Panbela Therapeutics Inc (PBLA) 2023 Q2 法說會逐字稿

Greetings, and welcome to the Panbela Therapeutics second quarter 2023 earnings call. (Operator Instructions) Please note this conference is being recorded.

您好，歡迎參加 Panbela Therapeutics 2023 年第二季度財報電話會議。 （操作員說明）請注意，本次會議正在錄製中。

I will now turn the conference over to your host, James Carbonara, Investor Relations at Panbela. James, you may begin.

現在我將把會議交給主持人 Panbela 投資者關係部門的 James Carbonara。詹姆斯，你可以開始了。

Thank you, operator. With me on the call are Jennifer Simpson, Chief Executive Officer; and Sue Horvath, Chief Financial Officer.

謝謝你，接線員。與我一起參加電話會議的是首席執行官 Jennifer Simpson；和首席財務官 Sue Horvath。

Before I turn the call over to Dr. Simpson, please note that statements made on this call that are not historical facts may be forward-looking statements. Significant risks and uncertainties that could cause actual results to differ from those expressed or implied in the forward-looking statements are detailed in the company's annual report on Form 10-K, and supplemented by subsequently filed quarterly reports on Form 10-Q, as well as in other reports that the company has filed with the SEC.

在我將電話轉給辛普森博士之前，請注意，本次電話會議中所做的非歷史事實的陳述可能是前瞻性陳述。可能導致實際結果與前瞻性陳述中明示或暗示的結果不同的重大風險和不確定性在公司 10-K 表格年度報告中詳細說明，並由隨後提交的 10-Q 表格季度報告進行補充正如該公司向美國證券交易委員會提交的其他報告一樣。

Any forward-looking statements made on this call are made only as of today's date, and the company does not undertake any obligation to update or supplement any such statements to reflect subsequent developments.

本次電話會議中所做的任何前瞻性陳述僅截至今天為止，公司不承擔更新或補充任何此類陳述以反映後續發展的義務。

Now, I would like to turn the call over to Jennifer Simpson, CEO of Panbela. Jennifer, please proceed.

現在，我想將電話轉給 Panbela 首席執行官 Jennifer Simpson。詹妮弗，請繼續。

Thank you, James, and thank you, everyone, for joining. I will begin the call with a review of our clinical development program, recent accomplishments, and upcoming milestones. Sue will then follow with a review of the financial results, and then we will open it up for Q&A.

謝謝詹姆斯，也謝謝大家的加入。我將在電話會議開始時回顧我們的臨床開發計劃、最近取得的成就以及即將到來的里程碑。然後，蘇將審查財務業績，然後我們將進行問答。

Starting with our Phase III program, I'd like to begin with our ASPIRE global clinical trial in the first-line treatment of metastatic pancreatic cancer. ASPIRE is a global randomized, double-blind, placebo-controlled clinical trial to evaluate ivospemin, or SBP-101, in combination with gemcitabine and nab-paclitaxel in patients with untreated metastatic pancreatic ductal adenocarcinoma.

從我們的 III 期項目開始，我想從轉移性胰腺癌一線治療的 ASPIRE 全球臨床試驗開始。 ASPIRE 是一項全球隨機、雙盲、安慰劑對照臨床試驗，旨在評估 ivospemin 或 SBP-101 聯合吉西他濱和白蛋白結合型紫杉醇治療未經治療的轉移性胰腺導管腺癌患者。

Last month, we opened enrollment in the UK and Germany. We now have all planned countries in the ASPIRE trial opened and actively enrolling.

上個月，我們在英國和德國開始招生。我們現在已開放所有計劃參與 ASPIRE 試驗的國家並積極招募。

Also in July, the Independent Data Safety Monitoring Board, or DSMB, for the ASPIRE trial completed its pre-specified review of safety data for treated patients in the trial. The DSMB has recommended that the study continue without modification. Having all countries opened and enrolling, and DSMB approval to proceed, is highly encouraging as we continue to advance the trial. Interim data is expected as soon as early 2024.

同樣在 7 月，ASPIRE 試驗的獨立數據安全監測委員會 (DSMB) 完成了對試驗中治療患者的安全數據的預先指定審查。 DSMB 建議繼續進行該研究，無需修改。隨著我們繼續推進試驗，所有國家/地區都開放並註冊，並且 DSMB 批准繼續進行，這非常令人鼓舞。中期數據預計最早將於 2024 年初公佈。

Turning to familial adenomatous polyposis, or FAP. In April, we regained the North American rights to develop and commercialize Flynpovi, which is the combination of eflornithine and sulindac, in patients with FAP. This opportunity surfaced as a result of the termination of a licensing agreement between our subsidiary Cancer Prevention Pharmaceuticals, or CPP, and One-Two Therapeutics Assets Limited.

轉向家族性腺瘤性息肉病（FAP）。今年 4 月，我們重新獲得了 Flynpovi 的北美開發和商業化權利，該藥物是依氟鳥氨酸和舒林酸的複方製劑，用於治療 FAP 患者。這一機會是由於我們的子公司 Cancer Prevention Pharmaceuticals (CPP) 與 One-Two Therapeutics Assets Limited 之間的許可協議終止而出現的。

Panbela has now taken a lead on designing the global trial protocol and presenting it to the Federal Drug Administration, or FDA, and the European Medicines Agency, or EMA, for agreement on the registration pathway. Panbela is committed to working collaboratively with the FDA, EMA, and the FAP community to advance this program and to ultimately provide a new treatment option for FAP patients.

Panbela 目前已牽頭設計全球試驗方案，並將其提交給美國聯邦藥物管理局 (FDA) 和歐洲藥品管理局 (EMA)，以就註冊途徑達成一致。 Panbela 致力於與 FDA、EMA 和 FAP 社區合作推進該計劃，並最終為 FAP 患者提供新的治療選擇。

Once agreement is achieved on a global registration program from the FDA and EMA, we plan to advance this program while maintaining our current cash burn, and we'll evaluate opportunities to maximize the value of this asset.

一旦 FDA 和 EMA 就全球註冊計劃達成協議，我們計劃在維持當前現金消耗的同時推進該計劃，並且我們將評估最大化該資產價值的機會。

Moving to the PACES trial, our Phase III double-blind, placebo-controlled trial of Flynpovi to prevent recurrence of high-risk adenomas and second primary colorectal cancers in patients with Stage 0 to 3 colorectal cancer.

轉向 PACES 試驗，這是我們對 Flynpovi 進行的 III 期雙盲、安慰劑對照試驗，旨在預防 0 至 3 期結直腸癌患者的高風險腺瘤和第二原發性結直腸癌復發。

The PACES trial is funded by the NCI in collaboration with the Southwest Oncology Group, also known as SWOG. The trial is designed to evaluate the combination of eflornithine and sulindac and reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through 3 colon or rectal cancer. In June, the trial passed a single-planned futility analysis and will continue.

PACES 試驗由 NCI 與西南腫瘤學組（也稱為 SWOG）合作資助。該試驗旨在評估依氟鳥氨酸和舒林酸的組合，以及降低先前接受0至3期結腸癌或直腸癌治療的患者腺瘤和第二原發性結直腸癌的三年事件率。六月，該試驗通過了單一計劃無效分析，並將繼續進行。

Moving to Phase II studies. In July, we announced we would receive a total of up to $9.5 million in non-dilutive funding for divestiture of assets within the eflornithine pediatric neuroblastoma program to US WorldMeds. We look forward to helping US WorldMeds with the ongoing FDA review of a new drug acquisition.

轉向第二階段研究。 7 月，我們宣布將獲得總計高達 950 萬美元的非稀釋性資金，用於將 eflornithine 兒科神經母細胞瘤項目中的資產剝離給美國 WorldMeds。我們期待幫助美國 WorldMeds 完成 FDA 對新藥收購正在進行的審查。

Panbela received initial upfront payment of $400,000, and is entitled to future payments upon US WorldMeds' successful completion of milestones related to eflornithine's clinical development, regulatory approval, and commercial sales. This agreement further expands our portfolio of partner-funded programs and has the potential to generate considerable development milestone payments. We welcome US WorldMeds to our portfolio of partners who continue the development of our product candidates.

Panbela 收到了 400,000 美元的初始預付款，並有權在美國 WorldMeds 成功完成與 eflornithine 臨床開發、監管批准和商業銷售相關的里程碑後獲得未來付款。該協議進一步擴大了我們合作夥伴資助的項目組合，並有可能產生可觀的發展里程碑付款。我們歡迎美國 WorldMeds 加入我們的合作夥伴組合，繼續開發我們的候選產品。

Continuing with Phase II studies, we are excited to have had the first patient enrolled in the Phase II trial for CPP-1X led by Indiana University School of Medicine and funded by the Juvenile Diabetes Research Foundation, or JDRF, the leading global organization advancing life-changing breakthroughs for Type 1 diabetes. This trial was advanced based on the preclinical and Phase I data.

繼續進行II 期研究，我們很高興有第一位患者參加了CPP-1X II 期試驗，該試驗由印第安納大學醫學院領導，並由青少年糖尿病研究基金會(JDRF) 資助，該基金會是全球領先的促進生命發展的組織- 1 型糖尿病的突破性進展。該試驗是根據臨床前和一期數據進行的。

Two posters were presented highlighting the results for CPP-1X, also known as DFMO or eflornithine, in recent onset Type 1 diabetes at the Endocrine Society Meeting in June of this year and the Immunology of Diabetes Society Meeting in May of this year. The work reflects the company's ongoing collaboration with Indiana University School of Medicine. The research is part of a multi-site clinical trial, led by Indiana University School of Medicine and supported by funding from JDRF.

在今年6 月的內分泌學會會議和今年5 月的糖尿病免疫學學會會議上，展示了兩張海報，重點介紹了CPP-1X（也稱為DFMO 或eflornithine）在最近發病的1 型糖尿病中的研究結果。這項工作反映了該公司與印第安納大學醫學院的持續合作。該研究是由印第安納大學醫學院領導並得到 JDRF 資助的多中心臨床試驗的一部分。

These preclinical studies examine the role of ornithine decarboxylase, or ODC, on beta cell stress that occurs in Type 1 diabetes. Results show that stressed human islet cells treated with CPP-1X had alterations in several pathways, such as antigen presentation and reactive oxygen species.

這些臨床前研究探討了鳥氨酸脫羧酶 (ODC) 對 1 型糖尿病中發生的 β 細胞應激的作用。結果表明，經 CPP-1X 處理的應激人類胰島細胞的多個途徑發生了改變，例如抗原呈遞和活性氧。

Together with data from recent onset Type 1 diabetes patients treated with CPP-1X in the multi-site randomized, placebo-controlled Phase I trial, these results suggest that inhibition of ODC by CPP-1X may preserve beta cell function in response to stress.

結合多中心隨機、安慰劑對照 I 期試驗中最近發病的 1 型糖尿病患者接受 CPP-1X 治療的數據，這些結果表明，CPP-1X 抑制 ODC 可能會保留 β 細胞響應應激的功能。

Furthermore, these results expand on the previously presented work, identifying potential mechanisms for CPP-1X and its potential role in the clinical management of recent onset Type 1 diabetes. We are excited to support the recently initiated IU and JDRF-funded Phase II trial in recent onset Type 1 diabetes and the goal of developing effective novel therapies for patients with unmet medical needs.

此外，這些結果擴展了之前提出的工作，確定了 CPP-1X 的潛在機制及其在新發 1 型糖尿病臨床管理中的潛在作用。我們很高興能夠支持最近啟動的 IU 和 JDRF 資助的針對近期發病的 1 型糖尿病的 II 期試驗，以及為醫療需求未得到滿足的患者開發有效的新療法的目標。

Results from these studies suggest that CPP-1X is a safe oral treatment option that may improve beta cell function and/or survival in recent onset Type 1 diabetes.

這些研究的結果表明，CPP-1X 是一種安全的口服治療選擇，可以改善新近發病的 1 型糖尿病患者的 β 細胞功能和/或生存率。

In Phase I development, we have three programs that we will be starting. First, in May, we entered into a clinical trial agreement with Moffitt Cancer Center for a Phase I/II program in the STK11 mutant non-small cell lung cancer patients. The initial goal of the Phase I trial will be to ascertain the maximum tolerated dose of eflornithine while evaluating efficacy and then moving into a Phase II efficacy trial. We anticipate data from the Phase I trial by the end of this year with a look to start the Phase II trial at the end of the year or early 2024.

在第一階段的開發中，我們將啟動三個項目。首先，5月份，我們與莫菲特癌症中心簽訂了針對STK11突變非小細胞肺癌患者的I/II期項目的臨床試驗協議。 I 期試驗的初步目標是確定依氟鳥氨酸的最大耐受劑量，同時評估療效，然後進入 II 期療效試驗。我們預計第一階段試驗的數據將在今年年底獲得，並有望在今年年底或 2024 年初開始第二階段試驗。

Our second Phase I program, which is scheduled to begin this year, will focus on the evaluation of ivospemin in the platinum-resistant ovarian cancer population.

我們的第二個 I 期項目計劃於今年開始，重點是評估 ivospemin 在鉑類耐藥卵巢癌人群中的作用。

In April, we presented a poster titled evaluating the efficacy of spermine analogue ivospemin, SBP-101, in combination with chemotherapy in ovarian cancer at the American Association for Clinical Research, or AACR meeting. The poster highlights the efficacy of SBP-101 in combination with the standard-of-care chemotherapy agents used to treat platinum-resistant ovarian cancer.

4 月，我們在美國臨床研究協會 (AACR) 會議上展示了一張海報，題為評估精胺類似物 ivospemin (SBP-101) 與化療聯合治療卵巢癌的療效。該海報強調了 SBP-101 與標準化療藥物聯合用於治療鉑類耐藥卵巢癌的療效。

Future studies will be designed to evaluate the effects of SBP-101 in combination with other polyamine metabolism modulators, as well as with immune modulators. The results suggest that SBP-101, in common with doxorubicin, may have a role in the clinical management of ovarian cancer, in particular, the platinum-resistant population where few options exist.

未來的研究將旨在評估 SBP-101 與其他多胺代謝調節劑以及免疫調節劑聯合使用的效果。結果表明，SBP-101 與阿黴素一樣，可能在卵巢癌的臨床治療中發揮作用，特別是在幾乎沒有選擇的鉑類耐藥人群中。

These studies are the basis for moving into a clinical trial program in ovarian cancer, with the goal of developing effective novel therapeutics in combination with standard of care for patients with unmet medical needs. The work reflects the company's ongoing collaboration with Johns Hopkins University School of Medicine.

這些研究是進入卵巢癌臨床試驗計劃的基礎，其目標是為醫療需求未得到滿足的患者開發有效的新型療法，並結合護理標準。這項工作反映了該公司與約翰霍普金斯大學醫學院的持續合作。

To that end, also in April, we announced a new research agreement with the Johns Hopkins University School of Medicine. The collaboration is intended to expand the development of Panbela's investigative agents ivospemin and eflornithine, including activity in models of ovarian and other cancer types, further evaluations into mechanism of action, and potential combination of ivospemin with eflornithine and standard-of-care agents.

為此，同樣在四月，我們宣布與約翰霍普金斯大學醫學院達成一項新的研究協議。此次合作旨在擴大 Panbela 的研究藥物 ivospemin 和 eflornithine 的開發，包括在卵巢癌和其他癌症類型模型中的活性、對作用機制的進一步評估，以及 ivospemin 與 eflornithine 和標準治療藥物的潛在組合。

Furthering the preclinical research, we announced in June that we entered into a sponsored research agreement with The University of Texas MD Anderson Cancer Center for the evaluation of polyamine metabolic inhibitor therapies in combination with CAR-T cell therapies in preclinical models. The initial goal of these studies will be to ascertain if eflornithine and/or ivospemin treatment will augment CAR-T-mediated cytotoxicity against CD19-positive large B-cell lymphoma cell lines.

為了進一步推進臨床前研究，我們於6 月份宣布與德克薩斯大學MD 安德森癌症中心簽訂了一項贊助研究協議，以在臨床前模型中評估多胺代謝抑製劑療法與CAR-T 細胞療法的結合。這些研究的最初目標是確定依氟鳥氨酸和/或 ivospemin 治療是否會增強 CAR-T 介導的針對 CD19 陽性大 B 細胞淋巴瘤細胞系的細胞毒性。

Recently, a metabolite panel primarily consisting of polyamines was identified as predictive of poor response to anti-CD19 CAR-T cell therapy in relapsed refractory large B-cell lymphoma. Additionally, the polyamine uptake transport system is upregulated in large B-cell lymphoma and multiple myeloma. Together, this suggests the potential for a polyamine-targeted therapy in combination with CAR-T therapies.

最近，主要由多胺組成的代謝物組合被確定為複發難治性大 B 細胞淋巴瘤抗 CD19 CAR-T 細胞治療反應不佳的預測因子。此外，多胺攝取轉運系統在大 B 細胞淋巴瘤和多發性骨髓瘤中上調。總之，這表明多胺靶向療法與 CAR-T 療法相結合的潛力。

Polyamine modulation of immune system is an important focus for Panbela, with our first clinical proof of concept of polyamine-targeted therapy in combination with a checkpoint inhibitor for patients with STK11 mutant non-small cell lung cancer. We are excited for this research collaboration to now evaluate the potential benefit of polyamine in immune modulation for hematologic malignancy.

免疫系統的多胺調節是 Panbela 的一個重要關注點，我們首次對多胺靶向治療與檢查點抑製劑聯合治療 STK11 突變非小細胞肺癌患者進行了臨床概念驗證。我們對這項研究合作感到興奮，現在評估多胺在血液惡性腫瘤免疫調節中的潛在益處。

Last, we are continuing to work with the key opinion leaders to finalize the neoadjuvant pancreatic cancer investigator initiative protocol and obtain the necessary institutional approval to open the trial in the second half of this year.

最後，我們將繼續與關鍵意見領袖合作，最終確定新輔助胰腺癌研究者倡議方案，並獲得必要的機構批准，以便在今年下半年啟動試驗。

To recap our planned milestones as we continue to execute our development programs: we anticipate the opening of a neoadjuvant trial and the ovarian cancer trial by year end; Phase I non-small cell lung cancer data in the second half of this year, which will inform the Phase II portion of the non-small lung cancer trial, which we hope to have opened by year end, or early 2024; FAP on track to submit and receive feedback from FDA and EMA in the second half of this year to obtain global harmonization for a registration protocol; data on our polyamine metabolic inhibitors in combination with CAR-T therapy in preclinical lymphoma and multiple myeloma models; and finally, the interim analysis of the ASPIRE trial in early 2024.

在我們繼續執行我們的開發計劃時，回顧一下我們計劃的里程碑：我們預計在年底前啟動新輔助試驗和卵巢癌試驗；今年下半年將公佈非小細胞肺癌 I 期數據，這將為非小細胞肺癌試驗的 II 期部分提供信息，我們希望該試驗在年底或 2024 年初啟動； FAP 有望在今年下半年提交並接收 FDA 和 EMA 的反饋，以獲得註冊協議的全球協調；我們的多胺代謝抑製劑與 CAR-T 療法聯合治療臨床前淋巴瘤和多發性骨髓瘤模型的數據；最後是 2024 年初 ASPIRE 試驗的中期分析。

In summary, we have made tremendous progress in Q2 and year to date. We are excited to build stockholder value as we move forward for the remainder of this year.

總而言之，我們在第二季度和今年迄今取得了巨大進展。我們很高興在今年剩下的時間里為股東創造價值。

I will now turn it over to Sue.

我現在把它交給蘇。

Thank you, Jennifer. General and administrative expenses were $1.6 million in the second quarter of 2023, compared to $1.3 million in the second quarter of 2022. This increase is primarily related to increased professional services and annual meeting costs.

謝謝你，詹妮弗。 2023 年第二季度的一般和管理費用為 160 萬美元，而 2022 年第二季度為 130 萬美元。這一增長主要與專業服務和年會費用的增加有關。

Research and development expenses were $4.2 million in the second quarter of 2023, compared to $20 million in the second quarter of 2022. The decrease is due primarily to a $17.7 million write-off of in-process research development, or IP R&D, in the second quarter of 2022 related to the CPP acquisition. Excluding this one-time write-off of IP R&D, R&D costs increased by $1.9 million due to the expected increase in spending on the ASPIRE clinical trial.

2023 年第二季度的研發費用為 420 萬美元，而 2022 年第二季度為 2000 萬美元。這一下降主要是由於在2022 年第二季度與 CPP 收購相關。排除這一一次性沖銷的知識產權研發費用，由於 ASPIRE 臨床試驗支出的預期增加，研發成本增加了 190 萬美元。

On June 1, 2023, we effected a reverse stock split at a ratio of 1-for-30 shares of the company's common stock. All share and per share amounts of our common stock presented here and in our report 10-Q have been retroactively adjusted to reflect the reverse split.

2023 年 6 月 1 日，我們以公司普通股 30 股換 1 股的比例進行了反向股票分割。此處和 10-Q 報告中列出的我們普通股的所有股數和每股金額均已進行追溯調整，以反映反向分割。

Net loss in the second quarter of 2023 was $5.8 million, or $7.95 per diluted share, compared to a net loss of $22.1 million, or $1,843.68 per diluted share, in the second quarter of 2022.

2023 年第二季度的淨虧損為 580 萬美元，即稀釋後每股 7.95 美元，而 2022 年第二季度的淨虧損為 2210 萬美元，即稀釋後每股 1,843.68 美元。

Total cash was approximately $7.2 million as of June 30, 2023. Total current assets were $10.8 million, and current liabilities were $10.6 million as of the end of the quarter.

截至 2023 年 6 月 30 日，現金總額約為 720 萬美元。截至本季度末，流動資產總額為 1,080 萬美元，流動負債為 1,060 萬美元。

On June 30, 2023, total non-current assets consisting primarily of cash deposits held by our contract research organization was $8.7 million. During the quarter, we also completed a public offering for gross proceeds of approximately $8.5 million.

截至 2023 年 6 月 30 日，我們的合同研究機構持有的非流動資產總額為 870 萬美元，主要包括現金存款。本季度，我們還完成了公開發行，總收益約為 850 萬美元。

As a result of the CPP acquisition in Q2 of 2022, we added debt and accrued interest to our balance sheet. During the quarter ended June 30, 2023, no debt or interest payments were made. The principal balance remaining on the note is $5.2 million, and there is $100,000 of accrued and unpaid interest on the balance sheet.

由於 2022 年第二季度收購 CPP，我們在資產負債表中增加了債務和應計利息。截至 2023 年 6 月 30 日的季度，未支付任何債務或利息。票據上剩餘的本金餘額為 520 萬美元，資產負債表上還有 10 萬美元的應計未付利息。

Looking to the cap table, as of June 30, 2023, we had approximately 2.6 million common shares outstanding. And including shares reserved for options and warrants, we were at a total of approximately 7.5 million shares. The shares reserved number includes all outstanding equity awards, including stock options, which were held primarily by insiders, and all warrants to purchase common stock.

從股權結構表來看，截至 2023 年 6 月 30 日，我們已發行約 260 萬股普通股。包括為期權和認股權證保留的股份在內，我們總共擁有約 750 萬股。預留股份數量包括所有已發行的股權獎勵，包括主要由內部人士持有的股票期權，以及購買普通股的所有認股權證。

Due to the exercise of pre-funded warrants and the alternative cashless exchange of warrants subsequent to June 30, common shares outstanding today total approximately 3 million shares.

由於預先融資認股權證的行使以及 6 月 30 日之後的替代性無現金認股權證交換，今天已發行的普通股總數約為 300 萬股。

Our cash used in operations for the six months ended June 30, 2023 totaled approximately $15.5 million. The quarterly burn rate for Q2 was approximately $5.7 million. Cash used in operations for the six months ended June included approximately $3.1 million in prepayments necessary to secure supply of standard-of-care chemotherapy agents for the ASPIRE trial, as well as payments made to increase the deposits held by our CRO for future clinical trial costs.

截至 2023 年 6 月 30 日的六個月，我們用於運營的現金總額約為 1550 萬美元。第二季度的季度燒錢率約為 570 萬美元。截至 6 月的六個月運營中使用的現金包括約 310 萬美元的預付款，以確保為 ASPIRE 試驗提供標準護理化療藥物，以及為增加 CRO 為未來臨床試驗而持有的押金而支付的款項成本。

We anticipate that the ongoing cash used in operations will be approximately $5.5 million per quarter. However, additional cash may be required to secure standard of care chemotherapy and fund new deposits held by our CRO. And therefore, we are projecting that the current cash on hand will take us through the end of Q3 2023.

我們預計每季度運營中持續使用的現金約為 550 萬美元。然而，可能需要額外的現金來確保化療標準並為我們的 CRO 持有的新存款提供資金。因此，我們預計目前手頭的現金將支撐我們度過 2023 年第三季度末。

We will continue to focus our cash on those items in our plans, which will drive value for our stockholders, such as the ASPIRE clinical trial.

我們將繼續將現金集中在計劃中的這些項目上，這將為我們的股東帶來價值，例如 ASPIRE 臨床試驗。

Operator, can you please open the phone lines now for Q&A and poll for questions?

接線員，您現在可以打開電話線路進行問答和投票嗎？

(Operator Instructions) Jonathan Aschoff, ROTH MKM.

（操作員說明）Jonathan Aschoff，ROTH MKM。

Thank you. Good afternoon, Jennifer and Sue. I was curious, I don't know if you covered this, just been juggling three calls single-handedly. Did you -- what do you think you'll do with Flynpovi with respect to maybe handing it to somebody else, or doing it internally? Maybe you covered that, I'm not sure.

謝謝。下午好，詹妮弗和蘇。我很好奇，我不知道你是否涵蓋了這一點，只是單槍匹馬地處理三個電話。您認為您會對 Flynpovi 做什麼，是把它交給其他人，還是在內部做？也許你已經涵蓋了這一點，我不確定。

No, certainly. First of all, hello Jonathan. How are you? And we certainly understand juggling calls.

不，當然。首先，你好喬納森。你好嗎？我們當然理解雜耍調用。

For Flynpovi, for us, as we have maintained, we will advance the program without changing our cash burn. So probably, the first and most important step since we have the expertise in-house is to work with the FDA and EMA to have agreement on a global registration protocol.

對於 Flynpovi 來說，對於我們來說，正如我們所堅持的那樣，我們將在不改變現金消耗的情況下推進該計劃。因此，既然我們擁有內部專業知識，第一步也是最重要的一步可能就是與 FDA 和 EMA 合作，就全球註冊協議達成一致。

And again, if you remember, Flynpovi had been in a Phase III registration program prior where it showed in an A priority analysis, or post-hoc analysis -- actually, correction, it was post-hoc analysis. It showed a significant benefit to the patients in the lower GI space. So we are taking this information back to the FDA and EMA to get the agreement on a global protocol. And we feel at that point, it will be in a really good place to secure a partner or path forward in terms of funding that won't impact our cash burn.

再說一遍，如果你還記得的話，Flynpovi 此前曾參與過 III 期註冊計劃，該計劃顯示在 A 優先分析或事後分析中 - 實際上，更正，這是事後分析。它對較低胃腸道空間的患者顯示出顯著的益處。因此，我們將這些信息返回給 FDA 和 EMA，以就全球協議達成一致。我們認為，到那時，它將處於一個非常好的位置，可以在不會影響我們現金消耗的資金方面找到合作夥伴或前進的道路。

But we're very excited to be moving this program forward. And as I said, we do have the expertise in-house, so I think this is something we're pretty excited about.

但我們非常高興能夠推動這個計劃。正如我所說，我們確實擁有內部專業知識，所以我認為這是我們非常興奮的事情。

Okay. And did you give something in your prepared remarks about the timing of a few items? My next question is the timing for a public dissemination of both the STK11 data and the JDRF-funded trial. I guess that one's [covered on your hands].

好的。您在準備好的發言中是否對一些項目的時間安排做出了說明？我的下一個問題是公開傳播 STK11 數據和 JDRF 資助的試驗的時間。我猜那個是[覆蓋在你的手上]。

Yeah. Certainly, certainly. So the STK11 trial, we started the [ZETA] signed, and so, we are working with Moffitt in terms of enrollment for the Phase I portion, which will occur first. We -- at this point, we are still anticipating data in the Phase I portion by year end, which obviously, would inform the Phase II portion starting either year end or early 2024. So that will be something we will certainly work with them in terms of a way to highlight the data, assuming we move into that Phase II portion.

是的。當然，當然。因此，STK11 試驗，我們開始簽署 [ZETA]，因此，我們正在與 Moffitt 合作進行第一階段部分的註冊，這將首先進行。目前，我們仍然預計到年底第一階段部分的數據，這顯然將為年底或 2024 年初開始的第二階段部分提供信息。因此，這將是我們肯定會與他們合作的事情。假設我們進入第二階段部分，這是一種突出顯示數據的方式。

For JDRF, that Phase II trial that - or the Indiana University and JDRF-funded Phase II trial has just started. But I do think it's going to be some time before we have data from that Phase II trial.

對於 JDRF 來說，第二階段試驗——或者印第安納大學和 JDRF 資助的第二階段試驗剛剛開始。但我確實認為我們還需要一段時間才能獲得第二階段試驗的數據。

Okay. And I believe I heard Sue correctly. You said cash through three quarter -- through this quarter or comfortably into the fourth --?

好的。我相信我沒聽錯蘇。你說的是現金通過三個季度 - 通過本季度或舒適地進入第四個 - ？

Through this -- the end of this quarter.

到本季度末為止。

Okay. Thank you very much. Thank you.

好的。非常感謝。謝謝。

Certainly, thank you.

當然可以，謝謝。

(Operator Instructions) Joe Pantginis, H.C. Wainwright.

（操作員說明）Joe Pantginis, H.C.溫賴特。

Hi. This is Josh on for Joe. Thank you for the update. I was just wondering in terms of the ASPIRE trial, so now that you have all the sites opened, what could we expect in terms of enrollment? When that may be completed, and potentially the number of patients that are expected?

你好。這是喬什代替喬。謝謝你的更新。我只是想知道 ASPIRE 試驗的情況，現在所有站點都已開放，我們在註冊方面可以期待什麼？什麼時候可以完成，預計患者數量是多少？

Certainly. Hi, Josh, How are you?

當然。嗨，喬什，你好嗎？

I'm good. How are you?

我很好。你好嗎？

This is Jennifer. Good, thank you. So we anticipate a total enrollment of approximately 600 patients. And we believe that the enrollment will take in total roughly 36 months.

這是詹妮弗。好的謝謝你。因此，我們預計總共招募約 600 名患者。我們認為註冊總共需要大約36個月的時間。

So we - the enrollment, I will say, has been quite robust. So we've been very pleased. And this puts us on track for the interim analysis as early as the early portion of 2024. And so, I think that that's really the first and most important milestone really from an efficacy standpoint. And obviously, we are very pleased to pass the first DSMB pre-specified analysis as well.

所以我想說，我們的入學人數非常強勁。所以我們非常高興。這使我們有望最早在 2024 年初進行中期分析。因此，我認為從功效的角度來看，這確實是第一個也是最重要的里程碑。顯然，我們也很高興通過第一個 DSMB 預先指定的分析。

Perfect. Thank you so much.

完美的。太感謝了。

No, thank you very much.

不，非常感謝。

Thank you. And there were no other questions in the Q&A queue at this time. That does conclude today's call. Ladies and gentlemen, thank you for your participation. You may disconnect your lines at this time.

謝謝。而此時問答隊列中也沒有其他問題了。今天的電話會議到此結束。女士們、先生們，感謝您的參與。此時您可以斷開線路。