Alaunos Therapeutics Inc (TCRT) 2023 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Alaunos Therapeutics First Quarter 2023 Conference Call. (Operator Instructions) Please be advised that today's conference call is being recorded.

您好，感謝您的支持。歡迎參加 Alaunos Therapeutics 2023 年第一季電話會議。 （操作員指示）請注意，今天的電話會議正在錄音。

I would now like to hand the conference over to your speaker today, Alex Lobo. Please go ahead.

現在，我想將會議交給今天的發言人 Alex Lobo。請繼續。

This morning, Alaunos issued a press release announcing financial results for the 3 months ended March 31, 2023. We encourage everyone to read today's press release as well as the Alaunos quarterly report on Form 10-Q for the quarter ended March 31, 2023, which was filed this morning with the SEC. The company's press release and quarterly report will also be available on the Alaunos' website at alanos.com. And in addition, this conference call is being webcast through the Investor Relations section of the company's website and will be archived there for future reference.

今天早上，Alaunos 發布了一份新聞稿，宣布了截至 2023 年 3 月 31 日的三個月的財務表現。我們鼓勵大家閱讀今天的新聞稿以及 Alaunos 截至 2023 年 3 月 31 日季度的 10-Q 表季度報告，該報告於今天早上向美國證券交易委員會提交。該公司的新聞稿和季度報告也將在 Alaunos 的網站 alanos.com 上發布。此外，本次電話會議將透過公司網站的投資者關係部門進行網路直播，並將存檔以供日後參考。

Please note that certain information discussed on today's call is covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Participants are cautioned that this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 10, 2023. Actual results could differ materially from those stated or implied by forward-looking statements made today due to risks and uncertainties associated with the company's business. Information on potential risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this webcast, except as may be required by applicable securities laws.

請注意，今天電話會議上討論的某些資訊受到《1995 年私人證券訴訟改革法》安全港條款的保護。請與會者註意，本次電話會議包含時間敏感訊息，這些資訊僅在本次直播之日（2023 年 5 月 10 日）準確無誤。由於與公司業務相關的風險和不確定性，實際結果可能與今天前瞻性陳述中明示或暗示的結果有重大差異。有關潛在風險和不確定性的資訊已載列於我們最近向美國證券交易委員會 (SEC) 提交的公開文件中（sec.gov）。除非適用的證券法另有規定，否則本公司不承擔修改或更新任何前瞻性陳述以反映本網路廣播日期之後的事件或情況的義務。

With me today are Kevin Boyle, Senior Chief Executive Officer; Drew Deniger, Vice President of Research and Development; and Mike Wong, Vice President of Finance; Abhishek Srivastava, Vice President of Technical Operations, will also be available for the Q&A session. With that said, I would like to turn the call over to Kevin. Kevin, you may go ahead.

今天與我一起的是資深執行長 Kevin Boyle；研發副總裁 Drew Deniger；以及財務副總裁 Mike Wong；技術營運副總裁 Abhishek Srivastava 也將參加問答環節。話雖如此，我想把電話轉給凱文。凱文，你繼續吧。

Thank you, Alex. Good morning, everyone, and thank you for joining us. The disruptive technology Alaunos is delivering to patients has the potential to transform the cancer treatment paradigm. We believe that our innovative approach, targeting high-frequency driver mutations is the most promising therapy for solid tumors. We're encouraged by the fact that our first patient treated had a meaningful clinical response and established for the first time that nonviral TCR-T cells can bring hope to patients with high unmet clinical need. And we are not alone in our excitement.

謝謝你，亞歷克斯。大家早安，感謝大家的收看。 Alaunos 為患者提供的顛覆性技術有可能改變癌症治療模式。我們相信，我們針對高頻驅動突變的創新方法是實體腫瘤最有希望的治療方法。我們感到鼓舞的是，我們接受治療的第一位患者獲得了有意義的臨床反應，並首次證實非病毒TCR-T細胞可以為尚未滿足臨床需求的患者帶來希望。我們並不是唯一感到興奮的人。

Our accelerated enrollment compared to the prior year highlights the enthusiasm shared by the prospective patients. The Alaunos team is off to a productive start in 2023 as we progress towards important clinical milestones. We've worked diligently to advance our TCR-T library Phase I/II trial and have accelerated enrollment with a manufacturing suite that is busier than ever. Since our last update, we have implemented multiple enhancements to our screening enrollment and manufacturing protocols that we added through an IND amendment at the end of 2022.

與前一年相比，我們的招生速度加快，凸顯了潛在患者的熱情。隨著我們朝著重要的臨床里程碑邁進，Alaunos 團隊在 2023 年取得了豐碩的開局。我們努力推進 TCR-T 庫 I/II 期試驗，並透過比以往更繁忙的生產套件加速註冊。自上次更新以來，我們對篩選登記和製造協議實施了多項增強，這些增強是我們在 2022 年底透過 IND 修正案添加的。

We aim to build on the encouraging early clinical data we have generated to date and expect to report interim results in the third quarter, including new data from multiple patients. In addition, to the clinical progress made, we've also taken important steps to strengthen our balance sheet. The full prepayment of our loan with Silicon Valley Bank enables us to move forward unencumbered by debt. Our recently amended agreement with Precigen eliminates royalty and milestone obligations to Precigen. Altogether, we believe that we are taking the right financial and corporate steps as we work towards becoming a Phase II-ready company by the end of 2023.

我們的目標是在迄今為止產生的令人鼓舞的早期臨床數據的基礎上，預計在第三季度報告中期結果，包括來自多名患者的新數據。此外，除了臨床上的進展外，我們還採取了重要措施來加強我們的資產負債表。我們向矽谷銀行全額提前償還了貸款，這使得我們能夠不受債務的束縛繼續前進。我們最近與 Precigen 修改的協議取消了對 Precigen 的特許權使用費和里程碑義務。總而言之，我們相信，我們正在採取正確的財務和公司措施，努力在 2023 年底成為一家準備進入第二階段的公司。

I'd like to discuss our TCRT library Phase I/II trial in more detail. We have worked to capitalize on the growing excitement and momentum around this trial. As you will recall, this is a basket trial targeting driver mutations across 6 solid tumor indications, non-small cell lung, colon, endometrium, pancreas, ovary and bile duct cancers. We are actively enrolling patients at MD Anderson with any one of these 6 cancers based on matching both a specific mutation and HLA combination to a TCR that is available in our library.

我想更詳細地討論我們的 TCRT 庫 I/II 期試驗。我們一直致力於利用這次試驗所引發的日益高漲的熱情和勢頭。您可能還記得，這是一項針對 6 種實體腫瘤適應症、非小細胞肺癌、結腸癌、子宮內膜癌、胰腺癌、卵巢癌和膽管癌的驅動突變的籃子試驗。我們正在 MD 安德森癌症中心積極招募患有這 6 種癌症中任何一種的患者，招募依據是特定突變和 HLA 組合與我們庫中可用的 TCR 相符。

During the first quarter, we worked to operationalize the critical enhancements to our screening enrollment and manufacturing processes that were included in this expansive fourth quarter 2022 IND. These improvements have facilitated faster patient accrual. We have also implemented cryopreservation to our manufacturing process, increasing flexibility for patient scheduling and treatment. Since adopting cryopreservation, we have manufactured multiple patient products with viability, purity and TCR positivity comparable to our prior process. We believe that these enhancements will enable us to meet our program milestones this year.

在第一季度，我們致力於實施 2022 年第四季度 IND 中包含的篩選登記和製造流程的關鍵改進。這些改進促進了患者更快累積。我們也在製造過程中採用了冷凍保存技術，增加了患者安排和治療的靈活性。自從冷凍保存以來，我們已經生產出多種患者產品，其活力、純度和 TCR 陽性率與我們先前的製程相當。我們相信，這些改進將使我們能夠實現今年的計畫里程碑。

Additionally, our investigators at MD Anderson have been staunch supporters of this trial, identifying promising patients and generating a fully booked manufacturing schedule through the coming months. Looking ahead, early translational data from our first 3 patients treated will be highlighted in a poster at the 2023 ASCO Annual Meeting taking place in early June. In total, this year, we anticipate treating between 9 and 12 patients completing the Phase I portion of the study.

此外，MD Anderson 的研究人員一直是這項試驗的堅定支持者，他們發現了有希望的患者，並在接下來的幾個月裡制定了滿滿的生產計劃。展望未來，我們治療的前 3 名患者的早期轉化數據將在 6 月初舉行的 2023 年 ASCO 年會的海報中重點展示。總體而言，今年我們預計將治療 9 至 12 名患者，完成研究的第一階段。

As we progress towards this important milestone, we'll provide a more fulsome readout with new clinical data on multiple patients in the third quarter. We are singularly focused on advancing our TCR platform targeting solid tumors. Recent corporate and capital changes have supported our belief in the tremendous upside potential of this platform. In April, we were pleased to amend our license agreement with Precigen. This amendment maintains our exclusive rights to use Sleeping Beauty or TCRs targeting neoantigens, including driver mutations.

隨著我們朝著這一重要里程碑邁進，我們將在第三季提供更詳細的數據，包括多名患者的新臨床數據。我們專注於推進針對實體腫瘤的 TCR 平台。最近的公司和資本變化增強了我們對該平台巨大上行潛力的信心。四月，我們很高興修改了與 Precigen 的授權協議。該修正案保留了我們使用「睡美人」或針對新抗原（包括驅動突變）的 TCR 的獨家權利。

At the same time, the amendment eliminates all commercial sales-based royalties and milestone obligations due to Precigen. This represents a potential savings of over $160 million. In return, Precigen regains the rights to our noncore CAR-T and IL-12 assets. As Alaunos is one of the most advanced TCR-T companies targeting driver mutations, we believe that unencumbering our TCR-T assets allows us to maximize the shareholder value and further facilitate partnering discussions. There have been several partnering transactions announced recently in our space, and we believe this is a positive sign for TCR companies.

同時，該修正案取消了 Precigen 應得的所有商業銷售特許權使用費和里程碑義務。這意味著可能節省超過 1.6 億美元。作為回報，Precigen 重新獲得了我們非核心 CAR-T 和 IL-12 資產的權利。由於 Alaunos 是針對驅動突變的最先進的 TCR-T 公司之一，我們相信，釋放我們的 TCR-T 資產可以讓我們實現股東價值的最大化，並進一步促進合作討論。我們領域最近宣布了幾項合作交易，我們相信這對 TCR 公司來說是一個積極的信號。

I would also like to highlight that earlier this month, we fully prepaid the remaining balance owed under our term loan with Silicon Valley Bank. This prepayment also allowed us to upgrade the quality of our depository bank to further protect our cash. The decisive actions with regards to our SVB loan and Precigen licenses allow us to move forward unencumbered by these obligations.

我還想強調的是，本月初，我們已全額預付了矽谷銀行定期貸款的剩餘欠款。這筆預付款也使我們能夠提升存款銀行的質量，從而進一步保護我們的現金。我們在 SVB 貸款和 Precigen 許可證方面採取的果斷行動使我們能夠不受這些義務的束縛繼續前進。

Also, on the corporate side, we are excited to welcome Robert Hoffmeister to our Board of Directors. For those of you who don't know, Robert, he is an expert in the discovery and development of engineered TCR therapies and brings a wealth of experience in cancer immunology. We are thrilled to have him on the Alaunos team, and Drew and Abhi have already been leveraging his insights and expertise. In addition, to the exciting progress, we've made in the clinic and enhancements to our corporate structure, we're making significant progress towards expanding our industry-leading library of TCRs through the Hunter platform.

此外，在公司方面，我們很高興歡迎羅伯特·霍夫邁斯特加入我們的董事會。對於那些不認識羅伯特的人來說，他是工程化 TCR 療法發現和開發方面的專家，在癌症免疫學方面擁有豐富的經驗。我們很高興他加入 Alaunos 團隊，Drew 和 Abhi 也已經開始利用他的見解和專業知識。此外，除了我們在臨床上取得的令人興奮的進展和公司結構的增強之外，我們還在透過 Hunter 平台擴展我們行業領先的 TCR 庫方面取得了重大進展。

I would like to now turn the call over to Drew to highlight these ongoing R&D efforts. Drew?

現在我想將電話轉給德魯，來強調這些正在進行的研發工作。德魯？

Thank you, Kevin. Good morning, everyone. I'm excited to share with you an update on the continued progress of our R&D efforts, including Hunter. As a reminder, Hunter is our cutting-edge proprietary TCR discovery platform and is the foundation of our 2-pronged library expansion strategy to increase the addressable market for our therapeutic drug candidates. One way we are expanding the library is by adding TCRs targeting more HLAs combined with our current KRAS TP53 and EGFR mutations.

謝謝你，凱文。大家早安。我很高興與大家分享包括 Hunter 在內的我們的研發工作持續進展的最新進展。提醒一下，Hunter 是我們尖端的專有 TCR 發現平台，也是我們雙管齊下的庫擴展策略的基礎，旨在增加我們治療候選藥物的潛在市場。我們擴展庫的一種方法是添加針對更多 HLA 的 TCR，並結合我們目前的 KRAS TP53 和 EGFR 突變。

Another way is adding more TCRs targeting new mutations within these critical gene families. Through this strategy, we believe we can bolster our IP portfolio, strengthen our pipeline for next-gen TCRT and potentially deliver effective treatments to a larger number of patients. We have already shown twice that we have the manufacturing and regulatory structure to expand our clinical library. When we added the 2 additional TCRs to the library last year, we brought the total number of TCRs to 12.

另一種方法是添加更多針對這些關鍵基因家族中的新突變的 TCR。透過這項策略，我們相信我們可以增強我們的智慧財產權組合，加強我們的下一代 TCRT 產品線，並有可能為更多的患者提供有效的治療。我們已經兩次證明我們擁有擴大臨床庫的製造和監管結構。去年，我們在庫中添加了 2 個額外的 TCR，使 TCR 總數達到了 12 個。

Our screening match rate has grown to over 10% as a result and effectively doubled the potential addressable market. This year, we expect to grow the library to 15 total TCRs as part of our strategy to expand the number of patients that could potentially benefit from our TCR-T cell therapy. We recently expanded the infrastructure for our Hunter platform to increase throughput of TCR discovery.

我們的篩選匹配率已增長到 10% 以上，並有效地使潛在目標市場翻了一番。今年，我們預計將 TCR 庫擴大到 15 個 TCR，這是我們擴大可能從 TCR-T 細胞療法中受益的患者數量的策略的一部分。我們最近擴展了 Hunter 平台的基礎設施，以提高 TCR 發現的吞吐量。

We have introduced new bioinformatics capabilities and advanced lab equipment, which greatly increases screening rates while maintaining our high TCR discovery success rate. Dozens of tumor samples have already been processed, and we anticipate ramping up our screening pace in the second quarter. From each tumor sample, we can line up thousands of individual T-cells and sequence them simultaneously as single cells. We are then able to make the TCR and identify which ones are reactive to a specific mutation in HLA combination. Once the TCR is identified as a valuable addition to our clinical library, we can amend our I&D to incorporate the new TCR.

我們引進了新的生物資訊能力和先進的實驗室設備，大大提高了篩選率，同時維持了較高的TCR發現成功率。目前已有數十個腫瘤樣本得到處理，我們預計在第二季將加速篩檢速度。從每個腫瘤樣本中，我們可以排列數千個單獨的 T 細胞，並同時對它們進行單細胞定序。然後我們就能製作 TCR 並辨識哪些對 HLA 組合中的特定突變有反應。一旦 TCR 被認定為我們臨床庫的寶貴補充，我們就可以修改我們的 I&D 以納入新的 TCR。

We think we can do this in 9 to 12 months, which we believe is markedly faster than competing platforms. We are proud of Hunter believe it offers significant advantages over traditional TCR discovery methods. We believe our rapid and high throughput approach to generate proprietary TCRs potentially increases the value of the company's pipeline. These TCRs may be used in the exploration of next-generation TCR-T cell therapies, including membrane ban IL-15 and multiplex TCR-T, which aim to further deepen clinical responses.

我們認為我們可以在 9 到 12 個月內完成這一目標，我們相信這比競爭平台要快得多。我們很自豪 Hunter 相信它比傳統的 TCR 發現方法具有顯著的優勢。我們相信，我們快速、高通量產生專有 TCR 的方法可能會增加公司管道的價值。這些TCR可能用於探索下一代TCR-T細胞療法，包括膜抑制劑IL-15和多重TCR-T，旨在進一步深化臨床反應。

We also believe Hunter has the potential to generate out-licensing or partnering opportunities that could result in non-dilutive capital. I'm so proud of the team who has more than doubled the screening pace over the past year and strongly believe that we will be successful in identifying valuable TCRs for Alaunos.

我們也相信，Hunter 有潛力創造外部授權或合作機會，從而帶來非稀釋性資本。我為團隊感到驕傲，他們在過去一年中將篩選速度提高了一倍多，並堅信我們一定能夠成功為 Alaunos 找到有價值的 TCR。

I would now like to turn the call over to Mike for a financial update.

現在我想將電話轉給麥克，讓他報告財務最新情況。

Thank you, Drew. As an organization, we remain intentional with our capital. With the team of less than 35 people, we continue to make valuable investments to fulfill our commitments to patients and to create value for our shareholders. We are confident based on recent conversations that our science will continue to be recognized by investors for what it is, a unique and disruptive technology that has promised to be curative for solid tumors.

謝謝你，德魯。作為一個組織，我們始終注重資本的運用。儘管團隊不到35人，我們仍不斷進行有價值的投資，以履行對患者的承諾並為股東創造價值。根據最近的對話，我們有信心，我們的科學將繼續得到投資者的認可，因為它是一項獨特的顛覆性技術，有望治癒實體腫瘤。

Now allow me to review our financials for the 3 months ended March 31, 2023. For the first quarter of 2023, we reported a net loss of approximately $10 million or a $0.04 net loss per share compared to a net loss of approximately $9.8 million or a $0.05 net loss per share for the same period in 2022. I -- as we look into the numbers in a bit more detail, research and development expenses were approximately $6.5 million for the first quarter of 2023 compared to approximately $5.6 million for the same period in 2022, an increase of 17%, which was primarily due to increased manufacturing and TCR discovery activities.

現在，請容許我回顧一下截至 2023 年 3 月 31 日的 3 個月的財務狀況。 2023 年第一季度，我們報告淨虧損約為 1,000 萬美元或每股淨虧損 0.04 美元，而 2022 年同期的淨虧損約為 980 萬美元或每股淨虧損 0.05 美元。我——當我們更詳細地研究這些數字時，2023 年第一季的研發費用約為 650 萬美元，而 2022 年同期約為 560 萬美元，增長了 17%，這主要是由於製造和 TCR 發現活動的增加。

General and administrative expenses were approximately $3.2 million for the first quarter of 2023 compared to approximately $3.5 million for the same period in the prior year, a decrease of 10%, which was primarily due to lower professional fees as we continue to be focused on being good stewards of capital. As of March 31, 2023, Alaunos had approximately $37.4 million in total cash balances.

2023 年第一季的一般及行政開支約為 320 萬美元，而去年同期約為 350 萬美元，下降了 10%，這主要是由於我們繼續專注於做好資本管理，導致專業費用降低。截至 2023 年 3 月 31 日，Alaunos 的總現金餘額約為 3,740 萬美元。

Our operating cash burn for the first quarter of 2023 was approximately $9.4 million compared to approximately $7.8 million in the same period in 2022, an increase of approximately $1.6 million. This amount was in line with our expectations as it reflects the increase in our manufacturing activities resulting from the active enrollment of patients in our TCR-T library Phase I/II trial. Based on our current operating plans, we continue to expect our operating cash outflows for 2023, excluding debt service costs to be between approximately $35 million to $40 million. As a result, we expect to have sufficient cash resources into the fourth quarter of 2023 to fund operations and R&D programs.

我們 2023 年第一季的營運現金消耗約為 940 萬美元，而 2022 年同期約為 780 萬美元，增加了約 160 萬美元。這筆金額符合我們的預期，因為它反映了我們 TCR-T 庫 I/II 期試驗中患者積極招募導致的製造活動的增加。根據我們目前的營運計劃，我們繼續預計 2023 年的營運現金流出（不包括債務服務成本）將在約 3,500 萬美元至 4,000 萬美元之間。因此，我們預計到 2023 年第四季將有足夠的現金資源來資助營運和研發專案。

As Kevin noted earlier, at the beginning of this month, we fully repaid the remaining amounts owed under our term loan with Silicon Valley Bank, which was $11 million as of March 31, 2023. We are pleased to report that with no remaining obligations to SBB, a restricted cash balance of $13.9 million as of March 31, 2023, has also been fully released back to Alaunos. This allows us to have complete operational control over our cash and eliminates additional interest expense.

正如 Kevin 先前提到的，本月初，我們已全額償還了與矽谷銀行定期貸款的剩餘欠款，截至 2023 年 3 月 31 日，該金額為 1,100 萬美元。我們很高興地報告，由於對 SBB 不再有任何債務，截至 2023 年 3 月 31 日，1390 萬美元的受限現金餘額也已全額返還給 Alaunos。這使我們能夠完全控制現金的運作並消除額外的利息支出。

I'd like to leave you with a biotech capital markets update. Investor engagement remains encouraging and evidence points to capital markets being supportive of transactions for companies with differentiated science. Despite the disruption following regional bank failures, the follow-on market continues to outpace this point last year. $7.3 billion has been raised by 60 follow-ons year-to-date compared to $4.6 billion raised in 44 follow-ons at this point in 2022. We believe this is a positive sign for biotech, which is also aligned with the interest we have received from prospective investors.

我想向你們提供生物技術資本市場的最新情況。投資者參與度仍然令人鼓舞，有證據顯示資本市場支持差異化科學公司的交易。儘管地區性銀行倒閉造成混亂，但後續市場仍超過去年的水平。今年迄今，60 家後續公司已籌集 73 億美元，而 2022 年迄今，44 家後續公司籌集 46 億美元。我們認為這對生物技術來說是一個積極的信號，這也與我們從潛在投資者那裡獲得的興趣一致。

I would now like to turn the call to Kevin for closing remarks.

現在我想請凱文作結束語。

Thank you, Mike. Enrollment has been brisk and manufacturing suite has been occupied. We've told our hard-working employees, buckle your seatbelt, low and tight around your waste and be prepared for an exciting ride. Things are getting busy around here. I am proud to say that we have manufactured multiple products at the same time, and our team is committed to producing therapies for patients in need. The translational data is most encouraging, and we will share an update at ASCO, including safety, persistence and efficacy data. We look forward to providing an interim trial readout in the third quarter, highlighting additional patients treated.

謝謝你，麥克。報名工作進展順利，生產車間已全部佔滿。我們告訴辛勤工作的員工，係好安全帶，將腰部放低並係緊，為激動人心的旅程做好準備。這裡的事情變得越來越忙碌。我很自豪地說，我們同時生產多種產品，我們的團隊致力於為有需要的患者生產治療方法。轉化數據最令人鼓舞，我們將在 ASCO 上分享最新動態，包括安全性、持久性和有效性數據。我們期待在第三季提供中期試驗數據，重點介紹接受治療的其他患者。

We are also enjoying success identifying new TCRs in our Hunter program. We will strive to strengthen our IP position, generate partnering opportunities and increase the addressable market with this platform. The building momentum and interest in our TCRT platform gives us great confidence in the potential value of our disruptive technology as we seek to revolutionize the treatment of solid tumors. I'd like to thank all of my colleagues at Alaunos as well as our patients, shareholders and partners for their continued support as we weaponize the immune system with powerful TCRs to treat solid tumors.

我們也很高興在 Hunter 計劃中成功識別了新的 TCR。我們將努力利用這個平台來加強我們的智慧財產權地位、創造合作機會並擴大潛在市場。在我們尋求徹底改變實體腫瘤治療的過程中，TCRT 平台的不斷發展和興趣使我們對這項顛覆性技術的潛在價值充滿信心。我要感謝 Alaunos 的所有同事以及我們的患者、股東和合作夥伴，感謝他們在我們利用強大的 TCR 武器化免疫系統來治療實體腫瘤時給予的持續支持。

We will now open the call to questions. Cory?

我們現在開始提問。科里？

At this time, we will conduct the question-and-answer session. (Operator Instructions) Please stand by while we compile the Q&A roster. Our first question comes from Prakhar Agrawal at Cantor Fitzgerald.

現在，我們將進行問答環節。 （操作員指示）我們正在編製問答名單，請稍候。我們的第一個問題來自 Cantor Fitzgerald 的 Prakhar Agrawal。

So first question is for the update at ASCO, it seems that there is translational data getting presented for patient #3 as well for whom we have not seen any efficacy. So could you confirm if you get any efficacy data for patient #3. If not, what translational data would you be presenting and why only translation data for third patient? And I had a couple of follow-ups, please.

因此，第一個問題是關於 ASCO 的最新消息，似乎也呈現了針對患者 #3 的轉化數據，但我們尚未看到其任何療效。那麼您能否確認是否獲得了患者#3 的任何療效數據。如果不是，您會提供什麼翻譯數據，為什麼只提供第三位病患的翻譯數據？我還有一些後續問題要問。

Absolutely. So we're limited in part per car by what we can say since the full abstract has not been released with ASCO. But the poster will, as you say, include data on patients 1, 2 and 3 that we've previously disclosed that we've treated. The embargo will lift and the full abstract will come out on May 25, I believe, in the afternoon. But before that time, unfortunately, we are not able to disclose any further detail on the data being presented. What I can say is we believe that the data that we're presenting is just the start, and we look forward to providing a more wholesale in the third quarter of this year as promised with additional patients.

絕對地。由於 ASCO 尚未發布完整的摘要，因此，我們對每輛車的了解有限。但正如您所說，海報將包含我們先前揭露的已治療過的患者 1、2 和 3 的數據。禁令將會解除，完整的摘要預計將於 5 月 25 日下午發布。但不幸的是，在此之前我們無法透露有關所呈現數據的任何進一步細節。我可以說的是，我們相信我們所呈現的數據只是一個開始，我們期待在今年第三季度為更多患者提供更全面的服務，正如我們承諾的那樣。

And second question, if I heard correctly, 9 to 12 patients are expected to be dosed by end of the year. to complete Phase I, which seems lower than the 12 to 15 patients target noted previously. So maybe first, if you could confirm whether there has been a change in the target enrollment for Phase I. Any reason for this change? And will we have enough patients at each dose to make a call on the recommended Phase II dose?

第二個問題，如果我沒聽錯的話，預計到今年年底將有 9 到 12 名患者接受治療。完成第一階段，這似乎低於之前提到的12到15名患者的目標。所以首先，能否確認第一階段的目標招募人數是否有變動。這種變化有什麼原因嗎？我們是否有足夠的患者接受每種劑量的治療，從而決定建議的第二階段劑量？

Thanks for the question. Just simple math, adding the 3 patients that we treated last year, the 9 to 12 range. And if you add 3 patients that we already treated in 2022 gets you to the same guidance that we provided previously 12 to 15 patients. So guidance has not changed, and we're really quite encouraged by how engaged RPIs have been literally fighting over manufacturing slots that we have to get their patients enrolled in this trial. So very excited about the momentum that we have and look forward to providing further updates.

謝謝你的提問。只需簡單的計算，加上我們去年治療的 3 名患者，人數就達到 9 到 12 人。如果您加上我們在 2022 年已經治療過的 3 名患者，您將獲得與我們之前為 12 到 15 名患者提供的相同指導。因此指導方針沒有改變，我們確實非常高興地看到，零售物價機構 (RPI) 一直在積極爭奪製造時段，以便讓他們的患者參與這項試驗。我們對所取得的進展感到非常興奮，並期待提供進一步的更新。

Got it. And last question for me, cash guidance is until 4Q, and you have the interim update in Q3. The timing of the interim data is quite close to the cash runway guidance. So there's a lot of stake from this interim update. You have more visibility than us. How confident are you at this interim update will be meaningfully positive to finance the company? And could you explore other financing avenues before the interim.

知道了。對我來說最後一個問題，現金指導截止到第四季度，您在第三季度提供了中期更新。中期資料的時間與現金跑道指引非常接近。因此，這次中期更新具有很大的利害關係。你的知名度比我們高。您對於此次中期更新將對公司融資產生何種意義的正面影響有多大信心？您是否可以在中期之前探索其他融資管道？

Mike, do you want to take that?

麥克，你想接受這個嗎？

Thanks, Prakhar. Yes, we believe our cash runway will set the next data readout in our library Phase I/II trial, which is obviously an important inspection plan for Alaunos. And from a fundraising perspective, we continue to be good stewards of capital, as mentioned earlier, and we remain sensitive to dilution. With that said, we remain opportunistic and consider all options available to us.

謝謝，普拉卡爾。是的，我們相信我們的現金跑道將在我們的圖書館 I/II 期試驗中設定下一個數據讀數，這顯然是 Alaunos 的一項重要檢查計劃。從籌資角度來看，如同前面提到的，我們將繼續做好資本的管理，並且對股權稀釋​​保持敏感。話雖如此，我們仍然抓住機會，並考慮所有可用的選項。

Our next question comes from Thomas Flaten of Lake Street Capital Markets.

下一個問題來自 Lake Street Capital Markets 的 Thomas Flaten。

I'm curious in the interim readout in Q3, is it reasonable to assume that we'll see patients that have been dosed at the third dose level as well? Or will they be from the second dose level only?

我對第三季的中期讀數感到好奇，是否可以合理地假設我們也會看到接受第三劑量水平給藥的患者？還是他們僅來自第二劑量水平？

Thomas, we would steal the thunder if we gave you any more insights about what we would release with regards to the third quarter. I will say, just as a reminder, the trial design is quite flexible with regards to how many patients get dosed at this level. We're going to be guided overall by conversations with our PIs with regards to dose levels and what they believe is the appropriate number of cells with regards to treating those patients. What I can reiterate is that there will be multiple patients that we will be speaking to when we provide a clinical update in the third quarter and are very excited to provide an update to our investors, prospective investors and research analysts.

托馬斯，如果我們能向您提供有關我們將在第三季度發布的更多消息的見解，那我們就太搶眼了。我要說的是，只是提醒一下，對於多少患者接受這種程度的劑量，試驗設計是相當靈活的。我們將總體上根據與我們的 PI 的對話來確定劑量水平以及他們認為治療這些患者的適當細胞數量。我可以重申的是，當我們在第三季度提供臨床更新資訊時，我們將與多位患者交談，我們非常高興向我們的投資者、潛在投資者和研究分析師提供更新資訊。

Got it. And will that release be done in the context of a scientific meeting or just something that you do on a stand-alone basis?

知道了。發表會在科學會議上進行嗎？還是只是你們獨立進行的活動？

We're going to keep all options open and be flexible in that regard. I think it's important to just have the flexibility at this point. What we do want to commit to is just as we had guided earlier, honing in on that guidance to say it will be in the third quarter. So we look forward to connecting with everybody then. And I think everybody will be excited as we are. We hope to hear an update on the trial.

我們將保留所有選擇的餘地並保持靈活性。我認為此時擁有靈活性非常重要。我們確實想要承諾的是，正如我們之前的指導一樣，我們將根據這項指導意見，宣布它將在第三季實現。因此我們期待與大家建立聯繫。我想每個人都會跟我們一樣興奮。我們希望聽到有關審判的最新消息。

And switching gears a little bit, maybe a year ago, we were talking about having capacity for 1 patient per month kind of was the maximum. I mean you guys have done a great job in expanding your manufacturing capacity. But I was wondering if you could contextualize for us as you move into Phase I next year, what that manufacturing capacity needs to be? And over what time period do you guys think you can get there with current resources and planned resources for that matter?

稍微轉換一下主題，也許在一年前，我們討論的是每月最多只能接收 1 名患者。我的意思是，你們在擴大生產能力方面做得很好。但我想知道，您是否可以為我們介紹一下，當您明年進入第一階段時，製造能力需要達到什麼水平？那麼，你們認為利用現有的資源和計畫的資源，在什麼時間內可以實現這一目標？

Sure. Why don't I pass that over to Abhi since he's in charge of manufacturing here.

當然。既然他負責這裡的製造，我為什麼不把它交給阿比呢？

Thanks, Thomas, for this question. We are very excited about our manufacturing platform. As we mentioned last time, we have expanded our manufacturing capacity for Phase I, which is 2 patients per run. That really has worked out pretty well, especially after the introduction of the Caeservation program, which is well received by our PIs, which has really helped us out putting our schedule upfront into the calendar. So we are busier than ever in our manufacturing suite.

謝謝托馬斯提出這個問題。我們對我們的製造平台感到非常興奮。正如我們上次提到的，我們已經擴大了第一階段的生產能力，每次可容納 2 名患者。效果確實很好，特別是在引入 Caeservation 計劃之後，該計劃受到了我們的 PI 的一致好評，這確實幫助我們將日程安排提前到日曆中。因此，我們的生產車間比以前更加忙碌。

As far as increasing the capacity for the Phase II, we are investing in a multipronged manufacturing strategy. We're going to be -- we have a multiple option in our side where we can expand our manufacturing capacity in multi-different way either in-house or going to the CDMO or the combination of hybrid approach, we're going to be utilizing one of those as time comes. And whatever is in the best interest of the company as well as the shareholders. So we are very excited about it, and we are looking forward to going into the Phase II and making more patient cells.

為了提高第二階段的產能，我們正在投資多管齊下的製造策略。我們有多種選擇，可以透過多種不同的方式擴大我們的生產能力，無論是內部擴大，還是採用 CDMO 或混合方法相結合，我們將隨著時間的推移利用其中一種。一切都是為了公司和股東的最大利益。因此我們對此感到非常興奮，我們期待進入第二階段並製造更多的患者細胞。

Please stand by for our next question. Our next question comes from Swayampakula Ramakanth of HCW.

請等待我們的下一個問題。下一個問題來自 HCW 的 Swayampakula Ramakanth。

This is RK from H.C. Wainwright. So in the third quarter, you're expecting to put some additional data out there on the current study. How many patients do you think you can get to by that time? Because obviously, you're making multiple changes not only on the manufacturing side but also on the on the trial itself, you said you did some amendments. So kind of 2 questions. One is like what sort of amendments helped increase the enrollment rate? And 2, are we talking more like 7, 8 patients are almost getting to the end of the trial sort of data we'll have there? Just trying to get a feel for things.

這是來自 H.C. 的 RK。溫賴特。 因此，在第三季度，您希望在當前研究中添加一些額外數據。您認為到那時您可以接待多少名患者？因為很明顯，你不僅在製造方面做出了多項改變，而且在試驗本身也做出了多項改變，你說你做了一些修改。所以有兩個問題。一個問題是，什麼樣的修正案有助於提高入學率？第二，我們談論的更像是第 7、8 名患者即將完成試驗，屆時我們將獲得什麼樣的數據？只是想了解事物。

Absolutely. Okay. And it was great seeing you last week. So the I&D amendment in the fourth quarter of 2022 was really excellent. It -- we took our learnings from the clinical trial in 2022 and just adapted. And so, in the fourth quarter, the updates included a combination of things. One, is we combined what we had as separate protocols under treatment and screening, combining that to one. And that really made the entire enrollment process a lot easier, both for patients and for physicians. So I think it was well received by our PIs, also well received by patients who are interested in this study.

絕對地。好的。我很高興上週見到你。因此，2022 年第四季的 I&D 修正案確實非常出色。我們吸收了 2022 年臨床試驗的經驗並進行了調整。因此，在第四季度，更新內容多種多樣。一是，我們將治療和篩檢下的單獨方案合併為一個。這確實使整個入組過程變得容易得多，無論對於患者還是醫生而言。所以我認為它受到了我們的 PI 的好評，也受到了對這項研究感興趣的患者的好評。

One in the details a little bit more is we no longer had a requirement for retesting of the tumor mutation. Previously, we had required a retest of the mutation if we had more than 6 months between the last test. What we learned and what we've shared previously is in our early learnings post-treatment biopsies, we've been able to confirm that the mutation has remained present. And so, we felt quite comfortable that since these driver mutations are at the core of cancer that mutation is going to remain. And so, we eliminated that retesting aspect, and that also really facilitated and eliminated a prior hurdle. So again, taking our learnings.

更詳細一點的是，我們不再要求重新檢測腫瘤突變。以前，如果上次測試間隔超過 6 個月，我們就要求重新測試該突變。我們在早期治療後活檢中所了解和分享的訊息，我們已經能夠確認突變仍然存在。因此，我們感到相當放心，因為這些驅動突變是癌症的核心，所以這種突變將會保留下來。因此，我們消除了重新測試的環節，這也確實促進並消除了先前的障礙。所以，我們再一次吸取教訓。

The other thing that we did is added cryopreservation. And let me tell you, that just has made the predictability, great. We talked about the ability of getting the patient cells earlier in their cancer journey. And that's allowed us to manufacture products in a very efficient way, freeze down the products and have that ready for the patients if, unfortunately, other treatments fail them and they are ready for our treatment. And so, those are the learnings. That's the amendment that's really facilitated enrollment and has really kind of buoyed us and exciting.

我們做的另一件事是添加了冷凍保存。我告訴你們，這使得可預測性變得非常好。我們討論了在患者癌症早期獲取其細胞的能力。這樣一來，我們就能以非常高效的方式生產產品，將產品冷凍起來，當患者不幸對其他治療方法不滿意，需要接受我們的治療時，就可以立即使用。這就是我們所學到的知識。這項修正案確實方便了入學，確實讓我們感到振奮和興奮。

And I applaud all of you analysts were trying to figure out more detail of how many patients we've treated to the as we're trying -- I'm going to do my best though early in the morning to not answer that and leave you wanting more at the update in the third quarter, if that's all right.

我讚揚你們所有的分析師，他們在試圖弄清楚我們治療了多少患者的更多細節——我將盡力在早上不回答這個問題，讓你們在第三季度的更新中了解更多信息，如果可以的話。

I wish you had one less cup of coffee this morning, Kevin, it would have been helpful. So talking to Drew and a question for Drew, on the Hunter platform, it's great to hear that you can expand the platform to produce additional TCRs. So in terms of trying to generate non-dilutive funding through partnerships, what sort of targets are you looking at? Or can you give us any additional color as to how you are able to attract some partnerships or you're in the process of attracting additional partnerships?

凱文，我希望你今天早上少喝一杯咖啡，那會很有幫助。因此，在與 Drew 交談並向 Drew 提出一個關於 Hunter 平台的問題時，很高興聽到您可以擴展該平台以生產更多的 TCR。那麼，在嘗試透過合作關係籌集非稀釋性資金方面，您正在考慮什麼樣的目標？或者您能否向我們進一步說明您如何吸引一些合作夥伴，或者您正在吸引更多合作夥伴？

Thank you for the question. We are so proud of our Hunter platform, and we have a very high success rate of TCR discovery. So we believe that as we explore partnership opportunities that would be attractive to a potential partner. We're able to look at multiple different targets. At the same time, we're really focused on KRAS, P53 and EGFR as part of our library expansion strategy. We can go after other targets as needed. It's important to note that the TCRs that we do discover are exclusively owned by Alaunos and are proprietary, so we could use those for TCR-T or for other treatment modalities. And so, we're quite excited about that part of the Hunter platform as well.

感謝您的提問。我們對我們的 Hunter 平台感到非常自豪，我們的 TCR 發現成功率非常高。因此，我們相信，當我們探索合作機會時，這將對潛在合作夥伴具有吸引力。我們能夠觀察多個不同的目標。同時，作為我們圖書館擴展策略的一部分，我們非常重視 KRAS、P53 和 EGFR。我們可以根據需要追擊其他目標。值得注意的是，我們發現的 TCR 歸 Alaunos 獨家擁有且是專有的，因此我們可以將其用於 TCR-T 或其他治療方式。所以，我們對 Hunter 平台的這一部分也感到非常興奮。

What's nice about this platform as Drew is able and his team is identifying not just these driver mutations but has the ability to identify many other assets that could be valuable for partnering and that sort of robust flexibility and power of discovery. And I think you also heard Drew highlight the fact that there's been some recent implementations over there increasing the throughput. So the -- you can think about it 2 ways, they can either be discovering more things more quickly and processing more samples or you're getting more efficiency out of all the people that are on the team with the adoption of some AI tools and some adoption of new equipment and new processes. So the bioinformatics team is -- it's amazing how they harness the power of AI to really accelerate the throughput over there.

這個平台的優點在於，Drew 和他的團隊不僅能夠識別這些驅動突變，還能夠識別許多其他可能對合作有價值的資產，以及這種強大的靈活性和發現能力。我想您也聽到了德魯強調的一個事實，那就是最近那裡已經採取了一些措施來提高吞吐量。所以——你可以從兩個方面來考慮，他們要么可以更快地發現更多的東西並處理更多的樣本，要么通過採用一些人工智能工具和一些新設備和新流程，從團隊中的所有人那裡獲得更高的效率。生物資訊團隊利用人工智慧的力量來真正加速那裡的吞吐量，這真是令人驚訝。

One last question from me on the cash. So did the release of the restricted cash, the $13.9 million. Is that included into the $37.4 million that you're talking about? Or is that -- is this 13.9% in addition to the 37.5%.

我最後一個問題是關於現金的。 1,390 萬美元受限現金的釋放也是如此。這包括在您所說的 3740 萬美元中嗎？或者是——除了 37.5% 之外還有 13.9%。

RK, thanks for the question. The $13.9 million of restricted cash is included in the $37.4 million of total cash balances that we had as of March 31, 2023. And as mentioned earlier, our cash runway is expected to extend into the fourth quarter of 2023, which is in line with previous guidance.

RK，謝謝你的提問。 1,390 萬美元的受限現金包含在我們截至 2023 年 3 月 31 日的 3,740 萬美元總現金餘額中。如前所述，我們的現金跑道預計將延長至 2023 年第四季度，這符合先前的指引。

Thank you. We appreciate your participation in today's conference. This does conclude the program, and you may now disconnect.

謝謝。感謝您參加今天的會議。這確實結束了程序，您現在可以斷開連接了。