發生率，與先前 ALISCA 單藥治療小細胞肺癌的第二期試驗（稱為 C14007 研究）中所觀察到的發生率。C14007 先前已於 2010 年發表於《Lancet Oncology》。

As a reminder, in C14007, GCSF prophylaxis was not mandated, while ALISCA Lung 1 requires mandatory prophylactic GCSF. As can be seen on the slide, the use of prophylactic GCSF appeared to reduce the rates of Grade 3 or higher neutropenia compared to what we've seen in the previous trial.

提醒一下，在 C14007 中並未強制要求使用 GCSF 預防性治療，而 ALISCA Lung 1 則要求必須使用預防性 GCSF。如投影片所示，預防性使用 GCSF 似乎可降低第 3 級或以上中性球減少症的發生率，相較於我們在先前試驗中所見。

The next move to the efficacy seen in the trial. As you can see in slide 13, in the 52 patients in ALISCA Lung 1, they were treated at 50 milligrams. We have seen four patients, or 11.5%, with a best response of a partial response, and 18 patients, or 34.6% with stable disease. The median PFS for the 50-milligram arm was 1.7 months.

接下來轉到本試驗所觀察到的療效。如投影片 13 所示，在 ALISCA Lung 1 的 52 名患者中，皆以 50 毫克治療。我們觀察到 4 名患者（11.5%）的最佳反應為部分緩解（partial response），以及 18 名患者（34.6%）為疾病穩定（stable disease）。50 毫克組的中位無惡化存活期（PFS）為 1.7 個月。

In the first 15 patients, in the 60 milligram arm, we have seen one patient, or 6.7% with a best response of a partial response, and seven patients, or 46.7%, with stable disease. The median PFS for the 60 milligram arm is currently 4.2 months.

在 60 毫克組的前 15 名患者中，我們觀察到 1 名患者（6.7%）的最佳反應為部分緩解，另有 7 名患者（46.7%）為疾病穩定。60 毫克組目前的中位 PFS 為 4.2 個月。

Slide 14 shows the Kaplan-Meier curve for PFS between the 50 milligram and 60 milligram arm of the trial. As previously stated, the median PFS of the 16-milligram arm is currently 4.2 months. However, we caution it is still early, and we await additional patient numbers and additional follow-up. We will now move to the biomarkers in the trial.

投影片 14 顯示本試驗 50 毫克組與 60 毫克組之間 PFS 的 Kaplan-Meier 曲線。如先前所述，60 毫克組目前的中位 PFS 為 4.2 個月。然而，我們提醒目前仍屬早期，仍需更多患者數與更長追蹤時間。接下來我們將轉到本試驗的生物標記（biomarkers）。

Slide 16 presents the Kaplan-Meier curve for the patients according to C-Myc score. C-Myc score is a semi-quantitative immunohistochemical assessment. That measure the intensity and percentage of tumor cells staining for the C-Myc protein, typically ranging from 0 to 300. High C-Myc scores are believed to be associated with poor prognosis and lower overall survival in various cancers.

投影片 16 呈現依 C-Myc 分數分組之患者的 Kaplan-Meier 曲線。C-Myc 分數是一種半定量的免疫組織化學評估。其衡量 C-Myc 蛋白染色之腫瘤細胞的染色強度與比例，通常範圍為 0 至 300。一般認為，高 C-Myc 分數與多種癌症的不良預後及較低的整體存活期相關。

As you can see on slide 16, for the combined doses of 50 milligrams and 60 milligrams, patients with a C-Myc score of between 0 and 100 had a median PFS of 1.68 versus a PFS of 4.17 for the patients with a C-Myc score of between 101 and 300. This would suggest that Alisertib has better activity in cancers with a higher amount of C-Myc activity.

如投影片 16 所示，在合併 50 毫克與 60 毫克劑量分析時，C-Myc 分數介於 0 至 100 的患者中位 PFS 為 1.68 個月；而 C-Myc 分數介於 101 至 300 的患者 PFS 為 4.17 個月。這提示 Alisertib 在 C-Myc 活性較高的癌症中可能具有較佳活性。

Slide 17 presents the KM curve for the 50 milligram and 60 milligram dose separately for the patients according to C-Myc H-score. As you can see on the slide, for the 50 milligram dose, patients with H-score of between 0 and 100 had a median PFS of 1.68 months versus a PFS of 2.83 months for the patients with a C-Myc score of between 101 and 300. While for the 60-milligram dose, patients with H-score between 0 and 100 had a median PFS of 1.41 months, while the median PFS has not yet been reached for the patients with C-Myc H-score of 101 to 300.

投影片 17 分別就 50 毫克與 60 毫克劑量，呈現依 C-Myc H-score 分組之患者的 KM 曲線。如投影片所示，在 50 毫克劑量下，H-score 介於 0 至 100 的患者中位 PFS 為 1.68 個月；而 C-Myc 分數介於 101 至 300 的患者 PFS 為 2.83 個月。至於 60 毫克劑量下，H-score 介於 0 至 100 的患者中位 PFS 為 1.41 個月；而 C-Myc H-score 介於 101 至 300 的患者其中位 PFS 尚未達到。

We believe that these slides are suggesting that Alisertib has greater activity in tumors with higher C-Myc H-scores and hence more C-Myc activity, which we believe is due to the inhibition of the aurora kinix pathway by Alisertib.

我們認為這些投影片顯示：Alisertib 在 C-Myc H-score 較高、因此 C-Myc 活性較高的腫瘤中具有更強的活性；我們認為其原因在於 Alisertib 對 aurora kinix 路徑的抑制。

Slide 18 presents the KM curve for the patients according to percent of tumor cells that are C-Myc positive. As you can see on slide 18, for the combined doses of 50 mg and 60 mg for tumors having between 0% and 10% of the cells C-Myc positive, there's a median PFS of 1.68 months versus a PFS of 2.83 months for the patients with tumors having between 11% and 100% of the cells C-Myc positive.

投影片 18 呈現依 C-Myc 陽性腫瘤細胞百分比分組之患者的 KM 曲線。如投影片 18 所示，在合併 50 mg 與 60 mg 劑量分析時，腫瘤細胞中 C-Myc 陽性比例介於 0% 至 10% 的患者中位 PFS 為 1.68 個月；而腫瘤細胞中 C-Myc 陽性比例介於 11% 至 100% 的患者 PFS 為 2.83 個月。

Slide 19 presents the KM curve for the 50 milligram and 60 milligram doses separately for the patients according to the percent of tumor cells that are C-Myc positive. As you can see on the slide, for the 50 milligram dose, patients with tumors having between 0% and 10% of the cells C-Myc positive had a median PFS of 1.68 months versus a PFS of 2.73 months for patients with tumors having between 11% and 100% of the tumor cells C-Myc positive.

投影片 19 分別就 50 毫克與 60 毫克劑量，呈現依 C-Myc 陽性腫瘤細胞百分比分組之患者 KM 曲線。如投影片所示，在 50 毫克劑量下，腫瘤細胞中 C-Myc 陽性比例介於 0% 至 10% 的患者中位 PFS 為 1.68 個月；而腫瘤細胞中 C-Myc 陽性比例介於 11% 至 100% 的患者 PFS 為 2.73 個月。

While for the 60-milligram dose, between 0%and 10% of C-Myc positive had a median PFS that has not been reached, versus a PFS of 4.17 months for the patients with between 11% to 100% of the tumor cells C-Myc positive.

而在 60 毫克劑量下，C-Myc 陽性比例介於 0% 至 10% 的患者其中位 PFS 尚未達到；相較之下，腫瘤細胞中 C-Myc 陽性比例介於 11% 至 100% 的患者 PFS 為 4.17 個月。

We believe that these slides are suggesting that Alisertib has greater activity in the tumors where a higher percentage of the cells are C-Myc positive. Which we again believe is due to the inhibition of the aurora kinase pathway by Alisertib.

我們認為這些投影片顯示：當腫瘤中有較高比例的細胞為 C-Myc 陽性時，Alisertib 的活性更高。我們同樣認為其原因在於 Alisertib 對 aurora kinase 路徑的抑制。

We believe that the initial clinical data with Alisertib in small cell lung cancer are demonstrating that Alisertib is showing better activity in patients where C-Mycis playing a role in driving the tumor, which is indicative of tumors where aurora kinase A is activated. There are currently 32 patients enrolled in the 60-milligram arm of the trial.

我們認為 Alisertib 在小細胞肺癌的初步臨床數據顯示：在 C-Myc 參與驅動腫瘤的患者中，Alisertib 的活性更佳；這也代表腫瘤中 aurora kinase A 被活化。目前本試驗 60 毫克組已入組 32 名患者。

Based on this preliminary safety seen at this dose, we are continuing the dose escalate to 70 milligrams, and we hope to begin enrollment of the 70-milligram cohort in the second-half of 2026. We believe that the data generated thus far in ALISCA-Lung 1 is showing that Alisertib monotherapy is showing a PFS at higher doses and in certain biomarker-directed populations that is as good or slightly better than the PFS for currently approved drugs in this space.

基於在此劑量下所觀察到的初步安全性，我們正持續將劑量遞增至 70 毫克，並希望於 2026 年下半年開始招募 70 毫克隊列。我們認為截至目前在 ALISCA-Lung 1 所產生的數據顯示：在較高劑量以及某些以生物標記導向的族群中，Alisertib 單藥治療所呈現的 PFS 與目前此領域已核准藥物的 PFS 相當或略優。

As discussed previously, we are hopeful that with increasing doses of Alisertib monotherapy in ALISCA-Lung 1, we can achieve higher concentrations of Alisertib in these biomarker-defined populations. And potentially open up the opportunity for a Phase 3 design that tests Alisertib monotherapy in a randomized trial.

如先前所討論，我們希望在 ALISCA-Lung 1 中提高 Alisertib 單藥治療的劑量後，能在這些以生物標記界定的人群中達到更高的 Alisertib 濃度。並且有機會開啟一個第三期試驗設計，在隨機試驗中測試 Alisertib 單藥治療。

As investors are aware, Alisertib was previously tested in a randomized Phase 2 trial of paclitaxel plus Alisertib versus paclitaxel plus placebo, where a PFS and OS benefit was seen in patients with tumors with biomarkers that appear to indicate that the aurora kinase A pathway was activated. Based on this data and the data from ALISCA-Lung 1, Puma will be looking to a dual approach for the development of alisertib in small cell lung cancer.

投資人應已知悉，Alisertib 先前曾在一項隨機第二期試驗中進行測試，該試驗比較紫杉醇合併 Alisertib 與紫杉醇合併安慰劑；在腫瘤具有某些生物標記、顯示 Aurora kinase A 路徑被活化的患者中，觀察到 PFS 與 OS 的獲益。基於這些數據以及 ALISCA-Lung 1 的數據，Puma 將採取雙軌策略來推進 alisertib 在小細胞肺癌的開發。

Therefore, in addition to the monotherapy dose escalation approach in ALISCA-Lung 1, Puma will also be looking to initiate ALISCA-Lung 2, which will investigate the efficacy of Alisertib given in combination with paclitaxel using mandatory G-CSF prophylaxis. We are hoping to initiate this trial in the second-half of 2026.

因此，除了在 ALISCA-Lung 1 中採用單藥劑量遞增策略外，Puma 也將著手啟動 ALISCA-Lung 2，以強制性 G-CSF 預防用藥的方式，評估 Alisertib 與紫杉醇合併給藥的療效。我們希望在 2026 年下半年啟動此試驗。

We are pleased with the interim data from Alisertib-Lung-1, and we believe it is showing an improved tolerability profile for allasserted monotherapy and improved efficacy with dose escalation as well as improved efficacy in a biomarker-directed population that is indicative of the Aurora kinase pathway activation. We anticipate additional interim efficacy data from ALISCA Lung 1 in the second-half of 2026 or the first half of 2027.

我們對 Alisertib-Lung-1 的期中數據感到滿意，並認為其顯示 Alisertib 單藥治療具有更佳的耐受性特徵；同時，隨著劑量遞增療效有所提升，且在以生物標記導向、提示 Aurora kinase 路徑活化的人群中亦顯示更佳療效。我們預期將於 2026 年下半年或 2027 年上半年取得 ALISCA Lung 1 的更多期中療效數據。

I will now move to the ALISCA Breast 1 interim presentation. As a reminder, and as previously stated, in clinical trials to date, Alisertib has shown single-agent activity and activity in combination with other cancer drugs in the treatment of many different types of cancer, including hormone receptor-positive breast cancer, triple-negative breast cancer, small cell lung cancer, and head and neck cancer. There's also a large, well-characterized clinical safety database with over 1,300 patients who were treated across 22 company-sponsored trials.

接下來我將轉到 ALISCA Breast 1 的期中發表。提醒各位，如先前所述，截至目前的臨床試驗顯示，Alisertib 在多種癌症治療中具有單藥活性，並且與其他抗癌藥物合併使用亦具活性，包括荷爾蒙受體陽性乳癌、三陰性乳癌、小細胞肺癌，以及頭頸癌。此外，亦有一個大型且特徵明確的臨床安全性資料庫，涵蓋超過 1,300 名患者，這些患者在 22 項公司贊助試驗中接受治療。

As previously stated, from a preclinical perspective, it has been shown that aurora kinase A&C-Myc upregulate each other, which suggests the existence of a positive feedback loop. Preclinical data has shown that Alisertib inhibited growth of cells with C-Myc overexpression, and in xenograft models that expressed higher levels of C-Myc tumor growth was inhibited.

如先前所述，從臨床前角度來看，研究顯示 Aurora kinase A 與 C-Myc 會彼此上調，提示存在正向回饋迴路。臨床前數據顯示，Alisertib 可抑制 C-Myc 過度表現細胞的生長；在表現較高 C-Myc 水準的異種移植模型中，腫瘤生長亦受到抑制。

Puma's Phase 2 ALISCA-Breast-1, also referred to as Study PUMA ALI-1201. Investigates Alisertib in combination with endocrine treatment consisting of either anastrozole, exomevestane, letrozole, fulvestrant, or tamoxifen in patients with HER2-negative, hormone receptor-positive, recurrent or metastatic breast cancer.

Puma 的第二期試驗 ALISCA-Breast-1，亦稱為研究 PUMA ALI-1201。該研究在 HER2 陰性、荷爾蒙受體陽性、復發或轉移性乳癌患者中，評估 Alisertib 與內分泌治療合併使用；內分泌治療可為 anastrozole、exomevestane、letrozole、fulvestrant 或 tamoxifen 之一。

Patients must be chemotherapy-naive in the recurrent or metastatic setting and have had previous treatment with a CDK4/6 inhibitor and have received at least two prior lines of endocrine therapy in a recurrent or metastatic setting to be eligible for the trial.

患者在復發或轉移性情境下必須為未接受過化學治療者，且需曾接受 CDK4/6 抑制劑治療，並在復發或轉移性情境下至少接受過兩線內分泌治療，方符合試驗資格。

Patients were dosed with Alisertib given at either 30 milligrams, 40 milligrams, or 50 milligrams BID on days 1 to 3, 8 to 10, and 15 to 17 on a 28-day cycle in combination with the endocrine therapy of investigator's choice. Patients must not have been previously treated with the endocrine treatment in the metastatic setting that will be given in combination with Alisertib in the trial.

患者接受 Alisertib 給藥劑量為 30 毫克、40 毫克或 50 毫克 BID，於 28 天週期的第 1–3 天、第 8–10 天及第 15–17 天給藥，並合併研究者選擇的內分泌治療。患者在轉移性情境下不得曾接受過本試驗中將與 Alisertib 合併給予的該內分泌治療。

The primary endpoints include objective response rates, duration of response, disease control, and progression-free survival. As a secondary objective, the company is evaluating each of these efficacy endpoints within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy, which might give the company the potential to focus future clinical development of Alisertib in combination with endocrine therapy for patients with HER2-negative hormone receptor-positive breast cancer in these biomarker-specific populations.

主要終點包括客觀反應率、反應持續時間、疾病控制，以及無惡化存活期（PFS）。作為次要目標，公司正在生物標記亞組中評估上述各項療效終點，以判定是否有任何生物標記亞組與較佳療效相關；若是如此，可能使公司得以在這些特定生物標記人群中，聚焦未來 Alisertib 合併內分泌治療於 HER2 陰性、荷爾蒙受體陽性乳癌患者的臨床開發。

Slide 25 shows the baseline characteristics for the 164 patients included in this interim analysis. As the slide shows, the majority of these patients were treated in the third line or later setting. First, discuss the safety in the trial. As previously mentioned, in previous clinical trials of Alisertib, the treatment emergent adverse events seen were those characteristic of a cell cycle inhibitor with neutropenia being the AAE seen in the highest percentage.

第 25 張投影片顯示本次期中分析納入的 164 名患者之基線特徵。如投影片所示，多數患者是在第三線或更後線治療情境下接受治療。首先，討論本試驗的安全性。如先前提及，在以往 Alisertib 的臨床試驗中，所見治療期間出現的不良事件屬於細胞週期抑制劑的典型特徵，其中以嗜中性球減少為發生比例最高的 AAE。

Slide 27 shows the rates of Grade 3 or 4 AEs seen in the trial. Of note, the Grade 3 or higher neutropenia rate was 8% in the 30-milligram arm, 10.2% in the 40-milligram arm, and 26.9% in the 50-milligram arm. It is important for investors to note that prophylactic GCSF was not given in the study.

第 27 張投影片顯示本試驗中觀察到的第 3 級或第 4 級不良事件（AE）發生率。值得注意的是，第 3 級或以上嗜中性球減少的發生率在 30 毫克組為 8%、40 毫克組為 10.2%、50 毫克組為 26.9%。投資人需注意，本研究未使用預防性 GCSF。

Slide 27 also compares the Grade 3 or 4 AE rates seen in the ALISCA Breast 1 trial to those that were seen in the previously published Phase 2 of Alisertib and HER2-negative positive breast cancer that was published in JAMA Oncology in 2020, referred to as study TBCRC41.

第 27 張投影片亦將 ALISCA Breast 1 試驗中觀察到的第 3 級或第 4 級 AE 發生率，與先前已發表於 2020 年《JAMA Oncology》的 Alisertib 與 HER2 陰性乳癌第二期試驗（稱為 TBCRC41 研究）中所見的發生率進行比較。

As can be seen in the slides, the rates of Grade 3 or higher neutropenia appear to be lower in the ALISCA Breast 1 trials compared to what was seen in TBCRC41. To next move to the efficacy seen in the trial. Slide 29 shows the summary of clinical benefits for the patients with at least one post-baseline scan or who ended treatment or died before they got a scan. As you can see in the slide, the best response was 5% in the 30-milligram arm, 20% in the 40-milligram arm, and 18.4% in the 50-milligram arm.

如投影片所示，ALISCA Breast 1 試驗中第 3 級或以上嗜中性球減少的發生率，似乎低於 TBCRC41 中所觀察到的水準。接下來轉到本試驗的療效結果。第 29 張投影片彙總了至少有一次基線後影像掃描，或在取得掃描前即停止治療或死亡之患者的臨床獲益。如投影片所示，最佳反應在 30 毫克組為 5%、40 毫克組為 20%、50 毫克組為 18.4%。

Slide 30 shows the Kaplan-Meier curve for PFS in the trial. As is seen in the slide, the median PFS of the 30-milligram arm is currently 2.04 months. The median PFS of the 40-milligram arm is 5.45 months, and the median PFS of the 50-milligram arm is currently 5.59 months.

第 30 張投影片顯示本試驗 PFS 的 Kaplan-Meier 曲線。如投影片所示，30 毫克組目前的中位 PFS 為 2.04 個月。40 毫克組的中位 PFS 為 5.45 個月，而 50 毫克組目前的中位 PFS 為 5.59 個月。

We will now move to the biomarkers in the trial. Slide 32 presents the KM curve for all the patients in the trial according to C-MYC copy number, also referred to as C-Myc copy number gain. As you can see on the slide, for all of the patients in the trial, for which there are tissue results, patients with C-Myc copy number of greater than two had a median PFS of 7.29 months versus a median PFS of 2.0 months for the patients with a C-Myc copy number equal to two.

接下來我們將轉到本試驗的生物標記分析。第 32 張投影片呈現依 C-MYC 拷貝數（亦稱 C-Myc 拷貝數增加）分層之所有患者的 KM 曲線。如投影片所示，對於所有具有組織檢測結果的患者而言，C-Myc 拷貝數大於 2 的患者其中位 PFS 為 7.29 個月；相較之下，C-Myc 拷貝數等於 2 的患者其中位 PFS 為 2.0 個月。

Slide 33 presents the KM curve for all of the patients for which there are tissue results according to percent of tumor cells that are C-Myc positive. As you can see on the slide, for the patients with between 0% and 10% of the cells C-Myc positive. The median PFS was 3.06 months versus a PFS of 5.62 months for the patients with between 11% and 100% of the cells C-Myc positive.

第 33 張投影片呈現對所有具有組織檢測結果的患者，依腫瘤細胞中 C-Myc 陽性比例分層之 KM 曲線。如投影片所示，對於 C-Myc 陽性細胞比例介於 0% 至 10% 的患者，其中位 PFS 為 3.06 個月；相較之下，C-Myc 陽性細胞比例介於 11% 至 100% 的患者之 PFS 為 5.62 個月。

Slide 34 presents the KM curve for the 50 milligram and 40 milligram doses separately for the patients according to percent of tumor cells that are C-Myc positive. As you can see on the slide, for the 40 milligram dose, patients with between 0% and 10% of the cells C-Myc positive had a median PFS of 3.9 months versus a PFS of 5.75 months for the patients with between 11% and 100% of the tumor cells C-Myc positive.

投影片34分別呈現50毫克與40毫克劑量下，依腫瘤細胞中C-Myc陽性比例分層之患者KM曲線。如投影片所示，在40毫克劑量組中，C-Myc陽性細胞比例介於0%至10%的患者其中位PFS為3.9個月；相較之下，C-Myc陽性腫瘤細胞比例介於11%至100%的患者PFS為5.75個月。

For the 50-milligram dose for patients with between 0% and 10% of the cells C-Myc positive, there was a median PFS of 3.58 months versus a PFS of 9.3 months for the patients with between 11% and 100% of the tumor cells C-Myc positive.

在50毫克劑量組中，C-Myc陽性細胞比例介於0%至10%的患者其中位PFS為3.58個月；相較之下，C-Myc陽性腫瘤細胞比例介於11%至100%的患者PFS為9.3個月。

Similar to the data from ALISCA Lung-1, we believe that these slides are suggesting that in patients that Alisertib has greater efficacy in ALISCA Breast-1 in tumors where a higher percent of the tumor cells are C-Myc positive, and hence a greater degree of C-Myc activation. Preclinically, it's been shown that Alisertib inhibits C-MYC positive cells, so we believe that this increased efficacy is due to the mechanism of action of Alisertib and the inhibition of the Aurora kinase pathway.

與ALISCA Lung-1的數據相似，我們認為這些投影片顯示：在ALISCA Breast-1中，Alisertib在腫瘤細胞中C-Myc陽性比例較高（因此C-Myc活化程度較高）的腫瘤患者身上具有更佳療效。在臨床前研究中已顯示Alisertib可抑制C-MYC陽性細胞，因此我們認為此療效提升源自Alisertib的作用機轉，以及其對Aurora激酶途徑的抑制。

Slide 35 presents the KM curve for all the patients according to ESR1 mutation status. As is seen on the slide, for patients at all three dose groups who are ESR1 mutated as measured by ctDNA, a median PFS of 5.62 months was seen versus a PFS of 3.58 months for the people who are ESR1 wild-type as measured by ctDNA.

投影片35呈現依ESR1突變狀態分層之所有患者KM曲線。如投影片所示，在三個劑量組中，以ctDNA測得ESR1突變的患者其中位PFS為5.62個月；相較之下，以ctDNA測得ESR1野生型者PFS為3.58個月。

For patients in all three dose groups who are ESR1 mutated as measured by tissue, a median PFS of 7.23 months was seen versus a PFS of 3.71 months for patients who are ESR1 wild-type as measured by tissue. It is important for investors to remember that these patients are being treated in the third-line setting. So these patients have already received treatment with a selective endocrine receptor degrader, or SERD.

在三個劑量組中，以組織檢體測得ESR1突變的患者其中位PFS為7.23個月；相較之下，以組織檢體測得ESR1野生型的患者PFS為3.71個月。投資人需記住，這些患者是在第三線治療情境下接受治療。因此，這些患者先前已接受選擇性雌激素受體降解劑（SERD）治療。

Since enrollment of this trial was done, while the newer oral SERDs have either been FDA approved or in later stages of clinical development, many of the patients in the ALISCA Breast -1 trial have been previously treated with the new oral SERDs. More specifically, approximately 58% of the ESR1 mutated patients in the trial were previously treated with oral SERDs, including camizestrant, Elacestrant, Giredestrant, Immunilestrant or Polyazestrant.

自本試驗開始收案以來，較新的口服SERD已獲FDA核准或進入臨床開發後期，ALISCA Breast-1試驗中的許多患者先前已接受新型口服SERD治療。更具體而言，試驗中約58%的ESR1突變患者曾接受口服SERD治療，包括camizestrant、Elacestrant、Giredestrant、Immunilestrant或Polyazestrant。

Slide 36 presents the KM curve for the 50-milligram and 40-milligram dose groups separately for patients according to ESR1 mutation status as measured by ctDNA. For patients in the 40-milligram group who are ESR1 mutated as measured by ctDNA, a median PFS of 3.7 months was seen versus a PFS of 5.75 months for the patients who are ESR1 myelotype as measured by ctDNA.

投影片36分別呈現50毫克與40毫克劑量組中，依ctDNA測得之ESR1突變狀態分層的患者KM曲線。在40毫克組中，以ctDNA測得ESR1突變的患者其中位PFS為3.7個月；相較之下，以ctDNA測得ESR1 myelotype的患者PFS為5.75個月。

For patients of the 50 milligram group who were ESR1 mutated as measured by ctDNA, a median PFS of 9.3 months was seen versus a PFS of 2.76 months for the patients who were ESR1 wild type as measured by ctDNA.

在50毫克組中，以ctDNA測得ESR1突變的患者其中位PFS為9.3個月；相較之下，以ctDNA測得ESR1野生型的患者PFS為2.76個月。

Slide 37 presents the KM curve for the 50 milligram and 60 milligram dose separately for patients who are ESR1 according to ESR1 mutation status as measured by tissue. For the patients at the 40-milligram group who were ESR1 mutated as measured by tissue, a median PFS of 4.86 months was seen versus a PFS of 4.04 months for the patients who were ESR1 wild-type as measured by tissue.

投影片37分別呈現50毫克與60毫克劑量下，依組織檢體測得之ESR1突變狀態分層的患者KM曲線。在40毫克組中，以組織檢體測得ESR1突變的患者其中位PFS為4.86個月；相較之下，以組織檢體測得ESR1野生型的患者PFS為4.04個月。

For the patients at the 50-milligram group who were ESR1 mutated and measured by tissue, a median PFS has not yet been reached versus a PFS of 3.58 months for patients who were ESR1 wild-type as measured by tissue.

在50毫克組中，以組織檢體測得ESR1突變的患者其中位PFS尚未達到；相較之下，以組織檢體測得ESR1野生型的患者PFS為3.58個月。

Slide 38 presents the KM curve for all the patients according to PIK3CA mutation status. As is seen on the slide, for patients at all three dose groups who were PIK3CA mutated as measured by ctDNA, a median PFS of 2.1 months was seen versus a PFS of 5.45 months for patients who were PIK3CA wild-type as measured by ctDNA.

投影片38呈現依PIK3CA突變狀態分層之所有患者KM曲線。如投影片所示，在三個劑量組中，以ctDNA測得PIK3CA突變的患者其中位PFS為2.1個月；相較之下，以ctDNA測得PIK3CA野生型的患者PFS為5.45個月。

For the patients at all three dose groups who were PIK3CA mutated as measured by tissue. A median PFS of 3.71 months was seen versus a PFS of 4.86 months for patients who were PIK3CA wild-type as measured by tissue.

在三個劑量組中，以組織檢體測得PIK3CA突變的患者。其中位PFS為3.71個月；相較之下，以組織檢體測得PIK3CA野生型的患者PFS為4.86個月。

Slide 39 shows the KM curve for the 50-milligram and 40-milligram dose separately for patients according to PIK3CA mutation status as measured by ctDNA. For patients at the 40-milligram group who were PIK3CA mutated as measured by ctDNA, a median PFS of 3.71 months was seen versus a PFS of 5.65 for patients who were PIK3CA wild type as measured by ctDNA.

投影片39分別呈現50毫克與40毫克劑量下，依ctDNA測得之PIK3CA突變狀態分層的患者KM曲線。在40毫克組中，以ctDNA測得PIK3CA突變的患者其中位PFS為3.71個月；相較之下，以ctDNA測得PIK3CA野生型的患者PFS為5.65個月。

For patients at the 50-milligram group who were PIK3CA mutated as measured by ctDNA, a median PFS of 3.58 months was seen versus a PFS that has not yet been reached. For patients who were PIK3CA wild-type as measured by ctDNA. Based on the efficacy seen in the patients who were ESR1 mutated and PIK3CA wild-type, the company conducted a subset analysis to specifically focus on these two subgroups.

在50毫克組中，以ctDNA測得PIK3CA突變的患者其中位PFS為3.58個月；相較之下，以ctDNA測得PIK3CA野生型的患者PFS尚未達到。基於在ESR1突變且PIK3CA野生型患者中觀察到的療效，公司進行了子集分析，以特別聚焦於這兩個亞族群。

Slide 40 presents the KM curve for patients who were PIK3CA wild-type according to ESR1 mutation status. As is seen on the slide, for patients at all three dose groups who were PIK3CA wild type and who had an ESR1 mutation as measured by ctDNA, a median PFS has not yet been reached versus a PFS of 3.48 months for patients who were PIK3CA wild type and ESR1 wild type as measured by ctDNA.

投影片40呈現PIK3CA野生型患者依ESR1突變狀態分層的KM曲線。如投影片所示，在三個劑量組中，PIK3CA野生型且以ctDNA測得ESR1突變的患者其中位PFS尚未達到；相較之下，PIK3CA野生型且以ctDNA測得ESR1野生型的患者PFS為3.48個月。

For patients at all three dose groups who were PIK3CA wild type and who had an ESR1 mutation as measured by tissue, a median PFS has not been reached versus a PFS of 2.79 months for patients who were PIK3CA wild-type and ESR1 wild-type as measured by tissue.

在三個劑量組中，PIK3CA野生型且以組織檢體測得ESR1突變的患者其中位PFS尚未達到；相較之下，PIK3CA野生型且以組織檢體測得ESR1野生型的患者PFS為2.79個月。

Slide 41 presents the KM curve according to 50 milligram and 40 milligram doses separately. For the patients who were PIK3CA wild-type according to ESR1 mutation status as measured by ctDNA. For PIK3CA wild-type patients at the 40-milligram group who are ESR1 mutated as measured by ctDNA, a median PFS of 4.86 months was seen versus a PFS of 5.75 months for the patients who are ESR1 wild-type as measured by ctDNA.

投影片41分別呈現50毫克與40毫克劑量下的KM曲線。針對以ctDNA測得之ESR1突變狀態分層的PIK3CA野生型患者。在40毫克組中，PIK3CA野生型且以ctDNA測得ESR1突變的患者其中位PFS為4.86個月；相較之下，以ctDNA測得ESR1野生型的患者PFS為5.75個月。

For PIK3C8 wild-type patients of the 50-milligram group who were ESR1 mutated, the median PFS has now been reached versus a median PFS of 2.14 months in the patients who were ESR1 wild-type as measured by ctDNA.

在50毫克組中，PIK3C8野生型且ESR1突變的患者其中位PFS目前已達到；相較之下，以ctDNA測得ESR1野生型的患者其中位PFS為2.14個月。

We are very pleased to see that at the 50 milligram dose group for the patients who were PIK3CA wild-type and ESR1 mutant, no patient has yet progressed, although we caution these numbers here are small and further patient follow-up is needed.

我們非常高興看到，在 50 毫克劑量組中，對於 PIK3CA 野生型且 ESR1 突變的患者，目前尚無任何患者出現疾病進展；不過我們也提醒，這裡的樣本數很小，仍需要進一步的患者追蹤。

Slide 42 presents the KM curve for the 50 milligram and 40 milligram dose separately for patients who were PIK3CA wild-type according to ESR1 mutation status as measured by tissue. For PIK3CA wild-type patients at the 40 milligram group who were ESR1 mutated as measured by tissue, a median PFS of 7.23 months was seen versus a PFS of 3.98 months for the patients who were ESR1 wild-type as measured by tissue.

投影片 42 分別呈現 50 毫克與 40 毫克劑量下，依據以組織檢測測得之 ESR1 突變狀態分類的 PIK3CA 野生型患者之 KM 曲線。對於 40 毫克組、且以組織檢測為 ESR1 突變的 PIK3CA 野生型患者，其中位無進展存活期（PFS）為 7.23 個月；相較之下，以組織檢測為 ESR1 野生型的患者之 PFS 為 3.98 個月。

For PIK3CA wild-type patients at 50 milligrams who were ESR1 mutated. The median PFS has not been reached versus a median PFS of 2.14 months in the patients who were ESR1 wild-type as measured by tissue. Again, we are very pleased to see that the 50-milligram dose group for the patients who are PIK3CA wild-type and ESR1 mutant, no patient has yet progressed, although we caution these numbers here are small and further patient follow-up is needed.

對於 50 毫克組的 PIK3CA 野生型且 ESR1 突變患者。其中位 PFS 尚未達到；相較之下，以組織檢測為 ESR1 野生型的患者其中位 PFS 為 2.14 個月。再次強調，我們非常高興看到，在 50 毫克劑量組中，對於 PIK3CA 野生型且 ESR1 突變的患者，目前尚無任何患者出現疾病進展；不過我們也提醒，這裡的樣本數很小，仍需要進一步的患者追蹤。

As was shown in the earlier slides, C-Myc appeared to play a role in the activity of Alisertib in HER2-negative positive breast cancer, and more specifically, the analysis on slides 33 and 34 showed that Alisertib had better activity in patients with a higher percentage of their cells being C-Myc positive. This analysis also showed that patients with between 11% to 100% of their cells being C-Myc positive showed the best activity with Alisertib.

如先前投影片所示，C-Myc 似乎在 Alisertib 於 HER2 陰性乳癌中的活性上扮演一定角色；更具體而言，投影片 33 與 34 的分析顯示，當患者細胞中 C-Myc 陽性比例較高時，Alisertib 的活性更佳。該分析亦顯示，細胞中 C-Myc 陽性比例介於 11% 至 100% 的患者，使用 Alisertib 的活性表現最佳。

We therefore conducted an analysis to see whether or not C-Myc had any correlation with the activity of Alisertib that we are seeing in the PIK3CA wild-type patients, the ESR1-mutated patients, or the patients who are both PIK3CA wild-type and ESR1 mutated.

因此，我們進一步進行分析，以評估 C-Myc 是否與我們在 PIK3CA 野生型患者、ESR1 突變患者，或同時為 PIK3CA 野生型且 ESR1 突變的患者中所觀察到的 Alisertib 活性具有相關性。

On slide 43, we present the data that shows the percent of C-Myc positive cells for PIK3CA wild-type, ESR1 mutated, and patients who were both PIK3CA wild-type and ESR1 mutated. The left-hand side of the slide presents the patients whose mutation status was determined by tissue. The right-hand side of the slide shows the patients whose mutation status was by ctDNA.

在投影片 43，我們呈現顯示 PIK3CA 野生型、ESR1 突變，以及同時為 PIK3CA 野生型且 ESR1 突變患者之 C-Myc 陽性細胞百分比的數據。投影片左側呈現其突變狀態由組織檢測判定的患者。投影片右側則顯示其突變狀態由 ctDNA 判定的患者。

As you can see on the slide, patients who are PIK3CA wild-type, patients who are ESR1 mutated, and patients who are both PIK3CA wild-type and ESR1 mutated appear to show an increase in the median percent of C-Myc positive cells. This is seen in both the patients where the mutation status is determined by ctDNA and in tissue.

如投影片所示，PIK3CA 野生型患者、ESR1 突變患者，以及同時為 PIK3CA 野生型且 ESR1 突變的患者，其 C-Myc 陽性細胞的中位百分比似乎有所上升。此現象在以 ctDNA 判定突變狀態的患者以及以組織判定的患者中皆可見。

It is also seen in this analysis that a high percent of the patients who are PIK3CA wild-type, who are ESR1 mutant and who are both PIK3CA wild-type and ESR1 mutant have between 11% to 100% of their cells being C-Myc positive, which is again where the best activity is Alisertib has been shown to occur.

本分析亦顯示，在 PIK3CA 野生型、ESR1 突變，以及同時為 PIK3CA 野生型且 ESR1 突變的患者中，有相當高比例的患者其細胞中 C-Myc 陽性比例介於 11% 至 100%；而這也正是先前顯示 Alisertib 活性最佳的區間。

We believe this analysis is suggesting that better activity being seen with Alisertib in the patients who are PIK3CA wild type, ESR1 mutated, or both PIK3CA wild type and ESR1 mutated may be due to this increased C-MYC activity, as it appears to be showing that C-Myc is playing a role in driving the tumor in these subgroups of patients, which is suggestive of tumors where the Aurora kinase A is activated, and hence where Alisertib's mechanism of action may be playing a role.

我們認為，此分析提示：在 PIK3CA 野生型、ESR1 突變，或同時為 PIK3CA 野生型且 ESR1 突變的患者中所觀察到的 Alisertib 較佳活性，可能與 C-MYC 活性增加有關；因為結果顯示 C-Myc 可能在這些患者亞群中驅動腫瘤，這也暗示其腫瘤可能存在 Aurora kinase A 的活化，因此 Alisertib 的作用機轉可能在其中發揮作用。

When Puma licensed asserted, it had stated that the goal was to enroll ALISCA Breast-1 in order to perform a biomarker analysis to better understand which biomarker subgroups had the best activity and then amend the trial to focus on a more biomarker-focused population.

當 Puma 授權取得 Alisertib 時，公司曾表示其目標是完成 ALISCA Breast-1 的收案，以進行生物標記分析，更深入了解哪些生物標記亞群具有最佳活性，並進而修訂試驗，使其聚焦於更以生物標記為導向的人群。

Based on the interim data from ALISCA Breast-1, the company is going to be expanding the enrollment in the trial to obtain more data on the biomarker-focused cohorts with a focus in the patients who are PIK3CA wild type, ESR1 mutant, or both.

基於 ALISCA Breast-1 的期中數據，公司將擴大該試驗的收案，以取得更多聚焦生物標記之隊列數據，並著重於 PIK3CA 野生型、ESR1 突變，或兩者兼具的患者。

The company anticipates this will occur in the second-half of 2026. The company also plans to present updated data on the ALISCA Breast-1 trial in the second-half of 2026. Similar to the data from ALISCA-Lung-1, we believe that the data generated thus far in ALISCA Breast-1 is showing that Alisertib in combination with endocrine therapy appears to be active in the third line setting and more specifically in patients who are PIK3CA wild type, ESR1 mutant, or both PIK3CA wild type and ESR1 mutant.

公司預期這將在 2026 年下半年發生。公司亦計畫於 2026 年下半年公布 ALISCA Breast-1 試驗的更新數據。與 ALISCA-Lung-1 的數據相似，我們認為截至目前 ALISCA Breast-1 所產生的數據顯示：Alisertib 與內分泌治療合併使用，在三線治療情境中似乎具有活性；更具體而言，在 PIK3CA 野生型、ESR1 突變，或同時為 PIK3CA 野生型且 ESR1 突變的患者中表現更為明顯。

Similar to ALISCA Lung-1, the activity of Alisertib in the trial appears to be driven by C-Myc. To our knowledge, we are not aware of any drugs that have shown this level of activity in these subgroups of patients in the third line, which we believe differentiates the drug from others in development. We believe that this activity is attributable to biomarkers that are indicative of Aurora kinase pathway activation, which we believe is in line with the mechanism of action of Alisertib.

與 ALISCA Lung-1 類似，本試驗中 Alisertib 的活性似乎由 C-Myc 所驅動。就我們所知，我們尚未看到有任何藥物在三線治療中，於這些患者亞群展現出此等程度的活性；我們認為這使該藥物與其他開發中的藥物有所區隔。我們認為此活性可歸因於指示 Aurora kinase 路徑活化的生物標記，且我們相信這與 Alisertib 的作用機轉一致。

As we've mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several commercial-stage and development-stage drugs to potentially in-license and acquire that would allow the company to diversify itself and leverage Puma's existing R&D, regulatory, or commercial infrastructure. The company will keep investors updated on this as it progresses.

如我們在先前的法說會以及回應投資人提問時所提到的，Puma 持續評估數項商業化階段與研發階段的藥物，可能透過引進授權或併購，以協助公司多元化，並運用 Puma 既有的研發、法規或商業化基礎設施。公司將在進展過程中持續向投資人更新。

I will now turn the call over to Heather Blaber for an update on our marketing initiatives. Roger Storms will follow with a review of our commercial performance during the quarter.

接下來我將把電話會議交給 Heather Blaber，請她更新我們的行銷推動事項。之後 Roger Storms 將接續回顧本季的商業表現。

Thanks, Alan. I appreciate the opportunity to share some additional insights into our marketing strategy. The marketing team is focused on continued awareness of both clinical data for NERLYNX as well as reinforcing the continued unmet need in HER2-positive early-stage breast cancer after adjuvant therapy.

謝謝你，Alan。我很感謝有機會分享我們行銷策略的更多洞見。行銷團隊專注於持續提升對 NERLYNX 臨床數據的認知，同時強化在完成輔助治療後，HER2 陽性早期乳癌仍存在未被滿足的醫療需求。

We continue to invest in market research to help us understand and validate the most effective ways to communicate our data with healthcare professionals through both personal and non-personal promotion.

我們持續投入市場研究，以協助我們了解並驗證，透過人員與非人員推廣兩種方式，向醫療專業人員傳達我們數據的最有效方法。

Our strategy is focused on increasing awareness of our dual indication in HER2-positive breast cancer. We believe NERLYNX plays an important role in the early stage by reducing the risk of recurrence and in the metastatic setting by helping protect against progression.

我們的策略聚焦於提升外界對我們在 HER2 陽性乳癌之雙適應症的認知。我們相信 NERLYNX 在早期治療中可透過降低復發風險而扮演重要角色，並在轉移性情境中透過協助防止疾病進展而發揮作用。

Not only do physicians who have experience with NERLYNX continue to identify appropriate patients that could benefit from additional therapy post-adjuvant treatment, but we continue to adopt new prescribers year over year who recognize the unmet need in HER2-positive early-stage breast cancer and how NERLYNX can help their patients.

不僅是對 NERLYNX 有使用經驗的醫師持續辨識出適合、可在完成輔助治療後受益於額外治療的患者；我們也逐年吸引新的開立處方醫師，他們認知到 HER2 陽性早期乳癌的未被滿足需求，以及 NERLYNX 如何幫助其患者。

In summary, we are excited and committed about the potential to engage with more oncologists and support their patients diagnosed with HER2-positive breast cancer in both the early and metastatic settings.

總結而言，我們對於能與更多腫瘤科醫師互動並支持其被診斷為 HER2 陽性乳癌的患者（涵蓋早期與轉移性情境）感到振奮，並且承諾持續投入。

I will now turn the call over to Roger Storms to provide an overview on the commercial performance for the first quarter.

接下來我將把電話會議交給 Roger Storms，請他概述第一季的商業表現。

Thank you, Heather, and thanks to everyone for joining our first quarter earnings call. Well, before I move into the commercial review, just a reminder that I'll be making forward-looking statements. The sales team remains focused on expanding overall HCP reach and frequency with a strong emphasis on driving engagement when treatment decisions are being made.

謝謝你，Heather，也感謝各位參加我們第一季的法說會。在我進入商業回顧之前，先提醒一下，我將會做出前瞻性陳述。銷售團隊仍專注於擴大整體醫療照護專業人員（HCP）的觸及與互動頻率，並特別強調在做出治療決策時推動更高的參與度。

Q1 2026 call activity increased 44% year over year and 14% quarter over quarter. The year over year and quarter over quarter increases are a direct result of continued emphasis put on executional excellence and increased field accountability. The commercial team continues to prioritize increasing use of NERLYNX with a main focus on patients at higher risk of recurrence.

2026 年第一季來電活動年增 44%，季增 14%。年增與季增的提升，直接源自於我們持續強調卓越執行力以及提高第一線的責任承擔。商業團隊持續優先推動提升 NERLYNX 的使用，主要聚焦於復發風險較高的病患。

They are also dedicated to enhancing clinical education and engagement through non-personal promotional efforts, as well as utilizing patient resources to support persistence and compliance during NERLYNX therapy.

他們也致力於透過非面對面推廣活動強化臨床教育與互動，同時運用病患資源，在 NERLYNX 治療期間支持病患的持續用藥與依從性。

Let me now transition to some of the commercial slides, where I'll provide some additional specifics around performance. Slide 3 is an illustration of our distribution model, which is broken out into the specialty pharmacy channel and the specialty distributor or in-office dispensing channel.

接下來我將轉到一些商業簡報頁面，並提供更多關於表現的具體細節。第 3 頁展示我們的配送模式，分為專科藥局通路以及專科經銷商或院內配藥通路。

Regarding the overall distribution of our business, in Q1 2026, about 58% of our business was purchased through the SB channel, and the remaining 42% was purchased through the SB channel. We continue to see stronger growth in the SB channel, driven mainly by increased sales in the group purchasing organizations or GPO segment.

就我們業務的整體配送而言，在 2026 年第一季，約 58% 的業務是透過 SB 通路採購，其餘 42% 亦是透過 SB 通路採購。我們持續看到 SB 通路有更強勁的成長，主要由團體採購組織（GPO）區隔的銷售增加所帶動。

Turning to slide 4. NERLYNX net product revenue in Q1 '26 was $42 million, which represents a decrease of $17.9 million from the $59.9 million we reported in Q4 2025 and a decrease of $1.1 million from the $43.1 million we reported in Q1 of 2025.

接著看第 4 頁。2026 年第一季 NERLYNX 淨產品營收為 4,200 萬美元，較我們在 2025 年第四季報告的 5,990 萬美元減少 1,790 萬美元，亦較我們在 2025 年第一季報告的 4,310 萬美元減少 110 萬美元。

As a reminder to investors, Puma's reported NERLYNX sales include both US net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-US partners. Please note that in Q1 of 2025, we reported product supply revenue to our international partners of approximately $400,000 versus the $150,000 in Q1 of 2026. Therefore, US net sales of NERLYNX in Q1 2026 were $41.8 million versus the $42.7 million in Q1 of 2025.

提醒投資人，Puma 所報告的 NERLYNX 銷售包含 NERLYNX 在美國的淨銷售，以及供應 NERLYNX 產品給 Puma 美國以外合作夥伴的產品供應收入。請注意，在 2025 年第一季，我們向國際合作夥伴報告的產品供應收入約為 40 萬美元，而 2026 年第一季為 15 萬美元。因此，2026 年第一季 NERLYNX 的美國淨銷售為 4,180 萬美元，相較於 2025 年第一季的 4,270 萬美元。

I'll provide some more details around inventory changes, and Maximo will provide some additional specifics around gross-to-net expenses during his update. In Q1 2026, we estimate that inventory decreased by about $7.9 million. As a comparator, we estimate that inventory increased by about $5.7 million in Q4 of 2025.

我將就庫存變動提供更多細節，而 Maximo 會在他的更新中就毛額轉淨額（gross-to-net）費用提供更多具體說明。在 2026 年第一季，我們估計庫存約減少 790 萬美元。作為比較，我們估計 2025 年第四季庫存約增加 570 萬美元。

Slide 5 shows Q1 2026 ex-factory bottle sales and also provides both a year over year and quarter over quarter comparison. In Q1 2026, NERLYNX ex-factory bottle sales were 2,328, which represents an approximate 29% decrease quarter over quarter, while remaining essentially flat at 0.4% year over year.

第 5 頁顯示 2026 年第一季出廠端（ex-factory）瓶數銷售，並提供年增與季增的比較。在 2026 年第一季，NERLYNX 出廠端瓶數銷售為 2,328 瓶，季減約 29%，而年增則基本持平，為 0.4%。

Let me specifically call out the inventory changes from a bottle perspective. In Q1 2026, we estimate that inventory decreased by about 439 bottles. As a comparator, we estimate that inventory increased by 343 bottles in Q4 of 2025 and decreased by 251 bottles in Q1 of 2025.

我特別就瓶數角度說明庫存變動。在 2026 年第一季，我們估計庫存約減少 439 瓶。作為比較，我們估計 2025 年第四季庫存增加 343 瓶，而 2025 年第一季庫存減少 251 瓶。

Let me take a moment to provide some additional metrics regarding our first quarter performance. In Q1 2026, we saw enrollments increase by about 10% quarter over quarter and about 1% year over year. Commercial new patient starts, or NRxs, were even stronger, increasing by about 25% quarter over quarter and about 11% year over year.

我花點時間提供一些關於第一季表現的其他指標。在 2026 年第一季，我們看到註冊人數季增約 10%，年增約 1%。商業端新病患起始用藥（NRx）表現更強，季增約 25%，年增約 11%。

Turning to total prescriptions, or TRx, we saw TRx decline about 4% quarter over quarter and about 1% year over year.

至於總處方量（TRx），我們看到 TRx 季減約 4%，年減約 1%。

Finally, let me share some specifics around commercial demand overall. In Q1 2026, we saw demand decrease by about 6% quarter over quarter, but increased by about 7% year over year. As mentioned, these dynamics are strongly influenced by SD patterns. In Q1 2026, we saw SD demand decrease by about 9% quarter over quarter due to Q4 buy-ins, while continuing to show strong growth year over year at about 28%.

最後，我分享一些關於整體商業需求的具體情況。在 2026 年第一季，我們看到需求季減約 6%，但年增約 7%。如前所述，這些動態深受 SD 模式影響。在 2026 年第一季，由於第四季的提前採購（buy-ins），我們看到 SD 需求季減約 9%，同時年增仍維持強勁，約為 28%。

Slide 6 highlights the quarterly adoption of dose escalation since the launch of NERLYNX. In Q1 2026, approximately 78% of patients started NERLYNX at a reduced dose. This is higher compared to the 75% we reported in Q4 of 2025.

第 6 頁重點呈現自 NERLYNX 上市以來，逐步加量（dose escalation）的季度採用情況。在 2026 年第一季，約 78% 的病患以較低起始劑量開始使用 NERLYNX。這高於我們在 2025 年第四季報告的 75%。

Continued messaging and adoption of dose escalation remains an important commercial priority. We believe dose escalation, coupled with patient education resources will give patients better support throughout their NERLYNX therapy and ultimately help (Inaudible - microphone inaccessible)

持續傳達並推動逐步加量的採用，仍是重要的商業優先事項。我們相信逐步加量結合病患教育資源，將能在整個 NERLYNX 治療期間為病患提供更好的支持，並最終有助於（聽不清楚——麥克風無法收音）

Slide 7 highlights the strategic collaborations we've formed across the globe, most recently in Q1 2026, NERLYNX was launched in Thailand also in the extended adjuvant setting. We really appreciate the excellent work being done by our partners around the world and look forward to supporting their continued success moving forward.

第 7 頁重點呈現我們在全球建立的策略合作關係；最近在 2026 年第一季，NERLYNX 也在泰國上市，同樣用於延伸輔助治療（extended adjuvant）適應症。我們非常感謝全球合作夥伴所做的出色工作，並期待在未來持續支持他們的成功。

I'll close by sharing my sincere appreciation for the entire Puma team and their steadfast commitment to supporting patients and families affected by breast cancer. This disease is truly devastating, and while meaningful progress has been made. We know there's still important work ahead and even more we can accomplish together.

最後，我要對整個 Puma 團隊表達由衷的感謝，感謝他們堅定不移地致力於支持受乳癌影響的病患與家庭。這個疾病確實極具破壞性，儘管我們已取得有意義的進展。我們知道前方仍有重要工作要做，而且我們能夠攜手完成更多。

I will now turn the call over to Maximo for review of our financial results.

現在我把電話會議交給 Maximo，請他回顧我們的財務結果。

Thanks, Roger. I will begin with a brief summary of our financial results for the first quarter of 2026. Please note that I will make comparisons to Q4 2025, which we believe is a better indication of our progress as a commercial company than year over year comparisons.

謝謝你，Roger。我將先簡要總結 2026 年第一季的財務結果。請注意，我將與 2025 年第四季進行比較；我們認為，對於一家商業化公司而言，這比年對年比較更能反映我們的進展。

For more information, I recommend that you refer to our first quarter 2026 [Thank-Q], which will be filed today and includes our consolidated financial statements.

如需更多資訊，我建議您參閱我們 2026 年第一季的 [Thank-Q]，該文件將於今日提交，並包含我們的合併財務報表。

For the first quarter of 2026, we reported a net loss based on GAAP of $3.8 million or $0.07 per share. This compares to net income in Q4 2025 of $13.4 million or $0.27 per basic share and $0.26 per diluted share. The fourth quarter of 2025 included a net change in valuation allowance that unfavorably impacted net income by $3.2 million. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported a net loss of $1.9 million or $0.04 per share for the first quarter of 2026.

2026 年第一季，我們依 GAAP 報告淨損 380 萬美元，或每股 0.07 美元。相較之下，2025 年第四季淨利為 1,340 萬美元，或每股基本 0.27 美元、每股稀釋 0.26 美元。2025 年第四季包含估值備抵（valuation allowance）的淨變動，對淨利造成 320 萬美元的不利影響。以非 GAAP 基礎（調整以排除股份基礎給付費用的影響）計算，2026 年第一季我們報告淨損 190 萬美元，或每股 0.04 美元。

Gross revenue from NERLYNX sales was $57.5 million in Q1 2026 and $82.9 million in Q4 2025. As Alan mentioned, net product revenue from NERLYNX sales was $42 million, a decrease from the $59.9 million reported in Q4 2025 and the $43.1 million reported in Q1 2025.

2026 年第一季 NERLYNX 銷售的毛營收為 5,750 萬美元，2025 年第四季為 8,290 萬美元。如 Alan 所提及，NERLYNX 銷售的淨產品營收為 4,200 萬美元，低於 2025 年第四季報告的 5,990 萬美元，也低於 2025 年第一季報告的 4,310 萬美元。

As a reminder to investors, Puma reported NERLYNX sales includes both US net sales of NERLYNX and product supply revenues of NERLYNX to Puma ex-US partners. Please note that in Q1 2026, we reported product supply revenue to our international partners of about $0.1 million. Therefore, US net sales of NERLYNX in Q1 2026 were $41.9 million versus $55.2 million in Q4 2025.

提醒投資人，Puma 所報告的 NERLYNX 銷售包含 NERLYNX 在美國的淨銷售，以及供應 NERLYNX 產品給 Puma 美國以外合作夥伴的產品供應收入。請注意，在 2026 年第一季，我們向國際合作夥伴報告的產品供應收入約為 10 萬美元。因此，2026 年第一季 NERLYNX 的美國淨銷售為 4,190 萬美元，相較於 2025 年第四季的 5,520 萬美元。

The decrease in Q1 2026 versus Q4 2025 was driven by lower demand, inventory reduction in Q1 of about $7.9 million versus inventory increase of $5.7 million in Q4 2025. Royalty revenue totaled $2.8 million in the first quarter of 2026 compared to $15.6 million in Q4 2025.

2026 年第一季相較於 2025 年第四季的下降，主要是由需求較低所致；此外，第一季庫存減少約 790 萬美元，而 2025 年第四季庫存增加 570 萬美元。2026 年第一季權利金收入合計 280 萬美元，較 2025 年第四季的 1,560 萬美元為低。

The decline in royalty revenue reflects a large Q4 2025 shipment to our partner in China. Our gross to net adjustment in Q1 2026 was about 27% and 27.8% in Q4 2025. A lower gross to net adjustment was driven mostly by lower government chargebacks.

權利金收入下滑反映了 2025 年第四季對我們在中國的合作夥伴有一筆大額出貨。我們在 2026 年第一季的毛額轉淨額（gross-to-net）調整約為 27%，而 2025 年第四季為 27.8%。毛額轉淨額調整較低主要是由政府回扣（chargebacks）較低所驅動。

(inaudible) sales for Q1 2026 was $10.4 million and includes $2.4 million for the amortization of intangible assets related to our (inaudible) license. (inaudible) sales for Q4 2025 was $23.2 million. Going forward, we will continue to recognize amortization of milestones to the licensure of about $2.4 million per quarter as cost of sales.

(聽不清) 2026 年第一季的銷貨成本為 1,040 萬美元，其中包含與我們的（聽不清）授權相關之無形資產攤銷 240 萬美元。（聽不清）2025 年第四季的銷貨成本為 2,320 萬美元。展望未來，我們將持續把與授權相關之里程碑攤銷（約每季 240 萬美元）認列為銷貨成本。

For fiscal year 2026, Puma anticipates that net NERLYNX product revenue will be in the range of $202 million to $206 million, higher than our prior guidance of $194 million to $198 million. We also anticipate that our gross to net adjustment for the full year 2026 will be between 26.5% and 27.5%, significantly higher than 2025 as we expect higher government chargebacks on Medicare and Medicaid share to maintain the labels we saw in the last two quarters of 2025.

就 2026 會計年度而言，Puma 預期 NERLYNX 產品淨營收將介於 2.02 億至 2.06 億美元，高於先前指引的 1.94 億至 1.98 億美元。我們亦預期 2026 全年的毛額轉淨額調整將介於 26.5% 至 27.5%，顯著高於 2025 年，因我們預期為維持我們在 2025 年最後兩季所見的標籤（labels），Medicare 與 Medicaid 佔比下的政府回扣將更高。

In addition, for fiscal year 2025 (sic - 2026), we anticipate receiving royalties from our partners around the world in the range of $20 million to $23 million. We don't expect any license revenue in 2025 (sic - 2026). We also expect that net income for the full year will be in the range of $16 million to $19 million, also higher than our prior guidance of $10 million to $13 million.

此外，就 2025 會計年度（誤稱—2026）而言，我們預期將自全球各地合作夥伴取得的權利金介於 2,000 萬至 2,300 萬美元。我們不預期 2025 年（誤稱—2026）會有任何授權收入。我們也預期全年淨利將介於 1,600 萬至 1,900 萬美元，同樣高於先前指引的 1,000 萬至 1,300 萬美元。

Current guidance does not include any potential release of any additional tax asset valuation allowance in our net income estimate. The company is reviewing its deferred tax assets as part of its ongoing tax valuation analysis as of not yet determined whether any adjustments will be required. If so, the potential timing or size of such an adjustment.

目前指引未將任何可能釋出額外遞延所得稅資產估值備抵（valuation allowance）的情況納入我們的淨利估計。公司正將遞延所得稅資產納入持續的稅務估值分析進行檢視，目前尚未決定是否需要任何調整。若需要，亦尚未決定此類調整的可能時點或規模。

We will continue to keep investors updated on this as it progresses. This time, we do not believe that tariffs imposed or proposed to be imposed by the United States, particularly with other countries will have a material impact on our product cost or costs or results of operations.

我們將在進展過程中持續向投資人更新。目前我們不認為美國已實施或擬實施的關稅（特別是針對其他國家）會對我們的產品成本、成本或營運結果造成重大影響。

However, shift in the trade policies in the United States and other countries have been rapidly evolving and are difficult to predict. As a point of reference, our manufacturing product cost accounts for a mid to high single-digit percentage of our total cost of goods sold.

然而，美國及其他國家的貿易政策變動正快速演進，且難以預測。作為參考，我們的製造產品成本約占銷貨成本總額的中至高個位數百分比。

We anticipate that for Q2 2026, NERLYNX product revenue will be in the range of $50 million to $52 million. We expect Q2 royalties revenues will be in the range of $2 million to $3 million and no license revenue. We further estimate that the gross to net adjustment in Q2 2026 will be approximately 27% to 28%.

我們預期 2026 年第二季 NERLYNX 產品營收將介於 5,000 萬至 5,200 萬美元。我們預期第二季權利金收入將介於 200 萬至 300 萬美元，且沒有授權收入。我們進一步估計 2026 年第二季毛額轉淨額調整約為 27% 至 28%。

[Uma] anticipates a Q2 net income between $2 million and $4 million. SG&A expenses were $18.4 million in the first quarter of 2026, unchanged from the fourth quarter of 2025. SG&A expenses include non-cash charges for stock-based compensation of $1.1 million for Q1 2026 and $1 million in Q4 2025.

[Uma] 預期第二季淨利介於 200 萬至 400 萬美元。2026 年第一季的銷售、一般及行政（SG&A）費用為 1,840 萬美元，與 2025 年第四季持平。SG&A 費用包含以股份為基礎之酬勞的非現金費用：2026 年第一季為 110 萬美元，2025 年第四季為 100 萬美元。

Research and development expenses were $19.8 million in the first quarter of 2026 and $16.8 million in Q4 2025. R&D expenses included non-cash charges for stock-based compensation of $0.8 million in Q1 2026 and $0.7 million in Q4 2025.

2026 年第一季研發（R&D）費用為 1,980 萬美元，2025 年第四季為 1,680 萬美元。研發費用包含以股份為基礎之酬勞的非現金費用：2026 年第一季為 80 萬美元，2025 年第四季為 70 萬美元。

On the expense side, Puma anticipates higher total operating expenses in 2026 compared to 2025. More specifically, we anticipate SG&A expenses to increase by 1% to 2%. And R&D expenses to increase by 34% to 37% year over year. The higher R&D expense, the higher increase in R&D expense is driven by the progress of our clinical trials.

在費用方面，Puma 預期 2026 年的總營運費用將高於 2025 年。更具體而言，我們預期 SG&A 費用將增加 1% 至 2%。而研發費用將年增 34% 至 37%。研發費用較高、增幅較大的原因在於我們臨床試驗的推進。

In the first quarter of 2026, Puma reported cash earned of approximately $4 million. This compares to cash earned of approximately $3.1 million in Q4. Please note that during Q1 2026, we made our eighth quarterly principal loan payment of $11.1 million related to our obligation with [Ethereum]. Furthermore, after quarter end, we made our final payment to Ethereum and as a result, Puma is now debt-free.

2026 年第一季，Puma 報告的現金收益約為 400 萬美元。相較之下，第四季的現金收益約為 310 萬美元。請注意，在 2026 年第一季期間，我們就與[Ethereum] 相關之義務，支付了第八次季度貸款本金 1,110 萬美元。此外，在季末之後，我們已向 Ethereum 支付最後一筆款項，因此 Puma 現已無負債。

On March 31, 2026, we had approximately $101.5 million in cash, cash equivalents and marketable securities versus about $97.5 million at year-end 2025. Our accounts receivable balance was $26.3 million. Our accounts receivables terms ranged between 10 and 68 days, while our day sales outstandings are about 46 days. We estimate that as of March 31, 2026, our distribution network maintained approximately three weeks of inventory.Overall, we continue to deploy our financial resources to focus on the commercial earnings and (Inaudible - microphone inaccessible) controlling our expenses.

截至 2026 年 3 月 31 日，我們持有的現金、約當現金及有價證券約為 1.015 億美元，而 2025 年底約為 9,750 萬美元。我們的應收帳款餘額為 2,630 萬美元。我們的應收帳款付款條件介於 10 至 68 天，而應收帳款週轉天數（DSO）約為 46 天。我們估計截至 2026 年 3 月 31 日，我們的配送網路維持約三週的庫存。整體而言，我們持續運用財務資源，聚焦於商業獲利與（聽不清—麥克風無法收音）控制費用。

Thanks, Maximo. On the past earnings calls, we have stressed that Puma senior management, in cooperation with the Board of Directors, continues to remain focused on earnings sales trends and recognizes its fiscal responsibility to shareholders to continue to maintain positive net income.

謝謝你，Maximo。在過去的財報電話會議中，我們強調 Puma 的高階管理團隊在董事會的合作下，持續專注於營收與銷售趨勢，並認知到對股東的財務責任，將持續維持正向淨利。

We believe that this focus has contributed to our commercial execution in a positive way, as according to our current projections, 2026 will mark the second year over year demand increase for NERLYNX in the United States and the first time in the history of the launch of NERLYNX in the US that we have seen two positive consecutive year-over-year increases in demand.

我們相信這項專注已對我們的商業執行帶來正面助益；依據目前預測，2026 年將是 NERLYNX 在美國需求連續第二年年增，也是 NERLYNX 在美國上市以來首次出現連續兩年需求年增為正的情況。

We are pleased to report this demand-driven growth in NERLYNX sales in the first quarter of 2026, which has been driven by better-than-expected enrollments and better-than-expected new patient starts, as well as strong increases in sales to our specialty distributors.

我們很高興報告 2026 年第一季 NERLYNX 銷售出現由需求帶動的成長，這主要來自高於預期的入組（enrollments）與高於預期的新病患開始用藥（new patient starts），以及對我們專科經銷商的銷售強勁增加。

In addition, we believe that the positive net income that the company is guiding to for full year 2026 has resulted from the continued financial discipline across the company over the last few years. The company remains committed to continuing to achieve this positive net income and will continue to reduce expenses if needed in order to achieve this. We look forward to updating investors on this in the future.

此外，我們認為公司對 2026 全年所提供的正向淨利指引，源自公司過去幾年持續的財務紀律。公司仍致力於持續達成此一正向淨利，並將在必要時持續降低費用以達成目標。我們期待未來就此向投資人更新。

There continues to remain a significant unmet need for patients battling breast cancer, lung cancer, and other solid tumors. We at Puma are committed and passionate about finding more effective ways at helping these patients during their journey, and we will continue to strive to achieve that goal.

對於與乳癌、肺癌及其他實體腫瘤奮戰的病患而言，仍存在顯著未被滿足的需求。我們 Puma 致力並熱忱於尋找更有效的方法來協助這些病患走過治療旅程，我們將持續努力達成此一目標。

This concludes today's presentation. We will now turn the floor back to the operator for Q&A. Operator?

以上為今日簡報內容。接下來我們把時間交還給接線員進行問答。接線員？

Thank you. We will now begin the question-and-answer session.

謝謝。我們現在開始問答環節。

(Operator Instructions)

（接線員指示）

Salvatore Caruso, TD Cowen.

Salvatore Caruso，TD Cowen。

Hi, congrats on the data. I'm looking forward to more mature data sets. This is on behalf of Mark Fram at TD Cowen. Two quick questions. The first one, given the emerging signal in C-Myc positive patients in both lung and breast that you presented today, how are you thinking about incorporating C-Myc biology going forward into future trial designs? Do you see like, for example, in your registrational strategy that it evolving into some sort of biomarker enriched program with maybe a more narrow patient selection?

嗨，恭喜你們的數據。我也期待看到更成熟的數據集。我代表 TD Cowen 的 Mark Fram 提問。兩個簡短問題。第一個，鑑於你們今天展示的在肺癌與乳癌中 C-Myc 陽性患者都出現的新興訊號，你們未來在試驗設計上打算如何把 C-Myc 生物學納入考量？例如，在你們的註冊性策略中，是否會演變成某種以生物標記富集的方案，並可能採用更狹窄的患者篩選？

And then I'll ask my second one after.

然後我再問第二個問題。

Yeah, this is Alan. So you're absolutely right. We are seeing a much better signal in the patients where there's a signal C-Myc positivity, if you will, using that in a broad sense. In small cell lung, you don't have the benefit of a lot of the kind of predetermined disease-driven categories like you do in positive breast.

好的，我是 Alan。你說得完全正確。我們確實在出現 C-Myc 陽性訊號的患者中看到更好的訊號（廣義地使用這個說法）。在小細胞肺癌中，你不像在陽性乳癌那樣，能受益於許多預先界定、由疾病驅動的分類。

So that likely may require some form of a C-Myc positive, now is that going to be like a C-Myc positive, which includes copy number or percent of cells, I think we need a little more data to say that. I think we're hopeful that as we increase dose, we may get in the overall population.

因此，這很可能需要某種形式的 C-Myc 陽性界定；至於會不會是像 C-Myc 陽性（包含拷貝數或細胞百分比等），我認為我們還需要更多數據才能下定論。我們也希望隨著劑量提高，能在整體族群中看到效果。

We may continue to see that signal in C-Myc, but in the overall population, we may see it as well, so we may be able to go for something a little more general. But I think likely that would, if we went for a biomarker focused in small cell lung, it would be something that's probably going to be inclusive of a number of different categories of C-Myc positivity, if you will.

我們可能會持續在 C-Myc 中看到那個訊號，但在整體族群中也可能同樣看得到，因此我們或許能採取更一般性的策略。但我認為，如果我們在小細胞肺癌走生物標記聚焦的路徑，那大概會涵蓋多種不同類別的 C-Myc 陽性定義。

Now, in positive breast, HER2-negative positive breast, we've got a very interesting situation because you're absolutely right, it is a C-Myc-driven signal. But for whatever reason, we're seeing an enrichment of that signal in the patients who are ESR1 mutated and PIK3CA wild or PIK3CA wild type or both, right?

至於陽性乳癌、HER2 陰性的陽性乳癌，我們有個非常有趣的情況，因為你說得沒錯，這是一個由 C-Myc 驅動的訊號。但不知為何，我們看到這個訊號在 ESR1 突變且 PIK3CA 野生型、或 PIK3CA 野生型、或兩者皆具備的患者中更為富集，對吧？

So if I remember this correctly, ESR1 wild type is probably 50% to 60% of the patients. I'm sorry, PIK3CA wild type is probably 50% to 60% of the patients. ESR1 mutated is about 40% to 50%, so that's quite a big number. Now, if we look at the patients that are in the both category, which is where we're seeing, especially with the 50-milligram dose, really compelling activity with no patients having progressed, that's about 20% of the patients there. So it's a 40,000-patient population. If that 8,000-patient population is the one that we focus on, I'm totally okay with that. It could be a fantastic benefit. So I think for right now, it looks like an positive breast.

如果我沒記錯，ESR1 野生型大概占 50% 到 60% 的患者。抱歉，PIK3CA 野生型大概占 50% 到 60% 的患者。ESR1 突變約占 40% 到 50%，所以這是相當大的比例。現在，如果我們看同時符合兩者的患者，也就是我們看到（特別是在 50 毫克劑量下）非常具說服力的活性、且沒有患者出現疾病進展的那一群，大約占 20%。因此那是一個 40,000 名患者的族群。如果我們聚焦在那個 8,000 名患者的族群，我完全可以接受。那可能帶來非常顯著的效益。所以我認為就目前來看，在陽性乳癌方面是這樣。

We have the benefit of just having enrichment of C-Myc in categories where the disease is already being the the biomarker, if you will, is already being determined. They already know post-CDK4/6 standard of care is to do either tissue-based or ctDNA or both.

我們的優勢在於：C-Myc 的富集出現在一些類別中，而這些類別本來就已經在做疾病／生物標記的判定。他們在 CDK4/6 後的標準治療流程，原本就會做組織檢測或 ctDNA（循環腫瘤 DNA）或兩者皆做。

To see are you PIK3SA wild type, PIK3SA mutated, are you ESR1 mild type or ESR1 mutated? So we kind of have the benefit of that already being done for us. So I think in positive breast, that's probably the path we're going down. Obviously, we got to get more data, but I think that's kind of the initial thoughts on that.

用來確認你是 PIK3CA 野生型、PIK3CA 突變，或是 ESR1 野生型、ESR1 突變。所以我們某種程度上已經受益於這些檢測本來就會替我們完成。因此我認為在陽性乳癌上，這大概就是我們要走的路徑。當然我們還需要更多數據，但這是目前初步的想法。

Awesome. That helps a lot. Thank you very much. And just like a quick second question, looking ahead to the next updates in both programs. Can you hear me, kind of how ballpark for us what specific outcomes would give you guys confidence to advance or keep progressing these programs or advance even to the next stage of development?

太好了。這幫助很大。非常感謝。再一個很快的第二個問題，展望兩個項目接下來的更新。你們聽得到我嗎？能否大概跟我們說一下，哪些具體結果會讓你們有信心推進或持續推進這些項目，甚至推進到下一個開發階段？

Yeah, so in terms of investing in the next stage of development, we're all systems go on both. At this juncture, I don't see any data that would tell us we're not continuing this into Phase 3. I think the question is just what's the design? And as you referenced in your earlier question, what's the exact patient population to focus on? So I think what we're looking for is going to be more patient numbers and then more duration.

好的，就投入下一階段開發而言，兩個項目我們都全速前進。在這個時間點，我沒有看到任何數據顯示我們不應該把它推進到第三期。我認為問題只是設計會是什麼？以及如你先前提到的，究竟要聚焦在哪個精確的患者族群？所以我們在尋找的是更多的患者數量，以及更長的追蹤時間／持續時間。

Thank you.

謝謝。

Sure.

不客氣。

Thank you. This concludes our question-and-answer session. Now I would like to turn the conference back over to Mariann for any closing remarks.

謝謝。以上為我們的問答環節。現在我想把會議交回給 Mariann，請她做結語。

Thank you all for joining us today. As a reminder, this call may be accessed by a replay of the webcast at pumabiotechnology.com, beginning later today. Have a good evening.

感謝各位今天加入我們。提醒大家，本次電話會議稍晚可至 pumabiotechnology.com 透過網路直播回放收聽。祝各位晚安。

Thank you, ladies and gentlemen. Thank you for participating in today's conference call. This concludes our program. Everyone have a great day, and you may now disconnect.

謝謝各位女士、先生。感謝各位參與今天的電話會議。本次活動到此結束。祝大家有美好的一天，現在可以掛線。