Sellas Life Sciences Group Inc (SLS) 2018 Q3 法說會逐字稿

Good morning, and welcome to the Sellas Life Sciences Third Quarter 2018 Financial Results and Corporate and Business Update Conference Call. (Operator Instructions) Please be advised that this call is being recorded at Sellas' request. I'll now turn the call over to Will O'Connor of Stern Investor Relations, please proceed.

早安，歡迎參加 Sellas Life Sciences 2018 年第三季財務業績及公司及業務更新電話會議。（操作員指示）請注意，此通話是應塞拉斯的要求錄製的。我現在將電話轉給 Stern Investor Relations 的 Will O'Connor，請繼續。

Thank you, operator. This is Will O'Connor with Stern Investor Relations, and welcome to Sellas' Third Quarter 2018 Financial Results and Corporate and Business Update Conference Call. The news release became available earlier this morning, and can be found on the Sellas website at sellaslifesciences.com. You may listen to a live audio webcast and replay of today's call on the Investors section of the website. Before we begin, I'd like to remind you that today Sellas will be making statements relating to the company's financials, future expectations regarding the further development of galinpepimut-S and nelipepimut-S, its interactions with regulatory authorities, its discussions with potential partners, and its plan for future development of its other clinical candidates.

謝謝您，接線生。我是斯特恩投資者關係公司的威爾·奧康納 (Will O'Connor)，歡迎參加 Sellas 2018 年第三季財務業績和公司及業務更新電話會議。新聞稿於今天早上發布，可在 Sellas 網站 sellaslifesciences.com 上查閱。您可以在網站的投資者部分收聽今天電話會議的現場音訊網路直播和重播。在我們開始之前，我想提醒您，今天塞拉斯將就公司的財務狀況、對 galinpepimut-S 和 nelipepimut-S 進一步發展的未來預期、與監管機構的互動、與潛在合作夥伴的討論以及其對其他臨床候選藥物未來發展的計劃發表聲明。

These statements constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995, and cover many events and matters that are subject to various risks that could cause actual results to differ materially from those expressed in any forward-looking statement. You are referred to the company's SEC filings and in particular to the risks set forth under the heading Risk Factors in Exhibit 99.1 in the company's current report on Form 8-K filed on July 18, 2018, and in the company's other filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent the company's views only as of today, and should not be relied upon as representing the company's views as of any subsequent date. While Sellas may elect to update these forward-looking statements at some point in the future, the company disclaims any obligation to do so, even if the company's views change. Participating on the call are Dr. Angelos Stergiou, Chief Executive Officer of Sellas; and Gene Mack, Chief Financial Officer of Sellas. With that, I'll now turn the call over to Dr. Stergiou.

這些聲明構成了《1995 年私人證券訴訟改革法案》安全港條款所指的前瞻性聲明，涵蓋了許多受各種風險影響的事件和事項，這些風險可能導致實際結果與任何前瞻性聲明中表達的結果存在重大差異。請您參閱本公司向美國證券交易委員會 (SEC) 提交的文件，特別是公司於 2018 年 7 月 18 日提交的 8-K 表格當前報告中附件 99.1 中「風險因素」標題下列出的風險，以及公司向美國證券交易委員會提交的其他文件中列出的風險。此外，任何前瞻性陳述僅代表本公司截至今日的觀點，不應被視為代表本公司在任何後續日期的觀點。儘管塞拉斯可能會選擇在未來某個時間點更新這些前瞻性聲明，但公司不承擔任何這樣做的義務，即使公司的觀點發生變化。參加電話會議的有 Sellas 執行長 Angelos Stergiou 博士和 Sellas 財務長 Gene Mack。現在，我將把電話轉給 Stergiou 博士。

Thank you, Will. Good morning, everyone, and thank you for joining us on today's call. This is our first earning call following the reverse merger of Sellas with Galena at the end of 2017. As you know our mission at Sellas is to develop and commercialize cancer immunotherapies for a wide area of solid and hematological cancers. Our late stage pipeline includes our lead candidate galinpepimut-S, or GPS, which was in license with Memorial Sloan Kettering Cancer Center, and is currently being evaluated in multiple tumor types as a monotherapy and in combination with pembrolizumab or Keytruda, a PD-1 checkpoint inhibitor, under our collaboration agreement with Merck. We're also developing nelipepimut-S, or NPS or NeuVax, from which we just announced positive Phase IIb results in triple negative breast cancer and which originated from MD Anderson Cancer Center. During Q3 and early Q4, we have made significant clinical and regulatory progress for GPS and NPS, which I will talk about shortly. We also made key corporate advancements with the closing of our approximately $22 million financing in July of this year, which bolsters our balance sheet and enables us to pursue our plans for our clinical programs. We have also just added $6.6 million to our balance sheet from a payment by JGB in connection of the litigation with them. This followed the dismissal by the court of JGB's complaint against our company. Sellas and JGB have also agreed to terminate the debenture and all related agreements. Just to be clear, our JGB debt is now extinguished, and we have no other outstanding debt. Turning to the progress we've made with our pipeline, I'd like to first discuss where we currently stand with our lead clinical candidate, GPS. Given the compelling evidence from our Phase I and II trials of GPS in treating acute myeloid leukemia, we've been planning a pivotal Phase III study. As you may know, acute myeloid leukemia, or AML, is an area of serious unmet need and we have both fast track and orphan drug designation for GPS in AML by the FDA, and orphan drug designation by the EMA. Current treatments include chemotherapy, or in some instances, hematopoietic stem cell transplant, which aims to achieve a complete response or CR. Despite this, essentially, all patients in CR still harbor evidence of minimal residual disease. To date, no therapies aside from allergenic hematopoietic stem cell transplant, which only about 7% of 60-year and older AML patients can receive, have been shown to provide meaningful benefit to patients in CR. This patient group, 60 years and older, constitutes the majority of AML patients and is the group we aim to treat. As a result, we see a real opportunity here for GPS to provide therapeutic benefit to these patients. As you know, we have already reached consensus with the FDA to enter into a registrational Phase III AML trial, and we expect to enroll the first patients in this study in early 2019. The second pillar of our development efforts around GPS is our collaboration with Merck, with our Phase I/II open-label five-arm basket type trial of GPS, administered in combination with Merck's anti-PD-1 therapy Keytruda. The potential clinical efficacy of GPS and Keytruda is premised upon the real biological and pharmacodynamic synergy between the 2 agents. Whereby, the tumor micro environment is mitigated by Keytruda, thus allowing the patient's own immune cells, which are specifically, sensitized against WT1 by GPS to invade and destroy cancerous cells.

謝謝你，威爾。大家早安，感謝你們參加今天的電話會議。這是自 2017 年底 Sellas 與 Galena 反向合併以來我們的首次財報電話會議。如您所知，Sellas 的使命是開發和商業化針對廣泛實體癌症和血液癌的癌症免疫療法。我們的後期研發管線包括主要候選藥物 galinpepimut-S（或 GPS），該藥物已獲得紀念斯隆凱特琳癌症中心的許可，目前正在根據與默克公司的合作協議，對多種腫瘤類型進行單一療法和與 pembrolizumab 或 Keytruda（一種 PD-1 檢查點抑製劑）聯合療法的評估。我們也正在開發 nelipepimut-S（或 NPS 或 NeuVax），我們剛剛宣布了該藥物在三陰性乳癌中的 IIb 期陽性結果，該藥物源自 MD 安德森癌症中心。在第三季和第四季初，我們在 GPS 和 NPS 方面取得了重大的臨床和監管進展，我很快就會談到這一點。今年 7 月，我們也完成了約 2,200 萬美元的融資，並取得了重要的企業進步，這增強了我們的資產負債表，使我們能夠實施臨床計畫。我們也剛從日本政府債券因與我們的訴訟而支付的款項中增加了 660 萬美元到我們的資產負債表中。此前，日本政府法院駁回了針對我公司的訴訟。Sellas 和 JGB 也同意終止債券和所有相關協議。需要明確的是，我們的日本國債債務現已還清，並且我們沒有其他未償還債務。談到我們在管道方面取得的進展，我想先討論一下我們目前的主要臨床候選藥物 GPS 的進展。鑑於我們在 GPS 治療急性髓性白血病的 I 期和 II 期試驗中獲得了令人信服的證據，我們一直在計劃一項關鍵的 III 期研究。您可能知道，急性髓性白血病 (AML) 是一個嚴重未滿足需求的領域，我們擁有 FDA 授予的 AML GPS 快速通道和孤兒藥資格，以及 EMA 授予的孤兒藥資格。目前的治療方法包括化療，或在某些情況下進行造血幹細胞移植，旨在實現完全緩解或 CR。儘管如此，基本上所有 CR 患者仍保留有微小殘留疾病的證據。迄今為止，除了過敏性造血幹細胞移植（只有約 7% 的 60 歲及以上 AML 患者可以接受）之外，沒有任何療法能夠為 CR 患者帶來有意義的益處。該患者群體年齡在 60 歲及以上，佔 AML 患者的大多數，也是我們旨在治療的群體。因此，我們看到了 GPS 為這些患者提供治療益處的真正機會。如您所知，我們已經與 FDA 達成共識，進入註冊性 III 期 AML 試驗，我們預計將於 2019 年初招募首批患者參與這項研究。我們圍繞 GPS 進行開發工作的第二個支柱是與默克公司的合作，進行 GPS 的 I/II 期開放標籤五臂籃式試驗，與默克公司的抗 PD-1 療法 Keytruda 聯合使用。GPS 和 Keytruda 的潛在臨床療效取決於兩種藥物之間真正的生物學和藥效學協同作用。透過 Keytruda 緩和腫瘤微環境，從而使患者自身的免疫細胞（GPS 特異性地針對 WT1 敏感）能夠侵入並破壞癌細胞。

As a reminder, GPS was also studied in combination with nivolumab or OPDIVO, another PD-1 immune checkpoint inhibitor in an open-label single-arm Phase I/II clinical trials at Memorial Sloan Kettering in collaboration with Bristol-Myers Squibb. This study in 11 patients with recurrent ovarian, fallopian tube or primary peritoneal cancer, who are in second or greater clinical remission was aimed to evaluate the safety and efficacy of this combination approach. We saw a striking 70% of patients that received at least one dose of GPS and OPDIVO remained progression-free compared to historical progression-free survival of no more than 50%. Furthermore, we also observed robust CD4 and CD8 immune responses as well as 86% of patients mounting a WT1 specific IgG response. These data were presented at ASCO in June of this year, and are informative of the possible activity of GPS in combination with a PD-1 blocker in ovarian cancer and other solid tumors in the presence of microscopic disease, which is the setting that we're studying in GPS with Keytruda in the Merck combo trial. The basket study will include up to 90 patients and will concentrate on tumor types with high WT1 expression, but in which Keytruda treatment alone achieves an overall response rate of only 10% to 15%. The indications to be studied include colorectal, ovarian, small cell lung, and triple negative breast cancers, and AML-treated patients on hypomethylaters. We have activated numerous clinical sites and we have begun to screen patients. I'd now like to turn to our nelipepimut-S NPS program, which we also refer to as NeuVax, for which we have had an exciting quarter with positive and final data from our Phase IIb trial in HER2 1+/2+ breast cancer patients. These data were presented at the annual meetings of both the European Society of Medical Oncology, and The Society for Immunotherapy of Cancer this fall. NPS is designed to prime the immune system to recognize and efficiently attack the HER2 protein, an antigen that is detected in the majority of breast cancers, including those defined clinically as triple negative breast cancer or TNBC. TNBC patients make up around 15% of all breast cancer patients. They also experience highly aggressive recurrence rates of 36% in 3 years. The trial was a positive prospective, randomized, single blinded, controlled Phase IIb independent investigator-sponsored clinical trial, of the combination of trastuzumab, or Herceptin, plus/minus NPS targeting HER2 low-expressing breast cancer patient cohorts. We reported interim data in April of this year, which showed with a median follow-up of 18.8 months, a clinically meaningful and statistically significant difference in the TNBC cohort of patients, between the active and the control arm with a low hazard ratio of 0.26, and a p-value of 0.023, in favor of the NeuVax plus trastuzumab combination compared to trastuzumab alone. After 7 months of additional follow-up, an analysis of the final data, which was reviewed by the Independent Data Safety Monitoring Board in October of this year, we observed that the TNBC cohort of 97 patients maintained the same low hazard ratio despite the longer follow-up period, benefiting from a 75.2% reduction in risk of relapse or death at the 24-month landmark, and with an even lower and thus more clinically and statistically significant p-value of 0.013. Importantly, there were no noted differences in the safety profile of both arms. Based on these positive results, the DSMB reiterated its earlier recommendation to expeditiously seek regulatory guidance from the FDA on the most optimal development of NeuVax in TNBC patients.

提醒一下，紀念斯隆凱特琳癌症中心也與百時美施貴寶合作，在一項開放標籤單臂 I/II 期臨床試驗中研究了 GPS 與 nivolumab 或 OPDIVO（另一種 PD-1 免疫檢查點抑制劑）的聯合作用。這項研究針對 11 名復發性卵巢癌、輸卵管癌或原發性腹膜癌患者，這些患者均處於第二次或更大的臨床緩解期，旨在評估這種聯合治療方法的安全性和有效性。我們發現，接受至少一劑 GPS 和 OPDIVO 治療的患者中，70% 的患者保持無進展狀態，而歷史上無惡化存活率不超過 50%。此外，我們還觀察到強大的 CD4 和 CD8 免疫反應以及 86% 的患者產生 WT1 特異性 IgG 反應。這些數據於今年 6 月在 ASCO 上公佈，顯示 GPS 與 PD-1 阻斷劑聯合治療卵巢癌和其他實體腫瘤時，在微觀疾病存在的情況下可能具有療效，這正是我們在默克聯合試驗中研究 GPS 與 Keytruda 聯合治療的環境。這項籃子研究將納入多達 90 名患者，並將集中研究 WT1 表達高的腫瘤類型，但單獨使用 Keytruda 治療的整體反應率僅為 10% 至 15%。待研究的適應症包括大腸直腸癌、卵巢癌、小細胞肺癌、三陰性乳癌、接受低甲基化治療的 AML 患者。我們已經啟動了許多臨床站點，並已開始篩檢患者。現在我想談談我們的 nelipepimut-S NPS 計劃，我們也稱之為 NeuVax，該計劃本季度取得了令人興奮的成果，我們在 HER2 1+/2+ 乳腺癌患者中進行的 IIb 期試驗獲得了積極的最終數據。這些數據於今年秋天在歐洲腫瘤內科學會和癌症免疫治療學會的年會上發表。NPS 旨在使免疫系統能夠識別並有效攻擊 HER2 蛋白，HER2 蛋白是一種在大多數乳癌中檢測到的抗原，包括臨床定義為三陰性乳癌或 TNBC 的乳癌。TNBC 患者約佔所有乳癌患者的 15%。他們的 3 年復發率也高達 36%。該試驗是一項積極的前瞻性、隨機、單盲、對照 IIb 期獨立研究者發起的臨床試驗，研究了曲妥珠單抗或赫賽汀聯合 NPS 治療 HER2 低表達乳腺癌患者群。我們在今年 4 月報告了中期數據，數據顯示，中位追蹤時間為 18.8 個月，TNBC 患者群體中，活性組和對照組之間存在具有臨床意義和統計學意義的差異，風險比低至 0.26，p 值為 0.023，與單獨使用曲妥珠單抗相比，NeuVax 加曲妥珠單抗的組合更有利。經過 7 個月的額外隨訪，我們對最終數據進行了分析，該分析於今年 10 月由獨立數據安全監測委員會進行了審查，我們觀察到，儘管隨訪期較長，但 97 名 TNBC 患者隊列仍保持相同的低風險比，在 24 個月時復發或死亡風險降低了 75.2%，並且具有更顯著的 0.013 值。重要的是，兩種療法的安全性並沒有明顯差異。基於這些積極的結果，DSMB 重申了其早先的建議，即迅速向 FDA 尋求監管指導，以便在 TNBC 患者中實現 NeuVax 的最佳開發。

Last week, data from a preplanned secondary efficacy analysis was presented at the Society for Immunotherapy of Cancer annual meetings, showing consistent clinical effect across HLA allele subgroups in TNBC patients, including clinically meaningful and statistically significant benefit in the Asian HLA-A24 subgroup, which is highly prevalent in the Asian population with a p-value of 0.003, and a 90.6% relative risk reduction of relapse or death.

上週，在癌症免疫治療學會年會上公佈了一項預先計劃的次要療效分析的數據，該分析顯示，TNBC 患者中不同 HLA 等位基因亞組的臨床效果一致，包括亞洲 HLA-A24 亞組的臨床意義和統計學顯著的益處，該亞組在亞洲人群中非常普遍，p 值為 0.003，復發或死亡的相對風險。

We found this data to be particularly exciting as it indicates potential for NPS globally. We'll continue to work closely with the FDA at our meeting with the agency next month, where we hope to reach agreement on the most optimal, efficient and expeditious development and regulatory path forward for NPS and TNBC.

我們發現這些數據特別令人興奮，因為它顯示了全球 NPS 的潛力。我們將在下個月與 FDA 的會議上繼續與該機構密切合作，希望就 NPS 和 TNBC 最優化、最高效和最快捷的開發和監管路徑達成一致。

As we've also previously stated, we're continuing to advance potential partnering discussions for NPS, and look forward to providing further updates to you very soon. Before I turn the call over to our CFO, Gene Mack to go through the third quarter financial results, I'd like to note the importance for Sellas of the 2 corporate events I mentioned earlier. The completion of our equity offering in July, which resulted in net proceeds of approximately $22 million, was important not only for the influx of cash, but it also brought new fundamental investors into the company.

正如我們之前所說，我們將繼續推進 NPS 的潛在合作討論，並期待很快向您提供進一步的更新。在我將電話轉交給我們的財務長 Gene Mack 來介紹第三季的財務業績之前，我想指出我之前提到的兩個公司事件對 Sellas 的重要性。我們在 7 月完成股票發行，淨收益約為 2,200 萬美元，這不僅對現金流入具有重要意義，也為公司帶來了新的基本面投資者。

This influx of cash in the early part of the quarter allowed us to ramp up our clinical and regulatory activities. The other very important event was the final resolution of the litigation commenced by JGB. This litigation brought by JGB in April related to a senior secured debenture, which our predecessor Galena had entered into in 2016. In late October, the U.S. District Court of the Southern District of New York granted in full, our motion to dismiss all of the JGB claims, while leaving in place our substantive counterclaims for breach of contract, thus deciding the underlying contractual dispute in our favor.

本季初的現金流入使我們能夠加強臨床和監管活動。另一個非常重要的事件是日本政府發起的訴訟的最終解決方案。JGB 於 4 月提起的訴訟涉及我們的前身 Galena 於 2016 年簽訂的優先擔保債券。10 月下旬，紐約南區美國地方法院全額批准了我們的動議，駁回了 JGB 的所有索賠，同時保留了我們因違約而提出的實質性反訴，從而對相關合約糾紛做出了對我們有利的判決。

Last week, we announced that we have reached a settlement with JGB of the remaining counterclaims, whereby they paid us $6.6 million, and the debenture and all related agreements, and security interests were terminated and this removed all our debt from our balance sheet. We're indeed pleased to have this litigation behind us and to have received the damages we requested in our counterclaims, which includes reimbursement of our legal fees and litigation expenses. I'll now turn the call over to Gene.

上週，我們宣布已與日本國債就剩餘的反訴達成和解，日本國債向我們支付了 660 萬美元，債券和所有相關協議以及擔保權益均被終止，這將我們的所有債務從資產負債表中移除。我們確實很高興這場訴訟已經結束，並且獲得了我們在反訴中要求的賠償，其中包括我們的律師費和訴訟費用的補償。我現在將電話轉給吉恩。

Thank you, Angelos. As a reminder, the full financial results for the third quarter of 2018 can be found in our press release issued earlier this morning. I'd also like to note that upon the merger of Sellas and Galena Biopharma, the financial statements of Galena became those of Sellas, and thus the results reported here are those of Sellas, reflecting the acquisition of Galena as of December 29, 2017. Moving to our financial results from the quarter. As of September 30, 2018, unrestricted cash and cash equivalents were $10 million, which does not include the $6.6 million payment received by the company that was related to the settlement of litigation with JGB in November, 2018.

謝謝你，安傑洛斯。提醒一下，2018 年第三季的完整財務業績可以在我們今天早上發布的新聞稿中找到。我還想指出，在 Sellas 和 Galena Biopharma 合併後，Galena 的財務報表成為 Sellas 的財務報表，因此這裡報告的結果也是 Sellas 的結果，反映了截至 2017 年 12 月 29 日對 Galena 的收購。轉向我們本季的財務業績。截至 2018 年 9 月 30 日，非限制現金和現金等價物為 1000 萬美元，其中不包括公司收到的與 2018 年 11 月與 JGB 達成訴訟和解相關的 660 萬美元付款。

At December 31, 2017, unrestricted cash and cash equivalents were $2.3 million. Net cash used in operating activities was $25.9 million for the 9 months ended September 30, 2018, which includes $4.3 million used to reduce payables related to the merger. As Angelos just mentioned, on July 16, 2018, Sellas completed an underwritten public offering of common stock for aggregate net proceeds of approximately $22 million after deducting underwriting discounts, commissions and offering expenses.

截至 2017 年 12 月 31 日，不受限制的現金和現金等價物為 230 萬美元。截至 2018 年 9 月 30 日的 9 個月，經營活動所用淨現金為 2,590 萬美元，其中包括用於減少與合併相關的應付款項的 430 萬美元。正如安傑洛斯剛才所提到的，2018 年 7 月 16 日，塞拉斯完成了普通股的承銷公開發行，扣除承銷折扣、佣金和發行費用後，總淨收益約為 2,200 萬美元。

Research and development expenses were $1.7 million for the third quarter of 2018, as compared to $1.1 million for the third quarter of 2017.

2018 年第三季研發費用為 170 萬美元，而 2017 年第三季為 110 萬美元。

The increase was primarily due to the initiation of the Phase I/II clinical trial for GPS, in combination with Keytruda in multiple tumor types, and ongoing costs incurred during the third quarter related to the Phase IIb trial for NPS, in combination with trastuzumab in breast cancer, as well as increased licensing fees resulting from our expanded clinical portfolio.

成長的主要原因是啟動了 GPS 與 Keytruda 聯合用於治療多種腫瘤類型的 I/II 期臨床試驗，以及第三季度與 NPS 與曲妥珠單抗聯合用於治療乳腺癌的 IIb 期試驗相關的持續成本，以及由於我們擴大臨床組合而導致的許可費用增加。

This increase was partially offset by a reduction in stock-based compensation during the third quarter of 2018. Research and development expenses for the 9 months ended September 30, 2018, were $5.1 million, and for the same period 2017 were also $5.1 million.

這一增長被 2018 年第三季股票薪酬的減少部分抵消。截至 2018 年 9 月 30 日的 9 個月研發費用為 510 萬美元，2017 年同期研發費用也為 510 萬美元。

G&A expenses were $1.3 million for the third quarter of 2018, as compared to a $3.2 million for the third quarter of 2017.

2018 年第三季的一般及行政費用為 130 萬美元，而 2017 年第三季的一般及行政費用為 320 萬美元。

The decrease in the current period was primarily due to a reduction in stock-based compensation, and the accounting treatment for costs related to litigation and other legal matters associated with the settlement of the JGB litigation and resulting reimbursement of legal fees.

本期減少的主要原因是股票薪酬減少，以及與日本國債訴訟和解相關的訴訟和其他法律事務相關成本的會計處理以及由此產生的法律費用報銷。

The decrease was partially offset by an increase in personnel related expenses, insurance and other expenses. G&A expenses for the first 9 months of 2018 were $10.1 million, as compared to $9.4 million for the 9 months ended September 30, 2017.

這一減少被人員相關費用、保險和其他費用的增加部分抵消。2018 年前 9 個月的一般及行政費用為 1,010 萬美元，而截至 2017 年 9 月 30 日的 9 個月的一般及行政費用為 940 萬美元。

The increase was primarily related to costs associated with outside services, accounting and audit expenses, insurance and public company costs, partially offset by a reduction in stock-based compensation and a decrease in financing and advisory fees associated with the merger.

成長主要與外部服務、會計和審計費用、保險和上市公司成本有關，但股票薪酬的減少以及與合併相關的融資和諮詢費用的減少部分抵消了這一增長。

Net loss attributable to common stockholders was $9.4 million for the third quarter of 2018, or a basic and diluted loss per share of $0.53 as compared to a net loss of $4.5 million for the third quarter of 2017, or a basic and diluted loss per share of $2.27.

2018 年第三季歸屬於普通股股東的淨虧損為 940 萬美元，即每股基本虧損和稀釋虧損均為 0.53 美元，而 2017 年第三季淨虧損為 450 萬美元，即每股基本虧損和稀釋虧損均為 2.27 美元。

I want to remind you that there was a greater number of shares outstanding at September 30 of this year than they were in September 2017.

我想提醒您，今年 9 月 30 日的流通股數量比 2017 年 9 月的多。

The increase in net loss was driven primarily by noncash charges related to equity issuances during 2018. Turning to our financial expectations, following the close of our most recent public offering in July 2018, we provided guidance that cash and cash equivalents would be sufficient to fund operations at least through March 2019, which we reiterate today. We will provide an update to that guidance when we report our fourth quarter and full year results early next year. With that overview, I'll turn the call back over to Angelos.

淨虧損的增加主要是由於 2018 年股票發行相關的非現金費用。談到我們的財務預期，在我們最近一次於 2018 年 7 月結束的公開募股之後，我們提供了指導，即現金和現金等價物足以為至少到 2019 年 3 月的運營提供資金，我們今天重申這一點。我們將在明年初報告第四季和全年業績時對該指引進行更新。了解完這些情況後，我會把電話轉回給安傑洛斯。

Thank you, Gene. As I said at the start of the call, we're really excited with the ramp up of our GPS clinical program, with the start of the combination study with Merck this quarter and the registrational AML study next quarter. We are as well advancing partnering discussions around NPS, and meeting with the FDA next month on an optimal development path forward, while putting the JGB litigation behind us. This has indeed been an instrumental year for all of us, and we believe we're indeed, well positioned for 2019. I would like to turn over the call to the operator, please, for Q&A.

謝謝你，吉恩。正如我在電話會議開始時所說的那樣，我們對 GPS 臨床計劃的推進感到非常興奮，本季將開始與默克公司的聯合研究，下季將開始註冊 AML 研究。我們也在推動有關 NPS 的合作討論，並將於下個月與 FDA 會面，探討最佳發展路徑，同時將 JGB 訴訟拋在腦後。對我們所有人來說，這確實是至關重要的一年，我們相信，我們確實已經為 2019 年做好了準備。我想將電話轉給接線員，以便進行問答。

(Operator Instructions) And our first question comes from Hartaj Singh from Oppenheimer & Company.

（操作員指示）我們的第一個問題來自 Oppenheimer & Company 的 Hartaj Singh。

Can you hear me fine?

你聽得清楚我說話嗎？

Yes, very well.

是的，非常好。

Just a few questions, so maybe just start off with NPS where you had the most amount of news recently. I think you're going to be presenting some more data at San Antonio, so a couple of questions. One is that the data you're going to present at San Antonio is that part of the overall dossier you've sent to the FDA for your discussions in December? Just what expectations should we have around at San Antonio and the discussions with the FDA? And then, Angelos if you can outline for us, what are the 2 or 3 scenarios that you could see coming out of the discussion with the FDA on MPS? Then I've got a few more follow-ups.

只問幾個問題，也許可以從最近新聞最多的 NPS 開始。我認為您將在聖安東尼奧展示更多數據，所以我有幾個問題。一是，您將在聖安東尼奧展示的數據是您 12 月發送給 FDA 進行討論的整體檔案的一部分？我們對聖安東尼奧和與 FDA 的討論究竟該抱持什麼樣的期望？然後，Angelos，您能否為我們概述一下，在與 FDA 討論 MPS 時，您認為會出現哪 2 或 3 種情況？然後我還有一些後續問題。

Yes, absolutely, Hartaj, thank you for the questions. At San Antonio breast, I think what you should be expecting is some additional correlative data that we have done as part of the Phase IIb study. And it's going to be data that has not been previously disclosed. And I think as far as the FDA is concerned, as we have stated, Hartaj, we have submitted a robust briefing document to the FDA, and we'll be meeting with them in December. And I think as far as the outcomes are concerned, trust me, you will be the first one to know what that outcome will be. So please stay tuned on that.

是的，Hartaj，謝謝你的提問。在聖安東尼奧乳癌研究中心，我認為您應該期待的是我們在 IIb 期研究中完成的一些額外相關數據。這將是以前從未披露過的數據。我認為就 FDA 而言，正如我們所說的，Hartaj，我們已經向 FDA 提交了一份詳盡的簡報文件，我們將在 12 月與他們會面。我認為就結果而言，相信我，你會第一個知道結果是什麼。因此請繼續關注。

Great. Great. And Angelos, so just on specifically for TNBC, if let's say one outcome was -- and I know that generally speaking, accelerated approvals are given only 10% or less of the time. But is there a surrogate endpoint in triple negative breast cancer that could be used for an accelerated approval with, let's just say, a follow-on trial being the confirmatory trial? I mean is that realistic or not really in TNBC?

偉大的。偉大的。安傑洛斯，具體針對 TNBC，如果說一個結果是——我知道一般來說，加速批准的機率只有 10% 或更少。但是，三陰性乳癌中是否存在一個替代終點，可以用於加速批准，比如說，後續試驗是確認性試驗？我的意思是，這在 TNBC 中是否現實？

Yes, I think Hartaj, I think you've known me long enough to know that I never speculate. And I think one thing that I believe is important to note is the fact that the Independent Data Safety Monitoring Board back in April, and yet again in October, stressed strongly to expeditiously seek regulatory guidance by the FDA. And that's exactly what we have done, both for the sake of patients as well as obviously for our shareholders.

是的，我想，哈塔吉，我想你認識我很久了，知道我從不猜測。我認為值得注意的一點是，獨立資料安全監測委員會早在 4 月份，以及 10 月份就強烈強調要迅速尋求 FDA 的監管指導。這正是我們所做的，不僅是為了患者，顯然也是為了我們的股東。

Yes, no, that's a great answer. I mean, we will be looking forward to get that update. And then just on NPS last question there, which is that, as you're thinking about potential partnering, how does San Antonio and the FDA discussions play into any discussions? Or any just thoughts you're having in terms of potential partners, or how to approach that?

是的，不，這是一個很好的答案。我的意思是，我們期待獲得該更新。然後關於 NPS 的最後一個問題，即當您考慮潛在的合作時，聖安東尼奧和 FDA 的討論如何影響任何討論？或者您對潛在合作夥伴有什麼想法，或如何處理這個問題？

Yes, I mean, as we have stated Hartaj, we are actively pursuing an out-licensing strategy for NPS. As you can certainly appreciate, we cannot comment about third-party discussions. But I definitely believe that December, with the FDA in particular, is going to be important.

是的，我的意思是，正如我們 Hartaj 所說，我們正在積極推行 NPS 的對外授權策略。如您所知，我們無法對第三方討論發表評論。但我確信 12 月，特別是對 FDA 來說，將會非常重要。

Great, fantastic. Then on GPS, Angelos, you've got the AML trial going. Could you have a trial in AML that could be sort of a worldwide trial, global, sort of one Phase III? I mean I know that there is other companies that have reached those kind of agreements in AML, because there is such a high unmet need. One of the companies I follow, Sunesis, actually had a global trial for Vosaroxin that didn't work. But they could've gotten approval on one trial. Could you see in AML one Phase III -- positive Phase III getting you to an approval with GPS?

太棒了，太棒了。然後關於 GPS，安傑洛斯，你已經開始了 AML 試驗。您是否可以進行 AML 試驗，這可能是一項全球性的、全球性的、類似 III 期的試驗？我的意思是，我知道其他公司已經在反洗錢方面達成了此類協議，因為存在如此高的未滿足需求。我關注的其中一家公司 Sunesis 實際上對 Vosaroxin 進行了全球試驗，但沒有成功。但他們本可以通過一次試驗獲得批准。您是否認為 AML 第一階段 III - 積極的第三階段可以讓您獲得 GPS 批准？

Yes, the answer is yes. We have had discussions with the FDA. And we would expect that one pivotal trial will suffice. And if it's positive and meets the primary endpoint would be warranted for regulatory approvals.

是的，答案是肯定的。我們已經與 FDA 進行了討論。我們期望一次關鍵的審判就足夠了。如果結果是正面的並且達到了主要終點，那麼就需要獲得監管部門的批准。

Great, okay. And then I assume we'll just get more updates on AML at the next quarter call or whenever you have something material?

太好了，好的。然後我假設我們會在下個季度電話會議上或當您有重要消息時獲得有關 AML 的更多更新？

That's correct, Hartaj. And I think, as I mentioned, we really look forward to enrolling our first AML patients in the first quarter of next year.

沒錯，Hartaj。我認為，正如我所提到的，我們非常期待在明年第一季招募第一批 AML 患者。

Great, great. You've also gotten fast-track designation also on your offering in multiple myeloma. Can you just talk a little bit about how you're thinking about a potential trial there? Would it be also analogous to complete response in Is or IIs? Or what line of therapy or response would that be? Or it's still a little bit away before you get to that stage, Angelos?

太好了，太好了。您在治療多發性骨髓瘤方面的產品也獲得了快速通道認證。您能否簡單談談您對在那裡進行潛在試驗的看法？它是否也類似於 Is 或 IIs 中的完全反應？或者那會是什麼樣的治療或反應？或者說距離你到達那個階段還有一段距離，安傑洛斯？

Yes, I think, there is maybe -- if I may just make 2 or 3 comments on the multiple myeloma study. As you may recall, this was a trial where we treated patients with high-risk cytogenetics, those patients unfortunately do really poorly and they typically relapse within 12 months. Our data showed a median progression-free survival of 23.6 months. Having said that, I -- really our core focus as a company is around the acute myeloid leukemia Phase III trial and the combination trial with PD-1. I think multiple myeloma is an important indication. And just like as we have done across all of our assets, we will do what is necessary to optimize shareholder value here.

是的，我想，也許有——如果我可以對多發性骨髓瘤研究發表 2 或 3 條評論的話。您可能還記得，這是一項針對高風險細胞遺傳學患者的治療試驗，不幸的是，這些患者的病情非常糟糕，通常會在 12 個月內復發。我們的數據顯示中位無惡化存活期為 23.6 個月。話雖如此，我——作為一家公司，我們的核心重點確實是急性髓細胞白血病 III 期試驗和與 PD-1 的聯合試驗。我認為多發性骨髓瘤是重要指徵。正如我們對所有資產所做的那樣，我們將盡一切必要努力優化股東價值。

Yes, got it, Angelos. And just the last question for me is just on the basket trial. Is there any sort of desire on your end, at the end of Sellas to have an update? If you have a 3+3 trial, just how could we see data flow there in 2019?

是的，明白了，安傑洛斯。對我來說，最後一個問題是關於籃框試驗的。在 Sellas 結束後，您是否希望進行更新？如果您進行 3+3 試驗，我們如何在 2019 年看到資料流？

Yes, I think the basket trial, Hartaj, is indeed quite exciting, because we have built in -- so it's 5 indications and we've built in quite sophisticated [bahesion] statistics and adaptive design. So this trial will indeed allow us at various looks to provide both efficacy data as well as human biological data. So certainly in 2019, I think you should expect a rigorous news flow around the basket trial.

是的，我認為籃子試驗，Hartaj，確實非常令人興奮，因為我們已經內置了 - 所以它有 5 個適應症，並且我們已經內置了相當複雜的 [bahesion] 統計數據和自適應設計。因此，這項試驗確實可以讓我們從各個角度提供功效數據以及人類生物學數據。因此，我認為在 2019 年，你應該可以期待圍繞籃框試驗的大量新聞報導。

Our next question comes from Caroline Palomeque from Maxim Group.

下一個問題來自 Maxim Group 的 Caroline Palomeque。

So just wondering how you're seeing trends in operating expenses for next year? Because I know you're having some new trials coming in the first quarter. Just wondering how you're seeing that? How are you thinking about that?

所以只是想知道您如何看待明年的營運費用趨勢？因為我知道你們在第一季會面臨一些新的考驗。只是想知道你是怎麼看待這個的？您對此有何看法？

Hi, Caroline, it's Gene. So we definitely have control over our current cash burn. Operating expenses, what we've guided to previously is that we have cash and equivalents to fund operations through at least March of next year. And we are going to update that guidance at the time that we report our fourth quarter, early next year.

你好，卡洛琳，我是吉恩。因此，我們肯定能夠控制目前的現金消耗。營運費用，我們之前的指導是，我們擁有現金和等價物來資助至少到明年 3 月的營運。我們將在明年年初報告第四季業績時更新該指引。

And I'm showing no further questions from the phone lines. I'd now like to turn the conference back over to Dr. Stergiou for any closing remarks.

我沒有在電話中提出其他問題。現在，我想將會議交還給 Stergiou 博士，請他作結束語。

Certainly, thank you again everyone for participating in today's call. And we very much look forward to updating you again very soon. Thank you.

當然，再次感謝大家參加今天的電話會議。我們非常期待很快能再次向您提供最新消息。謝謝。

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone, have a wonderful day.

女士們、先生們，感謝大家參加今天的會議。程式到此結束，大家可以斷開連線了。祝大家有美好的一天。