Panbela Therapeutics Inc (PBLA) 2023 Q1 法說會逐字稿

Good day, and welcome to the Panbela Therapeutics first-quarter 2023 earnings call. (Operator Instructions) It is now my pleasure to turn the floor over to your host, Mr. James Carbonara. Sir, the floor is yours.

美好的一天，歡迎參加 Panbela Therapeutics 2023 年第一季度財報電話會議。 （操作員指示）現在我很高興將發言權交給東道主 James Carbonara 先生。先生，地板是你的了。

Thank you, operator. With me on the call are Jennifer Simpson, Chief Executive Officer; and to 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；以及首席財務官 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.

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。

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.

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 表格季度報告以及該公司已向 SEC 提交的其他報告。

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 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。

We continue global enrollment and are focused on the country and site initiations for the ASPIRE trial as we aim to have the full complement of sites on board by the middle of this year. Having all three regions, Asia Pacific, Europe, and North America enrolling, with the recent release that South Korea enrolled its first patient, it's highly encouraging as we continue to advance the trial with the interim analysis expected in early 2024.

我們繼續在全球範圍內進行招募，並專注於 ASPIRE 試驗的國家和站點啟動，因為我們的目標是在今年年中之前擁有完整的站點。亞太地區、歐洲和北美這三個地區均已入組，最近韓國又招募了第一位患者，這非常令人鼓舞，因為我們將繼續推進試驗並預計在 2024 年初進行中期分析。

Additionally, in January, the European Medicines Agency or EMA's Committee for Orphan Medicinal Products issued the adoption of commission-implementing decision relating to the designation of ivospemin as an orphan medicinal product in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma.

此外，一月份，歐洲藥品管理局或 EMA 孤兒藥品委員會發布了一項委員會執行決定，涉及將 ivospemin 指定為孤兒藥品，與吉西他濱和白蛋白結合型紫杉醇聯合治療轉移性胰腺導管腺癌患者。

Medicines that meet the EMA's orphan designation criteria may qualify for financial and regulatory incentives, including a 10-year period of marketing exclusivity in the EU after product approval, product assistance from the EMA at reduced fees during the product development phase, and access to centralized marketing authorization.

符合 EMA 孤兒藥指定標準的藥品可能有資格獲得財務和監管激勵措施，包括產品批准後在歐盟的 10 年營銷獨家權、在產品開發階段以較低費用獲得 EMA 的產品援助以及獲得集中化的支持。營銷授權。

Turning to familial adenomatous polyposis or FAP, in April, we learned that we will gain the North American rights to develop and commercialize Flynpovi, which is the combination of eflornithine and sulindac in patients with FAP as a result of the pending termination of the licensing agreement between Cancer Prevention Pharmaceuticals or CPP and One-Two Therapeutics Assets Limited.

談到家族性腺瘤性息肉病或 FAP，4 月份，我們獲悉，由於許可協議尚未終止，我們將獲得 Flynpovi 的北美開發和商業化權利，Flynpovi 是依氟鳥氨酸和舒林酸的組合藥物，用於治療 FAP 患者Cancer Prevention Pharmaceuticals 或 CPP 與 One-Two Therapeutics Assets Limited 之間的合作。

Panbela is now positioned to take a lead on designing the global trial protocol and presenting it to the Federal Drug Administration or FDA and the EMA for agreement on the registration pathway.

Panbela 現在的定位是帶頭設計全球試驗方案，並將其提交給聯邦藥物管理局或 FDA 和 EMA，以就註冊途徑達成一致。

By leveraging Panbela's extensive experience with FAP and in designing global registration trials, the team can develop a high-quality trial protocol that meets the standards of regulatory agencies and is designed to efficiently and effectively demonstrate the potential safety and efficacy of Flynpovi in the treatment of FAP.

通過利用 Panbela 在 FAP 和設計全球註冊試驗方面的豐富經驗，該團隊可以開發出符合監管機構標準的高質量試驗方案，旨在高效、有效地證明 Flynpovi 在治療法普。

This approach will help achieve global regulatory approval and a successful launch of Flynpovi in the global market. We expect this new registration trial will focus on FAP patients who have intact lower gastrointestinal anatomy and will build upon the positive result results from the FAP-310 trial that were published in the New England Journal of Medicine by Burke et al. in 2020, and Disease of the Colon and Rectum by Balaguer et al. in 2022.

這種方法將有助於獲得全球監管部門的批准以及 Flynpovi 在全球市場的成功上市。我們預計這項新的註冊試驗將重點關注下胃腸道解剖結構完整的 FAP 患者，並將以 Burke 等人在《新英格蘭醫學雜誌》上發表的 FAP-310 試驗的積極結果為基礎。 2020 年，以及 Balaguer 等人的《結腸和直腸疾病》。 2022年。

That study showed 100% risk reduction in the need for surgery in patients with an intact lower gastrointestinal anatomy with Flynpovi versus eflornithine or sulindac alone. We believe the FAP-310 trial data is compelling, and the new registration trial could lead to the approval of Flynpovi.

該研究表明，與單獨使用依氟鳥氨酸或舒林酸相比，使用 Flynpovi 可以將下消化道解剖結構完整的患者的手術風險降低 100%。我們相信 FAP-310 試驗數據令人信服，新的註冊試驗可能會導致 Flynpovi 獲得批准。

Since there are currently no approved drug therapies for the treatment of FAP, this therapeutic option has the potential to impact this urgent unmet global need for patients with FAP. We are confident that the new FAP registration trial will have the potential to provide a non-surgical treatment option in both physicians and their patients with FAP.

由於目前尚無批准的治療 FAP 的藥物療法，因此這種治療選擇有可能影響全球對 FAP 患者的迫切未滿足的需求。我們相信，新的 FAP 註冊試驗將有可能為醫生及其 FAP 患者提供非手術治療選擇。

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 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。

We are excited to regain the worldwide rights to Flynpovi for FAP patients and believe our internal expertise, experience with health authorities, relationship with FAP experts throughout the US and Europe, and our commitment to FAP patients and their families in combination with the positive results from the prior FAP-310 trial, this gives a solid foundation for designing and executing a successful registration trial that has the potential to impact patients with FAP globally.

我們很高興為 FAP 患者重新獲得 Flynpovi 的全球權利，並相信我們的內部專業知識、與衛生當局的經驗、與美國和歐洲各地 FAP 專家的關係、我們對 FAP 患者及其家人的承諾以及積極的成果與先前的 FAP-310 試驗相比，這為設計和執行成功的註冊試驗奠定了堅實的基礎，該試驗有可能影響全球 FAP 患者。

We plan to advance this program while maintaining our current cash burn and will evaluate opportunities to maximize the value of this asset.

我們計劃在維持當前現金消耗的同時推進該計劃，並將評估最大化該資產價值的機會。

Finally, we move to the 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. This trial, known as the PACES trial, is funded by the National Cancer Institute or NCI in collaboration with the Southwest Oncology Group, also known as SWOG, and we look forward to a futility analysis in the first half of 2023.

最後，我們進入 Flynpovi 的 III 期雙盲安慰劑對照試驗，以預防 0 至 3 期結直腸癌患者的高危腺瘤和第二原發性結直腸癌復發。這項試驗被稱為 PACES 試驗，由美國國家癌症研究所 (NCI) 與西南腫瘤學小組 (SWOG) 合作資助，我們期待在 2023 年上半年進行無效分析。

Moving to Phase II studies, first, there is an ongoing trial in relapsed/refractory neuroblastoma utilizing eflornithine sachets. This trial is funded through the Children's Oncology Group or COG and the NCI. We also enrolled our first patient in a Phase II double-blind randomized study to evaluate CPP-1X-T or eflornithine tablets for recent-onset type 1 diabetes.

進入 II 期研究，首先，正在進行一項利用依氟鳥氨酸小袋治療復發/難治性神經母細胞瘤的試驗。該試驗由兒童腫瘤學小組 (COG) 和 NCI 資助。我們還招募了第一位患者參加一項 II 期雙盲隨機研究，以評估 CPP-1X-T 或依氟鳥氨酸片劑治療新發 1 型糖尿病的效果。

We are excited to have the first patient enrolled in the Phase II trial for CPP-1X-T 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.

我們很高興第一位患者參加由印第安納大學醫學院領導、青少年糖尿病研究基金會 (JDRF) 資助的 CPP-1X-T II 期試驗，JDRF 是推動 1 型糖尿病改變生活的全球領先組織糖尿病。

There are some 1.45 million Americans living with type 1 diabetes in the US, and there is approximately $16 billion in type 1 diabetes associated healthcare expenditures and lost income annually. We are excited for the opportunity to test and validate our therapy in type 1 diabetes and the potential of this Phase II trial to provide better treatment options for this patient population.

美國約有 145 萬美國人患有 1 型糖尿病，每年與 1 型糖尿病相關的醫療支出和收入損失約為 160 億美元。我們很高興有機會測試和驗證我們的 1 型糖尿病療法，以及這項 II 期試驗為該患者群體提供更好治療選擇的潛力。

Additionally, we recently announced that abstracts about CPP-1X research, also known as DFMO or eflornithine, have been accepted for poster presentations at the Immunology of Diabetes Society or IDS meeting, which will be held May 23 through 27, 2023; and at the Endocrine Society Meeting, which will be held June 15 through 18, 2023.

此外，我們最近宣布，有關 CPP-1X 研究（也稱為 DFMO 或 eflornithine）的摘要已被接受在糖尿病免疫學協會或 IDS 會議上進行海報展示，該會議將於 2023 年 5 月 23 日至 27 日舉行；以及將於 2023 年 6 月 15 日至 18 日舉行的內分泌學會會議。

In Phase I development, we have three programs that will be starting. First, eflornithine sachets will be evaluated in combination with KEYTRUDA in the STK11 mutation population of non-small cell lung cancer. 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.

在第一階段的開發中，我們將啟動三個項目。首先，將在非小細胞肺癌 STK11 突變人群中評估依氟鳥氨酸小袋與 KEYTRUDA 的聯合治療。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。

We recently 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 April 14 through 19 of this year. The poster highlights the efficacy of SBP-101 in combination with the standard-of-care chemotherapy agents used to treat platinum-resistant ovarian cancer.

我們最近在今年 4 月 14 日至 19 日舉行的美國臨床研究協會 (AACR) 會議上展示了一張海報，標題為：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。

Treatment with gemcitabine, topotecan, and doxorubicin have been shown to significantly increase the in vitro toxicity of SBP-101 in both cisplatin-sensitive as well as the cisplatin-resistant ovarian cancer cell line. Paclitaxel and docetaxel have been shown to not have any added benefit in vitro to SBP-101 alone.

在順鉑敏感和順鉑耐藥的卵巢癌細胞系中，吉西他濱、拓撲替康和阿黴素治療已顯示顯著增加 SBP-101 的體外毒性。紫杉醇和多西紫杉醇已被證明在體外與單獨使用 SBP-101 相比沒有任何額外的益處。

Utilizing the VDID8+ murine ovarian cancer model, the efficacy of SBP-101 in combination with either gemcitabine, topotecan, or doxorubicin was evaluated.

利用 VDID8+ 小鼠卵巢癌模型，評估了 SBP-101 與吉西他濱、拓撲替康或多柔比星聯合使用的療效。

Gemcitabine and topotecan alone had little effect on the overall survival of the mice, whereas either SBP-101 or doxorubicin treatment alone significantly increased median mouse survival time. The addition of SBP-101 improved the survival of mice treated with any of the three current -- any of the three chemotherapeutics.

單獨使用吉西他濱和托泊替康對小鼠的總體存活率幾乎沒有影響，而單獨使用 SBP-101 或多柔比星治療可顯著延長小鼠的中位存活時間。添加 SBP-101 提高了接受目前三種化療藥物中任意一種治療的小鼠的存活率。

The SBP-101 and doxorubicin combination might have the greatest survival time with a 265% increase in median survival compared to untreated animals. Additionally, combining DFMO or eflornithine with ivospemin in vitro resulted in a cooperative anti-proliferative response. DFMO has been shown to be well tolerated and can influence immune cells to promote a more immune-friendly tumor microenvironment.

與未經治療的動物相比，SBP-101 和阿黴素組合可能具有最長的存活時間，中位存活率增加了 265%。此外，在體外將 DFMO 或依氟鳥氨酸與 ivospemin 組合可產生協同抗增殖反應。 DFMO 已被證明具有良好的耐受性，並且可以影響免疫細胞，促進免疫友好的腫瘤微環境。

Future experiments will evaluate the effect of adding DFMO to ivospemin treatment as well as the influence on immune cells within the tumor microenvironment. The poster concludes that the treatment of mice containing VDID8+ ovarian cancer with SBP-101 in combination with doxorubicin significantly prolonged survival and decreased overall tumor burden.

未來的實驗將評估在 ivospemin 治療中添加 DFMO 的效果以及對腫瘤微環境中免疫細胞的影響。海報得出的結論是，用 SBP-101 聯合阿黴素治療含有 VDID8+ 卵巢癌的小鼠可顯著延長生存期並降低總體腫瘤負荷。

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，特別是對於鉑類耐藥人群，選擇很少。

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，其目標是為未滿足醫療需求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, 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，四月份，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。

Last, we are continuing to work with the key opinion leaders to finalize the neoadjuvant pancreatic cancer investigator-initiated protocol and obtain the necessary institutional approvals to open this trial in the first 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發起的方案，並獲得必要的機構批准，以便在今年上半年啟動這項試驗。

To recap the milestones, as we continue to execute our development programs, we anticipate the opening of the non-small cell lung cancer STK11 Phase I trial; futility analysis from the SWOG colon cancer risk-reduction trial; the opening of a neoadjuvant trial and the ovarian cancer trial; agreement of the FDA and EMA on a registration protocol for FAP; 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 cell lung cancer trial, which we hope to have open by year end; final data from the Phase I program in both first-line metastatic pancreatic cancer as well as early onset type 1 diabetes; and finally, the interim analysis of the ASPIRE trial in early 2024.

回顧一下這些里程碑，隨著我們繼續執行我們的開發計劃，我們預計將啟動非小細胞肺癌 STK11 I 期試驗； SWOG 結腸癌風險降低試驗的無效分析；啟動新輔助試驗和卵巢癌試驗； FDA 和 EMA 關於 FAP 註冊協議的協議；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前開放；一線轉移性胰腺癌和早發 1 型糖尿病 I 期項目的最終數據；最後是 2024 年初 ASPIRE 試驗的中期分析。

In summary, we have made tremendous progress in Q1 and year to date. We are excited to build stockholder value as we move ahead in 2023 and onward by executing against our milestones. I will stop here and turn it over to Sue to review the financials.

總而言之，我們在第一季度和今年迄今取得了巨大進展。我們很高興通過執行里程碑來在 2023 年繼續前進，為股東創造價值。我將在此停下來並將其交給蘇審查財務狀況。

Thank you, Jennifer. General and administrative expenses were $1.4 million in the first quarter of 2023 compared to $1.8 million in the first quarter of 2022. The first quarter of 2022 spend was higher due to the CPP acquisition.

謝謝你，詹妮弗。 2023 年第一季度的一般和管理費用為 140 萬美元，而 2022 年第一季度為 180 萬美元。由於 CPP 收購，2022 年第一季度的支出較高。

Research and development expenses were $3.5 million in the first quarter of 2023 compared to $2.2 million in the first quarter of 2022. The increase is due primarily to the expected ramp up of spending on the ASPIRE clinical trial.

2023 年第一季度的研發費用為 350 萬美元，而 2022 年第一季度的研發費用為 220 萬美元。這一增長主要是由於 ASPIRE 臨床試驗支出的預期增加。

On January 13, 2023, we effected a reverse stock split at a ratio of 1 for 40 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 1 for 40 reverse stock split.

2023年1月13日，我們以1股換40股公司普通股的比例進行了反向股票分割。我們此處和 10-Q 報告中列出的所有普通股的股數和每股金額均已進行追溯調整，以反映 1 比 40 的反向股票分割。

Net loss in the first quarter of 2023 was $5.1 million or $0.65 per diluted share compared to a net loss of $3.7 million or $10.91 per diluted share in the first quarter of 2022.

2023 年第一季度的淨虧損為 510 萬美元，即稀釋後每股 0.65 美元，而 2022 年第一季度的淨虧損為 370 萬美元，即稀釋後每股 10.91 美元。

Total cash was approximately $5.2 million. As of March 31, 2023. Total current assets were $7.8 million, and current liabilities were$ 9.7 million as of the end of the quarter. On March 31, 2023, total non-current assets consisting primarily of cash deposits held by our contract research organization was $8.6 million. During the quarter, we completed a public offering for gross proceeds of approximately $15 million.

現金總額約為 520 萬美元。截至 2023 年 3 月 31 日。截至本季度末，流動資產總額為 780 萬美元，流動負債為 970 萬美元。截至2023年3月31日，我們的合同研究機構持有的非流動資產總額為860萬美元，主要包括現金存款。本季度，我們完成了公開發行，募集資金總額約為 1500 萬美元。

As a result of the CPP. acquisition, we added debt and accrued interest to our balance sheet. During the quarter ended March 31, 2023, a portion of the debt and accrued interest was paid. A scheduled payment of $1 million plus accrued interest of approximately $295,000 was paid in the note with an original balance of $6.2 million. The principal balance now on this note is $5.2 million.

作為 CPP 的結果。收購後，我們在資產負債表中添加了債務和應計利息。截至 2023 年 3 月 31 日的季度，部分債務和應計利息已支付。票據中已支付預定付款 100 萬美元加上應計利息約 295,000 美元，原始餘額為 620 萬美元。目前該票據的本金餘額為 520 萬美元。

Also, during the quarter, the company made a payment of $650,000 in principal and accrued interest of approximately $85,000 on a second note. This note has now been paid in full.

此外，在本季度，該公司在第二張票據上支付了 650,000 美元的本金和約 85,000 美元的應計利息。該票據現已全額支付。

Looking at the cap table, as of March 31, 2023, we had approximately 16.1 million common shares outstanding. And including shares reserved for options and warrants, we were at approximately 20.2 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 3 月 31 日，我們擁有約 1,610 萬股已發行普通股。包括為期權和認股權證保留的股票，我們大約有 2020 萬股。保留的股票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。

Our cash used in operations for the quarter ended March 31, 2023, totaled approximately $9.8 million. Cash used in operations for the quarter included approximately $2 million in prepayments necessary to secure the supply of standard-of-care chemotherapy agents for the ASPIRE trial as well as payments made to obtain current balances with key vendors.

截至 2023 年 3 月 31 日的季度，我們用於運營的現金總額約為 980 萬美元。本季度運營中使用的現金包括約 200 萬美元的預付款，以確保為 ASPIRE 試驗提供標準護理化療藥物，以及為獲得與主要供應商的當前餘額而支付的款項。

As we have discussed, we anticipate that the ongoing cash used in operations will be between $5 million and $5.5 million per quarter and therefore are projecting that the current cash on hand will take us into very early Q3 of 2023. We will continue to focus our cash on those items in our plan, which will drive value for our stockholders such as the ASPIRE trial.

正如我們所討論的，我們預計每季度運營中使用的持續現金將在 500 萬至 550 萬美元之間，因此預計當前手頭現金將帶我們進入 2023 年第三季度初期。我們將繼續專注於我們的業務我們計劃中的這些項目將獲得現金，這將為我們的股東帶來價值，例如 ASPIRE 試驗。

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

接線員，您可以開通問答和投票的電話線路嗎？

Thank you. At this time, we will be conducting a question-and-answer session. (Operator Instructions) Jonathan Aschoff, Roth MKM.

謝謝。此時，我們將進行問答環節。 （操作員說明）Jonathan Aschoff，Roth MKM。

Thank you very much. Hi, guys. Good afternoon. I was wondering, for ASPIRE, are any new countries to be included for that trial, or will you just open additional sites in currently enrolling countries or stick with the sites you have?

非常感謝。嗨，大家好。下午好。我想知道，對於 ASPIRE 來說，該試驗是否會包括任何新的國家/地區，或者您會在當前註冊的國家/地區開設其他網站還是堅持使用現有的網站？

Yes, hi, good afternoon, Jonathan. For the ASPIRE trial, all countries have been approved. We have two European countries that we are working to get the first site active, all with the intent of having that full complement of sites on board by roughly the middle of this year. So we're making great progress.

是的，嗨，下午好，喬納森。對於 ASPIRE 試驗，所有國家都已獲得批准。我們正在兩個歐洲國家努力讓第一個站點活躍起來，所有這些都是為了在今年年中左右擁有完整的站點。所以我們正在取得巨大進展。

Okay, great. On FAP, can you tell us anything about securing partners for FAP?

好的，太好了。關於 FAP，您能告訴我們有關 FAP 合作夥伴的任何信息嗎？

Yes. So as we look at this, one of the things that we thought would be -- put us in the best possible position is to secure the approval from both FDA and EMA on a global registration of protocol. I think that gives us much more sure footing as we look to see how we can best maximize that asset through collaborations, partnerships, et cetera.

是的。因此，當我們考慮這一問題時，我們認為，讓我們處於最佳位置的一件事是確保 FDA 和 EMA 批准全球協議註冊。我認為，當我們尋求如何通過合作、夥伴關係等方式最大程度地最大化該資產時，這讓我們有了更加穩固的立足點。

So that will be the first step, is to seek that advice. And as I mentioned in my comments, we have a great deal of expertise as well as the relationships with the FAP community, both patients and KOLs. So we feel pretty confident that we'll be able to get this protocol together and through the regulatory bodies, hopefully very soon.

因此，第一步就是尋求建議。正如我在評論中提到的，我們擁有豐富的專業知識以及與 FAP 社區（包括患者和 KOL）的關係。因此，我們非常有信心能夠盡快完成該協議並通過監管機構。

Okay. That sounds like a good first step. Thank you. Thank you very much.

好的。這聽起來是一個很好的第一步。謝謝。非常感謝。

Absolutely.

絕對地。

Thank you. (Operator Instructions) Okay. We have no further questions in queue at this time. So this will conclude today's conference. You may disconnect your lines at this time, and we thank you for your participation.

謝謝。 （操作員指示）好的。目前我們沒有其他問題在排隊。今天的會議到此結束。此時您可以斷開線路，我們感謝您的參與。