Salarius Pharmaceuticals Inc (SLRX) 2022 Q2 法說會逐字稿

Welcome to the Salarius Pharmaceuticals second-quarter 2022 financial results and business update conference call. All participants will be in listen-only mode. (Operator Instructions) After today's presentation, there will be an opportunity to ask questions. (Operator Instructions) Please note this event is being recorded.

歡迎參加 Salarius Pharmaceuticals 2022 年第二季度財務業績和業務更新電話會議。所有參與者都將處於只聽模式。 （操作員說明）在今天的演示之後，將有機會提問。 （操作員說明）請注意正在記錄此事件。

I would now like to turn the conference over to Kim Golodetz with LHA Investor Relations. Kim, please go ahead.

我現在想將會議轉交給 LHA 投資者關係部的 Kim Golodetz。金，請繼續。

Thank you. This is Kim Golodetz, Senior Vice President and Principal with LHA Investor Relations. Thank you all for participating in today's call.

謝謝。我是 LHA 投資者關係高級副總裁兼負責人 Kim Golodetz。感謝大家參加今天的電話會議。

Joining me from Salarius Pharmaceuticals are David Arthur, Director and Chief Executive Officer; and Mark Rosenblum, Chief Financial Officer. In addition, Dr. Daniela Santiesteban, Director of Protein Degradation Development, will be available for Q&A.

和我一起來自 Salarius Pharmaceuticals 的是董事兼首席執行官 David Arthur；首席財務官 Mark Rosenblum。此外，蛋白質降解開發總監 Daniela Santiesteban 博士將出席問答環節。

During this call, Salarius will be making forward-looking statements about operating metrics, future expectations, plans, events, and circumstances, including statements about its strategy, future operations, the development, and effectiveness of its investigational drug candidates, seclidemstat and SP-3164, as well as its targeted protein degradation program and expectations regarding its capital allocation and cash resources.

在這次電話會議中， Salarius 將就運營指標、未來預期、計劃、事件和情況做出前瞻性陳述，包括關於其戰略、未來運營、開發和其研究候選藥物 seclidemstat 和 SP-的有效性的陳述。 3164，以及其有針對性的蛋白質降解計劃和對其資本配置和現金資源的預期。

These statements are based on Salarius' current expectations, and you should not place undue reliance on these statements. Actual results may differ materially due to risks and uncertainties, including those detailed in the risk factors section of the company's annual report on Form 10-K for the year ended December 31, 2021, and subsequent quarterly reports on Form 10-Q, as well as other periodic SEC filings. Except as required by law, Salarius disclaims any obligation to update information contained in these forward-looking statements, whether as a result of new information, future events, or otherwise.

這些陳述基於 Salarius 目前的預期，您不應過分依賴這些陳述。實際結果可能因風險和不確定性而存在重大差異，包括公司截至 2021 年 12 月 31 日止年度的 10-K 表年度報告的風險因素部分以及隨後的 10-Q 表季度報告中詳述的風險和不確定性，以及與其他定期向美國證券交易委員會提交的文件一樣。除法律要求外，Salarius 不承擔任何更新這些前瞻性陳述中包含的信息的義務，無論是由於新信息、未來事件或其他原因。

With that said, I'd like to turn the call over to David Arthur, CEO of Salarius Pharmaceuticals. David?

話雖如此，我想把電話轉給 Salarius Pharmaceuticals 的首席執行官大衛亞瑟。大衛？

Thank you, Kim. And thank you to all of you for joining this call and for your interest in Salarius, particularly for all of you joining us for your first Salarius earnings and business call update.

謝謝你，金。並感謝你們所有人加入這個電話會議並感謝你們對 Salarius 的興趣，特別是感謝你們加入我們的第一個 Salarius 收入和業務電話更新。

The second quarter and recent weeks were once again very productive for Salarius as we continue to advance both of our lead programs towards multiple near-term milestones. We are making excellent progress in pursuit of our vision of treating patients fighting cancer with either seclidemstat or SP-3164, while providing investors with potential value-creating inflection points later this year. Indeed, based on the progress we made in the first half of this year, we expect a busy second half of 2022.

第二季度和最近幾週對 Salarius 來說再次非常富有成效，因為我們繼續將我們的兩個領先項目推進到多個近期里程碑。我們在追求使用 seclidemstat 或 SP-3164 治療抗癌患者的願景方面取得了巨大進展，同時在今年晚些時候為投資者提供潛在的創造價值的轉折點。事實上，根據我們今年上半年取得的進展，我們預計 2022 年下半年會很忙碌。

I will first talk about seclidemstat, our reversible LSD1 protein inhibitor. And although, seclidemstat program is furthest along the development path, that does not in any way diminish the excitement we have for 3164, our targeted protein degrader, where we plan to submit an investigational new drug application to the FDA and begin human trials next year.

我將首先談談我們的可逆 LSD1 蛋白抑製劑 seclidemstat。儘管 seclidemstat 計劃在開發道路上走得最遠，但這絲毫沒有減少我們對 3164 的興奮，我們的目標蛋白質降解劑，我們計劃向 FDA 提交研究性新藥申請，並於明年開始人體試驗.

Enrollment in our Phase 1/2 study with seclidemstat in Ewing's and other FET-rearranged sarcomas is progressing well. Last week, we announced the addition of several prestigious sites to the study. The Seattle Cancer Care Alliance, which is comprised of the Fred Hutchinson Cancer Research Center, Seattle Children's Hospital, and the University of Washington Medical Center. All well-known names in cancer research.

我們在尤因氏肉瘤和其他 FET 重排肉瘤中使用 seclidemstat 進行的 1/2 期研究的招募進展順利。上週，我們宣佈在研究中增加了幾個著名的網站。西雅圖癌症護理聯盟，由 Fred Hutchinson 癌症研究中心、西雅圖兒童醫院和華盛頓大學醫學中心組成。癌症研究領域的所有知名人士。

We also added Oregon Health & Sciences University, another well-known name, which brings us to 15 total clinical sites, representing 23 separate locations around the country enrolling patients. We also plan to add a few more sites in the coming weeks and plan to make an announcement once those sites are active. We remain on track to report interim data later this year with additional data being available as patients continue to enroll and continue on seclidemstat treatment.

我們還添加了俄勒岡健康與科學大學，這是另一個眾所周知的名字，它使我們擁有 15 個臨床站點，代表全國 23 個不同的地方招募患者。我們還計劃在未來幾週內添加更多網站，併計劃在這些網站啟用後發佈公告。我們仍有望在今年晚些時候報告中期數據，隨著患者繼續登記並繼續接受 seclidemstat 治療，我們將提供更多數據。

As a reminder, Ewing's and FET-rearranged sarcomas are rare with limited treatment options and poor prognosis, which makes the work we do extremely important. All of us at Salarius, and hopefully you as investors and interested parties, are motivated by the prospect of making a difference in the treatment of these cancers with high unmet need.

提醒一下，尤因肉瘤和 FET 重排肉瘤很少見，治療選擇有限且預後不良，這使得我們所做的工作極為重要。我們 Salarius 的所有人，希望您作為投資者和感興趣的各方，都受到在治療這些具有高度未滿足需求的癌症方面有所作為的前景的激勵。

We are also excited to announce last week a collaboration with Volition Rx to advance rapid epigenetic profiling utilizing their Nu.Q technology. This profiling will support further development of seclidemstat by studying biomarkers to allow for a noninvasive method of determining target engagement. In other words, is the drug reaching and having activity in patient's cancer cells? So this exciting research collaboration provides us another tool to aid in the development of seclidemstat to treat patients in the clinic and beyond.

我們也很高興上周宣布與 Volition Rx 合作，利用他們的 Nu.Q 技術推進快速表觀遺傳分析。這種分析將通過研究生物標誌物支持 seclidemstat 的進一步開發，以允許採用一種非侵入性方法來確定目標參與度。換句話說，藥物是否到達患者的癌細胞並在其中發揮作用？因此，這項激動人心的研究合作為我們提供了另一種工具來幫助開發 seclidemstat 以治療臨床及其他患者。

The study of seclidemstat is also progressing at the MD Anderson Cancer Center in an investigator-initiated hematologic or blood cancer clinical trial. As a reminder, the cost of investigator-initiated clinical trials is usually significantly subsidized by the sponsoring institution, which in this case is MD Anderson, which markedly reduces the cost to generate key proof-of-concept patient data. We continue to expect interim clinical updates from this trial before the end of the year.

seclidemstat 的研究也在 MD 安德森癌症中心的研究者發起的血液學或血癌臨床試驗中取得進展。提醒一下，研究者發起的臨床試驗的成本通常由贊助機構（在本例中為 MD Anderson）提供大量補貼，這顯著降低了生成關鍵概念驗證患者數據的成本。我們繼續期待在今年年底之前從該試驗中獲得中期臨床更新。

Now, turning to our protein degrader asset, SP-3164. Recall that in January of this year, we acquired an intellectual property portfolio from DeuteRx, LLC, including the drug candidate SP-3164. 3164 now forms the basis of our targeted protein degradation or TPD drug development program.

現在，轉向我們的蛋白質降解劑資產 SP-3164。回想一下，今年 1 月，我們從 DeuteRx, LLC 收購了知識產權組合，包括候選藥物 SP-3164。 3164 現在構成了我們靶向蛋白質降解或 TPD 藥物開發計劃的基礎。

TPD is the subject of heightened interest in the pharmaceutical community, because of its potential to develop medicines that target cancer-promoting proteins that have historically been considered undruggable. In addition, we believe this is a validated area of cancer research with a class of early protein degraders called molecular glues, showing considerable therapeutic and commercial success.

TPD 是製藥界高度關注的主題，因為它有可能開發出靶向促癌蛋白的藥物，而這些蛋白在歷史上被認為是不可藥用的。此外，我們相信這是一個經過驗證的癌症研究領域，使用一類稱為分子膠的早期蛋白質降解劑，顯示出相當大的治療和商業成功。

Let's not forget, the Bristol Myers Squibb reported in their fourth-quarter and full-year financial results for 2021, that the first-generation molecular glues, Revlimid and Pomalyst generated over $16 billion in global sales in 2021. As I just mentioned, we believe this helps explain heightened interest in protein degradation among the pharmaceutical community.

別忘了，百時美施貴寶在其 2021 年第四季度和全年財務業績中報告稱，第一代分子膠 Revlimid 和 Pomalyst 在 2021 年的全球銷售額超過 160 億美元。正如我剛才提到的，我們相信這有助於解釋製藥界對蛋白質降解的濃厚興趣。

What we believe makes 3164 unique or differentiated from other molecular glues is that it is the preferred half or preferred enantiomer of the widely studied drug avadomide, with a potential for increased efficacy and improved safety versus avadomide and potentially other molecular glues. Since its acquisition at the beginning of the year, we have made good progress in advancing 3164 and have already completed the pre-IND meeting process with the FDA. That meeting process provided valuable input and clarity on pre-clinical, clinical, and other regulatory matters for preparing and submitting our IND.

我們認為，使 3164 與眾不同或與其他分子膠區別開來的是，它是廣泛研究的藥物 avadomide 的首選半對映體或首選對映體，與 avadomide 和其他可能的分子膠相比，具有更高的療效和更高的安全性。自年初收購以來，我們在推進3164方面取得了良好進展，並已完成與FDA的pre-IND會議流程。該會議過程為準備和提交我們的 IND 提供了寶貴的意見，並明確了臨床前、臨床和其他監管事項。

We are currently implementing IND-enabling studies and other development activities. And we believe we remain on track for an IND submission in the first half of next year with the start of clinical studies soon thereafter. Included in our IND-enabling work are studies evaluating 3164 as single-agent treatment used in combination with other common anticancer treatments and compared to other molecular glues. And we continue to look forward to providing updates later this year.

我們目前正在實施支持 IND 的研究和其他開發活動。我們相信我們仍有望在明年上半年提交 IND，此後不久將開始臨床研究。我們的 IND 支持工作包括評估 3164 作為單藥治療與其他常見抗癌治療聯合使用並與其他分子膠進行比較的研究。我們繼續期待在今年晚些時候提供更新。

Many large pharma companies are partnering with development stage protein degrader companies, likely catalyzed by the commercial success of first molecular glues like Revlimid and Pomalyst, which, as I mentioned earlier, had 2021 global sales of more than $16 billion. As a reminder, we have seen a large number of partnerships for both pre-clinical and early clinical stage drugs, including most recently in February, when Amgen signed a development deal for Plexium's protein degrader, valued at more than $100 million.

許多大型製藥公司正在與處於開發階段的蛋白質降解劑公司合作，這可能是 Revlimid 和 Pomalyst 等首批分子膠的商業成功所促成的，正如我之前提到的，它們 2021 年的全球銷售額超過 160 億美元。提醒一下，我們已經看到大量針對臨床前和早期臨床階段藥物的合作夥伴關係，包括最近的 2 月，當時 Amgen 簽署了價值超過 1 億美元的 Plexium 蛋白質降解劑的開發協議。

We were interested in hearing from pharmaceutical leaders with respect to both 3164 and seclidemstat. And with that in mind, we attended the 2022 BIO International Conference in San Diego, California. With over 15,000 attendees, BIO provided members of the Salarius team with multiple opportunities to provide updates not only on both the programs, but to capture input on what type of pre-clinical and clinical data a number of those pharmaceutical companies would like us to generate. We have taken that advice, so we consider BIO a success.

我們有興趣聽取製藥業領導者關於 3164 和 seclidemstat 的意見。考慮到這一點，我們參加了在加利福尼亞州聖地亞哥舉行的 2022 年 BIO 國際會議。 BIO 有超過 15,000 名與會者，為 Salarius 團隊的成員提供了多個機會，不僅可以提供有關這兩個計劃的最新信息，還可以獲取有關許多製藥公司希望我們生成的臨床前和臨床數據類型的意見.我們採納了這個建議，因此我們認為 BIO 是成功的。

Before I turn the call over to Mark to review our second quarter and year-to-date financial results, I want to add that we have managed our expenses very well while progressing towards our 2022 milestones. Each day draws us closer to achieving those milestones and potentially having two anticancer medicines to treat patients who have failed existing therapies.

在我將電話轉給馬克審查我們的第二季度和年初至今的財務業績之前，我想補充一點，我們在朝著 2022 年的里程碑邁進的同時很好地管理了我們的開支。每一天都讓我們更接近實現這些里程碑，並有可能擁有兩種抗癌藥物來治療現有療法失敗的患者。

Mark, over to you.

馬克，交給你了。

Thank you, David. Our net loss for the second quarter of 2022 was $4.7 million or $0.09 per share, and this compares to a net loss of $3.1 million or $0.07 per share for the second quarter of 2021. The increase in net loss was due to higher operating expenses and the absence of grant revenue in the 2022 quarter.

謝謝你，大衛。我們 2022 年第二季度的淨虧損為 470 萬美元或每股 0.09 美元，而 2021 年第二季度的淨虧損為 310 萬美元或每股 0.07 美元。淨虧損的增加是由於運營費用增加和2022 年季度沒有贈款收入。

Research and development expenses were $2.9 million for the second quarter of 2022, compared with $2.1 million a year ago. The $800,000 increase was primarily from spending on our targeted protein degradation technology purchased in January of this year. Overall spending for seclidemstat was unchanged compared to the prior year.

2022 年第二季度的研發費用為 290 萬美元，而一年前為 210 萬美元。 800,000 美元的增長主要來自我們今年 1 月購買的靶向蛋白質降解技術的支出。與上一年相比，seclidemstat 的總體支出沒有變化。

General and administrative expenses increased to $1.8 million during Q2 of 2022, from $1.6 million last year, due to higher personnel costs and proxy solicitation services for our annual meeting of stockholders held in June of this year.

2022 年第二季度的一般和行政費用從去年的 160 萬美元增加到 180 萬美元，原因是今年 6 月舉行的年度股東大會的人員成本和代理權徵集服務增加。

Net cash used for operating activities during the second quarter of 2022 was $3.6 million, and this compares to $3.2 million a year ago.

2022 年第二季度用於經營活動的淨現金為 360 萬美元，而一年前為 320 萬美元。

Turning to our year-to-date financial results, net loss for the first half of 2022 was $10.8 million or $0.22 per share, compared to a net loss of $4.9 million or $0.13 per share for the first half 2021. The increased loss was primarily due to higher research and development expenses, including a $2 million one-time non-recurring purchase of our targeted protein degradation portfolio and other spending for this technology.

談到我們年初至今的財務業績，2022 年上半年的淨虧損為 1080 萬美元或每股 0.22 美元，而 2021 年上半年的淨虧損為 490 萬美元或每股 0.13 美元。增加的虧損主要是由於更高的研發費用，包括 200 萬美元的一次性非經常性購買我們的目標蛋白質降解產品組合以及該技術的其他支出。

Seclidemstat costs for the six-month period increased, almost all of which occurred in the first quarter, resulting from higher development and clinical trial expenses and higher personnel costs, offset by lower manufacturing costs. We incurred higher general and administrative expenses resulting from higher personnel costs and public company costs. We recorded no grant revenue for the six-month period, whereas we reported grant revenue of $1.8 million for the first half of 2021.

六個月期間的 Seclidemstat 成本增加，幾乎全部發生在第一季度，這是由於更高的開發和臨床試驗費用以及更高的人員成本，被較低的製造成本所抵消。由於人員成本和上市公司成本增加，我們產生了更高的一般和行政費用。我們在六個月期間沒有記錄任何贈款收入，而我們報告的 2021 年上半年的贈款收入為 180 萬美元。

Net cash used in operating activities for the first half 2022 was $7.1 million, an increase of $1.2 million from the prior period. Net cash used in investing activities, $1.5 million, is the cash portion of our targeted protein degradation purchase in January of this year.

2022 年上半年經營活動使用的現金淨額為 710 萬美元，較上年同期增加 120 萬美元。用於投資活動的淨現金 150 萬美元是我們今年 1 月目標蛋白質降解採購的現金部分。

And now I will review key balance sheet items. We have benefited from grant revenue from the Cancer Prevention and Research Institute of Texas, or CPRIT, and note that we view receipt of these grants as a vote of confidence for our seclidemstat program. At this point, we have reached the maximum amount of eligible spending that can be reimbursed from CPRIT, and we have recorded a $1.6 million receivable on our balance sheet.

現在我將審查關鍵的資產負債表項目。我們受益於得克薩斯州癌症預防和研究所 (CPRIT) 的贈款收入，並註意到我們將收到這些贈款視為對我們的 seclidemstat 計劃的信任投票。此時，我們已達到 CPRIT 可報銷的最大合格支出金額，我們在資產負債表上記錄了 160 萬美元的應收賬款。

As of June 30, 2022, Salarius had cash, cash equivalents, restricted cash of $22.6 million, compared with $29.2 million as of December 31, 2021. Current cash and cash equivalents are expected to fund the company's planned operations into 2023.

截至 2022 年 6 月 30 日，Salarius 擁有現金、現金等價物、限制性現金 2260 萬美元，而截至 2021 年 12 月 31 日為 2920 萬美元。預計當前現金和現金等價物將為公司計劃的運營提供資金，直至 2023 年。

With that, I will turn the call back over to David.

有了這個，我會把電話轉回給大衛。

Thanks, Mark. One challenge I encounter with every investor call is communicating the confidence I have in Salarius and the excitement I have for the near future. Both seclidemstat clinical trials continue to enroll patients, and MD Anderson and Salarius are both collecting clinical data.

謝謝，馬克。我在每次投資者電話中遇到的一個挑戰是傳達我對 Salarius 的信心以及我對不久的將來的興奮。兩項 seclidemstat 臨床試驗都在繼續招募患者，MD Anderson 和 Salarius 都在收集臨床數據。

We continue to plan to share that interim data later this year. Either or both of these clinical interim data updates could be positive news for patients fighting these terrible cancers.

我們繼續計劃在今年晚些時候分享該中期數據。這些臨床中期數據更新中的一個或兩個對於與這些可怕的癌症作鬥爭的患者來說可能是個好消息。

In addition, our 3164 protein degrader program is proceeding as planned. Pre-clinical data is arriving. We are planning to provide updates on that data later this year. We are progressing towards an investigational new drug application, and I believe we will begin clinical trials next year with what could be the next-generation molecular glue.

此外，我們的 3164 蛋白質降解劑項目正在按計劃進行。臨床前數據即將到來。我們計劃在今年晚些時候提供該數據的更新。我們正在研究新藥申請，我相信明年我們將開始臨床試驗，可能是下一代分子膠。

And we recently completed a productive series of meetings with pharmaceuticals companies at the BIO International Convention. And as Mark just mentioned, we ended the second quarter with over $22 million in cash and cash equivalents in the bank. So a protein inhibitor in two clinical trials with interim clinical updates later this year, a protein degrader with pre-clinical data releases later this year, with plans to enter the clinic next year, and over $22 million in the bank as of June 30, 2022.

我們最近在 BIO 國際大會上完成了與製藥公司的一系列富有成效的會議。正如馬克剛才提到的，我們在第二季度結束時在銀行擁有超過 2200 萬美元的現金和現金等價物。因此，今年晚些時候進行兩項臨床試驗並進行中期臨床更新的蛋白質抑製劑，今年晚些時候發布臨床前數據的蛋白質降解劑，計劃明年進入臨床，截至 6 月 30 日，銀行存款超過 2200 萬美元， 2022.

This is why I am excited. And these are only some of the reasons why I have confidence in Salarius and I am excited about the future. I also want to mention that we will be presenting at the Ladenburg Thalmann Healthcare Conference being held in November -- in New York City on Thursday, September 29, and we'll be available -- Salarius management will be available for one-on-one meetings at the conference.

這就是我興奮的原因。這些只是我對 Salarius 充滿信心並對未來感到興奮的部分原因。我還想提一下，我們將在 11 月舉行的 Ladenburg Thalmann 醫療保健會議上發表演講——9 月 29 日星期四，在紐約市，我們將有空——Salarius 管理將提供一對一的——會議上的一個會議。

Also, earlier that week, we plan to be in New York for one-on-one meetings with the investment community. Please contact LHA Investor Relations, our IR firm, if you would like to arrange a meeting.

此外，那週早些時候，我們計劃在紐約與投資界進行一對一的會談。如果您想安排會面，請聯繫我們的 IR 公司 LHA Investor Relations。

And in addition, Dr. Daniela Santiesteban, has accepted an invitation to speak later this year at the 5th Annual Targeted Protein Degradation Summit in Boston, Massachusetts. Per the summit website, the annual TPD Summit is the world's leading industry dedicated conference that spans the full drug development pipeline from discovery through to the clinic. And they are expecting over 700 experts from pharma, biotech, and leading academic labs to attend their conference from October 25 to 28. And we are looking forward to Daniela providing an update on our 3164 program.

此外，Daniela Santiesteban 博士已接受邀請，將於今年晚些時候在馬薩諸塞州波士頓舉行的第 5 屆年度靶向蛋白質降解峰會上發表演講。根據峰會網站，一年一度的 TPD 峰會是世界領先的行業專門會議，涵蓋從發現到臨床的完整藥物開發管道。他們期待來自製藥、生物技術和領先學術實驗室的 700 多位專家參加 10 月 25 日至 28 日的會議。我們期待 Daniela 提供我們 3164 計劃的最新信息。

Before we open the call for questions, I want to let investors know that in addition to making a difference in the lives of patients fighting cancer, one of our goals is to provide transparency to investors so they understand the development timelines and our expected milestones. For that reason, moving forward, our conference calls are expected to be event-driven rather than adhering to a pre-determined schedule based on SEC financial filing deadlines. We will continue to issue earnings and business updates on the SEC schedule, but I expect our next public conference call will be held when we have interim clinical or significant pre-clinical data to discuss.

在我們開始提問之前，我想讓投資者知道，除了改變抗癌患者的生活外，我們的目標之一是向投資者提供透明度，以便他們了解開發時間表和我們預期的里程碑。出於這個原因，展望未來，我們的電話會議預計將由事件驅動，而不是遵守基於美國證券交易委員會財務申報截止日期的預先確定的時間表。我們將繼續按照 SEC 的時間表發布收益和業務更新，但我預計我們的下一次公開電話會議將在我們有臨時臨床或重要的臨床前數據要討論時舉行。

With those comments, I thank you for your time and attention. Joining us now for the Q&A portion of the call is Dr. Daniela Santiesteban, Director of Protein Inhibition Development.

有了這些評論，我感謝您的時間和關注。現在加入我們的電話問答部分的是蛋白質抑制開發總監 Daniela Santiesteban 博士。

And now, operator, we are ready to take questions.

現在，接線員，我們準備好接受提問了。

Thank you. (Operator Instructions) Ahu Demir, Ladenburg

謝謝。 （操作員說明）Ahu Demir，拉登堡

Good morning. Thank you very much for taking my question, and congrats on the progress you made this quarter. My first question will be about the partnership you established. I would like to get some more information on how you plan to implement that partnership with Volition Rx in the ongoing seclidemstat clinical trial and when we might see some patient epigenetic profiling data?

早上好。非常感謝您提出我的問題，並祝賀您本季度取得的進展。我的第一個問題是關於你們建立的伙伴關係。我想獲得更多信息，了解您計劃如何在正在進行的 seclidemstat 臨床試驗中與 Volition Rx 建立夥伴關係，以及我們何時可以看到一些患者表觀遺傳分析數據？

Ahu, this is David. It's good to hear from you. Thanks for the question. I think I am going to let Daniela take this question. She was the person spearheading this partnership and she is the best one to give you the information you are looking for.

阿虎，這是大衛。很高興收到你的來信。謝謝你的問題。我想我會讓丹妮拉回答這個問題。她是這一合作夥伴關係的帶頭人，她是向您提供所需信息的最佳人選。

Daniela, are you there?

丹妮拉，你在嗎？

Yes. Thank you, Ahu, for the question. So yeah, we are very excited about this collaboration with Volition. They will be taking samples from patients on our sarcoma trial and its plasma sample. So like David said, noninvasive. And they are looking at methyl marks for tumor nucleosomes.

是的。謝謝阿虎的提問。所以，是的，我們對與 Volition 的合作感到非常興奮。他們將從我們肉瘤試驗的患者身上採集樣本及其血漿樣本。所以就像大衛說的，非侵入性的。他們正在研究腫瘤核小體的甲基標記。

So what that will tell us is if seclidemstat is getting to the tumor and having an effect on cancer cells, we should see an increase in methyl marks. And that's what the Volition data will provide us with. And we are hoping to start collecting that data towards the end of this year and into early next year. Does that answer your question?

所以這將告訴我們，如果 seclidemstat 進入腫瘤並對癌細胞產生影響，我們應該會看到甲基標記的增加。這就是 Volition 數據將為我們提供的。我們希望在今年年底和明年初開始收集這些數據。這是否回答你的問題？

Yes, it does. Thank you so much for that answer. I have a follow-up question on the seclidemstat program. I am curious to know what is the current enrollment status? And you did mention there will be a data readout we are excitedly waiting for. Is there any determination or conferences when you would be disseminating the data? When we will see the data, or is it going to be a press release? Any information, any color will be very helpful?

是的，它確實。非常感謝您的回答。我有一個關於 seclidemstat 程序的後續問題。我很想知道目前的註冊狀態是什麼？你確實提到了我們正在興奮地等待的數據讀出。當您傳播數據時，是否有任何決定或會議？我們什麼時候能看到數據，還是會發布新聞稿？任何信息，任何顏色都會很有幫助嗎？

Yeah. Happy to provide some color, Ahu. As we have mentioned a number of times, we are looking to the second half of this year to be a period of time where we will have a very rich data update, series of announcements, both clinical from the seclidemstat program and pre-clinical from the 3164 program.

是的。很高興提供一些顏色，Ahu。正如我們多次提到的那樣，我們預計今年下半年將有非常豐富的數據更新、一系列公告，包括來自 seclidemstat 計劃的臨床和來自3164 程序。

Specifically about Ewing sarcoma, we don't discuss actual enrollment numbers. But as you can see, based on the data we are generating, we are continuing to get interest from clinical trial sites.

特別是關於尤文肉瘤，我們不討論實際的註冊人數。但正如您所看到的，根據我們正在生成的數據，我們將繼續從臨床試驗站點獲得興趣。

We just added four prestigious names to the list, and we have a couple more coming online any day now. And we are looking forward to that release. And that will take us up to, I think 17, maybe a few more. 17 sites with even more than, possibly, 23 locations across the country. So the enrollment is going well.

我們剛剛在列表中添加了四個享有盛譽的名字，而且現在隨時都會有更多的名字上線。我們期待著那個版本。這將使我們達到，我認為 17，也許更多。 17 個站點，甚至可能超過全國 23 個站點。所以招生進展順利。

Now what we are looking for in this patient data, and you are probably aware of this based on the recent release of the RECUR data coming out of Europe is that what's really important according to the principal investigator of RECUR is progression-free survival. And that just takes a little while.

現在我們在這些患者數據中尋找的是，根據最近發布的來自歐洲的 RECUR 數據，您可能已經意識到這一點，根據 RECUR 的主要研究者，真正重要的是無進展生存期。這只需要一點時間。

The progression-free survival data for the second -- for the first and second relapse patients with RECUR was sadly just terrible. And I can't remember the exact numbers. It's maybe 2.5 months and maybe 3.5 months or 4 months for the two different treatments they were releasing data on. And it's just terrible for these patients with Ewing.

第二次的無進展生存數據 - 對於第一次和第二次復發患者的 RECUR 可悲的是非常糟糕。我不記得確切的數字。他們發布數據的兩種不同治療方法可能需要 2.5 個月，也可能需要 3.5 個月或 4 個月。這對這些尤因病患者來說太可怕了。

So we are very fortunate that the patients we have enrolled are on drug, and we are monitoring them. And by the end of the year, definitely in the second half of this year, we will have enough data on their duration of treatment, [event-free] survival, progression-free survival, however you want to look at it. So we think really provides some great guidance to the marketplace and the doctors and investors on what we think we can do with this drug. And we will just have to wait and see what happens, but we feel really good about sticking to that timeline of being able to provide some data.

所以我們很幸運，我們招募的患者正在服用藥物，我們正在監測他們。到今年年底，肯定是在今年下半年，我們將獲得足夠的關於他們治療持續時間、[無事件] 生存期、無進展生存期的數據，無論你想看什麼。因此，我們認為確實為市場、醫生和投資者提供了一些很好的指導，讓我們知道我們可以用這種藥物做什麼。我們只需要等待，看看會發生什麼，但我們對堅持能夠提供一些數據的時間表感到非常高興。

Now, how will we do that? Not entirely sure yet. Once we have the information and we feel confident that it's ready to be released. From an ethical perspective, if it's good information, I am certainly not going to sit on it just to wait for a conference when we could be telling patients fighting this terrible disease that there might be a good option out there. And so, I think, the options of a press release or a late breaking conference submission are all on the table at this point.

現在，我們將如何做到這一點？還不完全確定。一旦我們獲得了信息並且我們確信它已經準備好發布。從倫理的角度來看，如果這是好的信息，我當然不會坐等會議召開，屆時我們可以告訴與這種可怕疾病作鬥爭的患者，那裡可能有一個好的選擇。因此，我認為，新聞稿或最新會議提交的選項此時都已擺在桌面上。

I gave you a long answer to a short question. Hopefully, I answered it.

我給了你一個簡短問題的長答案。希望我回答了。

Yes. Very helpful. David, thank you so much for taking my questions. I have other questions, but I would like to give it to other analysts to have the opportunity to ask, and I will jump in the queue for the follow-up questions. Thank you.

是的。很有幫助。大衛，非常感謝你回答我的問題。我還有其他問題，但我想把它交給其他分析師有機會問，我會插隊等待後續問題。謝謝。

Okay. Well, Ahu, we have a few minutes if you would like to continue now.

好的。那麼，Ahu，如果你現在想繼續，我們有幾分鐘的時間。

Yeah, of course. Yes. So my next -- one of the questions will be on the 3164 program. What stage of the IND-enabling studies are you at? And if you can give some information on that, that would be very helpful as well.

嗯，當然咯。是的。所以我的下一個問題——其中一個問題是關於 3164 程序的。您處於 IND 支持研究的哪個階段？如果你能提供一些相關信息，那也會非常有幫助。

Well, Ahu, I think, I am going to let our Director of Targeted Protein Development take that question.

好吧，Ahu，我想，我要讓我們的靶向蛋白質開發總監來回答這個問題。

All right. Thank you, David. And thanks, Ahu, again for the question. So yeah, like David mentioned during the call, we remain on track to submit an IND in the first half of next year. We kicked off the IND-enabling studies last quarter. So we are going through all of the required IND enabling studies right now.

好的。謝謝你，大衛。再次感謝 Ahu 提出的問題。所以是的，就像大衛在電話會議中提到的那樣，我們仍有望在明年上半年提交 IND。我們在上個季度啟動了支持 IND 的研究。因此，我們現在正在進行所有必需的 IND 支持研究。

And in addition to that, the data I will be presenting at the October conference will be more mechanism of action, more in vitro and in vivo proof of concept. So yeah, to answer your question, we remain on track to submit the IND in the first half. And then like David said, aims to start the trial soon after that.

除此之外，我將在 10 月的會議上展示的數據將是更多的作用機制，更多的體外和體內概念證明。所以是的，為了回答你的問題，我們仍然按計劃在上半年提交 IND。然後就像大衛說的那樣，目標是在那之後很快開始試驗。

Ahu, are you there?

阿虎，你在嗎？

Yes, I am. I could not hear you for a moment. Thank you very much. Very helpful. Thank you.

我是。我一時聽不見你說話。非常感謝。很有幫助。謝謝。

Okay. I think with that we are going to turn it back over to the operator.

好的。我認為我們將把它交還給運營商。

Thank you. Okay. Seeing no more questions in the queue, this concludes our question-and-answer question, or session rather. I would like to turn the conference back over to David for closing remarks.

謝謝。好的。隊列中沒有更多問題，我們的問答問題或會話就此結束。我想將會議轉回給大衛作閉幕詞。

Absolutely. So hopefully, this call has provided you with the opportunity to understand some of the confidence and excitement we feel at Salarius. We are certainly looking forward to the second half of this year, and I am sure you are all as well. I hope you all are as well.

絕對地。希望這次電話會議讓您有機會了解我們在 Salarius 感受到的一些信心和興奮。我們當然期待著今年下半年，我相信你們也是如此。我希望你們都一樣。

Let me thank you for your time and your attention. We look forward to keeping you apprised of our progress and expect a robust schedule of announcements in the second half of the year. Be safe and have a good day everyone.

讓我感謝您的時間和關注。我們期待讓您了解我們的進展，並期待在今年下半年發布一個強有力的公告時間表。大家注意安全，祝大家有美好的一天。

The conference has now concluded. Thank you for your participation. You may now disconnect.

會議現已結束。感謝您的參與。您現在可以斷開連接。