Panbela Therapeutics Inc (PBLA) 2023 Q3 法說會逐字稿

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

您好，歡迎參加 Panbela Therapeutics 2023 年第三季財報電話會議。 （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，接線生。與我一起參加電話會議的有執行長 Jennifer Simpson 和財務長 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. 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.

在我將電話轉交給辛普森博士之前，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、重大風險和不確定性，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- 前瞻性陳述在公司 10-K 表格年度報告中詳細說明，並由隨後提交的 10-Q 表格季度報告以及公司向 SEC 提交的其他報告進行補充。本次電話會議中所做的任何前瞻性陳述僅截至今天為止，本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 執行長 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。

So let's start with our Phase 3 initiative, specifically the ASPIRE global clinical trial. ASPIRE is a global, randomized, double-blind, placebo-controlled study designed to assess ivospemin, or SBP-101, in conjunction with gemcitabine and nab-paclitaxel for patients with untreated metastatic pancreatic ductal adenocarcinoma.

那麼，讓我們從我們的第三階段計劃開始，特別是 ASPIRE 全球臨床試驗。 ASPIRE 是一項全球、隨機、雙盲、安慰劑對照研究，旨在評估 ivospemin 或 SBP-101 與吉西他濱和白蛋白結合型紫杉醇聯合治療未經治療的轉移性胰腺導管腺癌患者的情況。

During Q3, we initiated enrollment in both the UK and Germany, successfully activating all intended countries for the ASPIRE trial, which are now actively enrolling patients. Additionally, in July, the Independent Data Safety Monitoring Board, or DSMB, completed its scheduled safety review for treated patients in the trial and recommended the study's continuation without any changes. This achievement, alongside the full activation of all countries and DSMB's green light, provides substantial encouragement as we propel the trial forward. We anticipate interim data around mid-year 2024.

第三季度，我們在英國和德國啟動了入組，成功啟動了 ASPIRE 試驗的所有目標國家，這些國家目前正在積極招募患者。此外，7 月份，獨立資料安全監測委員會 (DSMB) 完成了對試驗中接受治療的患者的預定安全審查，並建議繼續進行該研究而不做任何改變。這項成就，加上所有國家的全面啟動和 DSMB 的批准，為我們推動試驗的進展提供了巨大的鼓勵。我們預計中期數據將於 2024 年年中左右公佈。

Addressing familial adenomatous polyposis, or FAP, Panbela is dedicated to working with the FDA, EMA, and the FAP community to move this initiative forward, aiming to introduce a novel treatment option for FAP patients. Upon securing consensus on a global registration plan from the FDA and EMA, we intend to progress this endeavor while adhering to our existing cost structure. Simultaneously, we'll assess avenues to optimize the value of this asset.

針對家族性腺瘤性息肉症 (FAP)，Panbela 致力於與 FDA、EMA 和 FAP 社群合作推動這項舉措，旨在為 FAP 患者引入一種新的治療選擇。在 FDA 和 EMA 就全球註冊計畫達成共識後，我們打算在堅持現有成本結構的同時推進這項努力。同時，我們將評估優化該資產價值的途徑。

Shifting focus to the PACES trial. It's our Phase 3, double-blind, placebo-controlled study of Flynpovi. This trial aims to prevent the recurrence of high-risk adenomas and second primary colorectal cancers in patients diagnosed with stage 0 to 3 colorectal cancer. The PACES trial receives funding from the NCI and is being performed in conjunction with the Southwest Oncology Group, also known as SWOG.

將焦點轉移到 PACES 試驗。這是我們對 Flynpovi 進行的第三階段雙盲、安慰劑對照研究。該試驗旨在預防診斷為 0 至 3 期結直腸癌的患者的高風險腺瘤和第二原發結直腸癌的復發。 PACES 試驗由 NCI 資助，並與西南腫瘤學組（也稱為 SWOG）聯合進行。

The study's purpose is to assess the combination of eflornithine and sulindac in reducing the three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for stages 0 through 3 colon or rectal cancer. We've successfully cleared a planned futility analysis and will continue the study.

研究的目的是評估依氟鳥氨酸和舒林酸的組合在降低先前接受0 至3 期結腸癌或直腸癌治療的患者中腺瘤和第二原發性結直腸癌的三年事件率方面的作用。我們已經成功地完成了計劃中的無效分析並將繼續研究。

Transitioning to Phase 2 studies, in July, we disclosed that we would be receiving a total of up to $9.5 million in non-dilutive funding through the divestiture of assets from the Eflornithine Pediatric Neuroblastoma Program to US WorldMeds. We look forward to collaborating with US WorldMeds in the ongoing FDA review of a new drug approval.

在 7 月過渡到第二階段研究時，我們透露，將 Eflornithine 兒科神經母細胞瘤計畫的資產剝離給美國 WorldMeds，我們將獲得總計高達 950 萬美元的非稀釋資金。我們期待與美國 WorldMeds 合作，參與 FDA 正在進行的新藥審批審查。

Panbela has already received an initial upfront payment of $400,000 and stands to receive further payments as US WorldMeds achieves key milestones related to eflornithine's clinical advancement, regulatory approval, and commercial sales. This agreement not only broadens our range of partner-supported programs, but also holds the potential for significant development milestone payouts. We warmly welcome US WorldMeds to our network of partners dedicated to advancing our product candidates.

Panbela 已收到 40 萬美元的初始預付款，隨著美國 WorldMeds 實現與 eflornithine 的臨床進展、監管批准和商業銷售相關的關鍵里程碑，Panbela 還將收到進一步付款。該協議不僅擴大了我們合作夥伴支持的計劃範圍，而且還具有獲得重大發展里程碑支出的潛力。我們熱烈歡迎美國 WorldMeds 加入我們的合作夥伴網絡，致力於推進我們的候選產品。

One final item on this program and partnership, after the quarter ended, the FDA's Oncology Drug Advisory Committee, or ODAC, voted that there was sufficient evidence to conclude eflornithine, or DFMO, reduces the risk of relapse in pediatric patients with high-risk neuroblastoma who are in remission and have completed multi-agent, multimodal therapy. This recommendation is the first ever ODAC approval supported by a clinical trial that relied on an external control arm using patient-level data extracted from another trial.

該計劃和合作夥伴關係的最後一項是，在本季度結束後，FDA 腫瘤藥物諮詢委員會(ODAC) 投票認為，有足夠的證據表明依氟鳥氨酸(DFMO) 可以降低高風險神經母細胞瘤兒科患者的復發風險處於緩解期並已完成多藥物、多模式治療的人。該建議是 ODAC 首次獲得臨床試驗的支持，該臨床試驗依賴外部控制臂，使用從另一項試驗中提取的患者層級數據。

The FDA stated that the high unmet medical need for patients with neuroblastoma, a specific external control data source, and the results of the propensity score matched analysis impacted their willingness to consider an external control design in this circumstance. We view this ruling as additional validation of the potential clinical efficacy and safety of the drug and value that we expect to derive from its continued development.

FDA 表示，神經母細胞瘤患者的高度未滿足的醫療需求、特定的外部控制資料來源以及傾向評分配對分析的結果影響了他們在這種情況下考慮外部控制設計的意願。我們認為這項裁決進一步驗證了該藥物的潛在臨床療效和安全性以及我們期望從其持續開發中獲得的價值。

Staying with Phase 2 trials, in September, we entered into a clinical trial agreement for a Phase 2 trial in castration-resistant metastatic prostate cancer, or CRPC. The goal of the androgen and polymine elimination alternating with Xtandi, or APEX trial will be to evaluate if treatments with a combination of DFMO, or eflornithine, and high-dose testosterone will improve the prostate-specific antigen, or PSA, response rate in patients with metastatic CRPC compared with historical controls.

繼續進行 2 期試驗，9 月份，我們簽訂了一項針對去勢抵抗性轉移性前列腺癌 (CRPC) 的 2 期試驗的臨床試驗協議。雄性激素和多胺消除與 Xtandi 或 APEX 試驗交替進行的目標是評估 DFMO（或依氟鳥氨酸）和高劑量睾酮聯合治療是否會改善患者的前列腺特異性抗原（PSA）反應率轉移性CRPC 與歷史對照相比。

The study is actively enrolling, leveraging preclinical models that demonstrate a potential role for polymines in androgen-resistant prostate cancers. This clinical trial will determine if the addition of eflornithine to the treatment regimen will demonstrate further efficacy in these difficult-to-treat patients. If the trial is successful, it opens the door for combining polymine-targeted therapies, such as eflornithine and ivospemin, with bipolar androgen therapy, or BAT therapy, as a new treatment option for metastatic CRPC.

該研究正在積極招募，利用臨床前模型證明多地雷在雄性激素抗性前列腺癌中的潛在作用。此臨床試驗將確定在治療方案中添加依氟鳥氨酸是否能對這些難以治療的患者顯示出進一步的療效。如果試驗成功，它將為將多胺標靶療法（例如依氟鳥氨酸和 ivospemin）與雙極雄激素療法或 BAT 療法相結合，作為轉移性 CRPC 的新治療選擇打開大門。

There is a huge unmet need for new therapies for castration-resistant metastatic prostate cancer patients. Previous clinical studies demonstrated the efficacy of BAT as a monotherapy and its ability to sensitize to subsequent androgen inhibition. Preclinical studies show that superphysiological levels of androgen can upregulate ornithine decarboxylase, suggesting a role of eflornithine as a combination therapy. The trial will determine if modulating polymines can enhance the efficacy of BAT therapy in these patients.

去勢抵抗性轉移性前列腺癌患者對新療法的巨大需求尚未被滿足。先前的臨床研究證明了 BAT 作為單一療法的功效及其對隨後的雄激素抑制敏感的能力。臨床前研究表明，雄激素的超生理水平可以上調鳥氨酸脫羧酶，表明依氟鳥氨酸作為聯合療法的作用。該試驗將確定調節多地雷是否可以增強 BAT 療法對這些患者的療效。

Continuing with Phase 2 investigations, the Phase 2 trial for CPP-1X or eflornithine overseen by Indiana University School of Medicine and financially supported by the Juvenile Diabetes Research Foundation, or JDRF, continues to enroll patients. JDRF stands as the foremost global entity propelling transformative breakthroughs for type 1 diabetes. We are enthusiastic about backing the newly launched Phase 2 trial for early-stage type 1 diabetes run by Indiana University School of Medicine and funded by JDRF.

繼續進行 2 期研究，由印第安納大學醫學院監督並由青少年糖尿病研究基金會 (JDRF) 資助的 CPP-1X 或依氟鳥氨酸 2 期試驗繼續招募患者。 JDRF 是推動第 1 型糖尿病變革性突破的最重要的全球實體。我們熱衷於支持由印第安納大學醫學院開展並由 JDRF 資助的新啟動的早期 1 型糖尿病 2 期試驗。

The objective is to create innovative and effective treatments for patients facing significant medical challenges. This trial, based upon the recently published Phase 1 trial and preclinical data in the journal Cell Reports Medicine, investigated the mechanism of polymines and polymine inhibition by CPP-1X on beta cell stress that plays a role in the onset of type 1 diabetes.

目標是為面臨重大醫療挑戰的患者創造創新且有效的治療方法。該試驗基於最近發表的1 期試驗和《Cell Reports Medicine》雜誌上的臨床前數據，研究了多胺和CPP-1X 的多胺抑制對β 細胞壓力的作用機制，β 細胞壓力在1 型糖尿病的發病中發揮作用。

Results showed that DFMO or eflornithine treatment may preserve beta cell function reflected by C-peptide levels in patients with type 1 diabetes through the modulation of urinary polymines, in particular, putrescine. According to Simms et al., although therapy of type 1 diabetes has improved, the morbidity, mortality, and cost continue to impact the quality of life for those affected, highlighting the need for safe and effective therapies that address the underlying pathology.

結果表明，DFMO 或依氟鳥氨酸治療可以透過調節尿多胺（特別是腐胺）來保留 1 型糖尿病患者 C 肽水平所反映的 β 細胞功能。 Simms 等人表示，儘管 1 型糖尿病的治療有所改善，但發病率、死亡率和費用繼續影響患者的生活質量，這凸顯了對解決潛在病理學問題的安全有效療法的需求。

In Phase 1 development, we have three programs that we will be starting. We have an ongoing clinical trial partnership with Moffitt Cancer Center, focusing on a Phase 1/2 program tailored for patients with STK11 mutant non-small cell lung cancer. Initially, the Phase 1 trial aims to establish the highest tolerated dose of eflornithine while also assessing its effectiveness.

在第一階段開發中，我們將啟動三個專案。我們與莫菲特癌症中心建立了持續的臨床試驗合作夥伴關係，重點關注為 STK11 突變非小細胞肺癌患者量身定制的 1/2 期計畫。最初，一期試驗的目的是確定依氟鳥氨酸的最高耐受劑量，同時評估其有效性。

Subsequently, we plan to progress into a Phase 2 efficacy trial. We expect to have data from the Phase 1 trial early next year with the intention to commence the Phase 2 trial immediately following completion of the Phase 1 trial. Concurrently, our second Phase 1 program, set to commence later this year or early next year, will center on the assessment of ivospemin in the platinum-resistant ovarian cancer demographic. This effort exemplifies the company's continuous partnership with Johns Hopkins University School of Medicine.

隨後，我們計劃進入二期療效試驗。我們預計明年初將獲得第一階段試驗的數據，並打算在第一階段試驗完成後立即開始第二階段試驗。同時，我們的第二個一期計畫將於今年稍後或明年初開始，重點是對 ivospemin 在鉑類抗藥性卵巢癌人群中的評估。這項努力體現了該公司與約翰霍普金斯大學醫學院的持續合作關係。

Additionally, we have an ongoing collaborative research effort with the University of Texas MD Anderson Cancer Center, focusing on the evaluation of polymine metabolic inhibitor therapies in conjunction with CAR-T cell therapies using preclinical models. This research aims to determine whether treatments involving eflornithine and/or ivospemin can enhance CAR-T-induced cytotoxicity against CD19-positive large B-cell lymphoma cell lines. A metabolite panel predominantly consisting of polymines was identified as a predictor of limited response to anti-CD19 CAR-T cell therapy in cases of relapsed refractory large B-cell lymphoma.

此外，我們與德州大學 MD 安德森癌症中心正在進行合作研究，重點是使用臨床前模型評估多胺代謝抑制劑療法與 CAR-T 細胞療法的結合。本研究旨在確定涉及依氟鳥氨酸和/或 ivospemin 的治療是否可以增強 CAR-T 誘導的針對 CD19 陽性大 B 細胞淋巴瘤細胞系的細胞毒性。主要由多胺組成的代謝物組被確定為復發難治性大 B 細胞淋巴瘤病例中抗 CD19 CAR-T 細胞治療反應有限的預測因子。

Moreover, there is an observed upregulation of the polymine uptake transport system in both large B-cell lymphoma and multiple myeloma. These findings collectively indicate the potential for targeted polymine therapy in conjunction with CAR-T therapies.

此外，在大 B 細胞淋巴瘤和多發性骨髓瘤中都觀察到多胺攝取轉運系統的上調。這些發現共同顯示了標靶多胺療法與 CAR-T 療法相結合的潛力。

Recently, we announced that an abstract about SBP-101, or ivospemin, and CPP-1X, or eflornithine, research in multiple myeloma cell lines has been accepted for an online publication on the American Society of Hematology, or ASH, meeting site and will be printed in the November supplemental issue of the journal Blood.

最近，我們宣布，關於多發性骨髓瘤細胞系中的 SBP-101（或 ivospemin）和 CPP-1X（或 eflornithine）研究的摘要已被美國血液學會（ASH）會議網站的線上出版物接受，並將發表在《Blood》雜誌十一月增刊。

Panbela places significant emphasis on polymine modulation of the immune system. Our initial clinical proof of concept involves polymine therapy combined with a checkpoint inhibitor for STK11 mutant non-sponsored lung cancer patients. We are enthusiastic about extending this research collaboration to assess the potential advantages of polymines in immune modulation for hematologic malignancies.

Panbela 非常重視多胺對免疫系統的調節。我們最初的臨床概念驗證涉及針對 STK11 突變非贊助肺癌患者的多胺療法與檢查點抑制劑相結合。我們熱衷於擴大這項研究合作，以評估多地雷在血液惡性腫瘤免疫調節方面的潛在優勢。

Lastly, we're in the process of collaborating with key opinion leaders to complete the protocol for the neoadjuvant pancreatic investigator initiative. We're also in the final stages of obtaining the required institutional approval to launch this trial by the end of the year.

最後，我們正在與關鍵意見領袖合作，完成新輔助胰臟研究計畫的協議。我們還處於獲得所需機構批准以在今年年底前啟動這項試驗的最後階段。

Briefly turning to IP, we fortified our intellectual property portfolio, announcing the issuance of new patents in China and Australia for claims of a novel process for the production of SBP-101, developed in collaboration with Syngene International Limited. Additionally, we announced the issuance of a new patent in Chile for claims of a novel process for the production of Flynpovi, developed in collaboration with Sanofi.

簡單地轉向智慧財產權，我們強化了我們的智慧財產權組合，宣佈在中國和澳洲頒發新專利，以申請與 Syngene International Limited 合作開發的 SBP-101 生產新製程。此外，我們也宣佈在智利頒發一項新專利，用於與賽諾菲合作開發的 Flynpovi 生產新製程。

In closing, despite a very challenging biotech market, we are committed to advancing our development program for the benefit of patients around the world. To summarize our projected milestones, as we continue to progress with our development initiatives, we foresee the initiation of a neoadjuvant pancreatic cancer trial and an ovarian cancer trial by end of year, early next year. We anticipate the Phase 1 non-small cell lung cancer data early next year, which will guide the Phase 2 segment of a non-small cell lung cancer trial expected to be initiated immediately following the Phase 1 trial.

最後，儘管生物技術市場充滿挑戰，我們仍致力於推動我們的開發計劃，造福世界各地的患者。總結我們預計的里程碑，隨著我們繼續推進我們的開發計劃，我們預計將在年底明年初啟動一項新輔助胰腺癌試驗和一項卵巢癌試驗。我們預計明年初將獲得非小細胞肺癌一期數據，這將指導預計在一期試驗之後立即啟動的非小細胞肺癌試驗的二期部分。

Our focus for the FAP program is to obtain feedback from the FDA and EMA for global harmonization on a registration protocol. Additionally, we anticipate data on our polyamine metabolic inhibitors in combination with CAR-T therapy in preclinical lymphoma and multiple myeloma models. Finally, we look forward to the interim analysis of the ASPIRE trial mid-year 2024.

我們 FAP 計劃的重點是獲得 FDA 和 EMA 的回饋，以實現註冊協議的全球協調。此外，我們預期我們的多胺代謝抑制劑與 CAR-T 療法合併用於臨床前淋巴瘤和多發性骨髓瘤模型的數據。最後，我們期待 2024 年中 ASPIRE 試驗的中期分析。

To sum up, Q3 and year-to-date, we have seen remarkable progress. We are eager to continue creating value for our shareholders as we move ahead in the coming months and into 2024. I will now turn it over to Sue.

總而言之，第三季和今年迄今為止，我們看到了顯著的進步。隨著我們在未來幾個月和 2024 年的前進，我們渴望繼續為股東創造價值。我現在將把它交給 Sue。

Thank you, Jennifer. General and administrative expenses were $1.1 million in the third quarter of 2023, compared to $1.3 million in the third quarter of 2022. Research and development expenses were $6.7 million in the third quarter of 2023, compared to $2.3 million in the third quarter of 2022.

謝謝你，詹妮弗。 2023 年第三季的一般和管理費用為 110 萬美元，而 2022 年第三季為 130 萬美元。2023 年第三季的研發費用為 670 萬美元，而 2022 年第三季為 230 萬美元。

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 splits completed in January and June of 2023. Net loss in the third quarter of 2023 was $7.8 million or $2.69 per diluted share, compared to a net loss of $4.4 million, or $257.36 per diluted share, in the third quarter of 2022.

此處和10-Q 報告中介紹的所有普通股和每股金額均已進行追溯調整，以反映2023 年1 月和6 月完成的反向分割。2023 年第三季的淨虧損為780 萬美元，每股虧損2.69 美元。相較之下，2022 年第三季的淨虧損為 440 萬美元，即稀釋後每股虧損 257.36 美元。

Total cash was approximately $0.9 million as of September 30, 2023. Total current assets were $1.9 million and current liabilities were $8.9 million as of the end of the quarter on September 30. Total non-current assets consisting primarily of cash deposits held by our contract research organization were $8.7 million.

截至2023 年9 月30 日，現金總額約90 萬美元。截至9 月30 日季末，流動資產總額為190 萬美元，流動負債為890 萬美元。非流動資產總額主要包括我們合約持有的現金存款研究組織為870萬美元。

As a result of the CPP acquisition in Q2 of 2022, we added debt and accrued interest to our balance sheet. When the quarter ended September 30, 2023, no debt or interest payments were made. The principal balance remaining on the notes is $5.2 million and there is approximately $172,000 of accrued and unpaid interest on the balance sheet.

由於 2022 年第二季收購 CPP，我們在資產負債表中增加了債務和應計利息。截至 2023 年 9 月 30 日的季度結束時，沒有支付任何債務或利息。票據上剩餘的本金餘額為 520 萬美元，資產負債表上還有大約 172,000 美元的應計未付利息。

Looking to the cap table, as of September 30, 2023, we had approximately 3 million common shares outstanding and including shares reserved for options and warrants, we were at a total of approximately 7.1 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 9 月 30 日，我們擁有約 300 萬股已發行普通股，包括為選擇權和認股權證保留的股票，我們總共擁有約 710 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選擇權以及購買普通股的所有認股權證。

Our cash used in operations for the nine months ended September 30, 2023, totaled approximately $22.2 million. The quarterly burn rate for Q3 was approximately $6.7 million and included approximately $1 million paid to our CRO for incremental deposits. Cash used in operations for the nine months ended September 30 included approximately $3.7 million in payments necessary to secure supply of standard of care chemotherapy agents for the ASPIRE trial as well as $2.1 million in total payments made to increase those deposits held by our CRO for future clinical trial costs.

截至 2023 年 9 月 30 日的九個月，我們用於營運的現金總計約為 2,220 萬美元。第三季的季度燒錢率約為 670 萬美元，其中包括支付給 CRO 的約 100 萬美元增量存款。截至9 月30 日的九個月營運中使用的現金包括約370 萬美元的付款，以確保為ASPIRE 試驗提供標準護理化療藥物，以及為增加我們的CRO 未來持有的押金而支付的總付款210萬美元臨床試驗費用。

On November 2, 2023, the company induced certain warrant holders to exercise their warrants for cash. Gross proceeds received from this exercise totaled approximately $1.9 million. Approximately 2.1 million new shares were issued from this exercise, and the holders received new warrants, and the exercisability of those warrants is pending stockholder approval.

2023年11月2日，該公司誘導某些認股權證持有人行使其認股權證以換取現金。此次活動收到的總收益約為 190 萬美元。此次活動發行了約210萬股新股，持有人收到了新的認股權證，這些認股權證的行使尚待股東批准。

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

接線員，現在可以打開電話線路進行問答和投票嗎？

Certainly. The floor is now open for questions. (Operator Instructions) Jonathan Aschoff, Roth MKM.

當然。現在可以提問。 （操作員說明）Jonathan Aschoff，Roth MKM。

Thank you, guys. I was wondering, Jennifer, can you help us better understand what's required to unlock any of the remaining $9.1 million from the Florentine divestiture to US WorldMeds? Stuff like estimate of timing for even the first milestone, gross estimate.

感謝你們。我想知道，詹妮弗，你能幫助我們更好地了解需要什麼才能從佛羅倫薩向美國 WorldMeds 剝離剩餘的 910 萬美元嗎？諸如對第一個里程碑的時間估計、總估計之類的東西。

Yeah. So it's tied to approvals and commercial sales and some other statistical advancements. What I can tell you is that they had an ODAC meeting on October, and as I mentioned, in the remarks, it was a positive vote. And that then typically signals communication with the FDA in about four to six weeks from that time is when we would anticipate that they will hear from the FDA. So if it is a positive vote for approval, then that would start the clock and we probably are looking at some time to bring in funds not until next year. But at least it will be on the horizon.

是的。因此，它與批准、商業銷售以及其他一些統計方面的進步息息相關。我可以告訴你的是，他們在 10 月召開了 ODAC 會議，正如我在發言中提到的，這是一次積極的投票。然後，這通常意味著從那時起大約四到六週內與 FDA 進行溝通，我們預計他們會收到 FDA 的消息。因此，如果投票贊成通過，那麼就會開始計時，我們可能會考慮在明年之前引入資金。但至少它即將出現。

Okay. Did the 41-patient Phase 1 trial results that you presented at Endocrine Society and then later published, did that impact the enrollment of the JDRF trial at all? Was there any bump up from that?

好的。您在內分泌學會上提交並隨後發表的 41 名患者的 1 期試驗結果是否會影響 JDRF 試驗的招募？這有什麼提升嗎？

I'm not sure if I can say specifically. What I can tell you is that we have a great partner in Indiana University, and it is a multi-site center, and they have been actively enrolling, so I would anticipate that would enroll relatively quickly just because of their commitment to this study.

我不確定是否可以具體說。我可以告訴你的是，我們在印第安納大學有一個很好的合作夥伴，它是一個多站點中心，他們一直在積極報名，所以我預計，由於他們對這項研究的承諾，他們會相對較快地報名。

Okay. That is it. Thank you very much.

好的。這就對了。非常感謝。

Thanks so much, Jonathan.

非常感謝，喬納森。

Joe Pantginis, HP Wainwright.

喬潘吉尼斯，惠普溫賴特。

Hi. Thank you. This is Josh on for Joe. Okay. So I have a question about Flynpovi. I was wondering if we could get any color on the extent of the discussions that you may have been having with potential partners.

你好。謝謝。這是喬許代替喬。好的。我有一個關於 Flynpovi 的問題。我想知道我們是否可以了解您可能與潛在合作夥伴進行的討論的程度。

Yeah. So thanks, Josh. One of the things that we think is really important is first to have that global harmonization for the registration pathway. So we've been in conversation, well, in dialogue with the FDA, working on the EMA. Once we have that, that is probably a more optimal time to have those discussions because then we can have in our hands what is needed to get an approval for that indication. So I would imagine that -- we're hoping to kind of wrap that up either by year end, early next year, and then we'll be very active in seeking someone to help us with that.

是的。所以謝謝，喬許。我們認為真正重要的事情之一是首先實現註冊途徑的全球協調。因此，我們一直在與 FDA 進行對話，並就 EMA 開展工作。一旦我們有了這些，這可能是進行這些討論的更佳時機，因為這樣我們就可以掌握獲得該適應症批准所需的一切。所以我想——我們希望在年底或明年初之前完成這個工作，然後我們將非常積極地尋找有人來幫助我們。

Perfect. All right. Thank you so much.

完美的。好的。太感謝了。

Sure. Thank you.

當然。謝謝。

Thank you. And there are no further questions in queue at this time. This does conclude the Q&A session and today's conference call. We do thank you for your participation. You may disconnect your phone lines at this time and have a wonderful day.

謝謝。目前隊列中沒有其他問題。問答環節和今天的電話會議到此結束。我們非常感謝您的參與。此時您可以斷開電話線並度過美好的一天。